1)Introduction to Statements.

2)Key's to making your statement stand the test of time.

3) Facts, Hearsay vs. fact, when and how reports are written.

4) Report writing the "A Model", planning, fact gathering, material organization, outline, self-evaluation, report effectiveness, word mastery and the Fact Sheet.

5) Final Agent report, synopsis, confidential report, agent note, and Final sample report.

6) Undercover operative report, observed, talk,  sale record failure, overpricing, narcotics, and failed security. 

7) Writing up your 459 style reports for Burglary.

Sadly, because of the distance and time, their are normal and customary costs for my copyrighted materials albeit, they are short, concise, and exactly what you are looking for.  Let me know if you would like the materials and I remain truly yours, 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 RadioFrequency 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

  FCC Office of Engineering & Technology Contact: Bruce Romano (202) 418-2470

• 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.
  

• YOU DON'T KNOW WHAT YOUR GETTING WHEN YOU ORDER A DELL COMPUTER OVER THE PHONE.-coming soon

• 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).

  FDA and CDC will continue their efforts to prevent E. sakazakii infections associated with powdered infant formula.

• 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.

  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.

• 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 Comsumer 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.
  
  Nevertheless, as a science-based agency committed to openness and transparency in its processes, FDA is convening its Foods Advisory Committee to meet in an open, public forum to discuss this important public health issue.
  

• CHIRO CHAMPION, US PRESIDENT GEORGE W BUSH SIGNS CHIROPRACTIC MEDICAL DIAGNOSIS AND CARE FOR US VETERANS

President George W Bush signed H.R. 3447, the Department of Veterans Affairs Health Care Programs Ehhancement Act of 2001.  Public law 107-135 ( H.R. 3447) mandates to establish a permanent chiropracitc benefit within the Department of Veterans Affairs (DVA) health care system. 

• 2002 FDA SCIENCE FORUM: BUILDING A MULTIDISCIPLINARY FOUNDATION
  
  "Building a Multidisciplinary Foundation" is the theme for the 2002 FDA Science Forum to be held February 20-21 at the Washington Convention Center in Washington, D.C. The forum provides the latest scientific information and thinking on topics of interest to a wide audience within FDA and in the outside scientific, industry, health care, patient, and consumer communities.
  
  The forum is sponsored by the FDA, Association of Analytical Communities International (AOAC), and Sigma Xi, a scientific research society.
  
  This year's Science Forum will address the difficulty of translating new science into sound regulatory policy and decisions. It will be highlighted by discussions on the importance of basing regulatory public health decisions on sound science. Some of the topics to be discussed in breakout sessions are bioengineered plants and animals, genomics and proteomics, bioterrorism, and antibiotic resistance. Many of these sessions are interactive and offer the audience an opportunity to engage in discussion with the presenters.
  
  
• LESTER M. CRAWFORD JR. NAMED FDA DEPUTY COMMISSIONER

HHS Secretary Tommy G. Thompson today named Lester M. Crawford Jr., D.V.M., Ph.D., to serve as deputy commissioner of the Food and Drug Administration. Dr. Crawford begins in the position immediately.

As deputy commissioner, Dr. Crawford will be the senior official at FDA, pending the installment of a permanent commissioner of food and drugs.

"Lester Crawford has devoted his career to promoting safer products for the public, and he brings to the FDA valuable experience and leadership skills," Secretary Thompson said. "With his help, the FDA will continue to build on its successes in ensuring the safety of foods, drugs and medical products for all Americans."

Dr. Crawford takes over from Bernard A. Schwetz, D.V.M., Ph.D., a career FDA executive who has served as acting principal deputy commissioner since Jan. 21, 2001. Dr. Schwetz, senior advisor for science, will continue to work on public health and FDA issues within the agency.

"Dr. Bern Schwetz has led the FDA during a challenging year, when the nation faced its first bioterrorism attack," Secretary Thompson said. "Forward-looking actions by FDA, like early and rapid approval of effective drugs against anthrax, played a crucial role in saving lives. I thank Bern for his service over the past year."

Dr. Crawford most recently served as head of the Center for Food and Nutrition Policy at Virginia Tech. He also served as administrator of the U.S. Department of Agriculture's Food Safety and Inspection Service from 1987 to 1991 and as director of the FDA's Center for Veterinary Medicine from 1978 to 1980, and again from 1982 to 1985.

He received a Doctor of Veterinary Medicine from Auburn University in 1963 and a Ph.D. in pharmacology from the University of Georgia in 1969. During his career, he has also served as executive director of the Association of American Veterinary Medical Colleges, executive vice president of the National Food Processors Association, as chairman of the University of Georgia's Department of Physiology-Pharmacology and as a practicing veterinarian.

With a budget of nearly $1.6 billion and more than 9,000 employees, FDA assures that food is safe, wholesome and properly labeled; that pharmaceuticals, biological products such as blood and vaccines, and medical devices are safe, effective and properly labeled. FDA is the nation's oldest and foremost consumer protection agency. Its mission is to promote and protect the public health by helping to ensure that safe and effective products reach the market in a timely way, and by monitoring products for continued safety after they are in use.

• FTC Charges "Miss Cleo" Promoters with Deceptive Advertising, Billing and Collection Practices

  "Free Readings" Result in Large Phone Bill Charges

  "Miss Cleo," the purportedly "renowned psychic" whose ads promote "free" readings to callers seeking advice, is the subject of a federal district court complaint filed today by the Federal Trade Commission. The complaint charges two Florida corporations, Access Resource Services, Inc. (ARS), and Psychic Readers Network (PRN), with deceptive advertising, billing and collection practices.

  "You don't need a crystal ball to know that the FTC will continue to stop unfair and deceptive trade practices," said J. Howard Beales III, Director of the FTC's Bureau of Consumer Protection. "We want consumers to know that when companies make a promise in an ad, they need to deliver."

  The defendants' entire operation is alleged to be permeated with fraud. According to the complaint, the defendants misrepresent the cost of services both in advertising and during the provision of the services; bill for services that were never purchased; and engage in deceptive collection practices. The defendants also harass consumers with repeated, unwanted, and unavoidable telemarketing calls that consumers cannot stop. The FTC also alleges that the defendants often respond to consumers' inquiries with abusive, threatening, and vulgar language.

  The FTC's complaint names ARS, doing business as Aura Communications; Circle of Light; Mind and Spirit; and PRN, doing business as Psychic Readers Network, Inc., and their officers, Steven Feder and Peter Stolz. ARS and PRN, both located at the same address in Fort Lauderdale, Florida, operate as a common enterprise to induce consumers to buy their audiotext services -- information or entertainment programs provided over the telephone lines. The defendants purportedly are the largest providers of "psychic" audiotext services in the United States, and use a variety of marketing tools to attract consumers to their services, including TV, print media, the Internet, and direct mail. The defendants make their services available to consumers via 900 telephone numbers and bill for each minute spent on the line at a per-minute rate. They use a national network of "psychic readers" to provide "readings" to the consumer who calls the 900 number.

  Specifically, the FTC's complaint alleges that the defendants:

  • deceptively misrepresent, in their advertising, that a "reading" will be provided at no cost;
  • through their agents, misrepresent the cost of the calls by claiming that consumers' free minutes have not expired, that the consumer had been awarded additional free time, or that the consumer will not be charged while on hold;
  • falsely represent that consumers are legally required to pay for services even though, in many instances, no such legal obligation exists; and
  • engages in unfair practices by frequently and repeatedly calling consumers, including consumers who had previously indicated they did not wish to receive such calls, and by failing to provide consumers with a reasonable method to stop such calls.

  In addition, the complaint alleges that the defendants violated the FTC's 900 Number Rule by:

  • failing to make required cost disclosures in their advertisements, and diluting the disclosures that they do make with contradictory information; and
  • threatening to report adverse information to credit reporting bureaus without first conducting an investigation of billing errors.

  The FTC is seeking a temporary restraining order against the defendants.

  The Commission vote to authorize staff to file the complaint was 5-0. The complaint was filed in U.S. District Court for the Southern District of Florida, in Fort Lauderdale, on February 13, 2002.

• Internet Fraud Complaint Center Wins Excellence.Gov Award

  Richmond, VA-The Internet Fraud Complaint Center, a partnership between the Federal Bureau of Investigation (FBI) and the National White Collar Crime Center (NW3C), was recently honored with the Excellence.Gov award. The Excellence.Gov award is presented to federal government agencies that demonstrate innovative electronic government initiatives. Sponsored by the Industry Advisory Council, E-Gov, and the Federal Chief Information Officers Council, the award was presented to five government agencies during the recent E-Gov E-Procurement Conference in Washington, DC

  A panel of judges comprised of representatives from government and industry selected 25 finalists from more than 125 entries based on the following criteria:

  • Extent of the project's impact

  • How the project saved resources or increased productivity

  • Project's ability to simplify and/or unify processes

  • Repeatability for other government agencies

  The Internet Fraud Complaint Center (IFCC) was singled out for its progress on the fraud frontline and its efforts in the wake of the September 11 terrorist attacks.

  Created as a resource for law enforcement by law enforcement, the IFCC provides a single point of contact for consumers and businesses to file a fraud complaint and get the information into the hands of proper enforcement authorities. The number of complaints to the IFCC is rising rapidly. From May 2000 to April 2001, the number of filings increased by 64 percent. With the IFCC's recent role in collecting terrorist tips for the FBI, the activity to its Web site has soared and fraud complaints are expected to show a dramatic increase.

  "We anticipate the number of complaints to rise from 1,000 a day, said Dennis M. Lormel, Section Chief, Financial Crimes Section, Criminal Investigative Division of the FBI. "We know more Internet crime is out there, it's just a matter of victims knowing where to go to report it and then actually reporting it." A data trend report recapping victimization filings for 2001 is expected to be available in print and electronic format in March.

  Following the events of September 11, 2001, the IFCC Web site was designated as the single on-line portal for the public to report terrorist information. The IFCC continues to receive information. Since the IFCC was called on by the U.S. Justice Department to act in this highly specialized capacity, the IFCC Web site has performed flawlessly collecting over 155,000 leads. "We are proud of the IFCC's performance and grateful to both the public and private sector organizations that have supported us in this expanded mission," said Richard Johnston, Director of the NW3C.

  About the NW3C

  Funded by a grant from the Department of Justice, Office of Justice Programs, Bureau of Justice Assistance, the NW3C is a non-profit organization that provides a national support network for state and local law enforcement agencies involved in the prevention, investigation, and prosecution of economic and high-tech crime. More information on the NW3C and its initiatives is available at www.nw3c.org.
  
  About the IFCC

  The IFCC is a partnership between the Federal Bureau of Investigation and the National White Collar Crime Center. The IFCC Web site is located at www.ifccfbi.gov.

• More than 60% of heart disease deaths in 1999 were "sudden" and nearly half happened outside of hospital

  Despite advances in the prevention and treatment of heart attacks and improvements in emergency transportation, more than 60% of heart disease deaths in 1999—more than 460,000—were unexpected or "sudden," and nearly half of all heart deaths (46.9%) occurred outside of the hospital, according to an analysis of state data by the Centers for Disease Control and Prevention (CDC).
  
  Of the 728,743 heart disease deaths in 1999, 462,340 (63.4%) were defined as sudden cardiac deaths (SCD). Of those, 46.9% occurred outside of the hospital and 16.5% occurred in the emergency room or were pronounced dead upon arrival at the hospital, according to the latest death certificate data from the National Center for Health Statistics. Women were more likely than men to die before reaching the hospital (51.9% compared to 41.7%).
  
  The states with the highest percentages of SCD were Wisconsin (72.9% of all heart disease deaths), Idaho (72.2%), Utah (72.1%), Colorado (71.3%), and Oregon (71.0%). States with the lowest SCD still had percentages close to 60%: Hawaii (57.2%), Arkansas (57.5%), New Jersey (57.6), Kentucky (58.4%), and Oklahoma (58.5%).
  
  Possible reasons for the high percentages, according to the CDC researchers, are the unexpected nature of SCD and the failure to recognize early warning symptoms of heart disease, particularly heart attack. Early recognition of symptoms can lead to early treatment that results in less heart damage and fewer deaths.
  
  "These high numbers of sudden deaths from heart disease, and the fact that they occur outside of the hospital, are alarming," said CDC Director Jeffrey P. Koplan, MD, MPH. "CDC and its partners are working closely with states to educate Americans—and their health care providers—about the common and uncommon signs of heart attack and to encourage them to dial 9-1-1 immediately.”
  
  Uncommon symptoms of heart attack that the public and health care providers should watch for include breaking out in a cold sweat, nausea, and light-headedness. More common symptoms are chest discomfort or pain; pain or discomfort in one or both arms or in the back, neck, jaw, or stomach; and shortness of breath.
  
  Douglas Zipes, MD, president of the American College of Cardiology, concurred. "Because almost one of every two Americans will die of cardiovascular disease, and because about half of those deaths will be sudden, we need to train people in cardiopulmonary resuscitation and in use of the automated external defibrillator, and make that equipment widely available," Zipes said.
  
  CDC and its partners are working to increase public awareness about the signs and symptoms of a heart attack. The National Heart, Lung and Blood Institute of the National Institutes of Health and the American Heart Association recently launched a new heart attack education campaign called Act in Time to Heart Attack Signs. Information is available at www.nhlbi.nih.gov and www.americanheart.org.
  
  "This campaign is the latest example of the strong partnership and complementary efforts of public and private advocates devoted to preventing sudden cardiac deaths and other forms of heart disease in the United States," said David Faxon, MD, president of the American Heart Association.
  
  Cardiovascular diseases–principally heart attack, stroke and high blood pressure – kill nearly a million Americans each year, making it the leading cause of death among men and women and all racial and ethnic groups. About 62 million Americans live with cardiovascular disease, which in 2002 is expected to cost the nation an estimated $329.2 billion in health care expenditures and lost productivity. This burden continues to grow as the population ages.
  
  Besides being aware of the warning signs of heart disease and responding immediately when they occur, people can reduce their chances of disease through lifestyle changes: being physically active, eating a diet low in fat and high in fruits and vegetables, and stopping or never starting smoking.

• 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.

• HAPPY MARTIN LUTHER KING DAY: WE THE REGULAR FOLKS CAN DREAM

  Dr. Martin Luther King taught all of us that we dare to dream philanthropic dreams for all citizens of existence.  Not only can the rich businessmen dream of their profits but all of us regular folks can dream of a world absent crime, a world governed by the Ten Commandments and the teachings of Jesus Christ.   Dr. King's role model.  May all of us experience Dr. Kings' dreams and share a wonderful day of joy. InfoJustice 

• 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.

• NEW CDC GUIDELINES HELP SCHOOLS PREVENT INJURIES AMONG CHILDREN AND ADOLESCENTS
  
  School Health Guidelines to Prevent Unintentional Injuries and Violence appear in the December 7 issue of CDC's Morbidity and Mortality Weekly Report, Recommendations and Reports series. The report identifies school policies and practices that are most likely to be effective in preventing unintentional injury (such as playground and sports injuries), violence, and suicide among young people.
  
  "These new guidelines are an important public health resource for schools and communities," said Jeffrey P. Koplan, MD, MPH, director of the CDC. "More than two-thirds of all deaths among children and adolescents aged 5-19 in the United States result from injuries. We know that most of these can be prevented, and schools have a critical role in making that happen."
  
  The guidelines address recommendations in eight areas: a social environment that promotes safety; a safe physical environment; health education curricula and instruction; safe physical education, sports and recreational activities; health, counseling, psychological, and social services for students; appropriate crisis and emergency response; involvement of families and communities; and staff development to promote safety and prevent unintentional injuries, violence, and suicide.
  
  The recommendation on disaster planning can help schools prepare for a range of crises, from bioterrorism attacks to natural disasters, like tornadoes or earthquakes, to violent events or student suicides. Schools are advised to have a written plan for both immediate and long-term response. The plan should specify roles and responsibilities in case of emergencies; communication strategies; coordination with community law enforcement and emergency responders; evacuation procedures; and post-crisis counseling.
  
  The report was developed by CDC, in collaboration with experts in universities and from 57 national, federal, state, local, and voluntary agencies and organizations.
  
  "Effective injury prevention in schools involves more than just metal detectors and locker checks," said Lloyd Kolbe, PhD, director of CDC's adolescent and school health activity. "In developing this report, we looked at all the research on injury prevention and developed guidelines for a comprehensive, coordinated school program."
  
  He added that not every recommendation might be feasible or appropriate for every school and that schools need to decide which ones have priority, based on their needs and resources. Also, because many injuries among young people occur outside the school setting, the guidelines encourage families and communities to become involved in preventing injuries among young people.
  
  "The school setting offers an excellent opportunity to promote injury prevention," said Bill Modzeleski, director of the Safe and Drug Free Schools program in the Department of Education. "More than 53 million young people spend a substantial part of each day in schools, so it's vitally important that schools are safe places." He added that schools can teach students skills to prevent injuries at home and in the community.
  
  Injuries are the major health problem treated by school health personnel: approximately 4 million children and adolescents are injured at school. However, most of these injuries are minor, and fatalities in school are rare: fewer than 1 in 400 injury-related deaths among children aged 5-19 years occur in schools. An article just published in the December 5, 2001, issue of the Journal of the American Medical Association reported that fewer than 1% of child and adolescent homicides and suicides are school-associated.
  
  Overall, schools are relatively safe places for children and adolescents. The guidelines offer schools concrete ways to make schools even safer. One of the most important recommendations is creating a school environment that promotes safety and prevents unintentional injuries and violence.
  
  "Young people need a safe environment so they can learn effectively," said Lisa C. Barrios, DrPH, who directed the guidelines project for CDC's adolescent and school health program. "Schools that develop and consistently enforce policies to make schools safe–and that do not tolerate harassment or bullying–are creating a supportive and nurturing environment for all students."
  
  The main causes of injury death and mortality among children and adolescents include the following:
  
  * Motor vehicle-related injuries–70 % of injury deaths among young people aged 5 to 19 in the United States are caused by motor vehicle crashes, making this the leading cause of injury death in this age category. Young people also suffer from traffic-related injuries related to walking, riding a bicycle, or riding a motorcycle.
  
  * Violence–The rate of child homicide in the United States is 2.6 per 100,000 children under age 15, about five times greater than the rate of 25 other industrialized countries combined. Although the homicide death rate among children and adolescents decreased 30% between 1990 and 1998, homicide is still the leading cause of death among adolescents aged 15 to 19.
  
  * Suicide–This is the third leading cause of death among adolescents in this country. Almost 20% of high school students had suicidal thoughts, according to CDC's most recent Youth Risk Behavior Survey.
  
  Although there is no national system for reporting on injuries or violence associated with schools, studies estimate that between 10% and 25% of child and adolescent injuries occur on school premises. Most of these injuries are unintentional–sports injuries or playground falls, for example–rather than violent.
  
  "Childhood and adolescence are developmental periods when many injuries, some serious and some minor, are likely to occur," said Dr. Barrios. "However, it's important not to accept these as inevitable 'accidents,' but to see them as preventable. School policies and programs can help make that a reality."
  
  School Health Guidelines to Prevent Unintentional Injuries and Violence are available on the web at www.cdc.gov/mmwr.

• 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 Cardioseal was already approved for limited marketing under the agency's humanitarian device exemption, a special regulatory clearance that makes devices available for patients with rare medical conditions. Today's action gives NMT Medical approval for more widespread marketing.

• 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.  The Academy sincerely congratulates the president for understanding the needs of our nations health and its policing. InfoJustice

• LETTERS TO THE EDITOR:

Letter 1.

I´m looking for information on how to perform an anthropometric study following the Bertillon method. It is for a research project to prepare for entering the police Academy in Spain. Thank you  Dear Ramon,   This editor may be interested in your project.  I suggest sending me more information  as a sharing and perhaps I can help you in some referenced manner.  For example I will share a possible opening statement. 

     Portrait Parle is a holdover techniques from the Bertillon method of criminal identification by measurements of the human body and is still used to great advantage.  My research project will combine human anthropometrics and Kinesiology the study of Osteokinematics and Arthrokinematics in the scientific measurement of the size, weight, and proportions of the human body.  These understandings combined with the early criminal method of identification of Bertillion protocol aids in the identification, tracing, and arraigning of law breakers.  These two French words Portrait Parle mean, "speaking likeness."   Clearly law enforcement officers are taught to be able to understand and appreciate the value of the head and facial differences in human beings. Every investigative file should contain a complete description of the suspect.  My intention is to improve upon the Bertillon method by increasing the specificity of its analysis through addition of identifying factors of human individuality. 

