26 November 2004

Vioxx Whistleblower Points Finger At FDA

by Kate Melville

The British Medical Journal says that the FDA tried to discredit one of its own experts after he told a U.S. Senate hearing that the FDA had failed to protect the public over rofecoxib (Vioxx). 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 Vioxx. The study was to have been published in The Lancet but was pulled at the last minute after Dr Graham received a warning from his supervisor about publication. The FDA issued a statement 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 Government Accountability Project then received another request from an anonymous FDA staffer who claimed to be "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, in what would appear to be an attempt 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. Dr Kamran Abbasi, acting British Medical Journal Editor added that 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.