FDA Whistleblower Seeks Legal Help From Public-Interest Group

November 25, 2004

Dr. David J. Graham, the FDA drug safety reviewer who sounded warnings over five drugs he felt could become the next Vioxx has turned to a Whistleblower protection group for legal help.

Graham testified during a US Senate Finance Committee hearing looking into the the recall of Merck's arthritis drug Vioxx last week.

Graham fears being fired for testifying that the FDA was "virtually incapable" of protecting the public from unsafe drugs. Graham also testified that five other common drugs currently on the market could become the next Vioxx, and that Vioxx may have caused 55,000 deaths, as well as thousands of heart attacks and strokes.

Graham's lawyer, Thomas Devine, legal director of the Government Accountability Project indicated he had received anonymous telephone calls from people he believed were in FDA management attempting to discredit Dr. Graham.

In a statement, the FDA acknowledged an employee had made contact with the public-interest group, but denied any prior knowledge of the contact.

Graham, a 20-year veteran of the FDA has contributed to the recall of 10 medicines.

Before Vioxx was recalled by Merck, about 20 million Americans used the arthritis drug. A 2000 study of Vioxx showed that patients taking Vioxx had double the risk of heart attacks and strokes compared to those on a placebo.

Graham said the FDA should have acted in 2000 to ban Vioxx when results of the Vigor study were known.