Best of luck and I hope you will share your ideas. Perhaps if I have time this humble examiner can help you into your wonderful life choice, protecting "we, the people,", and I remain, InfoJustice

Letter 2

Is there any Thalidomide Victims Assistance money available from the US government to help aid victims with their medical costs etc.? Kansas medicaid is not reciprocal with Minnesota and I have a patient that would benefit from going to the Mayo Clinic in Rochester, MN, however they want to be paid cash and she has no other insurance. The Canadian government has a Thalidomide Victims assistance program and advocacy group. I am finding no such program in the US with my research. Help please.

Letter 2

Dear Gayle,

Contact directly USFDA and Health and Human Services.  They both have written much about the subject and have mentioned a program as you suggest, but I was unable (in my short search) to find if such programs are available now.  For example, they mention beginning such as program of funded care when certain med's become available.  Find out if med's approved for federal funding are now available drugs.  Look first at:

NIH Thalidomide Meeting, 9/9/97
... Thalidomide: The Survivor's Perspective Randolph Warren
Thalidomide Victims' Association of Canada. ...
http://www.fda.gov/oashi/patrep/nih99.html - Cached - 101k

NIH Thalidomide Meeting, 9/10/97
... I believe the thalidomide victims would agree with us ... recommended the approval of
thalidomide for the cutaneous ... later date a patient assistance program to find ...
http://www.fda.gov/oashi/patrep/nih910.html - Cached - 101k

20785medr.htm
... The US FDA provided assistance in maintaining product availability by ... representatives
from the Canadian Thalidomide Victims Association, the Committee ...
http://www.fda.gov/cder/news/thalinfo/20785medr.htm - Cached - 66k

Orphan Drug Law Matures into Medical Mainstay
... the Orphan Drug Act." Thalidomide also has received orphan ... quadriplegic patients.
Protocol assistance--FDA helps orphan ... Before the 1980s, victims of many rare ...
http://www.fda.gov/fdac/features/1999/399_orph.html - Cached - 15k

http://www.fda.gov/cder/pike/july98.pdf
... of the Prescription Drug User Thalidomide OK'd, PDUFA II ... 31 of its 33 victims. and
Communications (HFD ... last seek emergency assistance. These families especially ...
Cached -

TESTIMONY MICHAEL A. FRIEDMAN, MD (APRIL 22, 1998)
... are promoted to desperate victims of illness and injury. A ... FDA also has provided assistance
to OAM and to ... keep products such as thalidomide off the market for ...
http://www.fda.gov/ola/therapy.htm - Cached - 81k

http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3639t2b.pdf
101 inconclusive and conflicting. I don't think this is by 2 design. 3 Let me take
this second point first, the lack 4 of rigorously collected data, and say ...
Cached -

http://www.fda.gov/ohrms/dockets/ac/96/transcpt/3198t1b.pdf
... of American women will be honored here, and I am grateful for your assistance in
bringing American women the 105 improved standard of health care that they ...
Cached -

http://www.fda.gov/ohrms/dockets/dailys/051499/c001440.pdf
[814] 776-1800 310 Metoxet ... People, incineratorfighting community groups,and victims
of Club and the ... reaction to, not realizing thalidomide-like effect), no legs ...
Cached -

http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3639t1d.pdf
... current 23 experience is with the authorized pharmacy only option. We 24 have thalidomide
where there are authorized pharmacies 25 only.

I hope that this beginning willhelp you find funding.  Life means alive, and your search for health and life is meritorious.  Let me know if you find success and I remain,...InfoJustice

• FDA STRENGTHENS WARNINGS FOR DROPERIDOL
  
  FDA has strengthened the warnings and precautions sections in the labeling for droperidol, a tranquilizer used most often as a premedication for anesthesia, as treatment for nausea after anesthesia, and for sedation of agitated patients. Droperidol has been associated with fatal cardiac arrhythmias.
  
  Specific changes to the droperidol labeling include a "black box" warning, the most serious warning for a FDA-approved drug. The new warning is intended to increase the physician's focus on the potential for cardiac arrhythmias during drug administration, and to consider use of alternative medications for patients at high risk for cardiac arrhythmias.
  
  Droperidol currently carries a warning about cases of sudden death at high doses (greater than 25 mg) in patients at risk for cardiac arrhythmias. Recent research has shown QT prolongation (delayed recharging of the heart between beats) within minutes after injection of a dose of droperidol at the upper end of the labeled dose range. Prolonged QT is dangerous because it can cause a potentially fatal heart arrhythmia known as torsades de pointes (TdP).
  
  In the last year, there have been reports of TdP within or below the currently labeled dose range. There have also been reports of sudden death or other serious cardiac adverse events.
  
  FDA will continue to monitor the postmarketing safety data for droperidol to determine if further action is needed.
  
  The manufacturer, Akorn Pharmaceuticals, is sending a "Dear Healthcare Professional" letter to physicians, pharmacists, and other healthcare professionals in the U.S. The letter explains the black box warnings and highlights the potential for QT prolongation or torsades when this drug is administered.
  
  For more information, patients and healthcare providers can call Akorn Pharmaceuticals at 1-888-519-8384.
  

• FDA ALERTS SOUTHERN FLORIDA PATIENTS TO POSSIBLY INADEQUATE PROSTATE CANCER TREATMENTS

  The U.S. Food and Drug Administration (FDA) is alerting certain prostate cancer patients in South Florida to the possibility that they may have been given inadequate levels of the anti-cancer drug Lupron. This alert applies only to prostate cancer patients who have been treated at Urology P.A. - operated by Dr. Victor Souaid at 2100 East Sample Road, Pompano Beach, Florida.

  FDA is issuing this warning because of the potentially significant health implications for prostate cancer patients who may not have received sufficient amounts of Lupron.

  FDA strongly advises all patients treated for prostate cancer at Urology P.A. in Pompano Beach, Florida to contact their primary care physician immediately for evaluation and appropriate medical referral.

  Prostate cancer patients who have received Lupron treatments at Urology P.A. and need additional information may call Susan Snook, Victim/Witness Coordinator for the U.S. Attorney’s Office in Fort Lauderdale, Florida, at 1-800-379-4643.
  

• CDC'S GUIDE TO PREVENT COMMUNITY TODDLER TOOTH DECAY

  A report released today by the Centers for Disease Control and Prevention (CDC) issued a strong recommendation for two community-based interventions to prevent tooth decay — community water fluoridation and school dental sealant programs. Some programs provide pit and fissure sealants to children in a school setting, and others also involve private dental practices or public dental clinics.
  
  Promoting Oral Health: Interventions for Preventing Dental Caries, Oral and Pharyngeal Cancers, and Sports-related Craniofacial Injuries, A Report on the Recommendations of the Task Force on Community Preventive Services (www.cdc.gov/mmwr) summarizes the recommendations of the independent, non-Federal Task Force based on systematic reviews of the scientific evidence of effectiveness for selected community interventions to prevent and control tooth decay, oral (mouth) and pharyngeal (throat) cancers, and sports-related injuries to the head, mouth, and face. These conditions are common, sometimes life-threatening, costly, and potentially preventable by currently used strategies. For example, more than 90 percent of people 18 years and older have had tooth decay.
  
  "This new report combines the best available studies of community water fluoridation and school sealant programs to inform a broad public health audience that show that these interventions are among the most effective means we have for preventing tooth decay," said Dr. William R. Maas, director of CDC's oral health program. "These strategies are particularly useful for reaching entire communities, but especially groups at high risk for decay, and they are essential to achieving the national objectives put forth by Healthy People. Communities should use these findings to support their local planning processes; if local goals and resources permit, use of these interventions should be initiated or increased."
  
  Community water fluoridation is the adjustment of the natural fluoride level in a community's water system to the optimal level for preventing tooth decay, about 1 part per million. Dental sealants are plastic materials applied to the pits and fissures of teeth to prevent tooth decay. School-based programs provide pit and fissure dental sealants to children in a school setting. School-linked programs also involve private dental practices or public dental clinics.
  
  In their review of the evidence, the Task Force found that:

  • Tooth decay typically decreased by 30 percent to 50 percent after starting or continuing community water fluoridation.
    
  • In examining the effectiveness of school-based or school-linked dental sealant programs, there was typically a 60 percent decrease in tooth decay on the chewing surfaces of posterior teeth after sealant application. School-based and linked programs in the U.S. generally target vulnerable populations less likely to receive private dental care such as children eligible for free and reduced lunch programs.

  The Task Force also evaluated other community approaches that sought to increase use of dental sealants, to increase early detection of oral cancers and improve health status and reduce mortality from oral cancers, and finally, to encourage the use of helmets, facemasks, and mouthguards in contact sports. However, for these three interventions, the Task Force was unable to make a recommendation either for or against these approaches because of a lack of qualifying studies on which to base a recommendation. This finding indicates the need for more research on effectiveness for these interventions. In the meantime, potential users are encouraged to judge the usefulness of these interventions based on other criteria.
  
  The Task Force review was developed as part of The Guide to Community Preventive Services (Community Guide) which provides recommendations on population-based interventions to promote health and to prevent disease, injury, disability, and premature death, appropriate for use by communities and healthcare systems. More information about the Community Guide (including links to a variety of resources) is available at http://www.thecommunityguide.org . Further information about the Task Force's review on oral health can be found at http://www.thecommunityguide.org/Guide/oralhealth_f1.html

  Full findings of the Oral Health Chapter will be published in the American Journal of Preventive Medicine in 2002.

• FBI DEVELOPS NEW STATE OF THE ART HAZARDOUS DEVICE SCHOOL

  The FBI and the U.S. Army today announced plans to begin construction of a new world-class Hazardous Devices School (HDS) facility at Redstone Arsenal, Huntsville, Alabama. HDS provides the Basic and Recertification training for all of the approximately 2,300 public safety bomb technicians in the United States and certifies them to work as bomb technicians. HDS also provides speciality courses for bomb squad personnel, including a Robot Course. The current school, which has been at Redstone Arsenal since 1971, is funded and administered by the FBI and is operated by the US Army Ordnance Missile & Munitions Center and School.

  This construction project is being funded by the FBI, and will be managed by the US Army Corps of Engineers, Mobile District. It will include four administrative and classroom buildings containing nearly 64,000 square feet, along with 14 practical exercise training villages. The new construction will be situated near the existing HDS range on 295 additional acres that have recently been designated for this project. Completion of the project is anticipated within two years.

  The new construction will allow HDS to better meet the needs of the 421 accredited public safety bomb squads in the US The facility, designed by the Mason & Hanger architectural firm, is specifically planned to accommodate training on state-of-the-art tools i.e.- robots, available to bomb squads today.

• FDA APPROVES FIRST BIOLOGIC TREATMENT FOR SEPSIS

  FDA today approved the first biologic treatment for the most serious forms of sepsis, a life-threatening illness caused by severe infection. The new treatment is a genetically engineered version of a naturally occurring human protein, Activated Protein C, which interferes with some of the body's harmful responses to severe infection, including the formation of blood clots that can lead to organ failure and death. Eli Lilly and Co., Indianapolis, Ind., will market the product as Xigris.

  "Xigris is a new treatment that helps to save the lives of patients with the most severe forms of sepsis" said FDA's Acting Principal Deputy Commissioner Bernard A. Schwetz, D.V.M., Ph.D. "While not everyone will benefit from this treatment, we believe the approval of Xigris is an important advance for the treatment of this often deadly disease."

  Of about 750,000 people who get sepsis in the U.S. each year, an estimated 30% will die from it, despite treatment with intravenous antibiotics and supportive care. Patients with severe sepsis often experience failures of various systems in the body,including the circulatory system, as well as kidney failure, bleeding, and clotting.

  Xigris was approved by FDA for the treatment of adult patients with severe sepsis who have an especially high risk of dying from sepsis, as measured by a scoring system based on their general health and the severity of their illness.

  In a placebo-controlled, multi-center, randomized clinical trial of nearly 1700 patients, the overall mortality rate was reduced by 6%(from 31% to 25%) during the 28 day study period of the trial. Although treatment with Xigris did not lower mortality rates in patients in the study who were less severely ill, among patients at higher risk of dying, the group for whom Xigris is now indicated, mortality was reduced 13 percent (from 44% to 31%).

  Because Activated Protein C interferes with blood clotting, the most serious side effect associated with Xigris therapy is bleeding, including bleeding that causes stroke. During the period of time when the drug was infused (continuously over four days), serious bleeding episodes occurred in 2.4% of patients treated with Xigris compared to 1% of patients in the placebo group. Patients at high risk of bleeding were excluded from the trial, as were severely ill patients with pre-existing conditions not related to sepsis that made them likely to die within the study period.

  Xigris is contraindicated -- should not be used -- for patients who have active internal bleeding, or who are more likely to bleed because of certain medical conditions including recent strokes, recent head or spinal surgery or severe head trauma.

  Because sepsis is a life-threatening condition and because treatment with Xigris comes with potentially serious risks, the benefits and risks of treatment with Xigris must be carefully weighed for each individual patient.

• ANTHRAX SCOURGE OF 2001 IS FULLY EXPLAINED IN "ANTHRAX INSIGHTS" BY David N. Rahni AAJTS

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".  InfoJustice

• TALES OF THE RAILS RAILROAD CLAIMS STORIES BY NORMAN UDEWITZ ON SALE NOW.

This amazing book paints an intriguing picture of what occurs during the course of the claim and litigation process, and the reader also gets a view of the posturing of attorneys, judges, claimants and witnesses.  You will be amazed and entertained by the actual process involved in the resolution of these matters.  Click on the blue Publications button to your left and order yours now.  InfoJustice

• 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.

• FDA AND NTSB TO HOLD JOINT MEETING TO EXAMINE EFFECTS OF MEDICATION ON VEHICLE OPERATORS

  On November 14 and 15, 2001, the Food and Drug Administration (FDA) and the National Transportation Safety Board (NTSB) will host a special meeting, Transportation Safety and Potentially Sedating or Impairing Medication. This joint FDA/NTSB meeting will examine the impact of prescription and over-the-counter medications on peopleís ability to drive, fly, sail, or operate other vehicles. The meeting is open to the public and will be held in the NTSB Board Room and Conference Center at 429 LíEnfant Plaza, Washington, D.C.

  This transportation safety meeting is in response to recommendations by NTSB to FDA requesting clear and consistent warning labels on all medications that may impair a personís ability to operate a vehicle.

  Many prescription and over-the-counter medications are known to cause drowsiness or impaired motor abilities in users, and NTSB has investigated over 150 transportation accidents where the use of medication by the operator of a vehicle may have been a contributing factor. Yet little guidance or medication labeling exists to help consumers determine which medicines could adversely affect their ability to operate a vehicle.

  The meeting will also include experts from the Department of Transportation, Centers for Disease Control, the National Association of Boards of Pharmacy, American Association of Motor Vehicle Administrators, the military, unions and the insurance industry. Issues to be discussed include:

  • Severity of the problem of transportation safety and impairing medications
  • Criteria to determine a personís level of impairment
  • Current regulations and possible new regulations
  • Possible warning labels for impairing medications.

  More information on the November meeting, including a draft agenda and a link to the Federal Register announcement, is available on NTSBís web site at www.ntsb.gov/Events/2001/FDANTSB/agenda.htm. The meeting starts at 8:00 am each day, and a portion of time will be allotted for audience participation. If you wish to participate in a session, please follow the instructions for registration in the Federal Register notice.

• 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

• ACTUAL MAIL SAMPLES

• 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.

• NEW TOUGH SAFETY MEASURES BY THE UNITED STATES POSTAL SERVICE-NEW HEROES OF OUR TIME
  
  Postmaster General Jack Potter today announced tough new safety procedures as part of the Postal Service's four-part effort to make the mail safe. "We are taking concrete steps immediately to protect employees and the public through education, investigation, intervention and prevention," the PMG said. Potter said USPS is educating employees and the public about steps they can take to spot suspicious pieces of mail. "We also are investigating to find out who is sending these dangerous mailpieces," the PMG said, "and we are aggressively intervening when the public or our employees are put at risk by terrorists." The latest steps include:
  
  * Adopting and deploying new technology to neutralize anthrax that might move through the mail. This new technology, irradiation, already is being used successfully to fight bacteria in the food supply. "This new technology won't be cheap, but we are committed to spending what it takes to make the mail safe," Potter said.
  * We will be providing employees who process mail with masks and gloves for their protection if they choose to use them.
  * We are establishing field command centers so employees can notify the centers if they seek admission to a hospital. That way we can quickly identify any pattern of medical problems that might develop.
  * We are changing the procedures we use to clean mail sorting equipment. We are installing and will use vacuuming equipment exclusively to clean the equipment to absorb dust and other particles.
  * Postal facilities will use stronger, antibacterial cleaning chemicals as part of routine maintenance.
  * Supervisors and postmasters will continue to give mandatory stand-up talks to employees to provide the information they need to stay safe.
  
  We will keep you updated in future Newsbreaks on the facts as they become available. PMG Potter will address employees later today on USPS TV to talk about the prevention steps.

• CONFIRMED ANTHRAX CASES AND DEATH TERRORISM
  
  Based on a rigorous case definition, CDC is reporting 11 confirmed cases of anthrax: 2 in Florida, 3 in New York, 2 in New Jersey, and 4 in Washington, D.C. (in collaboration with MD and VA). These cases include the two deaths recently reported in Washington, D.C. Both cases were proven, through laboratory testing, to be cases of inhalation anthrax. One additional case has been reported by the New York City Department of Health. CDC is conducting additional tests to fully confirm this 12th case.
  
  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.
  
  Background
  
  · Anthrax is NOT contagious from one person to another. Family members and contacts of persons who work in or visited sites where exposure occurred are not at risk and antibiotic therapy is not recommended for them. Other members of the community are not at risk. Public health officials, together with the FBI, are continuing the investigation.
  
  · Inhalation anthrax is the most serious and rare form of human anthrax. It occurs when a person breathes a large number of anthrax spores that are in the air. Initial symptoms may resemble the common cold (including fever, muscle aches, and fatigue). After several days, symptoms may progress to severe breathing problems and shock. If left untreated, inhalation anthrax can be fatal.
  
  · Cutaneous (skin) anthrax is different from inhalation anthrax. A cutaneous infection due to anthrax can occur if the spores are in contact with an area of skin that is not intact, such as a cut or sore. Cutaneous anthrax is marked by a boil-like lesion that eventually forms an ulcer with a black center. The cutaneous forms respond well to antibiotics if treatment is started soon after symptoms appear.
  
  · For people with suspected anthrax disease, laboratory testing is essential to diagnosis. Tests may include:
  
  o Cultures of blood and spinal fluid (should be done before antibiotic treatment has been initiated)
  
  o Cultures of tissue of fluids from affected areas.
  
  o Microscopic examination of tissue.
  
  o PCR (polymerase chain reaction) test that amplifies trace amounts of DNA to document that the anthrax bacteria is present.
  
  · Antibiotics are an effective treatment if the disease is diagnosed early on; but anthrax can be fatal if left untreated.
  
  · The Centers for Disease Control and Prevention continues to work with state and local health departments, law enforcement officials, and other federal agencies to investigate incidents of possible anthrax exposures around the United States. In Atlanta, CDC officials continue to work out of a 24-hour Operations Center. The Operations Center staff is also responding to hundreds of calls each day from the public. CDC has dispatched more than three dozen employees to Florida, New York City, or Washington, D.C. More than 50 CDC laboratories have processed hundreds of specimens.
  

• FDA ENHANCES ITS ABILITY TO MONITOR MARKETED MEDICINES
  
  The Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) today announced that it has awarded contracts that give the agency access to commercial databases that contain non-patient-identifiable information on the actual use of marketed prescription drugs in adults and children.
  
  The information contained in these large databases will significantly augment the FDA’s ability to determine the public health significance of the reports it receives through its Adverse Event Reporting System (AERS), published information, and other data sources.
  
  The recipients of the contracts are AdvancePCS, Premier Inc., and Child Health Corporation of America.
  
  The AdvancePCS database will allow FDA to examine how long non-hospitalized patients stay on prescription medication therapy and to learn which combinations of medications are being prescribed to patients. The contract awarded to Premier Inc. will provide similar information on hospitalized patients.
  
