12 November 2004

Researcher Who Raised Concerns About COX-2 Inhibitor Bextra Removed From FDA Advisory Panel

Curt Furberg, a professor at Wake Forest University, has been removed from an FDA advisory panel set to review the safety of COX-2 inhibitors next year, after he publicly questioned the safety of Pfizer's Bextra, the Wall Street Journal reports (Mathews/Hensley, Wall Street Journal, 11/12). Preliminary results of a University of Pennsylvania study presented on Tuesday at the American Heart Association annual conference in New Orleans indicated that Bextra doubles patient risk for heart attack and stroke (Kaiser Daily Health Policy Report, 11/11). Furberg said FDA informed him that he would no longer participate in a committee meeting next year to review the safety of COX-2 inhibitors, including Bextra, Pfizer's Celebrex and Merck's Vioxx, after he was quoted in the New York Times as saying Bextra appeared to have similar risks to Vioxx -- which was withdrawn from the market in September for safety reasons -- and Pfizer tried to conceal that information (Wall Street Journal, 11/12). The FDA meeting on COX-2 inhibitors is scheduled for mid-February (Kaiser Daily Health Policy Report, 11/11).

 Reaction

"They'd said because I had taken a public position, I was disinvited," Furberg said, adding that his statements were "evidence-based." Furberg said, "I collected the information to get evidence to contribute to the debate, I drew a conclusion, and I'm off." Sandra Kweder, acting director of FDA's office of new drugs, said, "If he's already expressed a particular point of view, and especially written a paper on it, it would be difficult to expect him to come to such a meeting and be objective about the subject." An unnamed Pfizer spokesperson said, "Pfizer would never intervene in any way with the FDA's regulatory process" (Wall Street Journal, 11/12).

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