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 British Medical Journal.
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.