The INFOJUSTICE Journal

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by Dr. Scott D. Neff MPS MSOM DC DABCO DACFE FACFE CFE FFABS FFAAJTS Doctor of Medicine

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Nothing on this Beat the Press was written by this civilian editor and consumer advocate.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nothing on this Beat the Press was written by this civilian editor and consumer advocate.

 

 

 

 

 

 

 

 

 

Nothing on this Beat the Press was written by this civilian editor and consumer advocate.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nothing on this Beat the Press was written by this civilian editor and consumer advocate.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nothing on this Beat the Press was written by this civilian editor and consumer advocate.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LibertyYou will find in this section the latest medical thoughts expressed by the experts themselves which we feel are of national importance to all folks.  No opinions expressed were written by this civilian editor. Note - FDA is a patriotic institution.
  • FDA announces comprehensive regulatory plan to shift trajectory of tobacco-related disease, death

The U.S. Food and Drug Administration today announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to better protect kids and significantly reduce tobacco-related disease and death. The approach places nicotine, and the issue of addiction, at the center of the agency’s tobacco regulation efforts. The goal is to ensure that the FDA has the proper scientific and regulatory foundation to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act. To make certain that the FDA is striking an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes, the agency is also providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA’s authority to additional tobacco products. The agency will also seek input on critical public health issues such as the role of flavors in tobacco products.

Tobacco use remains the leading cause of preventable disease and death in the United States, causing more than 480,000 deaths every single year. In addition to the devastating human toll caused mainly by cigarette smoking, tobacco also causes substantial financial costs to society, with direct health care and lost productivity costs totaling nearly $300 billion a year. A key piece of the FDA’s approach is demonstrating a greater awareness that nicotine – while highly addictive – is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes.

“The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes –  the only legal consumer product that, when used as intended, will kill half of all long-term users,” said FDA Commissioner Scott Gottlieb, M.D. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts – and we believe it’s vital that we pursue this common ground.”

The FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. The agency intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. Because almost 90 percent of adult smokers started smoking before the age of 18 and nearly 2,500 youth smoke their first cigarette every day in the U.S., lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.

“Because nicotine lives at the core of both the problem and the solution to the question of addiction, addressing the addictive levels of nicotine in combustible cigarettes must be part of the FDA’s strategy for addressing the devastating, addiction crisis that is threatening American families,” said Commissioner Gottlieb. “Our approach to nicotine must be accompanied by a firm foundation of rules and standards for newly-regulated products. To be successful all of these steps must be done in concert and not in isolation.”

The FDA is committed to encouraging innovations that have the potential to make a notable public health difference and inform policies and efforts that will best protect kids and help smokers quit cigarettes. To make this effort successful, the agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. This action will afford the agency time to explore clear and meaningful measures to make tobacco products less toxic, appealing and addictive. For example, the FDA intends to develop product standards to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children’s exposure to liquid nicotine. It also will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.

The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.

Importantly, the anticipated new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly-regulated tobacco products such as cigars and e-cigarettes. This approach also will not apply to provisions of the final rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors. It also will not affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., "light," "low," or "mild," or similar descriptors.

In order to further explore how best to protect public health in the evolving tobacco marketplace, the agency also will seek input from the public on a variety of significant topics, including approaches to regulating kid-appealing flavors in e-cigarettes and cigars. In particular, the FDA intends to issue ANPRMs to: 1) seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery; and 2) solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars, which were included in the FDA’s 2016 rule. Additionally, the agency plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.

“This comprehensive plan and sweeping approach to tobacco and nicotine allows the FDA to apply the powerful tools given by Congress to achieve the most significant public health impact,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “Public input on these complex issues will help ensure the agency has the proper science-based policies in place to meaningfully reduce the harms caused by tobacco use.”

To complement these larger policy considerations, the FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission. Among other things, the FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS. The agency also will continue efforts to assist industry in complying with federal tobacco regulations through online information, meetings, webinars and guidance documents.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

  • FDA approves first treatment for certain types of poor-prognosis acute myeloid leukemia
The U.S. Food and Drug Administration today approved Vyxeos for the treatment of adults with two types of acute myeloid leukemia (AML): newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is a fixed-combination of chemotherapy drugs daunorubicin and cytarabine.

“This is the first approved treatment specifically for patients with certain types of high-risk AML,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Vyxeos combines two commonly used chemotherapies into a single formulation that may help some patients live longer than if they were to receive the two therapies separately.”

AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of white blood cells in the bloodstream. The National Cancer Institute at the National Institutes of Health estimates that approximately 21,380 people will be diagnosed with AML this year; approximately 10,590 patients with AML will die of the disease in 2017. T-AML occurs as a complication of chemotherapy or radiation in approximately 8 to10 percent of all patients treated for cancer within an average of five years after treatment. AML-MRC is characterized by a history of certain blood disorders and other significant mutations within cancer cells. Patients with t-AML or AML-MRC have very low life expectancies.

The safety and efficacy of Vyxeos were studied in 309 patients with newly diagnosed t-AML or AML-MRC who were randomized to receive Vyxeos or separately administered treatments of daunorubicin and cytarabine. The trial measured how long patients lived from the date they started the trial (overall survival). Patients who received Vyxeos lived longer than patients who received separate treatments of daunorubicin and cytarabine (median overall survival 9.56 months vs. 5.95 months).

Common side effects of Vyxeos include bleeding events (hemorrhage), fever with low white blood cell count (febrile neutropenia), rash, swelling of the tissues (edema), nausea, inflammation of the mucous membranes (mucositis), diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, shortness of breath (dyspnea), headache, cough, decreased appetite, abnormal heart rhythm (arrhythmia), lung infection (pneumonia), blood infection (bacteremia), chills, sleep disorders and vomiting.

Patients who have a history of serious hypersensitivity to daunorubicin, cytarabine or any component of the formulation should not use Vyxeos. Patients taking Vyxeos should be monitored for hypersensitivity reactions and decreased cardiac function. Vyxeos has been associated with serious or fatal bleeding events. Daunorubicin has been associated with severe damage (necrosis) where the drug leaks into the skin and subcutaneous tissue from the intravenous infusion (extravasation). Women who are pregnant or breastfeeding should not take Vyxeos, because it may cause harm to a developing fetus or a newborn baby.

The prescribing information for Vyxeos includes a boxed warning not to interchange Vyxeos with other daunorubicin- and/or cytarabine-containing products. 

The FDA granted this application Priority Review and Breakthrough Therapy designations. Vyxeos also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

The FDA granted the approval of Vyxeos to Jazz Pharmaceuticals.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products

  • Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions

U.S. District Judge Robert J. Shelby entered a consent decree of permanent injunction yesterday between the United States and Isomeric Pharmacy Solutions of Salt Lake City, Utah, two of the company’s co-owners, William O. Richardson and Rachael S. Cruz, and chief operating officer Jeffery D. Brown.

The consent decree prohibits Isomeric, its owners and chief operating officer from manufacturing, processing, packing, holding, or distributing drugs until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its regulations, in addition to other requirements.

According to the complaint for permanent injunction, Isomeric manufactured and distributed purportedly sterile drug products, including injectable and ophthalmic drugs that were adulterated because the drugs were made under insanitary conditions and in violation of current good manufacturing practice requirements under the FD&C Act. Drugs prepared, packed, or held under insanitary conditions may have been contaminated with filth or otherwise harmful if given to patients. The complaint also alleges that Isomeric manufactured and distributed unapproved drugs and drugs that were misbranded because their labeling did not bear adequate directions for use.

“Isomeric endangered the public health by manufacturing injectable drugs under poor conditions that compromised their required sterility and put patients at risk,” said FDA Commissioner Scott Gottlieb, M.D. “We will continue taking strong enforcement actions against compounders who violate the Drug Quality and Security Act and put patients at risk by failing to produce sterile drugs in compliance with the law.”

The FDA most recently inspected Isomeric from Feb. 22 to March 24, 2017. Following the FDA inspection, because of a lack of sterility assurance for its purportedly sterile drug products, Isomeric agreed to a voluntary nationwide recall of all lots of unexpired drug products produced for sterile use and distributed to patients, providers, hospitals, or clinics nationwide between Oct. 4, 2016 and Feb. 7, 2017.

Previously, the FDA inspected Isomeric in August 2015 and observed similar poor conditions and practices for sterile drug production. Despite assurances that Isomeric was correcting its violations, a follow-up inspection in June 2016 revealed that the company had not implemented adequate corrective actions. Following this inspection, the FDA issued a warning letter to Isomeric.

Isomeric initially registered as an outsourcing facility in July 2015, re-registered in December 2015 and January 2017. 

The complaint was filed by the U.S. Department of Justice on behalf of the FDA.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

UPDATED 08/07/2015 - Update includes a corrected and complete listing of affected drugs. If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. Originally Posted 07/24/2015

If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Posted 08/07/2015

Increased rate of pump thrombosis, high rate of stroke, bleeding complications. Posted 08/05/2015

Cases of PML in two patients with no prior exposure to immunosuppressant drugs. Posted 08/04/2015

Hospitals and health care facilities can, in addition to meticulously following manufacturer reprocessing instructions, take additional steps to further reduce the risk of infection. Posted 08/04/2015

Missing a dose of Hydrochlorothiazide could result in uncontrolled blood pressure or swelling caused by excess fluid (edema). Posted 07/31/2015

The device could be accessed remotely through a hospital’s network. This could allow an unauthorized user to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies. Posted...

ALZHEIMER'S DIAGNOSTIC GUIDELLINES UPDATED FOR FIRST TIME IN DECADES

For the first time in 27 years, clinical diagnostic criteria for Alzheimer’s disease dementia have been revised, and research guidelines for earlier stages of the disease have been characterized to reflect a deeper understanding of the disorder. The National Institute on Aging/Alzheimer’s Association Diagnostic Guidelines for Alzheimer’s Disease outline some new approaches for clinicians and provide scientists with more advanced guidelines for moving forward with research on diagnosis and treatments.

 
They mark a major change in how experts think about and study Alzheimer’s disease. Development of the new guidelines was led by the National Institutes of Health and the Alzheimer’s Association. The original 1984 criteria were the first to address the disease and described only later stages, when symptoms of dementia are already evident. The updated guidelines cover the full spectrum of the disease as it gradually changes over many years. They describe the earliest preclinical stages of the disease, mild cognitive impairment, and dementia due to Alzheimer’s pathology. Importantly, the guidelines now address the use of imaging and biomarkers in blood and spinal fluid that may help determine whether changes in the brain and those in body fluids are due to Alzheimer’s disease. Biomarkers are increasingly employed in the research setting to detect onset of the disease and to track progression, but cannot yet be used routinely in clinical diagnosis without further testing and validation.
 

CDC TRANSDISCIPLINARY RESEARCH ON FATIGUE AND FATIGABILITY IN AGING

CDC DIABETES FACT SHEET FOR 2011

CDC AMERICA AGEING IN POVERTY

USDA DIETARY GUIDELINES

FDA warns public of continued extortion scam by FDA impersonators

FDA NEWS RELEASE

For Immediate Release: Jan. 7, 2011

Media Inquiries: Christopher Kelly, 301-796-4676 christopher.kelly@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of a continued  international extortion scam.

The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via "telepharmacies" -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.

The criminals always request the money be sent by wire transfer to a designated location, usually in the Dominican Republic. If victims refuse to send money, they are often threatened with a search of their property, arrest, deportation, physical harm and/or incarceration.

"Impersonating an FDA official is a violation of federal law," said Dara Corrigan, the FDA’s associate commissioner for regulatory affairs. “FDA special agents and other law enforcement officials are not authorized to impose or collect criminal fines. Only a court can take such action.”

In most instances, victims of extortion-related calls have also received telephone solicitations for additional pharmaceutical purchases from other possibly related, illegal entities located overseas. The extortionists use customer lists complete with extensive personal information provided through previous purchase transactions. These include names, addresses, telephone numbers, Social Security numbers, dates of birth, purchase histories and credit card account numbers.

 

Typically, these criminals use telephone numbers that change constantly and make it appear as though their calls originate in the United States.

 

No known victim has been approached in person by a law enforcement impersonator associated with this scheme. 

 

The FDA’s Office of Criminal Investigations, with the U.S. Drug Enforcement Administration, and the U.S. Immigrations and Customs Enforcement, Homeland Security Investigations, with the support of various U.S. Attorneys, are pursuing multiple national and international criminal investigations.

 

Arrests have been made and additional prosecutions are pending; however, the scheme is likely to continue. The FDA has issued similar warnings in the past:

§  FDA Warns Public of Extortion Scam by FDA Impersonators1 (11/12/2008)

§  FDA Warns Public of Continued Extortion Scam by FDA Impersonators2 (12/29/2009)

 

Victims of this scheme who have suffered monetary loss through the payment of funds in response to an extortion call from a person purporting to be an FDA or other law enforcement official regarding illegal pharmaceutical transactions may obtain a victim questionnaire by contacting the FDA’s Office of Criminal Investigations3 and clicking “Report Suspected Criminal Activity.”

 

Anyone receiving a purported official document on agency letterhead may verify its authenticity by contacting that organization directly via a publicly available phone number. Additionally, all federal agencies use email addresses with a “gov” email extension.

 

The FDA also reminds consumers that pharmaceutical products offered online and by telephone by sources of unknown origin can pose a substantial health risk. Products recovered during this investigation that were purchased from online or telephone sources have been found to contain trace amounts of heroin, other undisclosed and potentially harmful active pharmaceutical ingredients, or no active ingredient at all. Purchases should only be made from licensed pharmacies located in the United States. In addition to the increased risk of purchasing unsafe and ineffective drugs from Web sites operating outside the law, personal data may be compromised.

 

For more on unlawful drug sales on the Internet, see Protecting Yourself4. 

 

Questions and Answers

 

How did these people obtain my information?

 

They likely obtained the victim’s information based on a previous online or telepharmacy transaction, or from a submitted medical questionnaire. These instances could have occurred years ago, with personal information now on customer lists trafficked by these criminal groups.  These customer lists can contain tens of thousands of names and a substantial amount of self-reported data provided by consumers during previous transactions.  Typically, victims are being contacted by multiple unrelated groups, often for different purposes. (extortion, selling illegal pharmaceuticals, etc.)

 

How do I make the calls stop?

 

The extorters, just like the majority of telephone solicitors for illegal prescription medication, are based overseas and use voice over internet protocol (VOIP) telephone numbers, most commonly “Magic Jack”.  These services provide the extorters with the flexibility to constantly change their phone numbers and select ones with U.S. area codes.  If the victims  change whatever number(s) were used to contact them, and do not engage in any additional risky pharmaceutical transactions, the threatening phone calls and associated telephone solicitations for pharmaceuticals should cease.

 

What proactive steps can victims take?

 

Individuals who purchase medication online or via tele-pharmacies are frequently victims of credit card fraud, since this is how the medication is often purchased.  Victims may want to consider alerting their applicable financial institutions to ensure that identity theft has not occurred.

 

Why is FDA only asking victims who have lost money to contact the agency?

 

The most effective way to track these criminals is to investigate the permanent record established when money transfers take place.

 

Have individuals been arrested?

 

Yes.  However, this scheme will likely not be eradicated and instead will continue to evolve.  For example, the extorters now occasionally reference other countries, such as Costa Rica, instead of the DR, as means to avoid all of the publicity regarding this scheme. 

 

Am I going to be able to get my money back?

 

In almost all instances victims will not be able to recoup losses.  Multiple criminal groups employ this scheme, principally from overseas, and large monetary seizures are not anticipated.

 

Am I in danger?

 

In terms of physical danger, no victim has ever been approached in person, and the vast majority of these callers, regardless of their intent, are based overseas.  Their use of “police-type scanners”, law enforcement language and fictitious documents are attempts at a false sense of legitimacy. Extorters also occasionally reference cars parked on a victim’s street -- information that can be obtained online at various Web sites, as a way to frighten individuals into believing the extorters are near their residence.  If an individual feels threatened for his or her personal safety, immediately contact the appropriate local enforcement agency.

 

Is it possible that these callers are part of some “secret” investigative group, and FDA is just not aware of it?

 

No.  Law enforcement officials from both the U.S. and the Dominican Republic are pursuing these criminals.   More information regarding this scheme is available on FDA and DEA Web sites, or through online searches.  Extradition proceedings  between countries require close cooperation and often a formal treaty, and this often takes an extended period of time to complete

CDC Releases 2011 National Diabetes Fact Sheet

According to the Centers for Disease Control and Prevention’s (CDC) new estimates, the number of Americans with diabetes has risen to 25.8 million. About 27 percent of those with diabetes – 7 million Americans – do not know they have the disease. 1 in 3 U.S. adults is at high risk of developing type 2 diabetes. Further, an estimated 79 million U.S. adults have prediabetes, a condition in which blood sugar levels are higher than normal, but not high enough to be considered diabetes. Prediabetes raises a person’s risk of type 2 diabetes, heart disease and stroke, and affects 35 percent of adults aged 20 years and older.

Get the facts about diabetes in the 2011 National Diabetes Fact Sheet, available at http://www.cdc.gov/diabetes/pubs/factsheet11.htm

New Dietary Guidelines Have Been Released by the U.S. Department of Health and Human Services and the U.S. Department of Agriculture

 
On January 31, 2011, the Secretary of Agriculture, Tom Vilsack and the Secretary of the Department of Health and Human Services, Kathleen Sebelius announced the release of the 2010 Dietary Guidelines for Americans, the federal government’s evidence-based guidance to promote health, reduce the risk of chronic diseases, and reduce the prevalence of overweight and obesity through improved nutrition and physical activity. The new 2010 Dietary Guidelines for Americans focus on balancing calories with physical activity, and encourage Americans to consume more healthy foods like vegetables, fruits, whole grains, fat-free and low-fat dairy products and seafood and to consume less sodium, saturated and trans fats, added sugars, and refined grains.
 
“Helping Americans incorporate these guidelines into their everyday lives is important to improving the overall health of the American people,” said HHS Secretary Sebelius. “The new Dietary Guidelines provide concrete action steps to help people live healthier, more physically active and longer lives.”
 
USDA and HHS have conducted this latest review of the scientific literature, and have developed and issued the 7th edition of the Dietary Guidelines for Americans in a joint effort that is mandated by Congress. The Guidelines form the basis of federal nutrition policy, as well as Federal nutrition assistance programs such as congregate and home delivered meals of the Older Americans Act Nutrition Program and nutrition advice provided by health care professionals. 
 
The 2010 Dietary Guidelines document is available at http://www.cnpp.usda.gov/DGAs2010-PolicyDocument.htm. Available materials include: a press release, the 2010 Dietary Guidelines, an Executive Summary, Selected Messages for Consumers, a Backgrounder, and Questions and Answers. For more information about this publication, please visit www.dietaryguidelines.gov.  
 

FDA: U.S. Marshals seize food products at Tennessee company
FDA acts to prevent distribution of food from rodent-infested facility

U.S. Marshals today seized about $200,000 worth of food products from Bedford Cheese Store Inc. in Shelbyville, Tenn., after U.S. Food and Drug Administration investigators found evidence of rodents throughout the company’s facility.

An FDA inspection found rodent feces, rodent hair, rodent nesting material, and building defects that could allow rodents and other pests to enter food storage areas and other areas that apparently contributed to the infestation.

Products seized at Bedford Cheese included cheese, frozen foods, pastas, salad dressings, prepared salads, soups, and various bulk ingredients. The products are adulterated under the Federal Food, Drug and Cosmetic Act because they have been held under unsanitary conditions and may have become contaminated with filth.

“The violations at Bedford Cheese are widespread and significant,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “This enforcement action was taken because the company failed to provide adequate safeguards to ensure that products they produce or hold for sale remain free of contamination.”

In a written response to the FDA following the inspection, Bedford Cheese committed to cleaning up its facility. However, the company failed to complete all corrective actions, including the development and implementation of a pest control plan to rid the facility of the active rodent infestation.

FDA: Advanced genomic test helps trace sources of foodborne illness outbreak
Next-generation sequencing provides important clues to traceback investigation

FDA scientists successfully used a new genome sequencing test to retrospectively examine a 2009-10 foodborne illness outbreak to help trace the source of the infection.

A Salmonella Montevideo outbreak that began early in 2010 was linked to spice rubs on certain salamis and sickened nearly 300 people in 44 states and the District of Columbia.

Field investigators collected samples of the suspect product to find the source of the contamination. However, conventional laboratory testing methods could not distinguish between the outbreak involving spiced meat and certain previous Salmonella contamination events.

FDA analysts then turned to next-generation sequencing (NGS) to test 35 samples suspected of being contaminated with the Salmonella strain. The samples came from suppliers, consumers who became ill and a variety of food sources from a broad range of places and times.

Test results showed a recent common origin of the outbreak strain – a single food facility. The results also indicated a single source: a spiced meat rub.

The findings supported the information gathered in the field phase of the investigation and suggest an important role for this novel tool in augmenting future outbreak investigations.

or more information:

Identification of a Salmonellosis Outbreak by Means of Molecular Sequencing
New England Journal of Medicine, http://www.nejm.org/doi/full/10.1056/NEJMc11004431

Salmonella Montevideo Outbreak: FDA News Release
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm204917.htm2 

Salmonella Montevideo Outbreak: CDC Investigation Update
http://www.cdc.gov/salmonella/montevideo/index.html3
 

FDA approves product to prevent bleeding in people with rare genetic defect

Corifact is 1st treatment for congenital Factor XIII Deficiency

The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

Patients with congenital Factor XIII deficiency don’t make enough Factor XIII, a substance that circulates in the blood and is important for normal clotting. Without treatment, people with the condition are at risk for life-threatening bleeding.

Congenital Factor XIII deficiency is rare and affects 1 out of every 3 million to 5 million people in the United States. The deficiency may lead to soft tissue bruising, mucosal bleeding and fatal intracranial bleeding. Newborns with Factor XIII deficiency may have umbilical cord bleeding.

“This product helps fill an important need,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.

Corifact received orphan-drug designation by the FDA because it is intended for use in a rare disease or condition. It was approved for marketing under the FDA's accelerated approval regulations that require an on-going study to demonstrate that patients actually receive the clinical benefit predicted by the data obtained so far.

The FDA approved Corifact based on results of a clinical study of 14 people, including children, with congenital Factor XIII deficiency. The most common side effects observed were hypersensitivity reactions (allergy, rash, pruritus, and erythema), chills, fever, arthralgia, headache, elevated thrombin-antithrombin levels, and an increase in liver (hepatic) enzymes.

Corifact is made from the pooled plasma of healthy donors. People receiving Corifact may develop antibodies against Factor XIII that may make the product ineffective. It potentially can cause adverse events from abnormal clotting if doses higher than the labeled dose are given to patients.

Corifact is manufactured by CSL Behring of Marburg, Germany.

For more information:
CBER Product Approvals1 
 

FDA warns against certain uses of asthma drug terbutaline for preterm labor
Certain uses could lead to maternal heart problems and death

The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.

Terbutaline is FDA-approved to prevent and treat narrowing of the airways (bronchospasm) associated with asthma, bronchitis, and emphysema. The drug is used off-label for obstetric purposes, including treating preterm labor and treating uterine hyperstimulation. Terbutaline has also been used in an attempt to prevent recurrent preterm labor. There is no evidence, however, that use of terbutaline to prevent preterm labor improves infant outcomes. Serious adverse events, including maternal deaths, have been reported with such use in pregnant patients.

“Women should be aware that serious and sometimes fatal side effects have been reported after prolonged use of terbutaline in pregnant women,” said Scott Monroe, M.D., director of FDA’s Division of Reproductive and Urologic Products. “It is important for patients and health care professionals to consider all the potential risks and known benefits of any drug before deciding on its use.”

The FDA is aware that administration of terbutaline by injection to pregnant women is used in hospital settings in certain urgent situations. The FDA warning relates to safety concerns about the prolonged use of terbutaline injection beyond 48-72 hours, and against any use of oral terbutaline in pregnant women for prevention or treatment of preterm labor.

The decision to require a Boxed Warning and Contraindication is based on the FDA’s review of post-market safety reports of heart problems and even death associated with terbutaline use for obstetric indications, as well as data from medical literature documenting the lack of safety and effectiveness of terbutaline for preventing preterm labor, and animal data suggesting potential risks. Based on this information, the FDA concluded that the risk of serious adverse events outweighs any potential benefit to pregnant patients for either prolonged use of terbutaline injection beyond 48-72 hours or use of oral terbutaline for prevention or treatment of preterm labor.

These changes to the drug labeling are consistent with statements from the American College of Obstetricians and Gynecologists discouraging use of terbutaline for preventing preterm labor.

There are multiple generic versions of terbutaline oral tablets and injectable formulations available. The brand name products were previously discontinued by the companies that made them. 

The FDA encourages patients to talk to their health care professional if they have concerns about any treatment they are receiving. Patients and health care professionals should report any side effects from the use of terbutaline to the FDA’s MedWatch adverse event reporting program at www.fda.gov/MedWatch1.

For more information:

U.S. Marshals seize Auralgan Otic Solution
Product is not FDA-approved

U.S. Marshals, at the request of the U.S. Food and Drug Administration yesterday, seized all lots of Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections, from Integrated Commercialization Solutions Inc. (ICS) in Brooks, Ky.  Auralgan is manufactured for Deston Therapeutics, located in Chapel Hill, N.C., and is warehoused at ICS. 

Deston’s sale of the product in the United States violates federal law because the product does not have FDA approval and its labeling does not include adequate directions for use.  The value of the products seized is estimated to be $16.5 million.

“The FDA is committed to taking enforcement action against companies marketing drugs that do not meet federal standards for safety, effectiveness, and quality,” said Deborah M. Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We will remain vigilant in our efforts to protect consumers from unapproved products.”

On Feb. 5, 2010, the FDA issued a Warning Letter to Deston, citing the company for distributing unapproved new drugs and misbranded drugs.  The FDA also warned Deston that Auralgan was an unapproved new drug in April, June, and September 2010, and the company continued distributing the drug in violation of the Federal Food, Drug, and Cosmetic Act.

Today’s action is part of the FDA’s Unapproved Drugs Initiative, established in 2006 to get unapproved drugs either approved or off the market.

For more information:

February 5, 2010 Warning Letter to Deston Therapeutics, LLC1

Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval

 

FDA seeks to invest in foodborne illness prevention, medical product safety and countermeasures
$4.3 billion request reflects a 33 percent increase from FY 2010 enacted budget
 

The U.S. Food and Drug Administration is requesting a budget of $4.3 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2012 budget — a 33 percent increase over the FDA enacted budget for FY 2010. The FY 2012 request covers the period of Oct. 1, 2011, through Sept. 30, 2012. 


“FDA protects and promotes the health of all Americans through every stage of life,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. “The breadth of this mandate means that FDA responsibilities continue to grow. The new budget contains new resources so that FDA can fulfill its growing responsibilities to the American public.”
 

The FDA 2012 budget proposes four critical initiatives and increases:

  • Transforming Food Safety and Nutrition ($324 million) Initiative: With this increase, FDA will begin to implement the landmark Food Safety Modernization Act and also empower Americans to make healthier food choices. FDA will establish a prevention-focused food safety system and leverage the valuable work of FDA’s state and local food safety partners. The result will be a stronger, more reliable food safety system to protect American consumers. FDA will also empower Americans to make more healthful food choices through menu and vending machine labeling.
  • Advancing Medical Countermeasures ($70 million) Initiative: This increase will ensure that FDA can support the development of medical countermeasures (MCMs) to respond to serious national security threats – chemical, biological, radiological and nuclear threats, as well as naturally emerging diseases such as pandemic influenza. With this initiative, FDA will enhance its review of countermeasures and develop and apply new tools and standards to speed the development of MCMs. To improve public health response, FDA will also modernize the legal, regulatory and policy framework that governs development and availability of MCMs.
  • Protecting Patients Initiative ($124 million): With this increase, FDA will develop a pathway for approving biosimilars, which are biological drugs shown to be highly similar to, and without clinically meaningful differences with, an FDA-approved reference biological product. Such biosimilars may also be shown to be interchangeable with the FDA-approved reference biological product. These biosimilars offer the potential of significant savings for government and private sector healthcare systems that provide care to millions of Americans. The Protecting Patients Initiative also strengthens FDA efforts to modernize and improve safety throughout the supply chain of medical products, and it contains other resources to assure the safety of medical products.
  • Regulatory Science and Facilities Initiative ($49 Million): This request will allow FDA to strengthen its core regulatory scientific capacity that support all elements of the FDA mission. This initiative will help harness advances in science and technology to modernize and streamline the regulatory pathway and improve the review and approval process for products relying on new and emerging technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease.

For more information:
The President’s FY 2012 budget for the FDA

http://www.hhs.gov/budget/

Food Safety Modernization Act: Putting the Focus on Prevention http://www.foodsafety.gov/news/fsma.html1 

FDA finalizes regulation for certain software, hardware used with medical devices
Rule provides more predictable path to market

Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

“This rule is a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems,” said Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health. “This shows our flexibility in applying regulations for medical device data systems that are not overly burdensome for manufacturers but continue to assure that data stored, transferred or displayed on these systems remain reliable.”

Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification.

Examples of MDDS products include: devices that collect and store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed at a nursing station for future use.

Prior to this rule, first proposed in 2008, FDA considered these devices to be either Class III (or high-risk) devices requiring premarket approval or accessories to an existing medical device.

By down-classifying these devices into Class I, the FDA is exempting all manufacturers of MDDS from premarket notification and applying the level of regulation reserved for low risk devices. Moreover, these manufacturers must comply with all Class I requirements including registering with the FDA, listing their MDDS products, reporting adverse events and complying with FDA’s Quality Systems regulation, a  basic system of manufacturing and design controls that, among other things, will ensure manufacturers test their products before marketing them.

The rule also levels the playing field for medical device manufacturers. Information technology companies that design, install or market these systems, and hospitals that develop them in their facilities, must follow Class I requirements as well.

The Medical Device Data Systems rule will be published in the Federal Register tomorrow and is available for advanced viewing today.

For more information
Medical Device Data Systems1

 
  • EFFECTIVENESS OF VARIOUS INTERVENTIONS FOR ACUTE OTITIS EXTERNA

    Authors  Kaushik Vivek, Malik Tass, Saeed Shakeel R

    Review Group  Cochrane Ear, Nose and Throat Disorders Group

    Abstract  Acute otitis externa is an inflammatory condition of the ear canal, with or without infection. Symptoms include ear discomfort, itchiness, discharge and impaired hearing. It is also known as 'swimmer's ear' and can usually be treated successfully with a course of ear drops.

    Objectives:

    To assess the effectiveness of interventions for acute otitis externa.

    Search strategy:

    Our search for published and unpublished trials included the Cochrane Ear, Nose and Throat Disorders Group Trials Register; CENTRAL; PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; mRCT and additional sources. The date of the most recent search was 6 January 2009.

    Selection criteria:

    Randomised controlled trials evaluating ear cleaning, topical medication or systemic therapy in the treatment of acute otitis externa were eligible.We excluded complicated acute otitis externa; otitis externa secondary to otitis media or chronic suppurative otitis media; chronic otitis externa; fungal otitis externa (otomycosis); eczematous otitis externa; viral otitis externa and furunculosis.

    Data collection and analysis:

    Two authors assessed eligibility and quality.

    Main results:

    Nineteen randomised controlled trials with a total of 3382 participants were included. Three meta-analyses were possible. The overall quality of studies was low.  Topical antimicrobials containing steroids were significantly more effective than placebo drops: OR 11 (95% CI 2.00 to 60.57; one trial).  In general, no clinically meaningful differences were noted in clinical cure rates between the various topical interventions reviewed. One notable exception involved a trial of high quality which showed that acetic acid was significantly less effective when compared with antibiotic/steroid drops in terms of cure rate at two and three weeks (OR 0.29 (95% CI 0.13 to 0.62) and OR 0.25 (95% CI 0.11 to 0.58) respectively).   One trial of low quality comparing quinolone with non-quinolone antibiotics did not find any difference in clinical cure rate.  No trials evaluated the effectiveness of ear cleaning.  Only two trials evaluated steroid-only drops. One trial of low quality suggested no significant difference between steroid and antibiotic/steroid but did not report the magnitude or precision of the result. Another trial of moderate quality comparing an oral antihistamine with topical steroid against topical steroid alone found that cure rates in both groups were high and comparable (100% (15/15) and 94% (14/15) respectively at three weeks).

    Authors' conclusions:

    There is a paucity of high quality trials evaluating interventions for acute otitis externa. The results of this systematic review are largely based on odds ratios calculated from single trials, most of which have very broad 95% confidence intervals because of small to modest sample sizes. The findings may not be wholly generalisable to primary care for a variety of reasons; only two of the 19 trials included in the review were conducted in a primary care population setting, and in 11 of the 19 trials ear cleaning formed part of the treatment (an intervention unlikely to be available in primary care). Despite these reservations, some meaningful conclusions can be drawn from the evidence available:  Topical treatments alone, as distinct from systemic ones, are effective for uncomplicated acute otitis externa. In most cases the choice of topical intervention does not appear to influence the therapeutic outcome significantly. Any observed differences in efficacy were usually minor and not consistently present at each follow-up visit. Acetic acid was effective and comparable to antibiotic/steroid at week 1. However, when treatment needed to be extended beyond this point it was less effective. In addition, patient symptoms lasted two days longer in the acetic acid group compared to antibiotic/steroid.  The evidence for steroid-only drops is very limited and as yet not robust enough to allow us to reach a conclusion or provide recommendations. Further investigation is needed.  Given that most topical treatments are equally effective, it would appear that in most cases the preferred choice of topical treatment may be determined by other factors, such as risk of ototoxicity, risk of contact sensitivity, risk of developing resistance, availability, cost and dosing schedule. Factors such as speed of healing and pain relief are yet to be determined for many topical treatments and may also influence this decision.  Patients prescribed antibiotic/steroid drops can expect their symptoms to last for approximately six days after treatment has begun. Although patients are usually treated with topical medication for seven to 10 days it is apparent that this will undertreat some patients and overtreat others. It may be more useful when prescribing ear drops to instruct patients to use them for at least a week. If they have symptoms beyond the first week they should continue the drops until their symptoms resolve (and possibly for a few days after), for a maximum of a further seven days. Patients with persisting symptoms beyond two weeks should be considered treatment failures and alternative management initiated.

    Implications  High quality level 1 evidence regarding interventions for acute otitis externa is sparse. The comparison categories studied in this review mostly contain single trials only. Only three meta-analyses were possible. Results are largely based on odds ratios calculated from single trials, most of which have very broad 95% confidence intervals because of small to modest sample sizes. A number of significant results have 95% confidence intervals whose limits approach 1.0, suggesting that negligible differences cannot be excluded. A number of recent trials report results using P values that do not allow the magnitude or precision of the results to be evaluated, and as a result any findings merit cautious interpretation. The findings of this systematic review may not be wholly generalisable to primary care for a variety of reasons; only two of the 19 trials included in the review were conducted in a primary care population setting, and 11 of the 19 trials had ear cleaning as part of the treatment. Having said all of this, a few salient points can be made from the evidence available:Topical treatments alone are effective for uncomplicated acute otitis externa. Additional oral antibiotics are not required.In most cases the choice of topical intervention does not appear to influence the therapeutic outcome significantly. Any observable differences in efficacy were minor and not consistently present at every assessment point.Evidence from one trial (Sabater 1996) of low quality found no difference in clinical efficacy between quinolone and non-quinolone drops. Quinolones are more expensive than non-quinolones. This finding may influence their use in cost-driven and resource-poor settings.  If treatment needs to be extended beyond one week acetic acid alone appears to perform less well when compared against other topical treatments. One high quality trial (van Balen 2003) compared acetic acid with antibiotic/steroid drops; although the cure rate was comparable at day seven to nine it was poorer in the acetic acid group at weeks two and three. A separate trial, of low quality, showed that acetic acid spray had a poorer cure rate than acetic acid/antibiotic/steroid spray at two and four weeks (Slack 1987). Acetic acid is available in many countries as a non-prescription remedy at low-cost, in both drop and spray form. The manufacturer recommends using it for a maximum of seven days. The results from van Balen 2003 support their use for this duration. However, their study also showed that symptoms were more prolonged in the acetic acid group (eight days versus six days in the antibiotic/steroid group); this may influence the decision to use acetic acid in primary care.There is some evidence which indicates that patients treated with topical antibiotic containing steroid benefit from reduced swelling (Mosges 2008), severe redness, secretion and analgesic consumption (Mosges 2007) compared to their non-steroid counterpart. There is a suggestion that high-potency steroids may be more effective than low-potency steroids (in terms of severe pain, inflammation and swelling) (Roland 2007). Further investigation is required.Evidence from one low quality trial (Masood 2008) suggests a glycerine-ichthammol medicated wick may provide better pain relief in early severe acute otitis externa than a triamcinolone/gramicidin/neomycin/nystatin medicated wick, but the magnitude or precision of effect has yet to be established.  The effectiveness of ear cleaning is unknown. The evidence for the efficacy of steroid-only drops is scant and has not been fully established. Further investigation is warranted in order to quantify the effects of both these interventions fully.  In general, given the apparent parity in clinical efficacy of topical interventions used to treat acute otitis externa, other factors such as cost, availability, dosing regimen, risk of contact sensitivity, risk of resistance and risk of ototoxicity may determine the choice of therapy. Parameters such as speed of healing and pain relief are yet to be determined for many topical treatments and may also influence this decision.  Patients prescribed antibiotic/steroid drops can expect their symptoms to last for approximately six days after treatment has begun. Patients are usually treated for seven to 10 days, although it is apparent that they are cured at different time points. It may be more useful when prescribing ear drops to instruct patients to use them for at least a week. If they have symptoms beyond the first week they should continue the drops until their symptoms resolve (and possibly for a few days after) for a maximum of a further seven days. Patients with symptoms beyond two weeks should be considered treatment failures and alternative management initiated.

    Citation  Kaushik V, Malik T, Saeed SR. Interventions for acute otitis externa. Cochrane Database of Systematic Reviews 2010, Issue 1. Art. No.: CD004740. DOI: 10.1002/14651858.CD004740.pub2.

     

  • IN BREAST CANCER SURVIVORS, ASPIRIN MAY DECREASE RISK OF DISTANT RECURRENCE AND BREAST CANCER-RELATED DEATH
    Summary  "Among women living at least 1 year after a breast cancer diagnosis, aspirin use was associated with a decreased risk of distant recurrence and breast cancer death."

    Basis for Study  "Animal and in vitro studies suggest that aspirin may inhibit breast cancer metastasis." This prospective study explored whether aspirin use reduces the risk of death from breast cancer and distant recurrence.

    Detailed Summary of Study  Breast cancer recurrence and death were tracked in 4,164 breast cancer patients who were participants in the Nurses’ Health Study, and rates were compared based on the number of days per week that the patients took aspirin.

    Results/Body  Compared to women who did not take aspirin, adjusted relative risks for breast cancer-related death was 1.07 for women who took aspirin 1 day/week, 0.29 for 2 to 5 days/week, and 0.36 for 6 or 7 days/week. Corresponding figures for distant recurrence were 0.91, 0.40 and 0.57.

    Sources & Other Links  Holmes MD, Chen WY, Li L, Hertzmark E, Spiegelman D, Hankinson SE. Aspirin intake and survival after breast cancer. J Clin Oncol. 2010 Feb 16. [Epub ahead of print]

     

  • STROKE PATIENTS FACE A HIGHER RISK OF RECURRENT STROKE, MYOCARDIAL INFARCTION OR DEATH
    Summary  This study of stroke patients in South Carolina found that over the next 4 years they had a higher risk of recurrent stroke, myocardial infarction (MI) or death. “These finding suggest there is room for further improvement in secondary stroke prevention in South Carolina.”

    Basis for Study  This study determined the risk of recurrent stroke, MI or death in stroke patients.

    Detailed Summary of Study  The incidence of recurrent stroke, MI and all-cause death was tracked in 10,399 patients who were hospitalized for a stroke in 2002. Follow-up was through 2006.

    Results/Body  Cumulative risk at 1 month, 6 months, 1 year, 2 years, 3 years and 4 years was 1.8%, 5.0%, 8.0%, 12.1%, 15.2%, and 18.1% for recurrent stroke; 0.3%, 1.0%, 2.1%, 3.7%, 5.0%, and 6.2% for MI; and 14.6%, 20.6%, 24.5%, 30.9%, 36.2%, and 41.3% for all-cause death. The combined risk for recurrent stroke, MI, or vascular death was 13.6%, 19.5%, 24.7%, 31.6%, 36.8%, and 41.3%. The combined risk for recurrent stroke, MI or death was slightly higher for older patients (hazard ratio 1.38) and for African-Americans (1.12).

    Sources & Other Links  Feng W, Hendry RM, Adams RJ. Risk of recurrent stroke, myocardial infarction, or death in hospitalized stroke patients. Neurology. 2010 Feb 16;74(7):588-93.

     

  • INCREASED CHD RISK WITH ESTROGEN PLUS PROGESTIN THERAPY IS LIMITED TO INITIAL FEW YEARS OF USE
    Summary  In postmenopausal women, the increased coronary heart disease risk produced by estrogen plus progestin therapy decreases only after 6 years of use

    Basis for Study  “Estrogen plus progestin therapy increases the risk for coronary heart disease (CHD) in postmenopausal women. However, this increased risk might be limited to the first years of use and to women who start therapy late in menopause.” This study was part of the Women’s Health Initiative.

    Detailed Summary of Study  The authors traced the CHD risk in 16,608 women who had been randomized to receive either no hormone therapy or estrogen plus progestin therapy. The influence of the duration of hormone use and the timing of use (years since menopause) was analyzed.

    Results/Body  Women who used estrogen plus progestin therapy continuously had a hazard ratio of developing CHD of 2.36 for the first 2 years and 1.69 for the first 8 years, compared to women who did not take hormones. Corresponding figures were 1.29 and 0.64 for women within 10 years after menopause. “The CHD-free survival curves for continuous use and no use of estrogen plus progestin crossed at about 6 years.”

    Sources & Other Links  Toh S, Hernández-Díaz S, Logan R, Rossouw JE, Hernán MA.Coronary heart disease in postmenopausal recipients of estrogen plus progestin therapy: does the increased risk ever disappear? A randomized trial. Ann Intern Med. 2010 Feb 16;152(4):211-7.

     

  • META-ANALYSIS FINDS STATIN USE SEEMS JUSTIFIED DESPITE SLIGHT INCREASE IN RISK OF DIABETES
    Summary  This meta-analysis found that although statin use may be associated with a modest increase in the risk of diabetes, its effectiveness at reducing the risk of coronary events appears to justify its continued use.

    Basis for Study  The authors conducted a meta-analysis in an attempt to resolve conflicting data over whether statin use increases the risk of diabetes.

    Detailed Summary of Study  The authors located and analyzed 13 randomized controlled trials of statins (n = 91,140 subjects) that tracked the development of diabetes.

    Results/Body  Over a mean of 4 years, statin users had a slightly increased risk of developing diabetes (odds ratio 1.09) compared to those assigned to placebo. “The risk is low both in absolute terms and when compared with the reduction in coronary events. Clinical practice in patients with moderate or high cardiovascular risk or existing cardiovascular disease should not change.”

    Sources & Other Links  Sattar N, Preiss D, Murray HM, Welsh P, Buckley BM, de Craen AJ, Seshasai SR, McMurray JJ, Freeman DJ, Jukema JW, Macfarlane PW, Packard CJ, Stott DJ, Westendorp RG, Shepherd J, Davis BR, Pressel SL, Marchioli R, Marfisi RM, Maggioni AP, Tavazzi L, Tognoni G, Kjekshus J, Pedersen TR, Cook TJ, Gotto AM, Clearfield MB, Downs JR, Nakamura H, Ohashi Y, Mizuno K, Ray KK, Ford I. Statins and risk of incident diabetes: a collaborative meta-analysis of randomised statin trials. Lancet. 2010 Feb 27;375(9716):735-742.

     
  • 2009-2010 INFLUENZA SEASON; INFLUENZA ACTIVITY REMAINED AT APPROXIMATELY AT THE SAME LEVELS AS WEEK 8

    Synopsis:

    1. 174 (5.1%) specimens tested by U.S. World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) collaborating laboratories and reported to CDC/Influenza Division were positive for influenza.
    2. All subtyped influenza A viruses reported to CDC were 2009 influenza A (H1N1) viruses.
    3. The proportion of deaths attributed to pneumonia and influenza (P&I) was below the epidemic threshold.
    4. No influenza-associated pediatric deaths were reported.
    5. The proportion of outpatient visits for influenza-like illness (ILI) was 1.9% which is below the national baseline of 2.3%. Three of 10 regions (Regions 4, 7, and 9) reported ILI at or above region-specific baseline levels.
    6. No states reported widespread influenza activity, five states reported regional influenza activity, Puerto Rico and six states reported local influenza activity, Guam, and 33 states reported sporadic influenza activity, the U.S. Virgin Islands and six states reported no influenza activity, and the District of Columbia did not report.

     

  • PLAVIX (CLOPIDOGREL) HAS REDUCED EFFECTIVENESS IN PATIENTS WHO ARE POOR METABOLIZERS OF THE DRUG
    FDA notified healthcare professionals and patients that a Boxed Warning has been added to the prescribing information for Plavix, an anti-blood clotting medication. The Boxed Warning in the drug label will include information to:
    1. Warn about reduced effectiveness in patients who are poor metabolizers of Plavix. Poor metabolizers do not effectively convert Plavix to its active form in the body.
    2. Inform healthcare professionals that tests are available to identify genetic differences in CYP2C19 function.
    3. Advise healthcare professionals to consider use of other anti-platelet medications or alternative dosing strategies for Plavix in patients identified as poor metabolizers.

    Plavix is given to reduce the risk of Heart attack, unstable Angina, Stroke, and cardiovascular death in patients with Cardiovascular Disease. Plavix works by decreasing the activity of blood cells called platelets, making platelets less likely to form blood clots. A data summary and additional information for healthcare professionals and patients are provided in the linked Drug Safety Communication.

     
  • BLOOD TRANSFUSION FOR PREVENTING STROKE IN PEOPLE WITH SICKLE CELL DISEASE

    Authors  Hirst Ceri, Wang Winfred C

    Review Group  Cochrane Cystic Fibrosis and Genetic Disorders Group

    Abstract  In sickle cell disease (SCD), a common inherited haemoglobin disorder, abnormal haemoglobin distorts red blood cells, causing anaemia, vaso-occlusion and dysfunction in most body organs. Stroke affects around 10% of children with sickle cell anaemia and recurrence is likely. Chronic blood transfusion dilutes the sickled red blood cells, reducing the risk of vaso-occlusion and stroke. However, side effects can be severe.

    Objectives:

    To assess risks and benefits of chronic blood transfusion regimens in people with SCD to prevent first stroke or recurrences.

    Search strategy:

    We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register, comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and conference proceedings.Last search of the Group's Trials Register: 22 May 2009.

    Selection criteria:

    Randomised and quasi-randomised controlled trials comparing blood transfusion as prophylaxis for stroke in people with SCD to alternative or no treatment.

    Data collection and analysis:

    Both authors independently assessed trial quality and extracted data.

    Main results:

    Searches identified two eligible trials. One compared a chronic transfusion regimen for maintaining sickle haemoglobin lower than 30% with standard care in 130 children with SCD judged (through transcranial doppler ultrasonography) as high-risk for first stroke. During the trial, 11 children in the standard care group suffered a stroke compared to one in the transfusion group. This 92% relative risk reduction meant the trial was terminated early. Thirty months treatment was planned, but median follow up was 21.1 months. The transfusion group had a high complications rate: iron overload; alloimmunisation; and transfusion reactions. The second trial investigated risk of stroke when transfusion was stopped after at least 30 months. The trial closed early due to a significant difference in risk of stroke between participants who stopped transfusion and those who continued (for whom it was deemed unsafe to recommend discontinuation), as measured by abnormal velocities on Doppler examinations, OR 0.02 (95% CI 0.00 to 0.43). No trials were identified investigating transfusion for preventing recurrence of stroke.

    Authors' conclusions:

    These trials demonstrated a significantly reduced risk of stroke in participants receiving regular blood transfusions. Data from a follow-up trial indicate individuals may revert to former risk status if transfusion is discontinued. Degree of risk must be balanced against the burden of chronic transfusions. Further research is required examining the use of transfusion in preventing secondary stroke, and further defining risk factors for stroke, to avoid unnecessarily starting children on blood transfusions.

    Implications  The STOP trial demonstrated a 90% relative reduction in risk of first stroke in high-risk children receiving regular blood transfusions, over a median follow up time of 21.1 months (STOP 1998). This must be balanced against the adverse effects and costs of a chronic transfusion regimen. The STOP 2 trial found that it is not safe to discontinue transfusion therapy, even after 30 months of treatment, in these high risk individuals (STOP 2 2005). No randomised controlled trials were found regarding prevention of secondary stroke by blood transfusion in people with sickle cell disease.

    Citation  Hirst C, Wang WC. Blood transfusion for preventing stroke in people with sickle cell disease. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD003146. DOI: 10.1002/14651858.CD003146.

     

  • CURRENT USE OF ASPIRIN AND ANTITHROMBOTIC AGENTS IN PATIENTS WITH ATHEROTHROMBOTIC DISEASE
    Summary  About 25% of outpatients with vascular disease or at risk for it did not take aspirin, and 15% did not take any antithrombotic medication.

    Basis for Study "Despite its proven efficacy, low cost, and wide availability, aspirin remains underused." As part of the Reduction of Atherothrombosis for Continued Health Registry, the authors identified predictors of aspirin use in outpatients with atherothrombosis.

    Detailed Summary of Study  Demographic information and data on aspirin use were collected from 25,686 outpatients with atherothrombosis or at least three risk factors for it.

    Results/Body  Aspirin use was more likely in men, whites, patients age <65 and residents of the Midwest. About two thirds of the aspirin users took low-dose aspirin. Antithrombotic use was more common in whites, patients with atrial fibrillation or vascular disease, patients taking" other risk-reducing medications" and patients being treated by cardiologists. Antithrombotic use was less likely in women, smokers and diabetics.

    Sources & Other Links <> Cannon CP, Rhee KE, Califf RM, Boden WE, Hirsch AT, Alberts MJ, Cable G, Shao M, Ohman EM, Steg PG, Eagle KA, Bhatt DL; REACH Registry Investigators. Current use of aspirin and antithrombotic agents in the United States among outpatients with atherothrombotic disease (from the REduction of Atherothrombosis for Continued Health [REACH] Registry). Am J Cardiol. 2010 Feb 15;105(4):445-52

     
  • EVEN SLIGHT REDUCTIONS IN DIETARY SALT COULD SUBSTANTIALLY REDUCE CARDIOVASCULAR DISEASE

    Summary "Modest reductions in dietary salt could substantially reduce cardiovascular events and medical costs and should be a public health target."

    Basis for Study  The authors projected the impact that lowering dietary salt levels would have on the incidence of cardiovascular disease in America.

    Detailed Summary of Study  The incidence of coronary heart disease, stroke, and myocardial infarction was estimated assuming a reduction in dietary salt intake by up to 3 g per day (1,200 mg sodium/day). The authors also examined the efficacy of salt reduction in various groups, compared the impact with that of other public-health efforts, and compared the cost-effectiveness of salt reduction vs. treatment of hypertension with medications.

    Results/Body "Reducing dietary salt by 3 g per day is projected to reduce the annual number of new cases of CHD by 60,000 to 120,000, stroke by 32,000 to 66,000, and myocardial infarction by 54,000 to 99,000 and to reduce the annual number of deaths from any cause by 44,000 to 92,000." It would save"194,000 to 392,000 quality-adjusted life-years and $10 billion to $24 billion in health care costs annually." Benefits were seen in all the groups analyzed, and salt reduction was found to be a more cost-effective way to reduce blood pressure than antihypertensive medications.  "The cardiovascular benefits of reduced salt intake are on par with the benefits of population-wide reductions in tobacco use, obesity, and cholesterol levels."

    Sources & Other Links  Bibbins-Domingo K, Chertow GM, Coxson PG, Moran A, Lightwood JM, Pletcher MJ, Goldman L. Projected effect of dietary salt reductions on future cardiovascular cisease. N Engl J Med. 2010 Feb 18;362(7):590-599

     

  • SEVERELY OBESE TEENS LOSE MORE WEIGHT WITH GASTRIC BANDING THAN LIFESYTLE INTERVENTION
    Summary  Severely obese adolescents who underwent laparoscopic adjustable gastric banding lost significantly more weight, reduced their risk of metabolic syndrome and improved their quality of life compared to those who took part in a lifestyle intervention. However, revision operations were common in the surgical group.

    Basis for Study  This prospective randomized trial from Australia compared the outcomes of these two treatments in severely obese teens.

    Detailed Summary of Study  Subjects age 14 to 18 with a BMI >35 underwent gastric banding (n = 25) or took part in a supervised lifestyle intervention (n = 25). Weight loss, metabolic syndrome, insulin resistance, quality of life and adverse events was noted after 2 years in 24 of the gastric banding patients and 18 of the lifestyle intervention participants.

    Results/Body "Twenty-one (84%) in the gastric banding and 3 (12%) in the lifestyle groups lost more than 50% of excess weight, corrected for age. "Mean weight loss was 34.6 kg in the gastric banding group and 3.0 kg in the lifestyle intervention group. 9 of the 25 patients in the gastric banding group had metabolic syndrome before surgery and none had it at follow-up; corresponding figures for the lifestyle group were 10/25 at baseline and 4/18 at follow-up."The gastric banding group experienced improved quality of life with no perioperative adverse events. However, 8 operations (33%) were required in 7 patients for revisional procedures either for proximal pouch dilatation or tubing injury during follow-up."

    Sources & Other Links  O'Brien PE, Sawyer SM, Laurie C, Brown WA, Skinner S, Veit F, Paul E, Burton PR, McGrice M, Anderson M, Dixon JB. Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial. JAMA. 2010 Feb 10;303(6):519-26.

     

  • LONGER NEEDLES SHOULD BE USED WHEN GIVING HEPATITIS B VACCINE TO OBESE ADOLESCENTS
    Summary  Obese adolescents who received the hepatitis B vaccine using a 1.5-inch needle had significantly higher antibody titers than those immunized with a 1-inch needle.

    Basis for Study  The authors determined whether a shorter needle’s inability to penetrate the deltoid fat pad in obese adolescents could account for their lower antibody titers.

    Detailed Summary of Study <> Obese adolescents were randomized to receive the hepatitis B vaccine using a 1-inch or a 1.5-inch needle. Antibody titers were compared after vaccination.

    Results/Body <> Median titers were 189.8 mIU/mL with the 1-inch needle and 345.4 mIU/mL with the 1.5-inch needle."Needle length accounts for a significant portion of the discrepancy in immune response to HBV vaccine that is seen among those with obesity."

    Sources & Other Links  Middleman AB, Anding R, Tung C. Effect of needle length when immunizing obese adolescents with hepatitis B vaccine. Pediatrics. 2010 Feb 8. [Epub ahead of print].

     

  • ORAL BISPHOSPHAONATES; ONGOING SAFETY REVIEW OF ATYPICAL SUBTROCHANTERIC FEMUR FRACTURES
    FDA notified healthcare professionals and patients that at this point, the data that FDA has reviewed have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures. FDA is working with outside experts, including members of the recently convened American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force, to gather more information and evaluate the issue further.

    FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing oral bisphosphonates.

    Patients should continue taking oral bisphosphonates unless told by their healthcare professional to stop. Patients should talk to their healthcare professional if they develop new hip or thigh Pain or have any concerns with their medications.

    [03/10/2010 - Drug Safety Communication: Ongoing safety review of oral bisphosphonates and atypical subtrochanteric femur fractures - FDA]

     

  • WINRHO SDF (Rho(D) IMMUNE GLOBULIN INTRAVENOUS (HUMAN): RISK OF INTRAVASCULAR HEMOLYSIS IN PATIENTS WITH IMMUNE THROMBOCYTOPENIC PURPURA
    Cangene, Baxter and FDA notified healthcare professionals that cases of intravascular hemolysis (IVH) and its complications, including fatalities, have been reported in patients treated for immune thrombocytopenic purpura (ITP) with WinRho SDF. IVH can lead to clinically compromising anemia and multi-system organ failure including acute respiratory distress syndrome. Serious complications including severe anemia, acute renal insufficiency, renal failure and disseminated intravascular coagulation have also been reported. Fatal outcomes associated with IVH and its complications have occurred most frequently in patients of advanced age (age over 65) with co-morbid conditions.

    The Boxed Warning informs healthcare professionals that:

    1. Patients should be closely monitored in a health care setting for at least eight hours after adminstration
    2. A dipstick urinalysis should be performed at baseline, 2 hours, 4 hours after administration and prior to the end of the monitoring.
    3. patients should be alerted to and monitor for signs and symptoms of IVH, including back pain, shaking chills, fever, ad discolored urine or hematuria.  Absence of these signs ad/or symptoms of IVH within eight hours do not indicate IVH cannot occur subsequently
    4. If signs and/or symptoms of IVH are present or if IVH is suspected after WinRho administration, post-treatment laboratory tests should be performed including plasma hemoglobin, urinalysis, haptoglobin, LDH and plasm bilirubin (direct and indirect).
     
  • INSULIN-SENSITIZING DRUGS FOR WOMEN WITH POLYCYSTIC OVARY SYNDROME

    Authors  Tang Thomas, Lord Jonathan M, Norman Robert J, Yasmin Ephia, Balen Adam H

    Review Group  Cochrane Menstrual Disorders and Subfertility Group

    Abstract  Polycystic ovary syndrome (PCOS) is characterised by anovulation, hyperandrogaenemia and insulin resistance. Hyperinsulinaemia is associated with an increase in cardiovascular risk and the development of diabetes mellitus. If insulin sensitising agents such as metformin are effective in treating features of PCOS, then they could have wider health benefits than just treating the symptoms of the syndrome.

    Objectives:

    To assess the effectiveness of insulin sensitising drugs in improving reproductive outcomes and metabolic parameters for women with PCOS and menstrual disturbance.

    Search strategy:

    We searched the Cochrane Menstrual Disorders & Subfertility Group trials register (searched September 2008), the Cochrane Central Register of Controlled Trials (Cochrane Library, third Quarter 2008), CINAHL (searched September 2008), MEDLINE (January 1966 to September 2008), and EMBASE (January 1985 to September 2008). All searches were rerun 13 August 2009 17 RCTs were located and await classification.

    Selection criteria:

    Randomised controlled trials which investigated the effect of insulin sensitising drugs compared with either placebo or no treatment, or compared with an ovulation induction agent.

    Data collection and analysis:

    Thirty one trials (2537 women) were included for analysis, 27 of them using metformin and involving 2150 women.

    Main results:

    There is no evidence that metformin improves live birth rates whether it is used alone (Pooled OR = 1.00, 95% CI 0.16 to 6.39) or in combination with clomiphene (Pooled OR = 1.48, 95% CI 1.12 to 1.95). However, clinical pregnancy rates are improved for metformin versus placebo (Pooled OR = OR 3.86, 95% C.I. 2.18 to 6.84) and for metformin and clomiphene versus clomiphene alone (Pooled OR =1.48, 95% C.I. 1.12 to 1.95) ). In the studies that compared metformin and clomiphene alone, there was no evidence of an improved live birth rate (OR= 0.67, 95% CI 0.44 to 1.02) but the pooled OR resulted in improved clinical pregnancy rate in in the clomiphene group (OR = 0.63 , 95% 0.43 to 0.92), although there was significant heterogeneity.There is also evidence that ovulation rates are improved with metformin in women with PCOS for metformin versus placebo (Pooled OR 2.12, 95% CI 1.50 to 3.0) and for metformin and clomiphene versus clomiphene alone (Pooled OR = 3.46, 95% CI 1.97 to 6.07).Metformin was also associated with a significantly higher incidence of gastrointestinal disturbance, but no serious adverse effects were reported.

    Authors' conclusions:

    In agreement with the previous review, metformin is still of benefit in improving clinical pregnancy and ovulation rates. However, there is no evidence that metformin improves live birth rates whether it is used alone or in combination with clomiphene, or when compared with clomiphene. Therefore, the use of metformin in improving reproductive outcomes in women with PCOS appears to be limited.

    Implications  In agreement with the previous review, metformin is still of benefit in improving clinical pregnancy and ovulation rates. However, there is no evidence that metformin improves live births whether it is used alone or in combination with clomiphene. In addition, metformin has limited effect on weight loss and metabolic parameters (insulin and the lipid profiles), especially in obese women with PCOS. Therefore, the use of metformin in improvement of reproductive outcomes or in reducing the risk of developing metabolic syndrome in women with PCOS appears to be limited. Furthermore, obesity poses a significant negative impact on the pregnancy outcomes Legro 2007. Hence, anovulatory obese women with PCOS should be advised to undergo life-style changes before fertility treatment (The Thessaloniki ESHRE/ASRM sponsored PCOS consensus workshop group, 2007) ESHRE/ASRM 2008.

    Citation  Tang T, Lord JM, Norman RJ, Yasmin E, Balen AH. Insulin-sensitising drugs (metformin, rosiglitazone, pioglitazone, D-chiro-inositol) for women with polycystic ovary syndrome, oligo amenorrhoea and subfertility. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD003053. DOI: 10.1002/14651858.CD003053.pub3.

     

  • GLUCOSAMINE THERAPY FOR TREATING OSTEOARTHRITIS
    Authors Towheed Tanveer, Maxwell Lara, Anastassiades Tassos P, Shea Beverley, Houpt JB, Welch Vivian, Hochberg Marc C, Wells George A

    Review Group  Cochrane Musculoskeletal Group

    Abstract Osteoarthritis (OA) is a common form of arthritis and is often associated with significant disability and impaired quality of life. This is an update of a Cochrane review first published in 2001 and previously updated in 2005.

    Objectives:

    To review randomized controlled trials (RCTs) evaluating the effectiveness and toxicity of glucosamine in OA.

    Search strategy:

    We searched CENTRAL and the Cochrane Database of Systematic Reviews (The Cochrane Library), MEDLINE, PREMEDLINE, EMBASE, AMED, ACP Journal Club, DARE (to January 2008); contacted content experts, and handsearched reference lists and pertinent review articles.

    Selection criteria:

    RCTs evaluating the effectiveness and safety of glucosamine in OA.

    Data collection and analysis:

    Data abstraction was performed independently by two review authors and investigators were contacted for missing data.

    Main results:

    This update includes 25 studies with 4963 patients. Analysis restricted to studies with adequate allocation concealment failed to show any benefit of glucosamine for pain (based on a pooled measure of different pain scales) and WOMAC pain, function and stiffness subscales; however, it was found to be better than placebo using the Lequesne index (standardized mean difference (SMD) -0.54; 95% confidence interval (CI) -0.96 to -0.12). Collectively, the 25 RCTs favoured glucosamine with a 22% (change from baseline) improvement in pain (SMD -0.47; 95% CI -0.72 to -0.23) and a 11% (change from baseline) improvement in function using the Lequesne index (SMD -0.47; 95% CI -0.82 to -0.12). However, the results were not uniformly positive and the reasons for this remain unexplained. WOMAC pain, function and stiffness outcomes did not reach statistical significance.RCTs in which the Rotta preparation of glucosamine was compared to placebo found glucosamine superior for pain (SMD -1.11; 95% CI -1.66 to -0.57) and function (Lequesne index SMD -0.47; 95% CI -0.82 to -0.12). Pooled results for pain (SMD -0.05; 95% CI -0.15 to 0.05) and function using the WOMAC index (SMD -0.01; 95% CI -0.13 to 0.10) in those RCTs using a non-Rotta preparation of glucosamine did not reach statistical significance. Two RCTs using the Rotta preparation showed that glucosamine was able to slow radiological progression of OA of the knee over a three-year period (mean difference (MD) 0.32; 95% CI 0.05 to 0.58).Glucosamine was as safe as placebo in terms of the number of participants reporting adverse reactions (relative risk ratio 0.99; 95% CI 0.91 to 1.07).

    Authors' conclusions:

    Pooled results from studies using a non-Rotta preparation or adequate allocation concealment failed to show benefit in pain and WOMAC function while those studies evaluating the Rotta preparation showed that glucosamine was superior to placebo in the treatment of pain and functional impairment resulting from symptomatic OA.

