FDA Vet Blows Whistle on "Broken" Agency

November 19, 2004

Audio Version

Congress has taken up the probe of how an FDA-approved drug like Vioxx could turn out to be harmful to the people who take it. The trail appears to be leading to the FDA's door.

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When a Senate committee began looking into the issue this week, it heard from David Graham, a long-time FDA drug reviewer. Graham told the committee that Vioxx is far from the only problem. He said five drugs currently on the market at dangerous.

He named the weight-loss drug Meridia, the anti-cholesterol drug Crestor, the acne drug Accutane, the painkiller Bextra, and the asthma treatment drug Serevent as being dangerous and said they should be immediately recalled.

This bombshell came as the committee was delving into what pharmaceutical company Merck knew about Vioxx's dangers, and when it knew it. Published reports appearing after Vioxx's recall have charged that Merck officials were told the arthritis pain killer might cause strokes and heart attacks, but covered up the data because the drug was so profitable.

Graham suggests that one company is not the problem, but that the FDA is "broken" and unable to deal seriously with questionable new drugs. He said the agency is defenseless to stop another tragedy like Vioxx.

Graham's blistering attack has already produced sharp rebuttals. Pharmaceutical companies insist their produces are safe, and FDA Deputy Director Sandra Kwedler denied her agency has fatal flaws

The head of Merck said he always believed in Vioxx, and that is wife was on the drug until the day it was recalled from the market. After hearing from several witnesses, some members of the Senate committee said an independent board should be set up to ensure the safety of medications - a job the FDA is supposed to be doing.

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