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Jan-06-2012 13:23printcomments

Is Intelligence Compromised by Working with FDA on Safety Issues?

It's obvious that intellectual ability is a threat to the tools working for the pharmaceutical industry within the FDA.

Sidney Wolfe, MD
Sidney Wolfe, MD

(MYRTLE BEACH, S.C.) - “It is an extremely dangerous drug, and it's just reckless for any company to be selling it, and it's reckless in the extreme for the FDA to allow this to stay on the market,” Sidney Wolfe, MD said in regard to Darvon or Darvocet, after it was finally taken off the market by the FDA in 2010. The drugs are the cause of over 2,000 accidental deaths since 1981 and were on the market for 32 years.

In 2009, Dr. Wolfe - Head of the Washington, DC based Public Citizen, and leading nemesis of the Federal Drug Administration (FDA) and the drug industry, was asked by the FDA to join their Risk Management Advisory Committee for a 4 year term. The committee is the most significant one at the FDA in connection with evaluating the safety of drugs. My guess is that no one was as surprised as Dr. Wolfe to be asked to serve on any committee of the FDA. (see: Drug Safety and Risk Management Advisory Committee Charter)

While Dr. Wolfe ran the Health Research Group at Public Citizen, the DC nonprofit founded by Ralph Nader, he waged war on dozens of drugs he felt were unsafe and was directly responsible for having 16 drugs removed from the market and out of the hands of the American consumer.  He was also responsible for having stronger black box warnings put on prescription drugs.  Some, like Merck’s Vioxx, have been pulled from the market; others, like GlaxoSmithKline’s Avandia, are still being peddled by physicians to their patients.

Dr. Wolfe is also an author of Worst Pills - Best Pills and his website is  One of the dangerous drugs he zoned in on was Yaz launched in 2006 by Bayer.  Yaz claims went beyond birth control to the treatment of acne and severe PMS without water retention issues. 

Worst Pills, Best Pills Newsletter Articles
Search results below include Worst Pills, Best Pills Newsletter Articles where your selected drug is a primary subject of discussion
  • Oral Contraceptives Containing Drospirenone - Increased Risk of Blood Clots
    (May 2011)
    This article reviews recent studies showing significantly increased risk of blood clots in high-selling contraceptives containing drospirenone, compared to the lower risk of blood clots with older contraceptives containing levonorgestrel. Drospirenone is an ingredient in the contraceptive pills Yaz and Yasmin, which are sold in the U.S.
The ever vigilant FDA, the watchdog for the American people, held hearings in December 2011 on the safety of the ingredient in Yaz, drospirenone.  But the FDA decided to ban Dr. Wolfe from voting at the Yaz hearings because his newsletter had classified the drug as a "do not use."  The FDA accused Wolfe of an "intellectual conflict of interest."

Maybe Dr. Wolfe should return his MacArthur "genius" award. (see: MacArthur Fellows Program- About the Fellows Program).  It's obvious that having an intellectual ability is a threat to the tools working for the pharmaceutical industry within the FDA.

Back in 2010, the FDA held hearings on Jazz Pharmaceuticals' fibromyalgia drug Rekinia. When Dr. Wolfe asked why the manufacturer's guilty plea and $20 million fine for illegal marketing a different drug was never brought up at the hearings, the good doctor's microphone was shut off. Bob Rappaport, MD, Director of FDA's Division of Anesthesia & Analgesics Products felt that bringing up the wrongdoing cited by Dr. Wolfe would "impugn the sponsor in the hopes that the committee would be punitive towards them in your deliberations and recommendations regarding

Former Conn. AG Richard Blumenthal

this application." In published reports, not only was the Jazz guilty plea irrelevant, the FDA was unaware of it until Wolfe disclosed it.

Approximately a dozen FDA scientists wrote to Obama’s transition team in 2009, calling for critical changes in the agency. The authors, whose names have not been made public, say managers have coerced agency scientists into manipulating data. An FDA spokeswoman told the WSJ the agency is “actively engaged in a process to explore the staff members’ concerns and take appropriate action.”

I hope these FDA scientists updated their resumes and were ready to "hit the pavement" as the FDA took "appropriate" action." A few years ago, then Connecticut Attorney General Richard Blumenthal called for a clean sweep of the FDA because of its inattentiveness to critical health issues. There is not a broom wide enough to accomplish this task -- it goes beyond inattentiveness and borders on criminal ties to the pharmaceutical industry. So maybe Dr. Wolfe would like to answer this for me -- Why are the Drug Enforcement Agency (DEA) statistics on the deaths related to OxyContin so outdated? Maybe Public Citizen could look into this for me -- thousands of families throughout the country and Canada would be so appreciative.

"The FDA may have some expertise when it comes to drug safety and efficacy, but on the only issue that matters — your trade-offs between various risks — you are the expert, and the FDA’s scientists are rank amateurs.”  David Henderson, Economist

LP --  Because we have gold and know that silver tarnishes in the rain forest. 

_________________________________ Reporter Marianne Skolek, is an Activist for Victims of OxyContin and Purdue Pharma throughout the United States and Canada. In July 2007, she testified against Purdue Pharma in Federal Court in Virginia at the sentencing of their three CEO's - Michael Friedman, Howard Udell and Paul Goldenheim - who pleaded guilty to charges of marketing OxyContin as less likely to be addictive or abused to physicians and patients. She also testified against Purdue Pharma at a Judiciary Hearing of the U.S. Senate in July 2007. Marianne works with government agencies and private attorneys in having a voice for her daughter Jill, who died in 2002 after being prescribed OxyContin, as well as the voice for scores of victims of OxyContin. She has been involved in her work for the past 8-1/2 years and is currently working on a book that exposes Purdue Pharma for their continued criminal marketing of OxyContin.

Marianne is a nurse having graduated in 1991 as president of her graduating class. She also has a Paralegal certification. Marianne served on a Community Service Board for the Courier News, a Gannet newspaper in NJ writing articles predominantly regarding AIDS patients and their emotional issues. She was awarded a Community Service Award in 1993 by the Hunterdon County, NJ HIV/AIDS Task Force in recognition of and appreciation for the donated time, energy and love in facilitating a Support Group for persons with HIV/AIDS.

End Israeli apartheid

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Anonymous January 6, 2012 2:44 pm (Pacific time)

but marijuana, with no deaths, is illegal. Go figure. I guess drugs they can patent and make money on is all that matters, and drugs they cant patent, make them illegal, and send those who get caught to the for-profit prisons to work for 25 cents an hour. When will people wake up to what is going on right in front of our faces?

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