    Implications  The previous review from 2005, with 20 studies and 2570 participants, showed that glucosamine sulphate taken orally in amounts of 1500 mg/day produced a 28% (per cent change from baseline) benefit in pain and an increase in function of 21% (per cent change in Lequesne Index from baseline) in osteoarthritis, without side effects.If only the best designed studies are included, the benefit in pain and WOMAC function is no longer present; as shown in this update which includes 25 studies and 4963 patients. Inclusion of five new studies reduces the overall benefit on pain to 22% and function to 11% in the Lequesne Index. Pooled results from studies using a non-Rotta preparation or adequate allocation concealment failed to show benefit in pain and WOMAC function, while those studies evaluating the Rotta preparation showed that glucosamine was superior to placebo in the treatment of pain and functional impairment resulting from symptomatic OA. WOMAC outcomes of pain and function showed a superiority of glucosamine over placebo for only the Rotta preparation of glucosamine.Some studies suggest the Rotta preparation of glucosamine sulfate may slow radiological progression of OA of the knee over a three-year period. The ability of glucosamine to improve symptoms and delay radiological progression of OA affecting other joint sites also needs further research.Glucosamine was as safe as placebo.

    Citation  Towheed T, Maxwell L, Anastassiades TP, Shea B, Houpt JB, Welch V, Hochberg MC, Wells GA. Glucosamine therapy for treating osteoarthritis. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD002946. DOI: 10.1002/14651858.CD002946.pub2.

     
  • INFLUENZA VACCINE MAY NOT BE BENEFICIAL IN PATIENTS WITH CYSTIC FIBROSIS

    Authors  Dharmaraj Poonam, Smyth Rosalind L

    Review Group  Cochrane Cystic Fibrosis and Genetic Disorders Group

    Abstract  Viral respiratory tract infections in people with cystic fibrosis (CF) have a deteriorating effect on their lung function and disease progression. Annual influenza vaccination is therefore commonly recommended for people with CF.

    Objectives:

    To assess the effectiveness of influenza vaccination for people with CF.

    Search strategy:

    We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises of references identified from comprehensive electronic database searches and hand searching of relevant journals and abstract books of conference proceedings. We also contacted the companies which market the influenza vaccines used in the trials to obtain further information about randomized controlled trials. Date of the most recent search of the Cystic Fibrosis Trials Register: 05 March 2009.

    Selection criteria:

    All randomized and quasi-randomized trials (published or unpublished) comparing any influenza vaccine with a placebo or with another type of influenza vaccine.

    Data collection and analysis:

    Two authors independently assessed study quality and extracted data. Additional information was obtained by contacting the investigators when it was indicated.

    Main results:

    Four studies enrolling a total of 179 participants with CF (143 (80%) were children aged 1 to 16 years) were included in this review. There was no study comparing a vaccine to a placebo or a whole virus vaccine to a subunit or split virus vaccine. Two studies compared an intranasal applied live vaccine to an intramuscular inactivated vaccine and the other two studies compared a split virus to a subunit vaccine and a virosome to a subunit vaccine (all intramuscular). The incidence of all reported adverse events was high depending on the type of influenza vaccine. The total adverse event rate ranged from 48 out of 201 participants (24%) for the intranasal live vaccine to 13 out of 30 participants (43%) for the split virus vaccine. With the limitation of a statistical low power there was no significant difference between the study vaccinations. None of the events were severe. All study influenza vaccinations generated a satisfactory serological antibody response. No study reported other clinically important benefits.

    Authors' conclusions:

    There is currently no evidence from randomized studies that influenza vaccine given to people with CF is of benefit to them. There remains a need for a well-constructed clinical study, that assesses the effectiveness of influenza vaccination on important clinical outcome measures.

    Implications  According to some national recommendations and the practice in many units caring for people with CF, it is advisable to vaccinate people with CF against influenza annually. Evidence from randomized controlled studies to support this recommendation in people with CF is lacking and clinicians must make judgments on the benefits and risks of this therapy in people with CF. The cost of annual influenza vaccination may also be considered before implementing changes to current practice. In the UK in 2008 annual influenza vaccination cost 3.55 (excluding VAT) per patient per year (RLCH Pharmacy 2009).

    Citation  Dharmaraj P, Smyth RL. Vaccines for preventing influenza in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2009, Issue 4. Art. No.: CD001753. DOI: 10.1002/14651858.CD001753.pub2.

     

  • IN ACUTE NECK STRAIN, CYCLOBENZAPRINE, IBUPROFEN, OR BOTH RELIEVE PAIN EQUALLY WELL
    There is little benefit to routinely using or adding cyclobenzaprine to NSAIDs for ED patients with acute cervical strain."

    Basis for Study  This randomized controlled trial compared the effectiveness of the NSAID ibuprofen, the centrally acting muscle relaxant cyclobenzaprine (Flexeril®), or both, in ED patients with acute neck strain.

    Detailed Summary of Study  Adult ED patients with cervical strain after a motor vehicle accident or a fall were randomized to receive ibuprofen (800 mg; n = 20), cyclobenzaprine (5 mg; n = 21) or both (n = 20) three times a day for lteq.gif7 days. Pain relief and adverse events were compared.

    Results/Body  No significant differences were found between the treatments in terms of pain relief or adverse events.

    Sources & Other Links  Khwaja SM, Minnerop M, Singer AJ. Comparison of ibuprofen, cyclobenzaprine or both in patients with acute cervical strain: a randomized controlled trial. CJEM. 2010 Jan;12(1):39-44.

     

  • 2009-2010 INFLUENZA SEASON ACTIVITY REMAINS AT APPROXIMATELY THE SAME LEVELS AS WEEK 6.
    185 (4.4%) specimens tested by U.S. World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) collaborating laboratories and reported to CDC/Influenza Division were positive for influenza.

    All subtyped influenza A viruses reported to CDC were 2009 influenza A (H1N1) viruses.

    The proportion of deaths attributed to pneumonia and influenza (P&I) was below the epidemic threshold.

    Three influenza-associated pediatric deaths were reported. One death was associated with 2009 influenza A (H1N1) virus infection and two deaths were associated with an influenza A virus for which the subtype was undetermined.

    The proportion of outpatient visits for influenza-like illness (ILI) was 1.8% which is below the national baseline of 2.3%. Three of 10 regions (Regions 1, 4, and 7) reported ILI above region-specific baseline levels.

    No states reported widespread influenza activity, three states reported regional influenza activity, Puerto Rico and eight states reported local influenza activity, the District of Columbia, Guam, and 35 states reported sporadic influenza activity, the U.S. Virgin Islands and four states reported no influenza activity.

     
  • FDA CLEARS NEW TEST FOR OVARIAN CANCER WHICH CAN HELP IDENTIFY POTENTIAL MALIGNANCIES AND GUIDE SURGICAL DECISIONS

    The U.S. Food and Drug Administration today cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom.

    OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer. If other test results suggest cancer, referral to an oncologist is appropriate even with a negative OVA1 result.

    OVA1 should be used by primary care physicians or gynecologists as an adjunctive test to complement, not replace, other diagnostic and clinical procedures.

    OVA1 uses a blood sample to test for levels of five proteins that change due to ovarian cancer. The test combines the five separate results into a single numerical score between 0 and 10 to indicate the likelihood that the pelvic mass is benign or malignant.

    OVA1 is intended only for women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

    The American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncologists published recommendations in 2002 for the role of generalist obstetrician-gynecologists in the early detection of ovarian cancer, which included a recommendation of patient referral to a gynecological oncologist when specific indicators of malignancy are present.

    These recommendations and later reports indicate that patients with ovarian cancer have improved survival when the surgery is performed by gynecologic oncologists as opposed to general gynecologists or surgeons.

    “Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications,” said Jeffrey Shuren, M.D., J.D., acting director of the FDA’s Center for Devices and Radiological Health.

    The FDA reviewed a study of 516 patients, including 269 evaluated by non-gynecological oncologists, which compared OVA1 results with biopsy results. When combined with pre-surgical information, such as radiography and other laboratory tests, results from the OVA1 tests identified additional patients who might benefit from oncology referral who were not identified using pre-surgical information alone.

    OVA1 is developed by Vermillion Inc., headquartered in Fremont, Calif., in conjunction with researchers at The Johns Hopkins University in Baltimore.

     

  • COLCHICINE MARKETED AS COLCRYS NOW FDA APPROVED

    FDA notified healthcare professionals of the approval of the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares and of two previously uncharacterized safety concerns associated with the use of colchicine. Oral colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.

    FDA analyzed safety data for colchicine from adverse events reported to the Agency, the published literature, and company-sponsored pharmacokinetic and drug interaction studies. This analysis revealed cases of fatal colchicine toxicity reported in certain patients taking standard therapeutic doses of colchicine and concomitant medications that interact with colchicine, such as clarithromycin. These reports suggest that drug interactions affecting the gastrointestinal absorption and/or hepatic metabolism of colchicine play a central role in the development of colchicine toxicity. Data submitted supporting the safety and efficacy of Colcrys in acute gout flares demonstrated that a substantially lower dose of colchicine was as effective as the higher dose traditionally used. Moreover, patients receiving the lower dose experienced significantly fewer adverse events compared to the higher dose.

    Based on this information, FDA has included important safety considerations in the approved prescribing information to assure safe use of Colcrys and is providing background information, a data summary and recommendations in this alert.

 

  • UNAPPROVED USE OF RELENZA (ZANAMIVIR) VIA NEBULIZATION/MECHANICAL VENTILATION CAN BE ASSOCIATED WITH FATAL OUTCOME

GlaxoSmithKline (GSK) and FDA notified healthcare professionals of a report of the death of a patient with influenza who received Relenza (zanamivir) Inhalation Powder which was solubilized and administered by mechanical ventilation. Relenza (zanamivir) Inhalation Powder is not intended to be reconstituted in any liquid formulation and is not recommended for use in any nebulizer or mechanical ventilator.

GSK is aware that Relenza Inhalation Powder is being removed from its FDA-approved packaging and dissolved in various solutions for the purpose of nebulizing zanamivir for inhalation by patients with influenza who are unable to take oral medications or unable to inhale Relenza Inhalation Powder using the Diskhaler. Relenza or zanamivir for nebulization have not been approved by the FDA. The safety, effectiveness, and stability of zanamivir use by nebulization have not been established.

Relenza Inhalation Powder should only be used as directed in the prescribing information by using the Diskhaler device provided with the drug product. Relenza Inhalation Powder is a mixture of zanamivir active drug substance and lactose drug carrier. This formulation is not designed or intended to be administered by nebulization. There is a risk that the lactose sugar in this formulation can obstruct proper functioning of mechanical ventilator equipment.

  • LHRH AGONISTS FOR ADJUVANT THERAPY OF EARLY BREAST CANCER IN PREMENOPAUSAL WOMEN

Authors  Sharma Rohini, Hamilton Anne, Beith Jane

Abstract  Approximately 60% of breast cancer tumours in premenopausal women are hormone sensitive (ER+). These patients may be suitable for hormonal treatment. The goal of hormonal therapy is to reduce the availability of oestrogen to the cancer cell. This can be achieved by blocking oestrogen receptors with drugs such as tamoxifen, suppression of oestrogen synthesis by LHRH agonists, or ovarian ablation either surgically or by radiotherapy. Chemotherapy can also have a hormonal action by inducing amenorrhoea in premenopausal women.

Objectives

To assess LHRH agonists as adjuvant therapy for women with early breast cancer.

Search strategy

The specialised register of the Cochrane Breast Cancer Group was searched on 19 December 2006. The reference lists of related reviews were checked. A final check of the list of trials maintained by the Early Breast Cancer Trialists' Collaborative Group was made in January 2008.

Selection criteria

Randomised trials of LHRH agonist versus LHRH agonist and tamoxifen, LHRH agonist versus chemotherapy, LHRH agonist versus ovarian ablation, or LHRH agonist versus LHRH agonist and chemotherapy, that recruited premenopausal women with early breast cancer.

Data collection and analysis

Data were collected from trial reports. We report estimates for the differences between treatments on recurrence free survival, overall survival, toxicity and quality of life using data available in the reports of each trial. Meta-analyses were not performed because of variability in the reporting of the trials and the need for more mature data.

Main results

We identified 14 randomised trials, involving nearly 12,000 premenopausal women with operable breast cancer, most of whom were ER+. The LHRH agonist in most of these trials was goserelin. For most of the treatment comparisons there are too few trials, too few randomised patients or too little follow-up to draw reliable estimates of the relative effects of different treatments. Four trials (nearly 5000 women) addressed the integration of LHRH agonists into adjuvant hormonal therapy, showing that a combination of an LHRH agonist and tamoxifen might be better than either alone. Insufficient data are available to inform a choice between tamoxifen and goserelin as sole adjuvant therapy. We included twelve trials (more than 10,000 women) of the integration of LHRH agonists into adjuvant chemo-hormonal therapy. Four trials assessed the effects of an LHRH agonist compared to chemotherapy and three other trials investigated a combination of an LHRH agonist and tamoxifen versus chemotherapy. One trial assessed the effects of adding chemotherapy to an LHRH agonist, five trials compared a combination of an LHRH agonist and chemotherapy versus chemotherapy alone, and three trials compared the combination of LHRH agonist, tamoxifen and chemotherapy versus chemotherapy alone. No trials compared an LHRH agonist containing regimen against chemotherapy and tamoxifen. No significant differences in recurrence free survival or overall survival were found between LHRH agonists, with or without adjuvant tamoxifen, and chemotherapy for premenopausal women with ER+ tumours, but hormonal therapy had fewer distressing side effects. The trials point to reductions in recurrence and death for premenopausal women with ER+ tumours who take LHRH agonists, with or without tamoxifen, along with chemotherapy.

Authors' conclusions

For premenopausal women with early breast cancer who are not known to be ER negative, the use of an LHRH agonist, with or without tamoxifen as adjuvant therapy is likely to lead to a reduction in the risk of recurrence and a delay in death. The evidence is insufficient to support the LHRH agonists over chemotherapy, or vice versa, in regard to recurrence free survival and overall survival, but LHRH agonists have fewer or less severe adverse effects. Further follow-up of women in these trials is needed to provide reliable evidence on long term outcomes. Direct randomised comparisons of different durations of LHRH agonists (for example, two years versus longer) and, in the presence of uncertainty, of different LHRH agonists among ER+ or ER unknown premenopausal women are also needed. It is also uncertain how the findings from the CMF-based trials in this review would relate to the use of LHRH agonists with more modern chemotherapy regimens or the comparison of LHRH agonist containing regimens with combinations such as chemotherapy and tamoxifen.

Implications  For premenopausal women with early breast cancer who are not known to be ER-, the use of an LHRH agonist, with or without tamoxifen as adjuvant therapy is likely to lead to a reduction in the risk of a recurrence and a delay in death. If the treatment decision is a choice between the use of an LHRH agonist and chemotherapy, this review does not provide evidence to choose between them on the basis of recurrence free survival or overall survival for ER+ women, but there were fewer or less severe adverse effects among women allocated the LHRH agonist. However, for ER- women, chemotherapy is likely to lead to a reduction in the risk of recurrence and a delay in death compared to an LHRH agonist. The LHRH agonist for which there is most evidence is goserelin, given as a 3.6 mg depot subcutaneously every 28 days for a couple of years.

  • IN NEWLY DIAGNOSED CANCER PATIENTS PROGNOSIS AFFECTS INFORMATION RECALL BETTER THAN AGE

    Summary  In newly diagnosed cancer patients, prognosis is a better indicator of information recall than age.

    Basis for Study/Article  This study identified variables affecting information recall in patients newly diagnosed with cancer.

    Detailed Summary of Study  The study comprised 260 cancer patients seeing an oncologist for the first time. The visits were audiotaped, and patients were later asked to recall details about their diagnosis, prognosis and treatment. The amount and accuracy of their recall were checked against the recordings.

    Results/Body  Prognosis had a strong influence on recall. Patients with a poorer prognosis remembered less information, but regardless of the prognosis, patients given more information about prognosis remembered less. Older patients remembered less information than younger ones, but only when a large amount of information given.

    Sources & Other Links  Jansen J, et al. Does age really matter? Recall of information to newly patients with cancer. J Clin Oncol 2008;Oct 20 [olbp]Article Link (JCO)

     

  • HIGH DOSES OF VITAMIN B DON'T SLOW COGNITIVE DECLINE IN ALZHEIMER'S DISEASE
    Summary  This randomized controlled trial found that high doses of vitamin B don’t slow cognitive decline in patients with mild to moderate Alzheimer’s disease.

    Basis for Study/Article  This multicenter trial assessed whether vitamin B supplements, by decreasing homocysteine levels, could slow the progression of Alzheimer’s disease.

    Detailed Summary of Study  Patients with mild to moderate Alzheimer’s disease (MMSE score 14-26) were randomized to receive high-dose folate (5 mg/day), vitamin B6 (25 mg/day) and vitamin B12 (1 mg/day) (n = 202) or placebo (n = 138) for 18 months. Change from baseline was assessed using the cognitive subscale of the Alzheimer Disease Assessment Scale.

    Results/Body  Patients taking the vitamins had lower homocysteine levels than those in the placebo group, but there were no significant differences between the groups in terms of cognitive function. The patients taking vitamins had “a higher quantity of adverse events involving depression.”

    Sources & Other Links  Aisen PS, et al. High-dose B vitamin supplementation and cognitive decline in Alzheimer disease: a randomized controlled trial. JAMA. 2008 Oct 15;300(15):1774-83. Article Link (NCBI)

     

  • PHENYTOIN AND FOSPHENYTOIN ALERT
    FDA is investigating new preliminary data regarding a potential increased risk of serious skin reactions including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen (HLA) allele, HLA-B*1502. This allele occurs almost exclusively in patients with ancestry across broad areas of Asia, including Han Chinese, Filipinos, Malaysians, South Asian Indians, and Thais. Because fosphenytoin is a prodrug and is converted to phenytoin after administration, any concern regarding this association is also applicable to fosphenytoin. Phenytoin and fosphenytoin are used to control tonic-clonic (grand mal) and complex-partial seizures in epilepsy.

    A recent FDA Information for Healthcare Professionals sheet (12/12/2007), described an increased risk of SJS/TEN with another antiepileptic drug, carbamazepine, in Asian ancestry patients with the HLA-B*1502 allele.

    The FDA is working to identify additional information to evaluate the possible risk of SJS/TEN from phenytoin and fosphenytoin in patients with HLA-B*1502. Until the evaluation is completed, healthcare providers who are considering the use of phenytoin or fosphenytoin should be aware of the risks and benefits described in the current prescribing information for this drug.

    Because this new data suggests a possible association between HLA-B*1502 and phenytoin or fosphenytoin-induced SJS/TEN, and because of the known association between phenytoin and SJS/TEN, healthcare providers should consider avoiding phenytoin and fosphenytoin as alternatives for carbamazepine in patients who test positive for HLA-B*1502.

     
  • GINKGO EVALUATION OF MEMORY (GEM) STUDY FAILS TO SHOW BENEFIT IN PREVENTING DEMENTIA IN THE ELDERLY

    In this news release written by the National Institute on Aging, the dietary supplement Ginkgo biloba was found to be ineffective in reducing the development of dementia and Alzheimer's disease in older people, according to a study published in the "Journal of the American Medical Association.  To read more, visit:

    nia.nih.gov/Alzheimers/ResearchInformation/NewsReleases/PR20081119ginkgo.htm

     
  • PSYCHOSOCIAL AND PHARMACOLOGICAL TREATMENTS VERSUS PHARMACOLOGICAL TREATMENTS FOR OPIOD DETOXIFICATION

    Authors  Amato L, Minozzi S, Davoli M, Vecchi S, Ferri MMF, Mayet S.

    Review Group  Cochrane Drugs and Alcohol Group

    Abstract  Different pharmacological approaches aimed at opioid detoxification are effective. Nevertheless a majority of patients relapse to heroin use, and relapses are a substantial problem in the rehabilitation of heroin users. Some studies have suggested that the sorts of symptoms which are most distressing to addicts during detoxification are psychological rather than physiological symptoms associated with the withdrawal syndrome.

    Objectives

    To evaluate the effectiveness of any psychosocial plus any pharmacological interventions versus any pharmacological alone for opioid detoxification, in helping patients to complete the treatment, reduce the use of substances and improve health and social status.

    Search strategy

    We searched the Cochrane Drugs and Alcohol Group trials register (27 February 2008). Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2008), PUBMED (1996 to February 2008); EMBASE (January 1980 to February 2008); CINAHL (January 2003-February 2008); PsycINFO (1985 to April 2003) and reference list of articles.

    Selection criteria

    Randomised controlled trials which focus on any psychosocial associated with any pharmacological intervention aimed at opioid detoxification. People less than 18 years of age and pregnant women were excluded.

    Data collection and analysis

    Three reviewers independently assessed trials quality and extracted data.

    Main results

    Nine studies involving people were included. These studies considered five different psychosocial interventions and two substitution detoxification treatments: Methadone and Buprenorphine. The results show promising benefit from adding any psychosocial treatment to any substitution detoxification treatment in terms of completion of treatment relative risk (RR) 1.68 (95% confidence interval (CI) 1.11 to 2.55), use of opiate RR 0.82 (95% CI 0.71 to 0.93), results at follow-up RR 2.43 (95% CI 1.61 to 3.66), and compliance RR 0.48 (95% CI 0.38 to 0.59).

    Authors' conclusions

    Psychosocial treatments offered in addition to pharmacological detoxification treatments are effective in terms of completion of treatment, use of opiate, results at follow-up and compliance. Although a treatment, like detoxification, that exclusively attenuates the severity of opiate withdrawal symptoms can be at best partially effective for a chronic relapsing disorder like opiate dependence, this type of treatment is an essential step prior to longer-term drug-free treatment and it is desirable to develop adjunct psychosocial approaches that might make detoxification more effective. Limitations to this review are imposed by the heterogeneity of the assessment of outcomes. Because of lack of detailed information no meta analysis could be performed to analyze the results related to several outcomes.

    Implications  Psychosocial treatments offered in addition to pharmacological detoxification treatments are effective in term of completion of treatment, use of opiate, results at follow-up and compliance. Although a treatment, like detoxification, that exclusively attenuates the severity of opiate withdrawal symptoms can be at best partially effective for a chronic relapsing disorder like opiate dependence, this form of treatment is an essential step prior to longer-term drug-free treatment and it is desirable to develop adjunct psychosocial approaches that might make detoxification more effective.

    Citation  Amato L, Minozzi S, Davoli M, Vecchi S, Ferri MMF, Mayet S. Psychosocial and pharmacological treatments versus pharmacological treatments for opioid detoxification. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD005031. DOI: 10.1002/14651858.CD005031.pub2.

     

  • NOVEMBER 12, 2008
    Update of Safety Review Follow-up to the October 1, 2007 - Early Communication about the Ongoing Safety Review of Bisphosphonates

    Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D)
    Etidronate (Didronel)
    Ibandronate (Boniva)
    Pamidronate (Aredia)
    Risedronate (Actonel, Actonel W/Calcium)
    Tiludronate (Skelid)
    Zoledronic acid (Reclast, Zometa)

    On October 1, 2007, FDA announced that it was reviewing safety data that raised concerns about a potential increased risk for atrial fibrillation in patients treated with a bisphosphonate drug http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm. An article and an accompanying letter to the editor in the May 3, 2007, issue of The New England Journal of Medicine described increased rates of serious atrial fibrillation in two different studies of women ages 65 to 89 years old with osteoporosis treated with the bisphosphonates, Reclast and Fosamax. Data available to FDA at that time, including data from the NDA approval of Reclast for osteoporosis, showed an increased risk of serious atrial fibrillation and this risk was reflected in the Reclast labeling. After our review, based on the data available at this time, healthcare professionals should not alter their prescribing patterns for bisphosphonates and patients should not stop taking their bisphosphonate medication.

    On October 1, 2007, FDA began requesting placebo-controlled clinical trial information from the sponsors of alendronate, ibandronate, risedronate, and zoledronic acid in order to explore the potential risk for atrial fibrillation in male and female patients treated with these bisphosphonate drugs.

    The data submitted by the four sponsors included data on 19,687 bisphosphonate-treated patients and 18,358 placebo-treated patients who were followed for 6 months to 3 years.

    The occurrence of atrial fibrillation was rare within each study, with most studies containing 2 or fewer events. The absolute difference in event rates between each of the bisphosphonate and placebo arms varied from 0-3 per 1,000.

    One large study of zoledronic acid showed a statistically significant increase in the rate of serious atrial fibrillation events. However, across all studies, no clear association between overall bisphosphonate exposure and the rate of serious or non-serious atrial fibrillation was observed. Increasing dose or duration of bisphosphonate therapy was also not associated with an increased rate of atrial fibrillation.

    The FDA is aware of discordant results from the literature and from other epidemiological studies about the incidence and clinical course of atrial fibrillation in patients taking bisphosphonates. FDA is exploring the feasibility of conducting additional epidemiologic studies to examine this issue. In addition, FDA is continuing to monitor post-market reports of atrial fibrillation in patients who have taken bisphosphonates.

    Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis. Bisphosphonates are also used to slow bone turnover in patients with Paget’s disease of the bone and to treat bone metastases and lower elevated levels of blood calcium in patients with cancer. There are 7 FDA-approved bisphosphonates: alendronate (Fosamax, Fosamax Plus D), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel, Actonel W/Calcium), tiludronate (Skelid), and zoledronic acid (Reclast, Zometa).

    This follow-up communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

    The FDA urges both healthcare professionals and patients to report side effects from the use of bisphosphonates to the FDA's MedWatch Adverse Event Reporting program.

     

     
  • CLASS 1 RECALL

    VIBE Technologies, Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Field Generator

    Product:

    Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator

    This product was manufactured and distributed from November 16, 2002 through March 19, 2008.

    Use:

    The company’s labeling reported that the device could be used to treat or cure medical conditions and diseases such as:

      cancer
      depression
      infection
      pain

    The firm has failed to provide FDA with any evidence to support these claims.

    Recalling Firm:

    VIBE Technologies
    2329 W. 10th St
    Greeley, Colorado 80634-3527

    Reason for Recall:

    This device has not been approved by FDA, lacks safety and effectiveness data, and is not manufactured under current good manufacturing practices.

    Public Contact:

    Customers or other individuals that have been treated with this device may contact VIBE Technologies at 1-970-356-9594.

    FDA District:

    Denver

    FDA Comment:

    On October 1, 2008, the company sent a certified letter to each customer who purchased the device to stop using it. The letter also included:

      a warning label to be permanently placed on the VIBE Machine stating that it is not a medical device and should not be used as one.
      an updated operation manual/users’ guide that contains no medical conditions or treatment claims.
      a certification to be signed by the user and returned to the company acknowledging that they:
      received the letter.
      attached the warning label on the device, and
      understand that the VIBE Machine does not affect the structure or function of the human or animal body.
      a request that the user certify that they will:
      not promote the VIBE Machine as a medical device.
      remove any medical claims from their individual websites, and
      destroy any VIBE literature making medical claims.
      a warning that failure to sign and return the certification will result in the company refusing to service their machine.

    Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

    Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX.

     
  • FDA ALERT

    Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence - Issued: October 20, 2008

    Dear Healthcare Practitioner:

    This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). Although rare, these complications can have serious consequences. Following is information regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks.

    Nature of the Problem

    Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.

    The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia.

    Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses.

    Specific characteristics of patients at increased risk for complications have not been determined. Contributing factors may include the overall health of the patient, the mesh material, the size and shape of the mesh, the surgical technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status.

    Recommendations

    Physicians should:

    Obtain specialized training for each mesh placement technique, and be aware of its risks.

    Be vigilant for potential adverse events from the mesh, especially erosion and infection.

    Watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations.

    Inform patients that implantation of surgical mesh is permanent, and that some complications associated with the implanted mesh may require additional surgery that may or may not correct the complication.

    Inform patients about the potential for serious complications and their effect on quality of life, including pain during sexual intercourse, scarring, and narrowing of the vaginal wall.

    Additional patient information can be found on the following FDA Consumer website at http://www.fda.gov/cdrh/consumer/surgicalmesh-popsui.html.

     
  • ANXIETY PLAYS A KEY ROLE IN DEPRESSION

    Summary Anxiety plays a key role in depression, although anxiety symptoms differ with varying levels of depression. "The relationship between anxiety-related symptoms and depression should be considered in the assessment of depression and evaluation of treatment strategies and outcome."

    Basis for Study/Article  The authors explored the effect that anxiety-related symptoms have in major depression.

    Detailed Summary of Study  Using data from four clinical trials, the authors analyzed the relationship between patient scores on the Hamilton Anxiety Rating Scale and the Hamilton Depression Rating Scale.

    Results/Body  In general, anxiety symptoms increased with more severe depression. Anxious mood, tension, insomnia, concentration and memory problems and depressed mood were present at all levels of depression, but anxiety-related somatic problems were present only with more severe depression.

    Sources & Other Links  Vaccarino AL, et al. Symptoms of anxiety in depression: assessment of item performance of the Hamilton Anxiety Rating Scale in patients with depression. Depress Anxiety. 2008 Sep 17. Article Link (NCBI)

     

  • METHYLXANTHINE TREATMENT FOR APNEA IN PRETERM INFANT

    Authors  Henderson-Smart David J, Steer Peter A

    Review Group  Cochrane Neonatal Group

    Abstract  Recurrent apnea is common in preterm infants, particularly at very early gestational ages. These episodes of loss of effective breathing can lead to hypoxemia and bradycardia that may be severe enough to require resuscitation including use of positive pressure ventilation. Methylxanthines (such as caffeine or theophylline) have been used to stimulate breathing and prevent apnea and its consequences.

    Objectives

    To determine the effects of methylxanthine treatment on the incidence of apnea and the use of intermittent positive pressure ventilation (IPPV), and other clinically important effects in preterm infants with recurrent apnea.

    Search strategy

    Searches were made of the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 4, 2007), the Oxford Database of Perinatal Trials, MEDLINE (1966 to January 2008), EMBASE (1982 - January 2008), previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants, journal hand searching mainly in the English language.

    Selection criteria

    All trials utilizing random or quasi-random patient allocation in which methylxanthine (theophylline or caffeine) was compared with placebo or no treatment for apnea in preterm infants were included.

    Data collection and analysis

    Methodological quality was assessed independently by the two review authors. Data were extracted independently by the two review authors. Treatment effects were expressed as relative risk (RR) and risk difference (RD) and their 95% confidence intervals, using a fixed effect model. For significant results, the inverse of the risk difference (1/RD) was used to calculate the number needed to treat (NNT).

    Main results

    The results of five trials that enrolled a total of 192 preterm infants with apnea indicate that methylxanthine therapy leads to a reduction in apnea and use of IPPV in the first two to seven days. There are insufficient data to adequately evaluate side effects and no data to examine effects within different gestational age groups. There are no data in the included studies that examine long-term effects.

    Authors' conclusions

    Methylxanthines are effective in reducing the number of apneic attacks and the use of mechanical ventilation in the two to seven days after starting treatment. In view of its lower toxicity, caffeine would be the preferred drug. The effects of methylxanthines on long-term outcomes will be addressed in data from the trial awaiting assessment (CAP Trial 2006).

    Implications  Methylxanthines are effective in reducing the number of apneic attacks in the short-term and in reducing the use of mechanical ventilation. In view of its lower toxicity, caffeine would be the preferred drug. In included studies, the safety of methylxanthine therapy is uncertain, especially in terms of lack of long-term growth and neurodevelopment outcomes.

    Citation  Henderson-Smart DJ, Steer PA. Methylxanthine treatment for apnea in preterm infants. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD000140. DOI: 10.1002/14651858.CD000140.

     

  • ARIPIPRAZOLE VERSUS TYPICAL ANTIPSYCHOTIC DRUGS FOR SCHIZOPHRENIA

    Authors  Bhattacharjee Jayanti, El-Sayeh Hany George G

    Review Group  Cochrane Schizophrenia Group

    Abstract  Aripiprazole is a relatively new antipsychotic drug, said to be the prototype of a new third generation of antipsychotics; the so-called dopamine-serotonin system stabilisers. In this review we examine how the efficacy and tolerability of aripiprazole differs from that of typical antipsychotics.

    Objectives

    To evaluate the effects of aripiprazole compared with other typical antipsychotics for people with schizophrenia and schizophrenia-like psychoses.

    Search strategy

    We searched the Cochrane Schizophrenia Group Trials Register (November 2007) which is based on regular searches of BIOSIS, CENTRAL, CINAHL, EMBASE, MEDLINE and PsycINFO. We inspected references of all identified studies for further trials. We contacted relevant pharmaceutical companies, drug approval agencies and authors of trials for additional information.

    Selection criteria

    We included all randomised trials comparing aripiprazole with typical antipsychotics in people with schizophrenia or schizophrenia-like psychosis.

    Data collection and analysis

    We extracted data independently. For dichotomous data we calculated relative risks (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis, based on a random effects model. We calculated numbers needed to treat/harm (NNT/NNH) where appropriate. For continuous data, we calculated weighted mean differences (WMD) again based on a random effects model. We have contacted representatives of Bristol Myers Squibb pharmaceuticals (UK) for additional data.

    Main results

    We included nine randomised trials involving 3122 people comparing aripiprazole with typical antipsychotic drugs. None of the studies reported on relapse - our primary outcome of interest. Attrition from studies was high and data reporting poor. Participants given aripiprazole were comparable to those receiving typical drugs in improving global state and mental state. Aripiprazole provided a significant advantage over typical antipsychotics in terms of fewer occurrences of extra-pyramidal symptom (n=968, 3 RCT, RR 0.46 CI 0.3 to 0.9, NNT 13 CI 17 to 10), and particularly akathisia (n=897, 3 RCT, RR 0.39 CI 0.3 to 0.6, NNT 11 CI 14 to 9). Fewer participants given aripiprazole developed hyperprolactinaemia (n=300, 1 RCT, RR 0.07 CI 0.03 to 0.2, NNT 2 CI 3 to 1). Aripiprazole presented a lesser risk of sinus tachycardia (n=289, 1 RCT, RR 0.09 CI 0.01 to 0.8, NNT 22 CI 63 to 13) and blurred vision (n=308, 1 RCT, RR 0.19 CI 0.1 to 0.7, NNT 14 CI 25 to 10); but enhanced risk of occurrence of dizziness (n=957, 3 RCT, RR 1.88 CI 1.1 to 3.2, NNH 20 CI 33 to 14) and nausea (n=957, 3 RCT, RR 3.03 CI 1.5 to 6.1, NNH 17 CI 25 to 13). Attrition rates were high in both groups, although significantly more participants in the aripiprazole group completed the study in the long term (n=1294, 1 RCT, RR 0.81 CI 0.8 to 0.9 NNT 8 CI 5 to 14).

    Authors' conclusions

    Aripiprazole differs little from typical antipsychotic drugs with respect to efficacy, however it presents significant advantages in terms of tolerability. Clearly reported pragmatic short, medium and long term randomised controlled trials are required to replicate and validate these findings and determine the position of aripiprazole in everyday clinical practice.

    Implications

    1.   For people with schizophrenia
    Aripiprazole is not clearly more or less effective than typical antipsychotics in terms of improving global outcomes or mental state. However it confers a significant advantage over older drugs in terms of fewer occurrences of extra-pyramidal symptom related adverse events, but it is more likely to cause dizziness and nausea. Hyperprolactinaemia and associated complications of unpleasant breast pain and secretion and osteoporosis do not seem to be a significant concern with aripiprazole; while they remain adverse effects commonly seen with the older drugs. There appears to be a lesser chance of developing sinus tachycardia whilst taking aripiprazole even though it does not present any significant advantages over the typical drugs in causing QTc abnormalities.
    2.   For clinicians
    Aripiprazole appears to be as efficacious and effective as the comparator typical antipsychotic drugs in the included studies. It presents a significantly favourable adverse effect profile when compared to the older drugs. This suggests a significant advantage over typical drugs in ensuring compliance. However aripiprazole has been compared to haloperidol, perphenazine, and chlorpromazine in the studies included in this review and a sensitivity analysis could not be conducted due to lack of adequate relevant data; it cannot therefore be definitively concluded that it is as effective as or better tolerated than all typical antipsychotic drugs at various dose ranges. More studies are needed to replicate and validate these findings.
    3.   For managers/policy makers
    No data has emerged about service outcomes. Data about economic outcomes are minimal and insignificant. Even though aripiprazole appears to be an efficacious and effective drug there is inadequate data about medium and long-term outcomes. In the context of finite resources, the lack of good quality data leaves managers and policy makers with difficult decisions to make.

    Citation  Bhattacharjee J, El-Sayeh HGG. Aripiprazole versus typical antipsychotic drugs for schizophrenia. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD006617. DOI: 10.1002/14651858.CD006617.pub3.

     

  • WHICH SHORT-CHAIN CARBS ARE THE VILLAINS IN IBS?

    Researchers challenged IBS patients with dietary fructose, fructans, and glucose.

    Malabsorption of fructose and other short-chain carbohydrates is thought to produce symptoms of irritable bowel syndrome (IBS). Common dietary sources of fructose include fruits, honey, and high-fructose corn syrup. Some carbohydrates, such as fructo-oligosaccharides (fructans) and galactosaccharides (e.g., raffinose), cannot be absorbed by humans.

    Now, in a double-blind, randomized, crossover trial, researchers have assessed the effects of fructose and fructans (alone or in combination) as dietary triggers of IBS symptoms. Twenty-five patients with known fructose malabsorption were challenged by graded-dose introduction of fructose, fructans, the combination, or a glucose control administered as drinks with meals for a 2-week test period, followed by a 10-day washout period.

    In a dose-dependent manner, fructose reproduced IBS symptoms in 70% of patients, fructans reproduced symptoms in 77%, and the combination induced symptoms in 79%. Only 14% of those challenged with glucose showed IBS symptoms (P≤0.002).

    Comment: Up to 40% of patients with IBS have been shown to absorb fructose incompletely (JW Gastroenterol Sep 28 2007). In this study, IBS symptoms were induced by either fructose or fructans, indicating that symptoms are reproduced by the bowel’s response to delivery of undigested carbohydrates to the colon and distal small bowel. These data supply more evidence to suggest that carbohydrate malabsorption plays a role in the pathogenesis of IBS symptoms. Douglas K. Rex, MD

     

  • NICONTINIC ACID – THE NEW OLD WONDER DRUG
    Many patients with coronary heart disease (CHD) or its equivalent will need a >50% reduction in low-density lipoprotein (LDL) cholesterol to achieve the LDL goal of <100 mg/dl. There are also patients with what the National Cholesterol Education Program calls “atherogenic dyslipidemia,” which includes a nasty metabolic stew of elevated triglycerides, low high-density lipoprotein (HDL) cholesterol, prothrombotic and proinflammatory states, and a preponderance of small, dense LDL particles, which are highly atherogenic and strongly predict cardiovascular events (Slide1)1 Moreover, all of the processes involved in atherogenesis can be exacerbated by insulin resistance and/or the metabolic syndrome (Slide 2).2

    There are numerous treatments that, to varying degrees, affect atherogenic dyslipidemia (Slide 3). While statins have dramatic effects on LDL cholesterol, they have little impact on the overall atherogenic lipoprotein profile (ALP). Interventions that improve ALP include fat weight loss, exercise, and good control of diabetes. One therapy that is particularly effective at improving ALP is nicotinic acid.2 (When the biological significance of nicotinic acid was recognized, there was a desire to distinguish it from nicotine; thus, it was named niacin from the words “nicotinic acid vitamin.”)

    In recent years, niacin has gained recognition as an atheroprotective agent, in part because of its capacity to lower plasma levels of cholesterol, triglycerides, and very-low- and low-density lipoproteins. Also, of currently approved drugs, niacin is the most effective at raising HDL cholesterol levels. However, there have been concerns, too, that niacin might increase insulin resistance and have adverse effects on blood glucose levels.

    Combination Therapy

    Current guidelines recommend consideration of combination drug therapy to achieve optimal low-density LDL cholesterol lowering and broader lipid-altering effects when treating hypercholesterolemic patients at high risk for atherosclerotic cardiovascular events.1 Because statins and niacin have potentially complementary actions, several studies have evaluated combination regimens.

    For example, investigators sought to determine whether intensive lipid therapy with a niacin-containing regimen would have a beneficial effect on cardiovascular disease, despite any increase in plasma glucose and insulin resistance in subjects with the metabolic syndrome. They evaluated 3 years of treatment with slow-release niacin plus simvastatin (N+S) on both angiographic and clinical outcomes in 160 subjects with coronary artery disease (CAD) and low levels of HDL from the HDL-Atherosclerosis Treatment Study (HATS).3

    Treating atherogenic dyslipidemia with combination therapy led to substantial benefits in terms of stenosis progression and clinical events, independently of whether the patient had metabolic syndrome or was insulin resistant. During the 3-year period, the beneficial effect of niacin in combination with simvastatin appeared to offset a modest adverse effect of niacin on glucose metabolism and insulin resistance in higher risk patients, “as long as careful attention is paid to glycemic control.”

    In another study, niacin extended release (niacin-ER) plus lovastatin was comparable to atorvastatin 10 mg and more effective than simvastatin 20 mg in reducing LDL cholesterol.4 The combination also was more effective in increasing HDL cholesterol than either atorvastatin or simvastatin and provided greater global improvements in non-HDL cholesterol, triglycerides, and lipoprotein(a) (Slide 4).

    Recently, investigators evaluated ezetimibe/simvastatin (E/S) plus niacin-ER in patients with type IIa or IIb hyperlipidemia.5 In this 24-week multicenter, double-blind study, 1,220 patients were randomized to treatment with E/S (10/20 mg/day), the same range of E/S per day plus niacin (titrated to 2 g/day), or niacin alone (titrated to 2 g/day).

    Coadministration of E/S with niacin-ER resulted in numerous beneficial effects (Slide 5), including significantly greater reductions in LDL cholesterol, non-HDL cholesterol, triglycerides, apolipoprotein B, and lipid/lipoprotein ratios, compared with either agent alone (p < 0.001). The combination increased levels of apolipoprotein A-I and HDL cholesterol significantly more than E/S (p < 0.001), and reduced high-sensitivity C-reactive protein levels significantly more than niacin alone (p = 0.005). The three-drug regimen was generally well tolerated aside from some niacin-associated flushing.

    Safety of Combo Rx

    In a recent State-of-the-Art paper for JACC, Davidson and Robinson reviewed the safety of aggressive lipid management.6 In a pooled analysis, ezetimibe + simvastatin 80 mg on average resulted in a 57% reduction in LDL, and ezetimibe + atorvastatin 80 mg in 60% reduction in LDL.7 E/S resulted in a similar rate of treatment-related discontinuation as simvastatin monotherapy. No differences in muscle-related adverse events were found between 4,558 subjects receiving E/S and 2,563 subjects who received simvastatin alone in this analysis of 17 12-week trials. Hepatic enzyme elevations ≥3x ULN on two or more occasions occurred in 1.4% of 925 ezetimibe + statin-treated subjects compared with 0.4% of 936 statin-only subjects. However, hospitalization for hepatic events was no higher for ezetimibe + statin combinations than for statin monotherapy.

    How does the addition of niacin to a statin effect safety endpoints? As mentioned, HATS randomized 160 subjects to placebo or to simvastatin + niacin (mean doses of simvastatin 13 mg and niacin 2.4 g). No cases of persistent ALT or CK elevations were found, and no cases of myopathy or rhabdomyolysis were reported. The ongoing AIM-HIGH trial will evaluate whether the addition of niacin-ER to simvastatin will result in a cardiovascular risk reduction greater than expected based on the degree of LDL lowering.

    Safety data also were recently published from both the OCEANS and SEACOAST studies evaluating niacin-ER and simvastatin.8,9 Combination therapy was consistent with the safety profile of each individual component.

    In April 2008, investigators published the results of adverse events reported to the U.S. Food and Drug Administration (FDA).10 The analyses demonstrated that niacin-ER has a significantly better safety profile compared with other niacin formulations and compares favorably with other commonly used lipid-altering drugs, including statins and fibrates. In addition, analyses of FDA adverse event reports of the pill combining lovastatin and niacin-ER suggest that the safety of combination therapy to comparable with the safety of each of the drugs alone.

    At about the same time, Goldberg and Jacobson reported the results of an extensive literature review evaluating the effects of niacin on glucose control in patients with dyslipidemia.11 They found that niacin (≤2.5 g/d), alone or in combination with statins, has only modest, transient or reversible effects on plasma glucose, and these effects are “typically amenable to adjustments in oral hypoglycemic regimens without discontinuing niacin.”

    What about triple-drug combination therapy? In the previously mentioned study of E/S with or without niacin therapy, triple therapy was generally well tolerated and showed a safety profile consistent with prior experience using these agents alone or in combination. This suggests that E/S plus niacin-ER may be an option in patients at high risk for CHD including those with diabetes, metabolic syndrome, and obesity, in whom polypharmacy otherwise might be a concern. The rates of serious adverse events were comparable for all treatment arms, and there were no statistically significant differences in muscle, liver, and gastrointestinal adverse events.

    Also, the Davidson and Robinson paper cited one study that formally evaluated the safety of triple therapy. A moderate dose of lovastatin (40 mg) was combined with niacin 200 mg and colestipol 20 g and evaluated in a crossover trial in 29 middle-aged men with CHD. This regimen resulted in 54-60% reduction in LDL, depending on the niacin formulation. Only 21% of subjects reported the regimen was "very easy" to take, although 79% thought it was "fairly easy." The primary adverse effects were cutaneous, which were less when sustained-release niacin formulations were used. No data on laboratory abnormalities or musculoskeletal complaints were reported.

    This interview features H. Robert Superko, MD, FACC, renowned for his work in metabolic heart disease diagnosis and treatment as well as research and publications on the effects of lipoprotein subclasses. He discusses the mechanism of action of nicotinic acid, new formulations that are increasing the interest in niacin therapy, and the value of using nicotinic acid in combination therapy.

    Source
    Content provided by the American College of Cardiology Foundation

    [Cardiosource CME link for American College of Cardiology members]

     

  • TO MAINTAIN WEIGHT LOSS, EXERCISE EVEN MORE

    Women who maintained a 10% weight loss during a 2-year study had better eating habits and more leisure-time physical activity than did those who regained weight lost during the first 6 months.

    Experts generally recommend a minimum of 30 minutes of moderate-intensity activity on most days of the week (150 minutes weekly), but substantially more exercise probably is necessary to lose weight and to keep it off. Investigators randomized 191 overweight and obese women who were attending a weight-loss clinic into four groups: high or moderate energy expenditure (2000 vs. 1000 kcal/week) in the form of vigorous- or moderate-intensity exercise. Participants also were instructed to maintain a prescribed, reduced-caloric intake; all received intensive weight-loss counseling, regular group visits, and periodic telephone contact. Previous data from this study showed that average 12-month weight losses of 10% and 8% from baseline were associated with high and moderate amounts of exercise, respectively (JW Womens Health Nov 18 2003).

    At 24 months, each group had regained on average about half the weight lost during the first 6 months. However, the 47 women who maintained weight loss of ≥10% had increased their leisure-time physical activity from baseline by a mean of 1515 kcal weekly — substantially more than did women whose weight returned to or exceeded baseline (mean of 480 kcal weekly). No group maintained all of the eating behavior improvements seen at 6 months; however, at 24 months, women who kept their weight at least 10% below baseline retained more of the recommended eating behaviors than did other participants.

    Comment: Once again, a study illustrates the difficulty of losing weight and keeping it off — even among highly motivated women enrolled in a weight-loss clinic and given significant support and resources (each participant received a treadmill). As backsliding occurred, the women regained weight. Those who sustained 10% weight losses during 2 years engaged in a level of physical activity that was approximately twice the typical public health recommendation. Considering the difficulty that overweight adults have in maintaining substantial weight loss, healthcare providers should continue to take a proactive stance toward minimizing weight gain in children and young adults, while also promoting more physical activity for all. Wendy S. Biggs, MD 

     

  • PERSONALIZED MEDICINE FOR QUITTING SMOKING

    Another step toward personalized medicine

    Assessing polymorphisms of cytochrome P450 (CYP) enzymes that metabolize bupropion might help to predict efficacy for smoking cessation (JW Psychiatry Nov 19 2007), but the cost-benefit ratio of testing has not seemed dramatic. Because people who metabolize nicotine rapidly have low between-cigarette nicotine levels and poor success in quitting smoking with nonpharmacologic treatments, these researchers investigated whether a marker of nicotine metabolism rate (NMR) would predict quit rates. In a 10-week study, 414 smokers (average, 1 pack/day) were randomized to counseling plus bupropion or placebo. NMR was measured by the ratio of trans-3´-hydroxycotinine to cotinine, two sequential metabolites of nicotine via CYP2A6.
    Among the slowest nicotine metabolizers (bottom NMR quartile), bupropion and placebo recipients had the same rate of smoking abstinence (32%) at the end of the trial and similar rates of maintenance of abstinence at 6-month follow-up. In contrast, among the fastest nicotine metabolizers (top NMR quartile), bupropion was associated with significantly higher rates than placebo for quitting at the end of treatment (34% vs. 10%; odds ratio, 4.84) and for maintenance at 6 months (27% vs. 8%; OR, 4.48).

    Comment: People who slowly metabolize nicotine seem to have no need for bupropion; they get good results with behavioral methods alone. Rapid metabolizers have poorer results and higher relapse rates with counseling alone, presumably because their nicotine levels drop swiftly, leading to intense craving. Nicotine supplements also might not be helpful because they will be eliminated too rapidly.

    Nicotine metabolism, but not bupropion metabolism, is dependent on CYP3A4; genotyping of this enzyme would predict outcomes only weakly because various environmental factors and unidentified alleles influence the enzyme’s activity. Measuring metabolism of both bupropion and nicotine might be useful in predicting responders to bupropion. Steven Dubovsky, MD 
     
  • RANDOMIZED COMPARISON OF GUAIAC-BASED VS. IMMUNOCHEMICAL FOBT  Douglas K. Rex, MD 

    Immunochemical FOBT’s better sensitivity but lower specificity for detecting cancer and advanced adenomas (compared with guaiac-based FOBT) led to similar positive predictive values for the two test types.

    The Joint Colorectal Cancer Screening Guideline recommends that fecal occult blood testing (FOBT) be performed using immunochemical methods rather than guaiac-based methods (JW Gastroenterol Apr 4 2008). However, direct comparisons between the two test types have been performed only in patients at high risk for, or previously diagnosed with, colorectal cancer (CRC).
    Now, investigators have prospectively compared the performance of guaiac-based FOBT (Hemoccult II) and immunochemical FOBT (OC-Sensor) in a general screening population. A random sample of 20,623 older Dutch adults (age range, 50-75) underwent CRC screening with one of the two types of tests. A standard cutoff of 100 ng/mL was used for immunochemical FOBT. Positive results on either type of FOBT were verified with colonoscopy.

    The proportion of completed tests was significantly higher for immunochemical FOBT than for guaiac-based FOBT (6157 vs. 4836). A total of 456 individuals had positive FOBT results; the positivity rate was higher with immunochemical FOBT than with guaiac-based FOBT (5.5% vs. 2.4%; P<0.01). Immunochemical FOBT detected cancer and advanced adenomas more often than did guaiac-based FOBT (24 vs. 11 cases and 121 vs. 46 cases, respectively). However, immunochemical FOBT was 2.3% less specific than was guaiac-based FOBT for detecting cancer and 1.3% less specific for detecting advanced adenomas.

    Comment: Immunochemical FOBT’s better sensitivity but lower specificity for detecting cancer and advanced adenomas (compared with guaiac-based FOBT) led to similar positive predictive values for the two test types. Although wider use of immunochemical FOBT would result in more colonoscopies, it would also lead to the detection of substantially more neoplasias, and the positive predictive value would be comparable to that seen with guaiac-based FOBT. The study’s authors could not explain the higher number of completed immunochemical tests, but this finding indicates a strong patient preference for immunochemical FOBT. Overall, these results support the Joint Colorectal Cancer Screening Guideline recommendations to abandon older guaiac-based cards in favor of immunochemical FOBT.
     
  • OTC COUGH AND COLD MEDICINES - PRODUCT LABELS BEING MODIFIED TO STATE "DO NOT USE" IN CHILDREN UNDER 4 YEARS OF AGE 10/09/2008

    FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.
     
    GALLBALDDER DISEASE AND USE OF TRANSDERMAL VERSUS ORAL HORMONE REPLACEMENT THERAPY IN POSTMENOPAUSAL WOMEN: PROSPECTIVE COHORT STUDY

    Bette Liu, clinical epidemiologist1, Valerie Beral, professor of epidemiology1, Angela Balkwill, statistical programmer1, Jane Green, clinical research scientist1, Siân Sweetland, statisticial epidemiologist1, Gillian Reeves, statistical epidemiologist1, for the Million Women Study Collaborators 1 Epidemiology Unit, University of Oxford, Oxford OX3 7LF Correspondence to: B Liu Bette.Liu@ceu.ox.ac.uk

    Objective To determine whether transdermal compared with oral use of hormone replacement therapy reduces the risk of gallbladder disease in postmenopausal women.

    Design Prospective cohort study (Million Women Study).

    Setting Women registered with the National Health Service (NHS) in England and Scotland.

    Participants 1 001 391 postmenopausal women (mean age 56) recruited between 1996 and 2001 from NHS breast screening centers and followed by record linkage to routinely collected NHS hospital admission data for gallbladder disease.

    Main outcome measures Adjusted relative risk and standardized incidence rates of hospital admission for gallbladder disease or cholecystectomy according to use of hormone replacement therapy.

    Results During follow-up 19 889 women were admitted for gallbladder disease; 17 190 (86%) had a cholecystectomy. Compared with never users of hormone replacement therapy, current users were more likely to be admitted for gallbladder disease (relative risk 1.64, 95% confidence interval 1.58 to 1.69) but risks were substantially lower with transdermal therapy than with oral therapy (relative risk 1.17, 1.10 to 1.24 v 1.74, 1.68 to 1.80; heterogeneity P<0.001). Among women using oral therapy, equine oestrogens were associated with a slightly greater risk of gallbladder disease than estradiol (relative risk 1.79, 1.72 to 1.87 v 1.62, 1.54 to 1.70; heterogeneity P<0.001) and higher doses of estrogen increased the risk more than lower doses: for equine estrogens >0.625 mg, 1.91 (1.78 to 2.04) v ≤0.625 mg, 1.76 (1.68 to 1.84); heterogeneity P=0.02; estradiol >1 mg, 1.68 (1.59 to 1.77) v ≤1 mg, 1.44 (1.31 to 1.59); heterogeneity P=0.003. The risk of gallbladder disease decreased with time since stopping therapy (trend P=0.004). Results were similar taking cholecystectomy as the outcome. Standardized hospital admission rates per 100 women over five years for cholecystectomy were 1.1 in never users, 1.3 with transdermal therapy, and 2.0 with oral therapy.

    Conclusion Gallbladder disease is common in postmenopausal women and use of hormone replacement therapy increases the risk. Use of transdermal therapy rather than oral therapy over a five year period could avoid one cholecystectomy in every 140 users.

     

  • CONTINUOUS GLUCOSE MONITORING IN TYPE 1 DIABETES Allan S. Brett, MD

    Published in Journal Watch General Medicine September 30, 2008

    Continuous monitoring helped lower HbA1c levels in patients who were older than 24, but not in children, adolescents, or younger adults.

    Continuous glucose monitoring devices, which measure interstitial glucose via subcutaneous sensors, now are available commercially. To determine the value of such devices, 322 adults and children with type 1 diabetes (glycosylated hemoglobin [HbA1c] level, 7%–10%) were randomized to continuous glucose monitoring or to conventional monitoring (fingerstick testing ≥4 times daily). Three prespecified age subgroups were enrolled: 8 to 14 years, 15 to 24 years, and 25 or older. Patients used either insulin pumps or multiple daily insulin injections and were instructed on adjusting insulin doses according to monitoring results.

    Among patients who were 25 or older, mean HbA1c concentration decreased by a mean of 0.5 percentage points at 26 weeks in the continuous monitoring group but remained unchanged in the conventional monitoring group — a significant difference. In contrast, among younger patients, continuous monitoring did not lower mean HbA1c levels more than conventional monitoring did. Continuous monitoring improved most secondary endpoints in the oldest patients and some endpoints (e.g., proportion of subjects with HbA levels <7% at 26 weeks) in the youngest patients, but among 15- to 24-year-olds, no significant differences emerged. Within the continuous monitoring groups, those in the 15- to 24-year-old group were less adherent to sensor use than were older or younger patients. Rates of hypoglycemia were similar with continuous and conventional monitoring in all age groups.

    Comment: Not surprisingly, continuous glucose monitoring was most effective in patients who were 25 or older and was no better than conventional monitoring in adolescents and very young adults. Continuous monitoring is expensive, has some accuracy limitations, and requires patient motivation. Although this method is appealing theoretically, the extent to which it will improve long-term clinical outcomes remains to be determined.

     

  • DECONGENSTANTS AND ANTIHISTAMINES FOR ACUTE OTITIS MEDIA IN CHILDREN

    Authors  Coleman Cassie, Moore Michael

    Review Group  Cochrane Acute Respiratory Infections Group

    Abstract  Acute otitis media (AOM) is a common and important source of morbidity in children, although the majority of cases resolve spontaneously. While frequently recommended, decongestant and antihistamine therapy is of unclear benefit. Objectives To determine the efficacy of decongestant and antihistamine therapy in children with AOM on outcomes of AOM resolution, symptom resolution, medication side effects, and complications of AOM.Search strategy In this updated review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, Issue 2); MEDLINE (January 2004 to May 2007); and EMBASE (July 2003 to May 2007).Selection criteria Randomized controlled trials (RCTs) evaluating decongestant or antihistamine treatment for children with AOM were included. Patient-oriented outcomes were considered most relevant. Data collection and analysis: The review authors independently evaluated studies for inclusion, performed validity assessments and completed data extraction. Dichotomous data were pooled to generate relative risks; homogeneity was assessed using approximate chi-square tests. Main results No new studies were included following this updated search. Fifteen trials involving 2695 people were included. Only the combined decongestant-antihistamine group demonstrated statistically lower rates of persistent AOM at the two week period (fixed relative risk (RR) 0.76; 95% confidence interval (CI) 0.60 to 0.96; number needed to treat (NNT) 10). No benefit was found for early cure rates, symptom resolution, prevention of surgery or other complications. There was a five to eight -fold increased risk of side effects for those receiving an intervention, which reached statistical significance for all decongestant groupings. Validity sub analyses demonstrated that lower quality studies found benefit, while analysis of those studies with higher validity scores found no benefit of treatment. Authors' conclusions Given lack of benefit and increased risk of side effects, these data do not support the use of decongestant treatment in children with AOM. There was a small statistical benefit from combination medication use but the clinical significance is minimal and study design may be biasing the results. Thus, the routine use of antihistamines for treating AOM in children cannot be recommended.

    Implications  This review did not find sufficient statistical or clinical benefit to decongestant, antihistamine or combination therapy for AOM. Treatment groups, however, experienced an increased risk of side effects. The current evidence suggests that decongestants and/or antihistamines not be routinely used to treat children with AOM.

    Citation  Coleman C, Moore M. Decongestants and antihistamines for acute otitis media in children. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD001727. DOI: 10.1002/14651858.CD001727.pub4.

     

  • RECOMMENDATIONS FOR TREATING LOW BONE DENSITY/OSTEOPOROSIS TO PREVENT FRACTURES
     

    Summary  The American College of Physicians has made four recommendations for treating low bone density/osteoporosis in an attempt to prevent fractures: 1) Patients with osteoporosis and those who have had fragility fractures should receive pharmacologic treatment; 2) Clinicians should consider pharmacologic treatment of patients at risk for developing osteoporosis; 3) Pharmacologic treatment should be based on a risk/benefit assessment in individual patients; 4) More research in needed to evaluate treatments for osteoporosis.

    Basis for Study/Article  The American College of Physicians “developed this guideline to present the available evidence on various pharmacologic treatments to prevent fracture in men and women with low bone density or osteoporosis.”

    Detailed Summary of Study  The authors conducted a literature search for relevant articles and analyzed the data.

    Results/Body  1) Patients with osteoporosis and those who have had fragility fractures should receive pharmacologic treatment (strong recommendation, high-quality evidence); 2) Clinicians should consider pharmacologic treatment of patients at risk for developing osteoporosis (weak recommendation, moderate-quality evidence); 3) Pharmacologic treatment should be based on a risk/benefit assessment in individual patients (strong recommendation, moderate-quality evidence); 4) More research in needed to evaluate treatments for osteoporosis.

    Sources & Other Links  Qaseem A, et al. Pharmacologic treatment of low bone density or osteoporosis to prevent fractures: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2008 Sep 16;149(6):404-15.

    Article Link (NCBI)

     

  • FEMORAL NECK STRENGTH IS HIGHER IN BOYS; INTENSITY OF ACTIVITY PREDICTS STRENGTH
     

    Summary  In 9-year-olds, the intensity of physical activity is a predictor of femoral neck strength, although it does not fully account for the greater bone strength in boys. “Daily vigorous physical activity for at least approximately 25 minutes seems to improve femoral neck bone health in children.”

    Basis for Study/Article This study from Portugal examined whether the intensity and duration of physical activity affected femoral neck strength and the bone mineral density of the femoral neck, lumbar spine and total body in children.

    Detailed Summary of Study  DEXA scans were done in 143 girls and 150 boys (mean age 9.7 years), and their physical activity was assessed using accelerometry. Compressive, bending and impact strengths were calculated.

    Results/Body  Gender differences of 9% for compressive strength, 10% for bending strength and 9% for impact strength were found. Vigorous physical activity was “the main physical activity predictor of femoral neck strength but did not explain gender differences.” The most active boys (top 50%) had higher values on all the strength ratings than the least active (bottom 25%) boys. In girls, the only difference between the most active (top 25%) and least active (bottom 25%) groups was bending strength. Physical activity did not affect lumbar spine strength.

    Sources & Other Links  Sardinha LB, et al. Objectively measured physical activity and bone strength in 9-year-old boys and girls. Pediatrics. 2008 Sep;122(3):e728-36.

    Article Link (NCBI)

     

  • ON SCREENING COLONOSCOPY, BLACK PATIENTS HAVE HIGHER RISK OF POLYPS >9 mm
     

    Summary  This multicenter study found that on screening colonoscopy of asymptomatic patients, the prevalence of polyps larger than 9 mm is 7.7% in black patients vs. 6.2% in white patients. Although the prevalence of proximal polyps <9 mm was similar between the races, the incidence was higher in blacks older than 60.

    Basis for Study/Article Black patients have a higher incidence of colorectal cancer and a higher mortality rate. This trial compared screening colonoscopy findings in asymptomatic black vs. white patients.

    Detailed Summary of Study  The study comprised 80,061 white patients and 5,464 black patients undergoing screening colonoscopy at 67 adult GI practice sites. The prevalence and location of polyps larger than 9 mm were recorded.

    Results/Body  The prevalence of polyps larger than 9 mm was 7.7% in black patients vs. 6.2% in white patients; adjusted odds ratios were 1.16 for black men and 1.62 for black women. The prevalence of proximal polyps <9 mm was similar between the groups, but they were more common in black patients older than 60.

    Sources & Other Links  Lieberman DA, et al. Prevalence of colon polyps detected by colonoscopy screening in asymptomatic black and white patients. JAMA. 2008;300(12):1417-22.

    Article Link (NCBI)

     

  • FDA APPROVES UPDATED LABELING FOR PSORIASIS DRUG RAPTIVA
    Safety concerns drove labeling changes

    The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA's post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

    Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy to control their psoriasis.

    The FDA's Office of Surveillance and Epidemiology, charged by the Agency with monitoring drugs once approved for the marketplace, has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva.

    The now-required Boxed Warning will highlight the risk of bacterial sepsis, viral meningitis, invasive fungal disease, progressive multifocal leukoencephalopathy and other opportunistic infections.

    Additionally, Raptiva's label will be updated to include data from juvenile animal studies in mice (age equivalent to a 1-14 year old human). These data indicate a potential risk for the permanent suppression of the immune system with repeat administration of Raptiva in this age group. Raptiva is not approved for children under 18 years of age.

    "As part of FDA's monitoring of the life-cycle of approved products, the agency received reports of serious infections in some patients taking Raptiva. These reports led to our decision to highlight these risks in the drugs labeling," said Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research. "Doctors and other prescribers should carefully evaluate and weigh the risk/benefit profile of Raptiva for patients who would be more susceptible to these risks."

    Raptiva works by suppressing the immune system to reduce psoriasis flare-ups, however by suppressing the body's natural defense system, it can also increase the risk of serious infections and malignancies in patients.

    Patients identified to begin therapy with Raptiva should have received all their age-appropriate vaccinations before starting the drug. Vaccinations should not be administered to patients taking Raptiva because immunity to the vaccination virus may not be conferred.