  The Child Health Corporation of America (CHCA) database contains information on the use of prescription drugs in hospitalized children. This information will, among other benefits, support the ongoing initiative at FDA to have more prescription drugs approved for use in children.
  
  These contracts represent another important advance in FDA’s continuing work to improve the management of risks associated with marketed medications.
  

• FDA APPROVED TREATMENTS FOR ANTHRAX
  
  * Penicillin
  * Doxycycline
  * Ciprofloxacin
  
  CDC Disease Detectives status
  
  The Centers for Disease Control and Prevention continues to work with state and local health departments, law enforcement officials, and other federal agencies to investigate incidents of possible anthrax exposures around the United States. In Atlanta, CDC officials continue to work out of a 24 hour Operations Center. The Operations Center includes approximately 50 work stations equipped with state of the art information systems, phone lines, and fax machines. The Operations Center is also responding to hundreds of calls each day from the public. CDC has dispatched more than three dozen employees to either Florida, New York City, or Washington, D.C. More than 50 CDC laboratories have processed hundreds of specimens.

• EVERYTHING YOU NEED TO KNOW ABOUT DETECTION OF ANTHRAX AND CURRENT INVESTIGATIONS
  
  For people with suspected anthrax disease, laboratory testing is essential to diagnosis.
  
  Tests may include:
  
  * Cultures of blood and spinal fluid (should be done before antibiotic treatment has been initiated)
  * Cultures of tissue or fluids from affected areas
  * Microscopic examination of tissue
  * PCR (polymerase chain reaction) test that amplifies trace amounts of DNA to document that the anthrax bacteria is present.
  
  Exposure to Anthrax Bacteria (Bacillus anthracis)
  
  Persons with an exposure or contact with an item or environment known or suspected to be contaminated with Bacillus anthracis — regardless of laboratory tests results — should be considered for antibiotic (prophylaxis) treatment. Exposure or contact, not lab test results, is the basis for initiating such treatment.
  
  Tests that might be conducted during an anthrax exposure investigation
  
  * Culture of nasal swabs are used to detect anthrax spores that may be resting in the nose. Nasal swabs can occasionally document exposure, but can not rule-out exposure to anthrax. In other words, a negative nasal swab test does not mean that exposure has not occurred. Nasal swabs are used during investigations of known or suspected anthrax exposures because they may provide clues to help investigators assess the exposure circumstances.
  * Antibody tests can be used to measure reactions in the blood of persons with anthrax infection and others who have received anthrax vaccine. Antibody testing also helps investigators make estimates of the number of exposures in a population affected by the investigation, but is not validated as a diagnostic tool for anthrax disease. For this reason, antibody tests are not available in most laboratories.
  * Two sequential tests are usually necessary to interpret the antibody test information. Therefore, persons who are tested as part of an investigation of anthrax exposure may be asked to return for a second test. This second test is compared with the first test to measure any changes in the antibody level over time. Results from the second antibody test can help investigators to interpret the significance of the initial test, and help assess the exposure (e.g., location in a building or number of persons exposed).
  
  Testing work environments and suspicious letters or packages
  
  Law enforcement officials and public health officials work together to investigate envelopes and packages suspected of containing anthrax or other biological agents. Powder and other specimens collected from these sources usually are analyzed through the Public Health Laboratory Network which includes the Laboratory Response Network (LRN).
  
  Powders
  
  Lab testing of powders or other materials suspected of harboring the anthrax bacteria is often an important component of an investigation. Tests may include:
  
  * Cultures of suspected materials.
  * Microscopic examination of a sample of a suspect material.
  * Evaluation of the characteristics of the suspect agent’s growth properties.
  * PCR (polymerase chain reaction) test that amplifies trace amounts of DNA to document that the bacteria is present.
  * DFA (direct fluorescent assay) to detect key bacterial proteins.
  * Other specialized tests to confirm the identification of the bacteria.
  
  Environment (where exposure may have occurred)
  
  During the course of an investigation important information may be obtained from sampling the environment where the exposure may have occurred. Testing of the environment is useful for detecting trace amounts of anthrax spores. Specimens obtained may include:
  
  * Samples of the air
  * Swabs of material on various surfaces
  
  These samples are processed in the laboratory to promote growth of any spores, if present. If suspicious bacteria grow, additional testing — like that conducted on suspect powders (see "Powders") — also may be performed.
  
  Where are specimens sent?
  
  The specimens are sent to various laboratories. Local clinical laboratory testing is confirmed at state and large metropolitan public health laboratories. The LRN is a collaborative partnership and multilevel system linking state and local public health laboratories with advanced capacity laboratories—including clinical, military, veterinary, agricultural, water, and food-testing laboratories—to rapidly identify threat agents, including anthrax. The Centers for Disease Control and Prevention (CDC) conducts highly specialized testing for anthrax as well.
  
  Clean-up of contaminated areas
  
  The U.S. Environmental Protection Agency (EPA) www.epa.gov, with help from 16 federal agencies and departments, including CDC, is responsible for environmental and cleanup issues. Federal agencies, in conjunction with local and state agencies, will determine the best approach to the cleanup.
  
  Update: On-going anthrax investigations
  
  NEVADA
  
  Test results sent to CDC on the initial samples from Nevada are negative. However, additional samples have been sent and will be tested.
  
  FLORIDA
  
  The Palm Beach Count Control and Prevention have confirmed that the 73-year-old male employee of American Media Inc., hospitalized since the beginning of October, has been diagnosed as a probable case of anthrax disease. The diagnosis cannot be confirmed according to the strictest diagnostic criteria (requires isolation of the bacteria from a clinical specimen such as blood, lung samples, or spinal fluid). However, the overall picture of clinical symptoms combined with positive results on laboratory tests suggest to the Health Department, Florida Department of Health, and the Centers for Disease health officials that this individual has anthrax disease.
  
  Also, a minuscule amount of anthrax spores has been found in a small, non-public mail processing area of the Boca Raton Main post office. There is no indication that these spores pose a health risk to workers or visitors. As an extraordinary precaution, health officials are asking employees to leave this small portion of the building. The affected area will be cleaned tonight — after the post office closes. The post office will be open again for business in the morning.
  
  In Florida, there are 2 cases of anthrax and 1 exposure.
  
  For more information on this investigation, contact the Palm Beach County Health Department, (561) 712–6488/6400
  
  NEW YORK
  
  Preliminary tests indicate cutaneous (skin) anthrax disease in an infant. The child’s mother, an ABC employee, took the child with her to the ABC building on West 66th Street in Manhattan on September 28. While it is not certain that the child came into contact with anthrax bacteria at the ABC building, it is currently the focus of the investigation. The child was started on a course of antibiotics and is doing well. The New York City Health Department is not aware of any other individuals with symptoms of cutaneous anthrax who work in, or visited, the ABC building. The infant’s doctor notified the Health Department on October 12 that the symptoms might be suggestive of a cutaneous anthrax infection. On October 13, a skin biopsy was CDC for testing and the Health Department received the results on October 15.
  
  In New York, there are 2 cases of anthrax and 3 exposures.
  
  For more information on this investigation, contact the New York City Health Department, (212) 295-5335 or online at: www.ci.nyc.ny.us/html/doh/home.html
  
  WASHINGTON
  
  CDC and health officials in the District of Columbia are conducting an public health investigation related to possible anthrax exposure on Capitol Hill. CDC has sent a team of investigators to assist with the investigation.
  
  NATIONALLY
  
  There are numerous reports of potential anthrax cases throughout the United States. The initial assessment of these incidents is made at the state level. CDC is providing technical assistance to the states on "How to handle anthrax and other biological agent threats."

• French Drug Firm Pleads Guilty to Felony: Sentenced to Pay U.S. $33 Million
  
  Greenbelt- Thomas M. DiBaggio, United States Attorney for the District of Maryland, Assistant Attorney General Robert D. McCallum, Jr., of the Department of Justice's Civil Division, and Bernard A. Schwetz, Acting Commissioner of the Food and Drug Administration announced today that a French corporation, Roussel Uclaf S.A., pleaded guilty to felony charges of conspiracy and defrauding the Food and Drug Administration. U.S. District Judge Peter J. Messitte then sentenced the company to pay criminal and civil penalties of over $33,000,000 pursuant to a plea agreement between Aventis, Pharma A.G.(the successor corporation to Roussel Uclaf) and the United States Attorney's Office for the District of Maryland and Department of Justice.
  
  This case represents the first time that a foreign corporation has been criminally punished based upon defrauding the FDA concerning a drug product which it manufactured wholly outside the United States but marketed to the American public. It is also among the largest monetary penalties ever imposed in a criminal pharmaceutical prosecution.
  
  Rousell Uclaf pled guilty and was sentenced under a two count information charging the company with conspiracy and the introduction of adulterated drugs in interstate commerce with the intent to defraud or mislead, in violation of the Federal Food, Drug, and Cosmetic Act.
  
  According to the statement of facts to which a Rousel Uclaf representative admitted, the case involved Roussel Uclaf's manufacture of the drug cefaclor in 1995 and 1996 through an Italian company, Biochimica Opos S.p.A., which was a wholly-owned subsidiary of Roussel Uclaf. Cefaclor is an antibiotic used to treat various infections, including upper and lower respiratory infections, pharingytis, tonsillitis, urinary tract infections, and skin infections. Although manufactured wholly outside the United States, Roussel Corporation, another wholly-owned subsidiary of Roussel Uclaf, distributed cefaclor and other drug products manufactured by Roussel Uclaf and Biochimica Opos in the United States.
  
  Since that time, through a series of corporate combinations, Roussel Uclaf has become part of Aventis S.A. and its pharmaceutical arm, Aventis Pharma AG. Aventis Pharma, located in Frankfurt, Germany, is now one of the largest pharmaceutical companies in the world.
  
  According to facts set forth in the plea agreement, between April 1995 and September 1996, various individuals, including authorized agents of Roussel Uclaf, willfully sought to mislead the Food and Drug Administration (FDA) about where and how cefaclor was being manufactured. The purpose of the illegal scheme was to increase the amount of cefaclor available for sale by Roussel Corporation in the United States. Agents of Roussel Uclaf misled the FDA by falsely representing that cefaclor was being manufactured at the production facilities listed in an application relied upon by the FDA when approving the drug for use within the United States. In fact, these persons knew that other facilities in Italy, France, and also in Romania were involved in the manufacture of the drug and that these facilities had not been disclosed to the FDA.
  
  FDA regulators need to know the location where approved drugs are manufactured in part so that they can effectively monitor and inspect the manufacturing facilities and methods used in making pharmaceuticals. Thus, pharmaceutical manufacturers who legally import drugs into the United States are required to create and maintain batch production and control records for each batch of a drug product, consisting of such information as the identity of each active and inactive ingredient used, the location of the manufacturing facility, in-process laboratory control test results, a description of each step in the drug's manufacturing process, and the names of all persons performing and supervising each significant step in the drug's manufacture.
  
  In this case, batch production records at Biochimica Opos' facility falsely misrepresented the production method for cefaclor and falsely showed the manufacturing facilities involved in the production of the drug. In or about May of 1996, members of the conspiracy actually provided false cefaclor batch records to inspectors of the Food and Drug Administration who were conducting an inspection in Biochimica Opos' facility in Agrate Brianza, Italy, and thus willfully misled the Food and Drug Administration about where the cefaclor manufacturing processes were located and how the manufacturing process was being conducted. In addition, a set of false records were kept regarding the manufacturing facilities involved, such as raw material log books, a double software application, and work orders.
  
  United States Attorney Thomas M. DiBiagio stated, "Today's massive criminal penalty sends an unmistakable message to all pharmaceutical companies worldwide. If you plan on selling drugs to the American public, you must play by our rules, whether your company is located inside or outside the United States. This kind of fraud will cost you dearly."
  
  "Quality control of pharmaceuticals distributed in our nation is a top priority," said Assistant Attorney General Robert D. McCallum, Jr., head of the Justice Department's Civil Division. "We will not tolerate any company's efforts to skirt the government's stringent requirements for the sake of profit over the health of our citizens. "
  
  This case was prosecuted by the Office of Consumer Litigation of the United States Department of Justice and the United States Attorney's Office for the District of Maryland. The case was investigated by the Food and Drug Administration's Office of Criminal Investigations.
  

• 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.

• USCDC REGARDING FLORIDA ANTHRAX CASE-Public Health Alert

  • Preliminary testing done at CDC along with clinical diagnosis indicates that an employee who works on the third floor at 30 Rockefeller Plaza has developed cutaneous anthrax, a bacterial infection of the skin. The source of the anthrax exposure is still being investigated but it is possible that it may have occurred when an envelope was opened on September 25, 2001 that may have contained material contaminated with the spore-form of anthrax. The employee developed a skin infection and was seen by an infectious disease specialist who suspected cutaneous anthrax. The patient has been treated with antibiotics and is doing well.
    
  • Although test results are normally not released to the public until there is confirmation, these preliminary results are being released given the current circumstances.
    
  • Anthrax is not contagious from one person to another.
    
  • Cutaneous (skin) anthrax is different from inhalation anthrax, which is the type of anthrax that resulted in the death of one person in Palm Beach County, Florida. A cutaneous infection due to anthrax can occur if the spores are in contact with an area of skin that is not intact, such as a cut or sore. Cutaneous anthrax is marked by a boil-like lesion that eventually forms an ulcer with a black center. The cutaneous forms responds well to antibiotics if treatment is started soon after symptoms appear, such as in this case.
    
  • Selected areas of 30 Rockefeller Plaza have been closed and environmental samples are being taken.
    
  • The risk of exposure is greatest for the few people who handled the letter after it was opened, or those in the immediate area at the time the envelope was opened. Nevertheless, as a precaution, all people who worked on the third floor will be given antibiotics.
    
  • CDC is supplementing a New York City Health Department team of epidemiologists investigating the case. CDC has provided personnel and is supporting New York with laboratory assistance, and antibiotics, if needed.
    
  • For more information regarding public health actions being taken in New York City, press can contact the NY City Health Department by calling 212-295-5335/5336. The public can call 1-877-817-7621 or visit nyc.gov/health.
    
  • To contact CDC, call 404-639-3286.
    
  • For information about how to handle suspicious mail, see the US Postal Service website at: www.usps.com/news/2001/press/pr01_1010tips.htm

   

• USCDC REGARDING FLORIDA ANTHRAX CASE-Public Health Alert

The Palm Beach County Department of Health, Florida State Department of Health and the CDC are continuing to conduct a public health investigation related to the anthrax exposure at the AMI Building in Palm Beach.

To date, the investigation has confirmed: 1) a single case of anthrax illness in a patient who died, 2) an individual exposed to anthrax with laboratory confirmation of exposure who continues to be hospitalized and, 3) another individual with laboratory confirmation of exposure who is not hospitalized. This latest exposure confirmation was based on a nasal swab from among evaluated workers and visitors to the AMI Building.

Evaluation and screening continues for people who worked or visited the AMI Building since August 1. To date nearly 1,000 people have been given health guidance and protective antibiotics. In addition, nasal swabs were taken from individuals who received the antibiotics to help evaluate the epidemiology of the exposure. A negative swab result does NOT rule out a possible exposure. For that reason, people MUST complete the full 60-day course, regardless of the results of the nasal swab.

Anthrax is a clinical illness caused by Bacillus anthracis (also called B. anthracis); three main types of anthrax are cutaneous (acquired through direct skin contact with source); gastrointestinal (acquired by ingestion); and inhalation (acquired through the airways from environmental sources). Anthrax is NOT contagious, meaning it CANNOT be transmitted from one person to another.

CDC, state and local health officials continue to work closely with medical professionals in Florida and nationwide to monitor hospitals and out-patient clinics for any possible additional cases of anthrax. So far, the cases of anthrax reported in Florida appear to be isolated, but an aggressive investigation is ongoing.

During this heightened surveillance, cases of illness that may reasonably resemble symptoms of anthrax will be thoroughly reviewed until anthrax can be ruled out.

The public health and medical community continue to be on a heightened level of disease monitoring. This is the disease monitoring system in action and that system is working.

Background:

For anyone exposed to anthrax, antibiotics are the appropriate preventive treatment. CDC has an emergency supply of antibiotics readily available for distribution. During this investigation, CDC tapped the National Pharmaceutical Stockpile, which guarantees enough antibiotics were in place to treat several thousand people in Palm Beach County, if needed. A total of 100 cases of antibiotics were air shipped to Palm Beach County and were in place before the clinic doors opened to the nearly 1,000 AMI building workers and visitors who were evaluated and prescribed protective antibiotics.

Every step in this public health investigation has been directed at answering: 1) who might also be ill and may need immediate treatment and, 2) what can be done now to protect anyone else from becoming ill. CDC's disease detectives have 50 years of on-the-job experience in getting answers to tough questions like these.

On October 4, based on a request from the state public health official, CDC had a team of investigators in the air and on their way to Florida, even before CDC's lab confirmed the diagnosis of the first case of anthrax illness.

Although the disease investigation continues at full tilt, CDC is far enough into this investigation to reassure the public that this appears to be a local and isolated exposure focused in one building. Nevertheless, CDC is not packing up and going home. The investigation continues as long as any public health questions remain.

CDC will release all information that is important for public safety. CDC's first priority is to protect the public's health.

Anthrax strain

The priority tests done at CDC were to 1) confirm the organism was Bacillus anthracis and 2) determine what antibiotics would protect people from developing anthrax illness, if exposed. The tests confirmed anthrax and determined that the strain of anthrax was sensitive to a wide range of antibiotics, including penicillin, giving public health officials important treatment information.

Testing to characterize the strain of the Bacillus anthracis found in the Florida case is ongoing. All three confirmed samples analyzed are the same strain. The strain characterization is an interesting part of a disease investigation, but not immediately required for the prevention and/or control of the those who may have been exposed in the AMI building. When available, information will be released, in collaboration with the FBI, and the U.S. Attorney's office.


• FDA APPROVES NEW TYPE OF PACEMAKER
  
  FDA today approved a new type of pacemaker that contains a tiny transmitter that automatically sends data on the patient's heart condition to the doctor between office visits.
  
  The product, the Biotronik Home Monitoring System, made by Biotronik, Inc., of Lake Oswego, Ore., is the first implanted medical device to be approved that is capable of automatic, remote data transmission.
  
  The system includes an already-marketed Biotronik pacemaker that has been modified to include a short-range radio frequency transmitter and a cell phone-like device that is carried by the patient in a pocket or handbag. The transmitter relays data from the heart to the phone, which transmits it to the company's service center where it is correlated and forwarded via fax to the physician.
  
  The device can be programmed by the physician to collect data as frequently as needed, from once a month to once a day. The information tells the physician how the electrical system of the heart is working and how much the pacemaker needs to work to help the heart function normally. The data is intended to supplement that gathered during the patient's regular office visits.
  
  The data can be transmitted from any location served by the digital cell phone provider used by the Biotronik system. There is no restriction on the patient's movement within this range.
  
  FDA based approval of the pacemaker on studies conducted by Biotronik that showed the product accurately and reliably transmits data.
  
  As with all pacemaker manufacturers, Biotronik will be required to track the new pacemaker for the life of the product and file annual adverse event reports with the FDA.
  

• USCDC REGARDING FLORIDA ANTHRAX CASE-Public Health Message 

  The Florida State Department of Health and the CDC are investigating a case of anthrax in a 63-year-old male Florida resident. The diagnosis is confirmed by CDC's laboratory. So far this appears to be an isolated case.

  Anthrax is not contagious. The illness is not transmitted person to person.

  Sporadic cases of anthrax do occur in the United States, so a single case is not an indication of an outbreak. The last case of anthrax reported in the United States was earlier this year in Texas.

  The rapid identification of this single case is the result of the heightened level of disease monitoring being done by the public health and medical community. This is the disease monitoring system in action.

  Right now, there is no suggestion of other possible cases, but we are aggressively checking to see if other people are similarly ill.

  The Florida State Health Department and a team from CDC are aggressively investigating the source of infection. They are reconstructing the patient's schedule for the last few weeks to attempt to determine the location where the patient may have been exposed.

  A team of CDC epidemiologists were sent to Florida to look for any indications of exposure to this disease. Medical teams and supplies are prepared to be moved quickly if needed.

  CDC and state health officials are alerting health care providers to look for unusual cases of respiratory disease. Although anthrax starts out with flu-like symptoms, it rapidly progresses to severe illnesses, including pneumonia and meningitis.

