Summary

Recent recalls of popular medications such as Vioxx have shed light on the failed approval process of the FDA, highlighting the fact that several medications with harmful side effects have been approved by the agency and directly resulted in the deaths of consumers. At this time, the general public's view of the FDA is in jeopardy and the FDA is increasingly being seen as an agency that values pharmaceutical industry profits over the health of the general public.

Original source:
http://www.newsday.com/news/health/ny-hsjama1123,0,3997545.story?coll=ny-health-headlines

Details

• Arguing that the country's system for monitoring drug safety is haphazard and ineffectual, editors of a leading medical journal Monday called for a radical overhaul and suggested the creation of a new independent drug safety board.
• The bluntly worded editorial in the Journal of the American Medical Association says the country's surveillance system of prescription drugs on the market is inherently flawed, largely relying as it does on pharmaceutical manufacturers to investigate the adverse effects of their own products.
• In response, a U.S. Food and Drug Administration official said the JAMA editorial proposal "warrants serious consideration."
• But, he said, the Institute of Medicine, an arm of the National Academy of Sciences that advises the government on health issues, has already been asked to study the drug safety system.
• The editorial noted that the institute's study would take too long to complete, and that urgent steps were needed to restore confidence in the FDA.
• "I reject the concept that there's a crisis of trust" in the agency, Dr. Steven Galson, the FDA's acting director of drug evaluation and research, said in a telephone interview.
• The article suggests the company's analyses that found an increased risk of rhabdomyolysis -- a breakdown in muscle that can cause kidney damage -- were never made public.
• Another large study based on claims filed with 11 health insurance plans found that patients taking three similar cholesterol-lowering drugs, or .statins -- atorvastatin (Lipitor), pravastatin (Pravachol), and simvastatin (Zocor) -- face a relatively low risk of developing the muscle disorder.
• The JAMA editorial suggested industry influence over the approval process has increased since 1992, when the FDA started charging companies seeking drug approvals "user fees."
• She noted that some countries monitor the first 10,000 users of a new drug over a prolonged period and others require re-approval every five years.

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