    Patients taking Raptiva should be educated about recognizing the signs and symptoms of infection, PML (confusion, dizziness or loss of balance, difficulty talking or walking, and vision problems), anemia (dizziness upon standing, weakness or jaundice), thrombocytopenia (bruising, bleeding gums, pin-point sized red or purple dots under the skin), or the worsening of their psoriasis or arthritis. Signs of a nervous system disorder include sudden onset of numbness, tingling or weakness in the arms, legs or face.

    If any of these signs appear, Raptiva patients should seek immediate medical attention. Patients with pre-existing infections or who have a compromised immune system should notify their health care professional before beginning treatment with Raptiva.

    Because reports of these adverse events were received voluntarily from populations of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug's use.

    One report of PML in a Raptiva-treated patient came from an ongoing post-marketing epidemiological study of patients with psoriasis.

    Health care professionals should monitor patients treated with Raptiva for the signs and symptoms of these adverse events and also instruct patients to report any such signs and symptoms to them without delay.

    Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online at www.fda.gov/medwatch/report.htm.

    Raptiva was approved in 2003. It is manufactured by Genentech, Inc. of San Francisco, Calif.

     
  • SEQUENTIAL THERAPY MAY BE EFFECTIVE FOR DRUG-RESISTANT H. PYLORI

    Summary  Sequential therapy consisting of 10 days of a PPI, with amoxicillin for the first 5 days and clarithromycin and tinidazole for the second 5 days, may be an effective way to treat infection with H. pylori, which is increasingly becoming resistant to standard medications.

    Basis for Study/Article  This article examines the effectiveness of various treatment strategies for H. pylori infection, given that “the rate of treatment failure associated with established drug regimens has increased at a rapid rate.”

    Detailed Summary of Study  H. pylori is becoming increasingly resistant to clarithromycin and metronidazole. The authors reviewed the effectiveness of standard regimens vs. sequential therapy for H. pylori infection.

    Results/Body  A large recent U.S. randomized trial showed that “triple therapy” (7 to 10 days of a PPI plus clarithromycin and amoxicillin) has an H. pylori eradication rate of 78%. The eradication rate for “quadruple therapy” (bismuth, metronidazole, tetracycline, and a PPI) was 87.7% in a 1999 study, before resistance became widespread. In contrast, sequential therapy—10 days of a standard-dose PPI b.i.d., with amoxicillin (1 g b.i.d.) for the first 5 days and clarithromycin (500 mg b.i.d.) and tinidazole (500 mg b.i.d.) for the second 5 day—showed higher eradication rates in several studies, with acceptable adherence rates. It was even effective in patients with infection that was resistant to clarithromycin. The authors also discuss the limited role of treatment with levofloxacin and rifabutin.

    Sources & Other Links  Vakil N, et al. Sequential therapy for Helicobacter pylori: time to consider making the switch? JAMA. 2008 Sep 17;300(11):1346-7.

     
  • IN OLDER WOMEN, HOSPITALIZATION FOR NONSPECIFIC CHEST PAIN DOUBLES RISK FOR CAD EVENT

    Summary  In postmenopausal women, hospital admission for nonspecific chest pain doubles the risk for a coronary artery disease event in the next 5 to 7 years. These women are “candidates for aggressive risk factor treatment.” Hormone replacement therapy does not affect the risk of either hospitalization for nonspecific chest pain or a subsequent CAD event.

    Basis for Study/Article  The authors explored whether being hospitalized for nonspecific chest pain is associated with a woman’s risk of suffering a CAD event.

    Detailed Summary of Study  This study comprised 9,427 women in the Women’s Health Initiative Estrogen-Alone study (follow-up, 7.1 years) and 15,105 women in the Women’s Health Initiative Estrogen Plus Progestin trial (follow-up, 5.6 years). They were postmenopausal (age 50 to 79) and did not have cardiovascular disease at baseline. Hospital admissions for nonspecific chest pain and subsequent CAD events were recorded.

    Results/Body  322 women in the Estrogen-Alone study and 249 in the Estrogen Plus Progestin trial were hospitalized for nonspecific chest pain. They had double the risk of subsequent nonfatal CAD events, including nonfatal MI (2.3% vs. 1.7%; hazard ratio 2.1), revascularization (3.5% vs. 2.6%; hazard ratio 1.99), and hospitalization for angina (3.7% vs. 2.3%; hazard ratio 2.39).

    Sources & Other Links  Robinson JG, et al. Cardiovascular risk in women with nonspecific chest pain (from the Women’s Health Initiative Hormone Trials). Am J Cardiol. 2008 Sep 15;102(6):693-9.  Article Link (NCBI)

     

  • OTC COUGH AND COLD MEDICINES - PRODUCT LABELS BEING MODIFIED TO STATE "DO NOT USE" IN CHILDREN UNDER 4 YEARS OF AGE

    MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    FDA notified healthcare professionals and consumers that the Consumer Healthcare Products Association (CHPA) is voluntarily modifying the product labels for consumers of over the counter (OTC) cough and cold medicines to state "do not use" in children under 4 years of age. FDA supports CHPA members to help prevent and reduce misuse and to better inform consumers about the safe and effective use of these products for children. FDA continues to assess the safety and efficacy of these products and to revise its OTC list of approved ingredients and amounts for these medicines. Parents and care givers should adhere to the dosage instructions and warnings on the label that accompanies OTC cough and cold medications before giving the product to children, and should consult their healthcare professionals if they have any questions or concerns.

    Read the entire 2008 MedWatch Safety Summaries, including a link to the FDA Press Release regarding the above issue at:

    Snapshot as on GMT: Fri Oct 10 04:50:38 2008

     
  • BRAIN SEROTONIN TRANSPORTER BINDING VARIES WITH THE SEASONS

    Summary  Brain serotonin transporter binding varies with the seasons, with higher levels during periods of less sunshine. “Since higher serotonin transporter density is associated with lower synaptic serotonin levels, regulation of serotonin transporter density by season is a previously undescribed physiologic mechanism that has the potential to explain seasonal changes in normal and pathologic behaviors.”

    Basis for Study/Article  “Brain serotonin is involved in the regulation of physiologic functions, such as mating, feeding, energy balance, and sleep.” This study from Canada examined whether brain serotonin transporter binding varies depending on the amount of daily sunshine.

    Detailed Summary of Study  Regional serotonin transporter binding potential values were obtained from 88 drug-naïve healthy volunteers by PET scanning over 4 years. Levels were then correlated with sunshine levels.

    Results/Body  Serotonin transporter binding levels were higher in all brain regions scanned during the fall and winter, when there was less sunlight.

    Sources & Other Links  Praschak-Rieder N, et al. Seasonal variation in human brain serotonin transporter binding. Arch Gen Psychiatry. 2008 Sep;65(9):1072-8.  Article Link (NCBI)

     

  • SURGERY VERSUS PRIMARY ENDOCRINE THERAPY FOR OPERABLE PRIMARY BREAST CANCER IN ELDERLY WOMEN (70 YEARS PLUS)

    Authors  Hind Daniel, Wyld Lynda, Beverley Catherine, Reed Malcolm W

    Review Group  Cochrane Breast Cancer Group

    Abstract  Several studies have evaluated the clinical effectiveness of endocrine therapy alone in women aged 70 years or over and who are fit for surgery. ObjectivesTo identify and review the evidence from randomised trials comparing primary endocrine therapy (endocrine therapy alone) to surgery, with or without adjuvant endocrine therapy, in the management of women aged 70 years or over with operable breast cancer. Search strategy For this update, the Cochrane Breast Cancer Group Specialised Register was searched 13th November 2007 using the codes for "early breast cancer", "endocrine therapy", "psychosocial" or "surgery". Selection criteria Randomised trials comparing primary endocrine therapy with surgery, with or without adjuvant endocrine therapy, in the management of women aged 70 years or over with early breast cancer and who are fit for surgery.Data collection and analysis Studies were assessed for eligibility and quality, and data from published trials were extracted by two independent reviewers. Hazard ratios were derived for time-to-event outcomes, where possible, and a fixed-effect model was used for meta-analysis. Toxicity and quality-of-life data were extracted, where present. Where outcome data were not available, trialists were contacted and unpublished data requested.Main resultsSeven eligible trials were identified of which six had published time-to-event data and one was published only in abstract form with no usable data. The quality of the allocation concealment was adequate in three studies and unclear in the remainder. In each case the endocrine therapy used was tamoxifen.Data, based on an estimated 869 deaths in 1571 women, were unable to show a statistically significant difference in favour of either surgery or primary endocrine therapy in respect of overall survival. However, there was a statistically significant difference in terms of progression-free survival, which favoured surgery with or without endocrine therapy.The hazard ratios (HR) for overall survival were: 0.98 (95% confidence interval (CI) 0.74 to 1.30, P value 0.9) for surgery alone versus primary endocrine therapy; 0.86 (95% CI 0.73 to 1.00, P value 0.06) for surgery plus endocrine therapy versus primary endocrine therapy. The HRs for progression-free survival were: 0.55 (95% CI 0.39 to 0.77, P value 0.0006) for surgery alone versus primary endocrine therapy; 0.65 (95% CI 0.53 to 0.81, P value 0.0001) for surgery plus endocrine therapy versus primary endocrine therapy (each comparison based on only one trial). Tamoxifen-related adverse effects included hot flushes, skin rash, vaginal discharge, indigestion, breast pain, sleepiness, headache, vertigo, itching, hair loss, cystitis, acute thrombophlebitis, nausea, and indigestion. Surgery-related adverse effects included paresthesia on the ipsilateral arm and lateral thoracic wall in those who had axillary clearance. One study suggested that those undergoing surgery suffered more psychosocial morbidity at three months postsurgery, although this difference had disappeared by two years.Authors' conclusions Primary endocrine therapy should only be offered to women with oestrogen receptor (ER) positive tumours who are unfit for or who refuse surgery. In a cohort of women with significant co-morbid disease and ER-positive tumours it is possible that primary endocrine therapy may be a superior option to surgery. Trials are needed to evaluate the clinical effectiveness of aromatase inhibitors as primary therapy for an infirm older population with ER-positive tumours.

    Implications  Primary endocrine therapy should only be offered to women with ER-positive tumours who are unfit for, or who refuse, surgery. In a cohort of women with reduced life expectancy, due to significant co-morbid disease, and ER-positive tumours, primary endocrine therapy may be an appropriate treatment choice.

    Citation  Hind D, Wyld L, Beverley C, Reed MW. Surgery versus primary endocrine therapy for operable primary breast cancer in elderly women (70 years plus). Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD004272. DOI: 10.1002/14651858.CD004272.pub2.

     
  • IN OLDER WOMEN WITH OSTEOPOROSIS, TIBOLONE REDUCES FRACTURE AND CANCER RISK BUT DOUBLES RISK OF STROKES

    Summary  In older women with osteoporosis, tibolone reduces the risk of fracture, breast cancer, and colon cancer, but it doubles the risk of stroke. Because of the increased risk of stroke, this trial was stopped early.

    Basis for Study/Article  This study examined the effects of tibolone, a synthetic hormone used in HRT, on the risk of fractures, breast cancer, colon cancer, and CV disease in postmenopausal women with osteoporosis.

    Detailed Summary of Study  4,538 women age 60 to 85 (BMD T-score of -2.5 or less at hip or spine, or T-score -2.0 or less and radiographic evidence of vertebral fracture) were randomized to receive tibolone (1.25 mg/day) or placebo. Annual spine radiographs were taken to assess for vertebral fractures, and other fractures, breast cancer, and CV events were also recorded over a median follow-up of 34 months.

    Results/Body  The rate of vertebral fracture was 70/1,000 person-years in the tibolone group vs. 126 in the placebo group (relative hazard 0.55), and the rate of nonvertebral fracture was 122 vs. 166 (relative hazard 0.74). The tibilone group had lower rates of invasive breast cancer (relative hazard 0.32) and colon cancer (relative hazard 0.31). However, the rate of stroke in the tibolone group was more than double that in the placebo group (relative hazard 2.19), and because of this the study was stopped early. The rate of CHD and VTE did not differ between the groups.

    Sources & Other Links  Cummings SR, et al. The effects of tibolone in older postmenopausal women. N Engl J Med. 2008 Aug 14;359(7):697-708.  Article Link (NCBI)

     

  • COST-EFFECTIVENESS OF PPI THERAPY ALONG WITH LOW-DOSE ASPIRIN DEPENDS ON PATIENT'S RISK OF GI BLEEDING

    Summary  In patients at average risk for upper GI bleeding, taking a PPI along with low-dose, long-term aspirin is cost-effective if the drug is purchased OTC. At prescription cost, it would be cost-effective only in patients at high risk for upper GI bleeding.

    Basis for Study/Article  Because of the risk of upper GI bleeding in patients taking long-term low-dose aspirin for CV protection, proton pump inhibitors are often prescribed as well. This study looked at the cost-effectiveness of taking a PPI and low-dose aspirin vs. aspirin alone.

    Detailed Summary of Study  The authors created a statistical model comparing the life-long costs of the two regimens. Variables tested were patient age (range 50 to 80), risk for upper GI bleeding, PPI effectiveness and PPI cost per year (range $250 to $1,400).

    Results/Body  In patients at average risk for upper GI bleeding, taking a PPI along with aspirin was cost-effective in terms of its cost per life-year saved if the drug was purchased OTC. At prescription cost, it was cost-effective only in patients at high risk for upper GI bleeding.

    Sources & Other Links Saini S, et al. Cost-effectiveness of proton pump inhibitor cotherapy in patients taking long-term, low-dose aspirin for secondary cardiovascular prevention. Arch Intern Med. 2008 Aug 11;168(15):1684-90.

    Article Link (NCBI)

     

  • TOPICAL GABAPENTIN REDUCES PAIN IN WOMEN WITH VULVODYNIA

    Summary  Topical gabapentin significantly decreases pain and improves sexual function in many women with vulvodynia.

    Basis for Study/Article  This retrospective study assessed the role of topical gabapentin in the treatment of vulvodynia.

    Detailed Summary of Study  The authors reviewed the outcomes of 51 women using 2% to 6% topical gabapentin to treat vulvodynia (19 generalized, 32 localized). 35 women were available for evaluation after at least 8 weeks of treatment.

    Results/Body  After treatment, the mean pain score was reduced from 7.26 to 2.49 on a scale of 0 to 10. 28 of the 35 women had at least a 50% drop in pain scores. Sexual function improved in 17 of the 20 evaluable women with localized vulvodynia. 14% of patients discontinued treatment.

    Sources & Other Links  Boardman L, et al. Topical gabapentin in the treatment of localized and generalized vulvodynia. Obstet Gynecol. 2008 Sep;112(3):579-85.  Article Link (NCBI)

     

  • HIGH VITAMIN D LEVELS PROTECT AGAINST TYPE 2 DIABETES

    Summary  This 22-year follow-up study showed that high vitamin D levels protect against type 2 diabetes. The effect was less marked in women, who as a group had lower vitamin D levels than men.

    Basis for Study/Article  This study from Finland examined whether high vitamin D levels decrease the risk of developing type 2 diabetes.

    Detailed Summary of Study  The researchers combined and analyzed the data from two case-control studies showing that high vitamin D levels protects against type 2 diabetes. Information on vitamin D levels was collected between 1973 and 1980 in subjects aged 40 to 74 year who did not have diabetes. Cases of diabetes were then recorded over 22 years of follow-up. Incidence rates were calculated based on the subject’s vitamin D level at baseline.

    Results/Body  Men with the highest vitamin D levels had a lower risk of type 2 diabetes (relative odds between highest and lowest levels, 0.28). Overall, women had lower vitamin D levels than men, and the relative odds for developing type 2 diabetes between the highest and lowest levels was 1.14.

    Sources & Other Links  Knekt P, et al. Serum vitamin D and subsequent occurrence of type 2 diabetes. Epidemiology. 2008 Sep;19(5):666-71.

    Article Link (NCBI)

     

  • HOME INTRAVENOUS ANTIBIOTICS FOR CYSTIC FIBROSIS

    Authors  Balaguer Albert, Gonz&aacute;lez de Dios Javier

    Review Group  Cochrane Cystic Fibrosis and Genetic Disorders Group

    Abstract  Background: Recurrent endobronchial infection in cystic fibrosis (CF) requires treatment with intravenous antibiotics for several weeks usually in hospital, affecting health costs and quality of life for patients and their families. Objectives: To determine whether home intravenous antibiotic therapy in CF is as effective as inpatient intravenous antibiotic therapy and if it is preferred by individuals or families or both. Search strategy: We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register comprising references identified from comprehensive electronic database searches and handsearches of relevant journals and abstract books of conference proceedings.Most recent search of the Group's Trials Register: April 2008. Selection criteria: Randomized and quasi-randomized controlled studies of intravenous antibiotic treatment for adults and children with CF at home compared to in hospital. Data collection and analysis: The authors independently selected studies for inclusion in the review, assessed methodological quality of each study and extracted data using a standardised form. Main results: Seventeen studies were identified by the searches. Only one study could be included which reported results from 17 participants aged 10 to 41 years with an infective exacerbation of Pseudomonas aeruginosa. All their 31 admissions (18 hospital and 13 at home after two to four days of hospital treatment) were analysed as independent events. Outcomes were measured at 0, 10 and 21 days after initiation of treatment. Home participants underwent fewer investigations than hospital participants (P < 0.002) and general activity was higher in the home group. No significant differences were found for clinical outcomes, adverse events, complications or change of intravenous lines, or time to next admission. Home participants received less low-dose home maintenance antibiotic.  Quality of life measures showed no significant differences for dyspnoea and emotional state, but fatigue and mastery were worse for home participants, possibly due to a higher general activity and need of support. Personal, family, sleeping and eating disruptions were less important for home than hospital admissions.  Home therapy was cheaper for families and the hospital. Indirect costs were not determined.  Authors' conclusions: Current evidence is restricted to a single randomized clinical trial. It suggests that, in the short term, home therapy does not harm individuals, entails fewer investigations, reduces social disruptions and can be cost-effective. There were both advantages and disadvantages in terms of quality of life. The decision to attempt home treatment should be based on the individual situation and appropriate local resources. More research is urgently required.

    Implications The current evidence is too limited to draw conclusions for practice. The limited evidence available is from participants who commenced treatment in hospital and suggests that, in the short term, home therapy is associated with less social disruption and no serious adverse events. The decision to commence home therapy should be based on the individual and be co-ordinated from units with appropriate outpatient resources.

    Citation  Balaguer A, Gonz&aacute;lez de Dios J. Home intravenous antibiotics for cystic fibrosis. Cochrane Database of Systematic Reviews 2008, Issue 3. Art. No.: CD001917. DOI: 10.1002/14651858.CD001917.pub2.

     

  • CLINICAL/DEMOGRAPHIC DETAILS, TREATMENT HISTORY DOES NOT APPEAR TO HELP IN CHOOSING A SECOND-LINE ANTIDEPRESSANT

    Summary  "Clinical, demographic, and treatment history were of little value in recommending one medication vs. another as a second-step treatment for major depressive disorder."

    Basis for Study/Article  This study identified characteristics of patients who responded to a second-line antidepressant after initial treatment with citalopram (Celexa®) failed to produce remission of major depressive disorder.

    Detailed Summary of Study  The 41-center study comprised 727 patients age 18 to 75 with major depressive disorder that did not remit with citalopram. The second-line treatments given were sustained-release bupropion (Wellbutrin®; 150 mg/day, titrated to 400 mg/day), sertraline (Zoloft®; 50 mg/day, titrated to 200 mg/day), and extended-release venlafaxine (Effexor®; 37.5 mg/day, titrated to 375 mg/day). Depressive symptoms were rated using 3 scales. Factors increasing and decreasing the odds of remission were identified.

    Results/Body  Factors increasing the odds of remission were white race, employed status, cohabiting or married status, private insurance, no suicide attempts, and a prior response to citalopram (including intolerance). Factors decreasing the odds of remission were greater Axis I psychiatric disorder comorbidity and concurrent substance abuse. Intolerance of the second-line treatment was more likely in patients with suicide attempts or intolerance to citalopram; it was less likely in Hispanics.

    Sources & Other Links  Rush AJ, et al. Selecting among second-step antidepressant medication monotherapies: predictive value of clinical, demographic, or first-step treatment features. Arch Gen Psychiatry. 2008 Aug;65(8):870-80.  Article Link (NCBI)

     

  • EATING NUTS, CORN POPCORN, SEEDS DOESN'T APPEAR TO INCREASE THE INCIDENCE OF DIVERTICULOSIS
    Summary  This long-term study found that eating nuts, corn, popcorn and seeds doesn’t increase the incidence of diverticulosis or diverticular disease. “The recommendation to avoid these foods to prevent diverticular complications should be reconsidered.”

    Basis for Study/Article <> This large prospective study evaluated the traditional belief that eating nuts, corn, popcorn and seeds can cause diverticular disease.

    Detailed Summary of Study  Dietary and medical information was collected over an 18-year period from 47,228 men aged 40 to 75 (participants in the Health Professionals Follow-up Study) who did not have diverticulosis, cancer or inflammatory bowel disease at baseline.

    Results/Body  During follow-up there were 801 cases of diverticulitis and 383 cases of diverticular bleeding. Men who ate popcorn and nuts at least twice a week were less likely to have diverticulitis than those who ate them less than once a month (hazard ratios 0.72 for popcorn, 0.80 for nuts). No link was found between corn consumption and diverticulitis or between nut, corn or popcorn consumption and diverticular bleeding or uncomplicated diverticulosis.

    Commentary  The tradition based medicine approach of repeating this long standing “ wisdom” of avoiding various dietary compounds to prevent diverticulitis has never been proven, but continues to be popular folklore. This study doesn’t fully evaluate this issue; but certainly calls it into question. Overall, healthcare providers should not advise patients to make dietary changes which are completely unsupported by facts.

    Grant E. Fraser M.D.
    MedAlert Editor

    Sources & Other Links  Strate LL, et al. Nut, corn, and popcorn consumption and the incidence of diverticular disease. JAMA. 2008 Aug 27;300(8):907-14.  Article Link (NCBI

     

  • INFANT FORMULA MANUFACTURED IN CHINA: HEALTH INFORMATION ADVISORY DUE TO REPORTS OF POSSIBLE CONTAMNATION WITH MELAMINE
     

    FDA issued a Health Information Advisory to consumers and healthcare professionals regarding milk-based infant formula manufactured in China. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can cause kidney diseases. Currently, no Chinese manufacturers of infant formula have fulfilled the requirements to sell this product in the United States. FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community. Caregivers should not feed infant formula manufactured in China to infants and should replace any product from China with an appropriate infant formula manufactured in the United States. Individuals should contact their health care professional if they have questions regarding their infant's health or if they note changes in their infant's health status.

    Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Health Information Advisory regarding the above issue:

    http://www.fda.gov/medwatch/safety/2008/safety08.htm#formulaChina
    or Snapshot as on GMT: Mon Sep 15 06:40:39 2008

     

  • TUMOR NECROSIS FACTOR-ALPHA BLOCKERS: DELAYS IN DIAGNOSIS OF FUNGAL AND OTHER OPPORTUNISTIC INFECTION

    *Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)* *Audience: *Rheumatological, gastroenterological and infectious disease healthcare professionals.

    FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor- blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dypsnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses. For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified.

    Read the complete MedWatch 2008 Safety summary, including links to the Information for Healthcare Professionals page, FDA press release and previous MedWatch alert on these products, at:

    www.fda.gov/medwatch/safety/2008/safety08.htm#TNF2
    or Snapshot as on GMT: Fri Sep 5 04:59:23 2008

     
  • HIGH FISH OIL INTAKE REDUCES ATHEROSCLEROSIS IN JAPANESE, JAPANESE-AMERICANS AND WHITE MEN

    Summary  Compared with Japanese-American and white men, Japanese men in their forties have twice the level of marine-derived omega-3 fatty acids and have the lowest levels of atherosclerosis.

    Basis for Study/Article  The authors compared the intake and effects of marine-derived omega-3 fatty acids in Japanese, Japanese-American and white men age 40 to 49.

    Detailed Summary of Study  Intake of marine-derived omega-3 fatty acids, intima-media thickness of the carotid artery, coronary artery calcification and serum fatty acids were assessed in 281 men born and living in Japan, 281 men born in Japan and living in the U.S., and 306 white men born and living in the U.S. All were age 40 to 49.

    Results/Body  The Japanese men had the lowest levels of atherosclerosis; the level was similar in the other two groups. The Japanese men also had double the level of marine-derived omega-3 fatty acids compared to the other two groups. The Japanese men had a significant inverse association of fatty acids with intima-media thickness that was not explained by traditional CV risk factors. This association was not found in the other two groups.

    Sources & Other Links  Sekikawa A, et al. Marine-derived omega-3 fatty acids and atherosclerosis in Japanese, Japanese-American, and white men: a cross-sectional study. J Am Coll Cardiol. 2008 Aug 5;52(6):417-24.  Article Link (NCBI)

     

  • OBSTRUCTIVE SLEEP APNEA WORSENS INSULIN RESISTANCE AND GLUCOSE TOLERANCE IN POLYCYSTIC OVARY SYNDROME

    Summary  Sleep apnea worsens insulin resistance and glucose tolerance in women with polycystic ovary syndrome.

    Basis for Study/Article  The authors investigated whether obstructive sleep apnea, which has been linked to metabolic dysfunction, affects insulin resistance and glucose tolerance in women with polycystic ovary syndrome.

    Detailed Summary of Study  52 women with PCOS and 21 women without PCOS matched for age and BMI underwent an overnight sleep study and a 75-g oral glucose tolerance test.

    Results/Body  56% of the PCOS women and 19% of the controls were found to have sleep apnea. Impaired glucose tolerance and insulin resistance were more common in the women with PCOS and sleep apnea vs. those with PCOS but without sleep apnea. “Insulin resistance and glucose tolerance were highly correlated with the presence and severity” of sleep apnea.

    Sources & Other Links  Tasali E, et al. Impact of obstructive sleep apnea on insulin resistance and glucose tolerance in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2008 Jul 22.  Article Link (NCBI)

     

  • ALOE VERA EFFECTIVE FOR THE TREATMENT OF ORAL LICHEN PLANUS

    Aloe Vera apears to be an effective, inexpensive, well-tolerated treatment for oral lichen planus.  Oral lichen planus affects 1% to 2% of the populartion.  Treatment options inlcude stroids, tacrolimus, retinoids,  Fifty-four (54)

     

  • GROWTH HORMONE REDUCES HIV-ASSOCIATED ABDOMINAL FAT ACCUMULATION

    Summary  This randomized controlled trial found that in HIV-positive patients receiving antiretroviral therapy, low-dose growth hormone reduces abdominal fat accumulation, truncal obesity, triglycerides, and diastolic blood pressure, but 2-hour glucose levels are increased.

    Basis for Study/Article  “Antiretroviral therapy can be associated with visceral adiposity and metabolic complications, increasing cardiovascular risk.” Because reduced secretion of growth hormone has been proposed as a contributing factor, the authors examined the effects of GH administration on “body composition, glucose, and cardiovascular parameters” in this population.

    Detailed Summary of Study  56 HIV-positive patients with abdominal fat accumulation and reduced GH secretion were randomized to receive subcutaneous GH (average dose 0.33 mg/day) or placebo for 18 months. Outcomes were change in body composition (CT and DEXA scans), glucose levels, IGF-1, blood pressure and lipids.

    Results/Body  Compared to the placebo group, the GH group had significantly decreased visceral fat, truncal obesity, triglycerides and diastolic blood pressure; however, their 2-hour glucose levels on glucose tolerance testing increased. The number of adverse events did not differ significantly (23% for GH, 28% for placebo).

    Sources & Other Links  Lo J, et al. Low-dose physiological growth hormone in patients with HIV and abdominal fat accumulation: a randomized controlled trial. JAMA. 2008 Aug 6;300(5):509-19.  Article Link (NCBI)

     

  • FATAL STROKES MORE COMMON IN PATIENTS WITH LOW VITAMIN D LEVELS

    Summary  In patients undergoing coronary angiography, low vitamin D levels are predictive of fatal stroke. “Vitamin D supplementation is a promising approach in the prevention of strokes.”

    Basis for Study/Article  This European study investigated whether vitamin D levels affect the risk for fatal stroke.

    Detailed Summary of Study  Levels of 25(OH)D and 1,25(OH)2D were measured in patients referred for coronary angiography (n = 3,299 and 3,315). Seasonal variations in vitamin D levels were corrected for statistically. Fatal strokes (ischemic and hemorrhagic) were recorded over a median follow-up of 7.75 years.

    Results/Body  During follow-up there were 42 fatal strokes, and low levels of 25(OH)D and 1,25(OH)2D were both independent predictors of fatal strokes. Patients who had a history of cerebrovascular disease at baseline also had lower vitamin D levels.

    Sources & Other Links  Pilz S, et al. Low vitamin D levels predict stroke in patients referred to coronary angiography. Stroke. 2008 Jul 17. [Epub ahead of print]  Article Link (NCBI)

     

  • LOW-ENERGY FEMORAL SHAFT FRACTURES HAVE A DISTINCTIVE PATTERN IN ALENDRONATE (Fosamax®) USERS
    Summary  Low-energy femoral shaft fractures have a distinctive pattern in patients who take alendronate (Fosamax®).

    Basis for Study/Article  “Long-term alendronate use may overly suppress bone metabolism, limiting repair of microdamage and creating risk for insufficiency fractures.” The authors examined whether alendronate use changes the patterns of low-energy femoral shaft fractures.

    Detailed Summary of Study  The authors examined the records of 70 patients (59 women, 11 men; average age 74.7) admitted to their institution with low-energy femoral shaft fractures. Fracture patterns were compared between those taking alendronate (n = 25) and those not taking it (n = 45).

    Results/Body  19 (76%) of the alendronate patients and only 1 of the non-alendronate group had “a simple, transverse fracture with a unicortical beak in an area of cortical hypertrophy.” Duration of use was 6.9 years for alendronate users with this pattern vs. 2.5 years in alendronate users who did not; only one of the patients with this pattern had been taking alendronate for less than 4 years. The pattern “may result from propagation of a stress fracture whose repair is retarded by diminished osteoclast activity and impaired microdamage repair” resulting from long-term alendronate use.

    Sources & Other Links  Neviaser AS, et al. Low-energy femoral shaft fractures associated with alendronate use. J Orthop Trauma. 2008 May-Jun;22(5):346-50.  Article Link (NCBI)

     

  • COMPARING LOW-CARBOHYDRATE, LOW-FAT, AND MEDITERRANEAN DIETS

    Summary  This 2-year trial found that “Mediterranean and low-carbohydrate diets may be effective alternatives to low-fat diets.” Physicians can use the particular strengths of the diets—the low-carb diet reduced lipids and the Mediterranean diet offered better glycemic control—to devise an effective plan for a specific patient.

    Basis for Study/Article  The authors compared the effects of the three diets in moderately obese patients.

    Detailed Summary of Study 322 patients with a mean BMI of 31 (mean age 52, 86% men) were randomized to one of three diets: low-fat, restricted-calorie; Mediterranean, restricted-calorie; or low-carbohydrate, without calorie restrictions. Adherence rates, food intake, weight loss and outcomes were recorded over 2 years.

    Results/Body <> Adherence rates were 95.4% at 1 year and 84.6% at 2 years. Mean weight loss was 2.9 kg for the low-fat group, 4.4 kg for the Mediterranean group and 4.7 kg for the low-carb group. In the 272 subjects who completed the intervention, the corresponding figures were 3.3, 4.6 and 5.5 kg. The subjects on the Mediterranean diet had the highest fiber intake and the highest ratio of monounsaturated to saturated fats. The low-carb group had the lower intake of carbohydrates and the highest intake of fat, protein and cholesterol. The ratio of total cholesterol to HDL decreased by 20% in the low-carb group and by 12% in the low-fat group. In the 36 diabetic patients, “changes in fasting plasma glucose and insulin levels were more favorable” in the Mediterranean group than in the low-fat group.

    Sources & Other Links  Shai I, et al. Weight loss with a low-carbohydrate, Mediterranean, or low-fat diet. N Engl J Med. 2008 Jul 17;359(3):229-41.ticle Link (NCBI)

     

  • VIVITRO (Naltrexone) - SERIOUS INJECTION SITE REACTIONS COULD OCCUR

    MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection.

    Read the entire MedWatch Safety Summary, including a link to the FDA Drug Information Page regarding this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#naltrexone
    or  Snapshot as on GMT: Wed Aug 13 04:52:34   2008

     
  • ASTHMA IS LESS COMON IN CHILDREN WITH H.PYLORI COLONIZATION

    Summary  Asthma and other allergy symptoms are less common in children with H. pylori colonization.

    Basis for Study/Article  The authors assessed whether there is an association between childhood asthma and exposure to H. pylori.

    Detailed Summary of Study  The authors used data from 7,412 subjects in the National Health and Nutrition Examination Survey (1999-2000).

    Results/Body  “H. pylori seropositivity was inversely associated with onset of asthma before 5 years and current asthma in children aged 3-13 years.” It was also inversely related to recent wheezing, allergic rhinitis, dermatitis, eczema or rash. “These findings indicate new directions for research and asthma prevention.”

    Commentary  H. pylori infection is also likely a marker for a “dirtier” environment growing up. Although this association may indeed be causative, it would seem much more likely that it is simply a marker for being exposed to many environmental factors at an early age.

    Grant E. Fraser, M.D.
    MedAlert Editor

    Sources & Other Links <> Chen Y, et al. Helicobacter pylori colonization is inversely associated with childhood asthma. J Infect Dis. 2008 Aug 15;198(4):553-60. Article Link (NCBI)

     
  • SUMATRIPTAN/NAPROXEN COMBINATION EFFECTIVE FOR EARLY MIGRAINE TREATMENT

    Summary  A fixed-dose combination of sumatriptan and naproxen aborts migraine if taken within 1 hour of onset.

    Basis for Study/Article  The authors examined the efficacy and safety of a fixed-dose combination of sumatriptan (85 mg) and naproxen (500 mg) for early treatment of migraine.

    Detailed Summary of Study  In two separate studies, adult patients (n = 576 and 535) were randomized to take either the sumatriptan/naproxen combination or placebo within 1 hour of migraine onset, while the pain was still mild. Pain relief and adverse events were recorded.

    Results/Body  2 hours after dosing, 52% and 51% of the sumatriptan/naproxen patients were pain-free vs. 17% and 15% of the control group. In the sumatriptan/naproxen patients, pain relief started as early as 30 minutes and lasted for 2 to 24 hours; they also had fewer migraine-associated symptoms than the control group. The most common adverse events were nausea (4% or less) and dizziness (2% or less).

    Sources & Other Links  Silberstein S, et al. Multimechanistic (sumatriptan-naproxen) early intervention for the acute treatment of migraine. Neurology. 2008 Jul 8;71(2):114-21.

    Article Link (NCBI)

     

  • SIMVASTATIN USED WITH AMIODARONE ALERT

    The FDA is notifying the public of the risk of a rare condition of muscle injury called rhabdomyolysis, which can lead to kidney failure or death, when simvastatin is used with amiodarone. This risk is dose-related and increases when a dose of simvastatin greater than 20 mg per day is given with amiodarone. A revision of the simvastatin labeling in 2002 described an increased risk of rhabdomyolysis when amiodarone is taken with simvastatin doses greater than 20 mg daily. However, the FDA continues to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin, particularly with simvastatin doses greater than 20 mg daily. Prescribers should be aware of the increased risk of rhabdomyolysis when simvastatin is prescribed with amiodarone, and they should avoid doses of simvastatin greater than 20 mg per day in patients taking amiodarone.

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this when additional information or analyses become available.

    Healthcare Professional Information Information for Healthcare ProfessionalsSimvastatin Prescribing (labeling) Information from Drugs@FDA Amiodarone Prescribing (labeling) Information from Drugs@FDA

    Other Information

    Simvastatin, Ezetimibe/Simvastatin, and Amiodaroneis marketed under these names: Simvastatin (marketed as Zocor and generics)Ezetimibe/Simvastatin (marketed as Vytorin)Niacin extended-release/Simvastatin (marketed as Simcor) Used with Amiodarone (Cordarone, Pacerone)

     

  • AUGUST 2008 FDA PATIENT SAFETY NEWS VIDEO IS AVAILABLE NOW

    MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

    Stories in the August 2008 edition include:

    Warning Added to Regranex (becaplermin) Label

    Use caution when treating diabetic foot and leg ulcers with Regranex in patients who have known malignancies...

    Cellcept and Myfortic Linked to Birth Defects and Fetal Loss

    Before prescribing these drugs, healthcare professionals should ensure that women are not pregnant and are using two effective forms of birth control...

    Possible Association between TNF Blockers and Cancer

    Ongoing safety reviews of Remicade, Enbrel, Humira, and Cimzia...

    Danger Giving Topical Thrombin Intravascularly

    ISMP recommends ways to reduce the risk of errors that can lead to extensive intravascular clotting and death...

    Potential Problems with Insulin Pens in Hospitals

    Insulin pen design and usage issues can present safety concerns...

    Nonoxynol 9 (N9) Contraceptives: No Protection against HIV and Other STDs

    Labeling warns that using nonoxynol 9 may increase the risk of contracting HIV/AIDS from an infected partner...

    For more "FDA Patient Safety News", visit http://www.fda.gov/psn. Please send any comments, questions or suggestions about the program to PSNews@fda.gov

     

  • VIAPRO 375 MG CAPSULES -  VOLUNTARY RECALL DUE TO POTENTIAL HARMFUL ANALOG OF SILDENAFIL

    MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    EG Labs, LLC, notified consumers and healthcare professionals not to buy or use Viapro 375 mg Capsules because one lot of the product was found to contain a potentially harmful undeclared ingredient, thio-methisosildenafil, an analog of sildenafil, a FDA approved product used to treat erectile dysfunction in men to enhance sexual performance. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have this product should discontinue using it and consult their healthcare professional if they experience any problems that may be related to taking Viapro.

     

  • ERYTHROPOIESIS STIMULATING AGENTS; PROCRIT, EPOGEN, AND ARANESP, - FDA CLARIFIES APPROVED CONDITIONS FOR USE OF ESAs IN PATIENT WITH CANCER- REVISES DOSING DIRECTIONS

    MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    Amgen and FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated. Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming. FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.

    Read the entire 2008 MedWatch Safety Summary, including a link to the FDA's Follow Up to an Ongoing Safety Review regarding this issue at:

    http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA2
     

     

  • VACCINES FOR PREVENTING INFLUENZA IN HEALTHY CHILDREN

    Authors  Jefferson Tom, Rivetti Alessandro, Harnden Anthony, Di Pietrantonj Carlo, Demicheli Vittorio

    Review Group  Cochrane Acute Respiratory Infections Group

    Abstract  The consequences of influenza in children and adults are mainly absenteeism from school and work. However, the risk of complications is greatest in children and people over 65 years old. Objectives: To appraise all comparative studies evaluating the effects of influenza vaccines in healthy children; assess vaccine efficacy (prevention of confirmed influenza) and effectiveness (prevention of influenza-like illness) and document adverse events associated with influenza vaccines. Search strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2007, issue 3); OLD MEDLINE (1950 to 1965); MEDLINE (1966 to September 2007); EMBASE (1974 to September 2007); Biological Abstracts (1969 to September 2007); and Science Citation Index (1974 to September 2007).Selection criteria Randomized controlled trials (RCTs), cohort and case-control studies of any influenza vaccine in healthy children under 16 years of age. Data collection and analysis : Two review authors independently assessed trial quality and extracted data. Main results Fifty-one studies with 294,159 observations were included. Sixteen RCTs and 18 cohort studies were included in the analysis of vaccine efficacy and effectiveness. From RCTs, live vaccines showed an efficacy of 82% (95% confidence interval (CI) 71% to 89%) and an effectiveness of 33% (95% CI 28% to 38%) in children older than two compared with placebo or no intervention. Inactivated vaccines had a lower efficacy of 59% (95% CI 41% to 71%) than live vaccines but similar effectiveness: 36% (95% CI 24% to 46%). In children under two, the efficacy of inactivated vaccine was similar to placebo. Variability in study design and presentation of data was such that a meta-analysis of safety outcome data was not feasible. Extensive evidence of reporting bias of safety outcomes from trials of live attenuated vaccines impeded meaningful analysis. Authors' conclusionsInfluenza vaccines are efficacious in children older than two but little evidence is available for children under two. There was a marked difference between vaccine efficacy and effectiveness. No safety comparisons could be carried out, emphasizing the need for standardization of methods and presentation of vaccine safety data in future studies. It was surprising to find only one study of inactivated vaccine in children under two years, given current recommendations to vaccinate healthy children from six months old in the USA and Canada. If immunization in children is to be recommended as a public health policy, large-scale studies assessing important outcomes and directly comparing vaccine types are urgently required.

    Implications  National policies for the vaccination of healthy young children are based on very little evidence.

    Citation  Jefferson T, Rivetti A, Harnden A, Di Pietrantonj C, Demicheli V. Vaccines for preventing influenza in healthy children. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD004879. DOI: 10.1002/14651858.CD004879.pub3.

     

  • IN SCIATICA, EARLY SURGERY HAS SHORT-TERM BUT NOT LONG-TERM BENEFITS OVER CONSERVATIVE CARE
     

    Summary  For sciatica due to lumbar disc herniation, this randomized controlled trial found that early surgery has short-term but not long-term benefits over conservative treatment.

    Basis for Study/Article  The authors of this multi-center Dutch trial compared early surgery vs. prolonged conservative treatment for sciatica.

    Detailed Summary of Study  Of 283 patients who had sciatica for 6 to 12 weeks, 141 were assigned to early surgery (89% had microdiscectomy) and 142 were assigned to 6 months of conservative treatment, with surgery if needed (44% of them eventually had surgery). Pain was assessed over 2 years of follow-up.

    Results/Body  Disability scores did not differ between the groups over 2 years. Leg pain improved more quickly in the early surgery group, but the difference was no longer significant by 6 months and continued to decrease over 2 years. Patient satisfaction fell slightly between 1 and 2 years; after 2 years 20% of patients reported an unsatisfactory outcome.

    Sources & Other Links  Peul WC, et al. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two-year results of a randomised controlled trial. BMJ. 2008 Jun 14;336(7657):1355-8.  Article Link (NCBI)

     

  • DIABETES INCREASES RISK OF HEARING LOSS

    Summary  Diabetes is an independent risk factor for hearing loss.

    Basis for Study/Article  The authors compared the prevalence of hearing impairment in adults with and without diabetes.

    Detailed Summary of Study  As part of the National Health and Nutrition Examination Survey, information was collected from 5,140 subjects (399 with type 1 or 2 diabetes) age 20 to 69 who underwent audiometry.

    Results/Body  The age-adjusted prevalence of at least mild low- or mid-frequency hearing loss was 21.3% in the diabetics vs. 9.4% in those without diabetes (adjusted odds ratio 1.82). The figures for high-frequency hearing loss were 54.1% vs. 32.0% (adjusted odds ratio 2.16). The higher figures for diabetics were not explained by risk factors for hearing loss such as noise exposure, ototoxic medication use or smoking.

    Sources & Other Links  Bainbridge KE, et al. Diabetes and hearing impairment in the United States: audiometric evidence from the National Health and Nutrition Examination Survey, 1999 to 2004. Ann Intern Med. 2008 Jul 1;149(1):1-10.

    Article Link (NCBI)

     

  • SAFETY REVIEW ERYTHROPOIESIS-STIMULATING AGENTS (ESAs) EPOETIN ALFA (marketed as Procrit, Epogen) DARBEPOETIN ALFA (marketed as Aranesp)

    On April 22, 2008, FDA notified the manufacturer of Epogen/Procrit and Aranesp of its decision to require additional safety-related changes to the labeling for these products.

    Amgen submitted labeling supplements for Epogen/Procrit and Aranesp on May 22, 2008, following the March 13, 2008 Oncologic Advisory Committee’s recommendations to make additional safety-related changes to the labeling for these products. Amgen and FDA have agreed on many of these changes, including to replace the existing Patient Package Insert with a Medication Guide and to modify certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of package insert.

    These changes are intended to clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should not be initiated. While agreement was reached on the general concepts, Amgen and FDA have not reached agreement on specific wording on two points, including a warning statement that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and statements regarding when to initiate and to discontinue ESA dosing. Labeling discussions concluded on July 15 and FDA issued a letter ordering the additional changes on July 30, 2008.

    FDA’s action to require these safety labeling changes follows the completion of the review of information received in November 2007 and December 2007 and are in keeping with the recommendations made at the March 13, 2008 Oncologic Drugs Advisory Committee meeting. Amgen has been ordered to make the additional changes under new authorities provided in the FDA Amendments Act of 2007 and has 5 days to appeal or 15 days to submit a supplement containing the labeling changes.

    FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.

    The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with Epogen, Procrit and Aranesp to the FDA MedWatch reporting program, as described below.  Online at www.fda.gov/medwatch/report.htm

     

  • DIETARY ADVICE IN PREGNANCY FOR PREVENTING GESTATIONAL DIABETES

    Authors  Tieu Joanna, Crowther Caroline A, Middleton Philippa

    Review Group  Cochrane Pregnancy and Childbirth Group

    Abstract  Gestational diabetes mellitus (GDM) is a form of diabetes that occurs during pregnancy which can result in significant adverse outcomes for mother and child both in the short and long term. The potential for adverse outcomes, in addition to the increasing prevalence of gestational diabetes worldwide, demonstrates the need to assess strategies, such as dietary advice, that might prevent gestational diabetes.ObjectivesTo assess the effects of dietary advice in preventing gestational diabetes mellitus.Search strategy. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2008) and reference lists of retrieved articles.Selection criteria Quasi-randomised and randomised studies of dietary intervention for preventing glucose intolerance in pregnancy.Data collection and analysis: Two review authors independently conducted data extraction and quality assessment. We resolved disagreements through discussion or through a third author.Main resultsThree trials (107 women) were included in the review. One trial (25 pregnant women) analysed high-fibre diets with no included outcomes showing statistically significant differences. Two trials (82 pregnant women) assessed low glycaemic index (LGI) versus high glycaemic index diets for pregnant women. Women on the LGI diet had fewer large for gestational age infants (one trial; relative risk (RR) 0.09, 95% confidence interval (CI) 0.01 to 0.69), infants with lower ponderal indexes (two trials; weighted mean difference (WMD) -0.18, 95% CI -0.32 to -0.04, random-effects analysis) and lower maternal fasting glucose levels (two trials; WMD -0.28 mmol/L 95% CI -0.54 to -0.02, random-effects model). Results for women on the LGI diet on neonatal birth weight were not conclusive under a random-effects model (two trials; WMD -527.64 g, 95% CI -1119.20 to 63.92); however, on a fixed-effect model, women on the LGI diet gave birth to lighter babies (two trials; WMD -445.55 g, 95% CI -634.16 to -256.95). High heterogeneity was observed between the trials in most results and both were relatively small trials. One of these trials also included a standard exercise regimen for all participants.Authors' conclusionsWhile a low glycaemic index diet was seen to be beneficial for some outcomes for both mother and child, results from the review were inconclusive. Further trials with large sample sizes and longer follow up are required to make more definitive conclusions. No conclusions could be drawn from the high-fibre versus control-diet comparison since the trial involved did not report on many of the outcomes we prespecified.

    Implications  Overall, results were inconclusive due to the limited number of trials, participants and data provided in addition to high heterogeneity between trials. While the results were promising, the evidence is not sufficient to change clinical practice without further research on dietary intervention for the prevention of gestational diabetes mellitus (GDM) and its associated outcomes. One study in Australia suggests that dietary advice for low and high GI diets can be acceptable and affordable for women.

    Citation  Tieu J, Crowther CA, Middleton P. Dietary advice in pregnancy for preventing gestational diabetes mellitus. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD006674. DOI: 10.1002/14651858.CD006674.pub2.

  • FDA ALERT [7/24/2008]: ABACAVIR (MARKETED AS ZIAGEN) AND ABACAVIR-CONTAINING MEDICATIONS

    Serious and sometimes fatal hypersensitivity reactions (HSR) caused by abacavir therapy are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*5701. Abacavir HSR is a multi-organ syndrome characterized by 2 or more clinical signs or symptoms that can include fever, rash, gastrointestinal symptoms, respiratory symptoms and constitutional symptoms.

    FDA has reviewed data from 2 studies that support the recommendation for pre-therapy screening for the presence of the HLA-B*5701 allele and the selection of alternative therapy in positive subjects. Genetic tests for HLA-B*5701 are already available and all patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with abacavir or abacavir-containing medications. Avoidance of abacavir therapy in HLA-B*5701 positive patients will significantly decrease the risk of developing clinically-suspected abacavir HSR. For HLA-B*5701-positive patients, treatment with an abacavir-containing regimen is not recommended and should be considered only under exceptional circumstances when the potential benefit outweighs the risk.

    Development of clinically-suspected abacavir HSR requires immediate and permanent discontinuation of abacavir therapy in all patients, including patients negative for HLA-B*5701. This new safety information will be reflected in updated product labeling.www.fda.gov/medwatch/report/hcp.htm

     
  • PREDICTING ELDERLY WOMEN AT HIGH V S. LOW RISK FOR OSTEOPOROTIC FRACTURE

    Summary  A low ultrasound bone stiffness index at the heel and four clinical risk factors (age, history of fracture, recent fall, “failed chair test”) can be used together to predict which elderly women are at high risk for osteoporotic fracture.

    Basis for Study/Article  The authors of this Swiss study developed and tested a predictive rule to identify elderly women at high vs. low risk for osteoporotic fracture.

    Detailed Summary of Study  The authors used data from a prospective multicenter study (6,174 women age 70 to 85) assessing the predictive value of an ultrasound bone stiffness index at the heel. Statistical analysis was used to identify additional factors that were predictive of fracture.

    Results/Body  Risk factors for osteoporotic fracture were age >75 years, low stiffness index in the heel, history of fracture, a recent fall and “a failed chair test” (inability to rise from a chair three times in a row without using the arms). A scoring system incorporating these risk factors assigned 1,464 women to a low-risk group and 4,710 to a high-risk group. The rate of osteoporotic fracture was 6.1% for the high-risk group and 1.8% for the low-risk group. 90% of those who had an osteoporotic hip fracture were in the high-risk group.

    Sources & Other Links  Guessous I, et al. Osteoporotic fracture risk in elderly women: estimation with quantitative heel US and clinical risk factors. Radiology. 2008 Jul;248(1):179-84.

    Article Link (NCBI)

     
  • IN NEWLY DIAGNOSED TYPE 2 DM, SHORT-TERM INSULIN THERAPY OUTPERFORMS OVRAL HYPOGLYCEMICS

    Summary  In patients with newly diagnosed diabetes, this randomized, multicenter trial found that short-term, intensive insulin therapy results in better beta-cell function and longer glycemic remission compared to oral hypoglycemics.

    Basis for Study/Article  This Chinese trial compared the effectiveness of intensive insulin therapy vs. oral hypoglycemics in terms of beta-cell function and diabetes remission rates in newly diagnosed diabetics.

    Detailed Summary of Study  382 patients ages 25 to 70 from 9 centers in China with a fasting plasma glucose level of 7.0 to 16.7 mmol/L were randomized to receive short-term therapy with insulin (continuous infusion or multiple daily injections) or oral hypoglycemics. Drug treatment was stopped after blood glucose levels were normal for 2 weeks. Glucose tolerance tests were done and blood glucose levels, insulin and proinsulin levels were measured at baseline, immediately after therapy, and 1 year after therapy.

    Results/Body  Compared with the oral hypoglycemic group, the patients who received early insulin treatment had significantly higher remission rates at 1 year (51.1% for continuous insulin, 44.9% for multiple daily insulin injections, 26.7% for oral hypoglycemics). More of the insulin group patients achieved their target blood glucose goals (97.1% of the continuous infusion group, 95.2% of the multiple injections group, 83.5% of the oral hypoglycemic group), and in less time (4.0 days, 5.6 days, 9.3 days). Beta-cell function improvements persisted at 1 year in the insulin group but declined significantly in the oral treatment group.

    Sources & Other Links  Weng J, et al. Effect of intensive insulin therapy on beta-cell function and glycaemic control in patients with newly diagnosed type 2 diabetes: a multicentre randomised parallel-group trial. Lancet. 2008 May 24;371(9626):1753-60.  Article Link (NCBI)

     

  • OLANZAPINE (Zyprexa®) USEFUL IN TREATING ANOREXIA NERVOSA

    Summary  In women with anorexia nervosa, this controlled trial found that olanzapine (Zyprexa®) promotes weight gain and reduces obsessive symptoms.

    Basis for Study/Article  The authors tested the utility of the atypical antipsychotic drug olanzapine in the treatment of women with anorexia nervosa.

    Detailed Summary of Study  34 women with anorexia nervosa were randomized to receive day hospital treatment plus either placebo or olanzapine (flexible dose). Weight and obsessive symptoms were recorded at baseline and after 10 weeks of treatment.

    Results/Body  Compared with the placebo group, the women taking olanzapine had a greater rate of weight gain, achieved their target weight earlier and had fewer obsessive symptoms. There were no differences in adverse events between the groups. The authors recommend that a large multicenter trial be conducted.

    Sources & Other Links  Bissada H, et al. Olanzapine in the treatment of low body weight and obsessive thinking in women with anorexia nervosa: a randomized, double-blind, placebo-controlled trial. Am J Psychiatry. 2008 Jun 16.

    Article Link (NCBI)

     

  • WHICH PRESCHOOLERS WITH WHEEZE WILL DEVELOP PERSISTENT ASTHMA?

    Summary  Preschoolers with exercise-induced wheeze and a history of atopic disorders are much more likely to develop persistent asthma.

    Basis for Study/Article  The authors identified predictors of persistent asthma in preschoolers with wheeze.

    Detailed Summary of Study  Parents of preschoolers in Manchester, England, received questionnaires asking about their children’s respiratory symptoms five times between 1993 and 2004. At baseline the 628 children were <5 years old. Follow-up was at least 6 years.

    Results/Body  32% of the children had wheeze at baseline and 27% had it at the second time point. Predictors of persistent asthma were exercise-induced wheeze (odds ratio 3.94) and a history of atopic disorders (odds ratio 4.44). Children with both predictors had a 53.2% likelihood of developing asthma; the likelihood was 10.9% if neither was present.

    Sources & Other Links  Frank PI, et al. Long term prognosis in preschool children with wheeze: longitudinal postal questionnaire study 1993-2004. BMJ. 2008 Jun 21;336(7658):1423-6.

    Article Link (NCBI)

     

  • OBSTRUCTIVE SLEEP APNEA IS COMMON IN WOMEN WITH NOCTURIA

    Summary  Obstructive sleep apnea is common in women with nocturia, and 88% of women with dilute nighttime urine have OSA. “We should consider a diagnosis of OSA in all patients with nocturia,” even those with daytime overactive bladder symptoms.

    Basis for Study/Article  The authors explored the association between obstructive sleep apnea and nocturia in women and tested urine samples to see whether urine concentration was predictive for sleep apnea.

    Detailed Summary of Study  21 women with nocturia (16 of them also had daytime overactive bladder) and 10 control subjects completed nocturia questionnaires, underwent a home sleep study and provided evening and morning urine samples.

    Results/Body  17 of the 21 women with nocturia (81%) were found to have sleep apnea (13 of the 16 with daytime overactive bladder and 4 of the 5 without) vs. 4 of the control group. “The presence of diluted nighttime urine in a patient with nocturia was 88% sensitive for the presence of OSA.”

    Sources & Other Links  Lowenstein L, et al. The relationship between obstructive sleep apnea, nocturia, and daytime overactive bladder syndrome in women. Am J Obstet Gynecol. 2008 May;198(5):598.e1-5.  Article Link (NCBI)

     

  • HAVING 1/2 TO 1 ALCOHOLIC DRINK PER DAY PROTECTS AGAINST HIP FRACTURE

    Summary  This meta-analysis found that people who have 1/2 to 1 alcoholic drink per day have a lower risk of hip fracture compared to nondrinkers and heavier drinkers.

    Basis for Study/Article  The authors performed a literature review to assess the effects of moderate alcohol consumption on bone density and the risk of osteoporotic hip fracture.

    Detailed Summary of Study  Effect sizes were pooled for hip fracture and bone density, and results were synthesized for four outcomes: non-hip fracture, bone density loss over time, bone response to estrogen replacement, and bone remodeling.

    Results/Body  People who had 1/2 to 1 alcoholic drink per day had a lower risk of hip fracture compared to nondrinkers (relative risk 0.80); the relative risk was 1.39 for those who had more than 2 drinks a day. “A linear relationship existed between femoral neck bone density and alcohol consumption,” but “a precise range of beneficial alcohol consumption cannot be determined.”

    Sources & Other Links  Berg KM, et al. Association between alcohol consumption and both osteoporotic fracture and bone density. Am J Med. 2008 May;121(5):406-18. Article Link (NCBI)

     

  • ADVERSE EVENTS ASSOCIATED WITH PCA AND INSULIN PUMPS IN ADOLESCENTS

    Summary  Over a 10-year period, there were 1,594 reports to the FDA of adverse events associated with adolescents’ use of insulin pumps (including 13 deaths) and 53 reports of adverse events associated with patient-controlled analgesia pumps. “Studies need to further identify safety problems in this age group.”

    Basis for Study/Article  After receiving five reports of deaths in adolescents associated with insulin pumps in 2005, the FDA conducted an assessment of the safety of insulin and PCA pumps in this population.

    Detailed Summary of Study  The authors reviewed reports submitted to the FDA from 1996 through 2005 about adverse events associated with use of insulin or PCA pumps by adolescents (ages 12 to 21). Demographics, type of adverse event, outcomes and contributing factors were analyzed.

    Results/Body  Over a 10-year period, there were 1,594 reports of adverse events associated with insulin pumps, including 13 deaths, 2 possible suicide attempts, and several reports of apparently device-related hyperglycemia or hypoglycemia. Some of the contributing factors were compliance problems, lack of education, “sports-related activities” and “dropping or damaging the pump.” In 82% of the events the patient was hospitalized. There were 53 reports of adverse events associated with PCA pumps. In half the patients received too much medication; “tampering and noncompliance were evident in some cases.”

    The authors suggest more studies on the safety of these devices in adolescents.

    Sources & Other Links  Cope J, et al. Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events. Pediatrics. 2008 May;121(5):e1133-8.  Article Link (NCBI)

     
  • DIABETES MELLITUS TYPE 2 AND ITS DURATION AFFECT COGNITIVE FUNCTION IN THE ELDERLY

    Summary  This prospective study found that community-dwelling older adults with diabetes mellitus type 2 and those with a longer duration of diabetes have a higher risk for cognitive decline.

    Basis for Study/Article  The authors assessed whether the presence of diabetes mellitus type 2 and its duration affect cognitive function in elderly men and women.

    Detailed Summary of Study  General cognition and verbal memory were assessed at baseline in 5,907 men (mean age 74.1) in the Physicians’ Health Study II and 6,326 women (mean age 71.9) in the Women’s Health Study. 553 men and 405 women had diabetes. Follow-up assessments were made 2 years after baseline; the women had a third assessment 4 years later.

    Results/Body  Diabetic subjects had significantly lower baseline scores. A longer duration of diabetes was significantly associated with lower scores at baseline and follow-up. Diabetic men and women had significantly greater cognitive decline at follow-up than those without diabetes.

    Sources & Other Links  Okereke OI, et al. Type 2 diabetes mellitus and cognitive decline in two large cohorts of community-dwelling older adults. J Am Geriatr Soc. 2008 Jun;56(6):1028-36. Article Link (NCBI)

     
  • HOME BLOOD PRESSURE MEASUREMENT IS USEFUL AND SHOULD BE COVERED BY INSURANCE

    Summary  Home blood pressure measurement is useful in the management of hypertension and should be covered by medical insurance.

    Basis for Study/Article  This is a scientific statement from the American Hearth Association, the American Society of Hypertension and the Preventive Cardiovascular Nurses Association. The authors reviewed the evidence on the use of home blood pressure monitoring by hypertensive patients and made recommendations for such use.

    Results/Body  Home monitoring should be part of the management regimen in all patients with known or suspected hypertension. It can be useful in identifying “white-coat hypertension.” Patients should use oscillometric monitors that measure BP on the upper arm, and should be shown how to use them properly. Target BP is <135/85, or <130/80 in high-risk patients. Home monitoring “has the potential to improve the quality of care while reducing costs and should be reimbursed.”

    Sources & Other Links  Pickering TG, et al. Call to action on use and reimbursement for home blood pressure monitoring: executive summary: a joint scientific statement from the American Heart Association, American Society of Hypertension, and Preventive Cardiovascular Nurses Association. Hypertension. 2008 Jul;52(1):1-9.  Article Link (NCBI)

     

  • DISTINGUISHING ORGANIC VS. MECHANICAL LOW BACK PAIN IN CHILDREN

    Summary 

    In children with short-term symptoms, a bone scan is particularly useful n distinguishing organic low back pain from mechanical back pain.

    Basis for Study/Article

    The authors identified "which combination of imaging modalities provides the most sensitive and specific screening protocol for children with low back pain."

    Detailed Summary of Study

    The authors reviewed the records of 100 children age 2 to 18 with low back pain without night pain or constitutional symptoms, examining the utility of the imaging studies that were done.

    Results/Body

    The hyperextension test and on x-ray had a negative predicative value of 0.81 and a sensitivity of 0.90.  For children with non-neurologic symptoms of <6 weeks duration, a bone scan had 100% negative predictive value and sensitivity; it is "the most useful screening test because it is accurate, accessible, inexpensive and unlikely to require sedation."  Mechanical back pain was most likely in children with painless hyperextension and negative AP, lateral and oblique lumbar x-rays and MRI.

    Sources & Other Links 

    Auerbach JD, et al, Streamlining the evaluation of low back pain in children.  Clin Orthop Relat Res.  2008 June 16.  Article-Link (NCBI)

     

  • ALPHA-LINOLENIC ACID REDUCES RISK OF MYOCARDIAL INFARCTION

    (HealthDay News) - Increased omega-3 fatty acid alpha-linolenic acid (ALA) intake is associated with decreased risk of non-fatal acute MI, according to a Harvard School of Public Health case-control study of 1,819 patients with a 1st non-fatal acute MI and 1,819 controls.  In a separate report, increased omega-6- fatty ALA intake is associated with reduction in systolic and diastolic blood pressure, according to a Japanese study of 2,238 patients without known cardiovascular disease.  Authors concluded that these results lend support to current recommendations for increased ingestion of polyunsaturated fatty acid from vegetable sources. (PubMed)

     
  • COFFEE RELATED TO A HEALTHIER HEART
    Heavy coffee drinking may lower risk of cardiovascular death. 

    Summary:  This long-term study found that people who drink six or more cups of coffee each day have lower risk of dying of cardiovascular disease.

    Basis for study/Article

    The authors explored the association between coffee and mortality (all-cause and disease-specific)

    Detailed Summary of Study

    As part of the prospective Health Professionals Follow-up Study and the Nurses' health Study, information was collected on self-reported coffee consumption and death rates for cancer and cardiovascular disease, and was recorded.  The participants were 41,736 men and 86,214 women who did not have cardiovascular disease or cancer at baseline.  Follow-up was 18 years in men and 24 years in women.  The six levels of coffee consumption were <1 cup per months, 1 cup per months to 4 cups per week, 5 to 7 cups per week, 2 or 3 cups a day, 4 or 5 cups a day and 6 or more cups a day.

    Results/Body

    At follow-up, 6,888 of the men had dies (2,049 due to cardiovascular disease, 2,491 due to cancer) and 11,095 of the women had died )2,368 due to cardiovascular disease, 5,011 due to cancer).  In men, the relative risks for al-cause mortality were 1.0, 1.07, 1.02, 0.97, 0.93, and 0.80 for the six levels of coffee consumption, after adjusting for age, smoking and other risk factors for cancer and CVD.  In women the figures were 1.0,0.98,0.3, 0.82, 0.74, and 0.83.  Most of the effect was due to a reduction in CVD mortality rather than cancer mortality.  "Decaffeinated coffee consumption was associated with a small reduction in all-cause and CVD mortality."

    Sources & Other Links

    Lopez-Garcia E, et al.  The relationship of coffee consumption with mortality.  Ann Intern Med. 2008 Jun 17;148(12):904-13

  • MEDICAL GRADE HONEY; LAST RESORT FOR DRUG-RESISTANT INFECTIONS

    In vitro studies of bactericidal activity show that a 40% solution of of honey reproducibly killed all bacterial isolates tested, including MRSA, vancomycin-resistant E. faecium, and multidrung-resistant gram-negative rods.  42 healthy volunteers had small forearm patches of skin swabbed with honey and covered with polyurethane dressings for 2 days.  Compared with control skin patches on the same volunteers, honey-covered patches were culture-negative significatly more often.  Medical-grade honey is produced by bees in closed greenhouses.  Grocery-grade honey is not standardized and can be bacterially contaminated.  Medline (Journal Watch).