  If anyone has been exposed, antibiotics are the appropriate preventive treatment. CDC has an emergency supply of antibiotics readily available for distribution. If the investigation of the cause of this illness indicated that you need antibiotics, your state and local health department will notify you and your physician and will assure you receive the drugs.

  Based on what we know right now, there is no need for people to take any extraordinary actions or steps. They should not go to a doctor or hospital unless they are sick. They should not buy and horde medicines or antibiotics. They should not buy gas masks.

  The public needs to understand that our public health system is on a heightened sense of alert for any diseases that may come from a biological attack. So we may have more reports of what may appear to be isolated cases. We're going to respond more aggressively to these cases than in the past.

• FDA APPROVES FIRST HORMONAL VAGINAL
  CONTRACEPTIVE RING

  The vaginal contraceptive ring -- a new birth control product -- consists of a flexible, transparent, colorless vaginal ring about 2.1 inches in diameter containing the hormones etonogestrel and ethinyl estradiol, which are similar to the active ingredients in some oral contraceptives. After the ring is inserted, it releases a continuous low dose of the hormones. A new ring is used each month for continuous contraception.

  The ring must be used as directed for maximum contraceptive effectiveness. A woman inserts the ring herself, and it should remain in the vagina for three weeks.

  She then removes the ring for one week during which she will have her menstrual period.

  Like oral contraceptives, NuvaRing is a highly effective contraceptive when used according to the labeling. Out of 100 women using NuvaRing for an entire year, one or two will become pregnant.

  The manufacturer will provide a patient information brochure describing the effectiveness, benefits, and risks of the product. The patient brochure also provides information about proper use, insertion, and removal, as well as storage and disposal of NuvaRing, and also includes information about reinserting the product if it is expelled. If the ring has been out of the vagina for more than three hours, an additional method of contraception (male condom or spermicide) must be used until the ring has been back in place for seven days. NuvaRing may interfere with the correct placement and position of a diaphragm.

  Other side effects of NuvaRing may include vaginal discharge, vaginitis, and irritation. Like oral contraceptives, NuvaRing may increase the risk of blood clots, heart attack, and stroke. The labeling for NuvaRing also carries the warning that cigarette smoking increases the risk of serious cardiovascular side effects from combined hormonal contraceptive use, and therefore cautions that women who use NuvaRing should be strongly advised not to smoke. Patients who have not adhered to the prescribed regimen and who have missed a menstrual period should have a pregnancy test to rule out pregnancy.

  The new vaginal ring was developed by Organon, Inc., headquartered in West Orange, N.J., and NV Organon, the Netherlands. Two large multi-center trials with more than 2,300 women were conducted in the United States, Canada, Europe, and Israel. The trials evaluated the product for its acceptability, contraceptive effectiveness, and safety. Like contraceptive pills, NuvaRing is not for everyone. It should not be used by women who have cardiovascular disease, blood clots, or certain types of cancer. Women who use NuvaRing should not smoke.

  By 1990, developers of the vaginal contraceptive ring were performing studies to determine the best ring size, ring material, and amount of hormones to be released.

• USFTC HELPING VICTIMS OF THE TERRORIST ATTACKS:

  In the wake of the September 11 terrorist attacks on the World Trade Center and the Pentagon, Americans are opening their hearts and wallets to help the nation recover. If you're thinking about donating to the cause, here are some tips to help you give wisely:

  • Donate to recognized charities you have given to before. Watch out for similar sounding names. Some phony charities use names that sound or look like those of respected, legitimate organizations.

  • Give directly to the charity, not solicitors for the charity. That's because solicitors take a portion of the proceeds to cover their costs. That leaves less for the victims.

  • Do not give out personal or financial information - including your Social Security number or credit card and bank account numbers - to anyone who solicits a contribution from you. Scam artists use this information to commit fraud against you.

  • Check out charities. Contact the Better Business Bureau's Wise Giving Alliance: 4200 Wilson Blvd, Suite 800, Arlington, VA 22203; (703) 276-0100; www.give.org.

  • Don't give cash. For security and tax record purposes, pay by check. Write the official name of the charity on your check. Or you can contribute safely online through www.libertyunites.org.

  • Ask for identification if you're approached in person. Many states require paid fund-raisers to identify themselves as such and to name the charity for which they're soliciting
    

• BLACK TUESDAY 9-11-01

Forevermore, yesterdays cataclysmic infamy, brought about through unconscionable and dastardly acts of tyranny against "all that is good" was met by unheralded acts of heroism.  Not since those great Americans of World War II, has this nation seen lines of Americans giving up their own blood to the red cross to be used for any color, creed or race of gods green creation.  The Black Tuesday calamity has brought all factions of Americans together.  American Jews, Moslems, those of Hispanic, German and Chinese decent were seen hugging and comforting each other yesterday pledging that we as Americans must step up to the plate, and meet the challenge. All people of any denomination or race is equal in America.   If you worked in downtown Los Angeles yesterday, as this reporter, you too would have seen a unity which as eluded us since our inception as a nation. 

Zero tolerance to the existence of terrorism was the conclusion.  No matter where, no matter by whom, freedom will seak out those enimies of god's creation ("life").  No matter what rock they hide under nor whom they hide behind,  the enimies of creation, equality, freedom and democracy will be brought to justice for the sake of our world. InfoJustice  

• HEINOUS ATTACKS ON AMERICA; TERRORISTS DECLARE WAR ON FREEDOM, DEMOCRACY, AND USA, September 11, 2001
  
  NEW YORK -- Airplanes struck the Pentagon and New York City's World Trade Center Tuesday morning in a massive terrorist attack.
  
  The Secret Service received a "credible" threat against the "presidential mansion" in Washington D.C. The White House, Capitol and the U.S. Treasury buildings were being evacuated.
  
  Paul Begala, a Democratic consultant, said he witnessed a explosion near the Pentagon shortly after two planes crashed into World Trade Center.
  
  "It was a huge fireball, a huge, orange fireball," Mr. Begala said in an interview on his cell phone. He said another witness told him a helicopter exploded.
  
  CNN also reported that witnesses spoke of a helicopter near the Pentagon before the crash.
  
  In New York City, one plane crashed into the World Trade Center's North Tower around 9 a.m. EDT. About 18 minutes later, a second plane collided into the South Tower.
  
  Smoke and flames were seen billowing from the buildings. Sirens blared, and papers were billowing around the World Trade Center like "bizarre confetti," one witness said.
  
  There was no immediate word on injuries or fatalities in the disasters. Witnesses at the scene saw people either falling or jumping from the upper stories of the World Trade Center.
  
  One of the two planes that crashed into the World Trade Center was hijacked after takeoff from Boston, a U.S. official said, citing a transmission from the plane.
  
  In a brief televised statement from Sarasota, Fla., President Bush said, "Two planes have crashed into the World Trade Center in an apparent attack on our country." Mr. Bush vowed the attackers would be caught, and asked all Americans to pray for victims and their families.
  
  Paul Ingrassia, president of Dow Jones Newswires, who witnessed the crash, said a plane that hit the World Trade Center appeared to be a commercial-sized jet. He described the scene of commotion and smoke, with many people running around and debris scattered from the collision.
  
  One person who was in a health club in the South tower of the World Trade Center said some windows there imploded from the plane crash.
  
  "The plane was coming in low and ... it looked like it hit at a slight angle," said Sean Murtagh, a CNN vice president, the network reported.
  
  Large holes were visible in sides of the 110-story buildings, landmark twin towers, and the tops of the twin towers were obscured by smoke.
  
  Thousands of pieces of what appeared to be office paper came drifting over Brooklyn, about three miles from the tower, one witness said.
  
  LaGuardia, JFK and Newark airports were closed, as were all bridge and tunnel crossings into and out of New York City. The New York Stock Exchange and Nasdaq Stock Market delayed opening. The White House, Pentagon, and the NYSE are being evacuated. All planes in US airspace have been grounded. 
  

• THE FBI IS GOING TO THE MOVIES LOOKING FOR DANGEROUS FUGITIVES AT LARGE.

From August 24, 2001 to September 7, 2001, movie theaters in Washington, D.C., and suburban Maryland and Virginia, will display slides featuring three men wanted by the FBI and the Washington Metropolitan Police Department (MPD). The slides, which will be shown on sixty-four screens in all, will run several times before the previews and feature presentation begins.

The FBI's Washington Field Office has an agreement with Cinema Advertising, Inc. of Mahwah, New Jersey to publicize fugitives in several of its movie houses.

The three fugitives appearing on the theater screens include:

1) Cornelius Smith, alias Thump. He is a 23-year-old black male, 5'10", 220 pounds, and is wanted on an outstanding Metropolitan Police Department, District of Columbia warrant charging Smith with first degree murder while armed.
2) Maurice Stewart is a 30-year-old black male, 5'8", 160 pounds, and is wanted on an outstanding Metropolitan Police Department, District of Columbia warrant charging Stewart with first degree murder while armed.
3) David Burno is a 33-year-old black male, 5'6", 220 pounds and is wanted on an outstanding Metropolitan Police Department, District of Columbia warrant charging Burno with armed robbery.

The following theaters are scheduled to show the fugitive's profiles: In Washington, D.C. - Cineplex Cinema, Cineplex Dupont 5, Cineplex Foundry, Cineplex Inner Circle 3, Cineplex Outer Circle, Cineplex Uptown, Cineplex Wisconsin Avenue Cinemas; In Maryland - Cineplex Marlow 6, Loews Rio 18, Wheaton Plaza Regional Center; In Virginia - Multiplex Cinemas Mt. Vernon.

Should the placement of fugitive photographs in theaters generate leads and be successful, the initiative may be continued by the FBI in additional cities.

If anyone recognizes any of these dangerous individuals or has information regarding their whereabouts, they are asked to contact the FBI's Washington Field Office at area code 202 - 278-2000. InfoJustice

• Lightlife Recalls Smart Cutlets Chicken Due to Undeclared Sulfites

  Lightlife Recalls Smart Cutlets Chicken Due to Undeclared Sulfites

  TURNERS FALLS, MA - August 24, 2001 -- Lightlife Foods is voluntarily recalling 7,710 pounds of Smart CutletsTM Seasoned Chick'n after recently being informed by an ingredient supplier that undeclared sulfites are present in one of their ingredients. Because the Smart Cutlets Seasoned Chick'n packages do not list sulfites among the ingredients, two production lots of the product are being recalled nationwide. The product contains undeclared sulfites, and people who are sensitive to sulfites run the risk of serious or life-threatening reaction if they consume this product.

  Available in retail refrigerator cases nationwide, Smart Cutlets Seasoned Chick'n, UPC #43454-10101, comes in an 8-ounce package, containing two 4-ounce servings. The recall covers product marked "Best by Oct 12 01" and "Best by Oct 14 01," found on the package side panel below the bar code. Consumers are urged to return the product to the store where it was purchased for a refund.

  None of Lightlife's other products are affected by this recall.

  No reports of illness related to this product have been received.

  This voluntary recall is being conducted in cooperation with the Food and Drug Administration.

  Consumers with questions can find answers 24 hours a day at www.lightlife.com or by calling 1-800-233-7022

• Georgia Defendant Settles FTC Charges in California Case:

  Permanently Barred From Marketing and Selling Credit-Related Goods

  In a proposed settlement, Mark Alan Conway, who did business out of Atlanta, Georgia as HomeLife Credit Services (HomeLife), has agreed to be permanently banned from any involvement in activities related to credit-related goods or services. Under the agreement, Conway is also prohibited from misrepresenting any fact material to a consumer's decision to make any purchase of goods or services from him, as well as from any future violations of the Federal Trade Commission Act and the Telemarketing Sales Rule (TSR).

  Conway was one of two individuals named as defendants in the FTC's 2000 case against HomeLife Credit Services, a result of "Operation Advance Fee Loan 2000," an aggressive sweep targeting corporations and individuals that falsely promised consumers could obtain loans and credit cards for an advance fee. It is a violation of federal law to request or receive a fee from a consumer in advance of obtaining or arranging a loan or other extension of credit when the seller has guaranteed or represented a high likelihood of success in obtaining or arranging for a loan or extension of credit.

  To conceal itself both from complaining consumers and law enforcement, HomeLife used a series of false addresses and mail drops in Los Angeles, California while operating out of a boiler room in Atlanta, Georgia. HomeLife used telemarketers to solicit consumers throughout the United States to apply for unsecured credit cards by falsely promising that, in exchange for a one-time fee of $129.95, consumers would receive credit cards with a $2,500 credit limit. HomeLife debited the fee directly from the consumers' bank accounts, but consumers never received the promised credit cards. Instead of a new credit card, consumers received a package from HomeLife containing a list of banks to which they could contact to apply for a credit card, along with a booklet about maintaining good credit. Consumers who sent complaints to the address on the company's letterhead had their mail returned "undeliverable."

  The FTC filed its complaint in June, 2000 in federal court in the Central District of California against "One or More Unknown Persons doing business as HomeLife Credit Services." The two-count complaint alleged that the defendants violated the FTC Act and the TSR by misrepresenting that consumers had been approved for an advance fee credit card. Judge Carlos Moreno issued a temporary restraining order and an asset freeze over all of HomeLife Credit Services' assets. In September 2000, the Commission amended the complaint to specifically name Mark Alan Conway and William Anderson, both of Atlanta, Georgia, as individual defendants.

  The stipulated final judgment, which required the court's approval, bans Conway from engaging in any activities relating to the advertising, marketing, telemarketing, offering for sale or sale of any credit-related goods or services, or assisting others in the same conduct. The judgment also prohibits Conway from making any misrepresentations of material fact in connection with the sale of any services related to credit cards, loans or other extensions of credit, including claims about the likelihood of a consumer receiving a credit card or extension of credit.

  In addition to the ban, the settlement contains a suspended judgment of $338,940 to be due immediately if it is found that Conway made any false representations on his financial statements to the FTC. The settlement also requires Conway to stop any collection attempts and to return any uncashed checks to consumers. He is also prohibited from selling his customer lists. Finally, the settlement contains various recordkeeping and reporting requirements to assist the FTC in monitoring the defendant's compliance.

  The Commission vote authorizing staff to file the stipulated final judgment was 5-0. It was filed in the U.S. District Court, Central District of California, Western Division, on August 24, 2001, and signed by the judge on August 27, 2001.

• FDA Approves First Pacemaker For Congestive Heart Failure

  FDA today approved a new type of pacemaker that sends specially timed electrical impulses to the heart's lower chambers to treat the symptoms of moderate to severe congestive heart failure.

  The device is the InSync Biventricular Cardiac Pacing System made by Medtronic, Inc., of Minneapolis.

  The InSync system is the first pacemaker approved for treating the symptoms of congestive heart failure, a condition in which the heart can not adequately pump blood around the body. Standard pacemakers are used to treat rhythm disturbances in the heart, a different condition.

  People with congestive heart failure typically experience fatigue and shortness of breath during exertion, and therefore have difficulty performing many of the routine tasks of daily living.

  The InSync System consists of a pulse generator that is implanted in the chest and connected to the heart by three wires (leads) that deliver electrical impulses. One wire is placed in the upper right heart chamber and the others are placed in each of the two lower chambers, where they simultaneously stimulate both the left and right ventricles. This device differs from a standard pacemaker in that it has three leads instead of one or two leads.

  FDA approved the product based on clinical studies of safety and effectiveness conducted by Medtronic and on the recommendation of the Circulatory System Devices Panel of FDA's Medical Devices Advisory Committee.

  Medtronic studied use of the device in 579 patients with moderate to severe congestive heart failure at 44 medical centers in the U.S. and Canada. Patients were randomized to either having the pacemaker turned on or turned off and were followed for six months.

  Overall, the majority of the patients in whom the pacemaker was turned on showed improvement in either quality of life scores, distance they were able to walk or their heart failure classification. Approximately one third of patients in the control group also saw improvement. There was no change in the mortality rates in the two groups.

  The study did not reveal any major safety issues with the device itself; however, implanting the device requires special training on the part of the physician.

  As part of the approval, Medtronic will be required to conduct a post-market evaluation of this device in 1,500 patients followed over three years.

  Not all people with congestive heart failure have been shown to benefit from the new device. Patients who have not been helped by drug treatment and whose ventricles are not synchronized correctly are suitable candidates.

• FBI Miami:

  Special Agents from the FBI raided four Florida offices of Liberty Medical Supply, a subsidiary of PolyMedica Corp., a distributor of diabetes home-testing kits. According to FBI Miami, about 85 Agents raided two offices in Palm City, and one office both in Stuart and St. Lucie. The FBI also executed search warrants at the homes of two current employees of the subsidiary as part of this ongoing investigation

• SEVERE AND FATAL LIVER INJURY CONNECTED TO LATENT "TB" TREATMENT

  The Centers for Disease Control and Prevention has investigated reports of 21 patients who were hospitalized because of severe liver injury associated with a two-month treatment regimen of rifampin and pyrazinamide (RIF-PZA) for latent TB infection (LTBI). Sixteen of the patients recovered and five died. Findings from the investigations into these cases are included in the August 31 edition of CDC’s Morbidity and Mortality Weekly Report (MMWR).

  CDC previously published findings from an investigation into two cases of severe liver damage associated with RIF-PZA. Only one of the patients recovered. These cases were outlined in the April 20 edition of the MMWR, at which time CDC requested reports of additional cases.

  CDC and ATS Revise Guidelines for Latent TB Treatment

  As a result of these investigations, CDC and the American Thoracic Society are issuing revised treatment guidelines for LTBI to limit the circumstances in which the combination of RIF-PZA is prescribed and to strengthen the level of patient counseling and monitoring recommended for LTBI treatment regimens.

  For most individuals with LTBI, the new guidelines recommend the nine-month regimen of daily INH as the preferred treatment. CDC recommends providers use RIF-PZA with caution, especially in those currently taking other medications that have been associated with liver injury, and those with alcoholism even if alcohol usage is discontinued during treatment.

  However, with careful clinical and laboratory monitoring as outlined in the recommendations, RIF-PZA remains an option for patients at high risk of developing active TB disease and who are unlikely to complete a nine-month regimen of isoniazid (INH). For HIV-negative individuals with LTBI, the new guidelines recommend the nine-month regimen of daily INH as the standard treatment.

  While available data do not suggest excessive risk of severe side effects associated with RIF-PZA among HIV-positive individuals, providers should consider the use of INH when completion of this longer regimen can be assured. Patients co-infected with HIV and LTBI are at increased risk for developing active TB disease.

  Guidelines Emphasize TB Testing and Treatment for People at High Risk

  The goal of testing people for TB is to find and treat those who have LTBI and are at high risk of developing active TB disease. Those at high risk include individuals with LTBI who are HIV-infected, were recent contacts of someone with active TB, injection drug users, and residents or employees of high-risk congregate settings, which include correctional facilities, nursing homes, homeless shelters, hospitals, and other health care facilities. Furthermore, providers are reminded that treatment is recommended for foreign-born people with LTBI who have lived in the United States for less than five years and who were born in countries with high rates of TB. After five years, treatment decisions should be made on the same basis as other patients.

  Because all regimens for treating LTBI have been associated with liver injury, careful monitoring during treatment is important to avoid severe damage. Any additional cases of severe liver damage associated with treatment of LTBI should be reported to the CDC’s Division of TB Elimination. These recommendations should not affect patients receiving treatment for active TB.

  Related MMWRs

  For information about the previous MMWR on severe liver damage associated with RIF-PZA:

  Fatal and Severe Hepatitis Associated With Rifampin and Pyrazinamide for the Treatment of Latent Tuberculosis Infection – New York and Georgia, 2000

  The findings from the April 20 MMWR article, "Fatal and Severe Hepatitis Associated With Rifampin and Pyrazinamide for the Treatment of Latent Tuberculosis Infection --- New York and Georgia, 2000," underscored the need for clinical monitoring for adverse effects in all patients receiving treatment for LTBI to help prevent severe liver damage as a result of LTBI treatment.

