You will find in this
section hot News articles which we feel are of national importance to all folks. Beat the Press is brought to you as a
free service from AAJTS. If you wish
to receive weekly forensic courses,
Dan Marius Stefan was arrested after having bilked
almost $500,000 by "phishing". Phishing is a high-tech scam that
uses e-mail based communications to deceive consumers into disclosing
their credit card numbers, bank account information, Social Security
numbers, passwords and other info-sensitive data. In Stefans case,
he would contact unsuccessful past bidders for on line auctions at eBay.
Stefans would then send his own created simile of eBay with similar
items at a better price. The duped victims would of course then
provide all of their info-sensitive data, such as credit card numbers,
social security numbers, debit card numbers, mothers maiden names, bank
accounts, and passwords. Then the victims were informed they won
and were sent to a "spoofed" escrow site produced by Stefans,
money agreed upon was forwarded to Stefans!
Six other cases have also been prosecuted advises the
Office of Homeland Security, and Secret Service one of its newest
members is actively on the job to stop scams, shams, schemes, and
blatant fraud relative to stealing your money as well as your most
private info-data. InfoJustice
On October 2,
top state, county, and municipal law enforcement leaders met at FBI
Headquarters to discuss and make recommendations to Director Mueller
on training provided by the FBI to law enforcement in the post-9/11
Dan Rosenblatt, Executive Director of the International Association
of Chiefs of Police (IACP). Sheriff Kevin Beary of Florida's Orange
County and President of the Major County Sheriff's Association.
Police Chief Scott Finlayson, Springfield, Utah, and President of
the State Association of Chiefs of Police. Chief Harold Hurtt,
Phoenix, Arizona, and President of Major City Chiefs. Chief Robert
Olson, Minneapolis, Minnesota, and President of the Police Executive
Research Forum. Sheriff Ken Ramsey, Kane County Illinois, and 1st
Vice President of the FBI National Academy Associates. Colonel Gary
Adams, Chief of the Oklahoma Highway Patrol, and Chairman of the
Southern Region of the IACP State and Provisional Police Division.
Sheriff Aaron Kennard, Salt Lake County, Utah, and 1st Vice
President of the National Sheriff's Association. Chief John McGowan,
East Norriton Township, Pennsylvania, and President of the Law
Enforcement Executive Development Association. And leadership from
the Department of Justice and the FBI Training Academy and Law
Director of Law Enforcement Coordination Lou Quijas (and former
Chief of Police in High Point, North Carolina) is the chairman of
these meetings of the Director's Law Enforcement Advisory Group. He
notes that this group has grappled specifically with information
sharing, security clearance, and threat assessment issues, and that
its efforts have been crucial to better protecting Americans and
They have helped expedite the process of obtaining security
clearances for law enforcement officers who need access to sensitive
information so they know what threats to look for in their
communities. They have helped secure technology solutions to ensure
instant threat and information sharing. And that's just the tip of
Mueller has put the crucial nature of these partnerships this way:
"Terrorist threats against the nation have created a new era in the
relationship between the FBI and local police. You are the first
lines of defense against danger. ...No one agency can handle these
complex, sophisticated threats alone. ...we in the FBI are proud to
be your partners
2002 FDA SCIENCE FORUM: BUILDING A
"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
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
"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
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
FTC Charges "Miss Cleo"
Promoters with Deceptive Advertising, Billing and Collection Practices
"Free Readings" Result in Large Phone Bill
"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
"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
- 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
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
- 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
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
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
"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.
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 1999more than
460,000were 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 Americansand
their health care providersabout 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
"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 diseasesprincipally 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.
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
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
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.
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. Attorneys Office in Fort Lauderdale,
Florida, at 1-800-379-4643.
CDC'S GUIDE TO PREVENT COMMUNITY TODDLER TOOTH
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
"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
FBI DEVELOPS NEW STATE OF THE ART HAZARDOUS
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
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
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
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.
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.
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
* Postal facilities will use stronger, antibacterial cleaning chemicals as part of routine
* 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.
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.
· 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
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
FDAs ability to determine the public health significance of the reports it receives
through its Adverse Event Reporting System (AERS), published information, and other data
The recipients of the contracts are AdvancePCS, Premier Inc., and Child Health Corporation
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
These contracts represent another important advance in FDAs continuing work to
improve the management of risks associated with marketed medications.
FDA APPROVED TREATMENTS FOR ANTHRAX
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.
For people with suspected anthrax disease, laboratory testing is essential to diagnosis.
EVERYTHING YOU NEED TO KNOW ABOUT
DETECTION OF ANTHRAX AND CURRENT INVESTIGATIONS
Tests may include:
* Cultures of blood and spinal fluid (should be done before antibiotic treatment has been
* 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
* 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).
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 agents 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 laboratoriesincluding clinical, military,
veterinary, agricultural, water, and food-testing laboratoriesto 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
Test results sent to CDC on the initial samples from Nevada are negative. However,
additional samples have been sent and will be tested.
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) 7126488/6400
Preliminary tests indicate cutaneous (skin) anthrax disease in an infant. The childs
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 infants 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
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.
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
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
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
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
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
"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. "
FDA PUBLIC HEALTH ADVISORY:
UPDATE ON USE OF DOXYCYCLINE FOR ANTHRAX EXPOSURE
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
- 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
- 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
- Selected areas of 30 Rockefeller Plaza have been closed and environmental samples are
- The risk of exposure is greatest for the few people who handled the letter
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
- 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
USCDC REGARDING FLORIDA ANTHRAX CASE-Public
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.
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.
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
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
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
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
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
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.
Supervisory Special Agent Bradlee Godshall: Operation Goldentooth was an undercover investigation where an
undercover investigator provided health insurance information to a group
of Mexican doctors who had submitted false claims seeking reimbursement
for surgeries and other medical procedures which were never rendered or
were really plastic surgeries. The doctors submitted claims for these
"phantom patients" which the FBI paid through agreements with private
insurance companies-USA Today.
OPINION; THE LOWEST FIRM IN THE NATION-ANYTHING BUT VALUE OR CUSTOMER
Anyone can get fleeced today, on a
daily basis, any week, and probably every week. As everyone must
know, this web-site receives many consumer complaints. Yet once
President Clinton and his DOJ and FBI tenor persons, created a web-site
for such legal consumer complaints, we simply stopped forwarding most .
Further, since my Merrill Lynch Exposé's of now several years ago, many
around the globe send in complaints. Two weeks ago, this examiner
had the most horrific experience with Scottrade; I would opine the worst
run firm in the nation. And thus for the first time in years, my
consumer complaint. When I enrolled on line, I was advised who my
trading broker would be. When I went into Scottrade, I witnesses
four elderly men walk out mad. Now a bit worried about the
operation, I continued with "How do you do, are you "blank"? My
name is Dr. Blank and I was told you would be my broker." The
response was "hey you, will you help this guy!" I was shocked that
my new broker was so snooty and rude (and I was now a factual victim of
false advertising as I was pre-informed who my broker would be and the
broker failed to spend any time with me, failed the advertised private
broker "bull" and his every word was an insult to any educated person"-"
I swear under penalty of perjury I never sat with my private broker nor
received any advise only denial when I began to explain the
discrepancies between my real life experiences and that which Scottrade
advertised; inconsistent). In fact the poor fellow that "was to
help me" could not answer my questions and I was given poor and as it
turns out invalid information. Next, when it was time to invest my
funds, they were shocked at the
amount I was depositing and was told that there would be a further
delay because their policy is not to believe a check has funds just
because some doctor comes in and gives us a check!.
I called the bank, and had the bank message give the account balance (which
was unnecessary, inappropriate and embarrassing),
and when they heard it was far over the amount I was depositing, I
was then told it was alright! Having had accounts with Merrill
Lynch, Pain Webber, and Morgan Stanley, in my experience,
I had never seen such an unprofessional operation. From that point
forward they refused to address me as I am accustomed which caused
immediate issues and of course I left understanding that I had just come
in contact with "Pond-Scum". They also taught this examiner they
were the "anti-value" firm, worst on the globe. With no
customer service mechanism (known as "active and responsive internal
controls for customer satisfaction"). Obviously I knew
what "value" means by doing business with true "Value" firms like Morgan
Stanley, and USB PaineWebber (Thus what "customer"
satisfaction is based on!). When Monday came
around, I found that after all of the planning, I was not able to
make the trade that I had spent months calculating the day, the hour to
begin and the amount to invest. I called to enquire and was now
told that it takes 48 hours plus four hours for my money to clear!
I was never informed of this additional hurtle and felt my money and I
were being held hostage. In shock I waited and when I was
able to make the trade, the stock was up about 4.84 percent. Lucky
for me, while I was waiting I made the purchase at a stock house with a
fully functional automated trading system and was able
to capitalize on about 3 percent of the gain. On my second day,
now after being told horrible things during my first complaint, I was up
$600 dollars. Clearly my thinking is very sound verified by the
"real" profit which was made despite Scottrades exceptionally slow
methods of monetary deposits, and almost child-like management of the
company, and total absence of broker assistance or a "customer service
mechanism". They appear to
this examiner to simply be a toy. Not a sound financial organization
which listens to its customers. "The customer is always wrong!"
The second day after my complaints possible front-running occurred.
However, when I called to request an explanation (could have been the
web had problems) I was then told to take a hike, and that Scottrade
acknowledges in the contract that I signed that there is no guarantee on
the executions of changing a trade! The fact is that this
statement proves an absence of any "value" relative to excellent stock
houses. Absurd, I know, but apparently this is their policy.
Well they have everything thought of ahead so that if something appears
inappropriate, Scottrade already advised the customer in print, never
verbally up-front to this examiner I must add, that these things can occur thus
in this instance would then not be Front-running (although customers
were allowed to go ahead of me for a long time when suddenly a point in
time arose when my cancelled/un-modified trade went through in lieu of
the correct changed trade which was continually bypassed.). Well, I
guess they thought of everything except customer courtesy, a real
absence of any speed of money deposit for fast trades, a system designed
to place people on margins because of the guaranteed absences of basic
services offered by normal brokers, or any experience of any other
trading professionals outside of Scottrade, in this humble souls
opinion. It is further my opinion, that the system design is to make
profit not on trades but a pre-programmed system delay which may force
one into margin absent a real need for funds visa vie the "real"
execution of the then cancelled and modified to a new trade which fit
within the constraints of the ever changing values within a trading day. For example,
this type of nonsense does not happen with either my other two on-line
trading platforms. Further, for customer service I have my choice of
several local brokers and office manager within one office and a customer
service number for expert and specialist brokers specifically for bonds,
mutual funds, commodities, equities and so forth which I carry in my
wallet, and the card also has my customer service phone number for internal control
questions. Further, immediately after I filed to transfer from
Scottrade, I received a wonderful call from a specialist who will be overseeing the transfer
(Scottrade offers no such avenues for customer service) who provided me with yet another avenue of customer service and
phone number! Thus, my experience
with Scottrade was one of unusual delay in money you submit for
expedient purchases, unusual delay transfers, pre-designed excuses in writing to
explain poor performance of trades and modified trades based on "Trade
Practices Acts", and thus
extremely slow executions visa vie their admitted and written possible
failing of their modified trade system which truly equates to "no value
for you time, hard earned monies, your precious trading strategies,
absolutely no personal broker as advertised nor any attempts at customer
service nor a system to address normal and customary issues of our day. I did not receive
what was advertised and my money is and continues to be held hostage
from its intent (Investment intent is profit, and my last two
trades produce monthly income and both stocks are up thus never ever
ever sell; yet Scottrades answer to everything is sell and get out and
be a looser which defines a company who believes in vengeance to the end;
Yet for the prophylactic protection "at all costs" of the solid
strategic investments and to deny them any further profit off of my
sound investments visa vie sales, I requested
to another branch albeit having
been horrifically treated yet further advised there was only one option which was to
sell! However, on my own, I simply went to a "real" firm and signed transfer to
the safe haven of solid growth and increasing
earnings) for an additional two weeks until funds are transferred to were my money can go to
work as intended. For more on my in depth personal
acquired Scottrade induced trauma and anguish over horrible persons in
charge of hard earned funds acquired by caring for the sick, suffering,
poor, weak, helpless, elderly, persons on fixed incomes and mostly disabled persons of the greater Los
Angeles Areas (three offices); a total waist of this
correspondents precious time and much much more please contact.
Cases in the United States
Data reported to the World Health Organization on April 28, 2003.
Misbranded Dietary Supplements Destroyed
The Food and Drug Administration (FDA) announced today that Nature's
Youth, LLC, of Centerville, Mass., has completed its voluntarily
destruction of approximately 5700 boxes (each containing a 30-day
supply) of its misbranded product, "Nature's Youth hGH." This
destruction, which occurred at locations in Massachusetts and Florida,
was recently completed and involved approximately $515,000 worth of
product. The firm also indicated it would change the labeling for future
marketing of the product in order to comply with the law.
"FDA is committed to help consumers make health and dietary choices
based on accurate information," said FDA Commissioner Mark McClellan,
M.D., Ph.D. "FDA will continue to take strong action to protect American
consumers from dietary supplements that are not accurately labeled or
that make misleading claims unsupported by scientific evidence."
FDA determined the product was misbranded after evaluating
unsubstantiated "structure and function" claims made on the company's
website, as well as a review of the labeling of the product line. Among
the false and misleading claims was that Nature's Youth hGH was a
"proprietary blend of amino acids and precursor nutrients which enhance
the body's natural production of Human Growth Factors and Insulin-like
Growth Factor-1" that would, among other things, "improve physical
performance, speed recovery from training, increase cardiac output, and
increase immune functions." The product also claimed to be "your body's
best defense against aging."
In this case, the company claimed that an article in the New
England Journal of Medicine (Volume 323:1-6, Number 1, July 5, 1990)
provided substantiation for their claim. However, the New England
Journal of Medicine (Volume 348:777-778, Number 9, February 27,
2003) included a clear statement that such a claim was misleading. The
editor-in-chief wrote in part, "If people are induced to buy a 'human
growth hormone releaser' on the basis of research published in the
Journal, they are being misled."
FDA will continue to monitor the marketplace to ensure that products
purporting to be dietary supplements are labeled properly and that
claims being made for these types of products are not false or
We receive too many unusual tips on
scams, shams, frauds, hucksters, or "Big Business Fraud" that we cannot
afford to look into each and every one. However, every so often a
ray of sunshine beams through my windowsill. I had met a very
interesting Orthopedic Surgeon during a luncheon about two weeks ago.
I knew his last name but could not recall his
first. I tried everything. Yellow pages, internet on several
different search sites. However, I tried google.com and a page
came up were I could locate a physician by zip code, city or name.
On my first attempt, I found the good doctor. When I investigated
the source of the good service which was free, I found that it was
sponsored by Chiropractic Physicians (DC's=Doctor of Chiropractic) as a
service to the sick. We all remember the doctor's of chiropractic
practicing on the streets in the rubble of 9-11, caring for the
Fire-fighters, Police, and emergency persons for free.
They kept the backbone of American strong for the
job. I must seriously congratulate these fine
contributors to our nation and can only say, I am sorry for not noticing
you sooner. Good Job. InfoJustice
JUST, "DAG NAB IT", CRAY! POOR HALLIBURTON
Today, April 29th, 2003 with less
then 1/2 the trading day behind ,my "Street Smart Pro" has brought to my
attention no less then four Articles on Halliburton. The "big
story" is how a quality company, with a past great leader, who became an
even greater vice president, should all be punished because jealous and
baseless rhetoric should be the design to admonish Halliburton from its
job intent. What firm has been and still is most familiar with
Iraq? It's Halliburton. What firm because of its familiarity
with Iraq has the least possibility of causing us backward logic
embarrassments. It's Halliburton. Who maintained an office
in Iraq prior to and during the war? It's Halliburton. This
begs the question be asked, "Did we not just fight a war to eliminate
radical extremist rhetoric for many reasons including a fight for
"truth"? Then why are we now copying backward radical extremist
logic and applying it to our great leaders who now have their plates
full with protecting a nation, and to the best company for this
particular situational psychology and environment; inconsistent.
It hurts my heart when I read baseless reasoning which does not account
for the brilliance and outstanding leadership of our Vice President, and
unfair punishment being aimed at a great company who coincidently once
had a great employee. InfoJustice.
FTC TO AANNOUNCE
"Crackdown on Internet Auction Scams"
The Federal Trade Commission
will hold a press conference on Wednesday, April 30, 2003, to announce a
federal, state, and local law enforcement crackdown on internet auction
scams. The enforcement actions are part of the FTC’s "Operation Bidder
FTC Bureau of Consumer Protection
Hon. Christine Gregoire, Attorney General
State of Washington
600 Pennsylvania Avenue, N.W.
||Wednesday, April 30, 2003
12:30 p.m. EST
will be open at 12:00 p.m. to allow for camera set-up.
Reporters unable to attend the press conference may call in:
Chairperson: Bruce Jennings
Call-in lines are for press only.
- GREETING CARD
BUSINESS OPPORTUNITIES "Fraudulently Marketed by Florida
FTC Charges Companies Defrauded Consumers Out of Approximately $3
Greeting Cards of America (GCA), and its officers, and American Eagle
Placements, and its owner, have been charged by the Federal Trade
Commission with using deceptive tactics in selling their greeting card
business opportunity. According to the FTC, since at least early 2001,
the defendants were engaged in the marketing and sale of a greeting card
business opportunity that defrauded consumers out of at least $3
million. In their advertisements, the GCA defendants allegedly made
earnings and success claims that vastly overstated the amount consumers
could expect to make from a GCA business opportunity. GCA allegedly also
used "shills" – phony references – to deceive consumers. According to
the FTC, American Eagle defendants operated a locator service which
consumers paid for separately to place the greeting card racks sold to
them by GCA. American Eagle defendants allegedly made false claims about
the quality of the locations the placement service obtained and the
sales support that they provided. The owner of the company also
allegedly reiterated to consumers GCA’s false earnings claims in advance
of the sale of the racks. The FTC alleges that these practices violate
the FTC Act and the FTC’s Franchise Rule.
The FTC is asking the court to prohibit misrepresentations, appoint a
receiver, freeze the defendants’ assets, and obtain consumer redress.
The Commission’s complaint names Greeting Cards of America, Inc.,
based in Plantation, Florida, and husband and wife team, Gerald (Jerry)
Towbin, also known as Alex Carr, and Susan Towbin. The FTC also alleges
that Jerry Towbin uses another alias, "John Grant," to pose as a
reference for GCA; that he deceptively states his success as a GCA
distributor, even though he does not have display racks, cards, or
locations; and that Susan Towbin acts as a reference, using the aliases
"Mary Grant" and "Sandy Grant."
According to the FTC, the defendants advertised on the Internet, on
the radio, and in newspapers. The ads contain statements such as:
"– Prime high volume locations are provided for you!"
"– With just 30 locations selling only 10 cards per day, you will
earn $135,000 per year."
"Sound too good to be true?? Not at all . . . With ‘Our
"No matter How you do the numbers, "It’s a Moneymaker !!!!"
"Greeting Cards of America provides the three basic components of a
"A great product, displayed effectively, and revenue productive
locations to sell them in." (Emphasis in the original.)
Through these ads, the FTC alleges, the defendants violated the FTC
Act by misrepresenting potential earnings consumers could realize and
misrepresenting that they provide significant assistance to purchasers
of their business opportunity. In addition, the FTC alleges that Jerry
and Susan Towbin, using aliases, have served as "shills" or references
for GCA. Many consumers relied on the Towbins’ representations and
purchased GCA’s business opportunity, the FTC stated.
In addition, the FTC alleges, the defendants violated the Franchise
Rule by misrepresenting a specific level of earnings without having a
reasonable basis for making such claims. The defendants also allegedly
made earnings claims without providing the prospective purchasers with a
disclosure document for earnings claims, as required by the Franchise
Rule. Further, the FTC alleges, the defendants violated the Rule by
failing to give a complete and accurate disclosure document.
The complaint also names American Eagle Placements, based in Stone
Mountain, Georgia, and its owner Forrest Adams. According to the FTC,
American Eagle is the locator service that GCA recommended to all of its
purchasers. American Eagle allegedly makes false claims about the
quality of the locations obtained for consumers and the sales support
that they provide. According to the FTC, American Eagle sends either a
locator to each consumer’s hometown or
arranges for a locator to find locations over the telephone. American
Eagle allegedly charges a separate fee for its services – $150 per rack
that it places. The FTC alleges that Adams also reiterates the Towbins’
outlandish earnings claims to consumers.
The Commission vote to authorize staff to file a complaint in federal
district court was 5-0. The complaint was filed in the U.S. District
Court, Southern District of Florida, Ft. Lauderdale Division, on April
21, 2003 under seal. The seal was lifted on April 24, 2003.
WHAT'S UP WITH SYRIA?
The Syrian ambassador last evening
advised "his regime is the only country on the globe which had no ties
to Saddam. No ambassadors, "nothing"". Yet his country was the
only Nation on earth to receive a pipe-line of the Iraqi peoples
oil, for 1/2 the cost of the rest of the needy world. Further,
everyone knows what a Freudian Slip is. That's why Syria is
running around like "chicken little" saying the sky's falling in.
They have something unknown to us, but the underlying truth is hidden
causing the most obvious propaganda to become just another
The problem in a nut shell. When in the course
of human events, a God-fearing person (one who is dedicated to the lord
and of course fears not the evil's of man, because faith is their
"rod and staff" protected from the valley of eternal death, who's
destiny is to walk in heavens light) is confronted with Hypocrites who
have no true faith or fear of God, but only believes in the fear of man;
albeit through suicide bombings, global terrorism and racial terrorism,
yield obvious inevitable conflicts. Only through
time, and the continual spreading of the teachings and covenant of
Abraham, and his disciples, i.e.., Isaac, Jacob, Joshua, Joseph, Moses,
David, Solomon, the Christ-Jesus of Nazareth, and of course, Mohammad,
will faith overcome the evil creations and intentions of man.
Subsequently when both sides deal with the hand of truth, resolutions to
disputes, and the deliverance of mankind will be at hand. These
teachings today reflect all of humanities civil liberties or rights to be free.
And have the
choice absent fear, to accept or refute democracy.
May our world have a Happy, Wonderful, and
peaceful observance of "Passover" and "Good Friday".
"Approves Drug-Eluting Stent for Clogged Heart
The Food and Drug Administration today approved the first
drug-eluting stent for angioplasty procedures to open clogged coronary
arteries. In most cases, a stent is left permanently in the artery to
keep the vessel open after angioplasty. The new stent slowly releases a
drug, and has been shown in clinical studies to significantly reduce the
rate of re-blockage that occurs with existing stents.
Drug-eluting stents may have a substantial impact on the occurrence
of re-blockages for patients with heart disease. Each year 800,000
angioplasty procedures are performed in the United States to open
clogged coronary arteries. In approximately 15%-30% of patients, the
artery becomes clogged again (a condition called restenosis) within a
year, and it must be treated again with a procedure such as angioplasty
or bypass surgery.
"Today's approval represents a significant step forward in the
treatment of heart disease," said HHS Secretary Tommy Thompson.
"Patients who receive this device will need fewer repeat operations to
unclog arteries, which can make a real difference in the quality of
The product is the Cypher Sirolimus-Eluting Coronary Stent (Cypher
stent), made by Cordis Corporation, of Miami Lakes, Fla. It is a tiny
metal mesh tube that is covered with the drug sirolimus. The company has
a license from Wyeth Pharmaceuticals for the use of sirolimus.
The Cypher stent provides a mechanical scaffold to keep the vessel
open while the drug is slowly released from the stent to prevent the
build-up of new tissue that re-clogs the artery. In studies conducted by
the firm, the stent reduced the rate of restenosis by about two-thirds.
"Drug-eluting stents combine drugs with medical devices to provide
more effective care for many patients with heart disease," said FDA
Commissioner Mark McClellan, M.D., Ph.D. "FDA is working to make sure
its regulatory procedures encourage the quick and efficient approval of
such safe and effective combination products."
FDA approved the stent based on a review of laboratory and animal
tests and two clinical studies of safety and effectiveness conducted by
Cordis, as well as review of manufacturing procedures for this new
In the U.S. study (called the SIRIUS study), 1058 patients received
either the Cypher stent or an uncoated stainless steel stent made by
Cordis. The patients in the SIRIUS study had blockages of 15mm to 30mm
long in arteries that were 2.5mm to 3.5mm wide.
Results were similar for both types of stents in the weeks
immediately following the procedure, but after nine months the patients
who received the drug-eluting stent had a significantly lower rate of
repeat procedures than patients who received the uncoated stent (4.2%
versus 16.8%). In addition, patients treated with the drug-eluting stent
had a restenosis rate of 8.9%, compared to 36.3% of patients with the
uncoated stent. The combined occurrence of repeat angioplasty, bypass
surgery, heart attacks and death was 8.8% for drug-eluting stent
patients and 21% for the uncoated stent patients.
A smaller study of 238 patients conducted outside of the U.S. (the
RAVEL study) was similar to the SIRIUS study, but it evaluated patients
with shorter blockage of the coronary artery. That study also showed
significant reductions in repeat procedures and restenosis.
This smaller study was the basis for the product's approval in
Europe, and supported the product's approval in the United States. While
the RAVEL study suggested that the Cypher stent showed promise, it was
not large enough to assess the patients most likely to benefit from the
The U.S. study evaluated the product's safety and effectiveness in a
much broader population. The additional evidence obtained from the U.S.
study required by FDA should allow doctors to use the drug-eluting stent
with more confidence about the benefits of the product in more patients.
The safety and effectiveness of the Cypher stent in smaller diameter
arteries or for longer blockage that required more than two stents was
not studied in either trial. Also, the safety and effectiveness have not
been studied in patients who are having a heart attack, patients who had
previous intravascular radiation treatment, or patients who had their
blockage in a bypass graft.
The types of adverse events seen with the drug-eluting stent were
similar to those that occurred with the uncoated stent.
Patients who are allergic to sirolimus or to stainless steel should
not receive a Cypher stent. Caution is also recommended for people who
have had recent cardiac surgery and for women who may be pregnant or who
are nursing. Patients who receive the drug-eluting stent will likely
need to take certain kinds of anti-platelet drugs for at least several
FDA is requiring Cordis to conduct a 2000-patient post-approval study
and continue to evaluate patients from ongoing clinical trials to assess
the long-term safety and effectiveness of the Cypher stent and to look
for rare adverse events that may result from the use of this product.
YIPPY YO KI
A-ITS ALL A LIE
The blood, the cries of mothers of
dead sons and daughters of freedom fighters, who accomplished the first
freedom for the Iraqi people since Babylon, still are slandered by the
Arab Propaganda Machine or Arab Media and press. It should be
clear to any "rational and responsible person" that the Arab Media, even
that portion carried by CNN (two women oversea reporters, too low to
report by name, who will surly
go to hell) lie about the truth at any chance they can, to report
"fraudulent news" which was created out of thin air, but
reported as "news". Thus far anything negative about Uncle Sam's
Children's motives, not only has been a fraud, but an abomination to the creator.