     
  • ANGINA PREVENTION

1 year after MI, angina remains in 20% of patients

Summary

This multi-center study found that 1 year after myocardial infarction, 20% of patients still have angina.  The most significant associated factors are depressive symptoms, a history of CABG surgery, and a prior history of angina.

Detailed Summary of Study

Angina was assessed 1 year after MI in  1,957 patients at 19 hospitals.  Information was collected on demographics, clinical history, MI presentation and inpatient and outpatient treatment.

Results/Body

19.5% of the patients had angina 1 year after their MI.  Associated factors were younger age (relative risk per 10-year decrease, 1.19), nonwhite race/male gender (relative risk 1.50), prior history of angina (1.78), CABG (1.92), recurrent rest angina during hospital stay (1.54), continued smoking after MI (1.23), history of revascularization after the first hospitalization (1.37), and presence of new (1.96), persistent (1.88) or transient (1.77) depressive symptoms.

Sources & Other Links

Maddox TM, et al. Angina at 1 year after myocardial infarction; prevalence and associated findings.  Arch Intern Med. 2998 Jun23;168(12);1310-6  Article Link (NIBI)

  • AVASTIN (BEVACIZUMAB) AND SUNITINIB MALATE ASSOCIATED HEMOLYTIC ANEMIA

Genentech, Inc. informed healthcare professionals of reports of several cases of microangiopathic hemolytic anemia (MAHA) in patients with solid tumors receiving Avastin in combination with sunitinib malate. Avastin is not approved for use in combination with sunitinib malate and this combination is not recommended. Twenty-five patients were enrolled in a Phase I dose-escalation study combining Avastin and sunitinib malate. The study consisted of 3 cohorts using a fixed dose of Avastin at 10 mg/kg/IV every 2 weeks and escalating doses of sunitinib that included 25, 37.5, and 50 mg orally daily given in a 4 weeks on/2 weeks off schedule. Five of 12 patients at the highest sunitinib dose level exhibited laboratory findings consistent with MAHA. Two of these cases were considered severe with evidence of thrombocytopenia, anemia, reticulocytosis, reductions in serum haptoglobin, schistocytes on peripheral smear, modest increases in serum creatinine levels, and severe hypertension, reversible posterior leukoencephalopathy syndrome, and proteinuria. The findings in these two cases were reversible within three weeks upon discontinuation of both drugs without additional interventions. Healthcare professionals should report cases of MAHA or any serious adverse events suspected to be associated with the use of Avastin

  • FDA PRELIMINARY PHN: POSSIBLE MALFUNCTION OF ELECTRONIC MEDICAL DEVICES CAUSED BY COMPUTED TOMOGRAPHY (CT) SCANNING

    FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, the Agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. FDA is continuing to investigate the issue and is working with the manufacturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event reports and recommendations regarding reducing the potential risk to patients.

     

  • DIABETES TYPE 1 & 2 CONTROL VIA THE DCCT AND UKPDS STUDIES-GROUND BREAKING HISTORY OF GLOBAL MEDICINE REVIEW

The Diabetes Control and Complications Trial (DCCT) evaluated the importance of strict glycemic control in patients.  Groups were originally (1993) divided into intensive therapy (average blood glucose of 155 mg/dL) versus conventional therapy on long-term microvascular complications in type 1 diabetes mellitus.  Compared to conventional therapy, the risk of development of retinopathy declined by 76%, the risk of progression of retinopathy even declined by 54%, the occurrence of microalbuminuria declined by 39%, the occurrence of overt proteinuria declined by 54%, and the risk of development of neuropathy declined by 60% in the intensive therapy group.  The major adverse event was a 2-fold to 3-fold increase in severe hypoglycemia.  New England Journal Medicine 1993:329:977-986.

Similar to the DCCT, the United Kingdom Prospective Diabetes Study (UKPDS) investigated the incidence of complications in groups receiving intensive therapy versus conventional therapy in patients with type 2 diabetes.  The intensive therapy group had a significant 25% decrease in incidence of microvascular complications.  Lancet 1998:352:837-852.

  • BRIGHT LIGHT MODESTLY IMPROVES FUNCTION IN ELDERLY INSTITUTIONALIZED PATIENTS

Summary  The randomized controlled trial found that exposure to bright light modestly improves function in institutionalized elderly patients. Melatonin has an adverse effect on function and should be used only in conjunction with bright light therapy.

Basis for Study/Article  Some of most troublesome symptoms of dementia have been associated with circadian rhythm disturbances. The authors explored whether bright light therapy and melatonin, two purported circadian-rhythm synchronizers, could improve the functioning of elderly patients living in institutions in the Netherlands.

Detailed Summary of Study  189 patients (90% female, 87% with dementia, mean age 85.8 years) living in 12 institutions were randomized to receive therapy with whole-day bright or dim light or melatonin or placebo for a mean of 15 months. Cognitive and noncognitive symptoms, ADLs and adverse effects were assessed every 6 months.

Results/Body  Findings showed that light therapy “has a modest benefit in improving some cognitive and noncognitive symptoms of dementia.” It slightly improved cognitive deterioration and depressive symptoms and slowed the increase in functional limitations. Patients taking melatonin fell asleep more quickly and slept longer, but melatonin also had an adverse impact on both positive and negative affect; if given without light therapy, it also increased withdrawn behavior. When given together, light therapy and melatonin lessened aggressive behavior, increased sleep efficiency and improved nocturnal restlessness.

Sources & Other Links  Riemersma-van der Leck RF, Swaab DF, Twisk J, et al. Effect of bright light and melatonin on cognitive and noncognitive function in elderly residents of group care facilities: A randomized controlled trial. JAMA. 2008;299(22):2642-2655.

  • DIETARY ADVICE IN PREGNANCY FOR PREVENTING GESTATIONAL DIABETES MELLITUS

Authors  Tieu Joanna, Crowther Caroline A, Middleton Philippa

Review Group  Cochrane Pregnancy and Childbirth Group

Abstract  Gestational diabetes mellitus (GDM) is a form of diabetes that occurs during pregnancy which can result in significant adverse outcomes for mother and child both in the short and long term. The potential for adverse outcomes, in addition to the increasing prevalence of gestational diabetes worldwide, demonstrates the need to assess strategies, such as dietary advice, that might prevent gestational diabetes.  Objectives, To assess the effects of dietary advice in preventing gestational diabetes mellitus.  Search strategy. We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (January 2008) and reference lists of retrieved articles.  Selection criteria Quasi-randomised and randomised studies of dietary intervention for preventing glucose intolerance in pregnancy.Data collection and analysis: Two review authors independently conducted data extraction and quality assessment. We resolved disagreements through discussion or through a third author.  Main resultsThree trials (107 women) were included in the review. One trial (25 pregnant women) analysed high-fibre diets with no included outcomes showing statistically significant differences. Two trials (82 pregnant women) assessed low glycaemic index (LGI) versus high glycaemic index diets for pregnant women. Women on the LGI diet had fewer large for gestational age infants (one trial; relative risk (RR) 0.09, 95% confidence interval (CI) 0.01 to 0.69), infants with lower ponderal indexes (two trials; weighted mean difference (WMD) -0.18, 95% CI -0.32 to -0.04, random-effects analysis) and lower maternal fasting glucose levels (two trials; WMD -0.28 mmol/L 95% CI -0.54 to -0.02, random-effects model). Results for women on the LGI diet on neonatal birth weight were not conclusive under a random-effects model (two trials; WMD -527.64 g, 95% CI -1119.20 to 63.92); however, on a fixed-effect model, women on the LGI diet gave birth to lighter babies (two trials; WMD -445.55 g, 95% CI -634.16 to -256.95). High heterogeneity was observed between the trials in most results and both were relatively small trials. One of these trials also included a standard exercise regimen for all participants.  Authors' conclusions While a low glycaemic index diet was seen to be beneficial for some outcomes for both mother and child, results from the review were inconclusive. Further trials with large sample sizes and longer follow up are required to make more definitive conclusions. No conclusions could be drawn from the high-fibre versus control-diet comparison since the trial involved did not report on many of the outcomes we prespecified.

Implications  Overall, results were inconclusive due to the limited number of trials, participants and data provided in addition to high heterogeneity between trials. While the results were promising, the evidence is not sufficient to change clinical practice without further research on dietary intervention for the prevention of gestational diabetes mellitus (GDM) and its associated outcomes. One study in Australia suggests that dietary advice for low and high GI diets can be acceptable and affordable for women.

Citation  Tieu J, Crowther CA, Middleton P. Dietary advice in pregnancy for preventing gestational diabetes mellitus. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD006674. DOI: 10.1002/14651858.CD006674.pub2

  • ANTIBIOTICS FOR ACUTE MAXILLARY SINUSITIS

Authors  Ahovuo-Saloranta Anneli, Borisenko Oleg V, Kovanen Niina, Varonen Helena, Rautakorpi Ulla-Maija, Williams Jr John W, M&auml;kel&auml; Marjukka

Review Group  Cochrane Acute Respiratory Infections Group

Abstract  Expert opinions vary on the appropriate role of antibiotics for sinusitis, one of the most commonly diagnosed conditions among adults in ambulatory care. Objectives: We examined whether antibiotics are effective in treating acute sinusitis, and if so, which antibiotic classes are the most effective.  Search strategy. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2007, Issue 3); MEDLINE (1950 to May 2007) and EMBASE (1974 to June 2007).  Selection criteria Randomized controlled trials (RCTs) comparing antibiotics with placebo or antibiotics from different classes for acute maxillary sinusitis in adults. We included trials with clinically diagnosed acute sinusitis, whether or not confirmed by radiography or bacterial culture. Data collection and analysis: At least two review authors independently screened search results, extracted data and quality assessed trials. Risk ratios (RR) were calculated for differences in the intervention and control groups to see whether or not the treatment was a failure. In meta-analysing the placebo-controlled studies, the data across antibiotic classes were combined. Primary outcomes were the clinical failure rates at 7 to 15 days and 16 to 60 days follow up. Main results: Fifty-seven studies were included in the review; six placebo-controlled studies and 51 studies comparing different classes of antibiotics. Five studies involving 631 participants provided data for comparison of antibiotics to placebo, when clinical failure was defined as a lack of cure or improvement at 7 to 15 days follow up. These studies found a slight statistical difference in favor of antibiotics, compared to placebo, with a pooled RR of 0.66 (95% confidence interval (CI) 0.44 to 0.98). However, the clinical significance of the result is equivocal, also considering that cure or improvement rate was high in both the placebo group (80%) and the antibiotic group (90%). Based on six studies, when clinical failure was defined as a lack of total cure, there was significant difference in favor of antibiotics compared to placebo with a pooled RR of 0.74 (95% CI 0.65 to 0.84) at 7 to 15 days follow up. None of the antibiotic preparations was superior to each other.  Authors' conclusions: Antibiotics have a small treatment effect in patients with uncomplicated acute sinusitis in a primary care setting with symptoms for more than seven days. However, 80% of participants treated without antibiotics improve within two weeks. Clinicians need to weigh the small benefits of antibiotic treatment against the potential for adverse effects at both the individual and general population level.

Implications  Antibiotics cause a small treatment effect in patients with uncomplicated acute sinusitis in a primary care setting with symptoms for more than seven days. However, 80% of patients treated with a placebo also improve within two weeks. The clinician needs to weigh the moderate benefits of antibiotic treatment against the potential for adverse effects at both the individual and general population level.

Citation  Ahovuo-Saloranta A, Borisenko OV, Kovanen N, Varonen H, Rautakorpi UM, Williams Jr JW, M&auml;kel&auml; M. Antibiotics for acute maxillary sinusitis. Cochrane Database of Systematic Reviews 2008, Issue 2. Art. No.: CD000243. DOI: 10.1002/14651858.CD000243.pub2.

  • IS TYPE 2 DIABETES A RISK FACTOR FOR DEPRESSION?

    Summary  Depressed people are slightly more likely to develop type 2 diabetes, mostly because of lifestyle factors. Conversely, depression was less common in people with impaired fasting glucose levels and untreated type 2 diabetes than it was in people with normal fasting glucose levels and those with treated type 2 diabetes.

    Basis for Study/Article  “Depressive symptoms are associated with development of type 2 diabetes, but it is unclear whether type 2 diabetes is a risk factor for elevated depressive symptoms.”

    Detailed Summary of Study  The researchers conducted two analyses of data from the Multi-Ethnic Study of Atherosclerosis, which comprised men and women age 45 to 84 who were enrolled in 2000-02 and followed up until 2004-05. The first analysis looked at the incidence of type 2 diabetes in 5,201 subjects who did not have diabetes at baseline, comparing the incidence in those with vs. without depressive symptoms. The second analysis looked at the incidence of depression in 4,847 subjects who were not depressed at baseline, comparing the incidence in those with vs. without diabetes. Depression was defined as use of antidepressants or a score of 16 on the Center for Epidemiologic Studies Depression Scale. Fasting glucose levels were defined as normal (<100 mg/dL), impaired (100 to 125 mg/dL) or type 2 diabetes (either receiving treatment or 126 mg/dL).

    Results/Body  In analysis 1, the incidence rate of type 2 diabetes was 22.0 per 1,000 person-years for those with depression and 16.6 for those without depression. This association was partially explained by lifestyle factors. In analysis 2, the incidence rate of depression was 36.8 per 1,000 person-years for those with normal fasting glucose levels, 27.9 for those with impaired levels, 31.2 for those with untreated diabetes and 61.9 for those with treated diabetes. Odds ratios for developing depression, compared to those with normal fasting glucose levels, were 0.79 for those with impaired levels, 0.75 for those with untreated diabetes and 1.54 for those with treated diabetes. The association remained significant after adjusting for multiple factors.

    Sources & Other Links  Golden SH, et al. Examining a bidirectional association between depressive symptoms and diabetes. JAMA. 2008 Jun 18;299(23):2751-9.  Article Link (NCBI)

     

  • H. PYLORI INFECTIONS MAY TRIGGER SIDS

    Summary  This study from Norway found that H. pylori infection is significantly more common in SIDS victims and infants who die of infection. The authors hypothesize that such infection “may be involved as the triggering pathogen” for SIDS.

    Basis for Study/Article  The authors explored the proposed link between H. pylori infection and SIDS.

    Detailed Summary of Study  Immunoassay for the H. pylori antigen was performed in infants who died of various causes (122 SIDS victims; 17 infants who died of infection; 11 accidental or violent deaths) and 156 live controls.

    Results/Body  H. pylori was found in stool samples of 25% of the SIDS victims (p <0.001 vs. live controls), 53% of the babies who died of infection (p <0.001), 9% of accidental deaths (p = 0.6) and 8% of the live controls. In infants ages 1 to 5 months of age, the classic age for SIDS, 21 of the 67 SIDS victims tested positive for H. pylori vs. only 1 of the 68 live controls. “We hypothesize that H. pylori infection in infancy may be involved as the triggering pathogen for sudden death during the first five months after birth.”

    Sources & Other Links  Stray-Pederson A, et al. Helicobacter pylori antigen in stool is associated with SIDS and sudden infant deaths due to infectious disease. Pediatr Res. 2008 Jun 4. [Epub ahead of print] rticle Link (NCBI)

     

  • ADDING SINGLE-DOSE DEXAMETHASONE TO ACUTE MIGRAINE TREATMENT LOWERS RECURRENCE RATE

    Summary  This meta-analysis found that adding a single dose of dexamethasone to standard abortive treatment for an acute migraine lowers the risk that the migraine will recur within 72 hours.

    Basis for Study/Article  The authors explored the role of parenteral dexamethasone in the treatment of acute migraine.

    Detailed Summary of Study  The authors analyzed the data from seven randomized controlled trials comparing the effects of standard abortive therapy for acute migraines plus either parenteral dexamethasone or placebo.

    Results/Body  Adding dexamethasone to the regimen did not improve pain relief, but it did reduce the risk of recurrence within 72 hours (relative risk 0.74) compared to placebo.

    Sources & Other Links <> Colman I, et al. Parenteral dexamethasone for acute severe migraine headache: meta-analysis of randomised controlled trials for preventing recurrence. BMJ. 2008 Jun 14;336(7657):1359-61.  Article Link (NCBI)

     

  • VITAMIN D DEFICIENCY IS COMMON IN HEALTHY YOUNG CHILDREN

    Summary  Vitamin D deficiency (20 mg/mL) is common in otherwise healthy young children, and a third of the children with vitamin D deficiency had evidence of bone demineralization. Significant predictors of deficiency were breastfeeding without supplementation in infants and lower milk intake in children.

    Basis for Study/Article  The authors assessed the prevalence of vitamin D deficiency in healthy infants and toddlers and identified predictors of deficiency.

    Detailed Summary of Study  25-hydroxyvitamin D levels were measured in 380 healthy infants and toddlers at one urban clinic. Information was also collected on the children’s sun exposure, nutrition, and skin pigmentation and the parents’ health habits. Deficiency was defined as a level 20 mg/mL; the “accepted optimal threshold” was 30 mg/mL. For those found to have a deficiency, wrist and knee x-rays were taken to assess bone mineralization.

    Results/Body  12% of the children had a vitamin D deficiency; 40% had less than the optimal level. A third of the children with deficiency had radiographic evidence of bone demineralization and 7.5% had rachitic changes. In infants, breastfeeding without supplementation was a significant predictor of deficiency; in children, lower milk intake was a significant predictor. Skin pigmentation was not a predictor.

    Sources & Other Links  Gordon CM, et al. Prevalence of vitamin D deficiency among healthy infants and toddlers. Arch Pediatr Adolesc Med. 2008 Jun;162(6):505-12.

    Article Link (NCBI)

     
  • CHILDREN WHO DRINK 100% FRUIT JUICE HAVE BETTER NUTRIENT INTAKE AND AREN'T OVERWEIGHT

    Summary  Children age 2 to 11 who drink 100% fruit juice have better nutrient intake and are not more likely to be overweight.

    Basis for Study/Article  The authors explored the impact of consumption of 100% fruit juice in terms of dietary intake and weight in children age 2 to 11 years.

    Detailed Summary of Study  The authors used data from the 1999-2002 National Health and Nutrition Examination Survey (n = 3,618 children). Mean daily intake of 100% fruit juice was 4.1 fluid ounces.

    Results/Body  Compared to those who didn’t drink 100% fruit juice, the children who did drink 100% fruit juice had significantly higher intakes of whole fruit, energy, carbohydrates, vitamin C, vitamin B6, potassium, riboflavin, magnesium, iron and folate. They had significantly less intake of total fat, saturated fatty acids, discretionary fat and added sugar. The amount of juice consumed did not affect the child’s weight or risk of being overweight.

    Sources & Other Links  Nicklas T, et al. Association between 100% juice consumption and nutrient intake and weight of children aged 2 to 11 years. Arch Pediatr Adolesc Med. 2008 Jun;162(6):557-65.  Article Link (NCBI)

     

  • FDA RECALL

    FOR IMMEDIATE RELEASE -- Pompano Beach, FL – July 01, 2008 – Jack Distribution, LLC, 1501 Green Road Unit C Pompano Beach, Florida 33064 and its wholesale distributors G & N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10).

    Jack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples from lots manufactured and packaged in 2007 found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that these lots of Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains that this ingredient is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

    Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

    Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

    Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

    The company advises that any unused portions from these lot numbers be returned to the place of purchase for a full refund of purchase price. G & N Works and Devine Distribution are not shipping any Rize 2 or Rose 4 Her that is in stock while additional samples are being tested, they expect to begin shipping again in 2-4 weeks.

    Rize 2 and Rose 4 Her are sold in adult stores, vitamin & nutrition shops, convenience stores, and via the internet nationwide. The Rize 2 product is sold as a (single blister pack, three count bottles, twelve count bottles, and thirty count bottles. Rose 4 Her is only available in single blister packs and three count bottles.

    The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Rize 2 and Rose 4 Her pills composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.

    FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.

    FOR IMMEDIATE RELEASE  Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria

     

  • ALZHEIMER'S DISEASE IS NOW THE  6th LEADING CAUSE OF DEATH

    Preliminary death statistics for 2006, released by CDC’s National Center for Health Statistics in early June 2008, found that Alzheimer’s Disease surpassed diabetes as the 6th leading cause of death in the United States.  To view the press release, please visit: http://www.cdc.gov/media/pressrel/2008/r080611.htm.

     

  • TRAUMATIC BRAIN INJURIES AMONG OLDER AMERICANS CAN RESULT FROM FALLS

    Traumatic brain injuries due to falls caused nearly 8,000 deaths and 56,000 hospitalizations in 2005 among Americans 65 and older, according to a new report from the Centers for Disease Control and Prevention released in the June issue of the Journal of Safety Research.  To learn more, please visit:  http://www.cdc.gov/ncipc/tbi/elder_fall.htm. 

     

  • CAR CRASHES MORE COMMON IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA

    Summary Car accidents are more common in patients with obstructive sleep apnea/hypopnea, and they are also more likely to be injured in the crash.

    Basis for Study/Article  The authors of this Canadian study investigated the incidence and severity of car accidents in patients with obstructive sleep apnea.

    Detailed Summary of Study  Information on the number and severity of vehicle accidents was obtained from 783 patients (71% men, mean age 50 years) undergoing sleep studies for suspected obstructive sleep apnea. The figures were compared to those from 783 age- and sex-matched controls.

    Results/Body  Over a 3-year period the patients had 252 car crashes and the controls had 123. Relative risks were 2.6 for patients with mild OSA, 1.9 for those with moderate OSA and 2.0 for those with severe OSA. The crashes involving OSA patients were more likely to cause personal injury; corresponding relative risks were 4.8, 3.0 and 4.3. The patients whose sleep studies were negative did not have a significantly increased risk of being in a crash compared to the controls, nor were they more likely to be involved in accidents involving injury. 80% of the serious crashes (head-on collisions or accidents involving pedestrians or cyclists) occurred in the patients.

    Commentary  This data indeed is concerning for not only the frequency of accidents, but the evidence that major lapses in attention must have occurred to result in the higher severity of each accident. Doctors of OSA patients need to counsel their patients that this is a risk of OSA and consider this when recommending therapy for OSA.

    Grant E. Fraser, M.D.
    MedAlert Editor

    Sources & Other Links  Mulgrew AT, et al. Risk and severity of motor vehicle crashes in patients with obstructive sleep apnoea/hypopnoea. Thorax. 2008 Jun;63(6):536-41.  Article Link (NCBI)

     

  • LONG-TERM EFFECTS OF DIET AND EXERCISE ON TYPE 2 DIABETES PREVENTION

    Summary  This study from China found that lifestyle changes (diet and exercise) can prevent or delay the onset of type 2 diabetes, but their effect on reducing the risk of cardiovascular disease and death remains unclear.

    Basis for Study/Article  The authors performed a follow-up analysis of their diabetes prevention study to assess the long-term effects of lifestyle changes. In the original multicenter study (1986–1992), 577 adults with impaired glucose tolerance were randomized to a control group or to one of three “lifestyle intervention groups” (diet, exercise, or both).

    Detailed Summary of Study  In this follow-up study, type 2 diabetes incidence, CVD incidence and mortality, and all-cause mortality were tracked in the original trial participants.

    Results/Body  At the 20-year follow-up, 80% of those who made lifestyle changes had developed type 2 diabetes vs. 93% of the control group. Those who made lifestyle changes had a 51% lower incidence of diabetes during the 6-year study and a 43% lower incidence at the 20-year follow-up, “controlled for age and clustering by clinic.” Average yearly incidence of diabetes was 7% for those who made lifestyle changes vs. 11% in the control group. Those who made lifestyle changes “spent an average of 3.6 fewer years with diabetes” vs. the control group. There were no differences between the groups in terms of rate of first CVD events, CVD mortality, and all-cause mortality, “but our study had limited statistical power to detect differences for these outcomes.”

    Sources & Other Links  Li G, et al. The long-term effect of lifestyle interventions to prevent diabetes in the China Da Qing Diabetes Prevention Study: a 20-year follow-up study. Lancet 2008 May 24;371(9626):1783-9.Article Link (NCBI)

     

  • TEENS WITH PRIMARY AMENORRHEA AND PCOS ARE A DISTINCT SUBGROUP

    Summary  Teenage girls with polycystic ovarian syndrome that manifests as primary amenorrhea form a subgroup distinct from those with PCOS and oligomenorrhea or secondary amenorrhea. They have “increased features of the metabolic syndrome and higher androstenedione levels and may represent a more severe spectrum of a common condition.”

    Basis for Study/Article  This study compared the characteristics of teenage girls with PCOS manifested by primary amenorrhea vs. that manifested by secondary amenorrhea or oligomenorrhea.

    Detailed Summary of Study  At a Canadian pediatric endocrine clinic, clinical, laboratory and ultrasound results were collected from 9 adolescent girls with PCOS and primary amenorrhea and 18 with PCOS and secondary amenorrhea or oligomenorrhea.

    Results/Body  The girls with primary amenorrhea and PCOS had “older age at pubarche, higher androstenedione levels, greater prevalence of family history of obesity, a tendency toward no withdrawal bleeding in response to the progesterone challenge, and more features associated with the metabolic syndrome.”

    Sources & Other Links  Rachmiel M, et al. Primary amenorrhea as a manifestation of polycystic ovarian syndrome in adolescents: a unique subgroup? Arch Pediatr Adolesc Med. 2008 Jun;162(6):521-5.  Article Link (NCBI)

     

  • MEN WITH LOWER VITAMIN D LEVELS HAVE A HIGHER RISK OF MYOCARDIAL INFARCTION

    Summary  This prospective study found that men with lower levels of vitamin D have a higher risk of myocardial infarction, with the degree of risk dependent on the level.

    Basis for Study/Article  The authors investigated whether low vitamin D levels raise the risk of coronary heart disease in men.

    Detailed Summary of Study  As part of the Health Professionals Follow-up Study, serum vitamin D levels (25-hydroxyvitamin D) were measured at baseline in 18,225 men age 40 to 75 who did not have cardiovascular disease. 10 years later, 454 of the men had developed nonfatal MI or fatal CHD. The authors compared vitamin D levels in those who did and did not develop heart disease.

    Results/Body  The risk of having an MI was 2.42 times higher in the men with low vitamin D levels (defined as 15 ng/mL), 1.43 times higher in those with levels 15 to 22.5 ng/mL, and 1.60 times higher in those with levels 22.6 to 29.9 ng/mL vs. those with “sufficient” levels (30 ng/mL). Adjusting for CV risk factors such as family history of MI, BMI, alcohol consumption, physical activity, lipid profile and others did not change the relationship.

    Sources & Other Links  Giovannucci E, et al. 25-hydroxyvitamin D and risk of myocardial infarction in men: a prospective study. Arch Intern Med. 2008 Jun 9;168(11):1174-80.  Article Link (NCBI)

     

  • IN YOUNG ADULTS, IBD HAS SERIOUS EFFECTS ON QUALITY OF LIFE, BODY IMAGE, AND SEXUAL FUNCTION

    Summary  In young adults, IBD has serious effects on quality of life, body image, and sexual function. “These issues need to be further addressed in both research & clinical settings.”

    Basis for Study/Article  The authors of this study from Australia explored how IBD affects quality of life, body image and sexual function in young adults.

    Detailed Summary of Study  The authors asked 183 patients (65% women, mean age 36 years) how IBD (mostly Crohn’s disease and ulcerative colitis) affected their lifestyle and body image.

    Results/Body  88% of the patients believed that IBD had affected their quality of life. 52% believed it had affected their relationship status; women were more likely to believe this, even though there was no actual difference in relationship status between men and women. 75% of women and half of men said it had affected their body image. 67% of women and 39% of men reported decreased libido due to IBD; 69% of those who had undergone surgery reported decreased libido vs. 49% of those who had not. 55% of patients reported decreased sexual activity since the onset of IBD symptoms: 87% attributed the decrease to feeling unwell, 48% to lower libido and 23% to concerns about their partner’s reaction.

    Sources & Other Links  Muller KR, et al. Female gender and surgery lead to greater perceived impact of inflammatory bowel disease (IBD) on body image and sexual function: a neglected issue. Presented at Digestive Disease Week, May 2008, abstract #944  Article Link (DOWNLOAD)

     

  • GREEN TEA MAY IMPROVE HEART FUNCTION ACCORDING TO ONE NEW STUDY-MORE STUDIES NEEDED TO CONFIRM

    More evidence for the beneficial effect of green tea on risk factors for heart disease has emerged in a new study reported in the latest issue of European Journal of Cardiovascular Prevention and Rehabilitation. The study found that the consumption of green tea rapidly improves the function of (endothelial) cells lining the circulatory system; endothelial dysfunction is a key event in the progression of atherosclerosis.

    The study, performed by Dr Nikolaos Alexopoulos and colleagues at the 1st Cardiology Department, Athens Medical School in Greece, was a randomized trial involving the diameter measurement (dilatation) of the brachial artery of healthy volunteers on three separate occasions - after taking green tea, caffeine, and hot water (for a placebo effect). The measurements were taken at 30, 90 and 120 minutes after consumption. Dilatation of the brachial artery as a result of increased blood flow (following a brief period of ischemia of the upper limb) is related to endothelial function and is known to be an independent predictor of cardiovascular risk.2

    Results showed that endothelium-dependent brachial artery dilatation increased significantly after drinking green tea, with a peak increase of 3.9 per cent 30 minutes after consumption. The effect of caffeine consumption (or hot water) was not significant.

    While black tea has been associated with improved short and long-term endothelial performance, this is the first time that green tea has been shown to have a short-term beneficial effect on the large arteries. Another study has already shown that green tea reverses endothelial dysfunction in smokers.

    Green tea, which originates in China but is now consumed throughout the world, is made with pure leaves, and has undergone little oxidization during processing. The cardiovascular benefits of all teas - as well as dark chocolate and red wine - are attributed to the flavonoids they contain and their antioxidant activity.3 However, says investigator Dr. Charalambos Vlachopoulos, flavonoids in green tea are probably more potent antioxidants than in black tea because there has been no oxidization.

    "These findings have important clinical implications," says Dr Vlachopoulos. "Tea consumption has been associated with reduced cardiovascular morbidity and mortality in several studies. Green tea is consumed less in the Western world than black tea, but it could be more beneficial because of the way it seems to improve endothelial function. In this same context, recent studies have also shown potent anticarcinogenic effects of green tea, attributed to its antioxidant properties."

  • ICY HOT HEAT THERAPY AIR ACTIVATED HEAT FOR BACK, ARM, NECK AND LEG RECALLED

    What is “Icy Hot Heat Therapy Air Activated Heat”?

    Icy Hot Heat Therapy Air Activated Heat is an adhesive patch that generates heat. The patch comes in a red sealed plastic pouch. Once the pouch is opened and the patch is exposed to air, the chemicals contained in the patch activate to produce heat. It is then applied to body surfaces to relieve muscle and joint pain associated with arthritis, backache, muscle strains and sprains.

    What is the problem with Icy Hot Heat Therapy Air Activated Heat products?

    Chattem, Inc. chose to recall their Icy Hot Heat Therapy products because they received consumer reports of first, second and third degree burns as well as skin irritation and skin removal resulting from the use of the Icy Hot Heat Therapy Air Activated Heat patch. As part of FDA's recall classification process, we will be reviewing the firm's root-cause analysis on what caused the burns.

    What is the difference between first, second and third degree burns?

    The type of burn is determined by how deeply it penetrates into the skin. There are two main layers of skin, and the degree of burn is based on how each layer is affected. First degree burns are the least severe and third degree burns are the deepest or most severe.

    First Degree Burns: Means the top layer of skin (the epidermis) is damaged but not destroyed and turns bright pink or very red. Pain from first degree burns ranges from mild to extreme. No skin comes off and there are no blisters. Mild sunburns are a good example of first degree burns.

    Second Degree Burns: Means burn damage has gone through the top layer (the epidermis) and into the 2nd layer of skin (the dermis). The top layer of skin is destroyed and may slide off or blister. Blisters are the first sign of a second degree burn. The wound appears red or pink and moist. Second degree burns are the most painful kind of burn.

    Third Degree Burns: Means the burn has destroyed both the first and second (epidermis and dermis) layers of the skin. The exposed wound appears white, gray, yellow, brown or black and is usually dry. There may be little or no pain or the area may feel numb because of nerve damage.

    When were the Icy Hot Heat Therapy Air Activated Heat patches produced and sold?

    The firm issued a press release, dated February 8, 2008, for their voluntary recall involving 2.3 million Icy Hot Heat Therapy Air Activated Heat patches distributed in the United State since December 2006. The products were manufactured between December 2006 and February 2008 and sold over the counter through food, drug and mass merchandisers. You can find a listing of retailers on Chattem, Inc.’s website at http://www.chattem.com/wheretobuy/icy.asp.

    What products are affected by the recall?

    All lots and all sizes of the following Icy Hot Heat Therapy products are affected by this recall:

    • Icy Hot Heat Therapy Air Activated Heat - Back
    • Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg
    • Icy Hot Heat Therapy Air Activated Heat - Arm, Neck, and Leg in single-use “samples” that were included on a limited promotional basis in yellow and red cartons of 3 oz. Aspercreme Pain Relieving Crème. The samples were distinct and stand-alone products, clearly labeled as "Icy Hot Heat Therapy Air Activated Heat." This recall only involves the above listed Icy Hot Heat Therapy products and does not involve any other Icy Hot products such as the medicated patch, cream, or balm/stick that also use the “Icy Hot” name. -Author FDA

     

  • HIGH FIBER DIET IMPROVED CONSTIPATION IN WOMEN WITH PELVIC FLOOR DISORDERS AKA THE BULK OF THE STUDY

    Constipation is a common and potentially burdensome problem, particularly among women with pelvic floor disorders. Nonpharmacologic treatment usually should be the first step. In a study evaluating whether augmenting dietary fiber can lessen self-reported constipation severity and laxative use, investigators recruited 41 women (mean age, 60) with constipation and a history of pelvic floor disorders. Twenty-five women had had previous surgery for pelvic organ prolapse. Participants were supplied with and instructed to eat high-fiber cereal, starting with one-quarter cup (7 g fiber) daily and gradually increasing to 1 cup per day (28 g fiber) during the 42-day study period. Women also were instructed to increase water intake and decrease caffeine consumption. In addition to maintaining daily diaries, women reported their constipation symptoms in standardized telephone interviews every 2 weeks.

    Six women withdrew from the study because they could not tolerate the high-fiber diet. Thirty women completed the study and reported less straining, less frequent sensations of incomplete emptying, and less frequent vaginal or perineal splinting than at baseline. Based on the Patient Assessment of Constipation Symptoms scale, participants reported improved abdominal, rectal, and stool symptoms. Caffeine intake decreased significantly, water intake remained largely unchanged, and weekly laxative use decreased by about half during follow-up.

    Comment: This simple prospective study demonstrates that increased fiber intake can help relieve constipation, particularly in women with pelvic floor disorders. The lack of a control group makes it difficult to compare this approach to others, and the multifaceted intervention makes it difficult to assess whether increased fiber consumption was the only factor that improved symptoms. Regardless, because low fiber intake often contributes to constipation, this treatment approach merits consideration by clinicians for their patients who are amenable to fiber supplementation. Cereal brands with the word "fiber" on the box are a good starting point; but because of the considerable confusion about high-fiber cereals, encouraging patients to read the rest of the nutritional information on the box is important.
    Sandra Ann Carson, MD
  • RISEDRONATE (Actonel®) PREVENTS BONE LOSS IN IBD PATIENTS ON STEROIDS

    Summary This randomized controlled trial found that risedronate (Actonel®) prevents steroid-induced bone loss in IBD.

    Basis for Study/Article  The authors of this study from England examined the efficacy of risedronate for preventing steroid-related bone loss in patients with IBD.  June 25, 2008

    Detailed Summary of Study  Patients receiving prednisolone for an IBD flare-up were randomized to receive placebo or risedronate, in addition to calcium and vitamin D. DEXA scans of the lumbar spine and hips were done at baseline and 8 weeks later in 73 patients (42 with ulcerative colitis, 31 with Crohn’s disease; average age 43.5 years; 42 patients were men).

    Results/Body  In the lumbar spine, the patients taking risedronate had a 1% gain in BMD vs. no change in the placebo group after 2 months of treatment. In the total hip, neither group experienced BMD change. In Ward’s triangle (neck of the femur), the risedronate group had a 1% loss and the placebo group had a 2% loss.

    Sources & Other Links  Kriel MH, et al. Risedronate protects against bone loss when a relapse of IBD is treated with steroids. Abstract #T1122 presented at Digestive Diseases Week, May 2008.  Article Link (DOWNLOAD)

     

  • IM DEXAMETHASONE + ANTIBIOTICS USEFUL FOR ACUTE EXUDATIVE PHARYNGITIS

    Summary  This randomized controlled trial found that for acute exudative pharyngitis, adding a single dose of IM dexamethasone to the antibiotic regimen relieves symptoms better than antibiotics alone.  June 25, 2008

    Basis for Study/Article  The authors of this single-center trial from Turkey tested the efficacy of a single dose of IM dexamethasone in the treatment of acute exudative pharyngitis.

    Detailed Summary of Study  Adults with acute exudative pharyngitis, sore throat, and/or odynophagia were randomized to receive either an 8-mg IM dose of dexamethasone (n = 31) or placebo (n = 42), in addition to 3 days of azithromycin and paracetamol (acetaminophen). Time to onset of pain relief and time to complete pain relief were compared.

    Results/Body  Onset of pain relief occurred in 8.06 hours in the dexamethasone group vs. 19.90 hours in the placebo group. Corresponding figures for complete pain relief were 28.97 hours and 53.74 hours.

    Sources & Other Links  Tasar A, et al. Clinical efficacy of dexamethasone for acute exudative pharyngitis. J Emerg Med. 2008 May 10. [Epub ahead of print]  Article Link (NCBI)

     

  • TIGHT DIABETES CONTROL LOWERS INCIDENCE OF NEPHROPATHY, VASCULAR EVENTS

    Summary  This large study with 5 years of follow-up found that tight diabetes control (using gliclazide [Diamicron®] and other drugs to obtain an HbA1c of 6.5% or less) lowers the incidence of macrovascular and microvascular events together, in particular reducing the relative risk of nephropathy by 21%.

    Basis for Study/Article  The ADVANCE Collaborative Group tested the effects of intensive glucose control on macrovascular and microvascular outcomes in patients with type 2 diabetes.  June 25, 2008

    Detailed Summary of Study  11,140 patients with type 2 diabetes were randomized to receive either standard glucose control or intensive control (using modified-release gliclazide [Diamicron®] and other drugs to obtain an HbA1c of 6.5% or less). After a median follow-up of 5 years, the number of major macrovascular events (CV death, nonfatal MI, nonfatal stroke) and major microvascular events (nephropathy, retinopathy) was assessed.

    Results/Body  At follow-up, mean HbA1c levels were 6.5% in the intensive group vs. 7.3% in the standard group. Combined major and minor macrovascular events occurred in 18.1% of the intensive group vs. 20% of the standard group (p = 0.01). Major microvascular events occurred in 9.4% of the intensive group vs. 10.9% of the standard group (p = 0.01). Nephropathy occurred in 4.1% of the intensive group vs. 5.2% of the standard group. There were no differences between the groups in the incidence of major macrovascular events alone, retinopathy, CV death or all-cause mortality. Severe hypoglycemia occurred in 2.7% of the intensive group vs. 1.5% of the standard group (p <0.001).

    Sources & Other Links  ADVANCE Collaborative Group. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-2572.  Article Link (NCBI)

  • SEQUENTIAL THERAPY IS BETTER THAN STANDARD TRIPLE THERAPY FOR H. PYLORI

    Summary  This meta-analysis found that 10-day sequential therapy is better than standard triple therapy for the treatment of H. pylori infection in treatment-naïve patients. However, the authors caution that most of the patients in the studies they reviewed were from Italy, only one study was double-blinded, and publication bias may have played a role. June 25, 2008

    Basis for Study/Article  Because standard triple therapy for H. pylori infection is unsuccessful in about a quarter of patients, the authors conducted a meta-analysis on the efficacy of sequential therapy in treatment-naïve patients.

    Detailed Summary of Study  The reviewers analyzed data from 10 randomized controlled trials (n = 2,747) comparing sequential vs. standard therapy.

    Results/Body  H. pylori eradication rates were 93.4% in the 1,363 patients receiving sequential therapy and 76.9% in the 1,384 patients receiving standard triple therapy. The success rate was affected by the patient’s smoking status, diagnosis and method of diagnosis, resistance to clarithromycin or imidazoles, and duration of triple therapy. Adherence rates were 97.4% for sequential therapy and 96.8% for standard therapy. Adverse effects were similar. The authors believe that if trials in other countries confirm the findings, “10-day sequential therapy could become a standard treatment for H. pylori infection in treatment-naïve patients.”

    Commentary  What is sequential therapy? Triple therapy has been common for some time. One article detailing one sequential regimen is available at: http://www.annals.org/cgi/content/abstract/146/8/556

    Briefly; the protocol used was:

      Days 1-5
      40 mg pantoprazole BID
      1 gram amoxicillin BID
      Days 6-10
      40 mg pantoprazole BID
      500 mg clarithromycin BID
      500 mg tinidazole BID

    Grant E. Fraser, M.D. MedAlert Editor

    Sources & Other Links  Jafri NS, et al. Meta-analysis: Sequential therapy appears superior to standard therapy for Helicobacter pylori infection in patients naive to treatment. Ann Intern Med. 2008 May 19. [Epub ahead of print]  Article Link (NCBI)

     

  • DEPRESSION AND TOO MUCH OR TOO LITTLE ACTIVITY CAN LEAD TO PERSISTENT ADOLESCENT FATIGUE

    Summary Teenagers with depressive symptoms and either sedentary or highly active lives are at risk for persistent fatigue.  June 18, 2008

    Basis for Study/Article The authors of this British study identified risk factors for persistent adolescent fatigue, defined as extreme tiredness twice weekly or more often in the previous month.

    Detailed Summary of Study 1,880 subjects age 11 to 16 (49% boys, 81% nonwhite) at 28 London schools completed questionnaires in 2001 and 2003 asking about persistent fatigue, activity level, depressive symptoms, BMI and smoking status.

    Results/Body  4% (84 students) of the students reported persistent fatigue; however, in both surveys (2001 and 2003) only 3 students reported chronic fatigue syndrome. Persistent fatigue was more common in teens who had depressive symptoms (odds ratio 2.0), who were sedentary more than 4 hours a day (odds ratio 1.6) or who were extremely active (odds ratio 1.5). BMI and smoking were not factors. Severe fatigue occurred in 11% of students aged 11 to 14 years and 17% of those aged 13 to 16 years.

    Sources & Other Links  Viner RM, et al. Longitudinal risk factors for persistent fatigue in adolescents. Arch Pediatr Adolesc Med. 2008 May;162(5):469-75.  Article Link (NCBI)

     
  • TABLE FOR CHRONIC  ANTIHYPERTENSIVE DRUGS FROM THE USFDA - 2008
    Pharmacologic Class

    Approved Drugs

    aldosterone antagonists Works on the blood side of the nephron-binds to aldosterone. eplerenone, spironolactone
    alpha adrenergic blockers doxazosin, phenoxybenzamine, phentolamine, prazosin, terazosin
    angiotensin converting enzyme inhibitors benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril
    angiotensin II receptor blockers candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan
    arteriolar vasodilators hydralazine, minoxidil
    autonomic ganglionic vasodilators mecamylamine
    beta adrenergic blockers acebutolol, atenolol, betaxolol, bisoprolol, carvedilol, carteolol, esmolol, labetolol, metoprolol, nadolol, penbuterol, pindolol, propranolol, timolol
    catecholamine-depleting sympatholytics deserpidine, reserpine
    central alpha-2 adrenergic agonists clonidine, guanabenz, guanfacine, methyldopa
    calcium channel blockers diltiazem, verapamil
    dihydropyridine calcium channel blockers amlodipine, felodipine, isradipine, nicardipine, nifedipine, nisoldipine
    loop diuretics bumetanide, ethacrynic acid, furosemide, torsemide
    potassium-sparing diuretics amiloride, triamterene
    renin inhibitors aliskiren
    thiazide diuretics Left ventricular hypertropy. chlorothiazide, hydrochlorothiazide, hydroflumethiazide, methyclothiazide, polythiazide
    thiazide-like diuretics chlorthalidone, indapamide, metolazone
  • BLACK BOX WARNING FROM FDA June 16, 2008

FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section.

  • FALLS AND FALL-RELATED INJURIES AMONG PERSONS AGED 65 YEARS OLD OR GREATER

Self-Reported Falls and Fall-Related Injuries Among Persons Aged >65 Years --- United States, 2006 From the CDC Morbidity and Mortality Weekly Report (March 7, 2008 / 57(09);225-229) http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5709a1.htm?s_cid=mm5709a1_e

  • HAVING 1/2 TO 1 ALCOHOLIC DRINK PER DAY PROTECTS AGAINST HIP FRACTURE

    Summary  This meta-analysis found that people who have 1/2 to 1 alcoholic drink per day have a lower risk of hip fracture compared to nondrinkers and heavier drinkers.

    Basis for Study/Article  The authors performed a literature review to assess the effects of moderate alcohol consumption on bone density and the risk of osteoporotic hip fracture.  June 11, 2008

    Detailed Summary of Study  Effect sizes were pooled for hip fracture and bone density, and results were synthesized for four outcomes: non-hip fracture, bone density loss over time, bone response to estrogen replacement, and bone remodeling.

    Results/Body  People who had 1/2 to 1 alcoholic drink per day had a lower risk of hip fracture compared to nondrinkers (relative risk 0.80); the relative risk was 1.39 for those who had more than 2 drinks a day. “A linear relationship existed between femoral neck bone density and alcohol consumption,” but “a precise range of beneficial alcohol consumption cannot be determined.”

    Sources & Other Links  Berg KM, et al. Association between alcohol consumption and both osteoporotic fracture and bone density. Am J Med. 2008 May;121(5):406-18.  Article Link (NCBI)

     

  • OBSTRUCTIVE SLEEP APNEA IS COMMON IN WOMEN WITH NOCTURIA

    Summary  Obstructive sleep apnea is common in women with nocturia, and 88% of women with dilute nighttime urine have OSA. “We should consider a diagnosis of OSA in all patients with nocturia,” even those with daytime overactive bladder symptoms.  June 11, 2008

    Basis for Study/Article  The authors explored the association between obstructive sleep apnea and nocturia in women and tested urine samples to see whether urine concentration was predictive for sleep apnea.

    Detailed Summary of Study 21 women with nocturia (16 of them also had daytime overactive bladder) and 10 control subjects completed nocturia questionnaires, underwent a home sleep study and provided evening and morning urine samples.

    Results/Body  17 of the 21 women with nocturia (81%) were found to have sleep apnea (13 of the 16 with daytime overactive bladder and 4 of the 5 without) vs. 4 of the control group. “The presence of diluted nighttime urine in a patient with nocturia was 88% sensitive for the presence of OSA.”

    Sources & Other Links  Lowenstein L, et al. The relationship between obstructive sleep apnea, nocturia, and daytime overactive bladder syndrome in women. Am J Obstet Gynecol. 2008 May;198(5):598.e1-5.

     

  • VOLUNTARY RECALL OF SINGLE LOT MORPHINE

ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by ETHEX Corporation under an "ETHEX" label between April 16th and April 27th of 2008. Opioids such as morphine have life-threatening consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.

  • ADVERSE EVENTS ASSOCIATED WITH PCA AND INSULIN PUMPS IN ADOLESCENTS

Summary  Over a 10-year period, there were 1,594 reports to the FDA of adverse events associated with adolescents’ use of insulin pumps (including 13 deaths) and 53 reports of adverse events associated with patient-controlled analgesia pumps. “Studies need to further identify safety problems in this age group.”

Basis for Study/Article  After receiving five reports of deaths in adolescents associated with insulin pumps in 2005, the FDA conducted an assessment of the safety of insulin and PCA pumps in this population. 

June 4, 2008Detailed Summary of Study  The authors reviewed reports submitted to the FDA from 1996 through 2005 about adverse events associated with use of insulin or PCA pumps by adolescents (ages 12 to 21). Demographics, type of adverse event, outcomes and contributing factors were analyzed.

Results/Body  Over a 10-year period, there were 1,594 reports of adverse events associated with insulin pumps, including 13 deaths, 2 possible suicide attempts, and several reports of apparently device-related hyperglycemia or hypoglycemia. Some of the contributing factors were compliance problems, lack of education, “sports-related activities” and “dropping or damaging the pump.” In 82% of the events the patient was hospitalized. There were 53 reports of adverse events associated with PCA pumps. In half the patients received too much medication; “tampering and noncompliance were evident in some cases.”

The authors suggest more studies on the safety of these devices in adolescents.

Sources & Other Links  Cope J, et al. Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events. Pediatrics. 2008 May;121(5):e1133-8.  Article Link (NCBI)

  • DRUG RECALLS LISTED: 

    Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutrition support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns.  June 02, 2008

    International Pharmaceuticals, Ltd. and FDA notified consumers and healthcare professionals that the company is recalling all supplement products sold under the brand name of Viril-ity Power (VIP) Tablets. The product is being recalled because one lot was found to contain a potentially harmful undeclared ingredient, hydroxyhomosildenafil, an analog of sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved drug used for erectile dysfunction. The undeclared ingredient may interact with nitrates found in some prescription drugs (such as Nitroglycerin) and may lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates. Consumers who have Viril-ity Power (VIP) Tablets should stop using it immediately and contact their healthcare professional if they experience any problems that may be related to taking this product.  May 30, 2008

    FDA informed consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Potentially harmful ingredients in the product are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause slow or shallow breathing in infants. Phenoxyenthanol, a preservative that is primarily used in cosmetics and medications, can also depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants. Mothers and caregivers should seek immediate medical attention if their child shows signs and symptoms of decreases in appetite, difficulty in awakening, limpness of extremities or a decrease in an infant's strength of grip and a change in skin color.  May 29, 2008

    FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablets (Lot# 6K029-SEI). The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement and to treat erectile dysfunction (ED). The product contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for ED. The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have used the product should discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product.

  • FDA AND CDC ISSUE ALERT ON MENACTRA  MENlNGOCOCCAL VACCINE AND GUILLAIN BARRE SYNDROME 

The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) are alerting consumers and health care providers to five reports of Guillain Barre Syndrome (GBS) following administration of Meningococcal Conjugate Vaccine A, C, Y, and W135 (trade name Menactra), manufactured by Sanofi Pasteur. It is not known yet whether these cases were caused by the vaccine or are coincidental. FDA and CDC are sharing this information with the public now and actively investigating the situation because of its potentially serious nature.

Guillain Barre Syndrome (GBS) is a serious neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in the legs and arms that can be severe and require hospitalization.

Meningococcal infection, which Menactra prevents, is a major cause of bacterial meningitis, affecting approximately 1 in 100,000 people annually. The infection can be life threatening:
10-14 percent of cases are fatal and 11-19 percent of survivors may have permanent disability.

According to Jesse Goodman, MD, Director of FDA’s Center for Biologics Evaluation and Research, at the present time there are no changes in recommendations for vaccination; individuals should continue to follow their doctors' recommendations. FDA and CDC are not able to determine if any or all of the cases were due to vaccination. The current information is very preliminary and the two agencies are continuing to evaluate the situation.

Because of the potentially serious nature of this matter, FDA and CDC are asking any persons with knowledge of any possible cases of GBS occurring after Menactra to report them to the Vaccine Adverse Event Reporting System (VAERS) to help the agencies further evaluate the matter. Individuals can report to VAERS on the web at www.vaers.hhs.gov <http://www.vaers.hhs.gov> or by phone at 1-800-822-7967.

The five cases of GBS reported following administration of Menactra occurred in individuals living in NY, OH, PA, and NJ. All five patients were 17 or 18 years of age and developed weakness or abnormal sensations in the arms or legs, two-four weeks after vaccination. All individuals are reported to be recovering or to have recovered. More than 2.5 million doses of Menactra vaccine have been distributed to date. The rate of GBS based on the number of cases reported following administration of Menactra is similar to what might have been expected to occur by coincidence, that is, even without vaccination. However, the timing of the events is of concern. Also, vaccine adverse events are not always reported to FDA so there may be additional cases of which we are unaware at this time.

Prelicensure studies conducted by Sanofi Pasteur of more than 7000 recipients of Menactra showed no GBS cases. CDC conducted a rapid study using available health care organization databases and found that no cases of GBS have been reported to date among 110,000 Menactra recipients
.

  • CONSUMER ALERT Some say that the age of chivalry is past, that the spirit of romance is dead.  The age of chivalry is never past, so long as there is a wrong left unredressed on earth."  Charles Kingsley, Vol., II, Ch 28: "A good conscience is a continual Christmas." Ben Franklin         

    Beat the Press News Exclusive: The following resources have been compiled by USCDC as a resource for older adults, their families, friends or caregivers, and those who would like to contribute to the relief efforts following the devastation caused by Hurricane Katrina along the US gulf coast.

    The web pages of the following organizations that are principals in disaster relief provide information on donating cash, volunteers and products. Each organization also states how they are aiding relief
    efforts.

    American Red Cross
    http://www.redcross.org/ To donate: Call 1-800-HELP NOW or 1-800-257-7575 (Spanish). Internet users can make a secure online contribution by visiting www.redcross.org. To volunteer: Individuals interested in volunteering for the American Red Cross should contact their local Red Cross chapter.

    America's Second Harvest
    (non-governmental hunger-relief organization)
    http://www.secondharvest.org/

    To donate: Internet users can make a secure online contribution by visiting www.secondharvest.org.
    Companies, manufacturers or retailers wanting to donate a full truckload of dry storage product, call 1-800-771-2303 and ask for the Food Sourcing Department Companies wanting to donate transportation of product, call 1-800-771-2303 and ask for the Logistics Department

    The Humane Society of the United States
    http://www.hsus.org/  To donate: Internet users can make a secure online contribution by visiting www.hsus.org. 

    The American Geriatrics Society Hurricane Katrina: Informational Resources http://www.americangeriatrics.org/news/hurricane_katrina.shtml
    Comprehensive list of sources of medical information for clinicians and caregivers, plus disaster and relief information.

    Federal Emergency Management Agency (FEMA)
    http://www.fema.gov/  The US federal agency in charge of disaster regularly updates information on relief efforts, and provides links to a number of disaster relief organizations.

    Hospice Foundation of America Establishes Hospice Patient Locater Message Board at www.hospicefoundation.org in Response to Hurricane Katrina

    The Salvation Army is currently providing services to storm survivors and first responders in the Gulf Coast states as well. You can visit their website at www.salvationarmy.com

    God Bless the US CDC and the United States of America.-"InfoJustice"

  • FDA's New Influenza Vaccine for Upcoming Flu Season

    The Food and Drug Administration (FDA) today approved Fluarix, an influenza vaccine for adults that contains inactivated virus. Fluarix is approved to immunize adults 18 years of age and older against influenza virus types A and B contained in the vaccine. Influenza is also commonly called the flu.

    "FDA"s approval of Fluarix is a big step toward providing an adequate supply of flu vaccine for the American public," said Mike Leavitt, Secretary of Health and Human Services (HHS). "Having more manufacturers of influenza vaccine licensed in the U.S., and having more vaccine dosages, is critical to public health and I applaud FDA for taking such quick action to obtain and evaluate the data needed to license Fluarix in time for this year"s influenza season."

    The approval of Fluarix breaks new ground in that it is the first vaccine approved using FDA"s accelerated approval process. Accelerated approval allows products that treat serious or life-threatening illnesses to be approved based on successfully achieving an endpoint that is reasonably likely to predict ultimate clinical benefit, usually one that can be studied more rapidly than showing protection against disease. In this case, the manufacturer demonstrated that after vaccination with Fluarix adults made levels of protective antibodies in the blood that FDA believes are likely to be effective in preventing flu. GlaxoSmithKline, the manufacturer of Fluarix, will do further clinical studies as part of the accelerated approval process to verify the clinical benefit of the vaccine.

    "Previous shortages highlighted the need for additional influenza vaccine manufacturers for the U.S. market," said FDA Commissioner Lester Crawford. "Accelerated approval has allowed us to evaluate and approve Fluarix in record time so that we can make available additional safe and effective flu vaccines. I commend our Center for Biologics for taking extraordinary steps to help us be better prepared for both the upcoming and future flu seasons."

    This success required close cooperation among the FDA, the National Institutes of Health, and the product manufacturer," said Dr. Jesse Goodman, Director of FDA"s Center for Biologics Evaluation and Research. "The dedicated staff of this Center is doing everything possible to prepare for the upcoming flu season."

    FDA based the accelerated approval of Fluarix on thorough evaluation of safety and effectiveness data from four clinical studies involving approximately 1,200 adults. Other data from post-marketing reports in other countries where Fluarix is already approved were also reviewed as part of FDA"s safety assessment.

    In the United States it is estimated that more than 200,000 people are hospitalized from flu complications, and about 36,000 people die from flu each year. Although no vaccine is 100% effective against preventing disease, vaccination is the best protection against influenza and can prevent many illnesses and deaths.

    Fluarix is manufactured in Dresden, Germany by Sächsisches Serumwerk (SSW), a subsidiary of GlaxoSmithKline Biologicals, of Rixensart, Belgium. It will be distributed by GSK in Research Triangle Park, NC.

  • FDA STRENGTHENS RISK MANAGEMENT PROGRAM; ISOTRETINOIN (ACCUTANE) DURING PREGNANCY

The U.S. Food and Drug Administration (FDA) is announcing approval of a strengthened distribution program for isotretinoin, called iPLEDGE, aimed at preventing use of the drug during pregnancy. Women who are pregnant or who might become pregnant should not take the drug. Isotretinoin (Accutane and its generics) is a highly effective drug for severe recalcitrant nodular acne, but it carries a significant risk of birth defects if taken during pregnancy.

The manufacturers are implementing a program that requires registration in iPLEDGE by doctors and patients who agree to accept specific responsibilities before receiving authorization to prescribe or use the drug. These measures are designed to guard against pregnancies while using the drug. Wholesalers and pharmacies must also comply with the manufacturers' program requirements in order to distribute and dispense the product. FDA is approving this program under its regulations, known as Subpart H, that require restrictions on the distribution of a drug to assure safe use.

"This stronger program is a major step in protecting against inadvertent pregnancy exposure by tightly linking negative pregnancy testing with dispensing of isotretinoin." said Dr. Steven Galson, Director, FDA's Center for Evaluation and Research. "iPLEDGE, using a computer-based and telephone system, will provide health care professionals with the real time information necessary to effectively manage the risks of isotretinoin."

In February 2004, at a joint meeting, FDA's Drug Safety and Risk Management Advisory Committee and Dermatologic and Ophthalmic Drugs Advisory Committee reviewed the existing isotretinoin risk management programs in effect at that time. Based upon their review, the joint committee called for major improvements in the restricted distribution program, including mandatory registration to ensure that patients who could become pregnant have negative pregnancy testing and birth control counseling before receiving the drug.

To inform health care providers about iPLEDGE, FDA has issued a Public Health Advisory and revised the Patient and Health Care Provider Information Sheets that detail the tightened restrictions and increased responsibilities under iPLEDGE for prescribing, dispensing, distributing, and obtaining isotretinoin.

To obtain the drug, in addition to registering with iPLEDGE, patients must comply with a number of key requirements that include completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and, for women of childbearing age, complying with required pregnancy testing.

A reporting and collection system for serious adverse events associated with the use of istotretinoin has also been implemented. All pregnancy exposures to isotretinoin must be reported immediately to the FDA via the MedWatch 1800-FDA-1088 and to the iPLEDGE pregnancy registry at 1-866-495-0654 or on the iPLEDGE website.

Doctors, patients, and pharmacies can obtain program information and register with iPLEDGE via the internet, beginning August 22, 2005, at www.ipledgeprogram.com or telephone 1-866-495-0654.

In addition to approving the iPLEDGE program, FDA has approved changes to the existing warnings, patient information and informed consent document so that patients and prescribers can better identify and manage the risks of psychiatric symptoms and depression before and after prescribing isotretinoin.

Under the program, after October 31, 2005, wholesalers and pharmacies will have to register with iPLEDGE to obtain isotretinoin from a manufacturer. Starting December 31, 2005, all patients and prescribers (doctors) must register and comply with requirements for office visits, counseling, birth control and other responsibilities.

The manufacturers participating in the iPLEDGE program include:

Hoffman-LaRoche manufacturer of Accutane; Genpharm manufacturer of Amnesteem which is distributed by Mylan/Bertek; Ranbaxy Pharmaceuticals manufacturer of Sotret; and Barr Laboratories manufacturer of Claravis.

  • BRILLIANT US DISTRICT JUDGE ISSUES INJUNCTION, USFDA INVESTIGATED THEN BLOCKS SALE OF ILLEGAL DRUGS

The U.S. Food and Drug Administration (FDA) today announced a permanent injunction shutting down operations at Pharmakon Labs of Florida. The company manufactured and distributed cough and cold liquids, tablets and caplets.

Following inspections by FDA and a trial in U.S. District Court, Judge Richard A. Lazzara found that drug products sold by Pharmakon Labs, Inc., its president Abelardo L. Acebo, and its secretary/treasurer Edward R. Jackson (the defendants) did not meet current good manufacturing practice (cGMP) standards and other legal requirements.

Judge Lazzara stated that he was "simply unwilling as a court of equity to place the health, safety, and welfare of the general public at risk in order to accommodate the economic well-being of Defendants." Thus, the defendants were ordered to stop manufacturing and distributing drugs until they become compliant with CGMP standards to the satisfaction of FDA and obtain marketing approvals.

"This action by Judge Lazzara sends a strong signal that FDA will take action against drugs that fail to meet quality standards," said FDA Commissioner Dr. Lester M. Crawford. "As the nation's top enforcer of manufacturing standards, the FDA will continue to ensure that drugs being sold in this country meet those crucial requirements."

The defendants have a long history of continued violations of the Federal Food, Drug, and Cosmetic Act. The government's initial complaint alleged numerous manufacturing violations documented in four inspections dating back to 2001. FDA later added charges related to Pharmakon's manufacture and distribution of unapproved new drugs, as part of the agency's longstanding policy to seek relief for all legal violations by a firm at the same time.

The government's request for a permanent injunction was based on the defendants' demonstrated unwillingness to comply with the law.

  • FDA ISSUES PUBLIC HEALTH ADVISORY FOR MIFEPRISTONE

The Food and Drug Administration (FDA) is investigating recently reported serious adverse events associated with mifepristone (trade name Mifeprex, also known as RU-486). As a result, the FDA is issuing a public health advisory today highlighting the risk of sepsis or blood infection when undergoing medical abortion using Mifeprex and misoprostol in a manner that is not consistent with the approved labeling. There are now four cases of deaths from infection from September 2003 to June 2005 following medical abortion with these drugs.

"The FDA is committed to sharing emerging drug information with the public and we believe it is important to share with healthcare providers and patients the latest serious reports of infection associated with this drug that we have received," said Dr. Steven Galson, Acting Director of FDA's Center for Drug Evaluation and Research.

The bacteria thought to have caused the fatal infection have been identified in two of the cases and the other two cases are under investigation by FDA along with the Centers for Disease Control and Prevention, State and local health departments, and the manufacturer of Mifeprex. Doctors are urged to have a higher level of suspicion for sepsis in their patients taking Mifeprex.

Previously, the FDA has received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death. Those reports led to the revision of the black box labeling. Mifeprex was approved by the FDA in 2000.

  • FDA Issues Nationwide Alert for "Liqiang 4" Due to Potential Health Risk 

The U.S. Food and Drug Administration (FDA) is warning consumers not to take Liqiang 4 Dietary Supplement Capsules because they contain glyburide – a drug that could have serious, life-threatening consequences in some people.

Glyburide is a drug used to lower blood sugar, and is safe and effective when used as labeled in FDA-approved medications. People who have low blood sugar or those with diabetes can receive dangerously high amounts of glyburide by consuming Liqiang 4. Consumers should immediately stop using these products and seek medical attention, especially if they are currently being treated with diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of the extremities. Consumers who have this product should dispose of it immediately. 

The product is sold as part of a shrink-wrapped two bottle set. One of the 90 capsule bottles is labeled Liqiang 4 Dietary Supplement Capsules, the other bottle is promoted as a “bonus pack” of Liqiang 1. At this time FDA is evaluating Liquang 1 and other versions of this line of products to determine their composition and safety. The product is manufactured by Liqiang Research Institute, China, and marketed throughout the United States in herbal stores and through mail order by Bugle International of Northridge CA.