  For a copy of the April 20 MMWR: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5015a3.htm

  For information about the original recommendations:

  Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection

  The recommendation on the treatment on LTBI was included in the Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection statement developed by a panel of 47 experts from three continents. American Thoracic Society (ATS) and CDC convened the panel. The Infectious Diseases Society of America also endorsed the panel’s statement. The American Academy of Pediatrics endorsed sections of the statement relating to infants and children. It was published as a supplement to the April 2000 issue of the ATS’s American Journal of Respiratory and Critical Care Medicine, and was reprinted in CDC’s Morbidity and Mortality Weekly Report on June 9, 2000

• FBI Kansas City:

  On August 22, 2001, the Office of the United States Attorney for the Western District of Missouri announced that it had asked for a civil injunction to be issued to shut down the operation of Research Medical Tower Pharmacy, require pharmacist Robert R. Courtney to surrender a series of licenses and operating permits, and freeze at least $6 million in assets owned by Courtney and the pharmacy.

  Special Agents of the FBI and the United States Food and Drug Administration’s Office of Criminal Investigations launched an investigation of Courtney and the pharmacy on July 27, 2001, after a medical doctor provided them with information.

  Courtney, 48, of Kansas City, Missouri, was charged with one felony count of misbranding and adulteration of a drug in a federal criminal complaint filed August 14, 2001, in Kansas City, Missouri. The charge alleges that he dispensed two chemotherapy drugs at potency levels ranging from only 39 percent to less than one percent of their prescribed strengths

• ELIMINATING LABORATORY ERRORS THAT CAUSE PATIENT ILLNESS AND DEATH-CDC

  In 1999, the Institute of Medicine reported that medical errors, including those that occur in laboratories, may result in as many as 98,000 patient deaths annually in the United States at a cost of $17-29 billion.

  To address this issue, the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality, the Centers for Medicare and Medicaid Services, and the Food and Drug Administration are participating in the Patient Safety Task Force, a federal initiative to monitor and promote patient safety in the United States. An important part of this initiative is to identify and eliminate laboratory errors.

  In addition, eliminating laboratory errors is one of "Seven Healthcare Safety Challenges" identified by CDC’s Division of Healthcare Quality Promotion to protect patients, protect healthcare personnel, and promote quality healthcare. For example, the Division is working with clinical microbiology laboratories across the United States to improve their capacity to perform confirmatory testing on certain germs that are resistant to antibiotics. Confirmatory testing is necessary to prevent an incorrect report about the true identification and drug resistance of an organism. An incorrect report can lead a doctor to misdiagnose an illness and recommend the wrong antibiotic.

  A recent CDC survey of over 400 clinical microbiology laboratories in the United States showed that 76 percent are aware of the need to perform confirmatory vancomycin testing in Staphylococcus aureus if reduced susceptibility to vancomycin is suspected. This percentage has increased almost 20 percent since 1997 due to CDC’s efforts to provide information and training to clinical laboratories. Additional efforts are underway to ensure that all laboratories perform the correct tests.

• FDA Issues Draft Guidance to Further Reduce the Possible Risk of Transmission of Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products

  FDA today issued draft revised guidance to the blood industry intended to further reduce the risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) to recipients of blood and blood products. Under the proposal, implementation of the policy would be phased in gradually in two stages next year to allow time to prepare for the changes and help maintain an adequate blood supply.

  “FDA’s goal is to strike a careful balance between increasing the safety of the blood supply while ensuring that life-saving blood and blood products remain available when needed,” said FDA’s Acting Principal Deputy Commissioner Bernard A. Schwetz, D.V.M., Ph.D. “We are taking these steps to help protect the safety of the blood supply at a time when science does not allow us to rule out the risk of transmission of vCJD through blood transfusions.”

  The recommendations proposed in this guidance are considered to be prudent until more definitive information about the natural history of vCJD is known, or donor-screening tests can be developed. Based on the best available science, the recommendations are designed to exclude donors who may have been exposed to the agent of BSE (bovine spongiform encephalopathy or “mad cow disease”) in the United Kingdom (U.K.) and other parts of Europe. BSE has been linked to vCJD, a fatal degenerative brain disease found almost exclusively in the U.K.

  Currently, vCJD is not known to have been transmitted by blood transfusion. Furthermore, no cases of BSE or vCJD have been reported in the United States. However, animal models suggest that transmission by blood products may be possible. In addition, cases of vCJD in the United Kingdom continue to increase and BSE has become widespread in Europe.

  The document is being issued as a draft for public comment within 30 days. Once comments have been evaluated, FDA intends to issue final guidance no later than the end of 2001.

  The revised guidance, as proposed, includes changes that would expand the donor deferrals that have been recommended since August 1999 for donors who have lived or traveled in the U.K. Also, it proposes exclusions for persons who were stationed at U.S. military bases in Europe from 1980 through 1996 because beef products from the U.K. were provided at these military bases during that period. FDA proposes that these changes be implemented by May 31, 2002.

  In addition, FDA is proposing in the draft guidance that blood establishments should defer blood donors who have lived a cumulative period of five years or more in Europe from 1980 until the present. This does not include donors of Source Plasma (plasma intended solely for use in making further manufactured products) because plasma derivative products are highly processed, reducing risks of infectious diseases, and because of supply concerns. Although the risk of BSE exposure in the rest of Europe is much less than in the U.K., this uniform recommendation for Europe takes into account the difficulty in predicting how the BSE epidemic will evolve in Europe. It also allows for variations in food chain protection measures and their
  enforcement in different countries. FDA proposes that this change be implemented by October 31, 2002.

  “Nationwide, under FDA’s proposal, about 95 percent of those currently eligible to donate blood would remain eligible, yet the risk of possible exposure to vCJD would be reduced by approximately 90 percent,” said Dr. Jay Epstein, Director of FDA’s Office of Blood Research and Review. “We will continue to review these recommendations in the light of evolving scientific information about vCJD risks and the impact these policies may have on the blood supply.”

  FDA regularly seeks scientific advice at public meetings from experts with FDA’s Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC). In June of this year, the TSEAC recommended that FDA revise its current guidance in accordance with the proposed recommendations described above.

  The impact of these deferrals will differ in various locations depending on the amount of travel made by potential donors. Deferrals are expected to be up to 50 percent greater than average in major urban areas along the East and West coasts. Additionally, the New York metropolitan area, which currently depends upon blood imported from Europe for approximately one fifth of its supply, will be particularly affected.

  The phased approach with two implementation dates is intended to allow more time for blood establishments to increase local recruitment efforts and, if needed, to establish alternate sources of supply. In order to accomplish this, it is important that blood centers avoid implementing the proposed deferrals more quickly than recommended.

  Last week, the Department of Health and Human Services announced it is launching a new blood-monitoring system that will help the blood distribution network to operate more effectively. HHS Secretary Tommy G. Thompson has also announced plans to accelerate research and surveillance on BSE and related diseases.

  Specific changes to the previous guidance that are being proposed include the following:

  For implementation by May 31, 2002, deferral of donors who:

  • Have spent three or more cumulative months in the U.K. from the beginning of 1980 through the end of 1996, when controls designed to keep BSE out of the human food chain were fully implemented in the U.K.
    (Previous guidance excluded donors who had spent six or more cumulative months in the U.K. in that same time period.); or
  • Have spent five cumulative years or more in France from 1980 to the present; or
  • As current or former U.S. military personnel, civilian military employees and their dependents, have lived for six months or more at U.S. military bases in Northern Europe Germany U.K., Belgium, and the Netherlands) from 1980 through 1990) or elsewhere in Europe (Greece, Turkey, Spain, Portugal, and Italy) from 1980 through 1996; or
  • Have received a blood transfusion in the U.K. between 1980 and the present.

  For implementation by October 31, 2002, deferral of donors who:

  • Have spent a cumulative total period of five years or more in Europe from 1980 until the present.

  The Department of Health and Human Services and FDA will work with others to promote increased blood donation by people who are eligible. New and former blood donors should contact their local hospital or blood bank to schedule a donation.

  “It is essential that healthy people donate blood,” said Dr. Schwetz. “It can be a gift of life.”

• 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.

• ELIMINATE BIGOTRY IN THE MEDICAL-LEGAL FIELD AND ELIMINATE FRAUD AND ABUSE.

Today pundits armed with bigotry, bios, and ignorance drive the litigation system through improper philosophy and training and thus false credentials.  These profiteers then create an environment of hostility which makes experts into martyrs for false causes.  Members, begin to document any perceived bigotry done consciously or unconsciously.  A healthy medical system breads self-evident findings reducing court time and court costs (5 out 10 cases this examiner accepted within the last few weeks has some hint of a bias against a "minority-group").   InfoJustice

• MEMBERS ADVISE THE HOME OFFICE IF ANY OF YOU HAVE BEEN CONTACTED ABOUT EXPERT TRAINING; HERE WE GO AGAIN! 

Members after careful review, at this point in time I must opine not to seek out any organization who's members or staff did not work on some of the largest cases against health fraud in US History.  Absent these types of "teachers", you have nothing to gain, and plenty of money to lose for eventually they fail on the simplest of details!  Don't fall prey to people "requesting your money" and promising you hope and leaving you unhappy for any reason in life; obviously opposite to our mission.  We have taught you the skills you need and remember believe in your selves for gods sake.  I have testified in court (so what!) and worked on many of the largest dollar civil as well as criminal cases relative to health care in US History.  Be yourself, be truthful, be scientific, be prepared and relaxed.  Tricky cross examiners with angles and objectives, look like tricky folks in court if you remain relaxed and consistent. In fact the more real life, unrehearsed yet prepared you look, the better you will be perceived.  I remember one Belli birthday party, Beverly Hills, 1983, when Mel advised "the best preparation for trial as an expert, is to be a master of your science".  Equate that to your field of expertise; i.e. CFE, MD, InfoJustice

• HAVE A HAPPY AND SAFE FOURTH OF JULY CELEBRATION

  On this most special of holiday's we must stop, smell the roses and count our blessings.  What other nation, can boast they have a holiday, who's message is one shared by all free folks in free lands today; the message of "Yankee Doodle Dandy".  We fought to be able to have free business unburdened by ridiculous over-regulation by local and central governing persons.  To be able to open a business unencumbered by prejudice, and conduct free trade.  Our free speech, and the ability to fight to maintain our basic rights, through communication and litigation methods, is still maintained.  As we celebrate the Fourth this year, think of the many persons in law and civilian entities who may have inhibited the rights of some free man or women you know, and be a stand up American and help that person.  The fight for freedom and the right to conduct free trade in our chosen labor fields is under attack even today.   Help the underdog this holiday, and remember what our ancestors fought for, what we gained, and where we have yet to go. 

  I would like to thank the entire body of the founding members of the Academy for reminding this editor to keep up the Journal; that of  Dr. John L Sullivan, and Dr. John (Jay) Sullivan Jr., as well as Norman Udewitz.  As can be evidenced by this web site, "team work" has formed the building blocks and strong foundation to which the "Academy" will continue to grow and fight consumer health fraud through our sword; communication.  I thank you for allowing me to be a part of this legacy. Happy and Safe Fourth of July from the American Academy For Justice Through Science. InfoJustice ™©

• NEWS FROM DR. JAY WHILE VISITING IN THE US.

Writing any update about Dr. Jay is difficult as you will see.  Briefly you remember our reporting about Robert Philip Hanssen, age 56 a veteran FBI counterintelligence Agent who was arrested by the FBI and charged with committing espionage by providing highly classified national security information to Russia and the former Soviet Union.  Well Hanssen went to Dental School with Dr. Jay and book authors and the press have been visiting him here and abroad.  Dr. Jay has interesting pictures of the young Hanssen prior to acceptance into the FBI.   What a small world.  In another vein, the California Sheriff's Department has asked Dr. Jay to place John L.'s first two books on display in the new California Museum of Law Enforcement.  He will be using our editorial about our founding board member for the Museum.  It's a small world; InfoJustice 

• 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.

  Further information about thimerosal is available at www.cdc.gov/nip/vacsafe/concerns/thimerosal/thimerosal.htm.

  Aventis Pasteur is located in Swiftwater, Pennsylvania.

• 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.) InfoJustice

• 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 devices. A system designed to prevent wasteful, duplicative review may have led to the unintended consequence of ineffective review." He urged the FDA and Congress to "take a hard look at the export regime to be sure that it is not inadvertently undermining U.S. and international efforts to combat the AIDS pandemic."

• USFDA EXPLAINS LASIK

LASIK is a surgical procedure intended to reduce a person's dependency on glasses or contact lenses. The goal of this Web site is to provide objective information to the public about LASIK surgery. See other sections of this site to learn about what you should know before surgery, what will happen during the surgery, and what you should expect after surgery. There is a glossary of terms and a checklist of issues for you to consider, practices to follow, and questions to ask your doctor before undergoing LASIK surgery.

LASIK stands for Laser-Assisted In Situ Keratomileusis and is a procedure that permanently changes the shape of the cornea, the clear covering of the front of the eye, using an excimer laser. A knife, called a microkeratome, is used to cut a flap in the cornea. A hinge is left at one end of this flap. The flap is folded back revealing the stroma, the middlesection of the cornea. Pulses from a computer-controlled laser vaporize a portion of the stroma and the flap is replaced.

• FDA PROPOSES NEW RULES FOR "GOOD TISSUE PRACTICE"

  FDA today proposed a new regulation on current good tissue practice (GTP), which includes the methods, facilities and controls used for the manufacture of human cellular and tissue-based products. This proposed rule is the last of three proposals designed to implement FDA’s 1997 “Proposed Approach to the Regulation of Cellular and Tissue-based Products”, a comprehensive risk-based regulatory framework designed to help ensure the safety and quality of products, including new technologies, without imposing unnecessary regulatory requirements.

  The purpose of the GTP regulations is to help ensure that donors of human cellular and tissue-based products are free of communicable diseases, and that the cells and tissues are not contaminated during manufacturing and maintain their integrity and function. Key elements of the proposed rule are:

  • Establishment of a quality program, which would evaluate all aspects of the firm’s operations, to ensure compliance with GTP;
  • Maintenance of an adequate organizational structure and sufficient personnel;
  • Establishment of standard operating procedures for all significant steps in manufacturing;
  • Maintenance of facilities, equipment and the environment;
  • Control and validation of manufacturing processes;
  • Provisions for adequate and appropriate storage;
  • Record keeping and management;
  • Maintenance of a complaint file;
  • Procedures for tracking the product from donor to recipient, and from recipient to donor.

  These fundamental, base-line regulations would apply to manufacturers of all human cellular and tissue-based products. In addition, all of these manufacturers would be required to report adverse reactions and certain product deviations, have adequate labeling that is not false or misleading and allow FDA inspections to ensure compliance with regulations. Certain cellular and tissue-based products that require licensing or premarket approval as biological products or medical devices would be subject to more comprehensive requirements based on their risks.

  Two other related proposed rules to implement the 1997 regulatory approach to tissues and cells have already been published. The first one was (“Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products”) published May 14, 1998 and required tissue facilities to register with the FDA and list their products. This proposed rule is currently undergoing review and is expected to be published in final form soon. The other one, (“Suitability Determination for Donors of Human Cellular and Tissue-Based Products”) issued on Sept 30, 1999, focuses on donor screening and testing measures to prevent the unwitting use of contaminated tissues with potential to transmit infectious diseases.

  FDA’s current regulations addressing tissues were promulgated in December 1993 with an interim final rule that required the screening and testing of tissue donors for certain transmissible diseases such as HIV and hepatitis, as well as the screening of donors for behavioral risk factors. The final rule, which was published on July 29, 1997, became effective on January 26, 1998. The new proposed rules are more comprehensive and include provisions for the regulation of innovative products.

• CUSTOMER SATISFACTION RESULTS FOR THE FOOD AND DRUG ADMINISTRATION REMAIN CONSTANT

  The results of the second government-wide customer satisfaction survey released today show that consumers continue to be satisfied with the FDA's performance in food labeling and consumer alerts on food safety issues, and continue to have confidence and trust in the FDA to ensure food safety for consumers.

  This survey, initiated last year by the National Partnership for Reinventing Government, was developed to measure how well key government agencies serve the American public and set a baseline for measuring customer satisfaction with the Federal government.

  The survey was conducted by the University of Michigan using a model established for the American Customer Satisfaction Index, which measures satisfaction with various industries. The FDA received an index score of 68 in the customer survey, which is two points higher than last year's score, but is not a statistically significant change.

  Customers were randomly selected and asked about their expectation and the quality of the services or products they received from the various agencies. Principal grocery shoppers and food preparers were interviewed for the FDA survey. Survey questions asked about the mission of the FDA to ensure food safety; the usefulness and clarity of nutrition labeling, customer awareness, and the views on effectiveness of inspecting, testing and labeling efforts.

  In addition, similar questions were asked about meat and poultry products regulated by the U.S. Department of Agriculture (USDA). In addition to the positive responses about nutrition labeling and food safety, those surveyed were concerned about the timeliness of consumer alerts and had less awareness of the FDA's mission in food safety. The survey results, as in the 1999 report, call for efforts to increase in public awareness on how FDA food safety activities affect the consumer.

  "The nutrition label has made it easier for Americans to make informed food choices," said Jane E. Henney, M.D., Commissioner of the Food and Drug Administration. "Food safety has been a top priority for the FDA as a part of the Food Safety Initiative and the public depends on the FDA to continue to build on its successes in protecting the public health, especially with egg, seafood, and produce safety."

  The FDA has undertaken a number of activities in the area of labeling and food safety this year. A new web site on using the nutrition facts panel of the food label was initiated this fall and can be accessed at http://vm.cfsan.fda.gov/~dms/foodlab.html In the arena of food safety, the agency has issued regulations on egg safety labeling and refrigeration; has approved the use of irradiation to reduce pathogen on sprout seeds, shell eggs and juice, and has completed an evaluation of the Seafood HACCP program. The agency is preparing draft risk assessments for the pathogens Listeria monocytogenes and Vibrio parahaemolyticus and is issuing regulations for food produced with biotechnology and dietary supplement good manufacturing practices. As well as posting FDA recall information on its web site, the FDA now includes press releases of voluntary recalls issued by manufacturers, so consumers will have this information in a timely manner.

  The agency continues to support a wide range of outreach activities including its website (www.fda.gov), the FDA information line (1-888-INFO-FDA), and the Center for Food Safety and Applied Nutrition information line (1-888-SAFEFOOD). The FDA also continues to support the "Fight BAC" campaign a collaborative program involving government, industry, academia, and consumer groups which focuses on consumer education about safe food handling. One example of this outreach is the FDA-National Science Teachers Association Food Science Professional Development Program designed to assist middle and high school teachers in working food science into their science curriculums.

• LEADING CAUSES OF DEATH
  (All figures are for U.S.)

  Ten Leading Causes of Death in the U.S.: (1998)
  Heart Disease: 724,859
  Cancer: 541,532
  Stroke: 158,448
  Chronic Obstructive Pulmonary Disease: 112,584
  Accidents: 97,835
  Pneumonia/Influenza: 91,871
  Diabetes: 64,751
  Suicide: 30,575
  Nephritis, nephrotic syndrome, and nephrosis: 26,182
  Chronic Liver Disease and Cirrhosis: 25,192
  Source: National Vital Statistics Reports, Vol. 48, No. 11
  
  Comprehensive Data
  Ten Leading Causes of Death, by Sex, Race, and Age
  View/download PDF
  Ten Leading Causes of Death Among Hispanics, by Sex and Age
  View/download PDF
  Selected Leading Causes of Death in 50 States
  View/download PDF

• PHYSICIAN LABELING PROPOSAL

  The Food and Drug Administration today proposed a new format for prescription drug labeling that will help reduce medical errors, which according to the National Academy of Sciences may be responsible for as many as 98,000 U.S. deaths annually. FDA believes that this new, user- friendly format will reduce errors in drug prescribing.

  "Today's proposal is FDA's latest initiative to improve the labeling of the products it regulates," said Dr. Jane E. Henney, FDA Commissioner. "This proposal is particularly valuable because it will make important information available in a clear, consistent, and readable format that is essential to proper prescribing practices."

  Prescription drug product labeling, also known as the package insert, represents a primary means of providing critical information about drugs to practitioners. As part of the drug review process, FDA reviews and approves drug product labeling that is initially proposed by manufacturers.

  An FDA study showed that practitioners found drug product labeling to be lengthy, complex, and hard to use. The proposed new format would provide user-friendly labeling that would allow practitioners to quickly find the most important information about the product. One major change is inclusion of a new introductory "Highlights" section of bulleted prescribing information. This section would include the information that practitioners most commonly refer to and view as most important, and it would provide the location of further details elsewhere in the labeling.

