FDA

JAMA editorial says FDA cannot be trusted to police itself

Friday, November 26, 2004
by Mike Adams, the Health Ranger
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Summary

The pressure on the FDA to quickly approve medications may be resulting in poor standards and a lack of complete and thorough testing of potentially harmful medications. Recent drug recalls prompted by numerous consumer deaths have raised suspicion of FDA practices and their lumbering mechanism to protect consumers once a drug has been approved. In some cases, years have gone by before the FDA takes action after studies prove that a medication is actually harmful to consumers.

There is also increasing concern that doctors are not being given enough documentation by the FDA and drug companies describing the dangers of these medications before prescribing them to patients.

Original source:
http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2004/11/23/MNGSPA04NI1.DTL

Details

  • The Journal of the American Medical Association, citing the slow pace of drug recalls after evidence turns up lethal side effects, called Monday for the creation of an independent agency to monitor the safety of pharmaceuticals once they come to market.
  • The call for more nimble "post-marketing" surveillance was prompted by a spate of recent drug failures such as the arthritis pill Vioxx and cholesterol- lowering Baycol, both of which were pulled off the market long after studies showed they could be dangerous.
  • In a sternly worded editorial released in advance of its Dec. 1 publication, the prestigious medical journal suggested that inherent conflicts of interest among industry researchers had led to suppression of study findings that were unfavorable to the companies for whom they worked.
  • The editors also faulted the U.S. Food and Drug Administration for lackluster response to reports of adverse side effects in newly approved medications and concluded that only a separate agency could be trusted to monitor safety once drugs cleared the FDA.
  • A professor of medicine at UCSF, Rennie said in an interview that the FDA itself has become a tool of the pharmaceutical industry it is supposed to regulate.
  • The Journal editors trace the problem, as they see it, to the adoption in 1992 of the Prescription Drug User Fee Act.
  • It was designed to speed up the agonizingly slow process of approving drugs by expanding the FDA's staff, drawing on drug company application fees to pay for it.
  • The Journal editors supported their case with a series of articles discussing the August 2001 withdrawal of Baycol, a cholesterol-lowering statin that was introduced by Bayer in February 1998.
  • His study released by the Journal analyzed the link between Baycol and the muscle-wasting disease rhabdomyolysis that led to the pill's withdrawal from the market in 2001.

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About the author: Mike Adams is a natural health author and award-winning journalist with a strong interest in personal health, the environment and the power of nature to help us all heal He has authored more than 1,800 articles and dozens of reports, guides and interviews on natural health topics, and he has published numerous courses on preparedness and survival, including financial preparedness, emergency food supplies, urban survival and tactical self-defense. Adams is an honest, independent journalist and accepts no money or commissions on the third-party products he writes about or the companies he promotes. In mid 2010, Adams produced TV.NaturalNews.com, a natural health video sharing website offering user-generated videos on nutrition, green living, fitness and more. He also founded an environmentally-friendly online retailer called BetterLifeGoods.com that uses retail profits to help support consumer advocacy programs. He's also a veteran of the software technology industry, having founded a personalized mass email software product used to deliver email newsletters to subscribers. Adams also serves as the executive director of the Consumer Wellness Center, a non-profit consumer protection group, and pursues hobbies such as martial arts, Capoeira, nature macrophotography and organic gardening. He's also author a large number of health books offered by Truth Publishing and is the creator of numerous reference website including NaturalPedia.com and the free downloadable Honest Food Guide. His websites also include the free reference sites HerbReference.com and HealingFoodReference.com. Adams believes in free speech, free access to nutritional supplements and the innate healing ability of the human body. Known as the 'Health Ranger,' Adams' personal health statistics and mission statements are located at www.HealthRanger.org

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