The FDA learned of the potential problem through an anonymous consumer complaint and followed up with testing that revealed the presence of glyburide in this product. 

The product has also been termed "Liqiang Xiao Ke Ling" (Liqiang Thirst Quenching Efficacious) in ads in Chinese language publications which also promote it as useful for the control of diabetes and being derived from only natural ingredients.

FDA encourages consumers, health care providers, and caregivers to report any adverse events related to this product to MedWatch, the FDA's voluntary reporting program at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857-9787; or online at www.fda.gov/medwatch/report.htm.

  • FDA Issues Information for Consumers about Claims for Green Tea and Certain Cancers

Under the Food and Drug Administration's (FDA) "Consumer Health for Better Nutrition Initiative," the Agency is announcing the results of a review of qualified health claims that green tea may reduce the risk of certain types of cancer. Based on a systematic evaluation of the available scientific data, the FDA intends to consider exercising its enforcement discretion for the following qualified health claims for breast and prostate cancer:

"Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer"; and

"One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer."

The FDA also concluded that existing evidence does not support qualified health claims for green tea consumption and a reduced risk of any other type of cancer.

Guidance on qualified health claims for conventional foods and dietary supplements was issued by the FDA in July 2003. FDA will continue to evaluate new information that becomes available to determine whether changes in these claims, or in the decision, are necessary.

  • ACADEMY NEWS-NEW LIFE FELLOW

    Under and by virtue of the full authority, provisions and privileges vested herein, the American Academy For Justice Through Science proclaim that in recognition of her valuable contributions in Ethics, Outstanding Medicine, and service to the public trust, hitherto Dr. Marie King PhD FAAJTS CA-#2008, Forensic Clinical Psychologist, life fellowship, full rights, privileges and honors status in the American Academy For Justice Through Science' as a 2005 Fellow of the Board. Congratulations - Press Release

  • LETTER TO THE EDITOR Some say that the age of chivalry is past, that the spirit of romance is dead.  The age of chivalry is never past, so long as there is a wrong left unredressed on earth."  Charles Kingsley, Vol., II, Ch 28: "A good conscience is a continual Christmas." Ben Franklin

Dear Dr. Neff,

I've been in contact with the people in Iowa that help victims. But the problem with my pains and memory loss was related to my thyroids all this time!  I feel deep sadness from what's happened; eight years wasted, sometimes it feels weird seeing my nine grandchildren and not remembering 5 of their births! You see I had a great memory and ears like tape recorders.  Now part of the gifts that I was born with have been erased, but the most sadness came...(Editor's Note: The rest of Paula's statements were simply too personal in nature relative to her loss of health.). Thank you for your emails and good advice.  It's good to know someone still has a heart!  Paula Nelson-05-21-2005 -"InfoJustice"

  • ACADEMY NEWS-NEW MEMBERS

    Under and by virtue of the full authority, provisions and privileges vested herein, the American Academy For Justice Through Science proclaim that in recognition of valuable contributions in Ethics, Outstanding Medicine, and service to the public trust and the Academy, hitherto Dr. Alan Dinehart DC MD FAAJTS CA & SC-#2009, full fellowship, rights, privileges and honors status in the American Academy For Justice Through Science' as a 2005 Fellow of the Board. Congratulations - Press Release

  • FDA APPROVES NEW COMBINATION VACCINE FOR ADOLESCENT AND ADULT WHOOPING COUGH

The Food and Drug Administration (FDA) today approved a new vaccine for a single booster immunization against pertussis (whooping cough), in combination with tetanus and diphtheria, for adolescents and adults 11-64 years of age. The vaccine will be marketed as Adacel by Aventis Pasteur Limited located in Toronto, Canada. Adacel is the first vaccine approved as a pertussis booster for adults. Vaccines for prevention of tetanus and diphtheria (Td vaccine) in adolescents and adults have been available for many years.

Adacel is a Tetanus Toxoid (T), Reduced Diphtheria Toxoid (d) and Acellular Pertussis Vaccine (ap), Adsorbed. Adacel contains the same components as Daptacel, a DTaP vaccine indicated for infants and children manufactured by Aventis Pasteur Limited, but the diphtheria toxoid and one of the pertussis components are in reduced quantities.

Recently, FDA approved a similar vaccine called Boostrix, manufactured by GlaxoSmithKline, for use in adolescents 10-18 years of age.

Pertussis is a highly communicable and potentially serious illness in adolescents and adults, and can cause prolonged cough and missed days at school and work. In young infants, pertussis is more frequently severe and can be fatal, particularly in those too young to be fully vaccinated. Since 1980, the rates of reported pertussis cases have been increasing in adolescents and adults, as well as in young infants. Adolescents and adults have been implicated as the source of pertussis infection for susceptible young infants, and other family members.

The ability of Adacel to protect against pertussis was assessed by comparing the antibody responses of adolescents and adults who received it with the antibody responses of infants who had received Daptacel in a clinical trial. The antibody responses of the adolescents and adults who received a single dose of Adacel were at least as good as those observed in the infants following three doses of Daptacel. For diphtheria and tetanus, the antibody responses following Adacel were comparable to those following immunization with a U.S. licensed Td vaccine.

In clinical trials, the safety of Adacel was compared to a U.S. licensed Td vaccine. Among adolescent recipients of Adacel, injection site pain and low grade fever were observed more frequently than among those who received Td vaccine. Rates of adverse reactions were similar in adults receiving Adacel vaccine or receiving Td vaccine.

  • FTC PUTS THE SQUEEZE ON TROPICANA'S ORANGE JUICE CLAIMS

The Federal Trade Commission has settled a complaint against Tropicana Products, Inc., in which it alleged the company misled consumers with claims that drinking two to three glasses a day of its “Healthy Heart” orange juice would produce dramatic effects on blood pressure, cholesterol, and homocysteine levels, thereby reducing the risk of heart disease and stroke. Under the terms of the consent agreement settling the charges, Tropicana is prohibited from making similar health-related claims in the future unless they can be substantiated by reliable scientific evidence.

According to the Commission, Tropicana ran the “Healthy Heart” ads between 2002 and early 2004, on television and in publications such as Newsweek magazine. The ads claimed that drinking two to three cups of Tropicana orange juice each day would lower systolic blood pressure by 10 points, raise HDL cholesterol by 21 percent and improve the HDL to LDL cholesterol ratio by 16 percent, increase blood folate levels by 45 percent and lower blood homocysteine levels by 11 percent. The complaint charges that the benefits were not substantiated and claims of clinical support for them were false.

“Orange juice contains many nutrients important to a healthy diet, and advertising can be an important source of information about the health benefits of foods,” said Lydia Parnes, Director of the Bureau of Consumer Protection. “But it is essential that such advertising be truthful. In this case Tropicana’s claims went well beyond its scientific support.”

According to the Commission, Tropicana ran the “Healthy Heart” ad as a two-page spread in Newsweek magazine in February 2004. In 2002, Tropicana ran a more extensive national advertising campaign, including several television commercials and a full-page print ad in the New York Times, as cited in the Commission’s complaint. The 2002 ad campaign made a claim virtually identical to the 10-point blood pressure reduction claim that appeared in the 2004 advertising. The Commission staff had specifically expressed its concerns about the blood pressure claim made in the earlier campaign in a public closing letter in July 2002, but did not seek formal agency action at that time. As the letter noted, although foods that are rich in potassium and low in sodium such as orange juice have been recognized by public health authorities, including the Food and Drug Administration (FDA), to help reduce the risk of hypertension and stroke, the 10-point blood pressure reduction claim did not appear to be substantiated.

The Commission’s complaint charges Tropicana with making unsubstantiated claims that: 1) drinking three cups of Tropicana orange juice a day for four weeks will raise HDL cholesterol by 21 percent and improve the ratio of HDL to LDL cholesterol by 16 percent; 2) drinking 20 ounces of Tropicana orange juice a day will increase blood levels of folate by almost 45 percent and decrease homocysteine levels by 11 percent; and 3) drinking two cups of Tropicana orange juice a day for six or eight weeks will lower systolic blood pressure an average of 10 points. The complaint also charges that Tropicana’s claims that clinical studies demonstrated these benefits were false.

The consent order prohibits Tropicana from making the challenged claims or any similar claims about the effects of orange juice or other foods on blood pressure, cholesterol levels, folate levels, and homocysteine levels or other biological markers or health-related endpoints unless the company substantiates the claim with competent and reliable scientific evidence. The order also prohibits claims by Tropicana that any food will have an effect on the risk of heart disease, stroke, or cancer unless substantiated by competent and reliable scientific evidence. The order also prohibits any misrepresentations relating to tests or studies. Tropicana is permitted under the settlement to make certain claims that comply with specific FDA regulations for food labeling. Finally, the order contains various record keeping requirements to assist the FTC in monitoring compliance.

  • HAPPY MEMORIAL DAY; PLEASE BE CAREFUL AND WATCH YOUR KIDS.

Please have a safe and happy holiday.  And may our troop abroad come home safe and soon.   Yet,  "Memorial Day" is one of those special holiday's statistically, which has very high incidents of injuries.  Children exited to get into the water for the first time this year, (oceans, lakes, rivers, and swimming pools) sustain serious neck and spine injuries.  These life threatening injuries can be avoided by becoming aware of the "holiday psychology in play", advise your children accordingly, and try to keep a special eye out for accidents.  Primarily the water injuries are sustained by diving and hitting the skull, although other out door water sports must be supervised such as waterskiing, surfboarding and the like.  If you or your children compete in a new spring event which requires exercise, warm up, stay out of prolonged sun exposure, and bring electrolytes or even a combination of the simple salts such as table salt, and 'kosher for their sodium and potassium respectively.  If you can prepare "Gator-aid" like drinks, these will be sufficient.  Consult your family physician for in-depth advise.

With the warmest of hopes, the members of the American Academy For Justice Through Science wish all Americans, a happy, healthy, thought provoking and safe Memorial Day weekend.-"InfoJustice"

  • LETTERS TO THE EDITOR

    Dear Dr. Neff,

    I was injured and treated by Doctor who  put me on SSI and treated me as mental patient.   My dead line for finding an attorney is Aug. of this year. Have a doctor now treating me for posttraumatic...  and can truly say the meds first doctor had me on were not only wrong but going off the charts.   Also I suffer lots of memory loss.  Is there truly still justice for the poor or only for those who can afford it?

    Dear Paula,  I am also from the great heartlands, and my social mores and sound ethics have proved that today is one of the most anti-justice, anti-science and anti-truth periods of the last 50 years.  Quackery, fraud, hucksterism and folks who just don't give a hoot about the truth are very prevalent today.  There are many folks who wish to rip off the insurance industry or steal money from you when you are ill, disabled or especially on fixed incomes or poor.   There are folks out there only after your money offering you incorrect medicinal substitutes which you discovered and described above in laymen's terms, " not only wrong but going off the charts" .  Be careful with your own health.  I will document your case further should you continue.

    Finally, seek out a quality specialist to assist your new doctor and attorney by August.  Do this by simply calling your states Medical Board and State Bar and get a referral for an MD and an attorney who specializes in working within the medicine arena.  Take an action step and act now.  If you need more assistance I will do what I can.-"InfoJustice"
     

  • HUMONGOUS ABLE  LABS RECALL FOR DRUGS WITH TAINTED ACETAMINOPHEN

    Able Laboratories of Cranbury, NJ, is conducting a nationwide recall of all of its manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen) because of serious concerns that they were not produced according to quality assurance standards. Able Laboratories has ceased all current production.

    "The FDA continues to evaluate the situation at Able Laboratories to determine the safety and quality of their products and will update the public on our findings as necessary," said Margaret O'K. Glavin, Associate Commissioner for Regulatory Affairs.  "In the meantime, the Agency recommends that people who have been taking drugs produced by this firm speak with their health care provider or pharmacist to obtain a replacement drug product.   The drug recall involves well over 150 different drug products which also contain Acetaminophen.  The drugs include such favorites as tablet Hydrocodone, Codeine, Lithium, Naproxen Sodium, Nitroglycerin Sublingual, Promethazine, Theophyllyine, and much much more as well as a list of inhaled and liquid medicines.-"InfoJustice"

  • COUNTERFEIT LIPITOR, VIAGRA AND EVISTA

The Food and Drug Administration has approved Requip (ropinirole) to treat moderate to severe Restless Legs Syndrome (RLS). The drug was first approved for Parkinson’s disease in 1997.

Restless Legs Syndrome is a condition that affects about ten percent of the population. The disorder is characterized by an urge to move the legs, usually accompanied by or caused by uncomfortable leg sensations. For most people with the condition, symptoms begin or worsen during periods of rest or inactivity and are partially or totally relieved by movement. Symptoms typically worsen or occur only in the evening or at night, and can disturb sleep.

Requip was found to be effective for RLS in three randomized, double-blind placebo controlled studies in adults diagnosed with moderate to severe RLS. The studies measured effectiveness of the drug using the International Restless Leg Syndrome Scale, a patient rated scale that measures different aspects of RLS including severity of muscle movement and discomfort, sleep disturbance, mood and overall effect on quality of life. The Clinical Global Impression-Global Improvement scale was also used. This is an investigator rated scoring of improvement following treatment. All three studies demonstrated a statistically significant difference between the treatment group receiving Requip and the group receiving placebo.

Common side effects of Requip reported in clinical trials include nausea, headache, and vomiting. The label for the drug will also include a caution that Requip has been associated with sedating effects, including somnolence (sleepiness), and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. Syncope (fainting) or symptomatic hypotension (low blood pressure) may occur, particularly during initial treatment or dosing.

  • FDA APPROVES REQUIP FOR RESTLESS LEGS SYNDROME

The Food and Drug Administration has approved Requip (ropinirole) to treat moderate to severe Restless Legs Syndrome (RLS). The drug was first approved for Parkinson’s disease in 1997.

Restless Legs Syndrome is a condition that affects about ten percent of the population. The disorder is characterized by an urge to move the legs, usually accompanied by or caused by uncomfortable leg sensations. For most people with the condition, symptoms begin or worsen during periods of rest or inactivity and are partially or totally relieved by movement. Symptoms typically worsen or occur only in the evening or at night, and can disturb sleep.

Requip was found to be effective for RLS in three randomized, double-blind placebo controlled studies in adults diagnosed with moderate to severe RLS. The studies measured effectiveness of the drug using the International Restless Leg Syndrome Scale, a patient rated scale that measures different aspects of RLS including severity of muscle movement and discomfort, sleep disturbance, mood and overall effect on quality of life. The Clinical Global Impression-Global Improvement scale was also used. This is an investigator rated scoring of improvement following treatment. All three studies demonstrated a statistically significant difference between the treatment group receiving Requip and the group receiving placebo.

Common side effects of Requip reported in clinical trials include nausea, headache, and vomiting. The label for the drug will also include a caution that Requip has been associated with sedating effects, including somnolence (sleepiness), and the possibility of falling asleep while engaged in activities of daily living, including operation of a motor vehicle. Syncope (fainting) or symptomatic hypotension (low blood pressure) may occur, particularly during initial treatment or dosing.

  • MARGARET O'K. GLAVIN AS NEW ASSOCIATE USFDA COMMISSIONER FOR REGULATORY AFFAIRS

John M. Taylor, III, U.S. Food and Drug Administration's (FDA's) Associate Commissioner for Regulatory Affairs, today announced his decision to leave FDA after a distinguished 14 year career at the agency. Margaret O'K. Glavin, FDA's current Assistant Commissioner in the Office of Counterterrorism Policy and Planning, has been named the new Associate Commissioner.

"As the head of our field force, John championed the public health by bringing some of the agency's largest and most significant enforcement actions," said Dr. Lester M. Crawford, Acting FDA Commissioner. "Indeed John's legacy at the agency includes significant accomplishments related to agency initiatives on blood safety, counterterrorism, food safety and pharmaceutical product quality."

Mr. Taylor joined FDA's Office of the Chief Counsel in 1991 after graduating from the law school of the College of William & Mary. Six years later he moved to the Office of the Commissioner as Senior Advisor on Regulatory Affairs. In 2000, he was named Director, Office of Enforcement, in FDA's Office of Regulatory Affairs, and served in that capacity until his appointment to his current position in 2002.

Prior to FDA, Ms. Glavin served at the U.S. Department of Agriculture as Acting Administrator of the Food Safety and Inspection Service (FSIS), a 10,000-person public health regulatory agency responsible for the safety of the meat and poultry supply. Before being named Acting Administrator in 2001, Ms. Glavin served as Associate Administrator of FSIS, a position in which she was responsible for the daily operations of that agency and its 7,000-person field force. Immediately prior to joining FDA in 2003, Ms. Glavin spent a year focusing on food safety issues as a visiting scholar at Resources for the Future, a prominent Washington, D.C. think tank.

"Maggie brings extensive leadership experience and a background in crisis management to this very important position at FDA," added Dr. Crawford. "The work of our field force is absolutely critical to our public health mission."

A graduate of Trinity College and Georgetown University, Ms. Glavin has published articles in various publications, including Food and Agriculture 2003, SAIS Review, and Food and Drug Law Journal.

Boris D. Lushniak, MD, MPH, will replace Ms. Glavin as the FDA's Assistant Commissioner for Counterterrorism Policy. Dr. Lushniak previously served as the Chief Medical Officer in the FDA's Office of Counterterrorism Policy and Planning. Dr. Lushniak is a Captain in the Commissioned Corps of the U.S. Public Health Service who has significant expertise in counterterrorism activities, disaster response, medical epidemiology and occupational diseases.

  • INVITATION TO DIPLOMATS OF THE AMERICAN ACADEMY FOR JUSTICE THROUGH SCIENCE ONLY:

Members:  The membership has been invited to attend a interesting conference for International Members of the Academy for Justice Through Science.  The invitation;

    The Forensic Institute...&...are presenting, as part of their ... conference series, the 1st International Human Identification...Symposium.  This International...  Conference will be held...on the 14 April 2005 and you are invited to register for the...Symposium free of charge.
                      
    The theme of the...Symposium - 'Bridging the Gap between Science and Law' -addresses one of the most pressing challenges the scientific, law enforcement and legal communities face today.  This high profile event aims to stimulate and feed this triangle of the scientific, law enforcement and legal communities with cutting edge knowledge delivered by world-renowned speakers.   
                      
      I would most appreciate inclusion in your event calendar and on your web site, if at all possible.
                      
                       Kind regards, ...
                      
Note:     Confidentiality: This e-mail and its attachments are intended for the above named recipient's only and may be confidential and/or privileged. If they have come to you in error you must take no action based on them, nor must you copy or disclose them or any part of their contents to any person or organization...

Contact the American Academy For Justice Through Science home office for dates, and times.-"InfoJustice"

  • CHILD AND ADOLESCENT ANTIDEPRESSANTS

AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY

FOR CHILD AND ADOLESCENT PSYCHIATRISTS REGARDING THE FDA BLACK BOX WARNING ON THE USE OF ANTIDEPRESSANTS FOR PEDIATRIC

October 31, 2004

 In making a decision affecting the health of our children who have psychiatric disorders, the FDA, of necessity, had to accept the very limit of available data, and in some aspects had to extrapolate entirely beyond available information.   

The FDA’s public health program on antidepressant medication use in children and adolescents now requires that pharmaceutical manufacturers place a black box in each antidepressant’s package insert.  The warning is about increased suicidal thinking and suicidal behavior that can occur in children and adolescents during the early phases of treatment.

Suicidality in Children and Adolescents

Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of [Drug Name] or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. [Drug Name] is not approved for use in pediatric patients except for patients with [Any approved pediatric claims here]. (See Warnings and Precautions: Pediatric Use)

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events on drug was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.

The FDA advisory panels, which met in September 2004, became concerned that physicians’ variable prescribing practices for these antidepressant medications might increase any potential problem. It should be noted that the data on which the concern was based was derived from clinical trials where clinical standards were optimal. There is no evidentiary basis for believing that current practices are contributing to any significant public health problem. To the contrary, the increase in SSRI prescriptions has been correlated with a decrease in the youth suicide rate, and consecutive autopsies have failed to demonstrate the presence of a significant number of suicides with evidence of SSRI exposure. 

The FDA followed several of the AACAP recommendations in the language and intent of the black box warning. These included the decision to require that a medication guide (Medguide) be distributed with each supply of antidepressant medication. This guide lays out specific warning signs of antidepressant side effects in lay language for parents.  

The FDA black box noted the serious impairments of untreated depression as well as the newly discovered low risk of suicidal thoughts. It also called for more research on the long-term effectiveness of antidepressants. It is important to note that the FDA did not assert that the use of these medications in children and adolescents with depression was contraindicated, so physicians can continue to prescribe them. 

What new research data actually support the FDA’s decision to use a black box warning?

Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4,400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. It should be noted that only 78 of the 4,400 patients experienced suicidal thinking or suicidal behavior, and no suicides occurred in these trials. The average risk of such events on a drug was 4 percent, twice the placebo risk of 2 percent.

What unintended effects on practice might occur following the FDA’s issuing a black box?

Probably this warning will discourage the capricious prescribing of these drugs, eliminate direct-to-consumer advertising, and stop physicians from distributing drug samples.  The warning may also keep depressed patients from seeking treatment. The black box warning also may cause physicians to avoid treating depressed children and adolescents because of fear of potential lawsuits. The Work Group on Research recommends that professional organizations support their members with open, strong statements about the value of this treatment.  

How frequently do the research data suggest I would encounter this risk in my practice if I treat children and adolescents with antidepressants? 

The FDA research has shown that there is a small increase in risk of suicidal ideation or suicidal behavior in children and adolescents treated with antidepressants. This effect represents a 2 % increase over that created by the use of a placebo. That means that if you institute medication treatment in 200 new patients, you will see approximately 8 child and adolescent patients with increased suicidal ideation or suicidal behavior. Four of those patients will have experienced these increased symptoms as part of their depression, while the remaining four may have increased ideation or suicidal behavior related to antidepressant treatment. It should be noted that both suicidal ideation and suicide attempts are very common in adolescence and do not have the same prognostic significance for completed suicide as those behaviors in later life. Thus, the annual prevalence of attempts in the U.S. is about 10 times greater than the prevalence of depression. Based on the most recent data, there are 370 attempts for every suicide among teen males and around 3,600 attempts among teen females each year for every suicidal death.  

What do the research data suggest about the efficacy of antidepressants for treating depression in children and adolescents? 

New research, such as the Treatment for Adolescents with Depression Study (TADS), confirms that using cognitive behavioral therapy (CBT) - a type of psychotherapy that focuses on managing negative emotions and thoughts - and fluoxetine (Prozac) results in successful treatment of moderate-to-severe adolescent depression. Seventy-one percent of the patients responded positively to the combination treatment of fluoxetine and therapy, which is a rate double the 35 percent response rate for patients on placebo. Over 60 percent of those assigned to fluoxetine alone were found to be responders by the end of the 12-week trial.  

This means that on average each practitioner would need to treat just three patients to see a strong response to fluoxetine. This is in contrast to the need to treat over 50 patients in order to see evidence of the medication causing suicidal ideation or suicidal behavior. The Work Group on Research finds this risk-benefit ratio for the treatment of pediatric depression acceptable for child and adolescent patients. 

How does the AACAP Work Group on Research recommend that I treat my child and adolescent patients with depression? 

The Work Group continues to advise the child and adolescent psychiatrists in the AACAP to continue to treat with psychotherapy or antidepressants or the combination based on the available research evidence.  The research evidence available to the FDA shows that fluoxetine, now the only SSRI antidepressant available as a lower-cost generic, has shown efficacy in the treatment of children and adolescents with depression and with OCD. Because of the data available, the Work Group recommends that fluoxetine alone, CBT alone or fluoxetine plus CBT be considered as first line treatment approaches for depressed pediatric patients. The Work Group also recommends that patients be monitored with the frequency of visits suggested by the FDA; although, there are no specific research data to support the frequency of face-to-face contacts.  

What if I receive a referral for a child or adolescent who has failed on fluoxetine? Can I still treat with an alternative antidepressant?   

The FDA did not contraindicate the use of any of the other SSRI antidepressants. Although there were some differences in the degree of risk among the nine antidepressants evaluated, the agency did not find compelling evidence to contraindicate any of the drugs with a higher than usual risk for the suicidal ideation or suicidal behavior, or, conversely, to not apply the black box warning to any antidepressant with a low risk rate.  For that reason, the Work Group on Research would recommend considering any of the other SSRIs that the practitioner has had success with in other pediatric patients with depression. 

What should I do if my child or adolescent depressed patient shows increased suicidal ideation or increased rates of suicidal behavior?   

The Work Group reminds practitioners that they should take all steps necessary to protect the well being of their patients. In patients whose depression is persistently worse, or who are experiencing emergent suicidality, consideration should be given to changing the therapeutic regimen, including reducing the dose of the antidepressant, and possibly discontinuing the medication.  Drug discontinuation should be considered if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Any discontinuation should be done carefully to prevent adverse events that may occur after abrupt antidepressant discontinuation. Doses should be tapered rather than an abrupt stoppage, particularly if the medication is an SSRI other than fluoxetine.  

In the new FDA labeling, which recommendations lack research support and may not protect my patients from these side effects?  

The new FDA labeling in the warnings and precaution section contain a number of suggestions that have yet to be supported by an adequate amount of research. For that reason, the AACAP Work Group on Research does not consider the factors listed below should be given more weight than other clinical issues in making treatment decisions.

►  Family history of bipolar disorder is not a reliable warning sign a patient will experience these side effectsThe FDA recommends that bipolar disorder be ruled out before treating children and adolescents with antidepressants. Although this warning is called a precaution, it is not a contraindication. The FDA suggested labeling language states, “It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder.” Although the label states that “such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression,” these factors were not shown to be predictive of increases in suicidal ideation or suicidal behavior in the FDA reviews. While the Work Group on Research agrees that a thorough evaluation should be done on each patient, the value of this data in guiding the decision of whether or not to treat with SSRIs is not established, and we do not believe such a history should preclude use of these agents beyond the caution of a “switch” from depression to mania or hypomania.

If there is a positive family history of bipolar disorder, a careful diagnostic assessment should be done to consider the possibility that the patient is not in the depressed phase of a bipolar illness. The risk of giving antidepressants to someone in the depressed phase of bipolar illness or a mixed episode is that the medication may switch the patient into a manic state, at least according to experience with adult bipolar patients. There are no definitive databased strategies for how best to treat depressed patients at genetic risk for bipolar disorder, including those patients who are at increased risk for developing bipolar disorder in the future.

►  Suicidal ideation or suicidal behavior does not always follow other SSRI side effects. The FDA label strongly hints that standard SSRI side effects may be precursors of suicidal ideation or suicidal behavior, and advises clinicians and parents to monitor for them without evidence that they are precursors for increased suicidal ideation or suicidal behavior. The new labeling states that “anxiety, agitation, panic attacks, insomnia, irritability, hostility (aggressiveness), impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and non-psychiatric.” These should be tracked, even though “a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established.” The Work Group on Research, while supporting the FDA’s concern over these side effects, does not agree that there are adequate data yet to support the FDA’s “concern that such symptoms may represent precursors to emerging suicidality.” The Work Group on Research does urge a discussion with patients and parents about the effects and side effects of SSRI medication and the natural or expected course of major depression. This will prepare them for managing the depressive thoughts that may persist after other symptoms resolve.  It will also help them manage any symptoms of akathisia, insomnia, or other antidepressant side effects that may occur. 

►  The effectiveness of a weekly monitoring program with face-to-face visits has yet to be proven. The FDA recommends a specific monitoring frequency for physicians when starting SSRI therapy. The FDA recommends that observation for clinical worsening, suicidality, or unusual changes in behavior during the initial few months of anti- depressant drug therapy “ideally would include at least weekly face-to-face contact with patients or their family members or caregivers during the first four weeks of treatment, then biweekly visits for the next eight weeks, then as clinically indicated beyond 12 weeks. Additional contact by telephone may be appropriate between face-to-face visits.” The AACAP Work Group on Research does not know of evidence that this frequency of visits is any better than phone contact with the family on a weekly basis with biweekly face-to-face visits during the first month of treatment.  

The optimal frequency of visits is an empiric question worthy of testing. Until those research findings become available, practitioners should attempt to follow the FDA frequency of monitoring guidelines. 

►  The FDA did not recommend a standardized rating form or side effect questionnaire for the practitioner to follow that would include the important concerns. The AACAP Work Group on Research is aware that two NIMH research projects now include forms with standard questions about important side effects that can be administered on a weekly basis. Forms such as these could prove to be effective in clinical care.  

What is the downside of not using antidepressant medications to treat my child and adolescent patients with depression?  

The NIMH TADS did not find an advantage of cognitive behavioral therapy (CBT) alone over placebo in the short term. However, CBT has been shown to be effective in other treatment studies of depression in children and adolescents. For that reason, effective treatment may include CBT or other evidence-based psychotherapies alone or with the antidepressant fluoxetine as a first-line treatment for depression. In particular, psychosocial treatment has been shown to have a protective effect against suicidal behavior or ideation when combined with antidepressant medication.  

Why should childhood depression be treated with medications that carry any risk at all?  

The AACAP Work Group on Research strongly supports the treatment of children and

adolescents with depression despite risks. Pediatric depression is a real illness, with neurobiological underpinnings. Effective treatments for this disorder are available. Although antidepressant treatment carries risks, untreated depression has potentially greater risks, and treatment is effective, especially when started early. Depression is a serious illness, sometimes episodic and often chronic, when it occurs in childhood. In addition to the human suffering that occurs because of the depression, the symptoms can and do interfere with academic learning, peer relationships, and family interactions, often derailing normal development.  

Follow-up studies have shown a higher than normal rate of serious mental disorder in adult life and shortened mortality in those with childhood- or adolescent-onset depression. There are about 1.7 million suicide attempts per year and about 60 percent of those have a depressive or anxiety diagnosis. Because of the severity of the disorder, the Work Group on Research supports treatments that have been shown to be effective in easing the depression and allowing normal development. The 2004 NIMH TADS study has confirmed that the SSRI fluoxetine, alone or in conjunction with CBT psychotherapy, is an effective treatment for youth-onset depression. 

What other steps is AACAP taking to support its members?  

 The AACAP plans to expedite the update on the practice parameter for depression and to distribute it in 2005. AACAP will also revise relevant Facts for Families to provide practitioners with suitable materials to hand out in the office.  AACAP members are contributing to other projects to be included in a practice toolkit, including this letter, a model parental consent form, and a rating form to track the adverse events in antidepressants, such as increased suicidal ideation and suicidal behavior. The sample letter to parents or guardians that is enclosed will also be part of the toolkit.   

 

 Sample Letter to Families:

Explaining the FDA warnings about antidepressants 

October 2004 

Dear Parent/Guardian, 

You may have heard media reports on concerns about prescribing antidepressant medication for children and adolescents. The reports describe the meeting at the Food and Drug Administration (FDA) in September 2004 to review the studies of children and adolescents taking antidepressants. The agency reviewed studies of depression and anxiety disorders, and an advisory committee discussed the effectiveness of these medications, as well as the concerns about increased risk of suicidal behavior in children and adolescents while taking the medications. This letter will explain some of the information and answer questions that you may have. 

What did the FDA Advisory Committee determine?

After two days of hearings, the advisory committee determined that there is some increased risk of suicidal behavior for some children or adolescents taking antidepressants. About 3-4% of children or adolescents with depression who took an antidepressant had some type of suicidal behavior (such as a suicide attempt or suicidal thoughts), while 1-2% of those taking placebo (inactive pill) did. Therefore, there was almost a 2-fold increase in suicidal behavior in youth taking an antidepressant to treat their depression. There were NO completed suicides in any of these studies, which included over 4,000 children and adolescents. For those with an anxiety disorder, there was no difference in suicidal behavior in those being treated with antidepressants as compared to placebo. 

The FDA advisory committee recommended that a stricter warning label be placed on all antidepressants. The type of warning label they recommended is called a “black box,” which means any doctor prescribing one of these medications has to clearly warn patients and their families about the risks associated with the medication. In this instance, the black box warns that there is a chance of increased risk of suicidal thoughts and behaviors in youth taking these medications. Although there were some minor differences between the various medications evaluated, the advisory committee decided that the same warnings should be given for all antidepressants. 

How does this affect your child?

If your child is already being treated with one of these medications and is doing well, then your child should continue on the treatment. In most cases, these increased risks occur during the first weeks of treatment. If your child has recently started one of these medications or is about to start, then you and your doctor will need to closely monitor him/her for any changes in behavior.  

Suicidal thoughts are a symptom of depression. Additionally, depression is one of the largest risk factors for suicide. It is difficult to interpret whether suicidal thoughts and behaviors in depressed individuals are due to the illness itself or the medication. It can be either of these. In some people, antidepressant medications may increase these types of thoughts, so this warrants close monitoring for all patients.   

It is important to note that, in the studies, 9% of adolescents in the general population make a suicide attempt, 3-4% had some suicidal behavior.  

What should you do?

First, be upfront and honest with your child about these risks.  Second, talk to your child or adolescent about whether they are having any suicidal thoughts, and let them know they should come to you if they start having such thoughts. Third, you, your child, and your child’s doctor should develop a safety plan for your child. This can include identifying an adult your child can call if he/she is thinking about suicide.  Finally, you and your doctor should closely monitor your child for the first weeks of treatment.  All child and adolescent patients beginning medication should be seen weekly for the first month, every other week for the second month, and at least once a month for the third month by the treating psychiatrist to closely monitor depressive symptoms and any problems. It is important that you do not change the dose of your medication without first discussing the change with your doctor. 

What should I look for?

Be on the look out for certain behaviors that appear for the first time, seem worse, or worry your child or adolescent or you. These include new or more thoughts of suicide, trying to commit suicide, new or worse depression, new or worse anxiety, or feeling very agitated or restless. If these appear, a medical professional should be contacted right away.

If you have any questions about this information, ask your doctor, who will answer all other questions you or your child have.

We hope that this information answers your questions.-InfoJustice

  • CRIMINAL JUSTICE PSYCHIATRIST JOINS THE ACADEMY

    Dr. James Drury DO is a Forensic Child/Adolescent/Adult Psychiatrist, who presently is heading up a New Jersey Juvenile Psychiatric Corrections Program.  Psychiatric Director-ConCEPT Program-New Jersey Training School for Boys-Jamesburg, NJ

    Responsible for the evaluation and care of children in a Medium Security Facility under the auspices of the New Jersey Juvenile Justice Commission. The patients in this specialized unit have multiple psychiatric and behavioral problems which have caused them to be readmitted multiple times into the Juvenile Justice setting. The focus of the program is to help intervene intensively through the use of behavioral/emotional/educational techniques to help prevent recidivism. Responsible for psychiatric/forensic evaluations, psychotherapy, behavioral interventions, and the prescription of medications. Serve as the sole psychiatrist to this population which includes being on-call 24 hours per day, seven days a week. Supervise a staff of, 2-3 social workers and 9-12 behavioral care specialists and also testify at commitment hearings for transfer to the state hospital if warranted by patient’s behaviors. This program is the first of its kind in the country and is subsidized by both Federal and State grants. It is believed that this program will become the measure by which other such programs in the state as well as in the nation are gauged. The program seeks not only to address the special needs of its clients buy also to educate the general population of the benefits of such intensive treatment and supervision.

    7/02 to date:  Lead Psychiatrist-New Jersey Juvenile Justice Commission

    Responsible for psychiatric/forensic evaluations, psychotherapy, behavioral interventions, and the prescription of medications at the state’s medium security juvenile facilities at both the Jamesburg and Bordentown Campuses, as well as the Boot Camp. Serve as the sole psychiatrist to this population which includes being on-call 24 hours per day, seven days a week. Supervise a staff of 4-5 nurses, 4-5 social workers and also testify at commitment hearings for transfer to the state hospital if warranted by patient’s behaviors. Also, responsible for referrals for substance abuse and other specialized program follow-up and treatment when discharged from the facility to address the individual child’s special needs. 

    7/02 to date    Consulting Psychiatrist-St. Peter’s University Hospital                   New Brunswick, NJ

    Consultant for an inpatient psychiatric facility serving adult and geriatric populations. Recommend therapy, pharmacology, and behavioral intervention options.  

    4/00 to date              Police Surgeon/Board of Directors-AMTRAK Police Fraternal Order of Police

    Responsible for the psychiatric care and counseling of the members of a federal police force and their families. Duties include medication evaluation, therapy, and screenings for mental illness. Involved in the establishment of protocols and procedures for the implementing of these programs as a member of the Board of Directors. 

    7/00 to 7/02    Psychiatric Director-Fayette County Prison  Uniontown, PA

    Responsible for psychiatric/forensic evaluations, psychotherapy, behavioral interventions, and the prescription of medications in an approximately 200-bed rural county prison facility with an average stay of two years or less. Serve as the sole psychiatrist to this population which includes being on-call 24 hours per day, seven days a week. Supervise a staff of 4-5 nurses and also testify at commitment hearings for transfer to the state hospital if warranted by patient’s behaviors. Also, responsible for referrals for substance abuse follow-up and treatment when discharged from the facility.

    7/00 to 7/02              Child/Adolescent/Adult Psychiatrist-Chestnut Ridge Counseling Services, Inc.

                                         Uniontown, PA

    Responsible for the psychiatric care and treatment of  outpatient psychiatric patients in a rural mental health  center. This includes psychotherapy, behavioral interventions, family therapy, and prescribing medications. This position includes provision of similar services to an Adult Outpatient Dual Diagnosis Partial Hospitalization Program.

    7/00 to 7/02  Consulting Psychiatrist-Highlands Hospital   Connellsville, PA

    Consultant for an inpatient psychiatric facility serving adult and geriatric populations. Recommend therapy, pharmacology, and behavioral intervention options.  

    7/98 to 7/00               Child and Adolescent Fellow/Assistant Clinical Instructor, East Carolina University School of Medicine

                                        Greenville, NC

    Responsible for the care and treatment of pediatric and adolescent psychiatric patients in outpatient, inpatient, substance abuse, and forensic settings. Duties included medication evaluation, psychotherapy, emergency room screenings, and consultations to other psychiatric services.

    The list of Dr. Drury's association with law enforcement, various medical associations and academy's is vast.  The American Academy For Justice Through Science welcomes Dr. Drury to our "team", and appreciate in anticipation any consumer advocacy writings, or consumer advice Dr. Drury contributes in his area of expertise.  Welcome Dr. James A B Drury DO, Forensic Psychiatrist and consumer advocate..

  • LETTERS TO THE EDITOR

Dear Dr. Neff:  I've been searching for information about the murder case of JonBenet Ramsey, because I have a research paper to write on the effect it had on America. I can't find the information that I need and was hoping you could help me out. And this this paper is very important for my req. for graduation. I was only 10 yrs old when she died so I'm not very educated on how it impacted other Americans. If you don't have any info or know of some other site that might I would be so very grateful if you would help me out.

Dear Andrea (lilchick), Somewhere on the Beat the Press page is a short forensic analysis that I did on that case.  However, the Crime Library http://www.crimelibrary.com/ramsey/ramseymain.htm has an interesting take on this case. Another comprehensive report was done by The Encyclopedia of Crime by Crime Magazine.  This can be found http://crimemagazine.com/jonbenet.htm This should start your mystery solving juices flowing.  Good Luck InfoJustice

  • September is National Menopause Awareness Month!
    Menopause and Hormones: "What Can You Believe"
    Campaign Spearheaded by FDA's Office of Women's Health

The Food and Drug Administration (FDA) is implementing a nationwide information campaign to raise awareness about the resources available to address questions related to the benefits and risks of hormone therapy for menopausal symptoms. According to Census data from 2000, there are about 37.5 million women reaching or currently at menopause (ages 40 to 59). FDA wants women to be informed about new and emerging safety information about menopausal hormone treatment.

"Menopausal hormone therapy like all medications has benefits and risks which is why it is important for FDA to provide the latest, most helpful information to assist women in making the best decision to fit their needs," said Dr. Susan Wood, Assistant Commissioner of FDA's Office of Women's Health. She continued, "FDA's main message is: If you choose to use hormones for treating symptoms of menopause, use them at the lowest dose that helps for the shortest time needed."

The FDA and its partners are working to distribute education materials to help women make informed decisions about their health. These materials address questions of concern to perimenopausal and menopausal women considering the use of hormone therapy for relief of their symptoms. This science-based information has been developed in collaboration with the National Institutes of Health and other agencies of the Department of Health and Human Services.

The campaign helps clarify the National Institutes of Health findings from their landmark Women's Health Initiative (WHI) studies about the benefits and risks of menopausal hormone therapy. This research dramatically changed the previous knowledge base about use of hormone therapy. Women now have questions about what these findings mean for them. The conclusions from WHI clinical studies showed that women using estrogen with or without progestin may increase their chances of strokes and blood clots. Using estrogen with progestin also increased a woman's chance of getting breast cancer and heart attacks, but using estrogen alone did not. For women with a uterus on hormone therapy, a combination of estrogen plus progestin is prescribed. Progestin prevents the overgrowth of the lining of the uterus, which can lead to cancer, a known risk of estrogen. For women who have had a hysterectomy, hormone therapy consists of estrogen alone. Using estrogen with or without progestin may increase the risk of dementia in women age 65 years or older. Estrogen, either alone or with progestin, decreased women's chances of developing weak bones. Estrogen with progestin decreased the risk of colorectal cancer in women.

Some of the important questions answered in the FDA education materials include examples such as:

"What are the benefits of using hormones for menopause?" Menopausal hormone therapy is the most effective FDA approved medicine for relief of hot flashes, night sweats, and vaginal dryness. For some women, menopausal hormone therapy may also reduce the chances of getting weak bones, a condition called osteoporosis. (For women at high risk of osteoporosis, other medications to prevent bone loss should be considered.)

"What are the risks of using hormones?"

For some women, menopausal hormone therapy may increase their chances of getting blood clots, heart attacks, strokes, breast cancer, and gall bladder disease. For a woman with a uterus, estrogen alone slightly increases her chance of getting endometrial cancer (cancer of the uterine lining).

The FDA continues to initiate information and education outreach activities regarding hormone therapy for menopause. Materials, such as printable brochures and a list of questions to take to doctor visits, are downloadable directly from the Internet at the following website location, www.fda.gov/womens/menopause/. In conjunction with help from its national partners, FDA's English and Spanish hormone therapy materials will help women:

  • To know that menopause is normal, and that all women go through it
  • To know what is available to them as they go through menopause
  • To increase their understanding of menopausal hormone therapy for treatment of their symptoms.
  • To make an informed decision with their doctor, nurse or pharmacist about ways to manage their menopausal symptoms

The FDA website lists informational resources, such as government agencies, private organizations, newsletters, magazines, and reports for women seeking more information about menopause at the following location: www.fda.gov/cder/drug/infopage/estrogens_progestins

Further information can be located on the Internet at www.4women.gov/Menopause/resources.htm. Organizations wishing to partner with the FDA, or those who wish to order English or Spanish materials may contact the National Women's Health Information Center (NWHIC) at (800) 994-9662. NWHIC is a service of the HHS Office of Women's Health.

The FDA, an agency of the Department of Health and Human Service (HHS), has partnered with other HHS agencies, as well as not for profit women's health organizations and professional associations. Currently, there are approximately 30 FDA partners helping to increase women's awareness about the use of menopausal hormone therapy.

Susan F. Wood, PhD, Assistant Commissioner for Women's Health, FDA Office of Women's Health, and Joseph Kaczmarczyk, DO, MPH, Medical Officer, FDA Office of Women's Health, are available as part of National Menopause Awareness Month, to discuss the benefits and the risks of using hormones for menopause and provide helpful resources to women concerning FDA's campaign.

To schedule an interview with either Dr. Wood, or Dr. Kaczmarczyk, contact Alice Fisher at 1-800-565-0770.

The U.S. Food and Drug Administration's Office of Women's Health (OWH) serves as a champion for women's health. It monitors progress of priority women's health initiatives within the FDA; It promotes an integrative and interactive approach regarding women's health issues across all the organizational components of the FDA; and it forms partnerships with government and non-government entities, including consumer groups, health advocates, professional organizations, and industry, to promote FDA's women's health objectives.

  • FDA Approves New Extended Release Pain Medication:
    Agency Works with Sponsor to Develop an Effective Plan to Reduce Inappropriate Use

The Food and Drug Administration (FDA) announced today the approval of Palladone (hydromorphone hydrochloride) capsules for the management of persistent moderate to severe pain in patients requiring continuous around-the-clock opioid pain relief for an extended period of time.

Palladone is an extended-release formulation that comes in 12, 16, 24, and 32 milligram (mg.) capsules. This drug should only be used in patients who are already receiving opioid therapy and who require a total daily dose of at least 12 mg. of oral hydromorphone or its equivalent. Palladone offers a therapeutic choice for opioid-tolerant patients who might otherwise be candidates for other opioids and who do not achieve satisfactory therapeutic results with these other products.

The active ingredient in Palladone, hydromorphone, is currently a Scheduled II controlled substance, which is the highest level of control for drugs with a recognized medical use. Based on the risks associated with the drug, including the potential for abuse of Palladone, FDA has worked with the sponsor to develop a comprehensive risk management program (RMP).

The RMP was designed with three potential risk situations identified. These are the risks posed by improper dosing, indication, or patient selection; the risk posed by accidental pediatric exposure to the drug; and the risk posed by abuse or diversion of Palladone Capsules.

As a controlled substance in Schedule II of the Controlled Substances Act (CSA), Palladone also comes under the jurisdiction of the Drug Enforcement Administration (DEA), which administers the CSA. Schedule II drugs are subject to manufacturing quotas set by DEA with input on medical need from FDA, distribution tracking, import and export controls, registration of prescribers and dispensers, and written prescriptions without refills.

In addition to the protection afforded patients through the status of Palladone as a controlled substance, the RMP includes provisions for clear and appropriate labeling, and appropriate education of healthcare professionals, patients, and caregivers. In addition, the sponsor has committed to offer appropriate training to sales representatives. To guard against the inappropriate use of the drug, the RMP also establishes a multifaceted program for monitoring and surveillance of abuse. If abuse, misuse, and diversion occur the program includes an array of interventions.

As part of the RMP, a Medication Guide (FDA-approved patient information which is required to be dispensed with each prescription) has been written for patients prescribed Palladone. FDA requires a Medication Guide only when one or more of the following circumstances exists: (1) the drug is one for which patient labeling could help prevent serious adverse effects; (2) the drug is one that has serious risks of which patients should be made aware because information concerning the risks could affect patients' decision to use, or continue to use the drug; and (3) the drug is important to health and patient adherence to directions for use is crucial to the drug's effectiveness. In addition, the physician labeling for Palladone contains a “black box” warning.

FDA is also part of a larger initiative to reduce diversion and abuse of prescription drugs. On March 1, 2004, the Office of National Drug Control Policy was joined by the Surgeon General, the DEA Administrator, and the FDA Commissioner to announce the National Drug Control Strategy . The strategy emphasized new collaborative efforts at the federal, state, and local levels to prevent and reduce diversion and abuse of prescription drugs. This strategy focused on three core tactics: (1) Business Outreach and Consumer Protection, (2) Investigation and Enforcement, and (3) Protecting Safe and Effective Use of Medications. During the approval process for Palladone, FDA incorporated many of the elements of this strategy as exhibited by inclusion of the “black box” warnings on the labeling, the Medication Guide, and the implementation of a RMP.

In addition to the potential for abuse and addiction, respiratory depression is the chief potential risk associated with Palladone, if not properly dosed. Respiratory depression is manifested by a reduced urge to breathe and a decreased rate of respiration, often referred to as “shallow” breathing, and can result in severe effects or fatalities. The risk of respiratory depression is greater in patients not used to taking opiates, and in elderly or debilitated patients.

Palladone must be swallowed whole because chewing, dissolving, or crushing the contents of the capsules leads to the rapid absorption of a potentially fatal dose.

Other common side effects include nausea, vomiting, dry mouth, dizziness, urinary retention, and constipation.

Palladone is manufactured and distributed by Purdue Pharma L.P., located in Stamford, Conn.

  • FDA Clears New Lab Test to Help Screen Newborn Infants for Congenital Disease

The Food and Drug Administration (FDA) today cleared for marketing a new laboratory blood test that will help doctors screen newborn infants for a variety of inherited diseases.

The test is done on blood from newborn heel-stick samples--the same kind of sample used for state-mandated newborn screening tests. The blood sample is measured for levels of amino acids and substances called free carnitine and acylcarnitines.

While small amounts of these substances are found in everyone, abnormally high amounts, or abnormal patterns, may indicate different disease states called inborn errors of metabolism. They include, but are not limited to, phenylketonuria (PKU) and maple syrup urine disease (MSUD), medium chain Acyl-CoA dehydrogenase deficiency (MCAD), isovaleric acidemia, homocystinuria and hereditary tyrosinemia.

While each of these individual disorders is relatively rare, as a group they are fairly common. These diseases can cause developmental delay, seizures, mental retardation and death.

With early identification, many of the effects of these diseases can be significantly reduced, with improved long-term outcome and improved quality of life.

FDA cleared the test based on results of a study of blood samples taken from more than 200,000 babies. The study was a part of a large multi-center, epidemiologic study performed by the sponsor. Blood samples from newborns were tested by current methods and by the new test, the NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit.

The NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit is not a stand-alone test for predicting these kinds of inborn errors of metabolism. The test provides screening information when used with clinical evaluation and other tools to determine a newborn baby’s risk for disorders of amino acid and/or carnitine and/or acylcarnitine metabolism. Abnormalities are distinguished by elevated levels or abnormal patterns of amino acids, free carnitine, and acylcarnitines.

The NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kit is manufactured by PerkinElmer Life and Analytical Sciences, Inc. of Norton Ohio.

  • FDA Approves Two Fixed-Dose Combination Drug Products
    For the Treatment of HIV-1 Infection

The Food and Drug Administration (FDA) today announced the approvals of Epzicom (abacavir/lamivudine) and Truvada (tenofovir disoproxil/emtricitabine), two fixed-dose combination treatments for HIV-1 infection. Control of HIV/AIDS generally requires simultaneous use of three or more drugs from different classes. Combination products bring together different HIV/AIDS drugs in a single medication or co-package and help make treatment regimens less complicated for patients to follow.

"We gained important scientific knowledge during the development of these products that will be especially useful in our efforts to speed the availability of safe and effective fixed-dose combination products to those who need them in this country and in developing countries..."Simplifying treatment regimens by reducing the number of pills and times per day patients need to take them provides significant public health benefits," Dr. Crawford added.

Epzicom and Truvada are indicated for use in combination with other antiretroviral drug products from different classes such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors for the treatment of adults with HIV-1 infection.

Epzicom is a fixed-dose combination of the antiretroviral drugs abacavir sulfate 600mg and lamivudine 300mg, both of which are approved individually under the brand names Ziagen (abacavir sulfate) and Epivir (lamivudine). Epzicomís approval is based on a large well-controlled clinical study which showed that abacavir dosed once daily had a similar antiviral effect as abacavir dosed twice daily both in conjunction with lamivudine and with efaviranz, another antiretroviral drug.

Truvada is a fixed-dose combination of the antiretroviral drugs tenofovir disoproxil fumarate 300mg and emtricitabine 200mg, both of which are approved individually under the brand names Viread and Emtriva, respectively. The approval of Truvada is based on data demonstrating therapeutic equivalence between the combination product and the individual products.

FDA completed its review of Epzicom in 10 months and its review of Truvada in 4 months. GlaxoSmithKline submitted their New Drug Application (NDA) for Epzicom in October 2003. Gilead Sciences, Inc., submitted their New Drug Application (NDA) for Truvada in March 2004.

  • FCC PROPOSED TO PLACE CABLE AND NET PHONES UNDER WIRETAP RULE

The Federal Communications Commission proposed that Internet-based phone and broadband services to design their networks so they can be easily wiretapped.  This action would assist the FBI in monitoring the communications of criminals and terrorists.  This would liken these services to phone calls which currently are under the Communications Assistance for Law Enforcement Act (CALEA).  This law requires “telecommunications” carriers to make their networks wiretap-friendly.  The law will probably also be written to include walkie-talkie services as well.-InfoJustice

  • DOJ INDICTS SO CALLED NATURAL CARE PRODUCER

    United States Attorney Carol C. Lam announced that a Grand Jury sitting in the Southern District of California returned an eight-count indictment against San Diego-based corporation Metabolife International, Inc., and its founder, Michael J. Ellis. The indictment charges both defendants with six counts of making false, fictitious and fraudulent representations to the Food and Drug Administration (“FDA”), and two counts of corruptly endeavoring to influence, obstruct and impede proceedings concerning the regulation of dietary supplements containing ephedra being conducted by the FDA, an agency of the Department of Health and Human Services. Until FDA banned the sale of ephedra in the United States in 2003, Metabolife was one of the largest retailers of dietary supplements in the United States, based largely on sales of its ephedra-based product, Metabolife 356.

    According to Assistant United States Attorneys Phillip L.B. Halpern and Kyle W. Hoffman, who are prosecuting the case, Metabolife and Ellis are charged with falsely representing a number of different material facts to the FDA in letters dated April 17, 1998 and February 9, 1999. These representations included false statements by the Defendants that “Metabolife ha[d] never received one notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356” and that the company
    had a “claims-free history.”

    United States Attorney Lam said, "It is never acceptable for corporations to lie to regulatory agencies, but it is particularly egregious when those lies threaten the public health."

    "One of FDA's highest priorities involves our responsibility to ensure that information about products we regulate is truthful and not misleading, because people depend on that information to make informed choices," said Acting FDA Commissioner Dr. Lester M. Crawford. "We will pursue to the full extent of the law those who would seek to mislead consumers by providing false information or impeding investigations of risky products."

    This case is being investigated by the FDA Office of Criminal Investigations and the IRS Criminal Investigation Division. United States Attorney Lam stated that the investigation is continuing.

    The defendants are scheduled to be arraigned before Magistrate Judge Louisa Porter in San Diego on Tuesday, July 27, 2004 at 10:30 a.m.

    DEFENDANTS Case Number: 03 CR 1088-J
    Metabolife International, Inc.
    San Diego, CA

    Michael J. Ellis


    SUMMARY OF CHARGES AND MAXIMUM PENALTIES

    Making False Statements to the Food and Drug Administration in violation of Title 18, United States Code, Section 1001 (Counts 1, 2, 3, 5, 6 and 7)

    Maximum penalty is five years in prison and a fine not to exceed $250,000.

    Obstruction of Agency Proceedings in violation of Title 18, United States Code, Section 1505 (counts 4 and 8)

    Maximum penalty is five years in prison and a fine not to exceed $250,000

    PARTICIPATING AGENCIES

    Food and Drug Administration, Office of Criminal Investigation
    Internal Revenue Service, Criminal Investigation Division

  • FDA Warns Consumers About Counterfeit Drugs Purchased in Mexico

The Food and Drug Administration (FDA) is warning the public about counterfeit versions of the drugs Zocor (simvastatin) and carisoprodol that were recently imported from Mexico by individual Americans. Tests indicate that the counterfeit Zocor did not contain any active ingredient and that the counterfeit carisoprodol differed in potency when compared to the authentic product. Carisoprodol is a drug used in the treatment of painful musculoskeletal conditions and Zocor is a cholesterol lowering drug. The counterfeit versions were reportedly purchased at Mexican border town pharmacies and sold under the names Zocor, 40/mg, (lot number K9784, expiration date November 2004), and Carisoprodol, 350/mg, (lot number 68348A). Patients who rely on these counterfeit versions of the drugs could develop serious health risks (with the counterfeit Zocor) or have insufficient pain relief (with the counterfeit carisoprodol).

FDA has repeatedly expressed its concern about the purchase by Americans of drugs from foreign countries. As demonstrated by this incident, purchasers cannot assume that the products meet the quality, efficacy, and safety standards of FDA authorized products or that FDA is assuring the quality, safety, and efficacy of products purchased from outside the United States.

Medications purchased within the US system for prescription drugs have undergone rigorous testing and review to verify their identity, potency, and purity and to ensure that they are safe and effective for their intended use. In addition, there are safeguards to help maintain the integrity of the products while in shipment to pharmacies and prior to dispending to patients.

Anyone who may have recently purchased the above described versions of Zocor 40/mg and Carisoprodol 350/mg from Mexican pharmacies should consult with their physician as well as notify their local FDA field office.

FDA is investigating this matter and working with the Mexican authorities to ensure that further sale and importation of these products is halted

  • FDA ALERTS CONSUMERS NOT TO FEED INFANTS. CHINESE INFANT FORMULA

The Food and Drug Administration is warning consumers not to feed their infants infant formula from China because the safety and nutritional adequacy of infant formula from China is unknown. Recently, infant formula from China by the name of Guan Wei Yuan was found for sale in an Asian retail market in New York.

To date, FDA is not aware of any illnesses or injuries associated with Chinese infant formula, Guan Wei Yuan. However, the analysis of certain Guan Wei Yuan powdered formulas by the New York State Department of Agriculture and Markets food laboratory found the formula to contain less than 1/7 of the federally required minimal amount of protein per serving, approximately 1/4 the required amount of fat and only minute amounts of declared calcium and magnesium. There is no guarantee that this product, as a potential sole source of nutrition, would provide adequate nutrients for an infant. Consumption by infants, under conditions of use described on the label and labeling, could result in outcomes including severe illness or death.

The federal law requires that any infant formula marketed in the U.S. must be registered with the FDA at least 90 days before marketing. Manufacturers are required to provide assurances that they are following good manufacturing practices and quality control procedures and that the formula will allow infants to thrive. Such assurances have not been provided for any infant formulas from China. Therefore, the agency is warning consumers that the safety and nutritional adequacy of infant formula from China is unknown.

FDA will continue to investigate and work with New York State Department of Agriculture and Markets and alert other states of the findings.

Consumers are advised to report any adverse reactions related to infant formula immediately to your health care provider as well as the FDA and state and local agencies.

  • FDA TO PROVIDE CLEARER INFO TO DRUG SPONSORS CONCERNING REVIEWS OF NEW DRUG APPLICATIONS

The Food and Drug Administration (FDA) is proposing to change the new and generic drug review processes by replacing "approvable letters" and "not approvable letters" with "complete response letters" that provide companies with specific information about what needs to be done before their drugs can be approved for marketing. This approach has been used by FDA for biological drugs for some time and would be formalized for all drugs by this proposal.

These changes will ensure a single, consistent method of advising drug manufacturers that FDA review of an application is complete.

"This new approach will provide a clearer and more consistent method for communicating to new and generic drug applicants about the status of their applications," said Dr. Lester M. Crawford, Acting Commissioner of Food and Drugs.

In addition, the proposed rule would amend the provisions on extending the review cycle for amendments to an unapproved application and for starting a new cycle after a resubmission in answer to a "complete response" letter.

Under existing regulations, a resubmission of a new or generic drug marketing application extends the review period following receipt of an "approvable" or "not approvable" letter.

Under the new proposal, responses to "complete response" letters for new drug applications would be classified by what needs to be done to obtain marketing approval. A "Class 1" resubmission would be defined as an application resubmitted after receipt of a "complete response" letter that includes only certain items such as draft or final printed labeling, safety or stability updates, or other minor clarifying information. A "Class 1" resubmission would start a new, two-month review cycle.

A "Class 2" resubmission would be one that would require information beyond that called for in a "Class 1" resubmission (for instance, information that would need to be presented at a public advisory committee meeting). A "Class 2" resubmission would start a new, six-month review cycle.

The agency's proposal would retain the current "major" and "minor" terminology for resubmissions of generic drug applications. Under the proposal, a "major" generic drug marketing application resubmission would start a new, six-month review cycle. A "minor" generic drug application resubmission would start a new cycle of from 30 days to a few months, depending on the issues involved.

These changes to the regulations are proposed to implement the user fee performance goals referred to in the Prescription Drug User Fee Amendments of 2002 (known as PDUFA III) that address procedures and establish target timeframes for reviewing human drug applications.

In conjunction with the Prescription Drug User Fee Act of 1992 (PDUFA), FDA committed to meet certain goals for reviewing and deciding on human new drug applications. FDA's drug application review performance goals were revised with the enactment of the Food and Drug Administration Modernization Act of 1997 (the user fee provisions of this act are known as PDUFA II).

FDA's performance goals were further revised in conjunction with the enactment of PDUFA III, set forth in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. Section 502 of PDUFA III states that user fees will be dedicated to expediting the drug development process and the process for the review of human drug applications in accordance with the new performance goals.

  • GLENCOE MAN SENTENCED FOR SELLING COUNTERFEIT & MISBRANDED PESTICIDES TO CITIES

WASHINGTON, D.C. - The Justice Department announced that William C. Murphy, 54, of Glencoe, Alabama was sentenced today in U.S. District Court to 41 months in prison, ordered to pay $45,305 in restitution, and was given 3 years supervised release for selling counterfeit and misbranded pesticides to municipalities in Alabama and Georgia for mosquito and West Nile Virus control.

In January, shortly before his trial was to begin, Mr. Murphy pled guilty to a twenty-eight count indictment charging him with having manufactured and sold counterfeit pesticides by using registered brand names that he had no authority to use in the marketing of chemicals he mixed and packaged in an Anniston, Alabama warehouse. According to the indictment, Murphy, operating under the name Sierra Chemical, sold imitations of brand-name pesticides which bore labels falsely identifying the brand name, manufacturer, or active ingredients to the following municipalities: Enterprise, Linden, Alexander City, Brundidge, Jacksonville, Oneonta, Talladega, Weaver, Cullman, Pell City, Union Springs, Tallassee, and Lee County, Georgia.

Murphy, who has been held in prison since his arrest in May, could have received a maximum fine of $2,000,000 and imprisonment of up to ten years for violating federal trademark protection laws, and a fine of up to $100,000 per count and imprisonment of up to one year per count for violation of federal pesticide control laws.

"This case is an example of how state and federal agencies can work together effectively to bring to justice those who violate the environmental laws that both the state and federal governments have a responsibility to enforce," said Thomas L. Sansonetti, Assistant Attorney General of the Justice Department's Environment and Natural Resources Division. "This Administration takes seriously its obligation to protect the public health and the environment. Those individuals and corporations whose conduct creates such a threat or who knowingly violate environmental laws will face the kind of prosecution and punishment demonstrated here."

"The sentence imposed in this case demonstrates the seriousness of environmental crimes, and my commitment to protecting the public from those who perpetrate such crimes," said U.S. Attorney Alice H. Martin.

David McLeod, Resident Agent in Charge, Environmental Protection Agency said, "Murphy's sentence should send a clear message to those persons who think they can get away with undermining the regulatory system that is intended to ensure the safety and efficacy of the pesticides sold in this country. It also demonstrates that we take these matters seriously and will vigorously investigate those who endanger public health."

This case was investigated cooperatively by Special Agents of the U.S. Environmental Protection Agency, Criminal Investigative Division and Office of Inspector General, the Federal Bureau of Investigation, and the Alabama Department of Agriculture and Industry.

Assistant United States Attorney Robert O. Posey, Department of Justice Environmental Crimes Section Senior Trial Attorney Jeremy Korzenik, and Environmental Protection Agency Region IV Senior Counsel Richard Glaze prosecuted the case

  • DIETARY CURE "OVER 650" DISEASES, SEASILVER USA ET AL SIGN FDA DECREE TO STOP SELLING

The Food and Drug Administration (FDA) today announced that Seasilver USA, Inc., and Americaloe, Inc., of Carlsbad, California, and their principals, Bela Berkes and Jason Berkes, have signed a consent decree of permanent injunction in which they agreed to stop manufacturing and distributing violative products, including “Seasilver” – a purported cure-all liquid supplement. This action is the culmination of coordinated efforts by FDA and the Federal Trade Commission (FTC) to act against the marketing of these violative products.

“This is yet another example of FDA’s strong commitment to protect the public from unscrupulous dietary supplement manufacturers that make unsubstantiated drug claims,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D.

The consent decree gives FDA the authority to order the firm to discontinue the marketing of and recall any products that violate the law in the future. The decree also allows for liquidated damages for any further violations. The liquidated damages provision of the consent decree requires the companies and their principals to pay $1,000.00 for each article distributed in interstate commerce in violation of the consent decree, the retail value of each lot manufactured in violation of the consent decree, but not distributed in interstate commerce, and $10,000.00 per day, per violation for any other violations of the consent decree. The consent decree was signed on March 8, 2004, by United States District Judge William Q. Hayes in San Diego, Calif.

This consent decree follows a coordinated effort in June 2003 between the Federal Trade Commission (FTC) and the FDA against Seasilver U.S.A., Inc., and Americaloe, Inc., their owners, and two of the companies' principal distributors. On June 16, 2003, at FDA’s request, U.S. Marshals seized 132,480 bottles of Seasilver, worth nearly $5.3 million, from Seasilver USA’s San Diego headquarters.

