BMJ  2004;329:935 (23 October), doi:10.1136/bmj.329.7472.935

News

US government agency to investigate FDA over rofecoxib

New York

The first 150 words of the full text of this article appear below.

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The drug was withdrawn on 30 September by its manufacturers, Merck, after a study found a fourfold increase in serious thromboembolic adverse events in patients receiving rofecoxib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[Free Full Text], 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" when he sent his report to superiors at the FDA, who wanted him to water down his findings.

The Government Accountability Office has already launched a separate investigation into the FDA after another FDA expert, Andrew Mosholder, said his report warning . . . [Full text of this article]

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