  The proposed new labeling is expected to reduce practitioners' time spent looking for information, decrease the number of preventable medical errors, and improve treatment effectiveness. The information will be easier to find, read and use, and it should also enhance the safe and effective use of prescription drugs and reduce medical errors caused by inadequate communication. Because these labeling revisions represent considerable effort and are most critical for newer and less familiar drugs, the proposal will apply only to relatively new prescription drug products.

  For further information, see the Federal Register for Dec. 21, 2000.

• FDA APPROVES NEW TREATMENT FOR ECZEMA

  The Food and Drug Administration (FDA) today approved a new treatment for atopic dermatitis (eczema) - a non-contagious skin condition that can cause redness, itching and oozing lesions.

  The drug is Protopic (tacrolimus) Ointment (0.1% and 0.03% for adults and 0.03% for children 2 years and older). The drug is for patients with moderate to severe eczema, for whom standard eczema therapies are deemed inadvisable because of potential risks, or who are not adequately treated by or who are intolerant of standard eczema therapies.

  FDA based its approval on the results of three 12- week studies which indicated that 28-37% of patients using Protopic experienced greater than or equal to 90% improvement of their skin condition, as measured by physicians, and two one year studies that indicated that the drug is safe for intermittent long term use.

  Common side effects associated with this drug include temporary stinging or burning sensations where the drug is applied, which may lessen if the diseased skin heals. There was evidence from an animal study that Protopic Ointment may accentuate the adverse effects of ultraviolet light on the skin. Therefore, it is important that patients avoid sunlight and sun lamps, tanning beds, and treatment with UVA or UVB light. Patients who need to be outdoors after applying Protopic should wear loose fitting clothing that protects the treated area from the sun. In addition, patients should ask their health care providers what other type of protection from the sun to use.

  The drug should not be used by patients who are allergic to its active ingredient, tacrolimus, or to its inactive ingredients. Women who are breastfeeding should also avoid using this drug. Women who are pregnant or who are planning to become pregnant should check with their physicians before using this product.

• Unpowered Scooter-Related Injuries --- United States, 1998--2000

  Injuries associated with unpowered scooters have increased dramatically since May 2000 (1). These scooters are a new version of the foot-propelled scooters first popular during the 1950s. Most scooters are made of lightweight aluminum with small, low-friction wheels similar to those on in-line skates. They weigh <10 pounds and fold for easy portability and storage. Up to 5 million scooters are expected to be sold in 2000, an increase from virtually zero last year (Consumer Product Safety Commission [CPSC], unpublished data, 2000). This report summarizes the results of a descriptive analysis of scooter-related injuries during the past 34 months and provides recommendations to reduce these injuries.

  CPSC and CDC analyzed preliminary data from CPSC's National Electronic Injury Surveillance System (NEISS) from January 1998 through October 2000 and the Injury and Potential Injury Incident File (IPII) during January--October 2000. NEISS is a probability sample of 100 U.S. hospitals with 24-hour emergency departments (EDs) and more than six beds. NEISS collects data from these hospitals on all persons seeking treatment for consumer product-related injury in the hospitals' EDs. Estimates of injuries in the United States associated with specific consumer products or activities can be made from NEISS data. Data were weighted according to the probability of hospital selection in the NEISS sample to provide estimates for the U.S. population (2). IPII consists of anecdotal information reported to CPSC from many sources (e.g., coroners and medical examiners; newspaper reports; consumer complaints through the CPSC hotline or CPSC's World-Wide Web site; and referrals from federal, state, and local officials). NEISS was used to estimate scooter-related injuries, and IPII was used to identify scooter-related deaths. Because the new scooters were introduced in large numbers into the United States market in 2000, the 1998 and 1999 data relate to the older versions of scooters.

  During January--October 2000, an estimated 27,600* (95% confidence limits [CL]=22,190--33,010) persons sought ED care for scooter-related injuries. In August, September, and October 2000, the estimated number of injuries requiring ED care was 6,529 (95% CL=4,610--8,450), 8,628 (95% CL=6,090--11,170), and 7,359 (95% CL=5,200--9,520), respectively (Figure 1); October data are incomplete and may change slightly as additional injury reports are filed. The estimated number of injuries during August--October represents 80% of the estimated total number of injuries for all of 2000. Each of the preceding 3 months also exceeded the 12-month total for either 1998 or 1999. The estimated number of injuries seen in EDs in September 2000 was nearly 18 times higher than in May 2000.

  Approximately 85% of persons treated in EDs were children aged <15 years, and 23% were aged <8 years; two thirds were male. The most common type of injury was a fracture or dislocation (29%), of which 70% were to the arm or hand. Other injuries included lacerations (24%), contusions/abrasions (22%), and strains/sprains (14%). Forty-two percent of all injuries occurred to the arm and hand, 27% to the head and face, and 24% to the leg and foot.

  Two persons have died while using a scooter. An adult fell and struck his head while showing his daughter how to ride the scooter. A 6-year-old boy rode into traffic and was struck by a car.

  Reported by: GW Rutherford, Jr, MS, R Ingle, MA, Consumer Product Safety Commission. Div of Unintentional Injury Prevention, National Center for Injury Prevention and Control, CDC.

  CDC Editorial Note:

  The findings in this report demonstrate the rapid increase in injuries associated with riding the new lightweight, folding, unpowered scooters, which are a fast-growing activity in the United States. Because these scooters are a recent phenomenon, scientific data about the efficacy of safety equipment to protect against scooter-related injuries are not available. However, lessons learned from similar recreational activities (e.g., in-line skating) can guide users in adopting reasonable safety precautions, such as wearing protective gear.

  On the basis of data from in-line skating and bicycling, many of these injuries might have been prevented or reduced in severity had protective equipment been worn. Helmets can prevent 85% of head injuries (3), elbow pads can prevent 82% of elbow injuries, and knee pads can prevent 32% of knee injuries (4). Although wrist guards are effective in preventing injuries among in-line skaters, the protection they provide against injury for scooter riders is unknown because wrist guards may make it difficult to grip the scooter handle and steer it.

  The public health community can be proactive and support efforts to decrease scooter-related injury in children by increasing awareness among parents and health-care providers of the injury potential and the need for safety measures when using scooters. Many children may not be prepared developmentally to handle the multitask challenges they may experience while riding a scooter. Changes in the product and rider behavior also may make riding scooters safer. The mechanisms and circumstances of scooter-related injury require further research.

  On the basis of evidence of injury prevention effectiveness for other related activities, the following recommendations may help prevent scooter-related injuries:

  • Wear a helmet that meets the standard established by CPSC;
  • Use knee and elbow pads;
  • Ride scooters on smooth, paved surfaces without traffic, and avoid streets and surfaces with water, sand, gravel or dirt;
  • Do not ride scooters at night; and
  • Young children should not use scooters without close supervision.

  References

  1. Consumer Product Safety Commission. National Electronic Injury Surveillance System [computer file]. Washington, DC: Consumer Product Safety Commission, November, 2000.
  2. Kessler E, Schroeder T. The NEISS sample (design and implementation). Washington, DC: Consumer Product Safety Commission, October 1998.
  3. Thompson RS, Rivara FP, Thompson DC. A case-control study of the effectiveness of bicycle safety helmets. N Engl J Med 1989;320:1361--7.
  4. Schieber RA, Branche-Dorsey CM, Ryan GW, Rutherford GW, Stevens JA, O'Neil J. Risk factors for injuries from in-line skating and the effectiveness of safety gear. N Engl J Med 1996;335:1630--5.

  * Estimates are based on the approximate range at the 95% confidence level of relative sampling error. For this analysis, the corresponding relative sampling error for the estimated number of injuries during January--October is 0.1.

• NATIONAL DRUNK AND DRUGGED DRIVING PREVENTION MONTH

December has been designated National Drunk and Drugged Driving Prevention Month by the National Drunk and Drugged Driving Prevention Month Coalition, reports the CDC.  The Coalition is a national public and private partnership devoted to preventing impaired driving crashes which was the focus of your authors auto courses at Lynn as well as present lectures.  During 1999, alcohol-related motor-vehicle crashes resulted in an estimated 15,786 deaths in the United States (National Highway Traffic Safety Administration (NHTSA), unpublished data, October 2000).  On the basis of data provided by NHTSA and the U.S Bureau of the Census, the rate of alcohol-related motor-vehicle deaths steadily declined form 8.9 to 5.8 per 100,000 persons during 1990-1999 (NHTSA, unpublished data, October 2000).  The 1999 rate nearly met the national health objective for 2000 of no more than 5.5 deaths per 100,000 persons.  The Healthy People 2010:  Health Objectives for the Nation has set a target for alcohol-related traffic fatalities of no more than 4.0 per 100,000 persons.   The 2010 objective will require a further decrease of 312% in the rate of alcohol-related traffic fatalities.

The passage of the national 0.08% blood alcohol concentrations standard for impaired driving represents an important step toward reducing alcohol-traffic fatalities.  Other strategies include strict enforcement of impaired driving and minimum legal drinking age laws and prompt suspension of licenses of persons arrested for driving while impaired.

• FDA ANNOUNCES NATIONWIDE RECALL OF CERTAIN SOUPS DUE TO POTENTIAL HEALTH RISK FROM BOTULISM

The Food and Drug Administration (FDA) is warning consumers not to purchase or consume various canned soups imported from Canada because they have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death. Consumers are not to use the products even if they do not look or smell spoiled. Les Produits Freddy Inc. (St-Hyacinthe, Quebec), a Canadian firm, has begun a voluntary recall of the products. FDA is taking this action as a result of the Canadian government's evaluation.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

All lots on the market are under recall. However, the volume of the product's distribution is not known at this time. The soups were distributed nationwide to retail stores. They were distributed to the following stores but may have been distributed elsewhere as well.

The Stop & Shop brand soups were sold at Stop & Shop Stores throughout Connecticut, Massachusetts, New Jersey, New York and Rhode Island and at Edwards Stores in New Jersey and New York.

The Tasty Classics brand soups were sold at Hy-Vee Food and Drug Stores in Minnesota, South Dakota, Illinois, Nebraska, Kansas, and Missouri; in Fareway Stores in Iowa and Illinois; and in Canned Foods Grocery Outlets stores in California, Washington, Oregon, Idaho, Utah, Arizona, Nevada, and Hawaii.

The Wegmans brand soups were sold at3 Wegmans Stores in New York, New Jersey, and Pennsylvania.

The Baron brand soups were sold nationwide at varous grocery stores.

The soups, manufactured by Les Produits Freddy, Inc., are sold in 10 3/4 fl.oz. cans. All codes are affected by this recall. They can be identified by the following brand names (may not be inclusive):

• Condensed Cream of Mushroom Soup
  Wegmans brand Cream of Mushroom Condensed Soup
  Stop & Shop brand Condensed Soup Cream of Mushroom
  Tasty Classics brand Cream of Mushroom Condensed Soup
  Baron Brand Condensed Cream of Mushroom Soup
  
• Cream of Chicken Soup
  Wegmans brand Cream of Chicken Condensed Soup
  Stop & Shop brand Condensed Soup Cream of Chicken
  Tasty Classics brand Cream of Chicken Condensed Soup
  Baron Brand Condensed Cream of Chicken Soup
  
• Cream of Celery Soup
  Wegmans brand Cream of Celery Condensed Soup
  Stop & Shop brand Condensed Soup Cream of Celery
  Tasty Classics Cream of Celery Condensed Soup
  

No illnesses have been reported to date.

FDA and the Canadian Food Inspection Agency are continuing to investigate this matter.

Consumers who have purchased any of the above products should not eat them, but instead return them to the place of purchase for a full refund. Those who have consumed these products and have experienced symptoms of botulism should seek medical attention. Consumers with questions may contact the manufacturer, Les Produits Freddy Inc., at 1-888-797-3210.

• USFDA'S DR. FRANCES KELSEY TO BE INDUCTED INTO NATIONAL WOMEN'S HALL OF FAME

  FDA's Frances O. Kelsey, Ph.D., M.D., will be inducted into the National Women's Hall of Fame on October 7 in Seneca Falls, New York. Dr. Kelsey has long been honored for her role in blocking approval of the drug thalidomide in the l960's. Her refusal to approve thalidomide for use in the U.S. earned her national recognition and her work led to strengthened regulation of the pharmaceutical industry.

  Dr. Kelsey, who was born in 1914, continues to work for FDA in the medical and scientific affairs staff in the agency's Center for Drug Evaluation and Research. She points out that thalidomide was the first drug application to which she was assigned after joining the agency in 1960.

  That thalidomide was not marketed at that time in the United States was largely due to the work of Dr. Kelsey whose concerns about insufficient data in the thalidomide application kept the drug out of American pharmacies. As she raised questions, news of thalidomide-induced birth defects from European countries demonstrated dangers of its use during pregnancy. On August 7, l962, President John F. Kennedy awarded Kelsey the President's Award for Distinguished Federal Civilian Service. The engraving on her presidential award reads, "Her exceptional judgment in evaluating a new drug for safety for human use has prevented a major tragedy of birth deformities in the United States. Through high ability and steadfast confidence in her professional decision she has made an outstanding contribution to the protection of the health of the American people."

  "I feel very honored," said Dr. Kelsey of her upcoming induction into the National Women's Hall of Fame. "I am pleased to be honored along with women that I admire, especially those that I personally have worked with in science and medicine."

  Dr. Kelsey will join a group of 19 American women who will be inducted on Oct 7 as part of a two-day 2000 Honors Weekend celebration starting Friday, October 6. With the induction of these 19 women, the total number of hall inductees numbers 176 women.

  For more information, see the web site for the National Women’s Hall of Fame, http://www.greatwomen.org

• FDA APPROVES NOVANTRONE FOR TREATING ADVANCED MULTIPLE SCLEROSIS

  FDA has approved Novantrone (mitoxantrone), an approved cancer drug, for treating patients with advanced or chronic Multiple Sclerosis (MS), a disease that attacks the nervous system and can cause weakness, impaired vision, loss of balance, and poor muscle coordination. MS can have different patterns, sometimes leaving patients relatively well after episodes of acute worsening, sometimes leading to progressive disability that persists after episodes of worsening. In the worst cases the disease can lead to paralysis.

  Two randomized multi-center clinical studies, totaling about 200 patients, demonstrated that Novantrone could reduce the number of relapse episodes and decrease the progression of disability in patients with secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting MS (all forms of the disease in which patients become significantly more abnormal between relapses as time passes). The trials showed that Novantrone can help reduce the number of relapses and help patients keep their mobility longer.

  This drug has not been studied in, and is not approved for treatment of primary progressive MS, a form of MS in which the patient’s neurologic condition deteriorates over time without specific relapses. The approval of Novantrone is the first approval of an anticancer drug for treatment of multiple sclerosis. Other approved treatments are several beta interferons, Copaxone (which also decreases the number of relapses, and Avonex (which has been shown to slow the accumulation of physical disability in addition to decreasing the number of relapses). Novantrone is also approved for treating patients with pain related to advanced hormone-refractory prostate cancer and, in combination with other drugs, in the initial therapy of acute nonlymphocytic leukemia in adults.

  Some patients treated with Novantrone may develop heart problems that can be very serious. The risk of heart disease increases with the cumulative dose, and patients with MS should ordinarily not receive more than 8 to 12 doses administered over two to three years. The professional labeling and patient information recommend that doctors closely monitor their patients. Patients will be advised that regular testing of heart and blood is needed to help avoid serious side effects. The most frequent side effects include nausea, hair thinning, loss of menstrual periods, bladder infections and mouth sores.

  Novantrone is manufactured for Immunex Corporation, Seattle, Wash., by Lederle Labs.

• FDA APPROVES SHOCK WAVE DEVICE FOR SEVERE HEEL PAIN

  FDA today approved a medical device that uses shock waves to relieve chronic heel pain.

  Shock wave treatment has been used for 10 to 15 years to break up kidney stones without surgery.

  The new device, the OssaTron, made by HealthTronics Inc. of Marietta, Ga., was approved to treat chronic proximal plantar fasciitis, a condition that causes severe pain in the heel of the foot. Plantar fasciitis is usually caused by an inflammation of the foot’s tissue.

  Plantar fasciitis is typically treated with physical therapy, pain relievers, cortisone injections, use of heel-cushions in shoes, and in severe cases, with surgery.

  The new device was approved for use on adults who have had plantar fasciitis for at least six months and have tried other standard methods for treating it, with little success.

  The OssaTron is a shock wave generator. The shock waves are created by a spark plug enclosed in a soft plastic dome filled with water. During treatment, the dome is placed closely against the heel so that the shock waves pass through the dome to the heel. Treatment is performed as an outpatient procedure and a total of 1500 shocks are usually delivered.

  Approval of the product was based on a review of clinical studies of safety and effectiveness conducted by HealthTronics and on the recommendation of the Orthopedics and Rehabilitation Devices Panel of FDA’s Medical Devices Advisory Committee.

  HealthTronics studied 302 people with chronic pain who had failed other treatments in the previous six months. Half were treated with the OssaTron; half received a sham treatment. All were given a local anesthetic or an ankle block before treatment. Patients were followed for three months.

  Most patients (60%) treated with the OssaTron reported that they experienced some improvement in pain; 48% of those treated with the sham said they experienced some improvement in pain.

  Complications included mild neurological symptoms in 6 patients (2%) and plantar facial tears (tears in the tissue in the bottom of the foot) in 2 patients (0.6%).

  As a condition of approval, FDA is requiring HealthTronics to conduct a study to further evaluate the problems of neurological symptoms and plantar fascial ruptures.

• JOHN RENNER MD PASSES

At the young age of 67, we lost one of our nations best Forensic Medical Investigators.   By virtue of the Forensic Bodies requesting years of consultation ( i.e. Federal Bureau of Investigation, US Department of Justice, Treasury etc.) Dr. Renner became one of the foremost experts on health fraud.   What was so unusual about Dr. Renner was that he was a distinguished medical doctor, medical school professor, and author.   This rare kind of a man was taken from us by medical illness September 2nd 2000.   I remember in 1988 at the Wisconsin meeting of the Government, AMA, Insurance Industry, etc., on proposed US PPO and HMO reform, Dr. Renner took time from his scheduled lectures, to personally advise (completely unsolicited) that "if I leave and become ""Certified as a Fraud Examiner"" by the founding members who were retired from FBI and Justice, Secret Service,  CIA, IRS, etc., I would gain "Certification" by the public, but gain negatives such as jealousy etc.  I was willing to give up government Consulting to become Certified and work within the private sector.   Dr. Renner, for all of his controversial cutting edge beliefs, often was proved correct in the end demonstrating that he really cared about people. 

He became controversial when he would provide a rational and reasonable scientific limitation to an alternative remedy. This was always followed by a knee jerk response from alternative care pundits along the lines of   "alternative care acceptance and science has proved you wrong"!  Yet it is this line of thinking which proved the traditional country MD correct for his intent.  Often Dr. John was actually speaking about trends of crime documented  by jailed criminals through vehicles of health care fraud and was Freudian fishing!    Not understanding these facts (forensic law enforcement techniques), alternative health practitioners would become paranoid and often delusional about John's warnings.  The truth was however, his statements had nothing to due with organized alternative care (unorganized) but simply speaking to the profile of a criminal trend.  When alternative care spokespersons responded very negatively it made it seem as though they were a part of the criminal activities John was reporting and he would receive more tips and leads then one could imagine. 

I met John, while attending an early meeting of a skeptics group comprised (to my surprise) by many law enforcement persons.  They introduced John to me as "the finest detective, (relative to criminal medical-legal cases) in the United States".  He laughed at their statements responding very slowly, "true, true" and proceeded to invite me out to dine with him the subsequent evenings.  He denied everything but said and go on to say in the future "I need to borrow a car.  I will pick you up at seven" and subsequently pick me up and drove to fine dinning in standard issue FBI-like wheels with installed protocol car radio/phone etc. in a number of locations in various states of the union spanning many years.  He would show up with that quiet friend with a good sense of humor. What annoyed me was on three occasions, once in Texas and then Wisconsin, and Missouri, while enjoying the ride, he would get excited and call local police from the vehicle, to alert them to a crazy dangerous driver/drivers and so forth for arrest.   Once, from the back seat I said, "John my colitis is flaring.  Can't you skip the calls and get me to the restaurant rest room"!  I remember that annoyed him. 

His adventures dressing in female wheelchair disguises infiltrating medical Mafia groups etc., were some of the most hilarious fiascoes, where justice prevailed though humbled by humor, in our young nations experiential existence.