The Government’s complaint alleges that, although Seasilver USA markets Seasilver as a dietary supplement, the companies promote it on the Internet and in marketing materials sent with the product as a treatment for “over 650” diseases including, for example, cancer, heart disease, stroke, diabetes, hepatitis, arthritis, depression and other diseases. These claims cause Seasilver to be an unapproved new drug under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Such claims also cause Seasilver to be misbranded under the FD&C Act because it lacks adequate directions for use.

Seasilver’s labeling also contains claims such as “cleanses your vital organs” and “oxygenates your body’s cells.” These claims show that Seasilver is intended to affect the structure or function of the body. Because the claims are unsubstantiated, Seasilver is misbranded under the FD&C Act.

The FTC, which regulates dietary supplement advertising, alleges, in part, that the defendants promoted Seasilver through false claims that it was clinically proven to treat or cure 650 diseases, including cancer and AIDS. Under a settlement with the FTC, entered on March 4, 2004, the Seasilver defendants and the individual distributors agreed to pay $4.5 million in consumer redress. In addition, the FTC settlements also bar defendants from making any false or misleading claims about the benefits of any food, drug, or dietary supplement.

"The claims for Seasilver threatened consumers’ health by encouraging delays and replacements for proven treatments," said Howard Beales, Director of the FTC's Bureau of Consumer Protection. "The FTC and FDA are committed to taking aggressive action against false and unsubstantiated claims in the dietary supplement market. Products touted as cure-alls almost always cure nothing.”

As a result of FDA’s consent decree, Seasilver U.S.A. and Americaloe, Inc., will destroy the seized products at their expense under the supervision of a Department of Health and Human Services representative within 60 days of posting bond.

  • GLENDALE MAN INDICTED FOR TRAFFICKING IN COUNTERFEIT VIAGRA TABLETS; "YOU JUST CANNOT MAKE THIS STUFF UP-little guy"

    U.S. Department of Justice, United States Attorney's Office, Central District of California (Los Angeles) - NEWS RELEASE -

    A federal grand jury in Los Angeles today indicted a Glendale man on charges of trafficking in counterfeit Viagra tablets that were manufactured in the People's Republic of China.

    Khoa Twan Do, also known as Chris Do, 31, was named in a three-count indictment returned this afternoon by the grand jury.

    The indictment alleges that Do conspired with a manufacturer in Beijing to import at least 40,000 counterfeit Viagra tablets into the United States. Do arranged to have the bogus Viagra tablets shipped to his business, Health Plus in Glendale, from which he would resell the fake goods.

    The indictment alleges that Do told his Beijing supplier that the counterfeit tablets needed to "look like the real thing" because "I can find many customers who want the real thing."

    "This is another example of the hazards presented by importation of counterfeit foreign drugs into North America," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "It's a form of the medical black market that endangers the public health and cannot and will not be tolerated."

    The indictment alleges one count of conspiracy, one count of trafficking in counterfeit goods and one count of selling a counterfeit drug. The three counts in the indictment carry a maximum possible penalty of 18 years in federal prison and a fine of more than $2 million.

    An indictment contains allegations that a defendant has committed a crime. Every defendant is presumed innocent until and unless proven guilty.

    Do will be summoned to appear for an arraignment in United States District Court in Los Angeles on January 26.

    This investigation was conducted by the United States Bureau of Immigration and Customs Enforcement, and the Food and Drug Administration's Office of Criminal Investigation.

    John M. Taylor, the FDA's Associate Commissioner for Regulatory Affairs, stated: "This indictment is a good demonstration of inter-agency cooperation at its best. FDA will continue to work closely with its law enforcement colleagues as part of its absolute commitment to aggressive enforcement of the laws that protect patients from unsafe medications." January 9, 2004 CONTACT: The Honorable Assistant United States Attorney John Owens (213) 894-3315...

  •  HAPPY NEW YEARS AMERICA

The American Academy For Justice Through Science wishes all Americans a safer, more prosperous, healthier and happier 2004.  God Bless America.-"little guy"-

  • FDA COUNTERFEIT POLYPROPYLENE HERNIA REPAIR MESH ALERT; "YOU JUST CANT MAKE THIS STUFF UP"-"little guy cfe"

The Food and Drug Administration (FDA) today alerted healthcare professionals to a counterfeit polypropylene mesh product labeled as PROLENE polypropylene mesh. The product is a non-absorbable mesh used in hernia repair and other surgery. The authentic PROLENE mesh is manufactured by Ethicon, Inc. Ethicon issued an alert to healthcare professionals about the counterfeit product on October 28.

Preliminary testing of the counterfeit PROLENE by FDA indicates that some samples are not sterile, although at this time FDA is not aware of a significant increase in the number of infections related to use of the counterfeit product. Additional preliminary testing indicates that the counterfeit product has a molecular structure similar to other polypropylene mesh products currently on the market. FDA is continuing to test the material.

FDA is continuing to investigate whether the counterfeit product is still being marketed. In the meantime, FDA recommends that healthcare professionals carefully examine all polypropylene mesh products and not use any suspected of being counterfeit. If they believe the counterfeit product may have been implanted in patients, they should continue to monitor the patients as they would any patient with a polypropylene mesh implant. Although FDA has not had reports of excess infections with the counterfeit product, the agency continues to be concerned about sterility.

The counterfeit mesh is labeled with lot numbers RBE609 (expiration date 1/07) and RJJ130 (expiration date 7/07). It can be further identified by one of the following:

  • A packaging seal that does not tear open smoothly;
  • An additional small seal on top corner edges of the package;
  • A fabric end that is jagged or not cleanly cut on the 3” side; and
  • An Ethicon logo in a thicker than usual typeface.

In a Public Health Notification issued today, FDA encouraged the medical community to report adverse events related to the counterfeit mesh to the FDA through procedures established by their medical facility or through MedWatch, the FDA’s voluntary reporting program.

The “Public Health Notification on Counterfeit Polypropylene Mesh” is available at http://www.fda.gov/cdrh/safety/121903.html.

Ethicon also manufactures PROLENE sutures, which are not the subject of this alert.

  • CONGRATULATIONS PLANET EARTH; "SADDAM IS OVER" Some say that the age of chivalry is past, that the spirit of romance is dead.  The age of chivalry is never past, so long as there is a wrong left unredressed on earth."  Charles Kingsley, Vol., II, Ch 28: "A good conscience is a continual Christmas." Ben Franklin

Rarely in mankind's experiential existence, can history report a time when the entire world benefited by the capture of a criminal.  This criminal, this Saddam, held captive the hearts, the minds, the earth souls and of freedom of the Iraqi peoples in the past and in the present.  This new "bastion of humanity", this new Iraq, can now attempt to contribute to the human experience in a positive way.  With a free Iraq, if possible, this will facilitate a free world.  And further demonstrate that no criminal can escape the law for the "Wheel of Justice Turns Slowly Yet Finely"

In some ways it is sad that the world will celebrate at the capture of a very sick human being.  Yet, with the world still where we are relative to human progress, Saddams' capture symbolizes the greatness of good.  The strength of love over hate.  The enormity of the human spirit to rise above evil, and bring all that is good, such as "freedom" to all peoples no matter their color, creed or race.  Last evening, Yankee Doodle Dandies in the form of US Special forces working with Army Infantry, prove once again, that when "Uncle Sam" wants you, you goSam wanted Saddam, we went, and Saddam now teaches the world that good does triumph over evil, albeit it is sometimes a hard example to illustrate.  Congratulations to all Americans, to all Iraqis, and to all peoples.  We as citizens earth, may yet prove someday, it will be a free world, a safe world, a caring world and a "God Loving" world. -"little guy"-12-14-2003

  • FDA AND CBP POLICY ON
    FOOD IMPORTS UNDER THE BIOTERRORISM ACT

This press release replaces an earlier version.

The United States Food and Drug Administration (FDA) and the U.S. Bureau of Customs and Border Protection (CBP) today issued a compliance policy guide that describes their strategy for maintaining an uninterrupted flow of food imports while improving their safety in accordance with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act).

The policy guide deals with the enforcement of the Bioterrorism Act's requirement, which becomes effective on December 12, 2003, that FDA receive a prior notification of all human and animal food, drinks and dietary supplements imported or offered for import to the U.S. Another requirement of the Bioterrorism Act mandates that all facilities that manufacture, process, pack or hold food for consumption in the U.S. be registered with FDA. This registration requirement for foreign facilities will be primarily enforced through the prior notice provision.

In October, FDA and CBP jointly published an interim final rule that specified that, among other requirements, the prior notice must be received by FDA between two and eight hours -- depending on the mode of transportation -- before each shipment's arrival at the U.S. border. The prior notice interim final rule also covers food packages mailed or brought to the U.S. by individuals from abroad.

As the rule becomes effective, FDA and CBP expect a "good faith" effort at compliance. The policy guide issued today makes clear that during the next 8 months, the two agencies will primarily rely on educating the affected firms and individuals. During this period, the agencies will utilize communication and education initiatives, escalating imposition of civil monetary penalities, and ultimately refusal of shipments. This phase-in period will end on August 12, 2004. As always, both agencies will continue to ensure that imported products are safe for human or animal consumption. Regarding food mailed, brought or accompanied to the U.S. by individuals for non-personal use, FDA and CBP generally will continue their education efforts and will not refuse its admission before August 12, 2004 because of inadequate or lacking prior notice.

"Our intention all along has been to implement the Bioterrorism Act in a way that would protect consumers without obstructing the food imports, on which we depend for 20 percent of all fresh produce and up to 60 percent of all the seafood consumed in the U.S.," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "The goal of the transition policy is to provide complete clarity and education about the new import requirements, and achieve a higher level of U.S. food security without disrupting trade. I am satisfied that this policy guide presents a realistic strategy for facilitating the flow of this essential commerce, as well as holiday food packages, while countering the threat of terrorism."

U.S. Customs and Border Protection Commissioner Robert C. Bonner said, "We at the CBP for decades have worked closely with the FDA in ensuring the safety and security of imported foods, especially perishables, that reach our dinner tables every day. The Bioterrorism Act provides us with yet another highly effective tool to safeguard America's food supply from the terrorist threat."

FDA and CBP personnel have already begun an extensive campaign to educate with written material, briefings, and seminars other government officials, domestic and foreign food importers, brokers, transporters, and other affected industry representatives on compliance with the Bioterrorism Act. In addition, during the 8-month transitional period, the two agencies plan to take the following steps:

  • Gather data to track compliance with the prior notice requirements and to determine how to best use FDA's and CBP's resources to educate industry and the public to achieve full compliance with the Bioterrorism Act.
  • Provide industry and the public with summary information about the level of compliance with the prior notice rules, including data on the types of errors in submitted prior notices.
  • Post the summary information on FDA's website at www.fda.gov.
  • Use the data and summary information to assist the industry and the public in improving the submission of prior notice.

During the phase-in period, FDA and CBP will generally use civil monetary penalties and refusals only in response to repetitive, flagrant and other serious violations.

The policy guide clarifies, however, that FDA and CBP will continue their surveillance of food imports to ensure they are safe, wholesome, and that they comply with other U.S. requirements. The transitional policy announced today does not affect FDA’s or CBP's ability to initiate other actions to protect U.S. consumers. If FDA decides during and after the transition period not to refuse an imported article of food under the provisions of the Bioterrorism Act, such decision will have no bearing on whether the article is admissible on other grounds.

Thus, for food that is imported or offered for imports, FDA will continue to carry out such routine food safety- and security-focused reviews, investigations, and enforcement actions as may be necessary. From December 12, 2003 on, the enforcement of the Bioterrorism Act will be carried out, on a round-the-clock, 7 days a week basis, by hundreds of FDA and CBP employees.

  • FDA ADIVISORY ON METHYLMERCURY

The Food and Drug Administration’s (FDA) Food Advisory Committee (FAC) will meet on December 10-11, 2003 to receive an update regarding the recommendations made during the July 2002 FAC regarding fish consumption and methylmercury. The revisions have resulted in the first unified FDA and EPA revised advisory concerning all fish and shellfish consumption for populations at risk from exposure to high mercury levels: pregnant women, nursing mothers, women who may become pregnant, and young children. In addition, the FAC will review reports from subcommittees: Infant Formula, Contaminants and Natural Toxicants, Dietary Supplements, Additives and Ingredients and Food Biotechnology. The meeting will be held at the Hotel Washington, Pennsylvania Avenue at 15th Street, Washington, D.C. 20004-1009.

In July 2002, FDA’s Food Advisory Committee met and made several recommendations to FDA on how to revise its consumer advisory on methylmercury in fish with special concern for pregnant women, nursing mothers, women who may become pregnant, and young children. One of these was for FDA and EPA to coordinate mercury advisories on commercial fish and recreational fish. Additionally, they recommended that the issue of tuna consumption be addressed.

FDA and EPA have been working diligently toward the goal of updating the consumer advisory in response to the recommendations from the Food Advisory Committee. This work has included: conducting ongoing interagency meetings; conducting field assignments which provided additional testing of methylmercury in fish for which there were low sample sizes; sampling 300 cans of tuna; undertaking exposure assessments using these new data; and testing the revised advisory with focus groups. As part of the meeting, FDA is seeking recommendations or concurrence from the committee before finalizing a joint FDA and EPA revised advisory concerning fish and shellfish consumption. The revised advisory now contains information concerning consumption of all fish, including both commercial fish and locally caught fish. Following the Committee’s concurrence, FDA will initiate an outreach and educational program early in 2004 for at-risk populations.

This advisory is directed to pregnant women, nursing mothers, women who may become pregnant, and parents of young children. This is because the nervous system of the developing fetus and of young children is most at risk from high methylmercury levels in fish.

  • PRESIDENT BUSH SIGNS IMPORTANT PEDIATRIC LEGISLATION HE BELIEVES OUR CHILDREN ARE THE FUTURE!

President Bush today signed important new legislation that will enable the United States Food and Drug Administration to improve the quality of health care for our children.

USFDA has worked diligently to use its available authorities and resources to give pediatricians and parents the solid information they need to treat children who are ill. These programs, which include financial incentives and new funding to conduct needed pediatric studies, have helped develop needed evidence on the effects of medicines in children. But in some cases needed studies have not been done. FDA's most recent attempt to require pediatric studies failed when the U.S. District Court for the District of Columbia held in October 2002, that our agency lacked sufficient statutory authority.

When it goes into effect today, the Pediatric Research Equity Act of 2003 will allow FDA to close the knowledge gap when it comes to treating children. FDA will now have clear authority to require pediatric studies of drugs when other approaches are not sufficient to ensure that drugs are safe and effective for children.

Prescription drugs can do more than ever to cure diseases, including illnesses in children. But it is not good medicine to assume that children can be treated like little adults. Parents and health professionals deserve confidence that medicines used to treat children are safe and effective. USFDA will use this important new law to require pediatric studies, when necessary, to give parents and doctors the confidence they deserve.12-07-2003

  • FTC  WORKING WITH YOUR USFDA

    In response to a request for public comment by the U.S. Food and Drug Administration (FDA), the staff of the Federal Trade Commission filed a comment on December 1, 2003 regarding direct-to-consumer (DTC) advertising of prescription pharmaceuticals. The staff’s response analyzes the overall economic effects of such advertising and provides the FDA with a number of suggestions about how its regulatory scheme for DTC advertising could be modified to communicate information to consumers in an easy to understand and accessible way.

    According to the staff’s comment, which can be found as a link to this press release on the FTC’s Web site, “Empirical evidence suggests that the FDA’s current approach to regulating DTC advertising generally benefits consumers.” Survey evidence suggests, according to the staff, that “DTC ads have provided consumers with useful information about the drug options open to them,” and this has “empowered consumers to interact with physicians more effectively.” The comment further states that the available evidence does not support concerns that DTC advertising has increased the sale of inappropriate drugs or led to increased drug prices.

    Analysis of DTC Advertising Regulations

    The staff comment also makes the following suggestions regarding how the FDA’s DTC advertising regulatory scheme could be modified to communicate truthful, non-misleading information in a way that is easier for consumers to understand and use:

     

    • The brief summary requirement for broadcast ads – a major statement of drug risks along with adequate provision for more complete risk information – should be retained, but modified.
    • The brief summary requirement for broadcast ads should be modified so that consumers would be directed to a more useful source of risk information than the labeling the FDA approved for the product as part of its drug approval process, such as FDA-approved patient labeling or other risk information that has been specifically designed for consumers.
    • The brief summary requirement for print ads – that complete risk information (such as the labeling that the FDA approved for the product as part of its drug approval process) be included in the ad – should be made consistent with the brief summary requirement for broadcast ads.
    • The fair balance requirement for DTC ads should prohibit only ads that convey a deceptive impression of the risk and benefits from the overall presentation of information, rather than those that fail to achieve a mechanistic balance between risk and benefit information.
    • Pharmaceutical manufacturers should be permitted to make truthful, non-misleading price comparisons and other types of relative cost claims.
    • The FDA should apply the same standards for endorsements and testimonials in DTC ads for prescription drugs as the FTC applies through its Guides Concerning the Use of Endorsements and Testimonials in Advertising to endorsements and testimonials for other products, including over-the-counter (OTC) drugs.
    • Internet advertising should be treated consistently with DTC ads in other media, and it would be beneficial if the FDA were to issue a guidance document addressing DTC ads available on the Internet.

    In concluding its comment, the FTC staff writes, “DTC advertising can play an important role in providing information about prescription drugs that may spur consumers to seek help for a previously untreated condition, encourage them to talk with a doctor about a new drug, or otherwise take a more proactive role in minding their health. We therefore encourage the FDA to examine ways to facilitate the flow of truthful, non-misleading information in DTC advertising in a manner that is easy for consumers to understand and access.”

    The Commission vote authorizing staff to issue the comment in response to the FDA’s request was 5-0.

    NOTE: The views expressed in the letter are those of the staff of the FTC’s Bureaus of Consumer Protection and Economics and the Office of Policy Planning, and do not necessarily represent those of the Commission or any individual Commissioner.

  • FBI HAS NEW WEB PAGE AGAINST SCAMS, SCHEMES, SHAMS, CONS, HUCKSTERISM, RACKETS,  HOAXES, WASTE, FRAUD AND ABUSE

As of October 4th, 2003 your FBI asks, "Want to know more about what the FBI is doing, big picture, to protect you and your family against fraud? Everything from corporate greedsters to financing and insurance con men? From criminal telemarketers to medical scams?

You may not realize that over one-third of FBI convictions and pre-trial diversions last year-over 6,000!-fell in the area of white collar crimes".

  • TEXAS BASED WEB SCAMMERS BUSTED.  MUST PAY REDRESS FOR DECEPTIVELY GUARANTEEING CONSUMERS CREDIT CARDS

    Texas-based defendants who engaged in a scam in which they e-mailed consumers promising to provide them with a credit card agreed to pay $815,000 in consumer redress to settle Federal Trade Commission charges. The defendants, ClickForMail.com, Inc., doing business as AllPreApproved.com, and Harvey B. Vaughn, III, were part of the FTC’s Southwest Netforce sweep that targeted Internet scammers and deceptive spammers. The FTC alleged that the defendants sent spam e-mail telling consumers they were approved and guaranteed to receive major, unsecured credit cards with credit limits up to $5,000 for an advance fee of $49.95. In addition to paying redress, the settlement prohibits the defendants from making any false claims to consumers in the future.

    In its complaint, filed in May 2003, the FTC alleged that the defendants sent spam e-mail telling consumers that they were guaranteed to receive a major, unsecured credit card with a high credit limit. Interested consumers then “clicked through” to the defendants’ Web site where they allegedly learned that they were required to pay a $49.95 advance fee to be debited from their checking account before they could get the card. According to the FTC, however, consumers who paid the fee did not receive the promised card. Instead, they allegedly received access to a set of hyperlinks to companies where consumers could apply for credit cards, and even then those were generally for secured credit cards, stored-value cards, or catalog charge cards. The FTC’s complaint alleged that the defendants falsely claimed that: (1) consumers who met minimum qualifying criteria and paid a $49.95 fee would receive unsecured major credit cards; and (2) that the defendants had special arrangements with banks or financial institutions to issue to its customers unsecured major credit cards.

    The proposed settlement announced today prohibits the defendants from making false claims that they:

    • will provide or arrange for consumers to receive major credit cards;
    • have arrangements with banks or financial institutions to offer credit to consumers; or
    • will provide consumers with any credit-related products, programs, or services.

    The settlement also prohibits the defendants from: (1) misrepresenting any material fact prior to a consumer’s purchase of any products, programs, or services; (2) assisting others who engage in any activity that may violate the order; and (3) selling their customer lists. In addition to the defendants paying redress, the settlement contains an avalanche clause that requires the defendants to pay $3.6 million if the court finds that they materially misrepresented their financial status to the Commission.

    Finally, the settlement contains various recordkeeping requirements to assist the FTC in monitoring the defendants’ compliance.

    The Commission vote authorizing staff to file the stipulated permanent injunction and final judgment order was 5-0. It was filed in the U.S. District Court for the Northern District of Illinois, Eastern Division, on October 2, 2003, and was approved by the Court the same day.

  • FEDERAL AGENCIES PUBLISH CONSUMER BROCHURE ON PREDATORY LENDING PRACTICES

The federal Interagency Task Force on Fair Lending has published a new brochure that alerts consumers to potential borrowing pitfalls, including high-cost home loans, and provides tips for getting the best financing deal possible. The brochure, Putting Your Home on the Loan Line Is Risky Business, warns that regardless of whether a home equity loan is for a home repair, bill consolidation or some other purpose, it is important to shop around

Borrowing from an unscrupulous lender, especially one that offers a high-cost loan using the home as security, could result in the loss of the borrower's home and their money.  Before signing the credit contract, consumers are encourage to

  • Think about their financing options
  • Do their homework
  • Think twice before they sign a loan contract
  • Know that they have rights under the law

The members of the Interagency Task Force are the Department of Housing and Urban Development, Department of Justice, Federal Deposit Insurance Corporation, Federal Housing Finance Board, Federal Reserve Board, Federal Trade Commission, National Credit Union Administration, Office of the Comptroller of the Currency, Office of Federal Housing Enterprise Oversight, and Office of Thrift Supervision 

For a copy of the complete brochure simply click or contact Justice as listed below:

Department of Justice: The Department's web site at http://www.usdoj.gov or contact the U.S. Department of Justice, Civil Rights Division, 950 Pennsylvania Ave., N.W., Housing and Civil Enforcement Section, NWB, Washington, D.C. 20530; (202) 514-1116.

  • FDA PUBLIC MEETING ON OBESITY

  • Date and Time: October 23, 2003 from 9:00 a.m. to 5:00 p.m.
    Place: Warren Grant Magnuson Clinical Center, Masur Auditorium, (Bldg. 10) National Institutes of Health, 9000 Rockville Pike, Bethesda, Md.
    Register by October 17, 2003

    The Food and Drug Administration will convene a public meeting to discuss issues within FDA’s jurisdiction related to obesity and nutrition. The purpose of the meeting is to discuss FDA’s role and responsibility in addressing the public health problem of obesity, promoting better consumer dietary and lifestyle choices that have the potential to improve the health and well-being of Americans, and how best to build a framework for messages to consumers about reducing obesity and achieving better nutrition.

    The public meeting will address the following questions:

    1. What is the available evidence on the effectiveness of various education campaigns to reduce obesity?
    2. What are the top priorities for nutrition research to reduce obesity in children?
    3. What is the available evidence that FDA can look to in order to guide rational, effective public efforts to prevent and treat obesity by behavioral or medical interventions, or combinations of both?
    4. Are there changes needed to food labeling that could result in the development of healthier, lower calorie foods by industry and the selection of healthier, lower calorie foods by consumers?
    5. What opportunities exist for the development of healthier foods/diets and what research might best support the development of healthier foods?
    6. Based on the scientific foundation available today, what are the most important things that FDA could do that would make a significant difference in efforts to address the problem of overweight and obesity?

    The Federal Register Notice is available at http://www.fda.gov/oc/opacom/hottopics/obesity.html

  • MARKETER OF ELECTRONIC ABDOMINAL EXERCISE BELT CHARGED WITH MAKING FALSE CLAMES

FTC Alleges "Ab Force" Belt Won't Provide Rock-Hard Abs

Telebrands Corp., TV Savings LLC, and their owner, Ajit Khubani, have been charged by the Federal Trade Commission with making the same type of false claims in the marketing and sale of their "Ab Force" electronic muscle stimulation (EMS) belt as those the FTC targeted in "Project ABSurd." The FTC alleges in an administrative complaint announced today that the respondents, through their advertisements and promotional materials for the Ab Force belt, falsely claimed that the belt causes loss of weight, inches, and fat; causes well-defined abdominal muscles; and is an effective alternative to regular exercise.

In May 2002, as part of "Project ABSurd," the FTC challenged claims made by the marketers of three widely advertised EMS belts - the Ab Tronic, AB Energizer, and Fast Abs. The Commission alleged that the marketers of those products falsely advertised that users would get "six pack" or "washboard" abs without exercise. In July 2003, the FTC announced a settlement of over $5 million resolving the Fast Abs litigation. The Commission also announced that the U.S. district court in Nevada granted the FTC's motion for partial summary judgment against five of the seven Ab Tronic defendants, holding them liable for $83 million in redress. The AB Energizer case still is pending.

"There is no 'free ride' on misleading advertising," said Howard Beales, Director of the FTC's Bureau of Consumer Protection. "If you purposely evoke the false claims made for a similar product, then your ads also are deceptive. And you should expect to hear from the FTC."

The FTC's complaint, filed before an administrative law judge, alleges that the New Jersey-based respondents violated the FTC Act by representing that Ab Force could produce the same results touted in the deceptive infomercials for Ab Tronic, AB Energizer, and Fast Abs.

Those infomercials essentially claimed that users could achieve weight loss, fat loss, and inch loss, get well-developed abs, and obtain results that were equivalent to volitional exercise. The Ab Force ads show well-muscled, bare-chested men and lean, shapely women wearing Ab Force belts and purportedly experiencing abdominal contractions. The ads expressly referred to "those fantastic electronic ab belt infomercials on TV" that the announcer is "sure" the viewer has seen. According to the FTC's complaint, the Ab Force ads, including through references to the prior ab infomercials, falsely claimed that:

  • Ab Force causes loss of weight, inches, or fat;
  • Ab Force causes well-defined abdominal muscles; and
  • Use of Ab Force is an effective alternative to regular exercise.

Previous FTC Actions

The FTC has taken four previous actions against Ajit Khubani and Telebrands. In 1990 and 1996, the Commission obtained consent judgments prohibiting Khubani and his corporations from violating the Mail or Telephone Order Merchandise Rule (Mail Order Rule) and requiring them to pay penalties of $35,000 (1990) and $95,000 (1996). In 1999, the FTC modified the existing 1996 consent judgment with the defendants and obtained penalties of $800,000 to resolve alleged violations of the Mail Order Rule. In addition, in 1996, the FTC obtained an administrative order prohibiting Khubani and Telebrands from violating the FTC Act in connection with the marketing of television antennas and hearing aids.

In an administrative trial, the FTC will seek to prohibit Telebrands, TV Savings, and Khubani from making any misrepresentations about Ab Force or any other EMS device. The FTC also will seek to prohibit them from making any unsubstantiated representations about weight, inch, or fat loss, muscle definition, or the health benefits, safety, or efficacy of Ab Force or any EMS device, or any food, drug, dietary supplement, device, or any other product, service, or program.

In addition, as set forth in the notice order, the FTC is seeking to require Khubani to obtain a $1 million performance bond before engaging in any manufacturing, labeling, advertising, promotion, offering for sale, sale, or distribution of any device. The notice order also includes various reporting requirements to assist the FTC in monitoring the respondents' compliance with its provisions. Finally, the notice order notes that the Commission may seek redress for consumers who purchased the Ab Force.

The Commission vote to issue the administrative complaint and notice order was 5-0.

NOTE: The Commission issues s a complaint when it has "reason to believe" that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. The complaint is not a finding or ruling that the respondents have actually violated the law. Such action marks the beginning of a proceeding in which the allegations will be ruled upon after a formal hearing.

  • USFDA APPROVES Stair-Climbing Wheelchair

The Food and Drug Administration (FDA) today approved a battery-powered wheelchair that relies on a computerized system of sensors, gyroscopes and electric motors to allow indoor and outdoor use on stairs, as well as on level and uneven surfaces.

FDA expedited review of the product, called the INDEPENDENCE iBOT 3000 Mobility System, because it represents a breakthrough technology with the potential to benefit people with disabilities. An estimated 2 million people in the United States use wheelchairs.

"This wheelchair represents a breakthrough in wheelchair technology," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "It can help improve the quality of life of many people who use wheelchairs by enabling them to manage stairs, reach high shelves and hold eye-level conversations. Its approval is emblematic of FDA’s commitment to help innovative medical technologies reach patients promptly."

The user can push a button to command the wheelchair to operate in several different ways. It can be easily converted from a standard chair with four wheels contacting the ground to an elevated chair balanced on only two wheels. This is done when the user wants to reach high objects or wants to be at eye level for conversation. Four-wheel drive enables the user to traverse rough terrain, travel over gravel or sand, go up slopes, and climb 4-inch curbs. For use on stairs, there are two sets of drive wheels that rotate up and over each other to climb up or down, one step at a time. Because of its unique balancing mechanism, the wheelchair remains stable and the seat stays level during all these maneuvers.

To climb up stairs, the occupant backs up to the first step and holds onto the stair railing. Then he shifts his weight over the rear wheels, causing the chair to begin rotation of the front wheels up over the rear wheels and then down onto the first step. As the user shifts his weight backward and forward, the chair senses this and adjusts the wheel position to keep his center of gravity under the wheels. The chair ascends stairs backward and descends forward (the user always faces down the stairs).

To reach high shelves or hold eye-level conversations with people who are standing, the occupant shifts his weight over the back wheels so that the iBOT lifts one pair of wheels off the ground and balances on the remaining pair of wheels. The user then presses a button to lift the seat to a higher position.

People must weigh no more than 250 pounds and must have the use of at least one arm to operate the chair. They also must have good judgment skills to discern which obstacles, slopes, and stairs to avoid in order to prevent serious falls. Users must be capable of some exertion when climbing stairs in the wheelchair by themselves. However, for users who cannot tolerate such exertion, there is a feature that allows someone else to hold onto and tilt the chair’s back to cause it to climb up or down stairs.

Physicians and other health professionals must undergo special training to prescribe the iBOT. The chair must be calibrated to the patient’s weight, and patients have to be trained in its use and pass physical, cognitive and perception tests to prove they can operate it safely.

FDA approved the wheelchair based on a review of extensive bench testing of the product conducted by the manufacturer, Independence Technology (a Johnson & Johnson company), of Warren, N.J., and on a clinical study of its safety and effectiveness. Approval was also based on the recommendation of the Orthopedic and Rehabilitation Devices Panel of FDA’s Medical Devices Advisory Committee.

The firm performed a wide range of tests on the chair, including mechanical, electrical, performance, environmental and software testing.

In the pivotal clinical study, 18 patients—mostly people with spinal cord injury-- were trained to use the iBOT and test-drove it for two weeks to allow researchers to compare maneuverability, falls and other problems to those encountered with their regular wheelchairs. They also tested it going up hills, over bumpy sidewalks, crossing curbs, reaching shelves and climbing stairs. Twelve patients could climb up and down stairs alone with the iBOT. The other six patients used an assistant. When these same 18 patients used their regular wheelchairs, one patient could "bump" down stairs, but no one could go up even one step.

During the pivotal study, three patients fell out of the iBOT and two fell out of their own wheelchairs. None of the falls occurred on stairs. Two patients experienced bruises while using the iBOT.

As a condition for approval, the manufacturer has agreed to provide periodic reports to the FDA to document the chair’s usage, functioning and any patient injuries.

  • FDA APPROVES LICENSE OF NEW RECOMBINANT ANTI-HEMOPHILIC FACTOR

  • FDA today licensed a new recombinant DNA-derived clotting factor to treat people with hemophilia A. This new antihemophilic human factor VIII product is the first one produced without using additives derived from human or animal blood in the manufacturing process.

    This advancement provides added reassurance against any theoretical infectious risks that may arise from the use of blood-derived additives in the manufacturing of factor VIII.

    The new product, called ADVATE Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method (rAHF-PFM), is approved to prevent and control bleeding episodes or to prepare persons with hemophilia for surgery. It is produced by genetically engineered Chinese hamster ovary cells that have been altered to produce factor VIII.

    A number of human factor VIII products have been approved to treat hemophilia A, an inherited disorder in which the blood clotting protein factor VIII is deficient or abnormal. Affected persons are unable to form blood clots normally and therefore risk serious and life-threatening bleeding episodes. Replacement therapy with any of the factor VIII products, which requires intravenous administration, corrects the defect only temporarily. For this reason, factor VIII products frequently must be given several times a week, or more often, to prevent or treat bleeding episodes.

    Current factor VIII products (both plasma-derived and recombinant) are considered very safe as a result of many technological advances in the last two decades. These include viral inactivation and removal steps in manufacturing that are believed to effectively prevent transmission of hepatitis B, hepatitis C or HIV from plasma-derived products. These same procedures are considered effective to minimize any infectious risks from products made by DNA technology, which uses living cells. None of these products has transmitted HIV, hepatitis B or hepatitis C since 1987.

    The first recombinant antihemophilic factor was approved in 1992. However, up until now, all recombinant factor VIII products still were made with the use of blood-derived additives of human or animal origin, such as albumin. These additives were needed to keep the cells viable so they could make the factor VIII protein. In this new product non-human and non-animal materials replaced these additives.

     

  • HO, HUM. FRAUD, A DAILY THEFT OF THE TRUST OF A NATIONS CONSUMERS.  HO, HUM. HUCKSTERS FLOURISH UNDER SEC:

    ACM Income Inc.'s (ACG) investment manager, Alliance Capital Management underwent unusual trading which took place this month.

    Edmund Bergan, chief counsel at Alliance, advised during a recent conference call "The activity on July 8 did our shareholders a disservice," and Alliance intends to discover what took place, Bergan said.

    Certain trades executed that day at both the Chicago Stock Exchange and NYSE were reported to be well below the stock's prevailing market price at the time of their execution, including two large blocks - made up of dozens of smaller stop-loss orders - totaling more than 1.1 million shares traded at the NYSE (Dow Jones Newswires).

    "Are the little people the only ones concerned about the conduct of those "regulated" (I mean kind of regulated; they don't even know where to begin the investigation under the current system!  When will SEC ask for help and become a "Team Player"?) by SEC?  "Does anybody really know what time it is?  Does anybody really care (Chicago)?-"little guy"-

 

  • FDA APPROVES HUMANTROPE FOR HEIGHT DEFICIENCY

    The Food and Drug Administration (FDA) today approved a new indication for Humatrope (Somatropin, rDNA origin, for injection), a brand of growth hormone, for the long-term treatment of children with idiopathic (of unknown origin) short stature, also called non-growth hormone deficient short stature.

    "Short stature" has been defined by the American Association of Clinical Endocrinologists and the Growth Hormone Research Society as height more than 2 standard deviations (SD) below the mean for age and sex. This corresponds to the shortest 2.3 percent of children. This new indication restricts therapy to children who are even shorter, specifically more than 2.25 SD below the mean for age and sex, or the shortest 1.2% of children. For example, for 10-year old boys and girls, this would correspond to heights of less than 4' 1" inch. This would further correspond to heights of less than 5' 3" and 4' 11" in adult men and women, respectively.

    Today's approval was based on 2 randomized, multicenter trials, conducted in approximately 300 children with idiopathic short stature. The diagnosis of idiopathic short stature was made after excluding other causes of short stature, including growth hormone deficiency.

    The pivotal trial was a randomized, double-blind study in 71 children aged 9-15 years. Patients received injections of either Humatrope or placebo three times weekly until adult height was reached. Thirty-three patients contributed final height measurements after a mean treatment duration of 4.4 years. Mean final height of the Humatrope patients exceeded that of the placebo patients by approximately 1.5 inches.

    In a second study, patients received one of three increasing doses of Humatrope, in divided doses six times weekly. The average duration of treatment to final height was 6.5 years. Final height exceeded that predicted at the time of enrollment in the majority of patients, and by up to nearly four inches in some. In the high-dose group, mean final height exceeded mean height predicted at baseline by nearly three inches.

    The safety profile of Humatrope in children with idiopathic short stature did not differ from that in children with other conditions for which growth hormone is indicated.

    Various growth hormone products are currently indicated in children for short stature associated with growth hormone deficiency, chronic renal insufficiency, Turner syndrome, Prader-Willi syndrome, and in children born small for gestational age.

    Humatrope's new indication for idiopathic short stature is the first indication for growth hormone in children that specifies a height restriction (see above).

    On June 10, 2003, the application for this new indication was presented to FDA's Endocrine and Metabolic Advisory Committee for public discussion and consideration. The advisory committee voted 8-2 in favor of approval.

    The manufacturer has advised FDA that it will not engage in direct-to-consumer advertising of Humatrope and will limit the marketing of this product for this new use to pediatric endocrinologists in order to better ensure the proper use of this product in the indicated pediatric population. In addition, the manufacturer intends to tightly control the distribution of Humatrope.

    Humatrope is manufactured and distributed by Eli Lilly Co. of Indianapolis, Ind.

    Nothing on this Beat the Press was written by this civilian editor and consumer advocate.

  • FDA APPROVES ENBREL TO TREAT ANKYLOSING  SPONDYLITIS

    FDA today approved an application for etanercept (trade-name Enbrel), a genetically engineered protein, for a new indication for treatment of patients with active ankylosing spondylitis (AS), a chronic inflammatory disease affecting primarily the lower back and joints. The product is manufactured by Immunex Corporation, Thousand Oaks, Calif. and marketed by Amgen and Wyeth Pharmaceuticals. Etanercept is also licensed for treatment of patients with rheumatoid arthritis, juvenile rheumatoid arthritis, and psoriatic arthritis.

    Approximately 350,000 patients in the United States have AS. The disease affects men more often than women. Symptoms of the disease may start in adolescence and are usually present by age 30. Patients often have lower back pain and stiffness, chest pain, joint pain and swelling, and tenderness due to the inflammation. In some patients the disease can cause significant pain and disability for many years.

    Currently approved drugs for AS include some non-steroidal anti-inflammatory drugs (NSAIDS) which are approved to treat the symptoms of AS. Disease Modifying Anti-Rheumatic Drugs (DMARDS) that are approved for use in other inflammatory joint diseases are sometimes used when NSAIDS are ineffective, but none is FDA approved for use in the treatment of AS.

    Etanercept binds to tumor necrosis factor (TNF), a naturally occurring protein in the body, and inhibits its action. TNF, which promotes inflammation in the body, is found at elevated levels in the blood and certain tissues of patients with AS. It is believed that interference with TNF plays a role in the beneficial effects of etanercept for AS.

    The major efficacy trial of etanercept for AS was a randomized, double-blind, placebo-controlled study of 277 patients. The study excluded patients with the most severe forms of AS. After six months of twice-weekly treatments, 58% of patients who received etanercept showed significant improvement on a scale that measured pain, function, and inflammation compared to 23% who received a placebo.

    The main side effects of etanercept in the study were similar to those previously seen for this drug for other indications, including injection site reactions and upper respiratory infections. The approved labeling warns physicians about post-marketing reports of serious infections. The labeling says that Enbrel should not be given to patients with any active infection, including chronic or localized infections. It also recommends that patients who develop a new infection while being treated with Enbrel should be monitored closely.

    Amgen will continue to follow patients in the trial to evaluate the long-term safety of etanercept in patients with AS.

     

  • UNITED STATES CLEAR ON  ALBERTA, CANADA MAD COW DISEASE DEBACLE

    The Food and Drug Administration (FDA) has learned from the government of Canada that the brain of an eight-year old cow in a remote area of Alberta has tested positive for bovine spongiform encephalopathy (BSE, also known as “Mad Cow Disease”).

    According to Canadian officials, meat from the cow did not enter the food supply. The animal had been on the farm in Alberta for three years. Although BSE has not been shown to be transmitted among cows in a herd, as a precaution the herd in Alberta is being destroyed.

    FDA is working closely with the U.S. Department of Agriculture, other U.S. agencies, and the appropriate Canadian officials to gather additional information about this case, including previous owners of the cow and its location, as well as records concerning animal feed the cow ate.

    To date, no case of BSE has ever been found in the U.S., despite years of intensive testing for the disease.

    After the original outbreak of BSE in the United Kingdom in 1986, the U.S. government established a comprehensive set of measures designed to protect Americans and U.S. cattle from BSE. These included a list of “BSE countries” from which cattle, meat, beef-derived products, and animal feeds could no longer be exported to the U.S.

    As in the past, when individual European countries and Japan discovered their first cases of BSE, today’s announcement means that Canada will be added to the list of BSE countries. As a result, cattle, beef, beef-based products, and animal feed will no longer be allowed to be exported from Canada to the U.S.

    Possible further actions will depend on the findings from the current investigation of this one confirmed case of BSE in Alberta.

    Since 1997, America has been protected from BSE by the prohibition against using most mammalian protein to manufacture animal feeds given to “ruminant” animals such as cows, sheep, and goats. The BSE epidemic in the U.K. is thought to have spread through the addition of such mammalian protein to the feed consumed by cows. The regulation is designed to prevent the spread of BSE in the U.S. if a case ever occurred here.

    In 2001, the Harvard Center for Risk Analysis concluded that the FDA’s “feed rule” provided the nation’s major defense against BSE.

    BSE is one of several diseases known as transmissible spongiform encephalopathies. These diseases are characterized by a long incubation period, a relatively short clinical course of neurological signs, and 100 percent mortality.

    FDA will provide updates on this case of BSE in Alberta as additional information becomes available.

     

  • FDA APPROVES "GLEEVEC" FOR PEDIATRIC LEUKEMIA

    The Food and Drug Administration (FDA) today announced the approval of Gleevec (imatinib mesylate) tablets for the treatment of pediatric patients with Philadelphia chromosome positive(Ph+)chronic myeloid leukemia (CML) in chronic phase — a rare, life-threatening form of cancer that accounts for approximately two percent of all leukemias in children.

    Gleevec is indicated for children whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy.

    This drug was approved under the accelerated approval program. The program helps make products for serious or life-threatening diseases available earlier in the development process by allowing approval to be based on a promising effect of the drug, such as tumor shrinkage. As of yet, there are no controlled trials demonstrating
    clinical benefit, such as improvement in disease-related symptoms or increased survival. Subsequent studies after approval will be conducted to confirm that the drug has improved survival or other clinical benefits in pediatric patients.

    “Gleevec was originally granted accelerated approval two years ago for certain kinds of leukemia in adults, and now has been shown to be a valuable treatment for certain leukemias in children that do not respond to other treatments,” said FDA Commissioner Mark B. McClellan, M.D., Ph.D. “ With follow up studies to confirm its benefits, Gleevec illustrates the type of significant medical advance for children that can be achieved quickly under FDA’s accelerated approval program.”

    “Today’s approval is the first approval of a new pediatric cancer drug treatment in over a decade,” added Dr. McClellan. “We hope to see more products developed that improve pediatric cancer care, and we are working to facilitate their development and timely approval.”

    In addition to its original approved indication for CML refractory to other treatments in adults, and expansion
    to use as a first line treatment for CML, Gleevec was also previously granted accelerated approval for the treatment of gastrointestinal stromal cancer in February, 2002.

    Today’s accelerated approval of Gleevec for pediatric use is based on extrapolation of results from Gleevec treated adults with CML together with good responses in a small number of children.

    As a condition of approval Novartis has agreed to conduct pediatric studies after approval to gain greater insight into the drug’s use in children.

    The most frequently reported adverse events reported with the use of Gleevec are nausea, vomiting, diarrhea, edema(sometimes severe), and muscle cramps. A considerable reduction in white blood cells and platelets was also reported with Gleevec treatment.

    The recommended dosage for pediatric populations is 260mg/m2/day. In children, Gleevec treatment can be given as a once daily dose or, alternatively, the daily dose may be split in two-once in the morning and once in the evening.

    Gleevec is manufactured by Novartis Pharma AG for Novartis Pharmaceuticals Corporation located in East Hanover, N.J

     

  • FDA Announces Smallpox Vaccine Guidance for Blood Industry

FDA has issued guidance for the blood industry regarding procedures for properly qualifying potential blood donors who have recently been inoculated with the smallpox vaccine (vaccinia virus) or those who may have had other direct exposure to smallpox vaccines.

These recommendations were developed in consultation with experts on the vaccine virus (smallpox vaccine) at the U.S. Centers for Disease Control and Prevention and the Department of Defense. They are preventive measures pertaining to non-emergency smallpox vaccination. In the event of widespread emergency vaccination due to an actual or impending smallpox outbreak, the procedures outlined in the guidance could be modified to adapt to changing risk/benefit assessments and other public health considerations.

The vaccine virus is closely related to smallpox (variola virus) and induces an immune response that is protective against smallpox. The vaccine virus has been used with great success for over 100 years to protect against smallpox.

FDA is issuing this guidance as a precautionary measure to reduce the very slight risk of blood borne exposure to the smallpox vaccine among certain small patient populations that may develop adverse reactions to the vaccine.

  • URGENT ACTION ALERT

   Call on your Senators and Representatives to Stop More Medicare        Payments Cuts...

Congress recessed in late October without taking final action on pending AMA and APA supported legislation to stop further reductions in Medicare payments to physicians.  The Medicare "update" was cut by 5.4 percent in 2002, and absent action by Congress, an additional cut of roughly 4.4 percent is expected in 2003, with still more payment update cuts in US civilian neccessary qualifed care.   The cuts are hurting present and future Medicare patients. Why? Because these cuts are and will continue to drive some doctors out of the business of treating Medicare patients.

Please add your personal voice to the chorus of people advising Congress to fix the problem and stop Medicare failure.  Call Toll Free 1-866-727-4894 to be connected to the Capitol Hill Switchboard.  When you reach the Capitol Operator, California residents ask for your Senators by name: Barbara Boxer and Dianne Feistein (out of state citizen mention your all important Senators' name).   When you are connected to their offices, leave the following brief message "in your own words of course":

"As a constituent, I urge you to pass legislation now, to stop additional cuts in Medicare payments to physicians.  These are real cuts that are hurting my doctors and Medicare patients, like me, who depend on them.   Please stop playing politics with Medicare payments and pass a payment update "fix" for all of Uncle Sams' neices and nephews now!  This action alone will prove to the world, that Americans care about Americans, and we are still "God's Country" for the defense of freedom, the health to experience it, and contribute to the continual improving progress in all areas of human life on "God's Green Earth". InfoJustice

·        FDA GRANTS CITIZEN'S PETITION SEEKING UNAPPROVED DRUG CLASSIFICATION FOR "NICOTINE WATER"

Today the Food and Drug Administration (FDA) issued a response to a Citizen's Petition submitted to the agency regarding the regulation of a product called "Nicotine Water." Based on several factors, including statements contained in the labeling of the product, and other evidence of intended use, FDA has determined that this product should be regarded as an unapproved new drug and cannot be legally marketed as a dietary supplement.

"FDA's decision underscores our commitment that consumers be protected from drug products that have not undergone our rigorous review process," said Dr. Lester M. Crawford, FDA Deputy Commissioner.

The petition was submitted in December of 2001, on behalf of several groups including the National Center for Tobacco-Free Kids, the American Medical Association, and the American Lung Association. The petitioners specifically requested that the FDA classify and regulate "Nicotine Water" as a drug under the Federal Food, Drug, and Cosmetic Act (the Act), or classify and regulate this product as a food containing an unapproved food additive under the Act.

FDA has concluded that "Nicotine Water" is an unapproved drug under the Act because it is intended to treat or mitigate nicotine addiction as a smoking cessation product. Because nicotine addiction is considered a disease, FDA requires safety and efficacy data to support any claims intended to treat this disease. After reviewing the claims on the manufacturer's Internet site, which were submitted with the Citizen's Petition, FDA concluded "Nicotine Water" is an unapproved drug and may not be legally sold in the United States until the manufacturer submits a new drug application to the agency and the agency approves the application.

FDA has also determined "Nicotine Water" which contains as an active ingredient nicotine or nicotine polacrilex, cannot be legally marketed as a dietary supplement. Although "Nicotine Water" is promoted by the manufacturer as a dietary supplement, this product does not meet the statutory definition of a dietary supplement. Under the Act, a "dietary supplement" does not include a product that contains an active ingredient that FDA has already approved for use in a drug. Because the nicotine and nicotine polacrilex in "Nicotine Water" are both active ingredients in FDA-approved drugs (such as Nicoderm CQ, Prostep, Habitrol, and Nicorette) "Nicotine Water" cannot be marketed as a dietary supplement.

In light of these determinations, FDA will notify manufacturers of "Nicotine Water" that this product cannot be marketed without new drug approval by the agency. FDA will continue to monitor the marketplace to ensure that consumers are protected from unapproved drug products.

  • FTC Charges Three Top-selling Electronic Abdominal Exercise Belts with Making False Claims

    Alleges Electronic Abdominal Gadgets Won't Provide Six-Pack Abs

    "Now you can get rock hard abs with no sweat"
    "Lose 4 Inches in 30 Days Guaranteed"
    "30% More Effective Than Normal Exercise"
    "10 Minutes = 600 Sit-Ups"

    These are the types of claims the Federal Trade Commission has challenged in complaints filed in federal district courts against three widely advertised electronic abdominal exercise belts - AB Energizer, AbTronic, and Fast Abs. The FTC alleges that the marketers of the devices, which use electronic muscle stimulation (EMS), have falsely advertised that users will get "six pack" or "washboard" abs without exercise.

    "For years, marketers of diet and exercise products have been preying on overweight, out-of-shape consumers by hawking false hope in a pill, false hope in a bottle, and, now, in a belt," said FTC Chairman Timothy J. Muris. "Unfortunately, there are no magic pills, potions, or pulsators for losing weight and getting into shape. The only winning combination is changing your diet and exercise."

    The FTC filed three separate complaints against the following defendants:

    • AB Energizer marketers: Electronic Products Distribution, L.L.C., based in San Diego, California, and its general partners, Thomas Nelson and Holly Hernandez, also known as Holly Bryan; Energizer Products, Inc., based in Tarzana, California; Ab Energizer, L.L.C., based in San Diego, California; and AbFlex USA, Inc., also located in San Diego, and its president, Martin Van Der Hoeven;
    • AbTronic marketers: Hudson Berkley Corporation, based in Las Vegas, Nevada, and also doing business as Hudson Berkeley, Inc., and its officer and director, Matthias Granic; Bismarck Labs Corporation, based in Palm Springs, California and also doing business as BLC Bismarck Labs Corporation; TMI Tricom Marketing, Inc., a Delaware corporation; CCI CAD CAM Industries Ltd., Inc., located in Hong Kong; and Bernd Ebert, a director and officer of BLC, managing director of TMI, and president of CCI; and
    • Fast Abs marketers: United Fitness of America, L.L.C., based in Ventura, California, and its sole manager, George Sylva; and Tristar Products, Inc., based in Parsippany, New Jersey, and its president, Kishore Mirchandani, also known as Keith Mirchandani.

    According to the FTC, the defendants sold their devices through heavily aired, 30-minute infomercials on national cable television stations such as USA, TNN, Lifetime, E!, FX, and Comedy Central. Each of the infomercials has been among the ten most frequently aired infomercials in weekly U.S. rankings and has aired well over a thousand times. The infomercials feature fitness professionals who tout the products' efficacy, user testimonials, photos of models sporting trim, sculpted midsections, and purported expert opinions from health care professionals. The AB Energizer and AbTronic marketers also aired shorter television commercials. In addition, Fast Abs has been advertised in national newspaper magazines such as Parade, and mailed circulars such as Clipper Magazine.

    The defendants advertised the three devices through Internet Web sites and at national retail outlets. In addition, the defendants made claims on the packaging for the three products, which the FTC also allege were false and deceptive. The products sell for about $40-$120.

    The FTC's complaints allege that the advertisements for the three ab devices falsely represent that:

    • the ab devices cause fat loss and inch loss;
    • the ab devices will give users well-defined abdominal muscles (e.g., "rock hard," "six pack" or "washboard" abs); and
    • use of the ab devices is equivalent to (and, for AbTronic and Fast Abs, superior to) conventional abdominal exercises, such as sit-ups or crunches.

    The complaint against the AB Energizer defendants also alleges that they falsely represented that the device will cause weight loss. The AbTronic complaint alleges that the defendants falsely represented that the device eliminates cellulite, and that a scientific study proves that use of the AbTronic improves abdominal strength better than exercise alone.

    The FTC complaints further allege that the advertising for all three devices falsely claimed that the devices are safe for all users and failed to disclose, or failed to disclose adequately, warnings about health hazards for some people. According to the FDA and leading texts on EMS therapy, EMS devices should not be used by persons with certain conditions, including implanted pacemakers or other implanted metallic or electronic devices, swollen or inflamed areas (such as phlebitis), or cancerous lesions. Additionally, safety of EMS during pregnancy has not been established. The AbTronic and Fast Abs complaints also allege that the marketers falsely advertised that the products are safe for use over the chest area.

    In addition to the false advertising allegations, the FTC complaints challenge refund, shipping, and warranty practices. The FTC alleges that all of the defendants misrepresented their "money-back guarantees" and, in many cases, failed to provide timely refunds. The FTC also alleges that marketers for all three devices violated the FTC's Mail or Telephone Order Merchandise Rule by failing to ship their direct-order products within the promised shipment time (and in some cases, failing to ship the products at all), and failing either to notify consumers of the delay or cancel the order and make a prompt and full refund. Further, the FTC alleges that the Fast Abs infomercial represented that the product comes with a one-year limited warranty, when in fact, some consumers received only a 30-day limited warranty with the product.

    The FTC is seeking permanent injunctions in each of these cases to prohibit the defendants from making false or deceptive advertising claims, stop them from engaging in other deceptive marketing practices, and require them to pay redress to consumers.

    The U.S. Food and Drug Administration and the Napa County, California District Attorney's Office provided assistance on these cases.

    The Commission vote to authorize staff to file the three complaints in the appropriate federal district courts was 5-0. The Ab Energizer matter was filed in the U.S. District Court for the Southern District of California, in San Diego, on May 7, 2002. The Fast Abs and AbTronics matters were filed in the U.S. District Court, District of Nevada, in Las Vegas, on May 7, 2002.

    Consumer Tips

    The FTC has updated two consumer publications about exercise equipment: "Avoiding the Muscle Hustle" www.ftc.gov/bcp/conline/pubs/alerts/musclealrt.htm and "Pump Fiction: When Marketers Overextend Their Fitness Claims." www.ftc.gov/bcp/conline/pubs/products/pumpfict.htm

    These materials offer tips to consider and questions to ask before buying exercise equipment, including:

    • Ignore claims that an exercise machine or device can provide long-lasting, easy, "no-sweat" results in a short time. These claims are false: You can't get the benefits of exercise unless you exercise.
    • Don't fall for claims that a product can burn fat off a particular part of the body - for example, the stomach, hips or buttocks. Achieving a major change in your appearance requires sensible eating and regular exercise that works the whole body.
    • Read the ad's fine print. The advertised results may be based on more than just using a machine; it also may be based on restricting calories.
    • Be skeptical of testimonials and before-and-after pictures from "satisfied" customers. Their experiences may not be typical. Just because one person had success with the equipment doesn't mean you will, too.
    • Get details on warranties, guarantees and return policies. A "30-day money-back guarantee" may not sound as good if you have to pay shipping on the equipment you want to "return to sender."
    • Check out the company's customer and support services. Call the advertised toll-free numbers to get an idea of how easy it is to reach a company representative and how helpful he or she is.
  • FDA-FCC Cellular Phone and Radio Frequency Energy Website Posted for Public Use and Comment

    The Food and Drug Administration (FDA) and the Federal Communications Commission (FCC) have established a joint web site, Cell Phone Facts, to provide consumer information regarding cellular phones and radiofrequency (RF) energy. This web site provides the public with information from both government agencies involved in the regulation of cell phones (also known as wireless, mobile, or PCS phones) and their base stations. It provides a review of how cell phones work and answers questions raised about their safety. It also includes a link to the FCC's web site that contains additional information about radiofrequency safety as it relates to other sources of RF energy.

    Most of the concerns about cell phone safety involve the phone's production of RF energy from a source close to the head or body of the user. The web site explains that although cell phones use RF to transmit calls, the FCC limits the amount of RF energy that may be produced by a cell phone to safe levels and the levels permitted are far below the levels determined by scientific experts to have the potential for an adverse effect on humans. It also observes that while no scientific evidence has been published demonstrating harm from short- term exposures to low levels of RF energy, studies are now underway to look at the possible risks of long-term exposures. The results of any such studies will also be posted on the web site and both agencies will take follow-up action as appropriate.

    The new web site summarizes the government's safety standards for cell phones and describes the role of each agency in RF safety regulation. It also explains what RF energy is, how it is used, and how it is measured; how the current safety standards were established; the role of local and state governments; and where to obtain additional information on related topics from other sources. The FDA and the FCC will periodically update the website in response to queries and comments received from the public and as new information becomes available.

    The FDA-FCC RF safety web site is available for public use and comment at www.fda.gov/cellphones and www.fcc.gov/cellphones

     

  • FDA CLEARS NEW RADIATION DEVICE TREATMENT FOR BREAST CANCER

    FDA today cleared a new medical device that provides another option for radiation treatment for women who have had a cancerous lump removed from their breast (lumpectomy).

    The device, a brachytherapy applicator, is designed to irradiate the surgical site from which the lump has been removed, with minimal irradiation of the surrounding tissue. (Brachytherapy is radiation treatment in which the source of radiation is close to the area being treated.)

    The new device is the MammoSite Radiation Therapy System, made by Proxima Therapeutics, Inc., of Alpharetta, Ga. It consists of a hollow catheter to which an inflatable balloon it attached.

    The device is implanted into the breast at the site of the lumpectomy, and the balloon is inflated. A radioactive source is then placed into the catheter. The balloon acts to center the radiation source within the wound. After a series of treatments are completed--typically over several days--the catheter is removed.

    The device is intended to be used primarily to treat breast cancer in its early stages when there is no need to remove the whole breast. It does not replace whole breast irradiation in women who need that treatment.

    FDA cleared the device based on information that showed it was comparable in safety and effectiveness to other devices used to deliver brachytherapy to the breast and other body parts. Such information included clinical data from 25 women at eight medical centers who had the device implanted after lumpectomy. The study showed that this new method of delivering brachytherapy was relatively simple and did not create increased risk to the patient.

    As a condition for clearance, FDA is requiring Proxima Therapeutics to include a warning in the product labeling that the safety and effectiveness of MammoSite as a replacement for whole breast irradiation to treat breast cancer has not been established.


  • Dietary Supplement Firm Signs Consent Decree with FDA to Stop Selling Product Containing Ephedrine Hydrochloride

    The Food and Drug Administration today announced that Biogenics Inc., of St. George, Utah, doing business as E'OLA International, has signed a consent decree that prohibits the firm from manufacturing and distributing violative products. These include AMP II Pro Drops, any product containing ephedrine hydrochloride, or any synthetic ephedrine alkaloid, or any drug product that is a new drug not approved by FDA.

    "This action is yet another example of FDA's strong commitment to protecting the public from the dangers of unlawfully marketed drug products," said Lester M. Crawford, D.V.M., Ph.D., Deputy Commissioner of The Food and Drug Administration.

    The decree also gives FDA the authority to order the firm to discontinue the marketing of and recall any
    products that violate the law in the future. The decree was signed Friday, April 12, 2002, by United States District Court Judge Tena Campbell in Salt Lake City, Utah.

    On October 30, 2001, at the request of the FDA, US Marshals seized $2.8 million worth of E'OLA's product, known as AMP II Pro Drops. Previous FDA inspections found that the products contain a drug, ephedrine hydrochloride, but are labeled as a dietary supplement for use in weight loss. These E'OLA products violate the law because drug ingredients are prohibited for use in dietary supplements.

    Ephedrine hydrochloride has been approved as a drug by FDA since 1948, and therefore cannot be legally marketed as a dietary supplement. E'OLA also marketed its product as a treatment for obesity. Products marketed to treat diseases are drugs.

    The product is also misbranded because its labeling fails to bear adequate directions for its intended use.
    As a result of this consent decree, E'OLA International will destroy the seized articles at its own expense under the supervision of a Department of Health and Human Services representative within 25 days

     

  • CALIFORNIA SENATOR WARNS THAT COMPANIES  MANIPULATED THE ENERGY CRISIS

    A California state lawmaker investigating the state's recent energy woes joined an industry coalition Wednesday to warn of broad U.S. vulnerability to energy-market manipulation.

    At a press briefing, California State Senator Joseph Dunn, R-Garden Grove, said he has new evidence Enron Corp. (ENRNQ) and other energy suppliers fixed prices during the state's 2000-2001 energy crisis.

    "Enron and its clones promised greater efficiency and cheaper energy prices, but have delivered just the opposite," Dunn said, citing an estimated $9 billion in costs to the state from the crisis.

    Dunn has been leading a 14-month study of the crisis, subpoenaing millions of documents from market participants and financial institutions. He says the evidence shows that unregulated marketing companies with control of 64% of interstate gas pipeline capacity into California used their power to drive the state's natural gas prices to unprecedented peaks in December 2000.

    Unregulated companies also controlled 74% of California's gas-fired electricity generation during the 2000-2001 winter, he said. Since companies controlled both natural gas and power generation, they were able to bypass emergency wholesale power price caps imposed by the federal government, he said.

    Dunn said the increasing use of gas-fired power generation makes other parts of the country similarly vulnerable. "This is not a California problem. It surfaced here first, but stay tuned," he said.

    The state senator was speaking in a teleconference with representatives of a group of gas producers and energy utilities calling itself the Coalition for Energy Market Integrity and Transparency.

    Apache Corp. (APA) Chief Executive Raymond Plank, a member of the coalition, said the California and Enron debacles demonstrate the conflicts of interest that "middle men" have under current U.S. energy regulations. "Don't think that there's only one company (like Enron)," Plank said. Apache is a Houston-based natural gas and oil producer.

    "The marketer-speculators are destroying North America's natural gas business by promoting unwarranted price volatility," Plank said. "Producers have no idea where the price of gas is going to be tomorrow, much less a year or two from now...so we drill fewer and fewer wells."

    Plank blamed energy marketers like Dynegy Inc. (DYN), El Paso Corp. (EP) and Williams Cos. (WMB) for killing a legislative proposal before the Senate that would have allowed federal oversight of over-the-counter energy markets, including online systems. "The last thing they want is the bright light of day shining on their operations," he said.

    Other members of the coalition include the American Public Gas Association, the American Public Power Association, the Texas Independent Producers and Royalty Owners Association, and numerous local utility companies.

  • TRAUMATIC BRAIN INJURY- PRECIOUS CUTTING EDGE INFODATA FROM CDC

Although injuries are the second leading cause of death among American Indians and Alaska Natives (AI/ANs), little is known about non-fatal injuries in this population. This study describes the causes and impact of one type of injury— traumatic brain injury (TBI) on AI/ANs using Indian Health Service (IHS), tribal or contract hospital discharge data.

Between 1992-1996, IHS, tribal, or contract care hospitals recorded 4,491 TBI-related hospitalizations among AI/ANs with an average length of stay of 4.7 days. Males had almost three times as many TBIs as females.

The major causes of hospitalizations for TBI were motor vehicle collisions (24%), assaults (17%), and falls (16%). These findings indicate that falls contribute to TBI among AI/AN almost as much as assaults.

Among AI/ANs age 15-24, motor vehicle collisions were the most common cause of TBI. For young adults 25-34 years and 35-44 years, assaults were the most likely cause of TBI, although only 5% of cases involved firearms. For youth 0-14 years and adults 45 years and older, falls were the leading cause of injury.

The highest number of hospitalized TBIs among AI/ANs were found in the Northern Plain states and Alaska.

In a previous CDC study, the Navajo Nation has shown that enactment and enforcement of a mandatory seat belt law led to increases in seat belt use and a 29% reduction in motor-vehicle-related injuries among Navajo Nation residents.

  • FDA WARNS ABOUT POSSIBLE ENTEROBACTER SAKAZAKII INFECTIONS IN HOSPITALIZED NEWBORNS FED POWDERED INFANT FORMULAS

    Warning Does Not Apply to Liquid Forms of Infant Formula

    FDA today alerted health care professionals about the risk of Enterobacter sakazakii (E.sakazakii) infections in hospitalized newborn infants, particularly premature infants or other immuno-compromised infants fed powdered infant formulas. This alert issued by FDA is targeted to concerns for immuno-compromised infants in hospital settings. The FDA is not aware of E. sakazakii infections among healthy full term infants in home settings. In addition, this alert does not involve the use of liquid infant formulas.

