FDA tried to discredit whistleblower over drug safety claims

The Food and Drug Administration tried to discredit one of its own experts after he told a US Senate hearing that the FDA had failed to protect the public over rofecoxib (Vioxx), according to two articles published online by the BMJ today. Dr David Graham, Associate Director in the FDA's Office of Drug Safety, said that the FDA was ''incapable of protecting America against another Vioxx.'' He also indicated that five other drugs currently on the market may be endangering patients.

From British Medical Journal:

FDA tried to discredit whistleblower over drug safety claims

The Food and Drug Administration (FDA) tried to discredit one of its own experts after he told a US Senate hearing that the FDA had failed to protect the public over rofecoxib (Vioxx), according to two articles published online by the BMJ today.

Dr David Graham, Associate Director in the FDA's Office of Drug Safety, said that the FDA was ''incapable of protecting America against another Vioxx.'' He also indicated that five other drugs currently on the market may be endangering patients.

Dr Graham led a study that looked at the cardiovascular risks in patients taking rofecoxib (Vioxx). This was to have been published in the Lancet but was pulled at the last minute after Dr Graham had a warning from his supervisor about publication

The FDA issued a statement after the hearing last week, claiming that Dr Graham had failed to adhere to agency protocol when he submitted his data to the Lancet.

Fearing for his job, Dr Graham sought the help of the Government Accountability Project, a public interest group that protects whistleblowers in order to promote governmental and corporate accountability.

But the group received another request from an anonymous whistleblower at the FDA who was being ''bullied'' by Dr Graham. The caller also said that Dr Graham's study could reflect scientific misconduct. After some investigation, the ''anonymous'' call was found to come from FDA management, attempting to discredit Dr Graham.

Mr Tom Devine, legal director of the Government Accountability Project said the FDA's attacks on Dr Graham's credibility were implausible.

Something is rotten at the heart of the FDA, adds Dr Kamran Abbasi, acting BMJ Editor. As one of the world's leading drug regulators, the FDA needs to show that its primary role is to protect the public and not to protect industry.

Four of the five companies whose drugs Dr Graham said might be endangering patients, have defended their drugs' safety when used as indicated. One company, Roche, had no comment to make on the allegations.

November 25, 2004