FDA and Vioxx
by Guest Blogger, 10/18/2004
In case you've been missing the story: "Since the Merck decision [to withdraw Vioxx], public health advocates and some congressional leaders have asked pointedly why the FDA, the nation's arbiter of drug safety, did not act sooner itself." Here's a review of FDA's role:
Independent studies of Vioxx users continued to add to the questions, and the FDA began its own review. The safety officer who conducted it concluded this summer that the drug posed a serious risk. But he said that the results were ignored and that the FDA made efforts to silence him. . . .
The FDA's own study of the Vioxx safety issue has become mired in controversy. The FDA safety officer in charge of the report, David Graham, concluded that Vioxx posed much greater cardiovascular risk than the other major drug in its class, Celebrex. He presented that information at a French conference this summer. Galson has said, however, that he only saw a short abstract of the study and so could not act on its conclusions, a contention that Graham disputes.
The controversy grew on Friday when Grassley asked Merck, among other things, about an e-mail provided by Graham in which a Merck official complained that the FDA had not lived up to a prior agreement to alert the company before releasing any negative information about its products.
--Brooke A. Masters & Marc Kaufman, "Painful Withdrawal for Makers of Vioxx: Pulling of Arthritis Drug Raises Questions on Marketing, Safety Risks," Wash. Post, Oct. 18, 2004, at A1.
