US government agency to investigate FDA over rofecoxib

doi:10.1136/bmj.329.7472.935

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Jeanne Lenzer

New York

The US Government Accountability Office, a regulatory watch-dog on federal government spending, is to investigate claims that the Food and Drug Administration attempted to silence one of its senior medical officers when he tried to warn that rofecoxib (Vioxx) caused heart attacks and strokes.

The drug was withdrawn on 30 September by its manufacturers, Merck, after a study found a fourfold increase in serious thromboembolic adverse events in patients receiving rofecoxib compared with patients receiving placebo (BMJ 2004;329: 816, 9 Oct).

David Graham, associate director for science in the FDA Drug Center's Office of Drug Safety, said that he was subjected to “veiled threats” …