Last evening this examiner had a horrible nightmare; albeit I was
sitting on the floor with long hair accompanied by a mass of people, all
content looking up and listening to the "word" of the lord. Then a
fraudulent news flash about all that is good, again "coviting lies"
which purported killing reporters, when suddenly the lord gently moved
his hand, and we could see below, all fraudulent reporters and evil
doers eliminated from earth, to go to the repetitive forever suffering
hell. I woke up for some reason with a start. Turned on the
TV and there was the fraud, again being reported by frauds, to so
irritate innocent Arab children of god, that they were lead astray to
cause anti-Christ actions, and anti-god violations of his commandments.
I shut off the TV, prayed to have a calm sleep, and indeed fell into a
deep sleep, awaking refreshed, and motivated to write about a simple
ACUTE RESPIRATORY SYNDROME:
Report of Suspected Cases Under Investigation
in the United States
These data were reported to the World Health Organization on April 6,
Total Suspected Cases Under Investigation
Respiratory illness of unknown etiology with onset since February 1,
2003, and the following criteria:
- Measured temperature
> 100.5°F (>38° C) AND
- One or
more clinical findings of respiratory illness (e.g. cough, shortness
of breath, difficulty breathing, hypoxia, or radiographic findings of
either pneumonia or acute respiratory distress syndrome) AND
within 10 days of onset of symptoms to an area with documented or
suspected community transmission of SARS (see list below; excludes
areas with secondary cases limited to healthcare workers or direct
household contacts) OR
Close contact* within 10 days of onset of symptoms
with either a person with a respiratory illness who traveled to a SARS
area or a person known to be a suspect SARS case.
Close contact is defined as having cared for, having lived
with, or having direct contact with respiratory secretions and/or body
fluids of a patient known to be suspect SARS case.
Areas with documented or suspected community transmission of
SARS: Peoples' Republic of China (i.e., mainland China and Hong
Kong Special Administrative Region); Hanoi, Vietnam; and Singapore
- GUBY GUBY GU, THAT'S WHAT
THE BABY SAYS, GUBY GUBY BU (Dean Martin?)!
"Young men" of American. Jessica is coming home.
Even though I'm an old-fart, if I were you, I would be lining up for
Marriage. If she's not a "Yankee Doodle Sweetheart", then this
examiner has never met one. And I have. "Young-men", you
could never be better served in judgment then to cherish an all American
gal like Jessica Lynch. InfoJustice
This examiner was advised last evening, by a
middle eastern source (always investigate this source because of spin
etc-Yet this was published because of all the speculation. Thus more
speculation for our diet) of questionable character, that Saddam was injured initially, with the
"be-Jesus" scared out of him, tied his tail between his legs, and fled
to Russia. The source claims that Saddam was subsequently seen in
a remote northern area of Russia. Further, he advised that,
because he is alive, his fear campaign continues by any means. The
latest is to hold several family members hostage, while one from each
family must ride in a vehicle used as a weapon. Orders,
simply hit any coalition members you can. However, because civilians
are sent out without their heart into murder, these missions have
subsequently been suicidal by "defeat". Again, this source is held suspect, yet the story was so riveting to this examiner, that after much
hesitation and contemplation, I have printed it here with the
prophylactic that this examiner has no way to verify this story; hope
its not true relative to the Russian connection (hope he is still in
Iraq which is consistent in my view), but feel it could possibly "Beat
the Press". InfoJustice
April 1st, 2003.
THE BRITISH ARE COMING THE
BRITISH ARE COMING
No-one will ever doubt the "Brits" resolve,
toughness, intelligence, and kindness. What a fighting force.
From the RAF to the Desert Rats, to the Marines etc . They are all
spectacular. You know, in a different world, or another time
perhaps 200 years in the future, would it not be grand, if the British
Isles, applied for Statehood? Just think, a fellow the
caliber of Tony Blair or Winston Churchill, could run for a US office.
A world truly uniting under the protective umbrella of the Constitution.
I guess, I have a dream. Maybe Mexico could become the next State and so
on. Outside of my dream, and in any event, the British are doing
the work of the lord, and I am proud to have them in our coalition.
With much respect, "Hale to the Brits".
THE DAY THE DOG STOOD
STILL-A WORD TO MY ARABIAN BROTHERS-IF YOU WERE NOT BORN ON THIS PLANET
GET OUT OF MY HOOD!
From my view, nothing which has occurred thus far
in this horrible war has been a surprise. I believe the US
military understood well the circumstances, and achievable outcomes.
Further, they are apologizing to have made underestimations, which were
again pre-planed. Why? The only way to expose a hidden
monster, is to take the high road. Thus, indubitably, the monster,
being multi-headed, with a goulash true identity, begins to reveal
itself to the peoples of the world. My African brothers, may soon
be crying like I have, to find a good and wonderful maintenance lady,
hooked up to a huge truck battery to places this examiner dare not
dream. Many of the lords children, on both sides of the conflict
have now been tortured by whom? My Arab brothers, son's of
the first of my brothers of the seed of Abraham, to the building of the
first shrine in Mecca, please, cry with me, at the horrific abominations
which are occurring to our heritage, God's females. Let not the
dark horse of evil, crush the Arabian white stallion of truth. Is
it too much to ask, that a "Judah Ben Hur type-a Yank", ride to the
glory of truth with you against "evil"-torturers of "women".
Cannot the US sons and daughters of freedom, be the driver of your
chariot of good. Did not Mohammad, the toughest man of his
peoples, then bring from his Christian and Jewish trading
partners, the "word" to his desert children's? God is Allah, God
is one! Is it not yet time, for a generation of "light of the
eternal mind", to unit, drop our differences, to illuminate truth to our
God if not forevermore, for a time to prove creation was worthy of the
noble creator? Or, must your cries, four times a day, that "God is
One" to the east, to the west, to the north, to the south be a
hypocrisy...torturer of women?. Never in my heart, for a moment would
this examiner doubt your light. Good Luck. And remember good
is winning, the inevitable will occur if not within weeks to a few
months, the world is not only beginning to see the monster, but
understand. Again, Good Luck and God-Bless.
Why is the media not reporting on itself (clearly
this examiner will never get work for the media)? That's the Beat
the Press issue today. For example. Everyone sees the Yanks
winning the day. Then several foreign press persons ask the same
question "Could you tell me why you are losing the Iraqi conflicts?"
Example two. Even from the get go, I warned people "What War".
The foreign press had the world at war while negotiations were pending
albeit based on failed UN work. So even before the war, the press
had us at war, egging Saddam the madman on. Example three.
Everyone from the President down, even prior to the war, warned us that
"no matter how long it takes, we are going to hunt them down, spook them
out of their foxholes, round em up, and bring them to justice".
Suddenly every question is "why has the war gone so badly and going to
take longer than expected?" What kind of irresponsible news is
this? Why should a newsperson be allowed to ask a false question
or a question based on known false hoods? Example four. Now
the "chicken-little" journalists are predicting dooms day with all this
house to house fighting nonsense. Has anyone ever studied history?
Believe it or not the German's were ten thousand times tougher than the
monsters were fighting now! History has taught us that first we
surround the city (Hale the Patton Strategies), then we simply clear
them out block by block. The troupes and tanks do not wander
aimlessly down the streets of Baghdad with the troupes hanging out like
foul at a turkey shoot. I just saw the animated nonsense of CNN
and frankly am disappointed. Our commander and chief is correct
when he says that there is some "silliness" in the investigative
reporting of the liberation of the people of Iraq.
I AM THAT YANKEE DOODLE BOY
From the time this examiner was yet 6 years of age
(until age 11), Mayor George Vavelous, then Mayor of St. Paul Minnesota,
would have this examiner get up and sing on stage at Como Park "I'm a
Yankee Doodle Dandy, Its a Grand Old Flag, Over There, Gary Indiana,
Mary, Harrigin, Give My Regards To Broadway, Rosy, Swanny, Mammi,
Rock-Aby-Your Baby With A Dixie Melody and so forth. Further, each
grade from 1st through 6th, the Principal would take me class
to class to stand on a box and sing the above. Finally, when I
went to camp the leaders, had me get up and sing these all American
songs. A few days ago, a friend of mine since second grade called,
and we found it a bit amazing how times, kids, adolescents, and social
moirés have changed. Maybe this generation can bring the "Glory of
Patriotism" back. Sorry about the memory lane, but to this
old examiner, I would opine that, I still am "That Yankee Doodle Boy".
THE DISEASE HAS SPREAD
Total Suspected Cases Under Investigation
SARS CASES UNDER INVESTIGATION
These data were reported to the World Health Organization on March
Numbers of suspected cases are expected to fluctuate as additional
information becomes available.
Total Suspected Cases Under Investigation
FDA Asks HHS Inspector General to Investigate
FDA-Sponsored Clinical Trial
The Food and Drug Administration (FDA) today announced that it has
asked the Inspector General of the Department of Health and Human
Services to investigate significant concerns involving a clinical trial
that FDA itself sponsored. The trial, named "Bone 97, A Dietary Strategy
to Maximize Bone Mass in U.S. Naval Academy Mid-Shipmen," was funded by
the Department of the Army. The principal investigator is an FDA
employee, and the co-principal investigator is employed by a private
FDA is requesting this investigation because of apparent lapses that
occurred during the conduct of this study and failure to safeguard
information collected as part of this research which could result in
divulging personal medical information in the study files to persons not
associated with the study. Specifically, FDA's Institutional Review
Board (IRB) has found that the principal investigators could not account
for the study files of at least 92 of the approximately 260 U.S. Naval
Academy midshipmen originally enrolled in the study.
"As the institution of the Federal government that oversees the
integrity of much of the nation's clinical trials, FDA must be held to
the same, if not higher, standards to which we hold others," said Mark
B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "I am
committed to helping assure that all clinical research conducted under
our auspices is of the highest scientific caliber and meets every
requirement designed to protect patients and their personal information.
I am equally committed to ensuring that every effort is made to locate
the missing records or to determine what happened to them."
In a letter to Janet Rehnquist, the Inspector General of the U.S.
Department of Health and Human Services, Dr. McClellan today asked that
the investigation examine three issues:
- FDA's efforts to locate the missing records and whether more can
be done to find them,
- Whether FDA's current and planned corrective actions are
sufficient to ensure that such problems do not occur again, and
- The study's financial management practices and financial
Dr. McClellan's letter also noted that FDA's Office of Internal
Affairs is conducting a thorough investigation of the problems
associated with this study.
The study, which FDA's IRB approved in April 1999, was designed to
evaluate the effect of specially formulated nutritional products on the
bone mass of the subjects. As part of enrollment, midshipmen completed
specific questionnaires and provided additional medical information to
the principal investigators. Although participants' names are not
included in the missing files, FDA is concerned that the personal
identity of study participants can be derived from information in those
files. FDA is unaware of any harm to the study participants because of
these problems. In addition, FDA has no knowledge that any of the
information contained in the study participants' records has been
divulged to any person not associated with the study.
Last November 15, the IRB became aware that at least 92 of the
participants' files could not be located. On January 15, FDA's IRB asked
FDA's bioresearch monitoring inspectors to inspect the study; the
results of that inspection are being released today.
In addition to asking the Inspector General to investigate this
matter, FDA is separately notifying study participants whose files are
affected. FDA has also taken the following actions:
- Instructed FDA's principal investigator to end all work on this
- Directed that no papers resulting from this work be published
To help prevent similar events in the future, FDA has begun or will
soon start the following corrective actions:
- Initiate an inventory audit of all clinical studies sponsored by
or involving principal investigators from all FDA centers to ensure
that all are being conducted in accordance with Departmental and FDA
regulations and policies,
- Require that all FDA centers examine current research monitoring
programs and develop specific clinical research quality assurance
- Make FDA center directors directly accountable for research
conducted by their center and its employees,
- Instruct the IRB representative from FDA's Office of the Chief
Counsel to help assure that clinical research reviewed by the FDA IRB
is being conducted under the appropriate regulatory scheme for the
product being tested,
- Increase funding for FDA's Office of Science to improve oversight
of the agency's clinical research program, including initiating
routine outside audits of FDA clinical research, and
- Establish a mandatory clinical research education and
certification program for all FDA clinical investigators and key
HALE TO THE
PRESIDENT THE INFOJUSTICE 2002 MAN OF THE YEAR
Every year, this examiner is to name
our InfoJustice man of the year. This examiner had been a Reagan
Republican. Someone who supported the Gipper years before he ran.
However, during the Clinton public trials, I had to leave the party
because of all the hatred that was being spewed. However, this
examiner never voted for Clinton because to me it was as clear as if the
hand of God had written the future on the wall. Thus, when he
did what he did, it was simply a fulfillment of my view. In fact I
was always a Bob Dole supporter and still feel our nation missed a good
one that time around. Thus, as an independent (Registered Democrat
because California needs Democrats now albeit my views are state by
state on that issue, and I cannot vote unless I register as a democrat
or republican). Having said that, Mr. Bush was the "your going to
have to prove yourself" president. Suddenly our world was attacked
worse than imaginable, worse than ever before. Out of the ashes,
arose the phoenix of Air force one, bringing each and every one of us,
up from the depths of tears and repose', to a vibrant, independent
Union. No man has ever earned as much respect from myself and the
academy to which I belong, as the honorable, one of a kind,
special, noble, nurturing, healing, fighting and protecting man; our
dear President George W. Bush. When I hear all the rhetoric, it is
recognized as subjective as it should. Objectively we are all
safer today, and in our future, than having the wrong man as president
at the wrong time. This great president, and his brilliant
choices, need our support. Anyone can claim political correctness
absent having to make the tough choices at tough times. But
everyone knows what happed to the show "Politically Correct".
Subjectivity is good for debate and the soul. Objectivity keeps us safe
from real hidden dangers that will get us, when our guard is down, our
back is turned, when were to ill to make healthy contemplations, when we
are asleep, or too feeble to care. From the bottom of my heart,
and that of my mentor the honorable John L. Sullivan Esquire
congratulate our 2002 man of the year, one of the greatest presidents
the lord ever sent us, the honorable and distinguished President George
W. Bush. And we thank you sir.
Turkey has pretended to be as much of
a friend to the US as has been the case in the past. However, the
facts show, they like to bring our hopes up, let us down, and continue
this cycle through today. Why? Bigotry, hatred, and all the
very things were fighting against right now. These delay and deny
tactics are as old as the sands in the deserts of Iraq. Once again
this examiner reminds that the father of our country said "No nation can
be trusted farther than their intent". The intent was to hide the
plan to "covet" Iraqi northern oil, and again the elimination of a
peoples; the Kurds. Thus, it is clear to me, that Turkey, who as a nation, is
our friend after all, would never ever' ask our nation for any money. Their our friend.
Thus, as friends they can borrow from the bank. In fact, I suggest
the favorite today of European borrowers the Wells Fargo-Washington
Mutual types (American's this examiner is being facetious. Stay
away from those two until you find out the truth-story pending.
Need a recommendation-we rate Bank of America number one).
My friends indicate no Wow, Bam, Shock, Owe, Slam attack
because "it's all in the eyebrows". No make-up.
My, My, My. Pundits, pundits, pundits. Give this examiner the glasses and
eyebrows and I could do Groucho-Marks! The Yanks are incredible.
Perhaps, we can get a quick change in Iraqi Government before any
"Over there. Over there. Spread the
word, spread the word, over there. For the yanks are coming, the yanks
are coming, so spread it everywhere" (George M Cohen VIP). When in the course of
human events, when tyranny rains, there is one special agent of God,
which has taken the role of Angels; that is the Yanks. Oil fields
are burning in Iraq yet the pundits claimed Iraqi leadership would never
hurt the people of Iraq. Your wrong again! The tears and the
cries of the Iraqi people have been heard, yet when all is said and
done, once again, the people will cry from loss of God's gift to the
Iraqi People, their oil. Rockets are being hurled at Iraqi peoples in
the north by the Iraqi Leadership! The Pundits claimed (that's why this
examiner advocated to Nix the Blix-why should he get paid for a job
which is a failure? You don't get paid in the real world when your
work is a continuous failure.) that Iraq had no weapons of mass
destruction. Yet now the Iraqi Leadership is hurling a poor mans
gas at his own people in the north, albeit into the sand.
You were wrong again! Our boys may be attacked by illegal weapons
banned by civilizations. Its easy for anyone that does not have to
pick up a weapon and fight for freedom, to be wrong. Get it.
We cannot afford to hide the truth in this world any longer. This
has become a fight for "truth and freedom". Let us hope the Iraqi
Leadership simply steps down. InfoJustice
FRENCH; BUT WE DON'T DESIRE THEIR AID
This examiner was the first to print,
"Forgive the French". Why? They have made fools out of a
"nation", their own. Now because of their mental case president,
the entire non-christojewish world knows they are weak in character,
absent any resolve, and the easiest prey in the known industrial world.
They are now the largest terrorist target visa vi their unconscious
invitation for terrorism. Lets face it. Terrorists take out
the easiest targets. I would also opine, that the French ask the
communists for help if they are attacked, as they cannot ask us.
It was a joke to believe siding with the communists on "this issue" was
nothing more than a hardy laugh for the wise Chinese. There was no
place for gamesmanship when people are suffering. I quote Moses
when he literally said "Let my people go". As an American endowed
with the upbringing that all peoples are equal under God, indivisible,
and free, we the people say, "Let our brothers and sisters of humanity,
the Iraqi People, be free. Let my people go". Thus, we
already forgave the French. That's enough.
Why are so many doomed to re-live history? First a prayer.
Oh Lord, may your kingdom live for ever and ever. Thank
you, oh lord for allowing our law enforcement to prevail by
protecting the rioting peace parades from Terrorism. Also
please forgive those who mean to perform good deeds, but fail to
understand the issues. Finally, forgive all those who have in
any way or form, consciously or unconsciously, support murderers.
Deliver us from evil Of Lord. Amen. The circle of death goes in and out of vogue
periodically as many things do over the years. For example, body
piercing is now in vogue again as well as tattoos. Yet just a few years
ago it was considered passé or gosh. Another example is support for
murderers. Just look around the globe. Now one can understand how so
many folks supported Hitler heinous crimes against humanity. Well, by
seeing who supports Sadam, we can get the rare opportunity to actually
see and listen to people rationalize about supporting that 21st century
Scar-face, mastermind of killings far exceeding the numbers and scope of
horror relative to the St. Valentines Massacres, Sadam the denier. What
do Sadam and Bin Laden have in common? Not good looks. Not good
manners. Not good hygiene. Not their good old family values? Its
MONEY! To end the terror the plug must be pulled on the money. Now
the circle (games). If this examiner told you there was a country so
evil, so anti-womanhood, anti-women's rights, anti-freedom of speech,
anti-freedom of religious practice and so forth, you would "so"
disbelieve the world would allow such evil. If this examiner told you
a tyrant every ten years commits evil aggression so heinous the entire
world stops him, but allows him to keep his nations vast moneys, you
would "so" disbelieve me. If I told you every ten years the world has
to return to the same place on the globe to intervene because of crimes
against humanity, but when we were done we allow a massive source of
income for evil. You would "so" disbelieve this examiner. Don't be
shocked good people, Sodom, by absconding the oil money he has played a
Childs game of "ring around the posy" with anyone he can get to support
him as the rosy posy fool. Its a cause and effect game with a
reproducible and quite predictable outcome. Kill, murder, mass homicide
by gas, germs, radioactivity, have the UN send back inspector "NIX the
Blix". It doesn't matter how well "NIX the Blix" intentions are, nor
how good the United Nations and are Allis intentions are, the
predictable game continues, of enough cooperation to get the world off
their back. Again when enough money earmarked by god for the people, is
absconded, weapons of mass destruction are either rebuild or purchased
with the latest technologies, diseases are sold to black market
terrorists able for a small fee, to get the illegal weapons to the worst
possible below the level of an ant-persons. Further a continuing fund
of monies stolen from the people is offered to any "foreign" family
whose member will commit murder. Murder, Murder, Murder, around the
circle, again and again over the years the vicious cycle continues the
circle of death. Does any one believe the circle of hypocrisy should be
broken. Or, are you a supporter of a deed God said never do if you wish
to come before "I am that I am"... The circle of death, or this game
promoted by the tyrannical leader supports murder. Do you support
murder? Of Course not. Many years ago a group of investigators had a
saying. Perhaps it might help. " Those people who truly study science
share a common reality"(1982 Neff/Jarvis National Council Against Health
Fraud Position Paper; Published 1984). This humble examiner must also
opine that those who are of similar intellectual levels share a common
IT’S A NEW
WORLD AFTER ALL OR, WAS CHICKEN-LITTLE ACCURATE?
Beginning approximately four years
ago, statistically relevant actions on the part of a few European
nations, were detected. These include a secretive boycott of American
made products and services where possible, a complete barricade in the
road to any US progress, i.e. such as the complete denial of the now
past tyrannical and Nazi like oppression of the Bosnian and
Yugoslavian peoples. Human Beings. During the Clinton years, a time
of American renaissance, the evil foes of good, trained, made
partnerships with a few European idiots, and especially wanted to make
a statement against REPUBLICAN PRINCIPALS; knowing these principals
began with Lincoln's equalization of citizens of America. This
equalization, or emancipation of all peoples on earth, is the greatest
fear of evil. So while it appeared that all was good in the world,
and behind everyone's back, while our guard was down, while we slept,
while we celebrated world peace and love, evil prepared. Of course
you don't believe the "Devil" or evil could motivate unscrupulous
egregious, self-aggrandizing people to try to derail progress, or the
hope of the poor, the weak, the innocent, the feeble, the elderly, the
sick, and our worlds children. But for what ever reason, these
anti-Christ, anti-god, anti-freedom delegates of the army of evil,
have used every spoken word to deceive us, cloud the issues, through
us off track, and destroy all that is good.
In a new world such as this, should
each member of the United Nations Begin to pay their own bills!
Should members of NATO pay for their own "mobile defense". Should we
boycott German and French Auto mobiles! After all lets look at
Chrysler. Here we all love Chrysler because of our history. So
German auto manufacturers have taken advantage of our love. Perhaps
this should stop. Lets face it, for a little bit more money, one can
finance a Lincoln and have a far superior vehicle in every way. It
may be years before the great peoples of Germany, replace their
malignant Chancellor so we can become the partners all reasonable and
rational citizens agree on. Need this examiner go on! We the people
of the united states, have paid through our hearts, our pocket books,
and our openness. Its time for us to re-asses our relationships,
perhaps buy more Eastern products, reduce European imports, create new
ideas for partnerships. The truth is the World of Nations, United
Nations, NATO etc are all outgrowths of the inevitable benefits of
peoples living under the American Constitution.
It is time for us to stop listening to the
"Chicken-Little" journalists/politicians/and pundits.
It is normal to fear war (even if this is not a war but emancipation
for the sake of the guarantee that all free peoples anywhere in the
world, can again sleep peacefully, absent the real fear they wont wake
up in the morning due to terrorist bombings, terrorist disease
infestations, or even bizarre gases).
again, be able to send the worlds children to Israel, to walk were
"David, Solomon, Jesus" and all the patriarchs of peace and freedom
for all mankind, eat, slept, spoke and walked. To be able to book a
flight absent the fear of not arriving at our destination. To be able
to send a high school graduation class on a trip across the globe
absent the fear of a probable catastrophe. To be able to send
emissaries to eliminate disease and hunger absent the fear they will
be kidnapped or killed. The reality of the situation
is to eliminate all this fear and paranoia albeit well deserved. Got
it! We will eliminate the terror and fear. Thus this subject, and
horrific fear all of the worlds good and normal people feel,
diminishes and becomes moot. However, the commitment to eliminate
terrorists takes tough actions on the part of tough peoples to make
this world a better place in which to live. In this new and better
world, all people must be free and equal. Children 'must never again
be starved by dictators or terrorists. Why. It makes the playing
field equal and thus no-one even needs to worry about evil coming into
the daily lives of the children, the grandparents and good and
innocent peoples of our time.
FDA Warns Public About
Misrepresentations in Marketing Claims About Drug to Treat Cancer
The Food and Drug Administration (FDA) is warning consumers and
health care practitioners about misrepresentations in a SuperGen, Inc.
press release dated November 15, 2002, in connection with a recently
approved cancer drug, Mitozytrex (mitomycin for injection).
The press release, entitled FDA approves SuperGen's New Drug
Application to Market Mitozytrex (MitoExtra) and disseminated by
SuperGen, Inc., exaggerates the efficacy of Mitozytrex and fails to
include the significant risks associated with the use of the drug.
Indeed, the press release does not even mention acute adverse
reactions that can result from administration of Mitozytrex, which
include fever, anorexia, nausea, and vomiting. The press release also
fails to disclose that Mitozytrex is associated with more serious
adverse events, such as myelosuppression and hemolytic uremic
A boxed warning included in the Mitozytrex package insert reads:
"Bone marrow suppression, notably thrombocytopenia and
leukopenia, which may contribute to overwhelming infections in an
already compromised patient, is the most common and severe of the
toxic effects of mitomycin."
"Hemolytic Uremic Syndrome (HUS), a serious complication of
chemotherapy, consisting primarily of microangiopathic hemolytic
anemia, thrombocytopenia, and irreversible renal failure has been
reported in mitomycin. The syndrome may occur at any time during
systemic therapy with mitomycin as a single agent or in combination
with other cytotoxic drugs, however, most cases occur at cumulative
doses greater than or equal to 60 mg of mitomycin. Blood product
transfusion may exacerbate the symptoms associated with this
The press release issued by SuperGen also makes unsupported claims
that Mitozytrex is a "supergeneric" from the company's Extra
technology platform and that the Extra technology is "designed to
enhance generic drugs," that is, create "improved generics, or
Mitozytrex is bioequivalent to the innovator mitomycin. It differs
from the innovator formulation only in that Mitozytrex contains the
excipient hydroxypropyl-beta-cyclodextrin (HPCD). No data submitted by
the company provided evidence that Mitozytrex is superior to existing
marketed formulations of mitomycin, and there is no evidence that the
addition of HPCD yields any clinical advantage over existing
formulations of mitomycin.
Despite the absence of any evidence of such a benefit, SuperGen's
release states that "SuperGen's Extra technology is designed to
'shield' the drug from the injection site, thus providing the patient
protection from tissue ulceration." This statement is unsupported. The
adverse events associated with Mitozytrex in the bioequivalence study
conducted before approval were consistent with those mentioned in the
product labeling for the innovator mitomycin. In addition, the repeat
dose study provided no evidence that the safety profile of Mitozytrex
is different from the innovator mitomycin. In fact, one patient in
this study did experience tissue necrosis at the injection site.