    E. sakazakii is an emerging foodborne pathogen that can cause sepsis, meningitis, or necrotizing enterocolitis in newborn infants, particularly premature infants or other infants with weakened immune systems. Over the last several years, investigations of several outbreaks of E. sakazakii infection occurring in neonatal intensive care units worldwide have shown the outbreak to be associated with milk-based powdered infant formulas.

    Recently, the U. S. Centers for Disease Control and Prevention (CDC) investigated a fatal E. sakazakii meningitis case in a neonatal intensive care unit in the United States. According to the CDC, the use of milk-based powdered formula was a likely factor in the infection of this child. The details of CDC's investigation will be outlined in an upcoming edition of the Morbidity and Mortality Weekly Report (MMWR).

    The FDA letter to health professionals, which is available at http://www.cfsan.fda.gov/~dms/inf-ltr3.html, provides recommendations for minimizing the risk in those circumstances when a powdered formula must be used for premature or immuno-compromised infants.

    FDA urges health care providers to report adverse events associated with the use of infant formulas as soon as possible to FDA's MedWatch program by calling their toll-free number (1-800-332-1088) or through the Internet (http://www.fda.gov/medwatch). Healthcare providers should report invasive disease in infants due to
    E. sakazakii, particularly bloodstream infection or meningitis with onset in the healthcare setting, to CDC's Division of Healthcare Quality Promotion (1-800-893-0485).

     

  • SMOKING COSTS NATION $159 BILLION EACH YEAR IN HEALTH COSTS AND LOST PRODUCTIVITY.

    Each pack of cigarettes sold in the United States costs the nation an estimated $7.18 in medical care costs and lost productivity, the Centers for Disease Control and Prevention (CDC) reported today.

    In a study of deaths related to smoking, years of life lost, and economic costs, CDC found that smoking continues to be the leading cause of preventable death in the United States, resulting in an estimated 440,000 premature deaths annually from 1995 through 1999. On average, adult men and women smokers lost 13.2 and 14.5 years of life, respectively, because they smoked.

    Economic costs during the same period were $81.9 billion in productivity losses from deaths (average for 1995-1999) and $75.5 billion in excess medical expenditures in 1998, for a total of more than $150 billion, according to the report. The reported medical and productivity losses were larger than previous estimates of $53 billion and $43 billion, respectively.

    "The fact that nearly half a million Americans lose their lives each year because of smoking-related illnesses is a significant public health tragedy," said Dr. David Fleming, acting director, CDC. "It's important now more than ever that states and local communities put in place comprehensive tobacco control programs to stem this tidal wave of preventable deaths."

    According to the analysis, for each of the 22 billion packs of cigarettes sold in the United States in 1999, $3.45 was spent on medical care related to smoking, compared with the previous 1993 estimate of $2.06 per pack. Another $3.73 per pack was spent on productivity losses from smoking. Overall, the economic cost of smoking equaled about $3,391 per smoker per year.

    "The stunning toll that smoking takes on life is unacceptable," said Rosemarie Henson, director of CDC's Office on Smoking and Health. "States and communities can and should do more to reduce the impact of smoking on the physical and financial health of their communities."

    Despite recent declines, young people in the United States are still using tobacco at a high rate: 34.5 percent of high school students and 15.1 percent of middle school students currently use some form of tobacco (cigarettes, smokeless, cigars, pipes, bidis, or kreteks). Every day, more than 2,200 young people under the age of 18 become daily smokers.

    Other findings from the new study include these:

    • Each year from 1995 through 1999, smoking caused more than 264,000 deaths in men and more than 178,000 deaths in women.
    • Among adults, most deaths were from lung cancer (124,813), heart disease (81,976) and lung disease (64,735).
    • Smoking-related cancer and lung disease deaths in women increased from 1995 to 1999.
    • Smoking during pregnancy resulted in more than 1,000 infant deaths annually.
    • Neonatal costs were $366 million--$704 per pregnant smoker—in 1996.

    The CDC is also releasing Tobacco Control State Highlights 2002: The Impact and Opportunity. This report, which provides current data on tobacco funding for states and the District of Columbia, can be viewed or downloaded today at http://www.cdc.gov/tobacco/. More information on CDC's tobacco control activities can be found at CDC's Tobacco Information and Prevention Source (TIPS) Web site at http://www.cdc.gov/tobacco/.

    In addition to these reports, the CDC is unveiling the Internet-based Smoking Attributable Mortality, Morbidity, and Economic Costs (SAMMEC) software. SAMMEC is a first of its kind online application that allows users to estimated the health and health-related economic consequences of smoking to adults and infants. Users can register for and use the software at http://www.cdc.gov/tobacco/sammec.htm.

     

  • FDA WARNS SELLERS OF NICOTINE LOLLIPOPS & LIP BALM THAT THEIR PRODUCTS ARE ILLEGAL

    Today FDA issued warning letters to three pharmacies that are selling "nicotine lollipops" and/or nicotine "lip balm" over the Internet. The letters inform the pharmacies that FDA has found their nicotine lollipops and lip balm to be illegal. Based on statements from the pharmacies' Internet sites, the products are promoted as aids for smoking cessation or to treat nicotine addiction.

    FDA is concerned about the health risk of these products because the appear to be compounded and dispensed without a doctor's prescription, contain a form of nicotine that is not used in FDA-approved smoking cessation products, and because these candy-like products present a risk of accidental use by children.

    The products cited in the letters include compounds incorporating nicotine salicylate, natural sweeteners, and flavorings in a sugar-free base and are available in ½ mg., 1 mg., 2 mg., and 4 mg. dosages. The claims on the websites include that the products help alleviate the "hand to mouth fixation" associated with smoking and are a "convenient, tasty way" to replace the cigarette habit. After investigating and carefully assessing these websites, FDA has determined that the pharmacies' nicotine lollipops and nicotine lip balm are intended for use as "drugs" and appear to be illegal for the following reasons:

    • They are compounded and dispensed without a doctor's prescription.
    • They are unapproved new drugs which need, but do not have, FDA approval.
    • They are made from a drug substance, nicotine salicylate, which is not permitted for use by pharmacists in compounding drugs. The FDA-approved smoking cessation products are made from different forms of nicotine.
    • They are misbranded because their labeling does not have adequate directions for the uses for which they are being offered and does not have adequate warnings against use by children.

    FDA is requesting a response from the pharmacies in writing within 15 days of receipt of the warning letters stating the action the firms will take to discontinue marketing of these drug products. Failure to do so may result in further regulatory action, potentially including a seizure or injunction action. FDA will take appropriate action to protect the public health.

     

  • Dell Computer should be Del (delete) in purchasing books.

As most of you know, for one year now, this examiner, has been morally dedicated to fulfill this presidents national agenda; (2002 FDA SCIENCE FORUM: BUILDING A MULTIDISCIPLINARY FOUNDATION) of bringing multidisciplinary care to our neighborhoods, in the effort of fulfilling America's health care destiny.  Thus I have had to reduce my consumer protection writings until someone in the Acadmy steps forward or I have additional "time".

AGAIN, after viewing a Dell Computer Add for a Pentium IV 1.8 with a 17" monitor for thirteen hundred and change I investigated the necessity of purchasing new computers for the corporation either as an upgrade or addition.  I still have the magazine albeit still current issue, which clearly depicts a lovely large 17" viewable monitor.  I found that with Compaq for just a little more money, I could essentially get the same computer with far greater innovation.  One of the innovations I liked was that you could impute analog or digital signals directly into the computer, and use its soft wear to make my own CD's.   For example, I could plug directly into my computer from my TV, VCR, CAMC, etc. absent the need for any external devices.  I called Dell to inquire the cost of the Dell System above with special card inside.  Of course they claimed that's why they are the best company taking everyone's business and on and on!  I went over all details, and they were paid up front Two thousand three hundred eighty eighty dollars and change.  Far more that the original thirteen hundred system they still advertise.   Of course to make the board I wanted work correctly I would need double the ram and double the hard drive size.  I believed them. 

About twelve days later my nightnear arrived at my main office of three.  In fact they knew if the system worked out well for this office, I was to purchase another within a few weeks.  Well, I opened the new third office yesterday!

In any event right off the bat I knew something was wrong because there were four boxes and there should only have been three.  I made the joke, "Gee, I hope they didn't forget to put my board in"!  Since Dell alleges they built this just for me and it went through extensive testing as all dell computers do.  Ha Ha.  Everything should have gone normally!  Stay tuned for this one takes the Poor Service, Poor Construction, Poor Consumer Business Award. InfoJustice

  • Tips for the Savvy Supplement User: Making Informed Decisions

    The choice to use a dietary supplement can be a wise decision that provides health benefits. However, under certain circumstances, these products may be unnecessary for good health or they may even create unexpected risks. The Food and Drug Administration, health professionals, and other health-related organizations receive many inquiries each year from consumers seeking health-related information, especially about dietary supplements. Clearly, people choosing to supplement their diets with herbals, vitamins, minerals, or other substances want to know more about the products they choose so that they can make informed decisions about them.

    Given the abundance and conflicting nature of information now available about dietary supplements, you may need help to sort the reliable information from the questionable. The FDA's Center for Food Safety and Applied Nutrition has prepared these tips and resources to help you become a savvy dietary supplement user. The principles underlying these tips are similar to those principles a savvy consumer would use for any product.

    Basic Points to Consider

    • Do I need to think about my total diet?
      Yes. Dietary supplements are intended to supplement the diets of some people, but not to replace the balance of the variety of foods important to a healthy diet. While you need enough nutrients, too much of some nutrients can cause problems. You can find information on the functions and potential benefits of vitamins and minerals, as well as upper safe limits for nutrients, on the National Academy of Sciences Web site at ww.iom.edu/iom/iomhome.nsf/Pages/FNB+Reports.
    • Should I check with my doctor or health-care provider before using a supplement?
      This is a good idea, especially for certain population groups. Dietary supplements may not be risk-free under certain circumstances. If you are pregnant, nursing a baby, or have a chronic medical condition, such as diabetes, hypertension or heart disease, be sure to consult your doctor or pharmacist before purchasing or taking any supplement. While vitamin and mineral supplements are widely used and generally considered safe for children, you may wish to check with your doctor or pharmacist before giving these or any other dietary supplements to your child. If you plan to use a dietary supplement in place of drugs or in combination with any drug, tell your health-care provider first. Many supplements contain active ingredients that have strong biological effects and their safety is not always assured in all users. If you have certain health conditions and take these products, you may be placing yourself at risk.
    • Some supplements may interact with prescription and over-the-counter (OTC) medicines.
      Taking a combination of supplements or using these products together with medications (whether prescription or OTC drugs) could, under certain circumstances, produce adverse effects, some of which could be life-threatening. Be alert to advisories about these products, whether taken alone or in combination. For example: Coumadin (a prescription medicine), ginkgo biloba (an herbal supplement), aspirin (an OTC drug) and vitamin E (a vitamin supplement) can each thin the blood, and taking any of these products together can increase the potential for internal bleeding. Combining St. John's wort with certain HIV drugs significantly reduces their effectiveness. St. John's wort may also reduce the effectiveness of prescription drugs for heart disease, depression, seizures, certain cancers, or oral contraceptives.
    • Some supplements can have unwanted effects during surgery.
      It is important to fully inform your doctor about the vitamins, minerals, herbals or any other supplements you are taking, especially before elective surgery. You may be asked to stop taking these products at least two to three weeks ahead of the procedure to avoid potentially dangerous supplement/drug interactions--such as changes in heart rate, blood pressure and increased bleeding--that could adversely affect the outcome of your surgery.
    • Adverse effects from the use of dietary supplements should be reported to the FDA.
      You, your health-care provider, or anyone may report a serious adverse event or illness directly to the FDA if you believe it is related to the use of any dietary supplement product. Report these concerns to MedWatch, the FDA's safety information and adverse event reporting system, by calling 1-800-FDA-1088, by fax at 1-800-FDA-0178 or online at www.fda.gov/medwatch/how.htm. The FDA would like to know whenever you think a product caused you a serious problem, even if you are not sure that the product was the cause, and even if you do not visit a doctor or clinic. In addition to communicating with the FDA online or by phone, you may use the MedWatch form available from the FDA Web site.
    • Who is responsible for ensuring the safety and efficacy of dietary supplements?
      Under the law, manufacturers of dietary supplements are responsible for making sure their products are safe before they go to market. They are also responsible for determining that the claims on their labels are accurate and truthful. Dietary supplement products are not reviewed by the government before they are marketed, but the FDA has the responsibility to take action against any unsafe dietary supplement product that reaches the market. If the FDA can prove that claims on marketed dietary supplement products are false and misleading, the agency may take action against products with such claims.

    Tips on Searching the Web

    When searching on the Web, try using directory sites of respected organizations, rather than doing blind searches with a search engine. Ask yourself the following questions:

    • Who operates the site?
      Is the site run by the government, a university, or a reputable medical or health-related association (such as the American Medical Association, American Diabetes Association, American Heart Association, National Institutes of Health, National Academy of Sciences, or the FDA)? Is the information written or reviewed by qualified health professionals, experts in the field, academia, government or the medical community?
    • What is the purpose of the site?
      Is the purpose of the site to objectively educate the public or just to sell a product? Be aware of practitioners or organizations whose main interest is in marketing products, either directly or through sites with which they are linked. Commercial sites should clearly distinguish scientific information from advertisements. Most nonprofit and government sites contain no advertising, and access to the site and materials offered are usually free.
    • What is the source of the information and does it have any references?
      Has the study been reviewed by recognized scientific experts and published in reputable peer-reviewed scientific journals, such as The New England Journal of Medicine? Does the information say "some studies show…" or does it state where the study is listed so that you can check the authenticity of the references? For example, can the study be found in the National Library of Medicine's database of literature citations (www.ncbi.nlm.nih.gov/PubMed/)?
    • Is the information current?
      Check the date when the material was posted or updated. Often new research or other findings are not reflected in old material; for example, side effects or interactions with other products or new evidence that might have changed earlier thinking. Ideally, health and medical sites should be updated frequently.
    • How reliable are the Internet and e-mail solicitations? While the Internet is a rich source of health information, it is also an easy vehicle for spreading myths, hoaxes and rumors about alleged news, studies, products or findings. To avoid falling prey to such hoaxes, be skeptical and watch out for overly emphatic language with UPPERCASE LETTERS and lots of exclamation points!!!! Beware of such phrases such as: "This is not a hoax" or "Send this to everyone you know."

    More Tips and To-Do's

    • Ask yourself: Does it sound too good to be true?
      Do the claims for the product seem exaggerated or unrealistic? Are there simplistic conclusions being drawn from a complex study to sell a product? While the Web can be a valuable source of accurate, reliable information, it also has a wealth of misinformation that may not be obvious. Learn to distinguish hype from evidence-based science. Nonsensical lingo can sound very convincing. Also, be skeptical about anecdotal information from persons who have no formal training in nutrition or botanicals, or personal testimonials (from store employees, friends, or online chat rooms and message boards) about incredible benefits or results obtained from using a product. Question these people on their training and knowledge in nutrition or medicine.
    • Think twice about chasing the latest headline.
      Sound health advice is generally based on a body of research, not a single study. Be wary of results claiming a "quick fix" that depart from previous research and scientific beliefs. Keep in mind science does not proceed by dramatic breakthroughs, but by taking many small steps, slowly building towards a consensus. Furthermore, news stories about the latest scientific study, especially those on TV or radio, are often too brief to include important details that may apply to you or allow you to make an informed decision.
    • Check your assumptions about the following:
      Questionable Assumption #1 -- "Even if a product may not help me, it at least won't hurt me."
      It's best not to assume that this will always be true. When consumed in high enough amounts, for a long enough time, or in combination with certain other substances, all chemicals can be toxic, including nutrients, plant components, and other biologically active ingredients.
      Questionable Assumption #2 -- "When I see the term 'natural,' it means that a product is healthful and safe."
      Consumers can be misled if they assume this term assures wholesomeness, or that these food-like substances necessarily have milder effects, which makes them safer to use than drugs. The term "natural" on labels is not well-defined and is sometimes used ambiguously to imply unsubstantiated benefits or safety. For example, many weight-loss products claim to be "natural" or "herbal" but this doesn't necessarily make them safe. Their ingredients may interact with drugs or may be dangerous for people with certain medical conditions.
      Questionable Assumption #3 -- "A product is safe when there is no cautionary information on the product label."
      Dietary supplement manufacturers may not necessarily include warnings about potential adverse effects on the labels of their products. If consumers want to know about the safety of a specific dietary supplement, they should contact the manufacturer of that brand directly. It is the manufacturer's responsibility to determine that the supplement it produces or distributes is safe and that there is substantiated evidence that the label claims are truthful and not misleading.
      Questionable Assumption #4 -- "A recall of a harmful product guarantees that all such harmful products will be immediately and completely removed from the marketplace."
      A product recall of a dietary supplement is voluntary and, while many manufacturers do their best, a recall does not necessarily remove all harmful products from the marketplace.
    • Contact the manufacturer for more information about the specific product that you are purchasing.
      If you cannot tell whether the product you are purchasing meets the same standards as those used in the research studies you read about, check with the manufacturer or distributor. Ask to speak to someone who can address your questions, some of which may include:
      1. What information does the firm have to substantiate the claims made for the product? Be aware that sometimes firms supply so-called "proof" of their claims by citing undocumented reports from satisfied consumers, or "internal" graphs and charts that could be mistaken for evidence-based research.
      2. Does the firm have information to share about tests it has conducted on the safety or efficacy of the ingredients in the product?
      3. Does the firm have a quality control system in place to determine if the product actually contains what is stated on the label and is free of contaminants?
      4. Has the firm received any adverse event reports from consumers using their products?

       

  • Overweight, Obesity Threaten U.S. Health Gains

    Health problems resulting from overweight and obesity could reverse many of the health gains achieved in the United States in recent decades, according to former Surgeon General David Satcher.

    A report issued in December titled The Surgeon General's Call to Action to Prevent and Decrease Overweight and Obesity outlines strategies that communities can use in helping to address the problems. Options include requiring physical education at all school grades, providing more healthy food options on school campuses, and providing safe and accessible recreational facilities for residents of all ages.

    "Overweight and obesity may soon cause as much preventable disease and death as cigarette smoking," says Satcher, whose term expired Feb. 13. "People tend to think of overweight and obesity as strictly a personal matter, but there is much that communities can and should do to address these problems."

    About 300,000 U.S. deaths a year are associated with obesity and overweight (compared to more than 400,000 deaths a year associated with cigarette smoking). The total direct and indirect costs attributed to overweight and obesity amounted to $117 billion in 2000.

    In 1999, an estimated 61 percent of U.S. adults were overweight, along with 13 percent of children and adolescents. Obesity among adults has doubled since 1980, while overweight among adolescents has tripled. Only 3 percent of all Americans meet at least four of the five federal Food Guide Pyramid recommendations for the intake of grains, fruits, vegetables, dairy products, and meats. And less than one-third of Americans meet the federal recommendations to engage in at least 30 minutes of moderate physical activity at least five days a week, while 40 percent of adults engage in no leisure-time physical activity at all.

    "Overweight and obesity are among the most pressing new health challenges we face today," says Tommy G. Thompson, secretary of Health and Human Services. "Our modern environment has allowed these conditions to increase at alarming rates and become a growing health problem for our nation. By confronting these conditions, we have tremendous opportunities to prevent the unnecessary disease and disability they portend for our future."

    While the prevalence of overweight and obesity has increased for both genders and across all races and ethnic and age groups, disparities do exist. In women, overweight and obesity are higher among members of racial and ethnic minority populations than in non-Hispanic white women. And, Mexican-American men have a higher prevalence of overweight and obesity than non-Hispanic men, while non-Hispanic white men have a greater prevalence than non-Hispanic black men. Members of lower-income families generally experience a greater prevalence than those from higher-income families.

    Already, these trends are associated with dramatic increases in conditions such as asthma, and in type 2 diabetes among children. Satcher says failure to address overweight and obesity "could wipe out some of the gains we've made in areas such as heart disease, several forms of cancer, and other chronic health problems."

    In preparation of the report, Satcher convened a listening session in December 2000 and held a public comment period to gather ideas from clinicians, researchers, consumers and advocates. The sessions generated a number of community-based strategies that were subsequently reviewed for their proven scientific effectiveness.

    The strategies include:

    • Ensure daily, quality physical education for all school grades. Currently, only one state in the country-Illinois-requires physical education for grades K-12, while only about 1 in 4 teen-agers nationwide take part in some form of physical education.
    • Ensure that more food options that are low in fat and calories, as well as fruits, vegetables, whole grains, and low-fat or non-fat dairy products, are available on school campuses and at school events.
    • Make community facilities available for physical activity for all people, including on the weekends.
    • Create more opportunities for physical activity at work sites.
    • Reduce time spent watching television and in other sedentary behaviors. In 1999, 43 percent of high-school students reported watching two hours of television or more a day.
    • Educate all expectant parents about the benefits of breast-feeding. Studies indicate breast-fed infants may be less likely to become overweight as they grow older.
    • Change the perception of obesity so that health becomes the chief concern, not personal appearance.
    • Increase research on the behavioral and biological causes of overweight and obesity. Direct research toward prevention and treatment, and toward ethnic/racial health disparities.
    • Educate health-care providers and students in health professions on the prevention and treatment of overweight and obesity across the life span.

    The Surgeon General's Call to Action to Prevent and Decrease Overweight and Obesity is available at: www.surgeongeneral.gov/topics/obesity.

     

  • Homicide Risk Among Infants

    • Homicide is the 15th leading cause of infant death in the United States. The risk of homicide is greater in infancy than in any other year of childhood before age 17.
    • Infants are at greatest risk for homicide during the first week of infancy and the first day of life.
    • Among homicides during the first week of life, 82.6% occurred on the day of birth.
    • The homicide rate on the first day of life was more than ten times greater than the rate during any other time of life.
    • Among homicides on the first day of life, previous work has shown that 95% of victims are not born in a hospital.
    • The second highest peak in risk for infant homicide occurs during the eighth week of life and may be due to a caregiver's reaction to an infant's persistent crying. Infant crying duration peaks at six to eight weeks of age.
    • Among homicides during the first week of life, 89% of perpetrators are female, usually the mother. Mothers who kill their infants are more likely to be adolescents and have a history of mental illness.
  • Teens Still Exposed to Tobacco Ads Despite Advertising Restrictions

Despite restrictions imposed on tobacco advertising, young people are frequently exposed to high levels of tobacco promotion in retail stores, according to a new study released today by the Centers for Disease Control and Prevention. The study found that more than 90 percent of retail stores that sell tobacco products had some form of tobacco advertising including interior and exterior advertisements; self-service pack placement; multi-pack discounts; and tobacco-branded functional objects such as shopping carts, counter mats, or tobacco vending machines.

Overall, the report concludes that convenience, convenience/gas, and liquor stores were most likely to have "tobacco-friendly" environments where patrons would be highly exposed to tobacco advertisement, promotions, and tobacco branded objects in the stores. The study, done in collaboration with the Robert Wood Johnson Foundation, indicates that 75 percent of teenagers shop at convenience or convenience/gas stores once a week or more.

"The pervasiveness of tobacco advertising in retail stores is weakening efforts to prevent adolescent smoking" said Dr. Jeffrey Koplan, director of the CDC. "Directly or indirectly, this highly visible advertising is encouraging a new generation of children to take up a deadly habit."

An estimated 80 percent of retailers had interior tobacco advertisements with 22.8 percent of stores having high levels of such ads. Exterior tobacco advertisements were observed in 58.9 percent of stores with 40.4 percent of stores having high levels of such ads. While tobacco control signs, such as "We Card" signs, were observed in 65.8 percent of stores, only 4.1 percent had tobacco health warning signs.

The study evaluated marketing trends within retail outlets where tobacco products are sold in 163 communities. Data collected on in-store tobacco product placement, promotions (discounts or gifts with purchase), tobacco-branded functional objects (free items provided to retailers such as shopping baskets and counter mats with tobacco brands on them), exterior and interior advertisements, and tobacco control signage.

Other findings of the study include:

  • Tobacco marketing expenditures increased from $6.7 billion in 1998 to $8.2 billion in 1999.
  • Overall, some form of advertisement (interior or exterior) was present in 84.1 percent of stores.
  • Self-service cigarette pack placement was observed in 36.4 percent of stores.
  • Multi-pack discounts were present in 25.2 percent of stores.
  • 68.5 percent of stores had at least one tobacco-branded functional object (such as shopping baskets or counter change mats).

"This study shows that tobacco advertising in retail stores is much more visible to our youth than tobacco health warning information," said Rosemarie Henson, head of the CDC's smoking and health program. "Public health efforts need to include strategies to decrease youth exposure to tobacco products and tobacco advertising in retail stores where they shop, and to increase youth awareness of the terrible health consequences of using these products."

  • Court Shuts Down Website Selling Bogus Domain Names ".USA," ".BRIT,"   Deceptively Marketed as Useable

    An operation that used deceptive spam messages and appeals to patriotism to sell Web addresses that don't work, including ".usa," has been shut down by a U. S. District Court at the request of the Federal Trade Commission. The court's action ensures that the defendants will not be able to reemerge by registering the same domain names offshore. The court also ordered an asset freeze to preserve money for consumer redress. Officials from the United Kingdom's Office of Fair Trading have been assisting the FTC on the issue of domain name sales and are investigating such activities in the U.K.

    According to the FTC, the bogus businesses sold domain names ending with suffixes such as ".brit," and ".bet ." After September 11, the companies launched an aggressive spam campaign in the United States to advertise domain names ending in ".usa." Subject lines in their e-mail read, "Be Patriotic! Register .USA Domains." The text of the e-mail said:

    "The latest domain name extension has arrived .USA!!! It's the fresh, new, exciting web address that is taking the world by storm. Who wants to be .com when you can now be .USA. Register your .USA domain name today exclusively at: http://www.dotusa.com."

    The hyperlink connected consumers to a Web site where they were offered the advertised domain names for $59 each. The FTC alleges that the companies are not accredited domain name registrars, that the ".usa" domain names are not usable on the Internet, and that they probably never will be useable. In papers filed with the court, the agency said that many consumers had purchased multiple bogus domain names, and the defendants likely pocketed more than $1 million from their illegal scheme in less than a year.

    "These spam scammers conned consumers in two ways," said J. Howard Beales, III, Director of the FTC's Bureau of Consumer Protection. "They sent deceptive spam, and they sold worthless web addresses from their Web sites. By closing down this operation we're sending a strong signal: We will not tolerate deceptive spam."

    The FTC alleges that the companies violated federal law by failing to disclose on their Web sites that the domain names they were selling were not useable on the Internet, and by sending the deceptive spam. The FTC has asked the court to permanently bar the operation from deceptively selling the domain names and to order consumer redress. The defendants' Web site domain names are registered with U. S. companies. The defendants will be prevented from reestablishing the same domain names in another country because the domain names have been suspended by court order. The FTC complaint names TLD Network Ltd., Quantum Management (GB) Ltd., TBS Industries Ltd., Thomas Goolnik, and Edward Harris Goolnik of Finchley Road, London, England.

  • JUSTICE ENFORCEMENT, FBI, ON WHITE- COLLAR CRIME

The Federal Bureau of Investigation today released The Measurement of White-Collar Crime Using Uniform Crime Reporting (UCR) Data, a study in the National Incident-Based Reporting System (NIBRS) Publication Series. Defined as ". . . a crime committed by a person of respectability and high social status in the course of his occupation," white-collar crime extracted from NIBRS data accounts for 4 percent of crime reported. Four percent of all arrestees reported in NIBRS were individuals arrested for bad check offenses. The majority of white-collar crime offenders have had contact with their victims and are typically white males aged late-twenties to early-thirties.

Computer crime, or technocrime, can be extracted in NIBRS by the data element that notes the offender was suspected of using a computer or computer equipment to perpetrate the crime. NIBRS data demonstrate that white-collar crime comprises 42 percent of the offenses committed with a computer. Of those offenses, the crime of larceny-theft accounts for the largest proportion. (See figure above.)

White-collar crime, on average, accounts for a greater dollar loss per incident when compared to other property crime incidents. The majority of white-collar crime incidents, with the exception of wire fraud, occur within public spaces.

Unique to NIBRS is the ability to capture information on nonperson entities that are victimized by crime. This is particularly useful when considering white-collar crime, where NIBRS data show that businesses are just as likely as individuals to fall victim.

In contrast to the limited data previously available on the topic of white-collar crime, NIBRS provides information on incidents, offenses, victims, and arrestees for five separate types of fraud, bribery, counterfeiting/forgery, embezzlement, and other offenses that in combination could constitute white-collar crime. (See figure below.)

  • FDA APPROVES FIRST NUCLEIC ACID TEST (NAT) SYSTEM TO SCREEN WHOLE BLOOD DONORS FOR INFECTIONS WITH HUMAN IMMUNODEFICIENCY VIRUS (HIV) AND HEPATITIS C VIRUS (HCV)

    The Food and Drug Administration has licensed the first nucleic acid test (NAT) system intended for screening donors of whole blood and blood components intended for use in transfusion. This test system can simultaneously detect the presence of HIV and HCV in blood using a semi-automated system and is expected to further ensure the safety of whole blood and blood components, including fresh plasma, red cells and platelets, by permitting earlier detection of HIV and HCV infections in donors.

    FDA also recently licensed the first NAT system for screening donors of plasma for the specific use in products that will be further manufactured, such as clotting factors and immune globulins.

    The approved test system was developed by Gen-Probe Inc., San Diego, Calif. and will be distributed by Chiron Corporation, Emeryville, Calif.

    Blood donors have been tested for evidence of HIV infection since 1985 and for evidence of HCV infection since 1990. Although increasingly sensitive tests for detection of HIV and HCV antibodies and HIV antigen were implemented during the past decade, in rare instances infections in donors have been missed.

    The NAT system is capable of detecting more infectious donations than current tests because it detects viral genes rather than antibodies or antigens (proteins from the virus). Detection of viral genes permits detection earlier in the infection since the appearance of antibodies requires time for the donor to develop an immune response, and since detection of antigens requires time for a higher level of virus to appear in the bloodstream.

    This new technology detects very small amounts of genetic material by copying the genes numerous times, resulting in a billion-fold amplification of the target gene. The approved test system can detect ribonucleic acid (RNA) from HIV-1 and HCV when tested in pools of 16 samples obtained from multiple donors. In a less automated format, it can also be used to test individual samples from whole blood collections. If a test pool is positive for either virus, the individual donation suspected of containing a virus can be identified and not transfused. The donor can be deferred from donating blood and notified.

    Currently, donors of blood and plasma are tested for antibodies to HCV, antibodies to HIV and HIV-1 antigens, which are the virus’s own proteins. However, there is still a “window period” during which a donor can be infected, but have negative screening tests. With the use of NAT for HCV, the window period is reduced by approximately 57 days (from an average of 82 days to 25 days). For HIV-1, the average window period with antibody is 22 days. This window period is reduced approximately to 16 days with antigen testing and to 12 days with NAT.

    In nation-wide clinical trials performed to support the approval of the test on pools, a total of 7 HIV-1 positive and 88 HCV positive donations were detected in more than 20 million donations tested confirming the effectiveness of the test. The NAT system using pools was evaluated at eight volunteer blood donor sites while NAT for use with individual donations used data from U.S. military blood donor sites.

    The use of the licensed test will allow blood banks that implement it to discontinue antigen testing, although blood donations will continue to be tested by antibody tests. FDA plans to issue guidance on the use of NAT in the near future.

    Since 1997, FDA has encouraged the large-scale study of NAT through the use of experimental protocols. More than one test system is under development. Most of the nation’s blood establishments now participate in these experimental protocols. The Gen-Probe NAT system is the first to be approved to screen donors of whole blood and blood components intended for use in transfusion.

     

  • COMMUNITY WATER FLUORIDATION NOW REACHES NEARLY TWO-THIRDS OF U.S. POPULATION

    Nearly two-thirds of U.S. residents who receive water from public water systems now receive fluoridated water, according to an article released today by the Centers for Disease Control and Prevention (CDC).

    The article, "Populations Receiving Optimally Fluoridated Public Drinking Water -- United States, 2000," provides the most recent information on the status of water fluoridation by state. Between 1992 and 2000, the percent of the U.S. population receiving fluoridated water increased from 62.1 percent to 65.8 percent, bringing the total U.S. population receiving fluoridated water to approximately 162 million.

    Fluoride, a naturally occurring element in the environment, is known to be effective in preventing tooth decay in children and adults. Over the past several decades, fluoridation has played an important role in the dramatic reduction of tooth decay and has been identified by CDC as one of
    the 10 greatest public health achievements in the twentieth century. However, tooth decay remains the most prevalent chronic infectious disease of childhood; 80 percent of all children have had dental decay by the time they are 18 years of age. Recent estimates of effectiveness indicate that water fluoridation reduces tooth decay among children by 18 percent to 40 percent.

    The importance of fluoridation for reducing tooth decay was highlighted in the first Surgeon General's report on oral health (http://www.surgeongeneral.gov/library/oralhealth/) issued in May 2000.

    The Healthy People 2010 national health initiative set an objective for 75 percent of the U.S. population on public water systems to receive fluoridated water. Between 1992 and 2000, five additional states (Delaware, Maine, Missouri, Nebraska and Virginia) achieved the Healthy People objective, and Oklahoma was close (74.6 percent) to achieving this goal. Twenty-six states and the District of Columbia have now met this objective. State-specific percentages range from 2 percent to 100 percent of persons on public water systems that receive optimally fluoridated water.

    "Water fluoridation is the most equitable and cost-effective means we have of delivering fluoride to all members of most communities," said Dr. William R. Maas, director of CDC's Oral Health Program. "While several states, such as California, New Hampshire and Nevada have made substantial progress, there is considerable need as well as opportunity for additional improvement, particularly in the 24 states that have not yet met the objective of having at least 75 percent of their populations on public water systems receiving fluoridated water."

    The fluoridation update appears in today's Morbidity and Mortality Weekly Report, which can be viewed or downloaded at www.cdc.gov/mmwr/
    preview/mmwrhtml/mm5107a2.htm. Other information on fluoridation and oral health is available on-line through the oral health web site: www.cdc.gov/nccdphp/oh or by calling 770-488-5131 or 770-488-6054.

    CDC protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.
  • FDA ANNOUNCES FOODS ADVISORY COMMITTEE TO MEET ON METHYL MERCURY IN SEAFOOD

    The Food and Drug Administration (FDA) today announced that it will soon schedule a meeting of its Foods Advisory Committee to review issues surrounding methyl mercury in commercial seafood. This review will include a re-examination of FDA's most recent Consumer Advisory, issued in January 2001 and revised in March 2001, for pregnant women and women of child-bearing age who may become pregnant.

    The advisory recommended that these women should avoid eating the four fish species with the highest levels of methyl mercury: shark, swordfish, king mackerel, and tile fish. It concluded that these women could safely eat 12 ounces per week of a variety of other fish, with the emphasis on choosing a variety of different species.

    At that time, FDA set forth its rationale for this decision in a formal, publicly available document, "Rationale for Issuance of Revised Advisory on Methyl Mercury and Fish Consumption." This document is available on FDA's web site at http://www.cfsan.fda.gov/~acrobat/hgadv4.pdf.

    A recent report by the Environmental Working Group calls into question the basis for FDA's Consumer Advisory and the way in which FDA reached its conclusions on methyl mercury in seafood for this group of women.

    FDA stands behind the process that led to its current Consumer Advisory on this subject, as well as the science that supports that advisory. In reaching its conclusions about methyl mercury in fish, FDA met with a broad range of interested parties, including consumer groups, health professionals, industry, and state public health officials.
  • Protein Patterns May Identify Ovarian Cancer

    Scientists from the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) report today, in a special fast-tracked release in The Lancet*, that patterns of proteins found in patients' blood serum may reflect the presence of disease. In the study, scientists used serum proteins to detect ovarian cancer, even at early stages. They report that this new diagnostic concept is potentially applicable to any type of disease.

    Using a test that can be completed in 30 minutes using blood that can be obtained from a finger stick, researchers were able to differentiate between serum samples taken from patients with ovarian cancer and those from unaffected individuals.

    The research, a joint effort between the FDA/NCI Clinical Proteomics Program and Correlogic Systems Inc., unites two exciting disciplines: proteomics - the study of the proteins inside cells - and artificial intelligence computer programs.

    The diagnostic test relied on software that is able to detect patterns of key proteins in the blood. Using a sophisticated artificial intelligence computer program developed by Correlogic, scientists were able to "train" the computer to distinguish between patterns of small proteins found in the blood of cancer patients vs. control samples. The artificial intelligence program identified a pattern consisting of only a handful of proteins, among thousands, that could be used to distinguish between women with ovarian cancer and women with non-cancerous conditions.

    "The idea that rather than a single biomarker, an entire pattern of proteins contains important diagnostic information, is an exciting new paradigm," said J. Carl Barrett, Ph.D., director of the NCI's Center for Cancer Research, which oversees the proteomics program.

    The scientists first used serum samples from known cancer patients and unaffected individuals to establish proteomic patterns which were present at different levels in the two groups. Once these patterns were identified, the researchers compared them with the patterns of the same proteins in serum samples from other patients with and without cancer. The researchers correctly identified 50 out of 50 cancers and 63 of 66 non-cancer samples.

    The researchers analyzed the serum proteins with mass spectroscopy, a technique used to sort proteins and other molecules based on their weight and electrical charge. The identity of the key proteins and the role they may play in cancer is unknown, but being investigated.

    An important finding was the ability to correctly identify, in a small sample of patients, all stage I ovarian cancer cases. Currently, more than 80 percent of ovarian cancer patients are diagnosed at a late clinical stage and have a 20 percent or less chance of survival at five years. In contrast, the 20 percent of women diagnosed with early-stage disease have an excellent prognosis, with over 95 percent alive at five years after diagnosis. The results of this study indicate that proteomic technology may help clinicians diagnose the disease much earlier than current methods.

    The authors of the paper caution that further study is needed to confirm the sensitivity and accuracy of this technique as a diagnostic tool. They hope that by combining the proteomic approach with other methods of ovarian cancer diagnosis, such as ultrasound, its accuracy can be further improved.

    "Simple, accurate, and non-invasive methods for early detection of epithelial ovarian cancer may improve quality of life and survival and reduce unnecessary suffering for patients," said Kathryn Zoon, director of the Center for Biologics Evaluation and Research (CBER) at the FDA. The majority of the individuals included in the study had an increased risk of ovarian cancer, due to a family history of the disease, or mutations in BRCA1 or BRCA2 genes, which increase risk for both breast and ovarian cancers. Researchers on the study from Northwestern University Medical School, Chicago, considered it important to test the method in this population, as these are the women most in need of effective screening options.

    "The most important next goal is validating the promise of these results in large, multi-institutional trials. Early detection means we can treat the cancer before it has spread," said Lance Liotta, M.D., Ph.D., the senior investigator on the study from the NCI's Center for Cancer Research. Such trials are under way at the NCI, evaluating proteomics both alone and in combination with current screening methods for ovarian cancer.

    "We're particularly excited about the potential of this technique to diagnose additional types of diseases. It may also be able to provide an early warning of impending toxicity," said the first author of the study, Emanuel Petricoin, Ph.D., of the FDA's CBER.

  • USFDA APPROVES NEW WEARABLE DEFIBRILLATOR
    FOR SERIOUSLY ILL HEART PATIENTS

    The Food and Drug Administration today approved a vest-like medical device that is worn under clothing to monitor and treat abnormal heart rhythms in people at risk of dying from sudden cardiac arrest.

    The product, made by Lifecor, Inc., of Pittsburgh, Pa., is the first cardioverter defibrillator that can be worn outside the body, rather than implanted in the chest.

    The device is a programmable system that senses heart function and automatically delivers an electrical shock when needed to restore normal heart rhythm.

    Until now, people who needed a cardioverter defibrillator had to have it surgically implanted into their chest.

    "Today's approval represents a significant advance in defibrillator technology. It means patients may now opt for a wearable defibrillator if they are not suitable candidates for an implanted defibrillator or do not want one," said FDA Acting Principal Deputy Commissioner Bernard A. Schwetz, D.V.M., Ph.D.

    The new product consists of an electrode belt assembly that is worn around the chest, touching the skin. It is connected to a monitor, with an alarm, that is worn in a holster at the waist. This entire device assembly is worn continuously 24 hours a day, except when the wearer is bathing or showering.

    The device continuously monitors the patient's heart to detect life-threatening abnormal heart rhythms. Typically, once a week the physician will want the patient to connect the monitor to an external modem and send the data over the phone to the physician's computer for his review.

    The defibrillator detects abnormal heart rhythms by sensing the heart's electrical activity on the surface of the chest. If a life-threatening rhythm is detected and the person loses consciousness, the device delivers an electrical shock to restore normal rhythm.

    FDA approved the wearable defibrillator based on a review of laboratory and animal tests and clinical studies of safety and effectiveness conducted by Lifecor.

    Some 289 heart patients at 16 medical centers in the United States and Europe were fitted with the defibrillator vest. All were either awaiting heart transplants or had recently had a heart attack or a coronary bypass operation. The patients wore the defibrillator for an average of 20 hours a day for approximately three months.

    The wearable defibrillator was 71 percent successful in treating sudden cardiac arrest episodes compared to 25 percent success for patients calling 911. It successfully detected and treated five episodes of sudden cardiac arrest, and detected but was unable to treat two other episodes. The two failures to treat resulted because the patients had incorrectly assembled the electrodes in the vest. Lifecor subsequently changed the design of the garment to make it more user-friendly.

    Two percent of patients experienced an unnecessary shock from the wearable device, compared to 2.3 percent false shocks per patient-month received by patients with an implantable defibrillator. Lifecor subsequently modified the device to further reduce the rate of unnecessary shocks.

    The most frequent side effect was a temporary skin rash, experienced by 5.9 percent of study patients.

     

  • PRO-ATHLETES HELP CDC LAUNCH TOBACCO-FREE SPORTS PLAYBOOK


    New Orleans Saints wide-receiver, Willie Jackson, and World Cup Mountain Bike Champion, Alison Dunlap, helped the Centers for Disease Control and Prevention (CDC) release The Tobacco-Free Sports Playbook, a new publication aimed at helping youth say "no" to tobacco and "yes" to better health. The launch took place at a press conference at the National Conference on Tobacco and Health in New Orleans.

    The Sports Playbook profiles many of the world's top athletes and sports figures and is designed to help communities throughout the country develop and implement programs that promote sports as a healthy alternative to tobacco use. It is part of the World Health Organization's (WHO) Tobacco-Free Sports Initiative.

    "Sports activities are a great way to reach our nation's young people with information about how to make important health decisions–specifically, those decisions related to tobacco use, physical activity, and good nutrition," said CDC Director Dr. Jeffrey P. Koplan.

    Research shows that students who participate in interscholastic sports are less likely to be heavy smokers while students who play at lease one sport are 40 percent less likely to be regular smokers and 50 percent less likely to be heavy smokers. Almost 90 percent of adult smokers began smoking before the age of 18. Each day, more than 3,000 kids become regular smokers and roughly one-third of them will eventually die from tobacco-related disease.

    "By getting kids involved in sports, you are reducing the amount of unsupervised time they can spend doing things like using tobacco," Jackson said. "I am very proud to have the opportunity to support the Sports Playbook."

    The Sports Playbook offers guidance and real-world examples of how coaches, teachers, school leaders, and community leaders can launch successful tobacco control initiatives and profiles many of the world's top athletes and sports figures in illustrating the wide variety of sports available to youth. "It is a step-by-step game plan for incorporating sports in tobacco-free activities," Koplan said.

    For more information about this initiative or other tobacco control programs, call CDC's Office on Smoking and Health at 770-488-5747 or visit the Tobacco Information and Prevention Source at www.cdc.gov/tobacco/

     

  • CALIFORNIA DEFENDANTS TO PROVIDE REDRESS FOR CHARGING CONSUMERS A"CANCELLATION" FEE FOR DELAYED SHIPMENTS

    Commission Also Alleged Other Violations of its Mail or Telephone Order Merchandise Rule

    The Federal Trade Commission today announced a consent decree with a California-based aftermarket automobile accessories seller resolving charges of violating the FTC's Mail or Telephone Order Merchandise Rule by making unsubstantiated shipment representations and failing to provide consumers with timely and complete delay notices. The Commission also alleged that the defendants violated the Rule by substituting merchandise that was materially different from what consumers ordered without the consumers' prior consent, and by charging consumers a 20 percent "cancellation" fee when consumers cancelled because of delayed shipment.

    Under the terms of the consent decree, filed by the Department of Justice (DOJ) on the FTC's behalf, the defendants, Charles Smith, Damian Smith, and Kymberli Smith, doing business as Salesco, will pay a $15,000 civil penalty, will provide redress to consumers whose refunds were discounted in violation of the Rule, and will be required to comply with the Rule in the future.

    "The Mail or Telephone Order Merchandise Rule guarantees that consumers get what they ordered -- and get it when it was promised," said FTC's Bureau of Consumer Protection Director Howard Beales. "The FTC expects catalog, telephone, and Internet retailers to deliver the goods as required by law, not only because it's good business, but because it enhances consumer confidence."

    An unincorporated business based in San Dimas, California, since 1995, Salesco has sold automobile accessories including audio equipment, seat belt extensions, canopies, chrome plated wheels, dashboards, seats, carpet kits, and car covers to consumers throughout the United States via mail order, telephone, and the Internet. The FTC's Mail or Telephone Order Merchandise Rule covers - in addition to orders by mail - orders by any "direct or indirect" use of the telephone, including orders by Facsimile or the Internet.

    The Commission's Complaint

    According to the Commission's complaint, the defendants violated the FTC's Mail or Telephone Order Merchandise Rule over a two-and-a-half year period in numerous transactions by making unsubstantiated shipment representations and failing to provide timely and complete delay notices to consumers. The defendants allegedly failed to keep records demonstrating Rule compliance, including inventory records and records relating to shipment. When shipment delays occurred, they often failed to notify consumers of the delay. In the instances in which they did notify consumers of delays, the FTC alleges, the notices failed to include a revised shipment date or the statement that the consumers could cancel and obtain prompt, full refunds, as required by the Rule.

    The FTC's complaint alleged that when consumers contacted the company in response to Salesco's Internet advertising, the defendants allegedly told them that the advertised merchandise was "in stock" and would ship within a certain time. In fact, the complaint alleged, the merchandise was often not in stock. On such occasions, defendants would, without the consumers' prior consent, ship items that were materially different from what they had ordered. Consumers dissatisfied with these substitutions had to pay to return them.

    On other occasions, the defendants charged consumers who cancelled because shipment had been delayed beyond the promised shipment time a 20 percent "cancellation" fee. The complaint alleges that the practice of unilaterally substituting merchandise that is materially different from the merchandise ordered by consumers by mail or telephone, and the practice of failing to provide full refunds when consumers cancel their mail or telephone orders because of delayed shipment, both violate the FTC's Mail or Telephone Order Merchandise Rule.

    The Consent Decree

    The settlement includes a $200,000 civil penalty against the defendants, all but $15,000 of which will be suspended due to their financial situation. In addition, the defendants will be required to compile (from their business records and other information) a list of consumers whose refunds were discounted and to provide them with full refunds. These redress activities must subsequently be reported to Commission staff.

    The settlement enjoins the defendants from failing to comply with the Rule in the future, including failing to: 1) have a reasonable basis for their shipment representations; 2) provide timely and compliant notification of delays; and 3) provide full and prompt refunds in all situations in which the Rule requires a refund. It also enjoins the defendants from substituting materially different mail or telephone order merchandise without the consumer's prior express consent. In situations in which consumers authorize the defendants to ship materially different merchandise, the defendants will be required to offer them the right to return the merchandise within a reasonable time at the defendants' expense.

    The consent decree requires the defendants to keep specific detailed records of their systems and procedures for complying with the Mail or Telephone Order Rule. Finally, the consent contains other recordkeeping, reporting and compliance requirements to which the defendants must adhere.

    The Commission vote to forward the complaint and consent decree to the Department of Justice for filing was 5-0. It was filed in the Federal District Court for the Central District of California. FTC staff was assisted in its investigation by the Better Business Bureau of the Southland

     

  • MARYLAND BUSINESSMAN SENTENCED FOR ILLEGALLY MARKETING ALOE VERA COMPOUNDS AS AIDS AND CANCER TREATMENTS

    The U.S. District Court of Maryland in Baltimore has sentenced Allen J. Hoffman to 46 months in prison and ordered him to pay $222,506 in restitution for selling aloe vera mixtures as treatment for AIDS, cancer and other auto-immune diseases in violation of the Federal Food, Drug, and Cosmetic Act.

    Hoffman pleaded guilty to two felony counts of introduction of an unapproved new drug into interstate commerce with the intent to defraud the public. Under the Federal Food, Drug, and Cosmetic Act, it is illegal to market a drug that has not been approved by the Food and Drug Administration (FDA) for treatment of specific illnesses.

    Hoffman, doing business as T-Up, Inc., of Baltimore, Md., and Astec Biologics, Inc. of Hanover, Pa., charged cancer patients and their families up to $18,000 for a two-week treatment with intravenous aloe vera. He also sold bottled combinations of aloe vera and other unapproved drugs to treat auto-immune diseases. More than 3,000 people purchased products from Hoffman, who falsely claimed to have a doctoral degree.

    This case was investigated by FDA's Office of Criminal Investigations, the Internal Revenue Service - Criminal Investigation and the United States Postal Inspection Service, with the assistance of the Maryland State Attorney General's Office of Consumer Protection.

    The sentence was announced by U.S. District Judge William M. Nickerson.

  • STRATEGIC FBI HEADQUARTERS REORGANIZATION

Congress approved, and today the Director implemented, a restructuring plan for Headquarters, Federal Bureau of Investigation (FBI), the first step in what will be a phased process of reorganizing assets, modernizing and integrating new technology, and consolidating functions. This reorganization was considered and approved by the Attorney General's Strategic Management Council and will serve as the foundation as the FBI redefines priorities and missions in the coming months.

This reorganization, the need for which is widely accepted within the FBI community, is consistent with the recommendations from several studies and inquiries, and recognizes new challenges and responsibilities. Among other things, it seeks to increase the emphasis in counterterrorism, counterintelligence, cybercrimes, and relations with state and local law enforcement. It also seeks to provide the vehicle for a vastly enhanced information technology upgrade, expanded training for the FBI workforce at all levels, improved security, and improved capabilities for FBI investigators, analysts, forensic examiners, and other specialists.

The major elements of the first phase of the Headquarters reorganization effort include the creation of four new Executive Assistant Director positions to oversee key FBI functions.

The positions and their designated heads include:

* Executive Assistant Director for Criminal Investigations - To be headed by Ruben Garcia, Jr., 23-year FBI veteran who was formerly the Assistant Director of the Criminal Investigative Division.
* Executive Assistant Director for Counterterrorism/Counterintelligence - To be headed by Dale L. Watson, currently the Assistant Director for the Counterterrorism Division. Mr. Watson entered the Bureau in 1978 and has served continually in intelligence and counterterrorism roles since 1982. In 1996, he was named the Deputy Chief of the CIA's Counterterrorist Center at CIA Headquarters.
* Executive Assistant Director for Law Enforcement Services - To be headed by 23-year veteran Kathleen L. McChesney. Currently the Assistant Director of the FBI Training Division, she has served as Special Agent in Charge of the Portland, Oregon and Chicago Field Offices.
* Executive Assistant Director for Administration - To be headed by Robert J. Chiaradio, currently an assistant to FBI Director Robert Mueller. A veteran of the FBI since 1984, Chiaradio was previously the Special Agent in Charge of the Tampa Field Office and the Chief of Staff for the FBI Deputy Director.

FBI divisions and offices will realign under one of these four Executive Assistant Directors who report through the offices of the Director/Deputy Director. This reorganization step effectively narrows the supervisory span of control and will greatly increase efficiency, accountability and oversight.

Two new divisions have also been created to increase emphasis on computer-facilitated crimes and security. The Cybercrime Division will address intellectual property investigations, as well as high tech and computer crimes. The Security Division will be responsible for ensuring the integrity of FBI employees, contractors, visitors, information systems, and facilities.

Also a part of this phase of reorganization is the opening of four new offices: Law Enforcement Coordination for improving FBI coordination with state and local law enforcement and information sharing; Chief Technology Officer reporting directly to the Office of the Director and charged with the implementation of the ongoing critical information technology projects; Office of Records Management whose function is the modernization of FBI records, including management policies and processes; and the Intelligence Office charged with enhancing analytical and intelligence capabilities, particularly in the critical counterterrorism and counterintelligence areas.

The Investigative Services Division will be disbanded as a result of this reorganization and its important responsibilities and assets integrated into current or newly created components as appropriate.

Attached to this release is an expanded breakdown of the Headquarters Phase I reorganization, an organizational chart showing the new realignments and biographical information on the newly appointed Executive Assistant Directors.

The second phase of Headquarters reorganization, which will deal with changes at the Divisional and Office levels of the FBI, will focus on such areas as eliminating duplication, consolidating functions, and realigning resources.

When coupled with new hiring priorities aimed at special skill sets, workforce development initiatives, and a particular emphasis on developing an overarching leadership climate at every level of Bureau operations, Phase II reorganization promises measurable enhancements in tune with new law enforcement challenges and realities.

The reorganization of FBI Headquarters is part of the Director's comprehensive plan to address not only the new challenges of terrorism, but to modernize and streamline the Bureau's more traditional functions so that it may better serve not only its law enforcement partners, but the nation.

  • FDA APPROVES TWO NEW MEDICAL DEVICES TO TREAT CONGENITAL HEART DEFECTS

    The Food and Drug Administration today approved two devices that may provide an alternative treatment to open heart surgery for patients with two types of congenital heart defects.

    The devices, called septal occluders, are implanted in the heart by way of catheters (thin plastic tubes) inserted into either an artery or a vein.

    The two types of congenital heart defects are ventricular septal defect, a hole between the bottom chambers of the heart, and atrial septal defect, a hole between the top chambers of the heart. Normally these defects are corrected through open heart surgery.

    The products are the Cardioseal Septal Occlusion System, made by NMT Medical, Inc., of Boston, Mass., approved to close complex ventricular septal defects; and the Amplatzer Septal Occluder, made by AGA Medical Corporation, of Golden Valley, Minn., approved to close secundum atrial septal defects, those located in the mid portion of the atrial septum.

    The devices are made from either a metal frame or wire mesh and fabric. The design and shape of the products vary, as does the exact mode of deployment.

    FDA based its approval of the two products on a review of clinical studies of safety and effectiveness conducted by the manufacturers and on the recommendation of the Circulatory Systems Devices Panel of FDA's Medical Devices Advisory Committee.

    FDA is requiring each company to continue to study its product over the next five years to better assess the long-term safety and effectiveness of the devices.

     

  • THE "HEALTH CARE PRESIDENT" SIGNS RECORD FY 2002 BUDGET

    For the first time in several years Congress has provided a budget for the Food and Drug Administration over and above increases requested for the Salaries and Expense account. The biggest impact will result from the funding for the full pay raise of 4.6%. FDA's total program level is $1.4 billion and includes full funding for the Buildings and Facilities account as well as Prescription Drug User Fees Act and Mammography Quality Standards Act User Fees, and the Export Certification and Certification fund. The Salaries and Expenses Appropriation totals $1.345 billion, including $1.2 billion for Salaries and Expenses, and $161.716 million for PDUFA. This budget reflects the commitment of the Administration and the Congress to continue strengthening the public health protection by focusing on urgent public health hazards. A breakdown of the increases follows:

    • $45.2 million to meet mandated cost-of-living and pay-related increases for FDA's employees. In the last eight years, FDA has had to absorb $284 million in unfunded pay raises and other inflationary costs;
    • $15 million to protect consumers against the new variant Creutzfeldt- Jakob Disease, a fatal illness associated with consumption of meat from cows with Bovine Spongiform Encephalopathy (BSE). The funds were provided to keep BSE, the "Mad Cow Disease," out of the United States;.
    • $10.3 million to prevent substandard food and health care products from reaching the U.S. market by increasing plant inspections and expanding surveillance of regulated imports;
    • $9.4 million to significantly upgrade food safety by expanding the highly successful Food Safety Initiative beyond microbiological contaminants to cover chemical and physical food hazards;
    • $10 million to safeguard patients against adverse events associated with the use of drugs, biological agents and medical devices by improving FDA's system for monitoring marketed products;
    • $10 million to protect the human subjects and research data in clinical trials by increasing FDA's inspections;
    • $10.1 million to enhance FDA's scientific potential and operational efficiency through infrastructure improvements. This includes funding for the development of an advanced financial management system, the completion of a new laboratory/office complex in Los Angeles, and the initial move of a FDA center to the White Oak campus;
    • $13.1 million for current low user fees, including increases for Prescription Drug User Fees Act and Mammography Quality Standards Act fees, Certification fund and Export fund.
    • Congress also provided $10.5 million in additional funding without impacting the President's budget request. Earmarks include $ 3.0 million for Dietary Supplements; $2.5 million for generic drug review and education; $1.0 million for Orphan Drug Grants and, $0.5 million for a gene therapy data base; $3.0 million for activities related to antibiotic drugs; and, $0.5 million to develop a database focused on woman’s health issues.

    These resources will allow FDA to continue its important role in effective health care delivery and ensure continued consumer confidence in the products we regulate. 

David N. Rahni, Ph.D is a Professor of Analytical Chemistry and Adjunct Professor, Environmental Law and Dermatology (NYMC).  David has been awarded an honorary fellowship in the Academy for Justice Through Science.  Read as "David takes on the Goliath" of germ/bio for 2001 by clicking on the link above or here now". 

  • FBI ASKS CAN YOU HELP IDENTIFY THE ANTHRAX LETTERS?

    Today the FBI is releasing linguistic and behavioral assessments of the person responsible for mailing anthrax-laden letters on September 18 and October 9, 2001. We ask the American public to study these assessments and reflect on whether someone of their acquaintance might fit the profile. The safety of the American people is at stake. If you have credible information that might help identify this person, please contact 1-800-CRIMETV (274-6388), use www.ifcc.fbi.gov, or call your local FBI field office.

    EVIDENCE DESCRIPTION

    Letter 1
    One page, hand-printed letter
    Transmittal envelope, also similarly hand printed
    Addressed to "NBC TV – Tom Brokaw" – No return address
    Postmarked Trenton, NJ 09/18/2001 (Tues.)

    Letter 2
    One page, hand-printed letter
    Transmittal envelope, also similarly hand printed
    Addressed to "NY Post" – No return address
    Postmarked Trenton, NJ 09/18/2001 (Tues.)

    Letter 3
    One page, hand-printed letter
    Transmittal envelope, also similarly hand printed
    Addressed to "Senator Daschle – 509 Hart Senate Office Building"
    Return address – "4th Grade, Greendale School, Franklin Park, NJ"
    Return address zip code – "08852"
    Postmarked Trenton, NJ 10/09/2001 (Tues.)

    LINGUISTIC ASSESSMENT

    It is highly probable, bordering on certainty, that all three letters were authored by the same person. Letters 1 and 2 are identical copies. Letter 3, however, contains a somewhat different message than the other letters. The Anthrax utilized in Letter 3 was much more refined, more potent, and more easily disbursed than letters 1 and 2.

    In the past, the public has helped the FBI solve high profile investigations that involved writings by coming forward to identify the author, either by how he wrote or by what he wrote. We are asking for the public's help here again in the same way.

    While the text in these letters is limited, there are certain distinctive characteristics in the author's writing style. These same characteristics may be evident in other letters, greeting cards, or envelopes this person has written. We hope someone has received correspondence from this person and will recognize some of these characteristics.

    The characteristics include:

    1. The author uses dashes ("-") in the writing of the date "09-11-01." Many people use the slash ("/") to separate the day/month/year.

    2. In writing the number one, the author chooses to use a formalized, more detailed version. He writes it as "1" instead of the simple vertical line.

    3. The author uses the words "can not," when many people prefer to spell it as one word, "cannot."

    4. The author writes in all upper case block-style letters. However, the first letter of the first word of each sentence is written in slightly larger upper case lettering. Also, the first letter of all proper nouns (like names) is slightly larger. This is apparently the author's way of indicating a word should be capitalized in upper case lettering. For whatever reason, he may not be comfortable or practiced in writing in lower case lettering.

    5. The names and address on each envelope are noticeably tilted on a downward slant from left to right. This may be a characteristic seen on other envelopes he has sent.

    6. The envelopes are of the pre-stamped variety, the stamps denoting 34 cents, which are normally available directly from the post office. They are not the traditional business size envelopes, but the smaller size measuring approximately 6 1/4" x 3 ½".

    BEHAVIORAL ASSESSMENT

    Based on the selection of Anthrax as the "weapon" of choice by this individual, the offender:

    • is likely an adult male.

    • if employed, is likely to be in a position requiring little contact with the public, or other employees. He may work in a laboratory. He is apparently comfortable working with an extremely hazardous material. He probably has a scientific background to some extent, or at least a strong interest in science.

    • has likely taken appropriate protective steps to ensure his own safety, which may include the use of an Anthrax vaccination or antibiotics.

    • has access to a source of Anthrax and possesses knowledge and expertise to refine it.

    • possesses or has access to some laboratory equipment; i.e., microscope, glassware, centrifuge, etc.

    • has exhibited an organized, rational thought process in furtherance of his criminal behavior.

    • has a familiarity, direct or indirect, with the Trenton, NJ, metropolitan area; however, this does not necessarily mean he currently lives in the Trenton, NJ, area.. He is comfortable traveling in and around this locale.

    • did not select victims randomly. He made an effort to identify the correct address, including zip code, of each victim and used sufficient postage to ensure proper delivery of the letters. The offender deliberately "selected" NBC News, the New York Post, and the office of Senator Tom Daschle as the targeted victims (and possibly AMI in Florida). These targets are probably very important to the offender. They may have been the focus of previous expressions of contempt which may have been communicated to others, or observed by others.

    • is a non-confrontational person, at least in his public life. He lacks the personal skills necessary to confront others. He chooses to confront his problems "long distance" and not face-to-face. He may hold grudges for a long time, vowing that he will get even with "them" one day. There are probably other, earlier examples of this type of behavior. While these earlier incidents were not actual Anthrax mailings, he may have chosen to anonymously harass other individuals or entities that he perceived as having wronged him. He may also have chosen to utilize the mail on those occasions.

    • prefers being by himself more often than not. If he is involved in a personal relationship it will likely be of a self serving nature.

    Pre-Offense Behavior

    • Following the events of September 11, 2001, this person may have become mission oriented in his desire to undertake these Anthrax mailings. He may have become more secretive and exhibited an unusual pattern of activity. Additionally, he may have displayed a passive disinterest in the events which otherwise captivated the Nation. He also may have started taking antibiotics unexpectedly.

    Post-Offense Behavior

    • He may have exhibited significant behavioral changes at various critical periods of time throughout the course of the Anthrax mailings and related media coverage. These may include the following;

    1. Altered physical appearance.
    2. Pronounced anxiety.
    3. Atypical media interest.
    4. Noticeable mood swings.
    5. More withdrawn.
    6. Unusual level of preoccupation.
    7. Unusual absenteeism.
    8. Altered sleeping and/or eating habits.

    These post-offense behaviors would have been most noticeable during critical times, including but not limited to: the mailing of the letters (09/18/01 and 10/09/01), the death of first Anthrax victim, media reports of each anthrax incident, and especially the deaths and illnesses of non-targeted victims.


    AGAIN, IF YOU HAVE CREDIBLE INFORMATION THAT MIGHT HELP IDENTIFY THIS PERSON, PLEASE CONTACT THE FBI IMMEDIATELY AT 1-800-CRIMETV
    (274-6388), AT WWW.IFCC.FBI.GOV, OR BY CALLING YOUR LOCAL FBI FIELD OFFICE. InfoJustice

     

  • CDC Prepares Teams to Respond to Possible Smallpox Outbreak

    CDC is taking steps to protect the public's health in case of an intentional release of smallpox. Teams – which include physicians, epidemiologists, laboratorians – have been vaccinated against smallpox and are attending readiness-training at CDC to identify and contain smallpox outbreaks. Each team could be immediately dispatched from CDC to assist local and state health departments if a case of this contagious disease is suspected. Smallpox is difficult to recognize because it was eradicated from the world more than 20 years ago. This is part of CDC's ongoing public health emergency response efforts. For more information, visit: http://www.bt.cdc.gov/DocumentsApp/ImprovingBioDefense/
    ImprovingBioDefense.asp
    .

