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FDA Officer Suggests Strict Curbs on 5 Drugs

Makers Dispute Claims About Health Risks

By Marc Kaufman
Washington Post Staff Writer
Friday, November 19, 2004; Page A01

A veteran Food and Drug Administration safety officer said yesterday at a Senate hearing on the abrupt recall of the arthritis drug Vioxx that five other widely used drugs should either be withdrawn or more sharply restricted because they have dangerous side effects.

Describing the agency he works for as incapable of stopping dangerous drugs from entering and staying on the market, David J. Graham, associate director of the Office of Drug Safety, told the senators that the FDA's role in reviewing and approving new drugs sometimes conflicts with its duty to address safety issues.

Sandra L. Kweder, acting director of the FDA's Office of New Drugs, center, prepares to testify. (Gerald Herbert -- AP)

The Post's Marc Kaufmann talks about an FDA official's suggestion that five widely used drugs should be withdrawn.
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Asked by Sen. Jeff Bingaman (D-N.M.) to identify the five drugs, Graham hesitated and then named them to the startled listeners: the popular cholesterol-lowering drug Crestor, the weight-loss drug Meridia, the painkiller Bextra, the acne medication Accutane and the asthma medication Serevent.

Each poses different issues, Graham said in response to senators' questions, but all require more aggressive FDA action.

AstraZeneca's Crestor, he said, poses risks of kidney failure and a rare muscle disease; Abbott Laboratories' Meridia is of little use and has cardiovascular side effects; Roche's Accutane can cause birth defects if used by pregnant women; Pfizer's Bextra carries cardiovascular risks similar to those linked to Vioxx; and GlaxoSmithKline's Serevent increases the risk of dying of asthma. The makers of all five drugs later defended their products vigorously.

A 20-year veteran of the FDA, Graham has played a significant role in the withdrawal of nine drugs over the past decade, and his highly unusual attack on his own agency astonished many in the hearing room. He called the FDA's handling of Merck & Co.'s Vioxx -- which he said should have been pulled from the market years ago -- the most distressing episode of all and a "profound regulatory failure."

"I would argue that the FDA as currently configured is incapable of protecting America against another Vioxx," Graham said in his scathing assessment. "The scientific standards [the FDA] applies to drug safety guarantee that unsafe and deadly drugs will remain on the U.S. market."

Citing estimates he said were based on the results of Merck's own clinical trials, Graham said that between 88,000 and 139,000 Americans probably have had heart attacks or strokes as a result of taking Vioxx, and that 30 to 40 percent probably died.

Graham's sentiments were endorsed at the hearing by two other drug safety experts, but they were disputed by a ranking FDA official as "not the FDA that I know."

Sandra L. Kweder, deputy director of the Office of New Drugs, said that the agency is dedicated to protecting consumers and that drug safety is at the heart of its activities. She acknowledged, however, that "clearly, there's concern by the public and this committee that the system isn't working as well as it should, and we need to address that."

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