SuperGen, Inc., claims in its press release that the company's
Extra technology could offer other important
advantages over existing generics, such as "increased solubility,
stability and shelf life." The instructions for
reconstitution of Mitozytrex and the innovator mitomycin, however, are
identical in terms of steps required and time necessary for
dissolution. The only difference is that Mitozytrex calls for a
slightly smaller amount of sterile water - an inconsequential
difference. With regard to stability and shelf life, storage
conditions for unreconstituted Mitozytrex and the innovator mitomycin
Finally, even though FDA rejected the name, "MitoExtra," as the
proprietary name for SuperGen's brand of mitomycin for injection, the
company presents the name "MitoExtra" as the drug's trade name in the
press release. FDA rejected this name because it suggests clinical
benefits that have not been substantiated by data. Notwithstanding
this rejection, the name "MitoExtra" is used "to market Mitozytrex (MitoExtra)."
SuperGen also uses the name "MitoExtra" interchangeably with "Mitozytrex"
as the proprietary name. The FDA-approved name for the drug, as it
appears in the approved product labeling, is "Mitozytrex (mitomycin
FDA believes the characterizations of Mitozytrex (mitomycin for
injection) warrant clarification of the
record. The company's press release concerned an oncology drug, and
FDA has a practice of focusing enforcement resources on misleading
information about products intended for life-threatening conditions.
Moreover, the company's press release is particularly egregious in
that it includes not only misleading statements about the benefits of
the company's drug compared to other similar versions, but also
statements that are demonstrably false. Under the circumstances, FDA
determined it was imperative to correct the record, and to do so in a
manner that would reached as many of the same recipients of the
original false and misleading messages.
The Federal Food, Drug and Cosmetic Act, gives FDA authority to
disseminate information to the public regarding drugs and other
products within FDA's jurisdiction to address imminent health dangers
or gross deception. To protect the public health, FDA is notifying the
public that a particular product has not been found by the agency to
have benefits that its manufacturer claims.
HERE WE ARE AGAIN! OUR DEEPEST CONDOLENCES
Once again, the American spirit,
removed from our lives, but never erased, furthers the evolution of scientific and human betterment,
through the heroic efforts of our United States and Israeli
astronauts. Our hearts and deepest condolences go out to the
families, relatives, friends, and supporters (all
that is good in the world) of the men and women of
Space "Ship" (Shuttle) Columbia 2003.
NOW JUST A COTTON "PICKIN" MOMENT:
What war? What hypocrisy? Where is
the unfairness? Give me a break. We the people have great historical
experiences in such matters. For example, we have learned from our
American Indian heritage, to "know when someone speaks with a forked
tongue, an egregious motive, a self-serving self aggrandizing
propaganda to cover the true motive; money". Do you really doubt that
if the Eiffel Tower were destroyed, along with the identical "monetary
damages" and identical "loss of life" in Paris, that the French would
be asking for our help to go after the terrorists of our world and our
times? And who is making monetary deals with a "Dictator by fear and
fraudulent elections"? If the heart of German Culture, Literature and
Science were destroyed in Berlin, with identical monetary damages and
identical loss of German life, does any rational person doubt that the
Germans would be asking for our help in destroying world terrorism and
the future threat to our modernizing and uniting world? And who is
making monetary deals with a "Dictator by fear and horror"? "Freedom,
everyone's freedom to walk absent fear from a car bomb, to stroll with
your lady and children into a dinner absent the fear of terrorism. To
once again fly "the friendly sky's", again absent fear of "Lunacy".
This is what we are fighting for and much much more. How about
"self-defense". "Truth is Justice in Action", and Freedom will soon
bring Justice and again free "truth" from her bondage. Finally, does
anyone really think its over after people are free from the "Last
Great Dictator"? This editor does not even believe that the "fat
lady" was invited to the party, let alone envision her singing until
all of the Terrorist thugs have been brought before the trials of
USFDA Clears New Lab
Test to Help Rule Out Heart Attack
The Food and Drug Administration (FDA) today cleared for marketing a
new laboratory blood test that will significantly increase the ability
of doctors to rule out a heart attack when a person shows up at an
emergency room with severe chest pains.
The test is the first new blood test for evaluation of heart attacks
since the introduction of the blood test for troponin, a protein present
in the blood after a heart attack, in 1994.
The test, the Albumin Cobalt Binding (ACB) Test, manufactured by
Ischemia Technologies, Inc., of Arvada Colo., works by measuring how
much cobalt is bound to the blood protein albumin. Changes in the
structure of albumin occur in several illnesses, including heart
The ACB test is not a stand-alone heart attack test but must be used
together with an electrocardiogram (ECG) and a blood test for troponin.
A normal ACB test with a normal ECG and normal troponin gives doctors
increased confidence that patients can go home because they did not have
a heart attack.
An estimated 3 million to 5 million Americans come to emergency rooms
each year with symptoms of a heart attack. Only an estimated 22 percent
actually have a heart attack. The rest have a variety of other ailments,
such as severe indigestion, hiatal hernia, pneumonia, gallstones, and
With the ACB test, a cobalt solution is added to a blood sample.
Results are read on a chemistry analyzer. In patients with a normal
albumin, more cobalt is bound to the albumin, leaving less free cobalt
to be detected by the test. In patients with abnormal albumin, less
cobalt is bound to the albumin, leaving more free cobalt to be detected
by the test.
FDA cleared the test based on results of a study conducted by the
manufacturer of more than 200 patients at high risk of heart attack who
had severe chest pain. Sixty three percent of the patients had heart
attacks. The ACB test helped to correctly identify the patients who did not have heart attacks.
The study showed that when the ACB test was used together with an ECG
and a troponin test, physicians were 70 percent accurate in ruling out
heart attack. With an ECG and troponin test alone, physicians were 50
percent accurate in ruling out a heart attack.
HELPING VICTIMS OF THE TERRORIST
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
Check out charities. Contact the Better Business Bureau's
Wise Giving Alliance: 4200 Wilson Blvd, Suite 800, Arlington, VA 22203; (703) 276-0100;
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
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.
NEW YORK -- Airplanes struck the Pentagon and New York City's World Trade Center Tuesday
morning in a massive terrorist attack.
HEINOUS ATTACKS ON AMERICA; TERRORISTS
DECLARE WAR ON FREEDOM, DEMOCRACY, AND USA, September 11, 2001
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
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
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
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
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.
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.
Lightlife Recalls Smart Cutlets Chicken Due to
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
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
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
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
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.,
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
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
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.
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
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
CDCs 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
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 CDCs
Division of TB Elimination. These recommendations should not affect patients receiving
treatment for active TB.
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 panels
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
ATSs American Journal of Respiratory and Critical Care Medicine, and was
reprinted in CDCs Morbidity and Mortality Weekly Report on June 9,
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
Administrations Office of Criminal Investigations launched an investigation of
Courtney and the pharmacy on July 27, 2001, after a medical doctor provided them with
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 CDCs 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 CDCs 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
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.
FDAs 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 FDAs 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
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
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 FDAs 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
FDAs 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 FDAs
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
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
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.
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.
Statement of FBI Director Louis J. Freeh Regarding the
Recent Waco Findings by Special Counsel/Senator John Danforth:
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.
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 Administrations 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.
An international team successfully collaborated to combat international trafficking of
dangerous herbals and illegal bulk drugs. The team of 15 scientists from the Food and Drug
Administration and five foreign countries will receive Vice President Gore's prestigious
Hammer Award for their efforts in this world-wide initiative.
FDA UPDATES WARNINGS FOR
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
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
Talk Paper T98-39).
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.
New Findings on Health, Quality of Life of U.S. Seniors Released
Surveillance for Selected Public Health Indicators Affecting Older Adults
United States (MMWR Vol. 48/No. SS-8/December 17, 1999)
A look at several indicators of the health of older Americans, including illness and
death, health risk behaviors, use of preventive services, medical expenditures, and
injuries and violence, indicates that older Americans could do more to improve their
health and quality of life as they age, according to a report released today by the
Centers for Disease Control and Prevention (CDC).
FIGHTS AGAINST HEALTH FRAUD-CALIFORNIANS CAN NOW SUE HMO QUACKERY
California can now bring
HMO's back to Medical School Science and Ethics after the ground shaking, earth moving,
life saving efforts by the new Golden States "Golden Boy" untarnished Governor
Gray Davis. "These are the types of rational and responsible actions on the
part of Professional elected servants that the Academy has been searching for" notes
Academy IG Sullivan. Two other states have enacted similar though weaker
legislation. The Academy calls out to the Nation to bring this fight to the people
and all states similar to our States and Federal Fights against Big Tobacco.
"Some say that the age of chivalry is past, that the spirit of
romance is dead. The age of chivalry is never past, so long as there is a wrong left
unredressed on earth."
Charles Kingsley, Vol., II, Ch 28:
"A good conscience is a continual Christmas."
Ben Franklin, Poor Richards Almanac. Gray
Davis Wins this months AAJTS Government Action Award for Consumer Protection.
here isn't a corner left in the nation; not a family can be found, that
does not know of a horrific and untimely death, rip off, scam, sham, or victim of HMO or
personal Quackery. Pity. Who Cares? InfoJustice
I am out of state and taking my
neuroboards. I cannot believe some of my luggage was lost including my notes.
Could you please attach in an Email, fax or post at our site, a quick review of the
Entrapment Syndromes as outlined in our Neurodiagnostic Course for Agents etc...,
LETTERS TO THE
How may we help? = A dear
friend is suffering from Hepititis C and his HMO (Independant Health) has refused to
continue paying for the treatments (shots) keeping him alive. How do we fight these
organizations? Who can we go to who can help him?
Dear Zizom, We need your full names, and ID
info if we are to help. We need the whole story. For example you have taken
the physicians within the HMO to pier review within the HMO? etc... Send the whole
situation from the "get go" to now, and perhaps, I cannot promise, one of the
Fellows may champion your case. Include any legal remidies you may have tried within
the confies of Knox-Keen and Erisa. If you have not done the basics as mentioned in
this note, do them, and if you are not satisified, respond.
Like any surgery, liposuction poses risks. Both tumescent liposuction and
UAL have been linked to rare but serious complications and even death. This is
an American Academy For Justice Through Science Warning Alert courtesy
The Verdict by the Judge in the first Criminal Auto Case under the new
Criminal Laws against Drunk Drivers, followed Dr. Scott Neff's recreation or forensic
analysis of the Crime and the fraudulent actives which followed.
Foreign and Domestic
Investors-Merrill Lynch: A Bunch Of Bull-Abandons the small investor leaving them victims
to fraud! Again
A month later, three months after our consumer was
defrauded by Earthlink, Merrill Lynch has not yet recovered our victims money. As a
test, just two days ago, this editor had the victom place a sell order and conversion
(trade within a fund) request with Merrill Lynch and promised to deposit extra funds
($1,300) which she did. She called yesterday and found neighter the sell-order nor
conversion was made. Merrill Lynch is failing consumers DURING A TIME WHEN THE NATION IS UNITED. COMPANIES LIKE MERRILL LYNCH MAKE
FOLKS IN OTHER COUNTRIES MAD TOO. WE CANNOT LET ANY COMPANY EMBARRASS US DURING
THESE TRYING TIMES. However, the same day unknown to Merrill Lynch OR Morgan
Stanley, I advised her to purchas 100 shares of a fine american company paying
a high return from Morgan Stanley; making the test scientific and blinded from the test
institutions. She found that trade was made. Morgan Stanley is statistically
100 percent superior to Merrill Lynch relative to accountability, profitability,
responsibility, and the American Way of Business. The victim consumer then transferred both of her Merrill Lynch
accounts, money market and Roth Ira to Morgan Stanley (the same day as the
findings). The big loser, Merrill Lynch that big bully who loses investors money insidiously absent a clean
recognizable and traceable track. Remember as long as you cover your
margins, even during another two thousand point drop from today (9-20-01), if you had
quality, and strategy, you will recover everything, and average 11% over the next decade.
Lets all support Morgan Stanley, the Yankee Doodle
Dandy's choice. Lets help Morgan Stanley recover from BLACK TUESDAY.
Remember if your Merrill Lynch visa is
billed by a company you never did business with such as Earthlink did with our consumer
victim (a credit card number gained illegally from another Internet provider- Firstworld),
Merrill Lynch will let them keep the money.
It only took 24 hours from our 'expose' on Merrill Lynches failure to act, to locate the perpetrators Firstworld
and Earthlink and for Earthlink to admit our consumer victim was fraudulently
billed. To compound corporate irresponsibility, Earthlink would not remit the money
to the victim directly because she made a fraud report which was proper. Earthlink
will only refund the money to Merrill Lynch which to this day has not even visited the
lost money allowing the predator to keep the money leaving the consumer a victim with
compounding damages! This proves Merrill Lynch failures with internal accounting, and
accountability for your hard earned investments and in some cases retirement nest eggs. InfoJustice
YOM KIPPER AMERICA, FROM THE AMERICAN ACADEMY FOR
JUSTICE THROUGH SCIENCE
Creator, Guard our tongues from evil, and our lips from speaking guile. To those
who slander us, let us give them no heed. May our souls be humble and forgiving unto all.
Open thou our hearts oh lord, onto thy sacred laws so that all thy statutes we may know
and all your truths pursue. Bring to naught designs of those who seek to do us ill.
Speedily defeat their aims, and thwart their purposes, for thy own name, for thy own sake
for thy holiness and law. Let thy loved ones be delivered. Answer us oh lord and save with
your redeeming powers. God, for us, your creation, we, the free American people, the mentors of
freedom, equality, and democracy ask forgiveness for our sins and bless us with your
wisdom to guide us and keep us, through yet another year. God Bless America: InfoJustice
NATIONWIDE RECALL OF SANGCYA ORAL SOLUTION
The Food and Drug Administration today announced the nationwide recall of SangCya oral
solution, a generic version of the anti-rejection drug cyclosporine (Neoral oral
solution), because of clinical evidence that the generic drug's availability is reduced
relative to Neoral oral solution if the drug is administered with apple juice. Patients
taking cyclosporine capsules are not affected by this recall.
SangStat Medical Corporation of Fremont, California, the makers of SangCya, recently
informed the FDA about a study that was completed before the approval of the application.
The data from this clinical study showed that taking SangCya oral solution with apple
juice diminishes its absorption relative to Neoral oral solution. Because the drug's
labeling suggests that it be taken with apple or orange juice, the agency asked the
sponsor to recall the product.
Since it is recognized that some patients may be adversely affected by abruptly
changing from SangCya oral solution to another cyclosporine product, FDA will allow the
product to remain in pharmacies and hospitals. This continued availability should allow a
smooth transition of patients from the SangCya product to another cyclosporine product.
FDA is reviewing all data related to this product and will take any appropriate further
steps needed to assure the safety patients. In the meantime, patients taking cyclosporine
oral solution should consult with their health care provider about their treatment.
Patients taking SangCya oral solution should not change how they are taking their drug
without talking to their health care provider. 7-11-00
ONLINE PRIVACY COMMITTEE MEMBERS NAMED BY FTC
The Federal Trade Commission has named the members of its Advisory Committee on Online
Access and Security and announced that the Advisory Committee's first meeting will be held
February 4. The Committee will provide advice and recommendations to the Commission
regarding the costs and benefits, to both consumers and businesses, of implementing the
fair information practices of access and security online. Providing consumers access to
the information collected from and about them and providing security for that information
are two of four core fair information practice principles described in the Commission's
1998 report, Privacy Online: A Report to Congress. The other two principles are
"notice," and "choice." The Commission also regards
"enforcement" as an essential component of effective self-regulatory programs.
In a follow-up report to Congress last year, the Commission noted that access and security
are important privacy safeguards, but that they may raise a number of implementation
In a Federal Register Notice published yesterday, the FTC announced that the
first meeting of the Advisory Committee, which will be open to the press and public, will
be held Friday, February 4, 2000, at FTC headquarters in Washington, D.C. The meeting will
explore the issues of what constitutes "reasonable access" to data collected
from and about consumers and what exemplifies "adequate security" for that
information. Subsequent Advisory Committee meetings will be held February 25, March 31,
and April 28, at FTC headquarters. Those, too, will be open to the public and press. The
Advisory Committee will present a written report to the Commission describing options for
the implementation of access and security online, and the costs and benefits of each
option, no later than May 15, 2000, and will conclude its work no later than May 31, 2000.
The Commission encourages the public to submit comments for the Advisory Committee's
consideration during the period in which the Committee is performing its work.
"The roster of distinguished members of this Advisory Committee represents a broad
cross-section of e-commerce experts, online businesses, security specialists, and consumer
and privacy advocates" said Robert Pitofsky, Chairman of the FTC. "The
Commission is gratified that the members have agreed to serve on the Advisory Committee as
we address the challenges of assuring consumer privacy online."
In selecting the members of the Advisory Committee, the Commission considered over 180
nominations received from a broad array of interested parties. According to the
Committee's charter, members will consider, among other things, whether the extent of
access provided by Web sites should vary with the sensitivity of the personal information
collected and/or the purpose for which such information is collected; whether the
difficulty and costs of retrieving consumers' data should be considered, whether consumers
should be provided access to enhancements to personal information (e.g., inferences
about their preferences or purchasing habits); appropriate and feasible methods for
verifying the identity of individuals seeking access; whether a reasonable fee may be
assessed for access, and if so, what a reasonable fee would be; and whether limits could
be placed on the frequency of requests for access, and if so, what those limits should be.
The Advisory Committee will also consider how to define appropriate standards for
evaluating the measures taken by Web sites to protect the security of personal
information; what might constitute reasonable steps to ensure the accuracy of this
information; and what measures should be undertaken to protect this information from
unauthorized use or disclosure.
FDA CLEARS NEW FEMALE SEXUAL THERAPY DEVICE
FDA recently cleared for marketing a new medical device to aid in female sexual arousal
The product is the Eros Clitoral Therapy Device, manufactured by UroMetrics, Inc., of
St. Paul, Minn. It is available by prescription only.
The device consists of a small, soft, plastic vacuum cup that is placed over the
clitoris immediately before sex and a palm-sized battery-operated vacuum pump. When
activated, the vacuum pump draws blood into the clitoris, causing engorgement, which helps
aid sexual arousal.
Clearance of the device was based on a review of safety and effectiveness data
submitted by the manufacturer.
Urometrics studied the device in 25 women, each of whom used it at home during six
sexual encounters. Fifteen of the women had FSAD and 10 did not.
The study tested for sensation, ability to achieve orgasm, sexual satisfaction and
lubrication. Results showed that it improved sexual arousal in many of the women with FSAD
and some of the women without FSAD. But some women in each group experienced no change.
Of the 15 women with FSAD who were treated, all 15 experienced more sensation; 7 more
orgasm; 12 more satisfaction; and 11 more lubrication.
Of the 10 women with normal sexual functioning, 4 experienced more sensation; 4 more
orgasm; 2 more satisfaction; and 3 more lubrication.
The device was shown to present a low risk of side effects. The women studied did not
experience any adverse events from use of the product.
FSAD is a persistent or recurrent inability to attain or maintain adequate vaginal
lubrication, expansion of the vagina and swelling of the external genitalia during sexual
FDA APPROVES CAMPTOSAR FOR FIRST LINE THERAPY IN
TREATMENT OF ADVANCED COLORECTAL CANCER
FDA has approved Camptosar (irinotecan) for a new indication for first-line therapy in
combination with 5-fluorouracil and leucovorin (5- FU/LV) to treat metastatic colorectal
cancer. The following may be used to respond to questions.
It is estimated that about 130,000 people in the United States will be diagnosed with
colorectal cancer this year. Primary treatment consists of surgery with or without
adjuvant chemotherapy or radiation. About half the people treated this way will progress
to metastatic disease (cancer that has spread outside of the colon or rectum). In these
patients, 5-fluorouracil plus leucovorin (5FU/LV) in combination has been standard
treatment. Camptosar was shown in two controlled studies to increase survival when it was
added to 5-FU/LV in patients wit metastatic disease.
Approval of the new indication was based on two randomized, controlled, clinical trials
in more than 800 patients comparing Camptosar in combination with 5-FU/LV to 5FU/LV
without Camptosar. In the studies, the combination of Camptosar and 5FU/LV resulted in a
significant delay in the time at which tumors progressed and significant improvement in
survival compared with 5-FU/LV alone.
In one study, the median survival for patients on the regimen including Camptosar was
17.4 months for patients treated with Camptosar and 5-FU/LV administered by slow infusion
compared to 14.1 months for patients treated with slow infusional 5-FU/LV alone. In the
other study the median survival for patients treated with Camptosar plus a rapid infusion
(bolus) of 5-FU/LV was 14.8 months compared to 12.6 months for patients treated with a
different regimen of bolus 5-FU/LV alone.
Side effects of Camptosar include severe diarrhea (which can be prolonged and require
supportive medical treatment), nausea, vomiting and neutropenia (drop in white blood
On March 16, 2000, the FDA's Oncologic Drugs Advisory Committee unanimously recommended
approval of the Camptosar plus 5-FU/LV regimen and agreed that this combination therapy is
an important alternative for patients.
In 1996, Camptosar was granted accelerated approval for treatment of patients with
metastatic carcinoma of the colon or rectum whose disease had recurred or progressed
following 5-FU based therapy.
Accelerated approval is a regulatory mechanism that allows early approval of cancer
drugs based on the effect on the tumor (shrinkage) rather than a clearly beneficial effect
on the patient (better survival) on the condition that survival effects be studied. In
l998, survival studies for Camptosar in refractory disease showed an effect on survival in
patients whose cancer had recurred or progressed on 5FU.
Camptosar(administered by infusion) is manufactured by Pharmacia Corp of Peapak, New
About a month ago, a tall and rather obese female
alleged workers compensation patient presented for a determination of continued
disability/Independent Medical Examination. She barley could walk in the door.
She was bent over at the waist and limping badly. As I walked into the office
observation would indicate I had a low back patient. Another younger women
accompanied her with a small child in toe. I waited for a long period of time and
inquired what happened to my IME. I was informed that the women wanted to come into
the exam room with her daughter and child as witnesses to any Disability exam.
Apparently they were afraid that absent a witness the exam might not come out their way,
and they would have no one to provide a false and misleading testimoney. I had no
problem with any witnesses. The patient presented with a history of a insidious
shoulder pain which has kept her disabled for an extended period of time. I found it
curious that she acted as if she had back pain when in fact she had none. The two
women argued in their native language for several minutes for each thirty seconds of exam
time. I then explained that one of the women would have to leave, because of all the
discussion. Just then a fight broke out between the two women and a touge of war
insueed with each women bent at the waist pulling on the child violently and yelling in
their native languge (they could not speak English) with the child laughing, not
cooperating, and caused such a commotion that two nurses left their patients to join my
observation. One nurse exclaimed after a few minutes of this "Doctor Neff, I
believe you have the smile of a Cheshire cat". I only winked and said
"Just watch, learn and enjoy". Another nurse joined us and we watched with
amazement. Obviously this patient had been scamming another facility (which is why
she was sent to us for review) and no injured patient could have done all the repetitive
stooping, bending, pushing, pulling, lifting, and violently tugging of anything with a
severely injured shoulder or a low back injury for that matter. I documented the
hillarious situation and to make a long story short, this patient was denied disability
and within two weeks had a sudden astonishing recovery, dropped her law suit and returned
to work stating "It was a miracle recovery". InfoJustice
COPYRIGHTS FOR COLLEGE COURSE TEXTBOOK AND BOOK
TAILS FROM THE RAILS; RAILROAD CLAIM STORIES RECEIVED
Our Editor received two copyrights last week for his
Ghostwritten and co-authored text with 34 year head of Claims and Investigations Norm
Udewitz and our College Course textbook. They came together in one envelope from US
Copyright. We will shortly resume the sales of our Academy Anti-Fraud and Forensic Medical
Police Science coures as well as approaching book publishers.
FDA ANNOUNCES THE AVAILABILITY OF NEW EPHEDRINE
AND "STREET DRUG ALTERNATIVE" DOCUMENTS
The Food and Drug Administration (FDA) today announced the public display of three
Federal Register documents involving dietary supplements containing ephedrine alkaloids,
and issued a new guidance to curb the use of alternatives to illicit street drugs. A
Federal Register notice announcing the availability of this new guidance also went on
public display today.
The Federal Register documents involving dietary supplements containing ephedrine
alkaloids address issues arising out of the Agency's proposal of June 4, 1997 (the
ephedrine alkaloids proposal) to establish a finding that a dietary supplement is
adulterated if it contains 8 milligrams or more of ephedrine alkaloids per serving within
a 6-hour period, or a total daily intake of 24 mg or more of the substance. The proposal,
which was developed after FDA received more than 800 adverse events reports (AERs)
associated with ephedrine alkaloids, also called for certain warnings on the label of such
products, including a statement that they are not to be used for more than 7 days.
During the comment period on the ephedrine alkaloids proposal, FDA received
approximately 14,775 comments, mostly from individual users and distributors of dietary
supplements containing ephedrine alkaloids. The proposal was also examined by the
Government Accounting Office (GAO), which last August concluded that FDA was justified in
determining that the number of events related to dietary supplements containing ephedrine
alkaloids warranted the Agencyís attention and consideration of steps to address safety,
but called for additional evidence to support the proposed limits on the dosing level and
duration of use.
In light of GAO's conclusions, comments from others on the ephedrine alkaloids
proposal, and having considered issues related to the proposed dietary ingredient level
and the duration of use limit, FDA has determined that these aspects of its proposed
approach to regulating these products should be reassessed. Accordingly, one of the
Federal Register documents withdraws the provisions of the ephedrine alkaloids proposal
relating to the dietary ingredient level and duration of use limit for these products. A
second Federal Register document released today announces the availability of additional
information concerning 17 ephedrine alkaloids-associated AERs received in 1997, that were
not part of the basis for FDA's June 4, 1997 ephedrine alkaloids proposal because they
were received after the Agency began its analysis for the proposal.
A third Federal Register document announces a new public docket (Docket No. 00N-1200)
that makes available new adverse event reports and related information, the vast majority
of which was received after the publication of FDA's June 1997 ephedrine alkaloids
proposal. It also announces FDA's intent to participate in a public forum to address the
new information. This public meeting will be sponsored by the Public Health Service and
will be designed to share information and seek opinion on the safety of dietary
supplements containing ephedrine alkaloids in the Agency's ongoing effort to assess the
safety of these products. More details will be provided concerning the public meeting by
May 1, 2000, including the name of a contact person.
One hundred forty of the adverse reports (New Case Series) being made available have
received an in-depth clinical review by FDA and by certain outside consultants whose
findings are included in the new public docket. This New Case Series constitutes all AER's
on dietary supplements containing ephedrine alkaloids reported to FDA from June 1, 1997 to
March 31, 1999. For completeness, FDA has also included in the new docket all AER's on
dietary supplements containing ephedrine alkaloids that fall outside these dates, up to
December 31, 1999, with any additional follow-up information received by February 15,
2000. The total number of AER's in this new docket is 273.
FDA welcomes any additional new data from interested parties and encourages such
information to be submitted to the docket within 45 days.
In addition to these three actions, FDA today issued a Federal Register notice
announcing the availability of a guidance for industry entitled
"Street Drug Alternatives" that outlines FDA's response to the proliferation
of various products promoted as alternatives to illicit street drugs. These products,
which are intended to affect psychological states, are generally labeled as containing
botanicals, and some are alleged to include vitamins, minerals, or amino acids.