Those that are in a position of knowledge will remember John as one of the men who cleaned up American Medical Care and indeed welcomed and groomed altruistic alternative care.  On a personal level, in 1988 he signed my copy of in his book Quackbusters, "Scott, to a fellow Q.B. I dedicate this copy. John Renner MD". 

The nation will suffer and morn the loss of a man who often did work at his own personal cost both financially and politically in order to eliminate white collar crime and not allowed to advertise his area of success.  Drs. John L., and John L. Sullivan Jr., myself and the entire executive board of AAJTS, wishes our deepest and most heart-felt condolences to the honorable Mrs. John Renner MD and family.   InfoJustice.

• FDA CREATES MEDICATION GUIDE FOR LOTRONEX Health Professional Labeling Revised to Help Manage Risks

  The Food and Drug Administration (FDA) today announced the development of a Medication Guide (FDA-approved patient labeling) to help ensure that women using the prescription drug Lotronex (alosetron hydrochloride) for treatment of the diarrhea-predominant form of irritable bowel syndrome (IBS) will understand the rare but serious risks of Lotronex and how they can recognize those risks and take early action to prevent serious harm.

• LETTERS ABOUT THE EDITOR

  Editor became official Ghostwriter and editor for DOJ; case dependent.  He was flown to Washington DC and Rockville Maryland to lobby and lecture to appointed panel of federal agents and scientists.  Received a national alert and eliminated the consumer fraud medical device and insurance scam on national basis in one fell swoop. Letter from retired Forensic US Social Security Attorney then practicing attorney and retired Forensic Judge then practicing attorney.  Then read for yourself, what the Los Angeles College of Chiropractic Student Advocate Associated Student Body Newspaper reports about our editor's discoveries and advancements in science as a student.  Then dean of the Los Angeles College of Chiropractic acknowledges his original concepts and ideas, now accepted as the forensic basis of Medical-Legal Chiropractic.  Forensic Science lecture at the University of Miami School of Medicine and a Cleveland Chiropractic College Lecture for the basic neurology and neuroscience education core correculum.

• FDA APPROVES FIRST NDA FOR LEVOTHYROXINE SODIUM

  FDA today approved the first NDA for the thyroid hormone replacement drug, levothyroxine sodium (Unithroid) for use in adults and children.

  In children, thyroid hormones are essential for normal physical growth and intellectual development. They are also involved in the regulation of a wide range of metabolic processes within the body in all age groups. Hypothyroidism, or low levels of thyroid hormone, may be due to a birth defect (e.g. partial or complete absence of the thyroid gland) or it may occur later in life due, for example, to thyroiditis, goiter, or surgical removal of the thyroid gland.

  Symptoms of hypothyroidism include poor growth in children and, in those born with this disorder, impaired intellectual development if this disorder is not promptly and adequately treated. Symptoms of hypothyroidism in children and adults include fatigue, cold intolerance, dry skin, lethargy and weight gain.

  Levothyroxine is identical to a natural thyroid hormone produced by the body and is most commonly used to return thyroid hormone levels to normal in patients with hypothyroidism. The dose of levothyroxine for replacement or supplemental therapy in patients with hypothyroidism must be individualized based on patient response. Patients taking levothyroxine as replacement must be monitored with blood tests at regular intervals to determine that thyroid hormone levels are within the normal range, to assure patient safety, and to help guide dose adjustments.

  During initiation of replacement therapy with levothyroxine, blood tests are usually performed every six to eight weeks in adults to aid in dose adjustment. Once the optimal replacement dose of levothryoxine for an individual adult patient is determined, blood tests are usually done less frequently; e.g., every six to twelve months. Infants and children are usually begun on full levothyroxine replacement doses and the frequency of monitoring of blood tests, growth and intellectual development is age-dependent.

  Side effects from levothyroxine are usually due to over-dosage and include nervousness, weight loss, tachycardia (rapid heart beat), irritability, and anxiety.

  Although oral levothyroxine drugs products have been marketed in the United States since the 1950's, the approval of Unithroid represents the first time that a single ingredient oral levothryoxine product has been approved by the FDA.

  In the August 14, 1997 Federal Register, FDA announced that orally administered drug products containing levothyroxine sodium are new drugs. The unapproved thyroid hormone replacement products that have been on the market have been associated with stability and potency problems. These problems have resulted in product recalls and have the potential to cause serious health consequences to the public.

  To address these concerns, the agency announced that after August 14, 2001, any orally administered levothyroxine drug product must be the subject of an approved New Drug Application. If there is no such approved application, the product will be subject to regulatory action as an unapproved new drug. With the approval today of Unithroid, patients and physicians will now have available to them an oral levothryroxine sodium drug product that has been determined to be safe and effective by the FDA and that also meets FDA standards for manufacturing processes, purity, potency, and stability.

  Unithroid is manufactured and distributed by Jerome Stevens Pharmaceuticals of Bohemia, NY.

• FDA ISSUES NATIONWIDE ALERT ON THE RECALL OF "RICH'S MSM EYE & EAR DROPS" BECAUSE OF HEALTH RISK

  FDA is warning consumers not to purchase or use a product known as Rich's MSM Eye & Ear Drops because it may be contaminated with yeast and Pseudomonas fluorescens - a bacteria that can cause severe, and in rare cases sight-threatening, eye injuries. The distributor of this product, Rich Distributing, of Portland, Oregon is voluntarily recalling the product.

  Although the scope and volume of the product's distribution is not known at this time, it was sold in one-ounce containers over the Internet and at retail locations to consumers throughout the country.

  The recall was undertaken after FDA laboratory analysis revealed these potentially serious contamination problems.

  Consumers who may have used this product are urged to contact their physicians, especially if they applied it to their eyes.

• 

"I would like to salute you guys.  You guys who won America's Battle.   You ordinary  guys.  You heroes of Iwo Jima"  Iwo Jima veteran Major General Fred Haynes, U.S Marine Corps (retired) told us not to forget the cost of freedom, in his own words this year Arlington, V.A. February 2000.  A West Point class mate sent this message to Robert Herb who presented it as Masonic Education in Capital Lodge 54 when he was Worshipful Master, which went out to retired Navy Norm Udewitz. Then today while finalizing my ghostwriting and editing of his new book soon off to the publisher, he asked me if I could memorialize for the InfoJustice readers Ira Hayes, Mike Strank, Franklin Sousley, Rene Gagnon, John Bradley and Harlon Block.  I said, "My honor" and indeed, if you simply look at the men, their actions under fire tell norms intent and my message to you.  For example, Ira Hayes is the last guy up there.  The next guy you're looking at is Franklin Sousley(he died at Iwo Jima at age nineteen).  Behind Franklin, obscured by Franklin, is Mike Strank.  Where is Mike's right hand?  Mike';s right hand is not on the pole.  Mike is behind his boys.  He is the Marine leader (Sergeant) and his right hand is gripping the right arm of Franklin Sousley, a young boy.  Mike is helping Franklin lift a heavy pole; a Marine leader caring for his boys.  Three weeks before Iwo Jima, his Captain said that he wanted to promote Mike Strank.  Mike turned it down on the spot saying, "I promised my boys I'd be there with them."  "Time Magazine, March 5th, 1945, wrote, "no battle of World War II - not even Normandy - was watched with as much interest as the battle of Iwo Jima...America's Battle...".   The Academy honors all US veterans and remembers the cost of our lifestyles through memorials like the "tears and fight of Iwo Jima". InfoJustice

• Finally-FDA Issues Final Guidance on Reuse of Single-Use Medical Devices. 

  FDA today issued final guidance on the practice of reusing medical devices intended to be used only once.

• NOTES TO THE EDITOR

Although I paid for the Ball, now I am sorry I missed it.  Young Man, in 1985 I needed a technical advisor for a federal court case involving Chiropractic Fraud (The permanent curing of "dyslexia" with Chiropractic), and I took your gorgeous wife and you to dine.   Was Jackie your X-wife?  My dear old friend.  Chelsea was the "gorgeous" lady your referring to.  Below are pictures I found from the evening after our wedding and another while running for Ms. Pennsylvania.  She was Ms. Teenage and Ms. Roslyn Pennsylvania among many lady titles.

I can see how you were confused.   Both ladies are teriffic.  Stay closer in touch and I hope to see you at our next Ball (I remember your wife was a terrific ballroom dancer).  InfoJustice

• ACADEMY BALL (CO-FOUNDER & FRIEND)

At our recent Academy Ball this picture was taken of our beautiful fellow Jackie and academy founder Dr. Scott Neff.  Jackie recently sent us this picture.  I wish all the members across all nations could have attended.  In any event for over seven years prospective members, active members, founding fellows have all asked why I had not placed a picture of myself at the Academy Web Site the InfoJustice Journal.   Honestly I thought I might break the web but now that I have mourned for the Shiva year since the passing of my fiancee, perhaps in time I will be ready to date.  However John L. felt that a picture of the young one of our two founders (that of myself: of course the other founder is John L who's picture can be found in the Fight for Justice Page) and the Webmaster should be found within the Journal.  In any event, for all of you curious about our Web Developer and Webmaster, editor and Academy Executive Director, there I am dressed as Prince Charming (albeit a poor attempt) with the beautifully dazzling and sexy lady academy fellow Jackie, dressed as Sleeping Beauty.  As more pictures come in relative to the Ball I will post them. God Bless from InfoJustice

• IMMEDIATE RELEASE FOR USDOJ/FBI BY INFOJUSTICE JOURNAL EDITOR

Statement of FBI Director Louis J. Freeh Regarding the Recent Waco Findings by Special Counsel/Senator John Danforth:

• FDA APPROVES MALARONE FOR THE PREVENTION AND TREATMENT OF MALARIA

  FDA today approved Malarone, a new combination drug for the prevention and treatment of acute, uncomplicated P. falciparum malaria. Malarone is a combination of atovaquone and proguanil HCL. Atovaquone is currently marketed in the United States under the trade name Mepron for pneumocystis carinii pneumonia.

• July 17th, 1999, Dr. Diana Brief, Academy Vice President, Director of Research, President of the Board of Psychology, Phi Beta Kappa, Summa Cum Laude, Golden Key National Honor Society, Distinguished Scholar Award UCLA, Died from Medical Lipo-Suction.

One year ago today, the person who would not let me fill up, refill my own drink, cook, and so forth was taken from me in a heinous, egregious, pontifical, self-aggrandizing and money grubbing manner by her un-caring, un-compassionate Quack and cold medical system.  InfoJutice 

After two long years Academy courses have begun to wave reviews.  

The U. S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) internet web site has expanded its capability to provide cancer-related information for consumers, patients, and health care professionals.

• FRAUD, WASTE AND ABUSE BECOMING A PATIENT PROBLEM: Upwards of 20% Fraud

Did you know the foxes are in charge of the Chicken Coups and even the Chickens are stealing.  InfoJustice

• InfoJustice Notice

This editor would like to thank all of the folks that contact us.  Unfortunately, the more requests I process appears to be directly proportional to the ever increasing mail volume.  I have already written an increase funding proposal and will submit during our next Executive Board Meeting.   On an additional note.  I am finalizing a two year project of the kind dreams are made of.  This editor has always wished to work on a humorous text. Within days, I will submit to Copyright my next Ghost Written and edited text for one of our Board members, which I believe will bring much uncontrollable and heartfelt laughter from Law Enforcement world wide, the Railroad and Insurance Industry, laughter from the Federal Court System as well as from the general reading public.  Upon Copyright the name of the text will be released with copies available from the Academy.  The Author Udewitz, will be available for pertinent comment. God Bless and thank you.   InfoJustice

• LETTERS TO THE EDITOR

Dear Dr. Neff.  In Europe today, the fastest growing health profession is Chiropractic.  How does one determine the correct Chiropractor for their Type M Neuromusculoskeletal Disease.  Honorable Doc.  Your questions are very interesting.   Long ago, from 1980-1983 I researched and subsequently wrote on this subject as an assignment for then HHS Consumer Affairs Officer Pico USA.  Although there have been advancements, this is a good beginning.  I could create an update for your European Union Group if you can achieve an Official Government request.  In any event our US Consumer Safety Tip on this subject can be found by striking this link.  Enjoy. InfoJustice

• LETTERS TO THE EDITOR

Dear Dr. Neff.  Super.... We would like you to lecture on your concepts for the entire Blank...  I lecture throughout Europe extensively on Manual Medicine. In fact had set up a lecture series for...Blank...   Please enroll me in the College of Justice, and send you courses...  Honorable Doc, This examiner is honored by your offers and that you enjoyed my articles and understand the progression of science through time.  The real test of a scientist's work is that it stand the test of time.  Unfortunetely, these next six months are booked solid. Relative to materials requested, until we receive total copyright protection we will not be forwarding.  I have been teaching out of California for those that just cannot wait.  Please accept our apologies.  The US Copyright office lost our materials, gave us a reference number, told us were covered and to resubmit, which we have just done.  We are all "Chopping at the Bit" so to speak. Complete the Join AAJTS Page and submit. InfoJustice

• LETTERS TO THE EDITOR

Dear Dr. Neff  I practice medicine in Norway and recently attended the American Back Society Educational Seminars held in Los Vegas (USA).  I was given your name as the founder of the Scientific Movement within organized Chiropractic?  Could you please send me a copy of any of your scientific contributions to medical science.  Please focus on those which explain what Chiropractors are treating and any mechanisms for such disease? Honorable Doc, I deeply appreciate the ABS for sending curious minds like yours to this humble albeit retired Chiro-scientist over the years.  If you click on this link it will take you the first two of my now accepted scientific contributions to medical history.  If you are interested please find my third now accepted scientific contribution to medical history by clicking on this link.  I am Sorry for the delay in responding to your requests. InfoJustice

• FDA UPDATES WARNINGS FOR CISAPRIDE

  The Food and Drug Administration (FDA) is advising health care professionals and patients of important new information, including recommendations for performing diagnostic tests, that should be considered prior to any use of the drug cisapride (Propulsid). Cisapride is a treatment for severe nighttime heartburn in patients with gastroesophageal reflux disease (GERD) who do not adequately respond to other therapies. The new measures are being recommended to help physicians avoid giving cisapride to patients at known risk of rare-- but serious--cardiac events associated with the drug.

  As part of an ongoing risk management effort, FDA is also announcing a public advisory committee meeting to be held on April 12, where the safety of the drug and additional methods to reduce the occurrence of adverse events will be discussed.

  Meantime, patients who already take the drug are encouraged to ask their doctors about having the recommended tests performed and whether they should pursue other treatment options.

  Today's actions are prompted by continuing reports of heart rhythm disorders and deaths associated mostly with the use of the drug in people who are either taking certain other medications or who have certain underlying conditions that are known risk factors. A recent analysis of 270 adverse event reports (including 70 fatalities) revealed that approximately 85% of these cases occurred in patients with these identifiable risks.

  The new risk management measures are being announced in conjunction with a "Dear Healthcare Professionals" letter issued today by the drug's sponsor, Janssen Pharmaceutica of Titusville, NJ, that summarizes the updates being made to the warnings and precautions sections of the drug's label. The changes include recommending that physicians perform an electrocardiogram and certain blood tests prior to prescribing the drug.

  The revised labels also list the contraindicated drugs and underlying conditions which put patients at increased risk. Cisapride should not be used by patients taking some of the following types of medications: anti-allergy, anti-angina, anti-arrhythmics (irregular heart rhythm), antibiotics, anti-depressants, anti-fungals, anti-nausea, anti-psychotics and protease inhibitors (anti-HIV infection).

  It is also advised that patients with any of the following conditions not take the drug: history of irregular heartbeats, abnormal electrocardiogram (ECG or EKG), heart disease, kidney disease, lung disease, low blood levels of potassium, calcium or magnesium, eating disorder (such as bulimia or anorexia), dehydration or persistent vomiting.

  Cisapride was approved by FDA in tablet form in 1993, and in suspension form in 1995. Unlike drugs that reduce stomach acid, cisapride works by a prokinetic mechanism that moves the harmful acids through the digestive tract thus preventing its painful reflux into the esophagus. A previous warning regarding cardiac risks was issued in June 1998 (see FDA Talk Paper T98-39).

• LETTERS TO THE EDITOR

Dear Dr. Neff.  I am a Certified Fraud Examiner who is actively involved in the Investigation of Mill Vengence Medicine.  Here in the Blank state, we have found key traits, that these Mills share.   For example they promise insidiously that they will get that Insurance Company, that Employer and so forth.  The Patients use these Clinics to get revenge!   In the treatment arena, can you point us to phony modalities which have little in the way of therapeutic value? Dear Mike. That is very interesting.   Look to the Clinics which bill electrical modalities for other than they were intended.  For example bill for nerve block from a Matrics in lieu of a Pain Control Center.  Look for the mainstay of phony care with Ten's Unites in Lieu of Interferencial for 20 minutes.  In fact see if the clinic uses Genie Rubs in Lieu of a G5.  A quality prescription would be Interferencial, Ultrasound and G5.  This session should last minimally 45 minutes.  Look to the Centers who's treatments last 10 to 20 minutes and no adjustments or Manual Medicine after said session.  Finally patients can apply hot packs at home.  Look to the Clinics that bill waste and abuse treatments like a hot pack, tens and perhaps a genie rub.  Finally look to Medical Clinics where they allege they treat trauma patients (PI and Workers Compensation) yet the MD's never prescribe the battery to control and eliminate severe pain, inflammation, muscle swelling tears and spasm.  Remember, today we know that the patient who is provided the therapy indicated above combined with Modern Medicine recovers 75% faster than Fool's medicine which I quickly outlined for you today.  Good Luck and perhaps we should compair notes? InfoJustice 

• LETTERS TO THE EDITOR

Dear InfoJustice Editor.  How may we help? = I am working with Coroners investigating the deaths of several people in Quebec following chiropractic neck manipulation. I need to contact as soon as possible Dr. Scott Neff who wrote a sample for InfoJustice.  Honorable Dr, Welcome to The InfoJustice Journal. You can contact this examiner at this email aajts@infojustice.com or drneff@infojustice.com   Have to Jump. Dr. Scott Neff CFE CFME FFAAJTS,    Executive Director AAJTS, Editor, The InfoJustice Journal www.infojustice.com InfoJustice

• LETTERS TO THE EDITOR

Dear Dr. Neff.  I would like to say how very impressed I was with your... and the expertise you possess.  That is why I have contacted you.  My hope is you will contribute that expertise...on the subject of forensics of vehicular collisions as it relates to the investigative field.  I wanted to obtain the best information possible...as an informational and investigative-related site for lawyers, experts, investigators, law enforcement, children and the general public...I have attached a biography of my background and expertise as a former federal agent and ...investigator /information provider...It is the best investigative information...Thank you.  Honorable Sir.  Welcome to the InfoJustice Journal.  Thank you.   Your credentials are "Impressive".  Since I will not return until Monday, this examiner will answer you now to defray any "Chopping at the Bit activities"; the answer "will be forthcoming".   I want you to know that I take these types of responsibilities very "seriously".  The development of a team of forensic experts to write for a network, as you have suggested, may become a "serious" and important aspect in assisting our nations developing forensic and investigative expertise.  I will contact you personally Tuesday, 1-25-00.   I may join said team project and assist.  When we speak I may need to garnish a bit more information.  Of course a reciprocal relation with our Academy for you and yours is available to individuals with your credentials.  I reference you to our "Join AAJTS Academy".  InfoJustice    

• LETTERS TO THE EDITOR

  Dr. Neff...Could you review for the pundits and those in a position of responsibility, any cases where the DA and Law Enforcement "switched sides" in a Class Action investigation you were hired to review? Yes. One huge case from the Trenches  is available through the InfoJustice Library.  This case will be sent to you through US Mail.   These particular types of events, as the result of my research, are considered need to know.   This principal was voted on by the academy board 5 to 0.  Reason:  We at the academy believe in bringing truth and justice to the American People.  Not to expose an early Law Enforcement posture prior to all of the forensic evidence being garnished and in focus.  InfoJustice

• LETTERS TO THE EDITOR

Dear Dr. Neff.  How may we help?  I was recently terminated from my job.  I would like to send you a letter explaining what happened.  After you read it, I would like to get some legal advice from you. Thank You, Patricia.  Dear Trish, you must seek out a licensed attorney in your own state.   Contact your state Bar for a referral to an attorney who specializes in Unfair labor Practices, Unjust Firings, Employment Development and Workers Compensation.  "It is part of the cure to wish to be cured".   Seneca, Hippolytus InfoJustice

• HAPPY AND HEALTHY MARTIN LUTHOR KING DAY

May we all learn to live together.  To forgive one an other for being different beyond ones control and that we are understanding and forgiving on to all.  Just as we fought to forgive President Clinton, so must we all learn that justice is wisdom, truth and mercy.  If one learns from her or his mistakes, justice is then mercy and mercy is justice.  We must all learn that the truth is often somewhere between two poles.  And that we take the time to search out the truth.  When will we become color blind? Not blind to one pole in a dispute in lieu of the other pole; no matter the sex, color, creed or race.  We must all learn to feel each others pain.  Be empathetic and truly wise.  Perhaps we can go back to simply abiding by all of the 10 COMMANDMENTS.  The American Academy for Justice Through Science wishes everyone an enjoyable, wise, and reflective (holiday: US) Martin Luther King Day.  "What doth the Lord require of thee, but to do justly, and to love mercy, and to walk humbly with thy God" by God-Micah, iv, 4. InfoJustice

• LETTERS TO THE EDITOR

Dr. Neff...Could you review for those in a position of responsibility, any death investigation cases you were hired to review?  One Malpractice case from the Trenches InfoJustice

• LETTERS TO THE EDITOR

  Dear Dr Neff.  Hi there, my name is Matthew... I'm a chiropractic student from Sydney Australia.  Recently I have been reading some articles on the pronated foot and its effects on low back conditions.  There is a lot mentioned on the pronated foot and the associated internally rotated tibia and femur as well as the anterior/superior ileum which ultimately results in an increased lumbar lordosis and hence low back pain.  I was hoping that you could enlighten me how the today's Chiropractic Physician attacks such a problem?  Do we adjust the back only?   Or do they fix the pronated foot and the rest fixes itself?  I would be very interested in your comments and thank you for your time.  Matthew. 

