SENATOR ACCUSES FDA OF WORKING TO DISCREDIT VIOXX WHISTLEBLOWER

Sen. Chuck Grassley (R-Iowa) is accusing the agency of actively working with Merck to discredit a Vioxx whistleblower and is asking the HHS Office of Inspector General to investigate this claim.

Grassley alleges in a July 19 letter that he has evidence an FDA official met with Merck to discuss strategies for undermining David Graham, an agency employee and the whistleblower who alerted the public to concerns with the safety and efficacy of Vioxx (rofecoxib). "This evidence makes it look like the FDA hung Dr. Graham out to dry," Grassley said in a release.

Graham was the lead witness in Grassley's November 2004 hearing on Vioxx. Merck voluntarily pulled its arthritis drug Vioxx from the market in 2004 after it was linked to heart attacks and strokes. The company now faces thousands of product liability suits stemming from this drug.

"It is no secret that Dr. Graham was and is a critic of the FDA," Grassley wrote. "However, that does not mean the FDA should scheme with drug sponsors to discredit its own employees. Moreover, the FDA may disagree with the characterizations made by Dr. Graham, but that does not absolve the FDA of its duty to maintain a clear, bright line between the regulated and the regulator," he added.

The senator has handwritten notes taken by Ned Braunstein, the senior director of Merck research labs, at a meeting with Brian Harvey, the agency's director of the Division of Gastrointestinal and Coagulation Drug Products and deputy director of the Office of Nonprescription Products, before a November 2004 Senate hearing on Vioxx, the letter said. In those notes, Braunstein detailed Harvey's suggestion that there be "an official rebuttal on Graham." The notes also discuss efforts by the agency to "get the message out on Graham," including suggesting to Merck that it provide journalists with a copy of its critique of him.

Grassley has been one of the agency's strongest critics, questioning the FDA's drug safety policies and accusing the agency of being too close to industry to effectively regulate in the public's interest.

Neither Merck nor the FDA could be reached for comment on this story. (http://www.fdanews.com/did/5_141/)