FDA does not consider street drug alternatives to be dietary supplements because they
are intended for recreational purposes to affect psychological states (e.g., to get high)
and are not intended to supplement the diet. The guidance, which is being implemented
immediately without prior public comment, states that street drug alternatives are
unapproved and misbranded drugs that can be subject to regulatory action, including
seizure and injunction.
All of these Federal Register documents will be made available on the Internet at FDA's
dockets Website: http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm.
Copies of the adverse events of the New Case Series will also be made available on this
Website no later than Friday, April 7.
For more information, see the pre-publication version of these Federal Register
Dietary Supplements Containing Ephedrine Alkaloids; Administrative Docket Update;
Dietary Supplements Containing Ephedrine Alkaloids; Availability
Guidance for Industry on Street Drug Alternatives; Availability
FDA Alerts Health Professionals and Consumers to
Nationwide Recall of Clinipad Antiseptic Sterile Products
The Food and Drug Administration today announced that Clinipad Corp. of Rocky Hill,
Conn., is voluntarily recalling antiseptic sterile skin preparations because of a
potential for bacterial contamination.
The reason for the recall is that the company has confirmed bacterial contamination in
some lots of its sterile products, including one lot with Pseudomonas aeruginosa and
Stenotrophomonas maltophilia (recalled in December 1999), and therefore cannot assure the
sterility of products labeled and sold as sterile.
These organisms can cause skin, wound, or other infections that may be serious or
life-threatening in some cases.
The nationwide recall of the Clinipad sterile-products line includes Povidone Iodine,
Tincture of Iodine, Benzoin Tincture, Acetone Alcohol and Alcohol Antiseptic Products, as
well as Sterile Cliniguard Protective Dressing Labeled as "sterile,"
manufactured since Jan. 1, 1997. The products (swabsticks, prep pads, towelettes,
ointments and pouches, as well as protective dressings) are distributed under the names:
Cliniswab, Clinipad, Clinidine, Cliniguard, EZ Prep, Cooper Instrument Corp., Moore
Medical Corp., and Rauscher. They are sold separately or packaged in various institutional
kits and are widely distributed to blood banks, hospitals, clinics, and retail pharmacies
and are used to control and prevent infection.
In addition to other medical uses, these products are used to prepare the skin prior to
the collection of blood or plasma donations. Although there have been no known instances
of blood contamination traced to the recalled products, clinicians should remain alert to
this possibility. Contamination of blood collections with bacteria from the skin
contributes to rare bacterial infections from transfusions. Serious bacterial infections
occur in approximately 1 out of 50,000 to 1 out of 500,000 transfusions, depending on the
exact blood product administered. Recent data from CDC have shown no increase in bacterial
contamination of transfused blood products over a two-year period.
All lots of the sterile products line involved in the recall have a lot number
beginning with 7, 8, 9, or 0, and are labeled as "sterile" on the unit of use
packaging, or "sterile unless opened or damaged." The lot numbers are also found
on the shipping carton or its label.
Clinipad Corp. is sending recall notices to 3,000 customers and 100 kit manufacturers.
These customers are being advised to examine stocks and remove the recalled products,
including products in kits, and to promptly destroy them. Health professionals and
consumers who have the product with the involved lot numbers should destroy the product.
To assist blood collection centers in developing alternative skin preparations, the
Food and Drug Administration, Center for Biologics Evaluation and Research, has posted
information on its Websites at www.fda.gov/cber/infosheets.htm
and www.fda.gov/cber/recalls.htm. The
sites identify alternative products and procedures that can be used at donor centers.
Health professionals and consumers who have these products can obtain more information
about the recall from FDA's MedWatch Website at www.fda.gov/medwatch/.
Also, consumers with questions may contact the Clinipad Corporation at 860-571-0100.
FDA WARNS ABOUT INFANT FORMULA FRAUDULENTLY
LABELED AS NUTRAMIGEN IN SOUTHERN CALIFORNIA
The Food and Drug Administration is warning parents in Southern California
who feed their babies Mead Johnson's Nutramigen Powder infant formula to be aware of a
potential counterfeit labeling fraud. FDA and the company have become aware of a small
number of cases in the Southern California area in which cans of a milk or soy-based
powder infant formula have been fraudulently labeled as Nutramigen. This has the potential
to cause mild to severe allergic reactions to babies who must use a hypoallergenic infant
Labels of Mead Johnson's Next Step Powdered milk or soy -based toddler
formula were removed from certain cans and the Nutramigen label was substituted. FDA is
warning parents to be aware of this potential fraud because babies who need hypoallergenic
formula may be highly sensitized to protein and may have adverse reactions to the milk
proteins in the Next Step formula. Such reactions could include severe gastrointestinal
problems, skin rashes, fevers, or severe allergic reactions.
Parents are asked to check the letters embossed on the bottom of any cans
of powdered infant formula with a Nutramigen label. The third line of the embossed copy on
the bottom of the can should read NUTRAM. If it does not, the infant formula should not be
fed to the baby, and parents should immediately notify Mead Johnson Nutritionals at
1-800-222-9123 for further instructions.
Mead Johnson Nutritionals notified stores and the media on Wednesday,
October 6, 1999, as soon as the problem of the counterfeit labels was discovered. The
counterfeit cans were purchased at several stores in southern California. Mead Johnson and
the FDA are investigating this potential fraud.
Only cans of powdered infant formula labeled as Nutramigen that do not
have NUTRAM embossed on the bottom of the can are involved in this FDA warning. Cans
embossed with NUTRAM are not affected and are safe to use. Other forms of Nutramigen, both
concentrate and ready-to-use, are not involved in this FDA warning.
Mead Johnson encourages parents who have any questions to call the
Consumer Resource Center at 1-800-222-9123. InfoJustice
PUBLIC MEETINGS ON BIOENGINEERED FOODS
The Food and Drug Administration today announced a new initiative to
engage the public about foods made using bioengineering. This initiative will begin with a
series of public meetings to be held in Chicago, Ill., Washington, D.C., and Oakland,
Calif., this November and December.
At the public meetings, the public will be informed about current FDA
policy for assuring the safety of bioengineered foods. The public will be asked whether
this policy should be modified and also to comment on appropriate means of providing
information to the public about bioengineered products in the food supply.
Under FDA policy developers of bioengineered foods are expected to consult
with the agency before marketing such foods, to ensure that all safety and regulatory
questions have been fully addressed. FDAs policy also requires special labeling for
a bioengineered food in certain circumstances. For example, a bioengineered food would
need to be called by a different or modified name if its composition were significantly
different from its conventionally grown counterpart, or if its nutritive value has been
significantly altered. Special labeling would be required if consumers need to be informed
about a safety issue, such as the possible presence of an allergen that would not normally
be found in the conventionally-grown product.
"FDA makes sure that our food supply is among the safest in the
world," said Health and Human Services Secretary Donna Shalala. "Although people
have enthusiastically accepted new drugs made from biotechnology, some consumers have
concerns about the use of this technology in foods, and we need to ask why those concerns
exist and how we can address them."
Modern bioengineering was first used to produce consumer products in the
early 1980s when FDA approved important new drugs to treat a range of diseases. In
the 1990s foods such as tomatoes, corn, and soybeans produced through bioengineering
began to appear. To date, biotechnology firms have completed consultation with FDA on more
than 40 food products, and a substantial portion of American cropland is planted with
seeds produced using this technology.
"FDAs food regulatory system relies on the best science
available to protect the public," said FDA Commissioner Jane E. Henney, M.D.
"Our scientists are not aware of any reason to question the safety of currently
marketed foods produced through bioengineering. Nevertheless, as a science- based agency,
FDA will consider any valid scientific information that suggests the agency should
reevaluate its process for overseeing the safety of these foods."
The first public meeting will be held on November 18 in Chicago, Ill.,
followed by a second on November 30, in Washington, D.C., and a third on December 13, in
to the Editor:
Now that the
JonBennett Ramsey case is over what do you think? Dear "Eye": It is clear that police investigations were again
inept. This is all too common. Far to often, either they accuse an innocent,
or fail to accuse. We generally only hear of the final success. As a
professional (paid investigator/research auditor) relative to the referenced case,
everyone missed the clues. In a
child murder look to games people play.
If the child was playing a game, then she would be quite. If someone was playing big
girl games and tease, and the friend was neurotic/psychotic....(she was a child). Further, who played with JonBennett? What
were their play habits? An investigation into her play habits and the play
habits of her environment, siblings, parents and friends surely would have paved the path. "Thankyou for
your note". InfoJustice
FDA ANNOUNCES NEW
INTERNET WEBSITE TO PROVIDE CONSUMERS WITH INFORMATION ABOUT BUYING PRESCRIPTION DRUGS AND
MEDICAL PRODUCTS ONLINE
The Food and Drug Administration today announced that it has established a new Internet
Website to provide consumers with useful, easy-to-understand information about buying
prescription drugs and medical products online. This public outreach initiative is part of
FDA's action plan to increase public awareness about the health, economic, and legal risks
of online sales of prescription drugs and medical products.
Increasingly, consumers are using the Internet to purchase medical products. Due to the
ease with which a Website can be created, a site may appear to be a legitimate pharmacy
when in fact both the seller and the product sold are illegitimate. Consumers need to know
the risks, and how they can protect themselves, when buying prescription drugs and medical
products on the Internet.
"The development of the Internet has opened up many new options for consumers to
purchase products more conveniently," said Dr. Jane Henney, Commissioner of Food and
Drugs. "However, the Internet has also provided unscrupulous individuals with immense
new opportunities to promote and sell prescription drugs unlawfully to unsuspecting
Under the Federal Food, Drug, and Cosmetic Act, FDA has the legal authority to regulate
the safety, effectiveness, manufacturing, labeling, and advertising of prescription drugs.
Consumers who suspect that a Website is illegally selling human or animal drugs,
medical devices, biological products, foods, dietary supplements or cosmetics over the Web
can also fill out an electronic complaint form provided at this site, and email it
directly to FDA.
ADMINISTRATION UNVEILS NEW INTIATIVE TO
PROTECT CONSUMERS BUYING PRESCRIPTION DRUG PRODUCTS
OVER THE INTERNET
The White House today will announce that President Clinton is proposing a new initiative
to protect consumers from the illegal sale of pharmaceuticals over the Internet. The
initiative, which will be included in this year's budget, would: establish new Federal
requirements for all Internet pharmacies to ensure that they comply with state and Federal
laws; create new civil penalties for the illegal sale of pharmaceuticals; give Federal
agencies new authority to swiftly gather the information needed to prosecute offenders;
expand Federal enforcement efforts; and launch a new public education campaign about the
potential dangers of buying prescription drugs online. The President's FY 2001 budget will
include $10 million to fund these and other activities.
UNSUSPECTING CONSUMERS MAY FALL PREY TO FLY-BY-NIGHT INTERNET
Use of the Internet to buy medical products is growing rapidly, and many consumers,
including those in rural areas or those
who cannot leave their homes, benefit from the convenience and privacy of this new option.
Unfortunately, the safe use of the Internet by both consumers and businesses is now being
threatened by fraudulent or disreputable Internet pharmacies that sell products illegally.
Internet Pharmacies Can Bypass Safeguards. Traditionally there have been several
safeguards to protect consumers against unsafe use of drugs, including the requirement
that drugs be dispensed only for valid prescriptions and that new prescriptions be issued
only after a physical exam. The Internet makes it easy to bypass these safeguards.
Unethical doctors can illegally prescribe pills online to consumers they have never met in
states where they are not authorized to work. Unscrupulous, unlicensed pharmacies can ship
pills across state lines.
Fly-By-Night Internet Pharmacies Put Online Consumers at Increased Risk. In cyberspace,
consumers have no way of telling whether an online pharmacy is a legitimate operation.
Consumers who buy prescription drugs online from illegitimate websites are at risk for
adverse effects from inappropriately prescribed medications, dangerous drug interactions,
or contaminated drugs. Some online pharmacies do not employ licensed pharmacists, removing
an important safety check. And because patients can easily provide false information to
obtain medications, the potential for serious abuse exists.
Federal Authority to Prosecute is Limited, Penalties are Inadequate. Because of some
limitations on Federal authority, it has been difficult for FDA to take action against
certain offenders, such as online corporations that employ licensed physicians who
prescribe drugs without taking a consumer's medical history or checking for potential drug
interactions. And even where FDA has authority to prosecute, the penalties in most
cases are not adequate and may not be enough to
deter these fly-by-night operations.
CLINTON-GORE ADMINISTRATION TAKES NEW STEPS TO PROTECT CUSTOMERS OF
Today, the Clinton-Gore Administration will unveil a new legislative proposal that
addresses these problems. Specifically, the initiative:
Enables Consumers to Identify Legitimate Pharmacy Sites. This proposal establishes a new
Federal requirement to enable consumers to identify legitimate Internet pharmacy sites.
Sites would have to demonstrate to FDA their
compliance with Federal and state law on pharmaceutical sales before they received
approval to operate. Sites operating without first demonstrating FDA compliance would be
subject to sanctions. This system would allow for rapid, coordinated Federal-state
investigations and prosecutions without disturbing state systems regulating the practice
of medicine and pharmacy.
Strengthens the Current Penalty Structure For Illegal Pharmaceutical Sales Over The
Internet. This proposal creates new civil money penalties of $500,000 per violation for
the sale of prescription drug to an individual without a valid prescription.
Provides New Authority to FDA in Order to Ensure Rapid and Effective Investigation of
On-Line Sites. In order to streamline the investigative process, this proposal also
provides FDA with administrative subpoena authority when investigating potentially illegal
Internet drug sales. Administrative subpoenas would be issued in accordance with standards
established by the Administration's draft privacy regulations.
In addition, the White House will also:
Unveil A New $10 Million Investment to Target and Punish Those Who Engage in Illegal Drug
Sales Over the Internet. The FY 2001 budget will invest $10 million to develop a rapid
response team and upgrade FDA's computer technology to identify, investigate, and
prosecute websites selling such items as: prescription drugs without a valid prescription,
unapproved new drugs, counterfeit drugs, and expired or illegally diverted
pharmaceuticals. This initiative will also help crack down on the marketing of products
based on fraudulent health claims.
Announce Plans for a New Public Education Campaign on the Dangers Of Buying
Pharmaceuticals Online. In the beginning of the new year, FDA will launch a new public
education campaign about safe ways to purchase pharmaceutical products over the Internet.
The campaign will include: placing advertisements on health related websites; taping
public service announcements for distribution to television stations nationwide; and
developing a "safety checklist" to be posted online and distributed through
health care providers and consumer advocacy organizations.
"CFMFE" RECOGNIZED AS QUALIFIED- EXPERT CREDENTIAL
Academy and College Executive Director, Scott Neff, CFMFE testified at
length as the Expert in a Criminal Auto case during its restitution phase. Dr. Neff
was queried on Forensic Science, Forensic Medicine, and to
a large extent, classifications and on the magnitude of alleged Fraud.
This case was subject to new Criminal laws relative to Vehicular Collisions and
Alcoholic Inebriation. There were no official Doctors of Chiropractic, Osteopathy or
Acupuncture (no Complimentary Care Modalities) present on behalf of the State. The
President of our Board Against Crime was the case's investigator. The defendant's counsel
was a retired long-time Policeman and Pillar-of-the-Rock Attorney who anchored the
adventure with excellent cross-examination by the D.A. It was a great day in court
which proved, given a seasoned Judge, Justice can resolve disputes in Criminal cases.
The Academy and College education associated with the "CFMFE" designation
were officially recognized as being sufficient to permit Dr. Neff to render expert
testimony on Forensic Science, Anti-Fraud and Forensic Medicine (a precedent the College
wishes to extend to all of our Fellows).
Other news: "InfoJustice"
has been officially registered with the United States Patent and Trademark Office. This second Academy Patents registration and
Trademark is for: "providing a database,
information website, and on-line professional journal on a Global Computer Network all
regarding Forensics, Fraud Investigation, and Medical and Legal Issues Relating to Auto
Collisions etc. and Intended for Doctors, Attorneys, Insurance Examiners, and Fraud
Investigators". Dr. D. Brief, CFP CFMFE FFAAJTS INFOJUSTICE
WINTER COURSE OUTLINE
RULES OF EVIDENCE (3
Units) Rules of evidence and their application to consumer
protection and proper law enforcement is emphasized. Tests of admissibility applied
by local, state and 1999 Federal courts, including direct and circumstantial evidence,
hearsay, confessions, dying declarations, documentary evidence, competency of witnesses,
"special" medical evidence, degrading and incriminating questions, protection
from entrapment, and privileged and non-privileged communications.
COURTROOM DEMEANOR,TESTIFYING AS AN EXPERT FOR STATE, FEDERAL
AND GRAND JURY CASES, PROFESSIONALIZATION AND LAW ENFORCEMENT ETHICS (3 Units): This course stresses the
fundamentals of how to be most effective as a witness in court. The fundamentals for
expert witnesses are stressed as well. Preparation before court, Appearance, manner,
and attitude in court while waiting to testify and while on the stand is presented in
full. Common pitfalls facing new and veteran examiners and officers, the use of notebooks
or tools as references, and techniques helpful during cross-examination are examined.
Further, Law Enforcement as a Profession or as defined as a profession is explored.
During the course we will define and discuss ethical and unethical acts.
Emphasis on the obligation of consultants and all officers to conduct themselves ethically
and to prevent unethical conduct is presented. Each student receives a copy of the
Law Enforcement Code of Ethics to adhere to.
AUTO COLLISION FORENSICS (6 Units): Methods
to determine forensic evidence in a vehicular accident, such as, but not limited to
definitive Mechanical failures, Driver failures, Occupant irresponsibility, criminal
intent, conspiracy, or simple failed, traffic safety is taught. Types of objective
measurement of vehicle damage, skid marks, pavement gouges, signals, quality
interrogations, as well as a review of documenting all crime- scene accouterments,
witnesses, (i.e., everything which could constitute forensic, measurable, physical
evidence and interrogatory evidence) is presented in full, with sample case studies and
mock trials to resolve disputes.
Forensic Medical Examination of
Traffic Collisions, Myth, Waste, Fraud, Abuse, Criminal Intent or Fact (6 Units) Course References Follow:
SECRETARY SHALALA URGES OLDER AMERICANS TO GET 1999 FLU SHOT
HHS Secretary Donna E. Shalala today urged older Americans to start
getting their 1999 flu shots to help protect against potentially life-threatening
Each winter, a flu epidemic sweeps the country and is responsible for
killing on average 20,000 Americans, most of them over age 65. While 65 percent of seniors
receive the flu shot, millions more remain unprotected, even though the vaccinations are
free under Medicare.
The flu poses a serious potential hazard to older Americans, but it's a
hazard we can all protect against," Secretary Shalala said. "Every senior
citizen needs to know that flu and pneumonia shots are convenient, free under Medicare,
and sometimes lifesaving. Tragically, many serious cases of flu and even deaths could be
prevented through immunizations. Flu shots work, but not when the vaccine sits on the
Pneumococcal disease, a common cause of pneumonia, kills more than 10,000
Americans each year, many of them age 65 and older. "Together, influenza and
pneumococcal disease are the most common causes of death in Americans from diseases that
can be prevented by vaccines," Secretary Shalala said.
Flu shots must be given every year because the influenza virus changes
from year to year and because antibody protection from the vaccine wanes over time. Flu
vaccine is specifically recommended for people who are at high risk for developing serious
complications as a result of influenza infection. These groups include all people aged 65
years or older; all people in nursing homes; and people of any age with chronic diseases
of the heart, lung, or kidneys, diabetes, immunosuppression or severe forms of anemia.
Adults with diabetes are three times more likely to die from influenza.
This is the second year of a Centers for Disease Control and Prevention (CDC) campaign
encouraging people with diabetes to get an annual flu shot. The campaign consists of
public service announcements in English and Spanish, information for health-care providers
and health systems interventions to ensure that patients with diabetes are reminded to get
a flu shot.
The CDC recommends that the best time to conduct annual vaccination
campaigns is between October and mid-November. However, after mid-November, people may
still benefit from influenza vaccination, even after flu cases begin to occur in the
community. Pneumococcal shots are recommended for most of the same people who should
receive flu shots. Pneumococcal shots are usually given once and do not need to be
CDC reports today that influenza A(H3N2) viruses continued to predominate
worldwide during May through September, 1999. In the United States, summer influenza
activity included an outbreak of influenza A(H3N2) virus infections among tourists to
Alaska and the Yukon Territory. The surveillance data are contained in CDC's Morbidity
and Mortality Weekly Report (MMWR) this week.
Also in the MMWR is a report on reasons given by Medicare
beneficiaries for not receiving influenza or pneumococcal vaccinations. Not knowing
vaccination was needed was the most commonly reported reason for not receiving influenza
(19 percent) or pneumococcal (57 percent) vaccination. Cost was a factor for less than 2
"We must be vigilant during this time of year to take every
opportunity to vaccinate our older adults and people with chronic illnesses to protect
them from influenza and pneumococcal disease. These vaccines are critical to the health of
our older Americans," said CDC Director Dr. Jeffrey Koplan.
Overall, 45 states have already surpassed the Year 2000 goal of having 60
percent of seniors immunized against the flu. But while 68 percent of white Americans over
age 65 usually receive flu shots, statistics from 1997 show that only 50 percent of
African Americans and 58 percent of Hispanics were vaccinated.
Medicare coverage for flu shots for the elderly began in 1993, as the
Clinton Administration launched an effort to increase immunization rates among older
adults. The shots are free for those enrolled in Medicare Part B from physicians who
accept Medicare payment as full payment. Medicare also covers vaccinations against
pneumonia. A beneficiary who has not previously received the pneumococcal vaccine can
obtain it at the same time as the flu shot.
"Millions have benefitted from the flu and pneumonia shots that
Medicare provides, but millions more still need them," said Michael Hash, deputy
administrator of the Health Care Financing Administration (HCFA), the agency that runs
Medicare. "Too often, people don't get the immunizations that could save their lives.
People age 65 and over are more likely to get flu or pneumonia and to experience serious
complications. That's why we're reaching out to remind beneficiaries that it's important
to get their shots and that they are covered by Medicare."
HCFA has undertaken an aggressive outreach program to remind seniors of
Medicare's free flu vaccination benefit. The agency is mailing nearly 8 million postcards
in four languages to remind Medicare beneficiaries to get immunized and is distributing
posters to senior centers, clinics and other places where Medicare beneficiaries are
likely to see them. In addition, HCFA plans to air two 30-second television public service
announcements in six target cities during flu season this year, and television and radio
announcements have been produced in English and Spanish for local outlets to use across
As part of its efforts, HCFA also is reaching out to African American
communities to raise awareness about the need for flu shots. Medicare's quality-review
organizations have begun a three-year project to measurably reduce death rates among
Medicare beneficiaries. These organizations also have joined with historically black
colleges and universities to develop strategies for boosting immunization rates among
African American beneficiaries. HCFA also is distributing a half-hour video documentary on
the 1918 flu epidemic that took a heavy toll on Baltimore's African American population.
For more information about receiving a flu shot covered by Medicare, call
toll-free 1-800-638-6833 or visit Medicare's Web site at http://www.medicare.gov.
FDA ISSUES NATIONWIDE PUBLIC HEALTH ADVISORY ABOUT CONTAMINATED PET CHEWS
The Food and Drug Administration today issued a nationwide public health
warning alerting consumers about a number of recent cases in Canada of human illnesses
apparently related to contact with dog chew products made from pork or beef-derived
materials (e.g., pigs ears, beef jerky treats, smoked hooves, pigs skins, etc.).
These products may pose a risk of bacterial infection such as Salmonella
infantis which can cause flu-like symptoms (e.g., nausea, vomiting, abdominal pain and
diarrhea) in normally healthy people, but may cause far more serious - even
life-threatening injury in immune-compromised patients.
FDA is urging pet owners who have these products to handle them carefully.
Anyone who comes in contact with these treats should wash their hands with hot water and
soap. Elderly people, young children, and people with weakened immune systems are
particularly at risk from exposure and should avoid any contact with these chews.
Initial reports of illnesses came from Canada and involved Canadian
products, but subsequent examination of similar products produced in the U.S. indicate
that all pet chew products of this type may pose a risk.
FDA is working with other U.S. and Canadian health authorities on this
issue and has issued an import bulletin on products that have been directly linked to
illnesses. The import bulletin focuses FDAs attention on imported pig ears at ports
of entry for possible sampling and analysis.
FDA is also examining the manufacturing processes for products containing
pig ears to determine how this product, and similar products, can be made safely. InfoJustice
ALPERT, Ph.D., M.D., NAMED CFSAN DIRECTOR OF FOOD SAFETY
FDAs Center for Food Safety and Applied Nutrition (CFSAN) today
announced the appointment of Susan Alpert, Ph.D., M.D., as the Centers Director for
Food Safety. In this capacity she will report directly to Joseph A. Levitt, director of
As Director of Food Safety, Dr. Alpert will provide leadership for the
Presidents Food Safety Initiative. As the Centers senior physician, she will
also provide oversight for all medical and clinical aspects of food safety across the
broad range of FDAs food safety responsibilities.
"As a pediatrician with a strong background in both infectious
diseases and in microbiology, Dr. Alpert brings unique skills and experience to this
critical job," said Levitt. "This means FDA will be bringing a clinical
perspective to all facets of its public health mission of ensuring that Americans continue
to enjoy a safe food supply," he added.
FDA is responsible for overseeing the safety of all food sold in the U.S.,
except for meat, poultry and eggs - some 78 percent of the food Americans consume.
Dr. Alpert currently serves as Director of the Office of Device Evaluation
in FDAs Center for Devices and Radiological Health, where she oversees FDAs
review of all medical devices. She has held that post since 1993, when she left her
previous position as supervisory medical officer in FDAs Center for Drug Evaluation
and Research. She joined the FDA in 1987.
Dr. Alpert has received numerous honors and awards, most recently the
Presidential Meritorious Executive Rank Award in 1998.
A graduate of Barnard College, Columbia University, Dr. Alpert received
her Ph.D. in medical microbiology from the New York University School of Medicine. She
earned her M.D. at the University of Miami School of Medicine and trained in pediatrics at
Montefiore Hospital of the Albert Einstein College of Medicine. She completed her training
in pediatric infectious disease at Childrens Hospital in Washington, D.C., as part
of a joint program with FDA.