  Hi Matthew.  These issues plague the Medical Amalgam today.  Yet in the multidisciplinary centers in the US, these issues become rudimentary.  When the Medical and Chiropractic Doctors work hand in hand, together, we can bring relief and restore function efficiently.  Because no two human beings are alike, and considering that the patients present health status as well as past health history such as cancer patient who underwent chemo, now in remission who presents with these problems would be treated differently that any of my athletes who were tackled and received a PI fixed Ileum for his trouble, or an ankle tackle would caused hypermobile ligaments and either a pronating, or other abnormality in the ankle, or was born with their structure and functions of pronated ankles or for that matter even flat feet.  Thus, first would be the Biomechanical Examination by the Quality Doctor of Chiropractic.  This entails an Orthopedic, Neurological and limited Physical Examination consistent with any special studies which may be performed such as X-rays, MRI and so forth.  The patient receives two to four weeks of care.  Prior to special studies other than X-ray, than our Orthopedic Specialist (MD) performs their exam and checks for consistency, results and any suggestions.  We generally handle these types of problems in under two weeks of case orchestration.  Good Luck on your career as a Chiropractic Physician and I hope you join the Academy Student Members.  Membership fees for students are $40.00 per year.  InfoJustice    

• BAYER FINALLY SETTLES FTC CHARGES

  "The Million Dollar Question for Consumers: Aspirin Regimen Therapy - Is It Right For You?"

  The Bayer Corporation will launch a $1 million consumer education campaign to settle Federal Trade Commission charges that it made unsubstantiated claims in a series of aspirin ads, in violation of a previous FTC order. The Bayer ads claimed that a regular aspirin regimen is appropriate for the prevention of heart attacks and strokes in the general adult population. The FTC alleged that since some adults are less likely to benefit from a daily aspirin regime, and some may suffer adverse health effects from taking aspirin on a daily basis, the ad claims were unsubstantiated. The proposed consent decree was filed today by the Department of Justice at the request of the FTC. It is subject to court approval. InfoJustice Press

• FDA FINALIZES RULES FOR CLAIMS ON DIETARY SUPPLEMENTS
  
  FDA today published its final rule that defines the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body pursuant to the Dietary Supplement Health and Education Act of 1994 (DSHEA). 
  
  Under DSHEA, dietary supplements may bear "structure/function" claims -- claims that the products affect the structure or function of the body -- without prior FDA review. They may not, without prior FDA review, bear a claim that they can prevent, treat, cure, mitigate or diagnose disease (a disease claim).
  
  This final rule describes how FDA will distinguish disease claims from structure/function claims. While this rule should not affect the availability of dietary supplement products or consumer access to them, it may affect whether certain claims can be made under DSHEA and therefore may result in some labeling changes for these products.
  
  The final rule precludes express disease claims ("prevent osteoporosis") and implied disease claims ("prevents bone fragility in post-menopausal women") without prior FDA review. The final rule clarifies that such express and implied disease claims can be made through the name of a product ("Carpaltum," "CircuCure"), through a statement about the formulation of a product (contains
  aspirin), or through the use of pictures, vignettes, or symbols (electrocardiogram tracings). The rule permits claims that do not relate to disease. These include health maintenance claims ("maintains a healthy circulatory system"), other non-disease claims ("for muscle enhancement," "helps you relax,"), and claims for common, minor symptoms associated with life stages ("for common symptoms of PMS," "for hot flashes").
  
  In response to comments from industry and consumers, FDA made several significant changes in the final rule. These changes,
  which have the effect of expanding the number of acceptable structure/function claims, include revising the definition of "disease" in response to comments that it was too broad and permitting structure/function claims about certain common conditions associated with aging, pregnancy, menopause, and adolescence. Serious conditions associated with aging, pregnancy, menopause, and adolescence, such as toxemia of pregnancy, and osteoporosis, will continue to be treated as diseases.
  
  Under DSHEA and existing regulations, dietary supplement manufacturers are already required to have, in their files, substantiation of any structure/function claims they make. They must also include a disclaimer on their labels that the dietary supplements are not drugs and receive no FDA pre-market approval. Finally, they must notify FDA of the claims they are making within 30 days of marketing a given dietary supplement.
  
  FDA believes that this rule, which clarifies appropriate structure/function claims, will ultimately provide consumers with better
  information on dietary supplement labeling that will help them select appropriate products. The issuance of this rule is an important part of FDA’s overall dietary supplement strategy, which was announced this past week, and which is aimed at providing consumers with a high level of confidence in the safety, composition, and labeling of dietary supplements.
  
  The rule publishes in the Jan. 6, 2000 Federal Register and will become effective 30 days after the date of publication. Any productthat is marketed for the first time after the date of publication and any new claims made for an existing product for the first time after publication will be expected to comply with the rule beginning 30 days after publication. Small businesses that marketed a product as of the publication date will have an additional 17 months to bring existing claims into compliance and all other products that were on the market as of the publication date will have an additional 11 months to bring existing claims into compliance. InfoJustice Press

• LETTERS TO THE EDITOR

How may we help? = Dear Dr. Neff, I can't find a civil attorney, a district atty, a US atty, or a referral from bar or Lawyer Referral Systems. Before I can use you, I need an attorney referral from you, please.  What baji rules will help my appeal?  My Dear Sandy, my investigation proves logically that you were the victim of malpractice!  Yet, recent experience has taught me that those empowered legally to judge, protect and serve and their representatives such as attorneys, take the simplest answer, naught always one with common since.  Common sense is lacking in our nations brightest graduates due to the reality that scammers are every where and they don't have to make sense!  My first suggestion, is that the next time you have an expert, who champions your cause with old fashioned deductive and inductive based reasoning, bringing your case to light through categorical syllogisms, forensic recreation of events in a common sense manner, treat them like gold.  Most people are in it for the money.  Some experts, walk to the beat of a different drummer, make money because that's the way the world works, not the way they work.  Your case had such a champion yet you allowed persons unfamiliar with the specifics of Chiropractic Medicine and its policing from the point of view of for example the IG's office, State Attorney Generals or in the old days the USFDA go to trial in lieu of your expert.  Remember only two Doctors of Chiropractic had input into the writing of the IG's Book on Chiropractic Licensing Boards, Policing, and progress.  Further, your case was based on the experts findings; a massive amount of research much like that commonly used on US Government cases, and yet at trial you brought in foolish pundits to argue with other foolish pundits and failed to use the hundreds of pages of research of cases like yours which were indeed malpractice and often resulted in death.  A good old boys club if you will at the trial alleged to be in an adversarial quest for truth and your consumer protection; the meeting of both sides in an action to protect your consumer rights!  They failed you badly however, it appears that you were instrumental in choosing your team for trial.  A deplorable situation. Good Luck. InfoJustice

• LETTERS TO THE EDITOR

My new friend mpyshnov after a through investigation of your case my advice to you follows:

• You did indeed conceive new ideas and addition to science however, you must grow to be successful.
• You must learn from one of the documents Professor Larsen's Affidavits, a letter of September 16, 1987, to the Editor (bearing the stamp of the Chair of the Department with this date, i.e., preceding the Chair's letter to you, which said that Prof. Larsen had withdrawn the manuscript). Here it is:

  "I am writing with reference to MS 483-87. I regret that owing to circumstances I shall outline below, I must withdraw this manuscript from consideration. I intend, however, to submit the results of a similar study (performed by myself and an undergraduate) in the very near future, one which because of its somewhat wider scope may actually be a more satisfying contribution.

  The first author of MS 483-87, Mr. M. Pyshnov was a graduate student under my supervision for some five years. In my opinion he is a very creative scientist with great technical flair. Unfortunately, after discovering disc specific cell arrangements [sic] and their modification in a homeotic mutant [sic] he became unable to do more research. A year after he produced his last preparations (those found in the MS) his graduate student status was changed to "lapsed student", ie, one who is free to return to complete requirements but who is no longer officially registered. I was hoping that publication of his work would encourage him and enable him to resume his progress towards a degree. Unfortunately he has changed his mind and decided for reasons of his own [sic] that he does not want his work published. I am not only disappointed with his decision but embarrassed to have to retract the work after so many other people have given it their expert time and effort.

  In the new paper I shall try to incorporate both the reviewers' and your excellent stylistic suggestions so that these efforts will not have been entirely wasted."  What the Professor tried to say but failed, and is clear from review of your further evidence  was that you ingeniously conceived a better mousetrap, and that your motivation came through your participation in his team.  You had to leave and no new advances to the mousetrap were made.  Now that your idea however has been going through the minds of a few scientists, the progression of scientific methods occurred and your mousetrap was improved upon!  Further if you study all of your evidence, the same theme occurs.  For example, the reading of your website is unclear but with strong militant language.  This takes away from the issue of intellectual theft and brings it to a more sub intellectual area detracting from your loss.  

• Assemble a new team to work with you.  I would advise that you seek out an editorial stay and webmaster to continue with your good ideas. Your are at times highly motivated with great creative ideas.  Try to remain above the clouds and those with their heads in the clouds will be revealed.
• Contact the Secretary to the President of the University of Toronto, for a meeting with either the President or a representative.  Perhaps bring a committee of calm experts from the various areas to help you get your credit.  
• Avoid making your's one of a militant crusade.  Through your own creative intellect, and calm, forgiving and wise judgments, and a new and updated scientific publication about your mousetrap, published within the Matria Scientific a with of course your own ISBN number for your copyright given to said scientific journal, you will have accomplished your goal the old fashioned and respected way; ethical and scientific methods.

  Good Luck.  Good things come to good people in time.  Sometimes late, but the truth finds a way to pave the path towards enlightenment.  InfoJustice.

• LETTERS TO THE EDITOR

How may we help? = I have a Web page...       Please, read it.   I need this case to be known to the public. Can you display this URL on your site and make appropriate comment drawing attention to this site? <Perhaps after further study> I am in a very difficult situation where this case can not be published in any newspaper and this site was even removed from Altavista search engine. The criminals who perpetrate the fraud on me are doing the 24- hours damage control now and continue to provoke me. I need your help.  Dear mpyshnov, upon initial review, this examiner may disagree with your terms to describe your actual "loss".  Please understand often to stop real fraud, the researcher must allow giants to stand on their shoulders, use their work in Toto, and allow claimed credit to the giant, much like a small point gaurd who dishes off to the "giant" Center for the easy two.  Why?  Because the disease, case, and so forth is of such importance, the entire team must know their role to achieve the correct outcome.  However, and again, academic theft of intellectual properties is quite common, and you might be surprised what giants as well as those that worked to make a system function, at some point, had their work stolen. Only later in life to prove through their next deed, and intellectual accomplishment, to have been the originator of a theory.  Finally, it would be unrealistic to not acknowledge academic intellectual theft when it occurs.  For you may sound quite silly to knowledgeable folks.  Thus, I would tone down the "Rhetoric" and focus on the loss.  In fact if you change your tone, you may begin to hit home runs for yourself.  As editor, I have given you many examples in this simple analysis for your overly complex explanation relative to your loss.  I personally will try to jump back to finish my audit.  Further, a Phi Beta Kappa MS and Academy PhD as well as Professor for Criminal Investigations, has agreed to consult on this when she has time.  However, no promises can be assumed from our search for truth.  InfoJustice 

• FDA'S NEW WEB PAGE FOR STOPPING PHARMACEUTICAL INTERNET FRAUD

With hundreds of drug-dispensing Websites in business, how can consumers tell which sites are legitimate ones, especially when it is very easy to set up a site that is very professional looking and promises
deep discounts or a minimum of hassles?

If you buy medical products online, be aware of the following dangers:

• Purchasing a medication from an illegal Website puts you at risk. You may receive a contaminated or counterfeit product, the wrong product, an incorrect dose, or no product at all.

• Taking an unsafe or inappropriate medication puts you at risk for dangerous drug interactions and other
serious health consequences.

• Getting a prescription drug by filling out a questionnaire without seeing a doctor poses serious health risks. A questionnaire does not provide
sufficient information for a health-care professional to determine if that drug is for you or safe to use, if another treatment is more appropriate, or if you have an underlying medical condition where using that drug may be harmful. The American Medical Association
has determined that this practice is generally substandard medical care. FDA agrees.

FDA offers these tips to consumers who buy health products online:

• Check with the National Association of Boards of Pharmacy (www.nabp.net, (847) 698-6277) to
determine whether a Website is a licensed pharmacy in good standing.

• Don't buy from sites that offer to prescribe a prescription drug for the first time without a physical exam, sell a prescription drug without a prescription, or sell drugs not approved by FDA.

• Don't do business with sites that have no access to a registered pharmacist to answer questions.

• Avoid sites that do not identify with whom you are dealing and do not provide a U.S. address and phone
number to contact if there's a problem.

• Don't purchase from foreign Websites at this time because generally it will be illegal to import the drugs bought from these sites, the risks are greater, and there is very little the U.S. government can do if you get ripped off.

• Beware of sites that advertise a "new cure" for a serious disorder or a quick cure-all for a wide range of ailments.

• Be careful of sites that use impressive-sounding terminology to disguise a lack of good science or those that claim the government, the medical profession, or research scientists have conspired to suppress a
product.

• Steer clear of sites that include undocumented case histories claiming "amazing" results.

• Talk to your health-care professional before using any medications for the first time.

Consumers who suspect that a site is illegal can report it to FDA. InfoJustice

• LETTERS TO THE EDITOR:

Dr. Neff I always appreciate the truth, even if it not in vogue.  It makes me proud to be an American when I visit a Patriotic Website or Press (Beat The Press).  "The Office of Inspector General was established at the Department of Health and Human Services by Congress in 1976 to identify and eliminate fraud, abuse and waste in Health and Human Services programs and to promote efficiency and economy in departmental operations.  To reduce fraud the IG's office actively investigates violations of the Medicare and Medicaid anti-kickback statute, 42 U.S.C. Section 1320a-7b(b).  This statute penalizes anyone who knowingly and willfully solicits, receives, offers or pays anything of value to induce or in return for

1. refers an individual to a person for the furnishing or arranging for the furnishing of any item or service payable under the Medicare or Medicaid program,
2. through purchasing, leasing or ordering or arranging for or recommending purchasing, leasing, or ordering any good, facility, service, or item payable under the Medicare or Medicaid program.

Qualified Wrongdoers are subject to criminal penalties, or exclusion from participation in the Medicare and Medicaid programs, or both.  Wasn't it  your friends from Minnesota which wrote the tracing program for MD Violators and their associates?  (No my friend.  The Brothers are from the great state of Wisconsin; albeit the mighty heartlands of the Great Northwest).  We have become aware through heroic physicians who are willing to cooperate with our US attorneys office for prosecution.  Prosecution of the aforementioned occurs due to arrangements between those in a position to refer business (such as a non-English speaking member of a Past Communist Russian Block known for this crime-going out and gathering others that do not speak English for a get rich quick scheme which robs the health of needy Americans), such as physicians, and those providing items or services for which Medicare or Medicaid pays such as a joint venture between lay persons and physicians. Remember 10's of millions of needy Americans especially the elderly who have paid into the system since the 1930's and want to get well, are denied medical care to save or preserve their lives every year become these thieves, pocket all the money.  I remember seeing my father work hard as an American.  To see these entrepreneurs, come to work for a few hours a day, not work but plot crimes against the medi-cal system, and pocket all the Medicaid and Medicare moneys is repulsive.   Further examples of the items or services provided in the arrangements include clinical diagnostic laboratory services which provide test results but no patient goes on for the cure, durable medical equipment (DME), and other diagnostic services.  Sometimes these deals are called "joint ventures."  Look for :

1. Large numbers of patients coming together in a station wagon, van, bus and driven by someone paid by the medical clinic to find non-English speaking patients for muti-dignostic workups with no goal of solving the illness.
2. Investors who are chosen because they are in a position to make referrals.
3. Physicians who will follow the work up and then simply start a new case absent correlation for the return to health.
4. Look for the "shell" game.  In Health Fraud William Jarvis coined this term at the 1980 meeting in La Jolla.  You can look under all the shells and not find a cure for disease.
5. The amount of capital invested by the physician may be disproportionately small and the returns or investment may be disproportionately large.  The physician simply pays other dups.
6. Investors may be paid extraordinary returns on the investment in comparison with the risk involved, often will over 1,000 percent per year.
7. Most Physicians are in the dark about the true shady character of the Mafia.

The following additions are taken from the InfoJustice library, specifically The Textbook of Forensic Criminal Investigations by Dr. Scott Neff.  

"Thus expanding the immunity provisions to protect insurers for sharing information with other insurers would be key to preventing a case like Adams vs. CSLA from broaching other insurers... 

It is comforting to note that recent legislation (Freedom of the Press and Free Speech) is in the works to:

• Provide unilateral immunity protection with respect to all health-care, anti-fraud investigative activities
• Extend immunity to all law enforcement officers (not just those connected with the administration of health care)
• Ensure information exchange between private-sector fraud investigators (i.e., information sharing among insurers)
• Require that any allegation of sharing false information be "pled with particularity" (a term under the Federal Rules of Civil Procedures)
• Allow the recovery of attorney fees to a payer that is sued and subsequently found to be entitled to immunity

Further, the American Medical Association has now suggested that:

• Shared information must be related to specific conduct, and the conduct must be outside the realm of legitimate disagreements on what care is medically necessary
• There must be substantiation of information, so that its credibility is not in question
• There must be an opportunity for one who is harmed by the sharing of "bad-faith" information to seek legal recourse.

InfoJustice Beat The Press.

• LETTERS TO THE EDITOR:

Dr. Neff, what do you say to those law enforcement persons within the blank and IG's office which have bowed to the public pressure of the late 1990's to wit; stick it to the feds...stick it to the state.  It's a get rich quick scheme which can Grease the palms of many people, important people in important positions.  Why should everyone else get rich and law enforcement, our elected officials both state and federal, our court system and all the employees therein work and not get a piece of the American Pie albiet a free pass to go which is not available elsewhere in white collar crime?  Dear Zip it...That was a bit quick!  Answer as soon as I can re-jump to this topic.  My Good Friend, when it comes to health care billing, there is no state and there are no feds.  Your looking and 60 years of elderly Americans whose money paid into a system to care for all Americans at some level and today's good citizens moneys which are egregiously taken for unnecessary Medical Testing and Services which bring no successful outcome to the very patients in question save some pocketbooks!  Look to the poor unselfish worker, not the Greedy egregious, self-aggrandizing entrepreneur who's goals are above the health and welfare of the American People.  If this examiner understood your query correctly than this is your simple answer..

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