    CDC confirmed cases of anthrax

    Summary of Local, State, and Federal Confirmed Human Cases and Exposures

    Case Status Florida New York City New Jersey Washington, DC Total
    Confirmed 2 5 5 5 17
        Cutaneous 0 4 3 0  
        Inhalational 2 1 2 5  
    Suspect 0 3 2 0 5
        Cutaneous 0 3 2 0  
        Inhalational 0 0 0 0  
    Total Cases         22

    There have been 4 deaths associated with inhalational anthrax.

    CDC confirmed cases are based on a rigorous case definition, which was published in CDC’s Morbidity and Mortality Weekly Report (MMWR) on October 19, 2001. The MMWR is available on-line at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5041a1.htm.

    CDC defines a confirmed case of anthrax as 1) a clinically compatible case of cutaneous, inhalational, or gastrointestinal illness that is laboratory confirmed by isolation of B. anthracis from an affected tissue or site or 2) other laboratory evidence of B. anthracis infection based on at least two supportive laboratory tests. CDC defines a suspect case as 1) a clinically compatible case of illness without isolation of B. anthracis and no alternative diagnosis, but with laboratory evidence of B. anthracis by one supportive laboratory test or 2) a clinically compatible case of anthrax epidemiologically linked to a confirmed environmental exposure, but without corroborative laboratory evidence of B. anthracis infection.

    CDC Telebriefings / Information

    Telebriefings regarding CDC activities and the anthrax investigations will be conducted during the entire month of November, on Monday through Friday, from Noon - 12:45 PM, EST. The toll-free number for these briefings is 1-866-254-5942. For the latest update on CDC activities and on-going anthrax investigations visit www.bt.cdc.gov or www.cdc.gov/od/oc/media.

     

  • CDC UDATE:

    CDC confirmed cases of anthrax

    Summary of Local, State, and Federal Confirmed Human Cases and Exposures

    Case Status Florida New York City New Jersey Washington, DC Total
    Confirmed 2 4 5 5 16
        Cutaneous 0 3 3 0  
        Inhalational 2 1 2 5  
    Suspect 0 4 2 0 6
        Cutaneous 0 4 2 0  
        Inhalational 0 0 0 0  
    Total Cases         22

    There have been 4 deaths associated with inhalational anthrax.

    CDC confirmed cases are based on a rigorous case definition which was published in CDC’s Morbidity and Mortality Weekly Report (MMWR) on October 19, 2001.   The MMWR is available on-line at:  http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5041a1.htm.

    CDC defines a confirmed case of anthrax as 1) a clinically compatible case of cutaneous, inhalational, or gastrointestinal illness that is laboratory confirmed by isolation of B. anthracis from an affected tissue or site or 2) other laboratory evidence of B. anthracis infection based on at least two supportive laboratory tests.  CDC defines a suspect case as 1) a clinically compatible case of illness without isolation of B. anthracis and no alternative diagnosis, but with laboratory evidence of B. anthracis by one supportive laboratory test or 2) a clinically compatible case of anthrax epidemiologically linked to a confirmed environmental exposure, but without corroborative laboratory evidence of B. anthracis infection.

    “Consumer Alert “ regarding antibiotics sold on-line
    Consumers who are visiting Web sites and receiving e-mail claiming to sell Ciprofloxacin (Cipro) and other antibiotics to treat anthrax should consult a new “Consumer Alert” before they buy products online, according to the Federal Trade Commission (FTC). The Alert, "Offers to Treat Biological Threats: What You Need to Know," was produced by the FTC, in conjunction with CDC and the Food and Drug Administration (FDA). The report is available online at www.ftc.gov/opa/2001/11/alert.htm

    Update: New York anthrax investigations and WTC survey
    The 61-year-old employee of Manhattan Eye, Ear, and Throat Hospital (MEETH) who contracted inhalation anthrax, died as a result of her illness. Thus far, all environmental samples from both MEETH, as well as the individual's home, have tested negative for the presence of anthrax.  At this point, the source of exposure to anthrax remains under investigation. As part of an on-going comprehensive epidemiological investigation, the New York City Department of Health, in collaboration with CDC, has interviewed over 250 co-workers and close contacts in an effort to establish a source of exposure. Further testing will be done at MEETH and in the individual's home. Results are not expected until later this week.

    As a precautionary measure the Health Department, working with Lenox Hill Hospital, has made antibiotics available to over 1,100 individuals who work in, visited, or were treated at MEETH since October 11. Nasal swabs have been limited to those individuals who worked in the immediate area of the deceased. Of the 28 nasal swabs, none tested positive for anthrax.

    The New York City Department of Health (DOH), in collaboration with CDC, is conducting a voluntary survey of lower Manhattan residents who have been affected by the World Trade Center disaster. DOH is administering this survey to address concerns and needs expressed by area residents pertaining to their mental and physical health. 

    For more information see www.ci.nyc.ny.us/html/doh/html/new/new.html.

    HHS/CDC staff deployment update (as of October 31, 2001)

    Washington, D.C.

    • 27 EIS Officers
    • 18 Epidemiologists
    • 15 Industrial Hygienists
    •   4 Laboratorians
    •   4 Media Specialists
    •   2 National Pharmaceutical Stockpile staff
    •   4 Nurses
    • 10 Public Health Advisors
    •   5 Public Health Prevention Specialists
    •   1 Medical Officer

    Trenton, N.J.

    •  7 EIS Officers
    •  5 Epidemiologists
    •  1 Industrial Hygienist
    •  1 Information Technology Specialist
    •  1 Media Specialist
    •  2 Public Health Advisors

    New York City (Anthrax)

    • 21 EIS Officers
    •  8 Epidemiologists
    •  4 Industrial Hygienists
    •  4 Laboratorians
    •  1 Media Specialist
    •  5 Public Health Advisors
    • 1 Public Health Prevention Specialists

    New York City (WTC)

    •  3 EIS Officers
    •  2 Industrial Hygienists

    Phoenix, AZ

    • 2 EIS Officers
    • 1 Epidemiologist

    West Palm Beach, FL

    • 4 EIS Officers
    • 3 Epidemiologists
    • 1 Industrial Hygienist
    • 1 Laboratorian
    • 1 Media Specialist
    • 1 Medical officer
    • 1 Public Health Advisor

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  • FDA PUBLIC HEALTH ADVISORY:
    UPDATE ON USE OF DOXYCYCLINE FOR ANTHRAX EXPOSURE

    Secretary of Health and Human Services Tommy G. Thompson announced on October 17 in testimony before the Committee on Governmental Affairs and Subcommittee on International Security, Proliferation and Federal Services of the United States Senate, that the Food and Drug Administration is approving new labeling for the use of several antibiotics to treat anthrax.

    The following is being issued to provide healthcare providers with clarification on dosing regimens about doxycycline. In addition, FDA is developing more information about the use of this and other antibiotics to treat anthrax and will provide this information soon.

    Doxycycline is approved for the treatment of anthrax in all its forms. The FDA is providing additional information concerning the dosing regimen for the treatment of anthrax, including cutaneous and inhalation anthrax (post-exposure). The currently recommended dosage regimen of doxycycline for severe disease is 100 mg every 12 hours for adults and 1mg per pound (2.2mg per kilogram) every 12 hours for children less than 100 pounds. These dosage regimens are appropriate for use in patients who have been exposed to anthrax (Bacillus anthracis) regardless of the route of exposure.

    FDA and other health authorities strongly discourage individuals from taking any antibiotic for prevention of anthrax without the specific advice of a physician and a clear indication that exposure to the organism may have occurred.

  • Marketer of Dietary Supplement Purporting to Treat Liver Diseases Agrees to Settle FTC Charges:

Must Have Adequate Scientific Evidence in the Future

Liverite Products, Inc., based in Tustin, California, its two principals, and two other individuals agreed to settle Federal Trade Commission charges that they made numerous unsubstantiated claims in Internet, radio, and print ads about the ability of "Liverite" dietary supplement products to treat or prevent a wide range of liver diseases or disorders, including cirrhosis and hepatitis. In an agreement to settle the charges, Liverite Products, Inc. and its principals will be required to pay $60,000 in redress, and all of the defendants will be prohibited from claiming that the Liverite products or any food, drug or dietary supplement treats, cures or prevents any disease or disorder, unless they have scientific evidence to support the claims.

The FTC's complaint names Liverite Products, Inc., Corinne and Steven Jacobson, and James and Sheri Grant. According to the complaint, defendants Corinne and Steven Jacobson direct and control Liverite Products, and defendants James and Sheri Grant developed the websites through which the Liverite products were advertised and sold. The Liverite products included: Liverite, the Ultimate Liver Aid; Liverite 3 in 1 for Men; Liverite 3 in 1 for Women; and Liverite Sports. The primary ingredient in each of these products was extract of beef liver. The products were sold at retail outlets, such as GNC and CVS, by telephone, and on the Internet at "liverite.com," "liveriteproducts.com," and "healthylifemarketing.com."

According to the FTC's complaint, the defendants' advertisements represented that Liverite can prevent and treat hangovers; prevent and treat alcohol-induced liver disease, including cirrhosis; treat liver diseases, including cirrhosis and hepatitis; and alleviate the toxic side effects of various drugs. The FTC complaint alleges that these representations were not supported by competent and reliable scientific evidence. The complaint further alleges that the defendants falsely claimed that clinical tests proved that Liverite is effective for the treatment of liver problems.

In addition to the defendants' advertisements that made unsubstantiated claims, the defendants also used "metatag" technology to deceive consumers. Metatags are key words embedded in the source code for a webpage that are invisible to the average consumer, but are used by search engines to respond to consumers' search requests. The complaint also alleges that the defendants embedded in the metatags of the Liverite websites terms such as AIDS, hepatitis A, B & C, liver problems, liver disease, liver detoxification, alcohol, hangover, cirrhosis, anabolic steroids, interferon, and hepatatoxicity, thereby increasing the likelihood that consumers who researched these topics on the Internet would be directed to defendants' websites.

The proposed stipulated final order, which requires the court's approval, will require the defendants to have scientific substantiation that the Liverite products or any food, drug, or dietary supplement:

is effective in the prevention and treatment of hangovers and liver damage due to alcohol consumption, cirrhosis or hepatitis;
 
is effective in the treatment of cirrhosis, hepatitis, damaged liver, and candida imbalance;
 
is superior to traditional treatments for hepatitis C;
 
lowers or regulates liver enzymes, restores liver cell integrity, and improves liver function;
 
prevents liver damage and other side effects from use of pain killers, allergy medications, prescription drugs, interferon, medications used for Hepatitis C and HIV, immuno-suppressant drugs, chemotherapeutic drugs, cholesterol-lowering drugs, and anabolic steroids;
 
protects and detoxifies the liver from toxins in the diet and environment; and  
reduces body fat.

The proposed stipulated final order also will require the defendants to possess scientific substantiation for claims that any food, drug or dietary supplement can treat, cure, alleviate the symptoms of, prevent, or reduce the risk of developing any disease or disorder. In addition, the defendants cannot claim that any Liverite product is "the ultimate liver aid," unless the claim is scientifically substantiated. The defendants also will be prohibited from misrepresenting the results of any test or study, and will be prohibited from misrepresenting that any testimonial or endorsement is the typical or ordinary experience of users of the advertised product, unless the claim is substantiated. Finally, the order requires Liverite Products, Inc. and the Jacobsons to pay $60,000.

The order would allow the defendants to make any claims that are approved for labeling by the Food and Drug Administration. The order also includes various recordkeeping and reporting requirements to help the FTC monitor the defendants' compliance with the order.

The Commission vote to authorize staff to file the complaint and proposed stipulated final order was 5-0. They were filed in the U.S. District Court for the Central District of California, Southern Division, in Santa Ana, on August 20, 2001, and require the court's approval.

  • NEW JOINT PROGRAM ANNOUNCED BY FDA AND NCI HOLDS PROMISE FOR CANCER

    The Food and Drug Administration (FDA) and the National Cancer Institute (NCI) announced today a new joint research and clinical program that holds great promise for developing better and more targeted treatments for cancer. The new program, called the Clinical Proteomics Program, melds the study of all proteins in living cells (or proteomics) to the clinical care of patients, the first time this new research technology has been applied directly to patient care.

    "This new approach to treatment holds the potential to revolutionize cancer detection and care," said Health and Human Services Secretary Tommy G. Thompson. "With this expanded collaboration, the FDA and NCI are employing powerful, new technologies they developed jointly." The agency collaboration began in 1997 and is led by Emanuel Petricoin, Ph.D., of FDA's Center for Biologics Evaluation and Research (CBER), and Lance Liotta, M.D. Ph.D., of NCI's Center for Cancer Research.

    The new Clinical Proteomics Program, funded for three years with $1.1 million per year, begins in the laboratory with recently developed tools capable of rapidly scanning cells for hundreds of proteins at once. Petricoin and Liotta have also created new technologies to generate protein fingerprints that may provide early warning of drug side effects. In addition, they have already invented or refined several key technologies used in proteomic analysis.

    "The great challenge now in proteomics research is to begin to apply these technologies to clinical care," said Petricoin. "We hope to take these techniques out of the lab to assess their benefit for people with cancer, in a true bench-to-bedside clinical research program."

    "The potential payoffs for this program are great, said Liotta. "Everything we learn while refining these cutting-edge technologies will benefit cancer patients and the people trying to help them.

    Potential benefits include:

    • developing individualized therapies using targeted treatments that have been predetermined to be effective for each patient;
    • determining the toxic and beneficial effects of treatments first in the lab before using them in patients;
    • diagnosing cancer earlier than is now possible;
    • improving the understanding of tumors at the protein level, leading to better treatments.

    Petricoin and Liotta have identified more than 130 proteins in cancers of the breast, ovary, prostate, and esophagus that change in amount as the cells in these tissues grow abnormally, which may provide new means of diagnosing and treating cancers earlier.

    The first step to take these techniques out of the lab to benefit patients has begun with the new FDA/NCI collaborative program. Through the Clinical Center at NIH, biopsied cells from cancer patients before and after treatment are extracted using a special microscope invented in Liotta's laboratory. The microscope allows them to isolate pure normal cells, pre-cancerous cells, and tumor cells from the same patient. By capturing cells directly from the tissue, the original protein pattern of the cells is maintained, which is not the case with traditional methods of isolating cells.

    Next, the scientists are analyzing the patterns of proteins in the extracted tumor cells after the patient has been treated. For instance, the researchers are trying to determine how a particular treatment changes the pattern of the proteins in a cell or whether the protein patterns change if the tumor returns after treatment.

    The NCI has recently begun clinical trials using proteomics to help make decisions about the course of the patients' experimental treatments.

     

  • BAYER VOLUNTARILY WITHDRAWS BAYCOL

    FDA today announced that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports this decision.

    Baycol (cerivastatin), which was initially approved in the U.S. in 1997, is a member of a class of cholesterol lowering drugs that are commonly referred to as "statins." Statins lower cholesterol levels by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. While all statins have been associated with very rare reports of rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have been reported significantly more frequently than for other approved statins.

    Fatal rhabdomyolysis reports with Baycol have been reported most frequently when used at higher doses, when used in elderly patients, and particularly, when used in combination with gemfibrozil (LOPID and generics), another lipid lowering drug. FDA has received reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol, 12 of which involved concomitant gemfibrozil use.

    Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body.

    Most frequently the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury. In rare cases the muscle injury is so severe that patients develop renal failure and other organ failure, which can be fatal.

    Bayer Pharmaceutical Division has announced plans to withdraw Baycol to the pharmacy level. Pharmacies will be instructed to return the product to the manufacturer for a refund.

    Patients who are taking Baycol should consult with their physicians about switching to alternate medications to control their cholesterol levels. Patients taking Baycol who are experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol immediately and consult their physician.

    There are five other statins available in the U.S. that may be considered as alternatives to Baycol. They are: lovastatin (Mevacor), pravastatin (Pravachol), simvastatin (Zocor), fluvastatin (Lescol), and atorvastatin (Lipitor).

    For further information regarding the withdrawal of Baycol, patients and physicians can contact Bayer Customer Service 1-800-758-9794 or the FDA's Drug Information Office at 301-827-4573 or 1-888-INFO-FDA, or go to "Baycol Information" on FDA's Website.

  • FDA CLEARS CAMERA PILL TO PHOTOGRAPH SMALL INTESTINE

    FDA today cleared for marketing a swallowable capsule containing a tiny camera that snaps pictures twice a second as it glides through the small intestine.

    The product represents a technological advance in methods of examining the gastrointestinal tract.

    The device, made by Given Imaging Ltd., an Israeli company with North American headquarters in Norcross, Ga., is intended to visualize the inside of the small intestine to detect polyps, cancer, or causes of bleeding and anemia.

    Currently the standard method of detecting abnormalities in the intestines is through endoscopic examination in which doctors advance a scope down into the small intestine via the mouth. However, these scopes are unable to reach through all of the 20-foot-long small intestine, and thus provide only a partial view of that part of the bowel.

    The camera capsule is designed to take photos of the entire small intestine, enabling doctors to see areas that the endoscope cannot reach.

    The device, called the Given Diagnostic Imaging System, comes in capsule form and contains a camera, lights, transmitter and batteries. The capsule has a clear end that allows the camera to view the lining of the small intestine.

    The patient swallows the capsule, and the natural muscular waves of the digestive tract propel it forward through the stomach, into the small intestine, through the large intestine, and then out in the stool. The capsule transmits the images to a data recorder, which is worn on a belt around the patient's waist. The physician then transfers the stored data to a computer for processing and analysis.

    The battery has an expected life of eight hours, which is generally long enough to photograph the small intestine, but not long enough to photograph the entire gastrointestinal tract.

    FDA cleared the device based on both animal and clinical studies of safety and effectiveness conducted by the manufacturer. In one of the human trials, Given Imaging studied the use of the camera capsule in patients with suspected small intestine disease. All patients had signs of either unexplained chronic gastrointestinal blood loss or anemia. All had undergone standard endoscopic and radiological evaluations prior to receiving the capsule.

    Study results showed that the camera pill was safe, without any side effects, and was able to detect abnormalities in the small intestine, including parts that cannot be reached by the endoscope.

    FDA cleared the device for use along with--not as a replacement for--other endoscopic and radiological evaluations of the small bowel. The capsule was not studied in the large intestine.
    The product is available by prescription only.

     

  • Merrill Settles Suit Over Blodget's Stock Call
     
    Merrill Lynch & Co. settled a high-profile arbitration case brought by a former client who claimed he was misled by a bullish stock call by technology-stock analyst Henry Blodget, potentially paving the way for similar actions by other aggrieved investors, Friday's Wall Street Journal reported.

    The nation's largest brokerage firm agreed to pay $400,000 to Debases Kanjilal, a 46-year-old pediatrician, capping a case he filed in March with the New York Stock Exchange, according to people with knowledge of the matter. In the civil case, Mr. Kanjilal contended that Mr. Blodget maintained a "buy" recommendation on InfoSpace Inc., an Internet stock, to support a lucrative financial deal for Merrill. Mr. Kanjilal said he had a loss of about $500,000, following Mr. Blodget's advice.

    The case could have broader ramifications for the brokerage business, which has come under pressure in recent months for conflicts involving often-bullish research it provides to investors.

    Arbitration cases have no precedential value, of course, and investors would have had to have suffered big losses to make it worthwhile for them to pursue similar claims against Wall Street firms or analysts.

    Still, by settling the matter, Merrill (MER) could open the door for more legal action by investors who believe they were burned by snapping up shares of once-highflying technology stocks hyped by, among other things, aggressive buy recommendations by analysts. In most cases, Wall Street firms only made minimal disclosures about any potential conflicts, including lucrative investment-banking relationships with firms whose stocks they were touting.

  • Foreign and Domestic Investors-Merrill Lynch: A Bunch Of Bull-Abandons the small investor leaving them victims to fraud-PART II

Within 24 hours of this expose', the guilty credit card scheme is revealed, and confession by a "nineteen year old" Internet executive is made absent any work or help from Merrill Lynch; inconsistent though demonstrative of the positive influence of this press.  More soon on this Merrill Lynch investor case; InfoJustice.

  • Foreign and Domestic Investors-Merrill Lynch: A Bunch Of Bull-Abandons the small investor leaving them victims to fraud!

An investor advised that they had a small account approximately $15,000.  They received their statement on this past Friday and noted they were down $2,000. and their were fraudulent charges on a Merrill Lynch Visa.   When the investor called on Monday morning, they were informed that Merrill Lynch made a International decision to send all class one investors to a team of specialists which is better than a broker.  When the investor explained they only went to Merrill Lynch for the benefit of a local neighborhood broker and not a team in New Jersey (the investor account was in Los Angeles) he was told in essence "tough bounce" (Well there goes the investors Roth Ira?).  The Torrance branch refused to discuss the fact that a fraud had been found and would not help.  They then claimed this was on the most recent statement.  The investor revealed the fraud was on the most recent statement and that there was no mention of Merrill Lynch abandoning investors.  Well, our investor caught this slight of hand tactic, and it will be next month allegedly that the "Big Bull" will inform investors.  Yet Merrill Lynch refused to help our investor catch the fraud prior to his notification of any Merrill Lynch Corporate changes to this families hard earned monies. 

     Our investor then called the corporate offices of Merrill Lynch in New York only to find one cannot complain to the President as "he has no phone"!.  In fact they have no mechanism or internal affairs to investigate mismanagement or internal fraud!  After many more calls he was forwarded to Merrill Lynches attorney and their Credit Card Fraud investigators (fine retired New York PD detectives).  Finally our investor found the facts.  The Detective explained that our investor contact the fraudulent credit card office (which they did and file a complaint) and cancel the card.  Then the complaint comes to him!  They further had to send a letter to the "Big Bully-Lynch" about the fraudulent charge (which they did).  Further the retired detective advised that this had just happened to him, but he lives in New Jersey and does not mind the local call.  He further advised that Merrill Lynch is in my language, dumping anyone they considered a small investor to this non-preferred system of dealing with computers, long lines of callers ahead of you to purchase/sell funds, report missing money and answer machines in lieu of a Broker.

     Thus only through our investors own vigilance will the credit card fraud or error (which ever) be eliminated and their money returned.  The Torrance branch manager refused to take our civilian investors calls or return the call as it would not make big dollars for the bull; obviously.  Yet my question's remain.  Were is the investors missing money, and to what end will they have to go to have their entire account reviewed with the "governing bodies" and establish corporate abandonment of services and a form of "internal/corporate fraud"? Lets face it this is a clear case where the investor sought out a Broker account and was bait and switched into a "team of experts" manned by answer phones, long lines on the telephone (you are caller number 109 please hold on to discuss your Merrill Lynch Loses) and failure to have any control or policing of investments.  The investor advises numerous failures such as inability to get requested deposit slips with I.D. and account number on them for one year, and numerous occasions where similar funds in others accounts failed to post similar loses, and deposited moneys earmarked for select stock purchases were not made and moneys went to margins

     International investors, beware, if you have a problem in your country you will never get any action if you have a problem and invest in Merrill Lynch.   Domestic investors watch your money like a hawk and get the heck out of Merrill Lynch or you to may get caught up in a bunch of Bull.  It amazes this examiner what companies will do when earnings are down: (Editor's note.   The following day after this article was posted, Merrill Lynch announced lower earnings expected in august-MOTIVE to lower internal costs such as broker volume at the expense of investors.  Transactions down 41%, and believes third quarter worse.   Standard @ drops Merrill Lynch ratting to "Poor" noting a cost side cut into profits; cutting cost by laying off the work force through select staff reduction no matter how it affects its investors. So much for the Merrill Lynch mission to advise investors to their best interests;inconsistent ) InfoJustice

  • FTC Announces a Second Case Focusing on Safety Risks of Comfrey Products Promoted via Internet  

    The Federal Trade Commission today is announcing a second case challenging the marketing and selling of unproven and dangerous comfrey products via the Web, as part of its ongoing and comprehensive "Operation Cure.All" initiative. The target of today's action is Western Botanicals, Inc., a Fair Oaks, California company that manufactured and marketed a variety of products containing the herbal ingredient comfrey, for both external and internal uses. The FTC charges that the company made unfounded claims that the products were beneficial in the treatment of a wide variety of serious diseases and health conditions, and that they were safe. In fact, comfrey contains toxic substances and, when taken internally, can lead to serious liver damage, according to the FTC. Western Botanicals has agreed, in a stipulated permanent injunction filed in federal court, to stop marketing comfrey products for internal uses or on open wounds, and to include a warning on comfrey products marketed for external uses. It has also agreed to stop making the challenged safety and health benefit claims.

    "The Internet is a powerful tool for consumers searching for health information," said Howard Beales, Director of the FTC's Bureau of Consumer Protection. "Unfortunately, it's also an outlet for unscrupulous marketers who use deceptive promotions to peddle their products. Consumers who delay or forego treatment while using unproven products that promise miracles can increase their health risks unnecessarily."

    According to the FTC, Western Botanicals, its president, Randy C. Giboney, and vice-president, Kyle D. Christensen, marketed and sold herbal products containing comfrey to distributors and directly to consumers by mail, newsletters, and on the Internet at www.westernbotanicals.com. The products purportedly treated and alleviated symptoms of various diseases and health conditions. In their advertising and promotional materials the defendants represented their comfrey products were safe for consumers, including nursing women, when taken internally or applied to open wounds. The defendants also claimed that their comfrey products, when taken internally, would treat chronic bronchial diseases, gastritis, duodenal ulcers, colitis, rheumatism, arthritis, osteoporosis, multiple sclerosis, amyotrophic lateral sclerosis and other conditions. The FTC alleges that the defendants' representation that their comfrey products were safe is false, and that they did not have scientific evidence to substantiate their safety or efficacy claims.

    The defendants have agreed to a stipulated final order for permanent injunction to resolve the FTC allegations. The stipulated final order would prohibit them from marketing any comfrey product for ingestion, for use as a suppository, or for external use on open wounds, unless they have evidence that the product is free of pyrrolizidine alkaloids and is safe. They would also be required to place the following disclosure warning in any advertisement, promotional material or product label for any comfrey products intended for topical use:

    WARNING: External Use Only. Consuming this product can cause serious liver damage. This product contains comfrey. Comfrey contains pyrrolizidine alkaloids, which may cause serious illness or death. This product should not be taken orally, used as a suppository, or applied to broken skin. For further information contact the Food and Drug Administration: http//vm.cfsan.fda.gov

    In addition, the order would prohibit the defendants from making the specific health claims challenged in the complaint or any unsubstantiated representations about the safety, health benefits, performance, or efficacy of any food, drug, dietary supplement or other health-related product or service. The order further would require them to notify their distributors that unsubstantiated claims violate the law and that the defendants will terminate distributors who make false or unsubstantiated claims. The stipulated order includes a suspended judgment of $50,800 and a right to reopen provision that would reinstate the judgment if the court finds that the defendants made material misrepresentations or omissions on their financial statements. Finally, the order includes various recordkeeping and reporting requirements designed to assist the FTC in monitoring the defendants' compliance.

    On Friday July 6, 2001, the Food and Drug Administration issued a letter to industry communicating concern about the safety of supplement products containing comfrey. FDA's letter, which has been sent to trade associations and other industry groups, advises that, because comfrey contains certain toxic substances - pyrrolizidine alkaloids - that have been associated with liver damage and other health hazards, it should not be used as an ingredient in supplements. FDA further recommends that firms immediately stop marketing comfrey-containing supplements and alert consumers to stop using the products. Finally, FDA is urging manufacturers to identify and report any adverse events, including liver disorders, that have been associated with comfrey and other ingredients containing pyrrolizidine alkaloids. The letter is also posted on FDA's website at  www.cfsan.fda.gov

    The Food and Drug Administration has been a close partner of the FTC and assisted the agency in today's enforcement action, as well as many other aspects of "Operation Cure.All." The FTC also thanks the Texas Department of Health for its participation in this phase of "Operation Cure.All."

    The Commission vote authorizing staff to file the complaint and proposed stipulated judgment in the Western Botanicals case was 5-0. They were filed in the U.S. District Court, Eastern District of California, in Sacramento, on July 11, 2001. The proposed judgment is subject to court approval.

  • CDC WARNS ABOUT EXTREME HEAT

    Each year more people in the United States die from extreme heat than from hurricanes, lightning, tornadoes, floods, and earthquakes combined. During 1979-1998, a total of 7,421 deaths that occurred in this country were attributed to excessive heat exposure. On average approximately 300 people die each year from exposure to heat. This year extreme heat is of particular concern because of the energy problems facing many areas of the country. Air conditioning is the number-one protective factor against heat-related illness and death. Brownouts that last a few hours will likely have little effect on people’s health. However, some people may be fearful of high utility bills and limit their use of air conditioning. Such action can place people who are already at risk for heat illness at increased risk. You can help by learning the warning signs of heat stroke and heat exhaustion and then checking on your neighbors frequently.

  • FDA Issues Guidance on Levothyroxine Sodium Products Compliance

    The Food and Drug Administration today published a guidance for industry explaining how the agency plans to handle oral levothyroxine sodium products that are being marketed without an approved application after August 14, 2001.

    On August 14, 1997, FDA announced in the Federal Register (62 FR 43535) that orally administered levothyroxine sodium drug products are "new drugs" and that manufacturers who wish to continue marketing these products must submit a new drug application (NDA) for approval. The agency based its decision on a history of potency and stability problems with orally administered levothyroxine sodium products. The notice stated that after August 14, 2000, any unapproved levothyroxine sodium drug product on the market would be subject to regulatory action by FDA.

    On April 26, 2000, FDA extended the deadline to August 14, 2001. As of July 2001, two levothyroxine sodium products have been approved by FDA to treat hypothyroidism. Unithroid, manufactured by Jerome Stevens Pharmaceuticals, was approved on August 21, 2000. Levoxyl, manufactured by Jones Pharma, was approved on May 25, 2001. Now that two products have been approved, FDA is issuing guidance regarding the transition of patients from unapproved to approved products.

    Because there is no public health emergency that requires an immediate switch to the approved drugs, FDA has established a gradual phase out of distribution of the unapproved products to allow manufacturers of approved products to scale up to meet demand and to allow adequate time for patients and health care providers to make an orderly transition from unapproved to approved products.

    On August 14, 2001, there will be two types of unapproved marketed levothyroxine sodium products: (1) those with NDAs that have been submitted to FDA and are under review and (2) those with no pending NDAs.

    Under the phase out outlined in the guidance, manufacturers of unapproved oral levothyroxine sodium drug products with NDAs pending as of August 14, 2001, should reduce the distribution of these products according to an incremental reduction of average monthly distribution. This phase-out schedule is explained in the guidance. By August 14, 2003, all distribution of unapproved oral levothyroxine sodium products must cease.

    Manufacturers of unapproved oral levothyroxine sodium drug products who do not have an NDA pending with the FDA by August 14, 2001, should cease distribution of their products by that date or they will be subject to regulatory action.

  • OPERATION CURE.ALL WAGES NEW BATTLE IN THE ONGOING WAR AGAINST INTERNET HEALTH FRAUD

    FTC, USFDA and other law enforcement agencies move to stop Internet schemes for scam and sham products that purport to cure cancer, HIV/AIDS and countless other life-threatening diseases.

  • FDA ISSUES A NATIONWIDE ALERT ON THE RECALL OF THIRTEEN "TREASURE OF THE EAST" HERBAL PRODUCTS BECAUSE OF POSSIBLE HEALTH RISK

    The FDA is warning consumers to discontinue use of thirteen Chinese herbal products containing aristolochic acid because they may present a serious health hazard to consumers. Aristolochic acid found in certain plants and botanicals is toxic to the kidneys and is a potent carcinogen. This chemical can cause serious kidney damage and the use of products that contain aristolochic acid has been associated with several occurrences of kidney failure. The use of aristolochic acid-containing products has also been linked to increased risk of kidney cancer in people who have consumed it.

    Blue Light, Inc., Ithaca, N.Y., has initiated a recall of these products sold under the "Treasure of the East" label with "MFG No. 200008" (2000=year, 08=month) and earlier production dates. Products with "MFG No. 200009" and later production dates are not affected.

    Products include:

    Item # Single-ingredient
    100176-0 Guan) Mu Tong
    100644-2 Ma Dou Ling (Mi)
    Item # Herbal combinations
    B015 Ba Zheng San
    D060 Dang Gui Si Ni Tang
    D075 Dao Chi San
    F050 Fu Fang Di Hu Tang
    G005 Gan Lu Xiao Du Dan
    K030 Kou Yan Ning
    L070 Long Dan Xie Gan Tang
    P005 Pai Shi Tang
    X072 Xiao Ji Yin Zi
    X125 Xin Yi San
    Y020 Yang Yin Xiao Yan Tang

    These products were distributed nationwide in small quantities primarily to acupuncturists, herbalists, and herbal stores. They are in powder form (3.5 oz. bottles) or capsule form (100 per bottle) under the "Treasure of the East" label.

    The recall was initiated as a result of public health concerns associated with the consumption of aristolochic acid products. No illnesses have been reported. Blue Light, Inc., has discontinued the distribution and use of products that may contain aristolochic acid.

    Consumers who have purchased any of these products with affected expiration dates should discontinue their use and may return them to place of purchase for a full refund. Consumers with questions may contact the company at 1-888-258-3548.

  • FDA APPROVES TWO NEW INTRAOCULAR PRESSURE LOWERING DRUGS FOR THE MANAGEMENT OF GLAUCOMA

    The Food and Drug Administration (FDA) announced the approval of two new drugs to treat the elevated intraocular pressure which is often associated with glaucoma - Lumigan (bimatoprost ophthalmic solution) 0.03% and Travatan (travoprost ophthalmic solution) 0.004%. They will provide additional alternatives for the reduction of intraocular pressure in patients who are intolerant of other intraoular lowering medications, or in patients who have had insufficient responses to other intraocular pressure lowering medications. Many of these patients might otherwise need surgery for management of their glaucoma.

    Glaucoma, a leading cause of irreversible blindness in the world, is the second most common cause of blindness in the United States. Glaucoma represents a family of diseases commonly associated with optic nerve damage and visual field changes (a narrowing of the eyes’ usual scope of vision). Elevated intraocular pressure is a primary risk factor for glaucoma.

    "Glaucoma is a serious eye disease affecting some two million older Americans," said Health and Human Services Secretary Tommy G. Thompson. "Early detection of glaucoma and management of raised eye pressure can usually prevent vision loss. These new drugs provide additional treatment alternatives to preserve vision as well as preserve an individual’s quality of life."

    In separate clinical trials, Lumigan and Travatan had similar effects in lowering intraocular pressure. Higher intraocular pressures greatly increase the risk of optic nerve damage and vision loss.

    Side effects associated with Lumigan and Travatan may include gradual darkening of eye color, darkening of eyelid skin, and increased thickness, number, and darkness of eyelashes.

    The availability of multiple medical alternatives provides physicians with additional treatment options for their patients whose glaucoma is difficult-to-manage.

    Lumigan will be marketed by Allergan, Inc. of Irvine, California. Travatan will be marketed by Alcon Universal, Ltd of Fort Worth, Texas.

     

  • NEWLY FORMULATED DTaP (DIPHTHERIA, TETANUS, AND PERTUSSIS) VACCINE APPROVED WITH ONLY TRACE AMOUNTS OF THIMEROSAL

    Today, the FDA approved a newly formulated version of Tripedia, a diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine without preservatives and with only a trace amount of thimerosal.

    "This approval is significant because now all routinely recommended pediatric vaccines will be available as either completely thimerosal free or without any significant amounts of thimerosal, a preservative that contains mercury," said Dr. Bernard Schwetz, Acting Principal Deputy Commissioner. "Although thimerosal is a very effective preservative, the Public Health Service recommended that thimerosal should be reduced or eliminated from vaccines as soon as possible to minimize the exposure of infants and young children to mercury."

    Tripedia now contains less than 0.5 micrograms of mercury per dose, a greater than 95% reduction in the amount of thimerosal per dose compared to the original version of Tripedia.

    The pediatric vaccines that are recommended for routine use are: DTaP, hepatitis B, Haemophilus conjugate (Hib), pneumococcal conjugate, inactivated poliovirus, varicella, measles, mumps and rubella. Since 1999, pediatric formulations of hepatitis B vaccines that either contain no thimerosal (Recombivax HB) or trace amounts (EngerixB) have been approved.

    In recent years, various federal agencies have been addressing the health risks of mercury, which is found in the environment, in food and in household products. Although no harmful effects have been reported from thimerosal at doses that were used in vaccines, the PHS agencies, the American Academy of Pediatrics, and vaccine manufacturers agreed that thimerosal should be reduced or eliminated in vaccines to make already safe vaccines even safer.

     

  • FBI ARRESTS AGENT FOR ESPIONAGE    

  • Attorney General John Ashcroft, FBI Director Louis J. Freeh and United States Attorney Helen Fahey announced today that a veteran FBI counterintelligence Agent was arrested Sunday by the FBI and charged with committing espionage by providing highly classified national security information to Russia and the former Soviet Union.

    At the time of the arrest at a park in Vienna, Virginia, Robert Philip Hanssen, age 56, was clandestinely placing a package containing highly classified information at a pre-arranged, or "dead drop," site for pick-up by his Russian handlers. Hanssen had previously received substantial sums of money from the Russians for the information he disclosed to them.

    FBI Director Louis J. Freeh expressed both outrage and sadness. He said the charges, if proven, represent "the most serious violations of law -- and threat to national security."

    "A betrayal of trust by an FBI Agent, who is not only sworn to enforce the law but specifically to help protect our nation's security, is particularly abhorrent. This kind of criminal conduct represents the most traitorous action imaginable against a country governed by the Rule of Law. It also strikes at the heart of everything the FBI represents -- the commitment of over 28,000 honest and dedicated men and women in the FBI who work diligently to earn the trust and confidence of the American people every day."

    "These kinds of cases are the most difficult, sensitive and sophisticated imaginable. I am immensely proud of the men and women of the FBI who conducted this investigation. Their actions represent counterintelligence at its very best, reflecting dedication to both principle and mission. It is not an easy assignment to investigate a colleague, but they did so unhesitatingly, quietly and securely."

    Hanssen was charged in a criminal complaint filed in Federal court in Alexandria, Virginia, with espionage and conspiracy to commit espionage, violations that carry a possible punishment of life in prison, and under certain circumstances, the death penalty. Following the arrest, FBI Agents began searching Hanssen's residence, automobiles and workspace for additional evidence.

    A detailed affidavit, filed in support of the criminal complaint and search warrants, provides a troubling account of how Hanssen first volunteered to furnish highly sensitive documents to KGB intelligence officers assigned to the Soviet embassy in Washington, D.C. The affidavit chronicles the systematic transfer of highly classified national security and counterintelligence information by Hanssen in exchange for diamonds and cash worth more than $600,000. Hanssen's activities also have links to other, earlier espionage and national security investigations including the Aldrich Ames and Felix Bloch cases, according to the affidavit.

    The affidavit alleges that on over 20 separate occasions, Hanssen clandestinely left packages for the KGB, and its successor agency, the SVR, at dead drop sites in the Washington area. He also provided over two dozen computer diskettes containing additional disclosures of information. Overall, Hanssen gave the KGB/SVR more than 6,000 pages of valuable documentary material, according to the affidavit.

    The affidavit alleges that Hanssen compromised numerous human sources of the U.S. Intelligence Community, dozens of classified U.S. Government documents, including "Top Secret" and "codeword" documents, and technical operations of extraordinary importance and value. It also alleges that Hanssen compromised FBI counterintelligence investigative techniques, sources, methods and operations, and disclosed to the KGB the FBI's secret investigation of Felix Bloch, a foreign service officer, for espionage.

    Freeh said that although no formal damage assessment could be conducted before the arrest without jeopardizing the investigation, it is believed that the damage will be exceptionally grave.

    During the time of his alleged illegal activities, Hanssen was assigned to New York and Washington, D.C., where he held key counterintelligence positions. As a result of his assignments, Hanssen had direct and legitimate access to voluminous information about sensitive programs and operations. As the complaint alleges, Hanssen effectively used his training, expertise and experience as a counterintelligence Agent to avoid detection, to include keeping his identity and place of employment from his Russian handlers and avoiding all the customary "tradecraft" and travel usually associated with espionage. The turning point in this investigation came when the FBI was able to secure original Russian documentation of an American spy who appeared to the FBI to be Hanssen, which subsequent investigation confirmed.

    Freeh said the investigation that led to the charges is a direct result of the combined and continuing FBI/CIA effort ongoing for many years to identify additional foreign penetrations of the U.S. intelligence community. The investigation of Hanssen was conducted by the FBI with direct assistance from the CIA, Department of State and the Justice Department, and represents an aggressive and creative effort which led to this counterintelligence success. Freeh said, "We appreciate the unhesitating leadership and support of Attorney General John Ashcroft from the moment he took office."

    Freeh also expressed his gratitude to Helen Fahey, United States Attorney for the Eastern District of Virginia, Assistant United States Attorney Randy Bellows, and senior Justice Department officials Robert Mueller, Frances Fragos Townsend, John Dion and Laura Ingersoll for their contributions to the case.

    United States Attorney Fahey said, "In the past decade, it has been our unfortunate duty to prosecute a number of espionage cases -- Ames, Pitts, Nicholson, Squillacote, Kim, Boone, and others. With each case, we hope it will be the last. Today, however with the arrest of Robert Hanssen, we begin again the process of bringing to justice a U.S. Government official charged with the most egregious violations of the public trust. The full resources of the Department of Justice will be devoted to ensuring that those persons who would betray their country and the people of the United States are prosecuted and severely punished."

    "I want to express my appreciation for the outstanding work done by the National Security Division and the Washington Field Office of the FBI in this investigation. Their superlative work in this extraordinarily sensitive and important investigation is testament to their professionalism and dedication. We also express our deep appreciation for the outstanding assistance provided by the Internal Security Section of the Criminal Division of the Department of Justice."

    Freeh and CIA Director George Tenet kept the Intelligence Committees of Congress, because of the clear national security and foreign policy implications, informed about the case.

    As a result of Hanssen's actions, Freeh has ordered a comprehensive review of information and personnel security programs in the FBI. Former FBI Director and Director of Central Intelligence William H. Webster will lead the review. Webster, currently in private law practice, brings a "unique experience and background in government management and counterintelligence," Freeh said. "Moreover, the respect he enjoys throughout the intelligence community and elsewhere in government is second to none. Judge Webster will have complete access and whatever resources that are necessary to complete the task and will report directly to Attorney General Ashcroft and me. I will share his report with the National Security Council and then Congress as well," Freeh said.

  • SUDDEN CARDIAC DEATHS ARE INCREASING IN YOUNG PEOPLE, ESPECIALLY AMOUNG YOUNG WOMEN

    San Antonio — Yearly death totals of sudden cardiac death (SCD) in people between the ages of 15 and 34 rose 10% overall during the past decade — from 2,719 in 1989 to 3,000 in 1996, according to data presented by researchers from the Centers for Disease Control and Prevention (CDC) during the American Heart Association’s 41st Annual Conference on Cardiovascular Disease Epidemiology and Prevention, in San Antonio, Texas.

    Alarmingly, although the numbers are very small, the SCD death rate increased by 30% in young women. Death rates were also higher among young African-Americans than whites.

    "We can’t fully explain this increase in SCD among young people, particularly young women," said CDC Director Jeffrey Koplan, M.D., M.P.H. "However, smoking cigarettes, obesity, and lack of physical activity are high among adolescents. Poor recognition of heart events in younger patients and delayed application of cardiopulmonary resuscitation or defibrillation may also be contributing to this increase."

    SCD typically is caused by ischemic heart disease, which restricts blood flow to the heart; arrhythmia (irregular heart beat); or cardiomyopathy (deterioration of the heart muscle). Ischemic heart disease has been associated with not being physically active, eating a poor diet, and smoking cigarettes. Arrhythmia and cardiomyopathy are often inherited or result from a structural problem in the heart.

    Lifestyle changes, plus early identification of risk and prompt attention when signs of heart distress are recognized, could help reduce SCD in people ages 15-34, according to the CDC.

    "Adopting a heart-healthy lifestyle that includes 30 minutes of moderate physical activity on most days of the week, a low-fat diet with lots of fruits and vegetables, and either stopping smoking or not starting, are three steps we all can take to help reduce the risk of sudden cardiac death," said George A. Mensah, M.D., chief of cardiovascular health at CDC and co-author of the report. "Families with a history of early heart disease or sudden cardiac death should talk to their doctors about screening younger family members."

    The report was presented in San Antonio by lead author Zhi-Jie Zheng, M.D., Ph.D., epidemiologist. Other researchers included Janet Croft, Ph.D., and Wayne L. Giles, M.D.

    CDC protects people’s health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national, and international organizations.

  • FDA UPDATES SAFETY INFORMATION FOR MICONAZOLE VAGINAL CREAM AND SUPPOSITORIES

FDA is advising women who take the prescription blood-thinner warfarin to consult their doctor or pharmacist for advice before using an OTC vaginal miconazole product.

FDA has also advised manufacturers of vaginal creams and suppositories containing miconazole to add a new warning to the Drugs Facts box on product labels. The warning states: Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur.

FDA is taking this action because the agency has received two adverse events indicating abnormal blood clotting tests with women who took anticoagulant therapy and used vaginal miconazole. In addition to abnormal tests, one woman developed bruises, bleeding gums and a nosebleed. Two articles from medical journals reported cases of probable warfarin interaction with vaginal miconazole. The agency believes that consumers should have all the information about a drug’s potential risks before deciding to use it.

Miconazole is an antifungal drug that has been available by prescription and over-the-counter in different forms such as creams and suppositories for many years. The vaginal creams and suppositories are used to treat vaginal yeast infections.

The interaction of systemically administered miconazole with warfarin is well established, and is included in the warfarin labeling. Because of the concerns raised by the recent reports of an interaction with vaginally administered miconazole with warfarin, physicians and patients should be aware that patients who need to use both products simultaneously should be appropriately monitored. In addition to being placed on the product labels, the new label will be included in consumer brochures. Products containing miconazole include the recently approved Monistat combination pack.

  • FDA ISSUES HEALTH WARNING ABOUT AVOCADO PULP IN SOUTHERN CALIFORNIA BECAUSE OF POSSIBLE HEALTH RISK

    FDA is warning consumers in southern California not to consume avocado pulp products from two distributors, G Products and T & G Sales, because these products have the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

    G Products is recalling three lots of its avocado products. T & G Sales was issued a warning letter by the FDA on February 1, 2001.

    The G Products bulk avocado pulp product was distributed in Southern California, primarily to small Mexican style fast food restaurants in Orange, Riverside, Los Angeles, and San Diego counties. T & G Sales bulk avocado pulp product was distributed in San Diego County, primarily to small Mexican style fast food restaurants from November 2000 through January 2001. These products, if frozen, have a shelf life of 3 to 4 months.

    The G Products avocado pulp is packaged in bulk heat sealed, 6 pound, clear plastic bags. Product labeling identifies the product as G Products Brand 100% Haas Avocado "Pulp" or "Chunky" style. The date codes are stamped on the label as "DEC 05 2000," "JAN 17 2001," and "JAN 30 2001."

    The T & G Sales bulk avocado product is packaged in bulk heat sealed, 6 pound clear plastic bags and 25 pound plastic pails.

    No illnesses have been reported to date.

    This recall is the result of routine sampling by the FDA at the time of importation. FDA laboratory findings confirmed Listeria monocytogenes in lots from each importer, and the importer was instructed to hold the lots intact and not distribute them. However, these products were distributed without an FDA release.

    It is recommended that restaurants that may have purchased avocado pulp products from these companies check their inventories and discontinue using any of these products listed above. Restaurant owners and concerned consumers with questions may call G Products at 619-295-7910 and T & G Sales at 619-232-9020 or 619-778-4957.

  • CDC AND WORLD BANK SIGN AGREEMENT TO IMPROVE HEALTH IN DEVELOPING COUNTRIES

    The Centers for Disease Control and Prevention (CDC) and the World Bank signed a groundbreaking agreement today to work more closely together to improve health in developing and transition countries through better communication, coordination, and collaboration.

    Under this agreement, CDC is assigning technical experts to the World Bank to collaborate in the design, implementation, and evaluation of projects on prevention and control of malaria in Africa; on environmental health in South Asia; on chronic diseases such as cardiovascular disease and cancer, and their risk factors including tobacco abuse in Latin America and in Eastern Europe/Central Asia; and on immunizations and vaccine preventable diseases globally.

    Dr. Jeffrey P. Koplan, CDC director, states, "The combination of CDC's health knowledge, skills and experience, and the World Bank's economic know-how and development capability make a powerful partnership to improve global health."

    The broader range of global health activities will also include: nutrition, maternal and child health, infectious diseases (e.g. HIV/AIDS, tuberculosis), public health, health surveillance, health policy, program planning and evaluation, health statistics, health economics, operational/applied research, health policy research, health services research, and health care technology.

    "To meet the development challenges of the 21st century, the World Bank needs to strengthen its partnerships with other agencies to advance international understanding and initiatives related to health, nutrition, and populations. We welcome this new opportunity to extend our collaborative and cooperative efforts with the CDC," said Christopher Lovelace, Director of the Health, Nutrition, and Population Sector at the World Bank.

    The urgency is evident in the fact that, as Dr. Stephen Blount, Associate Director for Global Health at CDC indicates, "Nearly 1.3 billion people, representing one fourth of the world's population, continue to live in absolute poverty. Ninety-three percent of the global disease burden is concentrated in low- and middle-income countries."

    Most developing and transition countries face difficult challenges caused by continued poverty, malnutrition, poor health, poor performance of many health systems, and inadequate and/or unsustainable health care financing. The World Bank is the leading global financial lender to low- and middle-income countries for development. The CDC is recognized as a leader in global disease prevention and control. The World Bank/CDC agreement was developed based on a recognition that a strong public-private partnership between these two unique organizations was needed to better combat the threats to global health.

    The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national and international organizations.

     

  • 2001 FDA SCIENCE FORUM: SCIENCE ACROSS THE BOUNDARIES

    "Science Across the Boundaries" will be the theme for the 2001 FDA Science Forum to be held February 15-16 at the Washington Convention Center in Washington, D.C. The forum will highlight issues in science that cross the boundaries of industry, academia, government agencies, consumer groups and international constituents.

    The forum will be sponsored by the FDA, AOAC International, formerly the Association of Official Analytical Chemists, and Sigma Xi, a scientific research society.

    The forum will address emerging issues connected to FDA's approach to new technology such as privacy and confidentiality; modeling and simulation; leveraging and partnerships across FDA boundaries, and laboratory accreditation.

    On February 15, AOAC International will sponsor a mock laboratory accreditation session.

    On February 16, a "Breakfast with the Authors" session will be held to allow individuals the opportunity to network and talk with the authors of scientific posters representing all areas of FDA regulatory science.

    As part of the second day's activities, the FDA Scientific Achievements Awards of Excellence will be announced. In addition, an FDA Center Director Roundtable session will be moderated by FDA's Office of Science Coordination and Communication.

    For more information on the 2001 FDA Science Forum, please contact FDA's Office of Science Coordination and Communication at 301-827-3340 or visit AOAC's website for registration information at www.aoac.org.

  • LETTERS TO THE EDITOR:

Dear Dr. Neff.  I was given your name by the Blank...Minister...Blank.  He advised you could steer me to actual scientific and forensic contributions to the advancement of science and medicine.  I must state that as a chiropractic student in Australia, I find that we are locked out of the rest of the medical system and am deeply discouraged about some of the irrational claims made by my new colleagues....  Dear Jeff (I apologize for the delay).  I have only typed your opening statements as I feel that as you grow, you will change your opinions and understand your colleagues through the wisdom of science and practical clinical science.   Don't be so hard on yourself. Your just beginning your wonderful journey into the health care amalgam.  Enclosed please find the following link to my first published work, which changed the basis of physiology text books of the day, as well as bringing DC's into their just realm of treating real conditions, experienced by people today, rendering a real diagnosis, and offering the correct consistent care.  Your wonderful and adventurous journey into Chiropractic Forensic Science begins here.

  • FDA ISSUES URGENT NOTICE OF RECALLED INJECTABLE DRUGS

    The Food and Drug Administration (FDA) is urging individuals, health care organizations and medical product distributors to stop dispensing and/or distributing certain injectable medications marketed by Phyne Pharmaceuticals of Scottsdale, Ariz. AMRAM Inc. of Rathdrum, Idaho manufactured these products for Phyne Pharmaceuticals, who was their sole customer.

    On December 14, 2000, AMRAM Inc. notified Phyne Pharmaceuticals that AMRAM Inc. was recalling these products because they were manufactured under sub-standard conditions.

    FDA is issuing today's warning because Phyne Pharmaceuticals has delayed taking prompt and appropriate action to remove these products from the market.

    The nationwide recall follows FDA's recent inspections of Phyne Pharmaceuticals and AMRAM Inc. During the inspections, FDA found violations of requirements for good manufacturing standards for pharmaceuticals. These requirements help ensure that drug products are safe and effective. The violations FDA found demonstrate that the products lack assurance of sterility and potency.

    Anyone in possession of these products is urged to contact and to return the products to Phyne Pharmaceuticals at 7950 East Red Field Rd., Scottsdale, Ariz. 85267, (800) 345-3391 or 480-998-4142, FAX (480) 443-4775. Phyne Pharmaceuticals has stated they will be providing specific return instructions to their customers by an "Urgent Voluntary Drug Recall" letter dated January 25, 2001.

    The following is the most up-to-date list of products under recall by Phyne Pharmaceuticals. Some of the products are labeled with both AMRAM, Inc. and Phyne Pharamceuticals; however, some may bear one or the other company's name as the manufacturer and/or distributor with or without the other company's name listed.

    All lot numbers and codes, strengths and sizes and expiration dates of the following injectable products are included in this recall:

    • Adenosine Monophosphate
    • Ascorbic Acid Injection
    • Beet Ascorbic Acid Injection
    • Biotin
    • Colchicine
    • Vitamin B-12(Cyanocobolamin)
    • Dexpanthenol
    • Disol, USP Brand of EDTA
    • Echinacea Homeopathic Injection
    • Edetate Disodium
    • Endocrine
    • Adrenal Cortex Extract (ACE)
    • Folic Acid
    • Germanium Sesg.(Sesguloxide)
    • L-Glutathione or Glutathione
    • Human Chorionic Gonadotropin
    • Hydrochloric Acid
    • Iron 59 Injection
    • Liver Injection, Crude
    • Lypo-Vite Injection
    • Magnesium Chloride Injection
    • M.I.C.
    • Procaine Hydrochloride Injection
    • Pyridoxine HCL (B-6)
    • Sodium Thiosalicylate
    • Superoxide Dismutase (S.O.D.)
    • L-Taurine Injection
    • Thiamine HCL
    • Thymus Extract
    • Choline Chloride
    • Diphenhydramine
    • Glycyrrhizen
    • Chlorpheniramine Injection
    • Hydrogen Peroxide
    • Hydroxocobalamin
    • MIC with Folic Acid
    • Niacin
    • Pangamic Acid
    • Riboflavin

    Patients who believe they might have been injured by these products should immediately consult with their health care provider. FDA is aware of three serious injuries associated with the use of one of the recalled products, Colchicine, labeled as containing .5mg/ml but actually formulated at a concentration of 5mg/ml.

    Any adverse reactions experienced with the use of these products should also be reported to the FDA's MEDWATCH Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MEDWATCH, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MEDWATCH web site at www.fda.gov/medwatch.

     

  • USFDA ANNOUNCES WARNING TO PREGNANT & PREGNANT TO BE WOMEN ON METHYL MERCURY IN FISH

    The Food and Drug Administration (FDA) is announcing its advice to pregnant women and women of childbearing age who may become pregnant on the hazard of consuming certain kinds of fish that may contain high levels of methyl mercury. The FDA is advising these women not to eat shark, swordfish, king mackerel, and tilefish. As a matter of prudent public health advice, the FDA is also recommending that nursing mothers and young children not eat these fish as well.

    Fish such as shark, swordfish, king mackerel, and tilefish contain high levels of a form of mercury called methyl mercury that may harm an unborn baby's developing nervous system. These long-lived, larger fish that feed on smaller fish accumulate the highest levels of methyl mercury and therefore pose the greatest risk to the unborn child. Mercury can occur naturally in the environment and it can be released into the air through industrial pollution and can get into both fresh and salt water.

    The FDA advisory acknowledges that seafood can be an important part of a balanced diet for pregnant women and those of childbearing age who may become pregnant. FDA advises these women to select a variety of other kinds of fish -- including shellfish, canned fish, smaller ocean fish or farm-raised fish -- and that these women can safely eat 12 ounces per week of cooked fish. A typical serving size of fish is from 3 to 6 ounces.

    The FDA's Center for Food Safety and Applied Nutrition will launch a comprehensive education program to reach pregnant women and women of childbearing age who may become pregnant and their health care providers concerning the hazard posed by methyl mercury to the unborn child. As one of its priorities for fiscal year 2001, the Center will also develop our overall public health strategy for future regulation of methyl mercury in commercial seafood.

    Today, EPA is also issuing advice on possible mercury contamination to women and children eating fish caught by family and friends (non-commercial fish). EPA particularly recommends that consumers check with their state or local health department for any additional advice on the safety of fish from nearby waters. Additional information is available on EPA's Web site at: http://www.epa.gov/ost/fish.

  • HERBAL CARCINOGEN AND CO-CARCINOGENIC DEATH DRUG IDENTIFIED AND RECALLED

    BMK International Voluntarily Recalls Neo Concept Aller Relief Because of Possible Health Risk

    WELLESLEY, MA - January 19, 2001 - BMK International is voluntarily recalling Neo Concept Aller Relief after receiving notification from the FDA that the product contains trace amounts of aristolochic acid. Aristolochic acid is a potent carcinogen and nephrotoxin found in certain plants and botanicals. Products that contain arstolochic acid have been associated with several occurrences of kidney failure in Europe. The use of aristolochic acid containing products has also been linked to the increase risk of kidney cancer in people who have consumed it.

    Aller Relief was distributed nationwide to licensed health care practitioners, and retail outlets. Aller Relief is packaged in 30-ct. and 90-.ct. capsules. The lot numbers covered in this recall are 30-ct. and 90-ct.: #003480, #0006480.

    No complaints or reports illnesses have been reported to date.

    The recall is a result of the FDA notification that recommended manufacturers test their products that contain herbs that may be contaminated with aristolochic acid. The company was informed by the FDA that the product contains trace amounts of aristolochic acid and thus is conducting a voluntary recall. The company has reformulated the Aller Relief product to ensure that in the future no herb in the formula contains or may be adulterated with aristolochic acid. The reformulated product will available shortly.

    Consumers with questions can call telephone: (781) 235-9999. Consumers should return the product to the place of purchase for a full cash refund.  (Editor's note: November 21, 2000, East Earth Herb recalled Jade Pharmacy Brand "Meridian Circulation and Quell Fire" do to similar patient catastrophes.)

  • CDC ANNOUNCES NEW YOUTH VIOLENCE PREVENTION WEBSITE

    CDC's National Center for Injury Prevention and Control announced today the launch of a new web-based resource for people interested in learning more about preventing youth violence and suicide. The National Youth Violence Prevention Resource Center will serve as a central source for prevention information gathered from institutions, community-based organizations and federal agencies.

    The Resource Center, designed and developed in partnership with the White House Council on Youth Violence, features a Web site, a toll-free hotline, and a fax-on-demand service. It offers access to information about prevention programs, publications, research and statistics, fact sheets and more.

    "In 1998, more than 3,400 people under 19 years old died from violence-related injuries. As a result, we find that parents, teachers, students, researchers and many others are becoming increasingly involved in identifying ways to reduce the spread of violence in their communities. We believe the Resource Center will give them the information they need to do that more effectively," said Rodney Hammond, Ph. D., director of the Division of Violence Prevention for the National Center for Injury Prevention and Control.

    The Resource Center's web site is www.safeyouth.org. In addition to serving the needs of public health professionals, the site includes separate sections for parents and teens. The hotline is available Monday through Friday, 8 a.m. to 6 p.m. EST, by calling 1-866-SAFEYOUTH (1-866-723-3968.) Fax-on-demand service is available at all times.

    The Centers for Disease Control and Prevention (CDC) protects people's health and safety by preventing and controlling diseases and injuries; enhances health decisions by providing credible information on critical health issues; and promotes healthy living through strong partnerships with local, national and international organizations.

  • FTC SETTLES FALSE RESULTS HIV CASE

    Two manufacturers of Food and Drug Administration unapproved rapid HIV tests have settled Federal Trade Commission charges that, in some instances, their tests did not accurately detect the presence of HIV antibodies. Under the terms of the settlements, Chembio Diagnostic Systems, Inc. and Alfa Scientific Designs, Inc. will be barred from making, or assisting others in making, any false or misleading representations concerning the accuracy of any unapproved HIV test or other unapproved device. The two settlements are the latest in a series of FTC enforcement actions against marketers of unapproved rapid HIV tests, and the first cases against manufacturers of the devices.

    Chembio is based in Medford, New York. Alfa is headquartered in San Diego, California.

    In its complaint against Chembio, filed in the Eastern District of New York last week, the Commission alleged that the company represented that its tests were more than 99 percent accurate in detecting the presence of HIV antibodies in human blood, serum or plasma. According to Commission allegations, however, Chembio's tests failed to detect the presence of HIV in some instances.

    Under the stipulated final order settling the charges, Chembio is prohibited from making false or misleading representations in connection with the advertising or sale of any HIV test, or any other medical device not approved by the U.S. Food and Drug Administration, including any claims regarding the accuracy of the tests. The settlement also requires the defendant to notify the Commission of any complaints or refund requests in the future and allows the Commission, for a period of five years, to randomly select and test any HIV test or other unapproved device for accuracy.

    In a separate matter, the Commission settled its lawsuit against Alfa Scientific, and amended its complaint to name as additional defendants Alfa Scientific's President, Naishu Wang, M.D., Ph.D., and the company's Chief Executive Officer, David F. H. Zhou, M.D., Ph.D. The Commission alleged in its amended complaint that Alfa, Wang and Zhou violated federal law when they represented on their Internet site that their "Alfa HIV-1/2 Rapid Tests" accurately detected HIV infection in human blood. According to the FTC, independent tests showed that Alfa's HIV tests produced false negative results when tested with HIV-positive whole blood samples.

    The settlement prohibits Alfa, Wang and Zhou from making false or misleading representations in connection with the advertising or sale of any HIV test, or any other medical device not approved by the U.S. Food and Drug Administration, including any claims regarding the accuracy of the tests. The settlement also requires the defendants to notify the Commission of any complaints or refund requests in the future and allows the Commission, for a period of five years, to randomly select and test any HIV test or other unapproved device for accuracy.

    In November 1999, the FTC settled similar charges against Cyberlinx Marketing, Inc., and its President, Jeffrey S. Stein, of Las Vegas, Nevada. Cyberlinx had obtained its rapid HIV tests from a San Francisco distributor, Sovo Tec Diagnostic Designs, Inc. Sovo Tec, which settled similar charges with the FTC last September, had purchased its HIV tests from Chembio, the subject of one of the actions announced by the Commission today.

    In March 2000, the Commission settled another case against a Florida distributor of rapid HIV tests, David M. Rothbart, President of Medimax, Inc. According to the FTC, Alfa manufactured the HIV tests distributed by Medimax.

    Rapid HIV tests use a simple finger prick process for blood collection or a special sponge device for saliva collection. The sample is applied to a plastic testing device and a developing solution, or diluent, is added to determine if the sample is positive for antibodies to HIV. Results are generally available in fifteen minutes. Currently, just one rapid HIV test is approved for sale in the U.S. and is available only to medical professionals. The rapid HIV tests both Alfa and Chembio manufactured and distributed cannot be sold in the United States but under federal law can be exported without FDA approval. Most unapproved rapid HIV tests are distributed in developing nations. In November 1999, the FTC and FDA issued a joint statement warning consumers that unapproved HIV tests can give inaccurate results.

    The Commission votes to approve the settlements were 5-0, with Commissioner Orson Swindle issuing a separate statement.

    Commissioner Swindle issued a statement praising both settlements as "a tremendous public service," but cautioned that "enforcement of the FTC Act cannot systematically address the export from the United States of potentially faulty HIV tests." Referring to his statement in a related case, Sovo Tec Diagnostics, Inc., in which he raised questions about the treatment under current U.S. law of exports of unapproved rapid HIV tests, Swindle expressed concern that "there may be unanticipated gaps . . . that allow the export of some U.S.-manufactured HIV tests and test kits without independent scrutiny of their effectiveness, whether by the FDA or by a foreign government that authorizes the marketing of such d