Dr. Alpert will assume her new duties October 25. She replaces Morris
Potter, D.V.M., who will leave FDA to become Executive Director of the International Life
Sciences Institute (ILSI) and ILSI North America. InfoJustice/FDA
LAST YEAR THE ACADEMY EXPOSED SLAMMING AND CRAMMING. THE
The Commission is aware that some
resellers appear to intentionally mislead customers by misrepresenting their relations
with better-known facilities-based carriers. The Commission is actively addressing these
and other practices associated with slamming on several fronts: by improving the
verification rules, by imposing fines, by creating other financial disincentives for
unscrupulous carriers, and by increasing consumer awareness. First, the Commission is
actively strengthening its existing slamming rules. We have proposed further rules in
response to the enactment of Section 258 of the Telecommunications Act of 1996. Commission
staff is currently reviewing parties' comments on the proposed rules and I expect the
Commission to adopt stricter anti-slamming rules during the second calendar quarter of
this year. The Commission's current anti-slamming rules require carriers to verify changes
to consumers'interexchange carriers. Among other things, the Commission is considering
expanding the scope of its rules to apply to all changes to a consumer's local and long
distance service. The Commission has also proposed to revise its anti-slamming rules by
restricting the methods by which carriers verify changes to telecommunications service
because some methods appear to be ineffective against slamming, especially when combined
with misleading telemarketing scripts. Furthermore, the Commission is considering adding a
provision to its anti-slamming rules that would absolve consumers of liability for charges
incurred after being slammed, in order to deprive slamming carriers of revenue. Second,
the Commission continues to investigate consumer slamming complaints and to impose
substantial fines where appropriate. The Commission's investigations of consumer
complaints has led to a series of enforcement actions against the responsible carriers.
Today the Commission revoked the operating authority of a group of long distance companies
owned and/or operated by Daniel Fletcher for engaging in slamming and numerous other
violations of the Communications Act. The Commission also assessed forfeitures against the
Fletcher Companies totalling $5,681,500. Prior to today's action, the Commission imposed
final fines totaling $280,000 against four companies engaged in slamming, including one of
the Fletcher companies; entered into consent decrees with ten companies with combined
payments of 1,260,000; and has proposed $280,000 in fines against two carriers. The
Commission will continue to take prompt action to enforce its anti-slamming rules so that
"slammers" are punished. Third, the Commission also has launched an aggressive
consumer education campaign committed to keeping the public apprised of their rights and
of FCC decisions. Information on slamming and other telephone-related issues is being made
available to the public expeditiously and inexpensively. Consumers may call the
Commission's National Call Center toll free at 1-888-CALL-FCC and the Call Center's staff
will respond to questions and concerns. Consumers can also obtain copies of a consumer
alert regarding slamming by calling: (1) the toll-free 1-888-CALL-FCC number; (2) the
Enforcement Division's Consumer Hotline at 202-632-7553; or (3) "Fax on Demand"
at 202-418-2830 and requesting document number 6716. The consumer alert can also be
accessed via Internet at http://www.fcc.gov/ccb.html (consumers should click on the fact
sheets option). As explained in the alert, consumers can file a slamming complaint simply
by sending a letter, in their own words, to the Commission. All such complaints are served
upon the responsible carriers, which are required by Commission rules to respond. I
appreciate your interest in this important issue. InfoJustice Beat the Press ©
- FIRST TOPICAL
TREATMENT FOR NAIL FUNGUS APPROVED
The Food and Drug Administration today announced the approval of Penlac Nail Lacquer
(ciclopirox) Topical Solution 8%,
the first topical treatment approved for the treatment of fingernail and toenail fungus in
the United States. Ciclopirox is a
synthetic broad-spectrum antifungal agent that inhibits the growth of dermatophytes, a
type of fungus that grows on the skin,
hair, and nails.
Simple daily activities such as walking can cause discomfort and pain for individuals with
nail fungus disease. Nails may
become opaque, white, thickened, and brittle, and may be easily broken. Infected nails can
provide a reservoir of
dermatophytes that can cause repeated infections.
Penlac Nail Lacquer is applied once a day with an applicator brush to all affected nails
and immediately adjacent skin. Daily
applications should be made over the previous coat and removed every seven days. Up to 48
weeks of daily applications,
weekly trimming by the patient, and monthly professional removal of the unattached,
infected nail, is needed.
Penlac Nail Lacquer was developed to provide topical therapy without systemic side
effects. In controlled clinical trials it
was found to be safe and effective in treating nail fungus, with some patients
experiencing resolution of the infection.
Ciclopirox has a long history of clinical use for other applications, and has been
marketed worldwide for 25 years in cream,
lotion and gel formulations, and in the U.S. since 1982.
Ciclopirox is manufactured by Aventis Pharma Deutschland GmbH of Frankfurt, Germany, and
will be marketed under the
tradename Penlac Nail Lacquer (ciclopirox) Topical Solution 8%. InfoJustice News
- LETTERS TO THE
EDITOR Dr. Neff, could you post a solid
elbow exam for court tomorrow...a review? Dr. William, below is the standard of
thought during the requested audit. Good Luck.
College of Justice ORTHOPRACTIC EXAMINATION OF THE ELBOW
The Elbow Carrying Angle. There would be a slight valgus deviation between the
humerus and the ulna when the forearm is supinated and the elbow is extended.
If the carrying angle is more than 15°
=cubitus valgus. &127;
If the carrying angle is less than 5-10° =cubitus
Swelling &127; resulting from olecranon bursitis (students elbow)
sharply demarcated as a "goose egg" over olecranon process.
If suspect fracture &127; or ipiphyseal injury the distal humerus and
cubitus varus results, a gun stock deformity &127;.
Pain Discovered over esimate normals.
/ Flexion of the elbow 140-150° -end feel is tissue
approximation. In a thin / individual the end feel may be bone to bone as a result of the
coronoid process / hitting against the coronid fossa.
/ Extension of the elbow 0-10° , extension is 0 but
hyperextension to 10° my be / noted especially in woman. This
is normal if on both sides and no hx of / trauma. The end feel is bone to bone. This is
the first motion lost in injury and / first to recover.
/ Supination of the forearm 90° end feel is tissue
/ Pronation of the forearm 80-90° end feel is tissue
Note: Both supinationof pronation ROM only 75° with the
remaining 15° result of wrist action.
Flexion-end feel is tissue approximation.
Extension-end feel is bone to bone.
Supination end feel tissue stretch
Pronation end feel tissue stretch.
A capsular pattern &127; for the elbow complex as a whole is more limitation of
flexion than extension.
RESISTED ISOMETRIC MOVEMENTS-SITTING:
Elbow Flexion Pain &127; Restriction &127;
Elbow Extension Pain &127; Restriction &127;
Supination Pain &127; Restriction &127;
Pronation Pain &127; Restriction &127;
Wrist Flexion Pain &127; Restriction &127;
Wrist Extension Pain &127; Restriction &127;
Only tests that will confirm the diagnosis should be performed.
Ligamentous Instability test. Patient's arm is stabilized with the examiners hand on
the elbow and the wrist. The elbow is slightly flexed 30-30° .
An adduction or varus forces is applied to test the lateral collateral ligament. Then the
examiner places a abduction or vlagus force to test the medial collateral ligament. Some
advocate varus done with arm in full medial rotation and valgus done in full lateral
rotation. Positive &127; Negative &127;
Tennis Elbow or Cozens' Test for Lateral epicondylitis. Extend and pronate arm and
extend the wrist. Stabilize the elbow and attempt to flex the wrist the patient resists. Positive
&127; Negative &127;
Golfer's Elbow Medial epicondylitis. Patient's forearm is supinated and the elbow
and wrist are extended by the examiner. + &127; -&127;
Tinel's Sign The ulnar nerve in the groove (between the olecranon process and
medical epicondyle is tapped. Tingling sensation in the ulnar distribution of the forearm
and hand=postive test for nerve regeneration at the most distal end of tingling=limit of
regeneration. Present &127; Absent &127;
Pronator Teres Syndrome Elbow flexed to 90 degrees. Examiner resists pronation as
the elbow is extended. Tingling or paresthesia in median nerve distribution. Positive
&127; Negative &127;
Pinch Grip Test Thumb and first finger should touch tip to tip. If pads of finger
and thumb touch then pathology to anterior interosseous nerve, branch of median nerve.
Thus entrapment os anterior interosseous nerve as it passes between the two heads of
the pronator teres muscle. Positive &127; Negative &127;
REFLEXES AND CUTANEOUS DISTRIBUTION-SITTING:
Bicep C5/C6 Right Left
Brachioradialis C5/C6 Right Left
Triceps C7C8 Right Left
Median Nerve A. pinched at elbow under ligament of Struthers (found in 1% of
population) medial elbow) known as Humerus supracondylar process syndrome &127;
Pronator Syndrome; B. entrapment of the median nerve by the pronator teres=weakness
of the flexor carpi radialis, palmaris with sensory disturbance to the median nerve.
Ant. Interosseous Syndrome C. Pinching of anterior interosseous (branch median n.)
by two heads of pronator teres muscle leads to funcitonal impairment of flexor pollicis
longus, flexor ditorum profundus, and pronator quadratus. Known as Anterior
interosseous nerve syndrome- characterized by pinch test. If pinched just before
anterior interosseous nerve then median nerve pinch known as pronator syndrome. &127;
Ulnar Nerve compressed in the cubital tunnel yeilds tardy ulnar palsy. The greater the
elbow is flexed the more the nerve is stretched. (medial side). Symptoms. &127;
RADIAL NERVE. The posterior interosseous nerve, in front of the lateral
epicondyle of the humerus can be compressed as it passes between the two supinator heads
in the arcade or canal of Frohse, a fibrous arch in the supinator muscle. Compression is
due to repetitive supination. Symptoms are functional involvement of the forearm extensor
muscles with no sensory deficit. This condition, Radial tunnel syndrome may mimic
tennis elbow. &127;
TX: rest, splinting in the neutral position when acute, and referral for injection if
necessary. May need surgical resection. If surgical resection is ruled out,
interferential, phonphoresis and cross friction massage.
JOINT PLAY MOVMENTS-SITTING
Pain &127; Restriction &127; Radial deviation of ulna and radius on humerus
(similar to stress test)
Pain &127; Restriction &127; Ulnar deviation of ulna and radius on humerus
(similar to stress test)
Pain &127; Restriction &127; Distraction of olecranon process on humerus in 90° of flexion
Pain &127; Restriction &127; Anteroposterior glide of radius on humerus
PALPATION-SITTING: (Positive findings noted to the left of area of
Soft: Medial Ulnar nerve
Medial collateral ligament
Supracondylar lymph nodes
Flexor muscles Lateral to Medial
Flexor Carpi Radialis
Flexor Carpi Ulnaris
Posterior Olecranon bursa
Lateral Wrist extensors Mobile wad of three
Extensor Carpi Radialis longus
Extensor Carpi Radialis Brevis
Anterior Cubital Fossa Borders
line between epicondyles
Contents (lateral to medial)
BIOMECHANICAL CORRELATION NORMS FOLLOW:
ACTION MUSCLE NERVE ROOT
Flexion Brachialis Musculocutaneous C5-C6 (7)
Biceps brachii Musculocutaneous C5-C6
Brachioradialis Radial C5-C6 (7)
Pronator teres Median C6-C7
Flexor carpi ulnaris Ulnar C7-C8
Extension Triceps Radial C6-C8
Anconeus Radial C7-C8 (T1)
Supination Supinator Post. interosseous radial C5-C6
Biceps Brachii Musculocutaneous C5-C6
Pronation Pronator quadratus Ant. interosseous median C8, T1
Pronator teres Median C6-C7
Flexor carpi radialis Median C6-C7
Flexion of wrist Flexor carpi radialis Median C6-C7
Flexor carpi ulnaris Ulnar C7-C8
Extension of wrist Ext. carpi radialis longus Radial C6-C7
Ext carpi radialis brevis Post. interosseous (radial) C7-C8
Ext carpi ulnaris Post interosseious (radial) C7-C8
Bill, your ready. Go Tiger. InfoJustice
- EDITORS COLUMN
last six years of being your Editor and Publisher has taught me much of being alone, and
responsible for communications, entertainment, scientific responsibility, clinical
reality, fiscal feasibility, publishing, editing, providing html, java, translating
languages, and membership motivation. Truly, my love for the truth, was fostered by your
voting me to this position. I hope that the time that we have spent together has fostered
your forensic scientific curiosities and perhaps you learned something as well. I know
that I have.
Having matriculated through the founding class and development of this Academy, I
surely have learned much. From the lecturers, to developers, through the many trips to
John L's house for that old time FBI style of thinking and training, along with the many
courses I attended by other members or had to teach myself (FDA Consumer style), as well
as keeping our members on an International Basis informed, the Yankee Doodle Way; I worked
I would like to thank the entire body of the founding members of the Academy for voting
me your confidence. I would first like to thank Dr. John L Sullivan, Greg Sullivan, and
Dr. John Jr. Absent John L's dedication to the executive actions by the Academy -
none of what was accomplished; my publications and choice of topics, his focused forensic
training courses, my medical biomechanical articles, the four various Presidents Messages
and motivations (Web Page-)- will never truly be understood. I must thank Dr. Jim Drury
for his Intermediate Vice President Term which filled a void which could of at any moment
needed his actions. We would like to thank Norman Udewitz for his hundreds of real
life investigations from the Rail Industry and all of our co-lecturers who continue
stimulate the learning process.
My hope is that from this declaration, the many members which
brought about the Growth of the Academy and our Web Pages, as well as next years copyright
of our entire course program, demonstrate that our "team work" will not be
forgotten history; rather the building blocks and strong foundation to which the
"Academy" will grow and gather to itself so much vibrancy and vitality that it
will live on to bring multidisciplinary medicine into the 21st Century along a
strong and sturdy pathway to freedom to care for the sick, suffering, poor, weak,
disabled, elderly, and those of a fixed income only to receive the "finest care in
mankinds experiential existence". I thank you for allowing me to be a part of
this legacy. Merry Christmas and a Happy Healthy New Year from the Academy.
CONSUMERS GIVEN CREDIT FOR RECOGNIZING FDA
According to a survey of 30 federal agencies being released today, consumers asked
about the FDA's performance believe that food labeling is useful, clear and
understandable, that consumer alerts of food safety issues are useful, and that customers
trust FDA to ensure food safety in the future.
This survey, commissioned by the Vice President's National Partnership for Reinventing
Government, was developed to measure how well these government agencies serve the American
people and to set a baseline for measuring customer satisfaction with the Federal
The FDA received an index score of 66 in the survey, conducted by the University of
Michigan using procedures established for the American Customer Satisfaction Index, which
measures satisfaction with many segments of American industry.
Customers of the agencies were interviewed and asked about their expectations, as well
as the quality of the services or products they receive from the agency. For the FDA
survey, the principal grocery shopper and food preparer for all food products except meat
and poultry were interviewed. The survey asked about the usefulness and clarity of food
labeling; customer awareness and the effectiveness of inspecting, testing and labeling
efforts; and the usefulness of consumer alerts, meats and poultry are regulated by USDA.
In addition to consumers' positive views of the food label and FDA's ability to ensure
that food is safe, the survey also indicated that the FDA should increase public awareness
of actions to ensure food safety and focus on awareness efforts during consumer alerts.
Fifty-four percent of the customers surveyed are more satisfied with these efforts now
than they were two years ago.
"I am proud of FDA's strong commitment to ensuring that food is safe and properly
labeled," said Jane E. Henney, M.D., Commissioner of Food and Drugs. "Millions
of Americans rely on the food label to make healthy food choices. They also depend on FDA
for accurate and timely information about potential health hazards associated with food.
We will continue to build on our record as we strive to serve the public even better in
The FDA has undertaken a wide range of outreach activities designed to foster extensive
and continuing interaction between the agency and the many customers it serves. Through
FDA's nationwide network of field offices, its Website and information line
(1-888-INFO-FDA), there are more ways than ever before for stakeholders to interact with
FDA. The agency has also recently opened an Outreach and Information Center in the Center
for Food Safety & Applied Nutrition (1-888-SAFEFOOD) that responds to telephone and
electronic inquiries and provides current, reliable food safety alerts and information to
consumers and industry. The FDA continues to be active in the "Fight BAC"
campaign, a collaborative program involving government, industry, academia, and consumer
groups which focuses on educating consumers about safe food handling. InfoJustice
INFOJUSTICE AGREES, OPEN
TRUTH WILL CLEAR THE PROBLEM
For over six years, our Academy Fellows, have heroically brought to the
forefront of the press, many of the medical failings killing Americans unnecessarily and
often at great monetary gain. Today, the AMA joins this great medical war, to win
back traditional medicine. With the safeguards brought back into place.
"Medical mistakes kill more Americans each year then auto
accidents"! In 1999 95,000 Americans died unnecessarily due to medical
mistakes". Let the Forensic Medical Experts, especially those that had served
with the Medical units within USFDA to once again bring reliability through safety,
reproducibility of all services, passage of double blind studies for new medical
innovations, and strict rules against those who would not prescribe medication for the
suffering. Lets face some real facts. Who in their right mind wants to be
sober and focus on their pain! Do these hypocrites want all of us to get in tough
with our inner pain? Countless times we have reported on atrocities relative to HIV,
Hepatitis C, Cancer, Liposuction Death & Denial and so forth patients whose HMO or
personal medical physicians failed to have any empathy, violate the Hippocratic oath
because they are so brilliant above all (pontifical, hubris, self-aggrandizing, egregious,
megalomaniac, greedy...). We must all care for our neighbor when medical needs are
the subject. We cannot afford to lose our greatest national resource, our civilian
health, welfare, and ability to build American. Please join the six year InfoJustice
Medical movement by supporting the American Medical Association. It takes great
people to secure the welfare for great nations. InfoJustice
LOW BACK PAIN AND THE
60-90% of humanity will experience Low back pain in their lifetimes.
The annual incidence of US low back pain suffers is 8-14% with costs of at least $25
billion resulting in 7.4 million Americans per year becoming disabled. The injury
rate for lifting activities in light industry is 3 to 5 per 1000 and 200 per 1000 in heavy
industry. InfoJustice ©
CDC ON INTEGRATING
GENETICS INTO PUBLIC HEALTH POLICY, RESEARCH AND PRACTICE
The Second National Conference on Genetics and Disease Prevention
Public health professionals; program directors; local, state and federal policymakers;
federal agency representatives; researchers and practitioners will be among participants
attending The Second National Conference on Genetics and Disease Prevention. HHS's,
Centers for Disease Control and Prevention (CDC), Health Resources and Services
Administration and the National Institutes of Health, in partnership with the Maryland
Department of Health and Mental Hygiene and Johns Hopkins University School of Hygiene and
Public Health will sponsor this conference, organized by the Association of State and
Territorial Health Officials.
Participants will discuss discoveries in human genetics as well as ideas about
integrating them into public health policy, research and practice. Some issues to be
addressed include: the continuity of genetic research--from discovery to health service
provision; advances in genetic technologies; quality assurance in genetic testing;
community perspectives on genetics and health; policy implications of using genetic
information to improve health and prevent disease; and building the capacity of public
service delivery systems to assure the safe and effective use of genetic information.
||Monday, Dec. 6, 12:00 p.m. (Luncheon Keynote)
Carol Greene, M.D., Congressional Fellow, Staff to Senator Edward Kennedy
Monday, Dec. 6, 2:30 p.m.
Peter C. van Dyck, M.D., M.P.H., HRSA Associate Administrator,
Maternal and Child Health Bureau
Wednesday, Dec. 8, 11:30 a.m. (Closing Plenary)
Claude Earl Fox, M.D., M.P.H., Administrator, HRSA
||Monday, Dec. 6, 8:30 a.m. - 5:45 p.m.
Tuesday, Dec. 7, 8:00 a.m. - 5:30 p.m.
Wednesday, Dec. 8, 7:30 a.m. - 12:30 p.m.
||Hyatt Regency Baltimore on the Inner Harbor, 300 Light Street, (410) 528-1234
||Gail Hayes, CDC Media Relations Division (404) 639-3286
Mona Finch, HRSA Communications (301) 443-3376
Cathy Yarbrough, National Human Genome Research Institute, NIH
Jacalyn Bryan, Deputy Director Policy and Programs, ASTHO (202) 371-9090
CDC CAUTIONS US MEDICAL
FORCE TO REDUCE WORKPLACE NEEDLESTICK INJURIES
NIOSH recommendations to protect healthcare workers
CDC, NIOSH today recommended that employers adopt strategic measures to protect the
Nation's 8 million health care workers from job-related injuries caused by needles in
syringes, intravenous delivery systems, and related medical devices.
"Today's health care workforce faces a multitude of risks," said NIOSH
Director Linda Rosenstock, M.D., M.P.H. "We know that needle-less devices and safe
needle devices can save lives. We must do everything we can to protect the health care
workers who have devoted their lives to keeping America healthy."
Every year 600,000 to 800,000 occupational needlestick injuries are estimated to occur
and can lead to serious or potentially fatal infections with bloodborne pathogens such as
hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV). The precise
number of injuries is not known because needlesticks often go unreported. The risk of a
bloodborne infection may not be immediately recognized, and symptoms may not become
apparent until weeks or months after the needlestick.
NIOSH recommendations for work-related needlestick injuries are outlined in a new
bulletin, "NIOSH Alert: Preventing Needlestick Injuries in Health Care
Settings." Developed in collaboration with other CDC centers and with extensive
outside scientific review by diverse industry, labor, and public health organizations, the
Alert provides detailed guidance and assistance to employers, workers, and others in
reducing needlestick injuries.
"Building on the success that some institutions have achieved in reducing such
injuries by as much as 88 percent, these suggestions offer achievable, practical guidance
for protecting the Nation's growing workforce of health care employees," said
NIOSH recommends that the use of needles be eliminated where possible. If safe and
effective alternatives to needles are not available, devices with safety features such as
shields and sheaths should be used. Devices should be selected, used, and evaluated as
part of a comprehensive program in which safe work practices, such as prohibiting
recapping, are established under written procedures, and workers are trained in those
practices. Each health care setting should have its own carefully tailored program,
developed with front line worker input and review.
Hollow-bore needles such as those used in syringes present the greatest risk for
needlestick, but potential for injury exists whenever any sharp device is used, the NIOSH
Alert reports. Most reported needlesticks involve nurses, but laboratory staff, doctors,
housekeepers, and other health care workers are also injured.
The Alert suggests examples of devices that may reduce the risk of needlesticks, but
advises that no one device will be appropriate or effective for every workplace. Examples
of such devices include but are not limited to:
- Needle-less devices, such as connectors for intravenous delivery systems that use blunt
or valved ends rather than needles for attaching one length of IV tubing to another.
- Devices in which safety features are an integral part of the design, such as sheaths and
shields over needles.
- Devices that operate passively without requiring user activation, such as an IV
connector with a permanent rigid housing over the needle.
- Devices designed so that the user can tell easily whether the safety feature is
activated, such as a visually obvious needle cover or the audible sound of a protective
sheath being engaged.
- Devices in which the safety feature cannot be deactivated and remains protective through
- Devices that perform reliably, are easy to use and practical, and are safe and effective
for patient care.
CDC is working with health care industry groups, employers, workers, unions, the public
health community, and others to disseminate its guidance and recommendations. Copies of
"NIOSH Alert: Preventing Needlestick Injuries in Health Care Settings," HHS
(NIOSH) Publication No. 2000-108, are available at no charge from the NIOSH toll free
information number, 1-800-35-NIOSH (1-800-356-4674). The document is also available online
- SOUL MATES
Terrific, how things that seemed right can go so wrong, A hope too
great, or a hung waited for too long, From my eyes follows the familiar mist like rain,
Will our souls be united again,
Tawas just yesterday that things seemed so right,Tis hard to
take your Kris cross on a summers night, Yet my heart remembers the kiss that stayed, All
the while months passed until today,
Was it really worth listening to ones philosophy that is so
so simple, Chance the loss again of one red heads dimples, Gods message was to leave the
enclosed poem and find, My true love in heaven who's inspiration could only be mine,
Truly the message is there can only be one right true love,
Yet lovers struggle through the shadows of companion doves, Like the birds and bees they
try each other yes many others, In pursuit of a love or friendship that we had at the
precipice of a joining of one another; soul mates,
Terrific, how easily things can go right, Just as easy as my
first call to you on a summers night, Wise old Owls lecture from the soul, But never
taught listening to folly could take a loves toll,
However, things can never go terribly wrong, If the heart be
true and the love be strong, For when we were together it matters not what eccentrics
train, Again the mist comes but true love rebounds into a new days dawn for in Heaven we
Poem "Soul Mates" by Dr. S D Neff for Dr. D
Brainowitz in Heaven. Happy Honokaa, Merry Christmas and Happy New
Years InfoJustice ©
APPROVES ZOLOFT FOR POSTTRAUMATIC STRESS
FDA has approved Zoloft (sertraline hydrochloride) as the first drug treatment for
posttraumatic stress disorder (PTSD).
This disorder has long been recognized as an important clinical problem.
Zoloft was approved in l992 for treating depression, and was subsequently approved to
treat obsessive compulsive disorder
and panic disorder. The following may be used to answer inquiries.
According to the American Psychiatric Association Diagnostic and Statistical Manual
(DSM-IV), a diagnosis of
posttraumatic stress disorder (PTSD) requires exposure to a traumatic event that involved
actual or threatened death or
serious injury, or threat to the physical integrity of self or others, and a response that
involves intense fear, helplessness, or
The types of symptoms that occur as a result of exposure to the traumatic event include
reexperiencing the event, in the form
of flashbacks or dreams, and avoidance of situations reminiscent of the traumatic event.
Patients also suffer from numbing of
general responsiveness as manifested by diminished interest in significant activities. And
patients also experience symptoms
of irritability, sleep disturbance, impaired concentration, and outbursts of anger.
A PTSD diagnosis requires that the symptoms be present for at least a month and that they
cause clinically significant distress or impairment in social, occupational, or other
important areas of functioning.
Zoloft,s effectiveness for treating symptoms of this disorder (PTSD) is based on two
multi-center placebo controlled,
12-week trials in adults who were diagnosed with posttraumatic stress disorder. The
overall positive outcome in these trials appeared to derive from the female patients, with
little effect seen in the male subgroups. The importance of this apparent gender
difference is unknown.
Common side effects of Zoloft include dry mouth, gastrointestinal distress and somnolence
On October 8, l999, FDA,s Psychopharmacological Drugs Advisory Committee recommended
approving Zoloft for the treatment of Posttraumatic Stress Disorder.
Zoloft is marketed by Pfizer, Inc., New York, NY. InfoJustice
COMBINED FDA DRUG-DEVICE THERAPY FOR KEY PRE-CANCEROUS SKIN LESIONS APPROVED
The Food and Drug Administration today announced the approval of Levulan
Kerastick (aminolevulinic acid HCI) for Topical Solution, 20%, to be used in conjunction
with photodynamic therapy for treatment of actinic keratoses (AKs)(pre-cancerous skin
lesions) of the face or scalp. It is the first combined drug and device treatment designed
for targeted treatment that can be limited just to the lesion site(s).
AKs are rough, scaly, red or brown patches that begin on the surface of the skin. They
are mostly found among light-complected individuals -- affecting over 50% of elderly
fair-skinned persons in hot, sunny climates. They can also be found more rarely in
individuals in their teens and twenties. Untreated, AKs may become malignant.
