On August 6, 2003, Timothy "Woody" Witczak went out to his garage and hung himself from a rafter. The 37-year-old, who had no history of depression, had been prescribed the antidepressant Zoloft to treat the insomnia he had experienced since starting a new job.
Neither Woody nor his family were warned that one of Zoloft's reported side-effects was suicidal behavior, despite the fact that for more than a decade, both Pfizer, the company that produces the drug, and the Food and Drug Administration had been aware of suicidal incidents linked to antidepressant use. In 2004, the FDA actually prevented one of its scientists from revealing the correlation to the House Energy and Commerce Subcommittee on Oversight.
Combined with the now infamous political intervention that stymied the approval process for the potentially over-the-counter morning-after pill Plan B, and the failure of the FDA to act in a timely manner in the Vioxx and Celebrex cases, it's apparent that the agency is failing in its responsibility to regulate the products that account for 25 cents of every consumer dollar spent in the US.
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Last week, the Union of Concerned Scientists released the results of an anonymous survey sent to 5,918 FDA scientists (of which, nearly 1,000 responded) that helps give a full picture of the dysfunction.
It paints an ugly picture.
The researchers' answers portray a culture of discontent where scientists report not having enough resources to properly evaluate products, having scientific results ignored, being pressured by political appointees to approve drugs and--most criminal, considering the FDA's mission--providing misleading information to the public.
The survey's critics, led by FDA spokeswoman Susan Bro, argue that its questions were leading and unscientific. But what they cannot refute is the 69 pages of scientist-penned essays, which clearly describe some of the agency's most disgusting practices: "They just take you off the product review if they don't like your opinion," was one common refrain. The scientists also reveal that "decisions are influenced by industry lobbying and political pressure," and that a division Deputy Director would approve "a drug, regardless of the medical and statistical review, without ever looking at the data."
In recent years, the FDA has been consistent in its denial of serious internal problems. In 2004, safety officer David Graham--who blew the whistle on Vioxx--testified in the Senate that the agency was unable to keep drugs that officers felt were unsafe off the market. Naturally, FDA officials refuted Graham's testimony, labeling it "inaccurate" and "unscientific."