WASHINGTON – A veteran Food and Drug Administration safety officer Thursday told a Senate hearing inquiring into the abrupt recall of the arthritis drug Vioxx that five other widely used drugs should be either withdrawn or sharply restricted because they have dangerous side effects.
Describing the agency that he works for as incapable of stopping dangerous drugs from coming to and staying on the market, David 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.
Asked by Sen. Jeff Bingaman, D-N.M., to identify the five drugs, Graham hesitated and then listed them to the startled hearing room: 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 answer to questions from senators, but all require more aggressive action by the FDA.
AstraZeneca’s Crestor, he said, poses risks of kidney failure and a rare muscle disease; Abbott Laboratories Inc.’s 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 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 US market.”
Citing estimates he said were based on the results of Merck’s own clinical trials, Graham said between 88,000 and 139,000 Americans have likely had heart attacks or strokes as a result of taking Vioxx, and that 30 percent 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 Kweder, deputy director of the Office of New Drugs, said the agency is dedicated to protecting consumers and 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.”
Asked about the five drugs that Graham identified as needing immediate action, Kweder said, “I don’t have reason to believe that set of five drugs gives more reason for concern than any other set.”
Talk to us
> Give us your news tips.
> Send us a letter to the editor.
> More Herald contact information.