"Almost half of the estimated 5 million cases of skin cancer began as AKs. We hope
that early detection and treatment of AKs may reduce the number of cases of skin cancer.
This novel treatment offers a less invasive treatment alternative for AKs," said Dr.
Jane Henney, Commissioner for Food and Drugs.
The Levulan Kerastick is a two-stage treatment process which involves the topical
application of aminolevulinic acid by a doctor directly to the individual AK lesions,
followed 14 to 18 hours later by photodynamic therapy. Photoactivation of treated AKs is
accomplished with blue light irradiation utilizing a special light source designed to
provide a uniform distribution of blue light to the affected face or scalp areas.
The Levulan Kerastick dosage form was designed to treat individual AKs lesions, thereby
reducing possible skin irritation of unaffected, non-lesional skin. It is not currently
indicated for the treatment of AKs of the back and arms.
In controlled clinical trials, the most common adverse event associated with treatment
was local discomfort (stinging/burning sensation) during light treatment.
Other treatments for AKs include cryosurgery (freezing the skin), curettage (scraping),
electrosurgery, excision, dermabrasion, laser surgery, and topical chemotherapy.
Medical experts still recommend that the best method of combating skin cancer is
prevention. Common sense measures such as wearing protective clothing, avoiding the midday
sun, and wearing sunscreen with a Sun Protection Factor (SPF) of at least 15 is still the
best defense against skin cancer.
Aminolevulinic acid HCI is marketed by DUSA Pharmaceuticals, Inc of Valhalla, NY and
will be marketed under the trade name LEVULAN KERASTICK for Topical Solution, 20%. It is
to be marketed in combination with the light source BLU-U Blue Light Photodynamic Therapy
Illuminator. InfoJustice ©
APPROVES NEW EPILEPSY DRUG
FDA has approved Keppra (levetiracetam), a new
epilepsy drug that controls partial onset seizures in adults--seizures that affect one
area of the brain -- when used with other epilepsy medications. The following may be used
to respond to enquiries.
About 2 million people in the United States are affected by epilepsy, a neurological
condition that can produce brief disturbances in the brain's electrical function. These
disturbances, known as seizures, occur when nerves in the brain fire spontaneously,
causing symptoms ranging from shaking of a single arm to loss of consciousness and
generalized spasms. Partial onset seizures occur when abnormal electrical activity only
involves one area of the brain.
Keppra, chemically unrelated to most currently marketed antiepileptics, provides a new
treatment option for these patients. Unlike most epilepsy drugs, Keppra as well as
Neurontin (gabapentin), another approved epilepsy drug, do not interfere with the
bodys metabolism of other epilepsy drugs. Studies have indicated that because the
drug is not metabolized through the liver, it is unlikely to cause interactions with other
epilepsy drugs or commonly used drugs such as oral contraceptives. In addition, no serious
blood or liver related toxicities were seen in clinical trials of more than 1300 patients
Three multi-center clinical studies in about 900 patients demonstrated Keppras
effectiveness as adjunctive therapy for adults who experience partial onset seizures.
Patients should be advised that Keppra may cause dizziness and somnolence (sleepiness).
The new drug will be manufactured and distributed by UCB Pharma, Inc., Smyrna, Ga.
About two dozen different drugs are available for the treatment of epilepsy. Gabatril
(tiagabine) was the latest, approved for epilepsy in l997. (PS...As
Editor, I appreciate USFDA Editors for returning to the common sense justification for
HTML Transparencies which aids disseminations through the International press! When
I retired as number 20,1015, there were 3,000 of us in the US and the rest outside.
Dr. Scott Neff CFE). InfoJustice
APPOINTEE BY ACADEMY DIRECTOR
Since the death of my wife, I have had the opportunity to quietly observe
Dr. Merlin C. Smith, M.D., Orthopaedic Surgeon, QME, AME, conduct his examinations, his
patient teaching sessions, his Agreed Medical Examinations for the Golden State, as well
as perform emergency flat plate radiographs at his medical need, as well as perform over
500 monthly disability exams, perform rehabilitative physiological therapeutic sessions
all within many of the same files as the Honorable Dr. Smith. It is with great
pleasure that we award Dr. M. C. Smith MD with status of Founding Fellow of the
American Academy For Justice Through Science. It is only through the pursuit of
scientific principals combined with Justice through mercy, sharing, and truth will we as a
society be able to continue to advance as a people, and become the very best that we can
be. We seriously congratulate Dr. Smith on becoming a Founding Fellow in the pursuit
of Justice Through Science. InfoJustice ©
Letters to the Editor
Dear Dr. Neff. After a careful review of the Academy Web Site; the
InfoJustice Journal, I can not for the life of me find a picture of you. As a
potential member and one who would enjoy writing for Beat the Press, could you post
a picture of yourself? Char.
Several of our members who have not traveled to our Conventions or courses, ask similar
questions. One Psychiatrist member, Dr. Jim wrote a similar comment "you must
be awful looking". Although I have pictures of myself with Ladies, I actually
do not have one of myself save year books, news paper articles, journal articles and so
forth. Perhaps I may post something soon. If I brake your monitor, I am
FDA Proposes New Rules
for Trans Fatty Acids
in Nutrition Labeling, Nutrient Content Claims, and Health Claims
The Food and Drug Administration (FDA) proposed today to amend its
regulations on nutrition labeling to require that the amount of trans fatty acids
in a food be included in the Nutrition Facts panel. Included in this proposal is a new
nutrient content claim defining "trans fat free" and a limit on trans
fatty acids wherever there are limits on saturated fat in nutrient content claims or
Trans fatty acids, also known as trans fat, are made through the
process of hydrogenation that solidifies liquid oils. Hydrogenation increases the shelf
life and flavor stability of these oils and foods that contain them. Trans fat is
found in vegetable shortenings, and in some margarines, crackers, cookies, snack foods and
FDA based its proposal on recent studies that indicate that consumption of
trans fatty acids contributes to increased blood LDL-cholesterol ("bad"
cholesterol) levels, which increase the risk of coronary heart disease (CHD). Recent
information from the American Heart Association indicates that CHD causes about 500,000
deaths annually, making it the number one cause of death in the United States. FDA is
proposing to provide for information on trans fatty acids in nutrition labeling and for
limits on trans fatty acids for content claims and for health claims in response to
this important public health matter. This proposal also responds to a petition submitted
by the Center for Science in the Public Interest.
"The Nation's experience with the new food label has shown that it
can be a powerful tool for consumers. By requiring information about trans fatty
acids, this proposal should assist individuals in their efforts to reduce their risk of
coronary heart disease," said Jane E. Henney, M.D., FDA Commissioner.
FDA is soliciting comments from the public on this proposed rule. The
proposal is on display at the Office of the Federal Register, at FDA's Dockets Management
Branch, and can be found at the following Website: www.access.gpo.gov/su_docs/. Comments may be
submitted for the next 90 days on this proposal to FDA's Dockets Management Branch,
HFA-305, Food and Drug Administration 5630 Fishers Lane, Room 1061, Rockville, MD 20852. InfoJustice
Letters to the Editor
Mrs. C, the simple answer to your many questions is the learning curve
associated with this topic. Feel proud of your ability to articulate the
problem. Failing the controls of "scientific scrutiny", ethics and fair
play, it is the litany of fraudulent claims based on bad lawyers and arguments on
fraudulent greedy, self aggrandizing, egregious claims cases, which causes the difficulty
you so eloquently delineated. With the burden of proof put back on the proponent,
which would be the Medico-legal system prior to HMO and this modern era of Quackery in
lieu of paying a medical bill, control over medical device and claims made fraud will
again begin (Prior to 1993 destruction of FDA by taking away their police badge and
gun! You can thank a key Republican Power Popular Senator). Once the
scientific burden of proof is placed responsibly as to double blind studies, passage of
repeat trials by a myriad of different physicians of different locality reproducing the
same results, results which are reliable and stand the test of a quality clinical trial
especially in the area of cosmetic change. Often the money is made on woman and thus
as a man, one is up against the mind of a "women". Who is the man to say
no too strongly? Love. Thus, the burden is on the proponent and thus liability
is established judiciously. I urge you to join AAJTS and await your
application. We have a place for a women with a brilliant and curious mind like
Letters to the Editor
How may we help? = Dr. Neff, The Dow Corning Bankruptcy proceedings permit
allowed claims based upon pre-considerations, or a systemic disease legal risks management
screening process. The systemic disease legal risks management screening process did
not screen for massive, invasive, not fully resectable fibrotic, soft tissue
tumors/silicone granulomas/a normal giant cell reaction to silicone. Extensive
impairment of connective tissue far exceeding the threshold of the manufacturers' warning,
not caused by a systemic disease is not an allowed claim. Benefit of review of risks of
extensive local complications of the silicone implant seen in MRI and surgical pathology
as opposed to immunology was not allowed during the claims classification process.
Coercive threat of legal harm and conflicts of interest in research in reference to the
proposed categories of consideration, to which other categories of consideration would
reduce funding is not considered by the Courts. Why are the civil rights of the
human research subject dependent upon a pre-considered research screening process without
benefit of review of risks during claims classification. Why is this happening when Human
Subjects Research protections against conflicts of interest in research are codified into
law within the judicial department? No single individual can protect individual
interests in the right to protect oneself from bodily harm, against extensive funding
conflicts of interest, when one's injury is at conflict, not measured by the screening
process in reference to the funded categories or within the research directed to answer
questions posed by litigation interests. Why does The Belmont Report appear to have little
effect in relation to review of risks and silicone implant subjects?
Objection to one's claim classification as was promised was not allowed review. In my
claim I simply received a letter from Dow attorneys (after the voting deadline) saying
that the Court could not respond to all of the objections, to vote anyway.) Why did the
Court promise to permit reaction to claims classification if it was not going to permit
consideration of objection to claims classification? I was not even allowed a vote,
because I assumed that the Court would fulfill the conditions that it presented on the
ballot. Thank you for any possible explanation. Dear
Charlotte, Thank you for reading my Whistleblower's article on this issue. I will
review my article on the Justice is Truth Page and contacted the Whistleblowers in
Washington DC last evening in fact. My answer soon.
NOSE & THROAT, EMERGENCY CARES, PI MEDICAL-FRAUD, WASTE AND ABUSE
The real skinny coming soon?
FDA STRATEGY ON REUSE OF SINGLE USE MEDICAL DEVICES NOW
FDA today released a proposed strategy for addressing the practice of
reuse of medical devices that are intended to be used only once. The proposed strategy is
designed to protect the public health by assuring that the practice of reprocessing and
reusing "single-use" products is based on good science. FDA is soliciting
comments, proposals for alternative approaches, and information on reuse from all
stakeholders and interested parties. The reprocessing of medical devices labeled, or
intended, for only one use has grown steadily in recent years, as has the complexity of
the devices being reprocessed. This has intensified concern about patient safety, informed
consent, the ethics of this practice, and equitable regulation of original equipment
manufacturers and reprocessing firms.
Under the proposed strategy, FDA would consider regulating third-party
processors and health care facilities that engage in reprocessing of single-use devices
the same way the agency has regulated original equipment manufacturers. This includes:
registration and listing of firms, premarket notification and approval requirements,
submission of adverse event reports under the Medical Device Reporting regulation,
manufacturing requirements under the Quality Systems regulation, labeling requirements,
medical device tracking, and medical device corrections and removals.
FDA believes the regulatory controls over reprocessed single-use devices
should be commensurate with the risk they pose to patients. FDA is seeking input on the
development of a device categorization system based on the public health risk of
reprocessing and reusing single-use devices. As this time, FDA believes that the
categorization system would be a three-tiered system ("low risk," "moderate
risk," "high risk"). A single-use device's risk category may depend on such
factors as the complexity of the procedures needed to reprocess the device, the risk of
infection from reusing the reprocessed device, any risk of performance failure with
respect to reprocessing, and the scientific information available on reprocessing the
For single-use devices in the "high risk" category, i.e.,
products that may pose a significant public health risk to patients and users after
reprocessing, FDA is considering enforcing all the agency's regulatory requirements,
including premarket applications. Under this approach, products in this "high
risk" category that are reprocessed would be removed from the market within a
relatively short time if reprocessors and hospitals did not comply with the applicable
FDA is considering actively enforcing premarket application or premarket
notification requirements (as appropriate), for "moderate risk" single-use
products to ensure that the reprocessed device remains as safe and effective as the
original product. The agency is considering allowing reprocessors to make declarations of
conformity to recognized consensus standards as a means of complying with premarket
requirements for these products.
At this time, FDA believes that premarket requirements for "moderate
risk" single-use devices should not be actively enforced for some limited time period
after the agency published a final policy. This would allow the community time to develop
the necessary standards and the reprocessors time to collect the data needed to document
the safety, effectiveness and performance of the reprocessed single-use devices in this
category. FDA is seeking opinions on the kind of data necessary to determine safety and
effectiveness of single-use devices in the "moderate risk" category.
FDA anticipates that "low risk" single-use devices would include
those products that pose little or no potential public health risk to patients or users
after reprocessing. The agency believes that products in this category would be a low
priority for the agency and that many could be exempt from any premarket submission
FDA also is considering whether original equipment manufacturers should
provide information on the label of their single-use products to alert users and
reprocessors of the risks or vulnerabilities associated with reprocessing of their
specific single-use devices. FDA will hold a public meeting in Rockville, Md., Dec. 14, to
gather comments on its proposed strategy. Details of the meeting will be announced in the
Federal Register within the next few weeks.
ABBOTT LABS SIGNS CONSENT DECREE WITH USFDA
The Food and Drug Administration today announced that Abbott Laboratories
has signed a consent decree of permanent injunction in which it agreed to stop
manufacturing and distributing many of its in-vitro diagnostic tests until it corrects
manufacturing problems in its Diagnostics Division. In-vitro diagnostic tests are those
designed to be performed in laboratories on samples of patients' blood, urine, mucous and
other bodily fluids for use in diagnosing and treating disease.
The decree was signed today by Judge Harry D. Leinenweber in Chicago.
Abbott is one of five major in-vitro diagnostic device manufacturers in
the world and the largest in the United States. Abbott's Diagnostics Division makes some
325 laboratory tests, including tests used for diagnosing disease and for screening for
infectious diseases in blood used for transfusion.
Over the past six years, Abbott has failed to comply with FDA's Good
Manufacturing Practice and Quality System (GMP/QS) regulation. Despite warnings from FDA,
Abbott has failed to correct its problems.
"This action underscores FDA's strong commitment to the enforcement
of laws designed to protect patients and consumers," said Jane E. Henney, M.D.,
Commissioner of Food and Drugs. "These violations do not necessarily mean that
Abbott's diagnostic products will harm patients, but the firm's failure to follow good
manufacturing requirements decreases the level of assurance," she added.
FDA is not recommending that diagnostic tests be repeated for those
patients whose initial testing was performed using Abbott's in vitro diagnostic test kits.
Abbott's manufacturing practices first raised FDA concern in 1993, when
deficiencies in good manufacturing practice were found during FDA inspections of the
firm's Abbott Park, Ill., and North Chicago, Ill., manufacturing facilities. Violations
were found in process validation, production and process control, and corrective and
After these inspections, FDA sent a warning letter to Abbott in March
1994. Subsequent FDA inspections during 1995, 1996, 1997 and 1998 continued to find the
same types of deficiencies. FDA tried to work with Abbott to correct these problems
without seeking relief from the courts. However, when the firm failed to meet promised
completion dates and failed to correct problems adequately, FDA sent another warning
letter in March 1999 and re-inspected the facilities during May, June and July. During
that inspection, FDA found continuing deficiencies and decided that a court order would be
necessary to ensure that the firmís processes were brought into compliance in a timely
and orderly fashion.
Under the consent decree, signed by Abbott and two of its top corporate
executives, FDA will allow the firm to continue distributing certain medically necessary
tests for screening blood donors for infectious blood-borne diseases such as HIV,
hepatitis B and hepatitis C. Such tests are already subjected to lot release by FDA as an
additional control, and there is no evidence that they have been ineffective.
All other Abbott in vitro diagnostic devices will remain available for 30
days, to permit users to standardize and obtain alternate test methods. FDA recommends the
use of additional quality control material (reagents used to help verify the proper
functioning of test kits) made by other companies to increase the assurance of successful
performance of Abbott tests.
After 30 days from the effective date of this agreement, Abbott will no
longer be permitted to manufacture or distribute non-medically necessary tests.
Abbott will also continue distributing a number of tests to laboratories.
These include tests for identifying tumors, tests to detect heart attack, and tests to
monitor levels of therapeutic drugs.
Abbott has agreed to comply with FDA's Quality Systems Regulation for
these products according to a schedule approved by FDA. The firm has also agreed to pay
$15,000 per manufacturing process, per day, (up to $10 million dollars cap) for failure to
adhere to that schedule.
The firm has also agreed to pay $100,000,000.00 to the U.S. Treasury
within 10 days after the decree has been entered by the court. The amount covered is
described in the complaint filed by the court as the equitable remedy of disgorgement. It
sets a precedent as the largest amount of money ever paid by an FDA-regulated company for
a civil violation of the Federal Food, Drug and Cosmetic Act.
In addition, if the medically necessary products are not brought into
compliance within one year after the court enters the decree, the company agreed to pay 16
percent of the gross proceeds generated by the sales of such products as determined by an
independent financial auditor.
In the meantime, FDA will be notifying the medical community by letter
about specific precautions that may be taken regarding continued use of these products.
Abbott has agreed to correct deficiencies in its manufacturing operations
for all other diagnostic tests as soon as possible. The corrections will be overseen by an
outside expert, hired by Abbott, who will certify to FDA that corrections have been made.
FDA will re-inspect Abbott's facilities to verify that the products have been validated
and that the manufacturing processes conform to the Quality System Regulation. At that
point, the products can once again be permitted on the market.
Once corrective action is complete and Abbott has been allowed to resume
manufacturing and distribution, the company will hire an independent auditor to conduct
audit inspections of its in-vitro diagnostic device manufacturing operations at least
twice a year for at least four years.
Results of these audit inspections will be reported directly to FDA. If
Abbott fails to comply with the Quality System Regulation or the terms of the consent
decree, FDA may order the firm to again stop manufacturing and distributing, recall the
products, or take other action.
The executive officers named in the consent decree for permanent
injunction are: Miles D. White, Chief Executive Officer, Abbott Laboratories, and Thomas
D. Brown, President of Abbott's Diagnostics Division. Abbott's corporate headquarters is
in Abbott Park, Ill. The Diagnostic Division's primary manufacturing facilities are in
Abbott Park and North Chicago.
CDC, NATIONAL CENTER FOR INFECTIOUS DISEASES STATEMENT ON WEST NILE VIRUS AND THE EMERGING
INFECTIOUS DISEASES PLAN
During CDC's outbreak investigation of arboviral (mosquito-borne)
encephalitis in New York City, which began in late August, we reported the introduction of
West Nile-like virus into the Western Hemisphere. One of the compelling questions in this
investigation is, "How did this virus migrate to the Western Hemisphere, and the
United States?" As interesting as this question may be, the answer may remain
elusive--Mother Nature does not always reveal her secrets.
We live in a global village and we take every disease outbreak and every
new or re-emerging disease very seriously. While we cannot expect to totally prevent the
migration of viruses from one part of the world to another, our best efforts should, and
do, concentrate on the steps outlined in the U.S. emerging infectious disease plan--strong
surveillance for early detection and response, well-equipped labs and a cadre of public
health officials trained and equipped to confront and control viruses.
Infectious diseases are a continuing menace to all people, regardless of
age, gender, lifestyle, ethnic background, or socioeconomic status. They cause suffering
and death, and impose an enormous financial burden on society. Although some diseases have
been conquered by modern advances, such as antibiotics and vaccines, new ones are
constantly emerging (such as AIDS, Lyme disease, and hantavirus pulmonary syndrome), while
others reemerge in drug-resistant forms (such as malaria, tuberculosis, and bacterial
The emergence and re-emergence of diseases have been fueled by: worldwide
population growth, behavior changes, international travel, worldwide transport of animals
and food products, human encroachment on wilderness habitats and microbial evolution and
their development of resistance to antibiotics and other antimicrobial drugs. Whatever the
cause, the resurgence of diseases attributed to newly emerging microbes poses a continuing
Because we do not know what new diseases will arise, we must always be
prepared for the unexpected. CDC's vision for the 21st century is of individuals,
communities, and nations joined in a common effort to control today's emerging infectious
diseases and to prevent those of tomorrow. To realize this vision, CDC scientists have
designed a plan to respond to the emergence and resurgence of microbial threats in the new
millennium -- Preventing Emerging
Infectious Diseases: A Strategy for the 21st Century. CDC/InfoJustice
Beats the Press
WOMEN TO "TAKE TIME TO CARE"-Nationwide
Education Campaign on the Safe Use of Medicine
This month(October), millions of women will have access to specialized
information about the proper use of medications in a national public awareness campaign
being jointly conducted by the U.S. Food and Drug Administration (FDA) and the National
Association of Chain Drug Stores.
An unprecedented partnership of more than 80 non-profit and corporate
supporters as well as 20,000 chain drug pharmacies are working together to provide women
with critical information about how to maximize the benefits and minimize the risks of
taking both over-the-counter and prescription medicines. Three out of four doctor visits
in the United States result in physicians issuing a prescription, and in 1999 alone, an
estimated 3 billion prescriptions will be dispensed to patients. And yet in hundreds of
cases consumers misread or don't read the label; combine different prescriptions and/or
over-the-counter drugs without knowing the possible side effects; take too little or too
much of a medication; or don't finish taking the prescribed amount.
The safe use of medicines is particularly important for women since they
use medications more frequently than men and are more likely to supervise medication use
by family members, including children and elderly parents.
"Women are the most active healthcare decision makers, and that's why
the FDA Office of Women's Health is encouraging women to be particularly vigilant when
taking or giving medications to their families, children and themselves," said Jane
E. Henney, MD, Commissioner for Food and Drugs.
Studies show that 30% to 50% of Americans do not take their medication as
directed and as a result, preventable medicine- related illnesses cost $76.6 billion
dollars each year in doctor visits, unnecessary prescriptions, lost productivity and
increased hospital and nursing home admissions. With the Take Time To Care program,
businesses, health service groups, professional associations, other federal agencies, and
religious and ethnic groups have committed to providing women with the information they
need to keep themselves and their families healthy. The goal of the campaign is to
distribute five million "My Medicines" brochures. The brochure has four key
messages: Read the label; Avoid Problems; Ask Questions; and Keep a Record. Attached is a
list of participating organizations.
In addition to pharmacy efforts, activities during the month of October
Providing one million mail order subscribers with the "My
Conducting a national media outreach campaign to raise awareness of this
Distributing materials at conferences, universities and religious
Reaching low-income women through community health centers.
Linking with nursing outreach efforts to educate groups with special
needs, including non-English speaking populations and those with mental illness.
Distributing materials through employee assistance programs.
Establishing a national toll free number, 1-877-RX WOMEN, for questions
regarding medicines on October 26th.
Informing the public through a network of linked web sites.
The brochure will be available in English, Spanish, Hmong, Russian, Polish
and a number of Asian languages. To receive a free copy of the "My Medicines"
brochure (in English and Spanish) call toll free 1-888-8-PUEBLO or log onto the Office of
Women's Health web site at www.fda.gov/womens/tttc.html.
The FDA acknowledges all of the Take Time To Care campaign's participating
organizations and pharmacies.
The Office of Women's Health was created by the Food and Drug
Administration in 1994. Its establishment began a new chapter in the agency's commitment
to women's health issues. The FDA has jurisdiction over the drugs, medical devices,
vaccines, blood and tissue products, foods and cosmetics on which every American woman and
her family depend about 25% of every consumer dollar. InfoJustice
CREATES TASK FORCE ON MEDICAL PRODUCTS
Medical products provide great benefit to the public, but they can also cause
injury. FDA and the many other participants in healthcare delivery act to maximize the
benefits and minimize the risks associated with using medical products, but often the
actions of the participants are insufficiently integrated. The Task Force believes that
the common goal of maximizing benefits and minimizing risks could be greatly advanced if
the participants in the system worked together to gain an understanding of these
activities within a systems framework. To achieve such a framework, we need a better
understanding of the risks involved and their sources, and we need to clarify our
individual roles and ensure that our individual roles are well integrated. Only then can
we plan effective risk management strategies.
The Task Force also examined in detail FDA's role in the overall system. We find that the
Agency's pre- and postmarketing risk assessment systems are performing well. Nonetheless,
we believe that additional emphasis should be placed on the quality assurance of our
premarketing review programs. In addition, the Task Force finds that program expansion is
needed to ensure that our postmarketing programs are able to meet the challenges of the
current regulatory and healthcare environment.
The Task Force is making a number of recommendations as a result of its review. Most
recommendations center around ways that FDA, within the confines of the current system,
can further improve its risk management activities. The Agency intends to implement these
recommendations. Many of these improvements already are underway, and the Task Force
recommends that ongoing enhancements be aggressively pursued. Specifics can be found at
the end of Parts 2, 3, and 4 of the report, but these recommendations generally include:
Initiate steps to have each Center establish separate quality assurance/quality control
Ensure and document ongoing professional education and core competency training for all
reviewers. Complete the good review practice documents and keep them current.
Rapidly complete AERS and enhance MAUDE adverse event reporting systems for pharmaceutical
products and medical devices. Integrate existing postmarketing systems so analytical
tools, data entry, and editing can be uniformly applied, and all information is readily
available to every reviewer. Enhance and intensify surveillance of newly marketed
Develop new methodological tools for inference from available datasets.
The Task Force also identified a number of options for consideration, which, if adopted,
might contribute to improved risk management. These ideas need full public policy analysis
and review to understand their potential value, costs, and acceptability to the various
stakeholders in medical product risk management. Some of the options would require
significant new resources and legislative changes. Input from stakeholders on these
options and their prioritization is needed. For these reasons, the Task Force's key
recommendation is that:
FDA join in or convene a meeting, or series of meetings, with stakeholders to discuss the
current system for managing risks. As part of this meeting, FDA should consult
stakeholders about the options identified in detail in the report and summarized below.
The Task Force identified a number of options that we believe may improve the FDA's risk
management activities as well as improve the overall system of managing the risks from
medical products. These options should be evaluated in the context of the stakeholder risk
confrontation meeting(s) recommended above. Only by working with all other participants in
the overall risk management system for medical products can the Agency arrive at the most
effective approach for managing those risks.
Details of the options for public consideration can be found in the relevant chapters of
this report. In summary, these options might include:
Examine and evaluate mechanisms designed to address the inherent limits of premarketing
development (e.g., wider use of large, community-based simple trials, restricting exposure
during the early postmarketing period). Design and implement additional mechanisms to
obtain postmarketing information (e.g., sentinel sites, prospective product use
registries, enhanced links to external databases). Enhance Agency epidemiological
and methodological research activities. Enhance the Agency's role and responsibilities in
risk communication. Increase the number of postmarketing risk interventions for products
with special risks, such as restricting distribution of products or requiring mandatory
educational programs for healthcare professionals and patients. Seek legislative changes
for other types of risk intervention, such as suspension authority for drugs.
1 Presidential/Congressional Commission on Risk Assessment and Risk Management, Framework
Health Risk Management - Final Report, Vol. 1, 1997.
2 Leviton, L.C., C.E. Needleman, and M.A. Shapiro, Confronting Public Health Risks: A
Decision Maker's Guide, SAGE
Publications, Inc., 1998.
3 Bates, D.W., L.L. Leape, and S. Petrycki, "Incidence and Preventability of Adverse
Drug Events in Hospitalized Adults,"
J Gen Intern Med., 8:289-294, 1993.
4 A number of terms are used to describe an adverse event, including adverse drug reaction
(ADR), adverse experience,
and adverse effect. In this report, the term adverse event is used in most cases to avoid
5 Through the Prescription Drug User Fee Act of 1992 (PDUFA) and the Food and Drug
Act of 1997, Congress has encouraged the FDA to act more rapidly in making decisions on
whether new medical products
may enter the marketplace.
6 Government Accounting Office, FDA Drug Review - Postapproval Risks 1976 -1985,
GAO/PEMD-90-15, April 1990.
7 FDA, Center for Drug Evaluation and Research, 1998 Report to the Nation, May 1999.
8 Redux, Pondimin, Seldane, Duract, and Posicor were withdrawn from the market in 1997 and
1998; Seldane and Pondimin were approved prior to PDUFA. For a full discussion, see
Friedman, M.A., J. Woodcock, M. Lumpkin, J.Shuren et al., "The Safety of Newly
Approved Medicines: Do Recent Market Removals Mean There is a Problem?" JAMA,
Vol. 281, No. 18, May 12, 1999. USFDA
FDA APPROVES FIRST NEW OPHTHALMIC
MAST CELL STABILIZER FOR ALLERGIC CONJUNCTIVITIS
The FDA has approved pemirolast potassium ophthalmic solution (Alamast) for the
prevention of itchy eyes due to allergic conjunctivitis.
Pemirolast potassium is a mast cell stabilizer that inhibits the antigen-induced
release of inflammatory mediators involved in the allergic process.
In clinical studies the most common side effects were headache, rhinitis and cold/flu
symptoms. The occurrence of these side effects were generally mild.
Alamast, which is a topical, sterile, ophthalmic solution, will be sold by Santen, Inc.
in Napa, California. InfoJustice/USFDA
SYNERCID FOR VANCOMYCIN RESISTANT INFECTIONS
FDA today approved Synercid, the first antibacterial drug to treat infections
associated with vancomycin-resistant Enterococcus faecium bacteremia (VREF) when no
alternative treatment is available. Synercid also received approval for complicated skin
and skin structure infections. The following may be used to respond to questions.
Infections due to Enterococcus faecium are particularly known to occur in hospitalized
or immunocompromised individuals. This organism is often resistant to multiple
antibiotics. Vancomycin has, for many years, served as the last resort for treatment of
these infections. In 1989 the first case of vancomycin-resistant Enterococcus faecium
(VREF) was reported in this country. Since then, there has been a rapid increase in the
incidence of VREF.
Synercid, a combination of quinupristin and dalfopristin, is the first drug in the
streptogramin class approved for use in humans in the United States. The drug has been
granted accelerated approval, a regulatory mechanism that allows early approval for
products intended to treat serious or life- threatening conditions when they provide
meaningful therapeutic benefit over existing treatments. Accelerated approval is based on
surrogate markers of effectiveness, in this case, the drug?s ability to clear VREF
infection from the bloodstream. A study to verify the clinical benefit (e.g., resolution
of the specific site of infection) of therapy with Synercid is underway.
Synercid?s approval was supported by clinical trials of more than 2000 patients; 1222
patients were treated with Synercid in four non-comparative studies for treatment of VREF
infections. In general, these patients were severely ill, making many of them unable to be
fully evaluated for purposes of the clinical trials. For those who were able to be
evaluated, based on strict study criteria, the overall effectiveness rate of Synercid was
52 percent. Sources of VREF infection included intra-abdominal sites, skin, soft tissue
and the urinary tract. Additionally 330 of the enrolled VREF patients (out of the original
1222) had VREF bacteremia of unknown origin. For this subgroup, 90 percent had clearance
of VREF in the first 48 to 72 hours of starting therapy.
Synercid was also found to be safe and effective for treatment of skin and soft tissue
infections caused by methicillin-susceptible Staphylcoccus aureas (MSSA) and by
Streptococcus pyogenes in two controlled clinical trials. In these studies 450 patients
enrolled in the Synercid arms were compared with 443 patients treated with antibacterial
drugs oxacillin or cefazolin.
The most frequently reported side effects attributed to Synercid in the clinical
studies were muscle and joint pain, nausea, diarrhea, vomiting and rash. In studies in
which the drug was administered through a peripheral vein (e.g., in the arm) many patients
experienced local reactions to the injection, including pain and inflammation at the
catheter injection site.
FDA's approval follows the recommendations of the Anti- Infective Drugs Advisory
Committee. Their recommendation for the approval of the VREF indication was based, in
addition to the results of the clinical studies, on the lack of availability of approved
drugs for the treatment of this resistant infection which may be serious and life-
Rhone-Poulenc Rorer, a French company with US headquarters in Collegeville, Pa., will
market Synercid in the United States.USFDA
COMPULSORY FTC PROCESS RESOLUTION AGAINST INTERNET FRAUD ENACTED
To ensure that its staff has the tools necessary to combat fraud and deception on
the Internet, the Federal Trade Commission today announced that it has approved an omnibus
compulsory process resolution to investigate Internet advertisers, sellers and
promoters. The compulsory process enables the Commission to require the
production of documents and other materials and to compel testimony in connection with an
investigation. The new omnibus resolution authorizes the use of compulsory process to
investigate possible violations of the FTC Act in connection with the advertising and sale
of goods or services over the Internet.
The Commission has omnibus resolutions in place for other consumer protection matters. Now
that the omnibus resolution for Internet investigations has been approved, a single
Commissioner will be able to review and sign Commission documents requiring the submission
ofmaterials or testimony regarding those investigations.
The Commission vote to authorize the resolution was 3-1, with Commissioner Orson Swindle
dissenting. In his dissenting statement, Commissioner Swindle wrote that the resolution's
"exceptionally broad delegation of power to staff simply is unnecessary" and
"hinders direct, proactive review by the full Commission of Internet-related
enforcement issues." He observed that "[j]ust about any business is likely in
the next few years to advertise, sell or promote its goods or services on the Internet,
thus bringing almost any investigation within the scope of this resolution."
Continuing, Swindle advocated the use of alternative forms of compulsory process
resolutions tailored by subject matter or limited to particular investigations. Noting
that in the past year only a few of these narrower resolutions had come before the full
Commission in consumer protection matters, he stated that "[i]t is premature to
conclude that these alternatives involve so much delay or impose so great a burden on
Commission resources as to warrant abandoning the benefits of full Commission review of
process resolutions in favor of a single resolution of unprecedented breadth."
In the majority statement FTC Chairman Robert Pitofsky and Commissioners Sheila F. Anthony
and Mozelle W. Thompson wrote, "The Commission has brought nearly one hundred
Internet-related cases and has taken the lead in combating online fraud. Speed and
anonymity are key in Internet fraud. Hence, speed is also critical to identifying
perpetrators and ending consumer injury. The proposed omnibus resolution affords needed
speed and efficiency to respond to the Internet's unique capabilities. ... [A]ppropriate
checks are still in place for all omnibus resolutions...To fulfill its law enforcement
duties, the Commission routinely has put in place such resolutions to ensure it can act as
efficiently as possible. This is no different ...." FTC/INFOJUSTICE
FDA APPROVES NEW
CHEMOTHERAPY AGENT TO TREAT BREAST CANCER
The FDA has approved epirubicin hydrochloride injection (epirubicin), a new drug for
treating early stage breast cancer that has spread to the lymph nodes under the arm and
that has been treated surgically with removal of all known tumor. This therapy is referred
to as adjuvant treatment. The following may be used to answer questions.
Epirubicin is a member of the anthracycline class of anti-cancer medications, which are
believed to work by interfering with a number of biochemical and biological functions
within cancer cells -- though their precise mechanism of action is not completely
understood. These drugs are commonly used in combination with other medications to treat
patients with cancer, slowing or halting the progression of cancer in some patients, and
prolonging the lives of patients in some settings.
FDA based its decision on the results of two long-term, open-label clinical studies
that enrolled approximately 1,200 patients. The findings showed significant lengthening of
the time without a relapse of the disease (reoccurrence of tumor) and increased 5-year
The first study compared an epirubicin-containing combination to a standard
combination. Patients in the epirubicin group had a significantly increased 5-year
survival without relapse rate (62% versus 53%) and increased 5-year overall survival (77%
versus 70%) compared to those given standard therapy.
The second study compared a higher dose epirubicin- containing regimen to a lower dose
epirubicin-containing regimen. Patients treated with the higher-dose epirubicin regimen
had significantly greater 5-year survival without relapse rate (65% versus 52%) and 5-year
overall survival (76% versus 65%) than patients given the lower-dose epirubicin regimen.
Adverse effects associated with the use of the drug include nausea, vomiting, diarrhea,
stomatitis and hair loss. Before initiating therapy with epirubicin, patients should be
informed that there is a risk of irreversible damage to the heart muscle associated with
the drug. For women who receive epirubicin as adjuvant therapy, there is a slightly
increased risk of treatment-related leukemia. Epirubicin may cause harm to the fetus if
given to a pregnant woman. The drug may also cause premature menopause in premenopausal
women. Men undergoing treatment with epirubicin should be advised to use effective
contraceptive methods because therapy with the drug can induce chromosomal damage in
On June 7 of this year, the FDA's Oncologic Drugs Advisory Committee recommended
approval of epirubicin for use as a component of adjuvant (post-surgical) combination
therapy of breast cancer patients in whom the disease has spread to the lymph nodes under
The drug will be marketed under the trade name Ellence by its manufacturer, Pharmacia
& Upjohn of Peapack, NJ. USFDA/InfoJustice
INCREASES IN BACTERIAL
STD'S AMONG GAY MEN INDICATES THE NEED FOR INCREASED VIGILANCE!
This article documents increases in syphilis, gonorrhea and chlamydia among men who have
sex with men (MSM) in King County, WA, which includes Seattle. By 1996, infectious
syphilis had been eliminated from King County. However, a resurgence of syphilis occurred
over the last 2 years, especially among MSM. Reported cases
increased from zero in 1996 to 19 in 1997, 42 in 1998, and 46 in the first half of 1999.
MSM accounted for 75 (85% of cases) in 1998 and 1999. Similar increases were reported in
gonorrhea and chlamydia rates among MSM attending public clinics. From 1997 to June 1999,
75% of MSM with syphilis and 18% of those with gonorrhea and chlamydial infections were
infected with HIV highlighting the close link between STDs and the sexual transmission of
SENIOR ADVISOR FOR SCIENCE RETIRES FROM USFDA
Commissioner of Food and Drugs Jane E. Henney, M.D., announced today that Elkan
Blout, Ph.D., Senior Advisor for Science, is leaving the Agency.
"Dr. Blout has been the spirit and chief advocate of scientific excellence in our
Agency," Commissioner Henney said. "More than anyone else, he has laid sound
foundations for the strengthening of FDA's scientific potential that is essential for the
continued fulfillment of our public health mission. We'll miss his congenial personality,
but his innovative ideas and guidance will remain always a significant part of this
Dr. Blout, a recipient of the National Medal of Science, joined FDA in 1991, following a
distinguished career in commerce and academia as one of the nation's outstanding experts
in biological sciences.
At FDA, he made important contributions in the selection of research priorities, provided
liaison with outside scientists, and promoted cooperation among the Agency scientists. His
main accomplishments include the formation of three bodies focused on Agency-wide science
issues and improvement of FDA's science base.
One of them, the Science Board, includes 12 prominent scientists from industry and
academia who meet several times a year with Agency representatives to discuss science
policy issues. The other two groups, the Senior Science Council and the Committee for the
Advancement of Science, are FDA internal forums for monthly discussions of Agency science
Dr. Blout will resign from FDA September 10. He plans to continue his activities as
consultant and board member of various profit and non-profit organizations. INFOJUSTICE/USFDA
TO THE EDITOR
I have been on Ritalin since I was diagnosed with Schizophrenia as a
child. My father and his father before him were diagnosed Schizophrenic's yet we
have all been productive members of society. As a second generation US Intelligence
officer, and now faced with the problem of my children wearing the cross of this drug for
ADHD, I have many concerns relative to new data! Since I have been on this
medication since the late sixties, could you delineate the truths relative to the usage of
Ritalin, the indications, causes, effects, and any long term side effects.
My Dear Old Friend. It is wonderful that you have found me after all
these years, and I have just the member on my editorial board to give the assit and score
the hoop. Please welcome the new Vice President of the Executive
Board of the American Academy For Justice Through Science and President of our Board of Forensic Psychology/Psychiatry,
Dr. James A B Drury CFOP, CFME-1, FFAAJTS.
"The question about Ritalin and all of the stimulants
is a tough one. I know that there are many FP and Pediatricians out there prescribing them
and have many different theories, dosages, and regimens. I will discuss the top three that
are used the most: Ritalin, Dexedrine, and Adderall. There is also Cylert but that is not
used in child psychiatry much if at all due to liver failure which does not show up on
liver function tests until it is too late. All of these medications work basically the
same: I use a description of "traffic lights in the brain". We all have two: one
that causes us to act and another that causes us to pause. The child with ADHD does not
have the pause one working too well and therefore is hyperactive, impulsive, easily
distracted and has difficult staying on task. I use the stimulants to cause the pause
light to work more and help them focus and learn. I believe that the question of altering
brain chemistry is valid but these kids would not learn or reach their potential without
their brain taking the time to learn. There has never been a study to prove that these
kids would be brighter if they had not used stimulants. I can tell you though that I have
had many kids who were failing and started on stimulants and are now at the top of their
I will discuss the particulars later after I discuss the
recommended regimen and dosing. As I mentioned before there are many thoughts on this
matter but I will give you what the Child Psychiatrists have adopted. The child can really
be started on either of the top three and it is felt that about 80% respond to the first
one tried, then another 80% of the none responders respond to the next one, and finally
another 80% of those who have not responded to the other two will respond to the third
agent tried. That leaves perhaps less than 2-3% which perhaps the diagnosis of ADHD should
be rethought or try the others again. The dosing should be in the range of between 0.5-1.0
mg/kg per dose and should be given at least twice a day and if needed even 3-4 times a
day, depending on whether the child develops side effects, such as appetite suppression or
insomnia. The child should also be receiving his medication on weekends and over the
summer as well until behaviors have improved. Later, in the course of therapy the
physician and caregiver can stop the meds for the summer and see how the child does.
Here is where there is another group of thoughts on
continuing the medicine. It is thought that 1/3 of the children "grow out of
ADHD" meaning that they have been able to control their ADHD through meds
and internal control and function similar to their non ADHD peers; 1/3 who although
still have symptoms but are able to function adequately and should probably still be on
meds but can do fairly well off of them; and then there is the final 1/3 who will need to
remain on medications for perhaps life to help them continue to function and grow.
The medicines, dosing, ages, and half life's are as
Ritalin(Methylphenidate)-0.5-1.0 mg/kg/dose given 2-4
doses/day; FDA approved for children over age 6.
Peak Serum Level 1.9 hrs. and Half-life 2-21/4 hrs. Time released form(Ritalin-SR) serum
level is 4.7 hrs., however it appears that 20 mgs of Ritalin does not equal 20 mgs of
Ritalin SR which should be a consideration for others prescribing it and titirating it to
Dexedrine(Dextroamphetamine Sulfate)-0.5-1.0 mg/kg/dose
given 2-3 doses/day; FDA approved for children over age 3. Peak Serum Level 2 hrs., Time
released spansule 8-10 hrs. Half-life is 6-8 hrs. for both. Yet again there seems to be a
difference between dose of regular and time released forms.
Adderall-[combination of various dexedrine salts]-0.5-1.0
mg/kg/dose given 1?-2 doses/day; FDA approved for children over 3. Peak Serum Level 2 hrs.
and Half-life 8-10 hrs. It is unclear whether once a day dosing is effective in ADHD.
Being a bit biased, I wish that affected children were
immediately referred to child psychiatrists for evaluations and recommendations as we are
more up on the claims(misclaims) of regular and time-released versions of the medications
for ADHD. Also, if the physician has used all the stimulants without any success then
there are other regimens and medications that can be used in addition to, or substituted
for stimulants. InfoJustice
Fluoridation and Costs of Medicaid Treatment of Dental Caries Louisiana,1995-1996
Community water fluoridation can substantially reduce Medicaid dental treatment costs for
A recent study in Louisiana compared Medicaid dental costs
for young children living in parishes with fluoridated water and those with low-fluoride
water. The study, conducted by the State of Louisiana and CDC, found that the average
costs of treating cavities for children living in parishes with low-fluoride water were
twice as high as the cost for children in fluoridated parishes. Children in low-fluoride
parishes were three times more likely to receive dental treatment in a hospital operating
room due to the severity of their tooth decay problem. On average, the annual cost for
treating dental disease, per Medicaid-eligible child, in fluoridated communities was $36
less per year than the cost in communities with low-fluoride water. Fluoridating the 39
low-fluoride systems, serving more than 10,000 people in Louisiana could potentially
reduce annual Medicaid dental costs for pre-schoolers by $1.4 million. CDC
- "THANK YOU FOR BEING
What is life all about? March 27th, 1999 there I
sat, alone in my chair, scheduling emergency patients, recording their history and intake,
triaging (examine, clean, sterilize and treat wounds, assist in surgery, perform
post-operation procedures and physical medicine, correlate prescriptions, diagnose and
treat my own patients etc), and forming my diagnoses, referring those that needed it to
the appropriate Medical Specialist, attending to everyone's needs. It felt nice to here
one infectious disease patient state, "Thank you for being there".
All Academy members know that one of my closest friends, old roommate, early advocate
and early supporter of my anti-fraud efforts has been diagnosed with cancer (alveolar
metastasis). He joined myself and my friends in presenting the National
Health Fraud Conference in Kansas City. Prior to 1988, my group silently put on the
first Health Fraud Conferences in the US beginning in 1980 and including the 1984
California Attorney General's Health Fraud Conference, until today various
groups-for-profit and certification of continuing education credits for civilian and
government employees, now put on such conventions. Since early in the course of
these horrific events, your editor closed his office to support the payment for additional
chemotherapy, special laser surgeries etc, and continue to care for my patients as well as
to triage all patients during my shifts (usually 10 to 14 hours per day) for emergency
medical patients. We are all striving to continue the standards set forth by one of
Los Angeles' finest Head and Neck Surgeons, a Specialist in Endoscopic Nasal Sinus
Surgery, Pediatric Otolaryngology, California-Qualified Medical Examiner, Specialist in
Ear Nose and Throat Disease, Certified Forensic Medical Anti-Fraud Examiner, Diplomat
Founding Fellow, past President, Vice Present and current Treasure of the American Academy
for Justice Through Science and Co-Founder of the College of Justice, and early
contributor to editorial content, while I was the Editor and Publisher for the American
Academy for Biomechanical Trauma (and presently as the Editor and Publisher of the
While balancing the necessary hats during shift changes, to keep the ship standard of
"OLD FASHIONED HIPPOCRATIC MEDICINE" on a true, and calm steady course for these
last 4 months, having the patient today thank me for being there reminded me what
medicine is all about: We cant always cure patients of their ailments, but we can make
sure that they are comfortable and that they are not alone. InfoJustice
HAS Y2K AND MEDICAL DEVICE FRAUD UNDER SURVIELLANCE
FDA has been receiving inquiries about the effect the Year 2000 (Y2K) date change will
have on computer-controlled medical devices and FDA's role in assuring these products will
function safely and effectively on January 1, 2000. The following Q & A will help put
the issue in some perspective.
What is FDA's role?
FDA is responsible for assuring the safety and effectiveness of the products it regulates.
In mid-1996, FDA began internal discussions on the potential for medical devices to be
adversely affected by the Y2K date problem. The problem can occur in products that were
programmed to recognize only the last two digits of a year, assuming the first two would
be 1 and 9. On
Jan. 1, 2000, unprepared machines will understand the year "00" not as 2000 but
as 1900, which may cause them to shut down or stop working properly. Since mid-1996, FDA
has been working aggressively with the medical device industry and
the healthcare community to assure that medical devices will continue to work as they
should. These efforts included stating FDA's expectations for manufacturers and providing
information on product status to the healthcare community.
Will medical devices be adversely affected by the Y2K date change?
The vast majority of computer-controlled medical devices used and marketed in the United
States will not be significantly affected by the Y2K date problem. Only about 2,000 of the
nation's 13,500 medical device manufacturers make products that
are the type that might be controlled by a computer and, therefore, potentially sensitive
to Y2K problems. Most of these do not depend on a date to function properly. However,
there are a few products--primarily used in hospitals and
laboratories--in which correct processing of date information is critical to the device's
What are these products and what has been done to ensure their safety?
Devices that could potentially be affected by the Y2K date problem include products that
use dates in a calculation or algorithm or for critical record keeping such as radiation
therapy treatment planning systems, hemodialysis machines, some
clinical laboratory systems, some blood product devices, and some ultrasound systems. FDA
has compiled a list of medical device types that, if computer-controlled and subject to a
Y2K failure, present a potential for causing serious adverse events. Most
manufacturers have already identified solutions and provided upgrades for
these types of devices and have notified their customers (hospitals and other healthcare
facilities) of their availability.
What about home medical devices and implanted devices like pacemakers and defibrillators?
Few, if any, of these products will be affected by the Y2K problem because most do not
depend on a current date to operate safely and effectively. Pacemakers, defibrillators and
other implanted devices will not be affected. Some products that
use computers to record data, such as some glucose monitors, could be affected.
What action has FDA taken so far?
Among the numerous actions taken:
In June, 1997, FDA alerted the medical device industry to the potential for a problem with
computer-controlled/date-sensitive devices. The agency put manufacturers on notice that
they were responsible for assessing all their products. Companies were informed that, if a
potential problem were identified, the manufacturer must provide or make available an
upgrade to the device, inform their customers not to use it, or provide information on how
it can be modified to avoid a problem. FDA has continued to work closely with the medical
device industry to assure medical devices are ready for Y2K. In March 1998, with
cooperation from other Executive Departments, FDA established a clearinghouse for
information on the status of biomedical equipment. The clearinghouse is designed to give
hospitals, medical research facilities, government agencies and the general public a
single, comprehensive source of information on the Y2K status of medical devices and
scientific research equipment. FDA asked manufacturers to provide information on the
status of their products.
What does the manufacturers' information show about their products?
In reviewing the data to date, FDA sees no indication of widespread problems which will
place patients at risk as long as the solutions now offered by manufacturers are
implemented by hospitals, other medical facilities and device users.
How does FDA know that the data provided by manufacturers is accurate?
To verify that manufacturers are taking necessary steps to be ready for Y2K, FDA checks
during regular inspections of manufacturing facilities to see what the firm has done to
assure that its products, manufacturing process and distribution systems are Y2K
compliant. If FDA investigators encounter serious problems or find that firms are not
taking appropriate steps to avoid serious Y2K problems, the agency will follow up with
regulatory action where appropriate.
In addition, to help provide further assurance of the adequacy of manufacturers'
Y2K-related activities, FDA has initiated a study of Y2K readiness of potentially
high-risk medical devices. FDA has asked a sampling of manufacturers of potentially
high-risk products to undergo voluntary assessment of their facilities to check their
procedures and records and to validate
any Y2K corrections they have made. The study results will be reported in October.
Can FDA recall a product if it's not Y2K compliant?
FDA has the authority to require a mandatory recall of a medical device that presents
"an unreasonable risk of substantial harm to the public health." The agency can
also require manufacturers to notify customers about devices that present such a risk.
Normally, manufacturers voluntarily recall problematic devices without FDA having to
require a mandatory action.
Mandatory recalls are undertaken in only the most severe situations. InfoJustice and the Academy Server is Y2K Compliant.
It is estimated that hundreds of millions of dollars each year are lost through the New
Millenium identity theft craze. You may not know your identity has been stolen
until months later. The congressional General Accounting Office cites statistics from one
leading credit bureau, Trans Union, that the number of reported ID theft cases at the
bureau has jumped from 35,000 in 1995 to 523,000 in 1997. With victims growing
exponentially, industry experts commonly refer to this phenomenon as the fastest growing
form of fraud in the United States. One reason for the enormous volume in cases is
that it is an easy and relatively low-risk crime. It starts with collecting personal
information?data many people casually give out on credit applications, to telemarketers,
or throw in the trash. Stealing wallets use to be the best way of obtaining credit card
and identity information. Not any more. Some crooks dig into trash cans for bank,
mortgage, credit or Social Security records, commonly referred to as "dumpster
diving." Some intercept financially related mail from mailboxes. Others have access
to credit reports by working for car dealerships or collection agencies. A dishonest clerk
could make an extra imprint from a credit card and use it to make personal charges.
Even Credit bureaus had to admit they are partly to blame for the increase in identity
theft cases, but they also point to retailers and lenders that issue credit despite
inconsistencies in credit reports and that seem to accept losses as a cost of business.
They point to law enforcement agencies that are reluctant to prosecute criminals. And they
point to consumers themselves, saying they routinely dispense personal information and
demand "instant credit" that forces lenders to take shortcuts.
Problems are inevitable because there is no central clearinghouse or enforcement agency.
No single agency is in charge of investigating such crimes, though responsibility falls at
times to U.S. attorneys, the Secret Service, the Social
Security Administration, U.S. Postal Service, International Revenue Service and local
police. Fortunately, President Clinton signed the Identity Theft and Assumption Deterrence
Act last fall that makes ID theft a felony, which will help
victims get police reports. It also compels the Federal Trade Commission to maintain a
record of ID theft reports, provide information to victims and refer complaints to the
appropriate law enforcement agencies.
August 1999 Best Practices For Comprehensive Tobacco
Control Programs provides states with recommended strategies and funding levels for
effective programs to prevent and reduce tobacco use, eliminate the publics exposure
to secondhand smoke, and identify and eliminate disparities related to tobacco use and its
effects among different population groups.
There are nine components of comprehensive tobacco control programs: community programs,
chronic disease programs (e.g.,heart disease prevention, cancer registries) to reduce the
burden of tobacco-related disease, school programs, enforcement of existing policies,
statewide programs, counter-marketing, cessation programs, surveillance and evaluation,
and administration and management.
CDC estimates that the annual costs to implement all of the recommended program components
range from $7 to $20 per person in small states (populations under 3 million) and from $5
to $16 per person in large states (population over 7 million).
Total recommended program costs for the average state would range between $31 million
(lower estimate) and $83 million (upper estimate) each year, translating to an annual
total of $1.6 billion to $4.2 billion for comprehensive tobacco control programs
Most states will receive a combined average of nearly $41 billion over the next five years
from their settlements with the tobacco industry. The mid-range of CDCs
nationwide funding estimates, $14.5 billion, would account for about a third of the
resources currently available to states.
California and Massachusetts have shown that implementing comprehensive statewide tobacco
control programs can result in substantial reductions in tobacco use. Between 1992, the
year prior to a voter-approved petition to raise tobacco taxes and to fund a statewide
mass-media antismoking campaign, and 1996, per capita consumption declined 20 percent in
Californias per capita consumption declined by 16 percent for the same period.
Oregon has achieved impressive initial declines in per capita consumption following the
implementation of a 1996 voter-supported initiative to raise tobacco taxes and authorize
funding of a statewide tobacco prevention and education program. Between 1996 and 1998,
per capita cigarette consumption declined 11.3% (or 10 packs per capita) in Oregon.
Floridas statewide antitobacco campaign that combines a counter-marketing media
campaign, community-based activities, education and training, and an enforcement program
was effective in reducing teen tobacco use. Tobacco use in Florida among middle school
students declined from 18.5 percent to 15.0 percent and among high school students from
27.4 percent to 25.2 percent
between 1998 and 1999."The true test of
civilization is not the census, nor the size of cities, nor the crops, -no, but the kind
of person the country turns out." Ralph Waldo Emerson"-Society and Solitude.InfoJustice
FINAL RULE ON OTC DRUG PRODUCTS CONTAINING COLLOIDAL SILVER
The FDA has issued a Final Rule declaring that all
over- the-counter (OTC) drug products containing colloidal silver or silver salts are not
recognized as safe and effective and are misbranded.
Colloidal silver is a suspension of silver particles in a colloidal (gelatinous) base. In
recent years, colloidal silver preparations of unknown formulation have been appearing in
stores. These products are labeled to treat adults and children for diseases including
HIV, AIDS, cancer, tuberculosis, malaria, lupus, syphilis, scarlet fever, shingles,
herpes, pneumonia, typhoid, tetanus and many others.
According to the Final Rule, a colloidal silver product for any drug use will first have
to be approved by FDA under the new drug application procedures. The Final rule classifies
colloidal silver products as misbranded because adequate directions cannot be written so
that the general public can use these drugs safely for their intended purposes. They are
when their labeling falsely suggests that there is substantial scientific evidence to
establish that the drugs are safe and effective for their intended uses.
The indiscriminate use of colloidal silver solutions has resulted in cases of argyria, a
permanent blue-gray discoloration of the skin and deep tissues.
Colloidal silver ingredients and silver salts include silver proteins, mild silver
protein, strong silver protein, silver chloride, and silver iodide. The dosage form of
these colloidal silver products is usually oral, but product labeling also contains
directions for topical and, occasionally, intravenous use.
In reaching its decision, FDA considered all of the information described in the
proposed rule (October 15, 1996) and submitted by the public in response to that proposal,
the Final Rule becomes effective on September 16, 1999, 30
days after publication. InfoJustice
CLEARS QUICK NEW LAB TEST FOR PNEUMONIA ANTIGEN
FDA has cleared for marketing a simple, quick, first-of-a-kind urine test for detecting
Streptococcus pneumoniae, one of the bacteria that is a leading cause of pneumonia.
The laboratory test, made by Binax, Inc., of Portland, Maine, provides results in 15
minutes. It is intended to be used in conjunction with review of a patient's symptoms to
rule out other potential causes of pneumonia. Test results can enable doctors to make a
probable diagnosis quicker and start treatment with the appropriate antibiotics sooner.
To perform the test, a swab is dipped into a urine specimen, removed and inserted into the
test device. The test detects S. pneumoniae antigen in the urine of infected patients
within 15 minutes. A positive result indicates that the patient most likely has
pneumococcal pneumonia. Results should be confirmed with culture.
Conventional methods for diagnosing pneumonia, primarily using sputum or blood, are
lengthy (requiring two to three days to several weeks for results), often complex and not
always reliable. The new test is not only quicker, but is much easier to use.
FDA's clearance of the Binax test was based on results of clinical studies in hospitals
and outpatient clinics conducted by the manufacturer at seven sites in the U.S. The
studies included consideration of substances in urine that might interfere with test
results and the effects of vaccination for pneumonia on test results.
The test was found to be 93 percent accurate in detecting S. pneumoniae when it was
performed on urine samples from 373 patients known to have pneumococcal pneumonia. It was
78 percent accurate when performed on urine from 215 patients who had typical symptoms of
pneumonia but may not have had the disease. Test results were not reliable in people who
had been vaccinated for pneumonia within the past five days. (USFDA)
of Better Business Bureaus Names Kenneth J. Hunter as President and CEO
In 1984 our Editor, Dr. Neff wrote the Consumer
Protection Tip on "How to Pick an Ethical Chiropractor" excepted by my now
retired good friend Ruthy, for the Council of Better Business Bureaus Washington DC.
This project had contributing editors such as Charles Duvall Sr, Lead Council for the ACA
Smith, Washington Ave. C. Attorney and old friend, Council Monico NIH, and William Jarvis.
We Solute Kenneth Hunter Anti-Fraud Fighter. Arlington,
VA, August 5, 1999 -- Kenneth J. Hunter, Chief Postal Inspector of the U.S. Postal
Service, has been named incoming President and CEO of the Council of Better Business
Bureaus (CBBB), it was announced today by Calvin J. Collier, CBBB Board Chair and Senior
Vice President & General Counsel/Corporate Affairs, Kraft Foods, Inc.
Mr. Hunter has served as Chief Postal Inspector of the U.S. Postal Service since August
1992. Under his leadership, the Postal Inspection Service made impressive strides in the
detection, deterrence and prevention of fraud. Through outreach to and partnerships with
industries historically plagued by fraud perpetrators, Hunter and his staff achieved
remarkable results educating the public and business community to potential fraud schemes.
"We are pleased that a person of Ken Hunter's caliber will take over the leadership
of the CBBB. He is committed to public service, enjoys an excellent record of
accomplishments in consumer protection and fraud prevention, and has demonstrated
expertise in driving technology advancements within the Postal Service organization. Ken
Hunter possesses strong coalition-building, advocacy and strategic management skills that
will help guide our Better Business Bureau system into the next
century," said Cal Collier.
Hunter will assume leadership of the CBBB in October 1999. He succeeds James L. Bast, who
has headed the CBBB for five years. Bast announced his retirement plans in February 1999
and continues to lead the CBBB until Hunter's arrival.
Ken Hunter Background:
As Chief Postal Inspector, Ken Hunter reports directly to the Postmaster General, with
responsibilities for managing a $450 million budget and 4,500 employees.
A career postal employee with extensive and varied postal experience in the field and at
headquarters, he first joined the Postal Service in 1964 as a letter carrier in Fort
Collins, Colorado. Ken Hunter advanced to Postal Inspector in 1969, Director of the
Minneapolis Postal Data Center in
1979, Assistant Postmaster General in 1985, and Senior Assistant Postmaster General in
1986. In 1988 he was promoted to Associate Postmaster General, and in 1992 named Chief
Over the years, Hunter's responsibilities within the Postal Service have included retail,
marketing, communications, employee and labor relations, training, information resource
management, procurement, facilities and real estate, technology and customer relations.
He attended the University of Colorado and Colorado State University, from which he
received an undergraduate degree in mathematics. Ken Hunter and his wife, Lyn are the
parents of six grown children and live in
Better Business Bureaus: Founded in 1970, the CBBB is the umbrella organization for the
nation's 132 Better Business Bureaus. The CBBB and all BBBs are private-non-profit
organizations funded by membership dues and other support and committed to promoting the
relationship between businesses and the public.
Consumers contact BBBs more than 20 million times annually, to get information about a
business or charity or to file a complaint. Most requests are for pre-purchase reports on
a specific company or charity; other calls are for general information or to file a
complaint about a local business (2 million). Information and assistance is also provided
through the BBB central web site (www.bbb.org) and the web sites of individual BBBs.
National Programs: Through its membership of 320 national corporations and the network of
BBBs, the CBBB provides voluntary self-regulation and consumer and business education
· Advertising Self-Regulation: Forums, including the CBBB National Advertising Division,
the National Advertising Review Board and CBBB's Children's Advertising Review Unit, that
help foster truth and accuracy in advertising and operate in partnership with the
National Advertisers, Inc. (ANA), the American Association of Advertising Agencies, Inc.
(AAAA), and the American Advertising Federation, Inc. (AAF).
· BBBOnLine: Promotes consumer trust and confidence on the Internet through online
reliability and privacy "seal" programs for qualified businesses.
· Dispute Resolution: Services, including mediation and arbitration, to assist businesses
and consumers in the resolution of marketplace disputes. BBB AUTO LINE, which serves the
automotive industry, is one of the largest customer-business dispute resolution programs
in the country.
· Philanthropic Advisory Service: Develops and distributes national charity reports on
non-profit soliciting organizations and determines which charities meet voluntary ethical
· Publications: Publications to provide consumers and businesses with wise purchasing
advice and information on how to avoid scams and frauds. InfoJustice
AND YOUNG ADULT LABOR DAY ALERT
MEASURES TO REDUCE THE THEORETICAL
RISK OF NEW VARIANT CJD FROM BLOOD PRODUCTS
FDA today issued guidance to blood establishments to reduce the theoretical risk of
transmission of new variant Creutzfeldt-Jakob Disease (nvCJD) to recipients of blood
This guidance, a precautionary measure, asks blood centers to exclude potential donors who
have spent six or more cumulative months in the U.K. between Jan 1, 1980, and December 31,
1996 from donating blood.
NvCJD, a fatal degenerative disease found almost exclusively in the United Kingdom (U.K.),
has been linked to an outbreak
of bovine spongiform encephalopathy (BSE) there. No evidence exists that the disease has
been transmitted by blood transfusion, but current studies cannot exclude this
The risk of nvCJD from BSE exposure is unknown. However, if the number of cases of nvCJD
in the U.K. remains low for the next several years, then scientists estimate that the
overall risk of nvCJD to people exposed to BSE will be small. No cases of BSE or nvCJD
have been identified in the U.S.
Also included in this deferral are donors who have received non-U.S. licensed bovine
insulin or other injectable products made from cattle in BSE endemic countries, although
there are no reports of nvCJD transmission by such products.
The U.K. includes England, Scotland, Wales, Northern Ireland, the Isle of Man and the
Previous guidance recommended that potential donors with risk factors or a diagnosis of
classical forms of CJD should be permanently deferred and that any blood products or
plasma derivatives from these donors should be immediately retrieved,quarantined, and
destroyed. However, under the revised guidance, withdrawal of plasma derivatives is no
longer recommended in these cases. (The guidance remains the same for deferral of donors
based on classical CJD and CJD risk and for quarantine of blood components not
manufactured into plasma derivatives.) The reason is that laboratory and large
epidemiologic studies suggest that the risk of classical CJD from plasma derivatives is
extremely low. In addition, shortages of plasma derivatives due partly to the withdrawal
policy related to CJD have caused serious disruptions in patient care.
Although there are no reports of transmission of classical forms of CJD from blood or
blood products, nvCJD differs both in its symptoms and biology. In addition, less is known
about nvCJD and whether it is transmissible through blood or blood products, although
laboratory and epidemiologic studies are underway to evaluate this risk. Therefore, until
more is known about the risk of nvCJD, withdrawal of all blood components and plasma
derivatives made from donations from people later
diagnosed with nvCJD is recommended. The USFDA
Baltimore Firm Recalls
Sausage For Possible Salmonella
WASHINGTON, Aug. 19, 1999 -- Paul Schafer Meat Products, Inc., a
Baltimore, Md., meat processing firm, is voluntarily recalling approximately 35 pounds of
sausage that may be contaminated with Salmonella, the U.S. Department of Agriculture's
Food Safety and Inspection Service announced today. The product subject to recall is
approximately one-pound packages of "Holsteiner Dry Sausage." The package labels
have no sell-by date or code, but "EST 2673" appears within the USDA seal of
inspection. The product was produced on July 30, 1999, and was distributed only in the
Baltimore area. FSIS discovered the problem through its routine monitoring program
for Salmonella. A sample was reported positive on Aug. 17, 1999. Consumption of
foods contaminated with Salmonella can cause salmonellosis, one of the most common
bacteria foodborne illnesses. Salmonella infections can be life-threatening, especially
for infants, the frail or elderly, and persons with chronic disease, HIV infection, or
persons taking chemotherapy. The most common manifestations of salmonellosis are diarrhea,
abdominal cramps, and fever within eight to 72 hours after consumption of product.
Additional symptoms may be chills, headache, nausea, and vomiting, which can last up to
seven days. No illnesses associated with consumption of the recalled product have
been reported to FSIS. Anyone concerned about an illness should contact a physician
immediately. Consumers and media with questions can call plant owner Harold Quaas at (410)
661-5252. Consumers with questions about food safety may call the toll-free USDA Meat and
Poultry Hotline at 1-800-535-4555. The hotline is staffed from 10 a.m. to 4 p.m. (Eastern
Time) Monday through Friday, and recorded information is available 24 hours a day.
MAYO CLINIC ON ANITBIOTIC
You've taken antibiotics in the past. But
this time around you're questioning whether the cure is worse than the illness. Although
the infection you're being treated for seems better, now you're contending with diarrhea a
couple of times a day.
Diarrhea is a potential side effect with almost any antibiotic. Usually it's mild and
clears up once you finish your medication or switch to another antibiotic. However, in
some instances, an antibiotic may cause a much more serious, but usually treatable,
Upsetting Your delicate balance
Antibiotics are prescribed to treat infections caused by bacteria. There are many
antibiotics. Some work against only a few types of bacteria. Others are broad-spectrum
they affect a wide range of bacteria.
Although bacteria are generally thought of as being 'bad,' some are 'good.' For
instance, under normal circumstances your intestines maintain a natural balance of 'good'
bacteria that aid in digestion and help ward off "bad" bacteria.
Antibiotics can upset this balance, allowing harmful antibiotic-resistant bacteria to
disrupt normal intestinal activity. If this happens, you may experience more frequent
bowel movements, loose stools or mild diarrhea.
In about one percent to two percent of people, the imbalance may lead to an overgrowth
of the bacteria Clostridium difficile.
Normally, C. difficile may reside in your intestine in low numbers, thanks to
suppression by 'good' bacteria. But when antibiotics disrupt the natural order, C.
difficile can multiply to the point where it produces a toxin that injures the lining of
the colon and rectum. The result is a condition called pseudomembranous colitis (PMC).
Recognizing and treating PMC
Generally, mild diarrhea associated with an antibiotic clears up once you finish your
medication. Don't hesitate to contact your doctor if you're concerned about the diarrhea
or are tempted to quit taking your antibiotic. If appropriate, your doctor can switch you
to an antibiotic that may not cause as much gastrointestinal trouble.
Pseudomembranous colitis is a different story and warrants immediate medical attention.
The signs and symptoms of PMC are usually much more severe and may include:
- Watery, profuse diarrhea that can be bloody
- Severe abdominal pain and cramping
PMC can develop any time from 2 days after you start an antibiotic to several months
after you've completed treatment.
Ironically, to treat PMC, your doctor may prescribe one of two antibiotics
metronidazole (met-ro-NI-duh-zole) or vancomycin (VAN-ko-mi-sin). Most of the time, the
treatment works with one course. For some people, PMC is severe enough to require
hospitalization while being treated.
PMC is highly contagious. So if you're diagnosed with it, take extra hygiene
precautions such as careful hand washing and not preparing food for others
until you're over the condition.
Living with antibiotics
Having had antibiotic-associated diarrhea or
PMC doesn't mean you can't take antibiotics in the future. But you should exercise certain
Take antibiotics exactly as your doctor directs (be careful not to double dose). Be
aware that antibiotics can make it more difficult to digest fruits and vegetables. The
same is true of carbonated drinks sweetened with fructose, such as soda pop.
If you develop loose stools while on an antibiotic, you may get some relief by reducing
intake of these foods and dairy products and following a bland diet that includes plenty
of fluids (Mayo 8-99).
Senior Health Issues Face The
The federal government offers many programs designed to help senior citizens maintain
good health. Now a new federal health Website called Access America for Seniors (Seniors.gov), brings federal health information for
older Americans in one convenient spot. Information on senior health issues, insurance,
food assistance, nursing homes, and hospitalization is available at a click. The Social
Security Administration hosts the site, which also includes information for seniors on
taxes, volunteer activities, travel, and educational opportunities. Seniors across
America are "mad" that Congress has been taking moneys from Social Security to
finance projects since the 1950's. Mrs. Bertha Snare FFAAJTS has written to the
Republicans, (From the InfoJustice Main Office via e-mail to then Speaker Gingrich, with
letters from Congress back to her) about these issues and believes she is witness to some
support finally developing. Although she is taking one month off to vacation in
Oregon, she will return to help the fight to save Social Security and Medicare for the
Seniors and their "baby boomers", "boomers" etc. InfoJustice
FDA APPROVES NEW DRUG FOR BRAIN
FDA has approved temozolomide, a cancer treatment for adult patients diagnosed with a
form of brain cancer -- anaplastic astrocytoma -- who have relapsed following chemotherapy
including a nitrosourea drug (carmustine or lomustine) and procarbazine. The following may
be used to respond to questions.
Approximately 18,000 new cases of primary intracranial (brain) cancer are diagnosed
each year in the U.S. This represents about 2 percent of all adult cancers. More than 50
percent of these are high-grade gliomas (i.e. glioblastoma multiform and anaplastic
astrocytoma tumors). Patients with these tumors often suffer from severe disabilities such
as motor dysfunction, seizures, and vision abnormalities. The approval of temozolomide
gives patients another option for treatment of their disease when they do not respond to
initial treatment with radiation and chemotherapy.
Temozolomide has been granted accelerated approval - a regulatory mechanism that allows
early approval for a product for the treatment of serious or life-threatening conditions
for which no acceptable alternative treatments exist or which provide a meaningful
therapeutic benefit over existing treatments. Accelerated approval is based on surrogate
markers of effectiveness such as shrinkage of a tumor rather than a documented effect on
clinical benefit such as survival or quality of life.
Temozolomide's approval was supported by a single arm multi-center trial in l62
patients who had anaplastic astrocytoma at first relapse and who had received previous
radiation therapy and may also have received chemotherapy. In the patients with tumors
resistant to previous chemotherapy with a nitrosourea and procarbazine, seven (7) out of
54 patients (13 percent) had partial shrinkage of their tumors while nine percent or 5 out
of 54 patients had a complete response.
Side effects reported include headaches, nausea, vomiting, fatigue and low blood
counts. Patients with severe vomiting may require antiemetic therapy before or during
FDA's approval follows the recommendation of the Oncologic Drugs Advisory Committee for
accelerated approval of temozolomide to treat patients with anaplastic astrocytoma tumors.
Temozolomide was granted orphan drug status in 1998. Orphan status provides incentives
to companies to develop products for use in small patient populations. The drug will
be marketed under the name Temodar.
BILL OF RIGHTS NEEDED TO SUPPORT US CONSTITUTION
All Americans know that absent Law, Society would degenerate into chaos.
Thus, HMO Medicine, (Errisa and Knox Keen Acts) absent the wisdom and Justice of
Law and Civil Remedy is in a state of Chaos. Power profit Big Business downgrading
the Health, Welfare, Life Expectancy and Quality of Life, Freedom, Democracy and a
pre-calculated HMO insidious genocide of you the American People is in the works.
Don't believe it. Look at your fathers, mothers, uncles etc. early death from
smoking Tobacco. Big Business pays big money to Law manipulators. Ask Ken
Starr. The facts remain so far everyone has fought to protect HMO profits.
When will we be a free society once more, able to reason rational and responsible problems
out, solve them and evolve as a nation as we did in the past? We are at a
pre-calcualted stailmate in the evolution of medical care and Insurance. Big
HMO Business and all of Managed Care has you bamboozled. No one fights for
you. Ask Anna Fajac's husband, who after being
told nothing was wrong with her, presented to a Chiropractic Physician, who carried
her from her car to her wheel chair, palpated non-tender swollen lymph nodes etc. during
the carry, called the HMO telling them she had Metestatic Carcinoma. He sent her to
the hospital who then agreed with the Physician. Anna was sent home to die 5 days
later and was cremated. However, her husband came back to tell the story to the
DC. The only health practitioner who told the truth and practiced orthodox
Hippocratic Medicine on that Case! His HMO Bill was
never paid. It went to review, the Doctor was called a Hero in writing by the HMO,
but because he did not perform Manual Medicine on a already fractured and porous spine,
his exam remained unpaid! Everyone fought to protect the HMO
accountants. No-one fought for Anna or for you. You cannot bring suit.
Try it and see what you spend and what you get other than death and loss of wealth.
When will we as Americans take back common sense in our lives, and demand that MD's, DO's,
and DC's be allowed to practice medicine as it is taught in the Medical Schools during
this time of fantastic scientific advancements? The HMO Big Business Amalgam will
spend 100 Million Dollars to fool you. Do you want to continue to be a fool?
Working Men and Women of American, lets join together to protect the right to see a
specialist, the right to go to the nearest ER during an emergency, lets make the HMO's
accountable. After all is that not the basic fundamental of being an
Accountant? I am a Certified Fraud Examiner. Accountants, you know the skills
I possess to have maintained this Cert. since 1993 and perhaps the cases I did prior to
1993. In any event this less than correct care,
authorized by the Business person or in house Big Business Review paid to reduce the bill
doctor must be eliminated and replaced by quality care. I think we as Americans, must
handle this the American Way.
And, hold our Elected Officials to Blaim.
If Big HMO Business want's to play that game, the American Voter can pass the buck
at the Election Booth. "Ah Ha"
! Let us know what you think. Editorial
ISSUES NATIONWIDE HEALTH WARNING ABOUT SUN ORCHARD UNPASTEURIZED ORANGE JUICE BRAND
The Food and Drug Administration is issuing a nationwide warning to consumers against
drinking unpasteurized orange juice products, both frozen and liquid, distributed under a
variety of brand names by Sun Orchard Inc.
of Tempe, Arizona, because they
have the potential to be contaminated with Salmonella
Muenchen, an organism which can
cause serious and sometimes fatal infections in young children, frail or elderly people,
and others with weakened immune systems. Healthy individuals may
suffer short-term symptoms such as high fever, severe headache, vomiting, nausea,
abdominal pain and diarrhea. Long- term complications can include severe arthritis.
Although the company has already issued a warning and undertaken a recall of the
affected product, FDA is taking this action because of continuing reports of illness
related to this product.
The product comes in a variety of forms distributed to retail stores, restaurants and
other dining institutions. The product sold in retail stores comes in clear plastic
gallon, half-gallon, quart, pint, 12 ounce and half-pint containers. The fresh,
unpasteurized orange juice has an enjoy by date of July 7, 1999 or earlier stamped on the
side. The products are identified on the labels as freshly squeezed or fresh orange juice.
The following labels are involved: Sun Orchard, Earls and Joey Tomatoís, Viola, Trader
Joeís, Aloha, Zupan, Markon, and Sysco.
In addition, to these liquid retail products, a frozen form of the unpasteurized juice
was sold under the brand name Vareva especially to restaurants, food services and other
institution. Therefore the agency recommends that consumers check their freezers for the
recalled product and inquire about the source of any unpasteurized orange juice they may
be served at a restaurant or other dining facility.
To date dozens of illnesses have been reported throughout the United States and Canada.
The potential for contamination was noted after several individuals in Pacific
Northwest became ill after drinking the juice. Subsequent investigation confirmed the
presence of Salmonella Muenchen.
Sun Orchard has stopped production of unpasteurized orange juice and is currently
pasteurizing all of its juice products.
Consumers who have purchased unpasteurized orange juice labeled with any of the above
listed trade names are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 206-780-
8042 or 212-213-7012.
HOSPITALS MAY LOWER RATES AND
CHARGE FAIRLY FOLLOWING THE BILLING RULES PROBE INTO COLUMBIA:
NEW YORK (AP) -- The government fraud probe into Columbia/HCA Healthcare Corp.,
resulted in convictions against two midlevel hospital administrators earlier this
month. These verdicts have caused hospitals nationwide to re-evaluate how well they
follow obscure Medicare billing rules. Yet Doctor's of Chiropractic (DC's) were the
practice grounds for twenty or more years. All DC's have always had to know relative
and obscure billing rules. It is clear some Physicians and Business Persons and
especially HMO's are cheating and enjoy making profit off of your lost hope, lost health,
promised hope yet left in medical disappear often drained dry and too penniless to
preserve your own personal best resource your level of critical thinking. As you
health declines so goes your common sense, good judgement, and intelligence.
hospitals have spent thousands of dollars to hire executives called "compliance
officers" who check if the institutions are correctly billing Medicare and other
government health insurance programs.
Some industry experts say hospitals have also become more conservative in
billing -- in effect they are asking the government for less money for some patients. They
note the change could be one reason why Medicare spending has fallen dramatically in the
first half of 1998.
How much hospitals are paid by Medicare depends on many factors, including the
patient's diagnosis at time of admission. A more complex case of pneumonia, for example,
nets a higher fees than a simple pneumonia. Hospitals that may have put more patients into
the complicated category now may be more likely to bill the government for a simple case
so as not to raise ire of government auditors.
The investigation into Columbia/HCA was one of hundreds occurring throughout
the hospital industry in recent years. Indeed, the government has accused hundreds of
hospitals of filing false claims, a civil violation which can result in huge fines. But
health experts say the Columbia/HCA investigation has drawn the most attention because the
chain is the nation's largest, and the inquiry included a criminal probe.
The defendants in the Columbia/HCA trial testified that their dispute with the
government was based on a difference in opinion about complicated Medicare regulations.
Prosecutors said the administrators knew what they were doing was trying to steal from the
Two executives with Columbia/HCA were found guilty July 2 of defrauding
Medicare and other government insurance programs of nearly $3 million. The jury acquitted
another executive and could not reach a verdict on a fourth defendant.
The trial resulted from a six-state investigation of Nashville, Tenn.-based
Columbia/HCA facilities over their billing practices for Medicare, Medicaid and CHAMPUS,
tax-supported health programs for the disabled, elderly, poor and military.
After the investigation began in 1997, Columbia/HCA ousted its top executives,
stopped an aggressive hospital acquisition program and began a major downsizing, trimming
from a high of 345 to its current level of 236. The company, which has operations in 31
states, England and Sweden, has been negotiating a settlement with federal authorities.
Nationwide, hospital trustees have become more vigilant in their oversight role
as a result of the Columbia/HCA probe, Smith said. "No one wants to see their
hospital publicly embarrassed," he said.
The verdicts in the Columbia/HCA case were irrelevant to the hospital industry,
which had begun to pay more attention to Medicare rules soon after government
investigators began serving subpoenas on Columbia/HCA hospitals in 1997, industry
officials said. InfoJustice via AP
ARTICLES LIKE THIS!