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Rick Munroe
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FDA Tosses Critical Professor off Advisory Board


Researcher Who Raised Concerns About COX-2 Inhibitor Bextra Removed From FDA Advisory Panel, Wall Street Journal Reports

[Nov 12, 2004]


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Vioxx, after he was quoted in the New York Times as saying Bextra appeared to have similar risks to Vioxx -- which was withdrawn from the market in September for safety reasons -- and Pfizer tried to conceal that information (Wall Street Journal, 11/12).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).


"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).



(from mydd.com) You'd think that the FDA would WANT academics serving on their advisory councils to have actually read the studies on the drugs they're supposed to be "advising" about; and you'd that that the FDA would most certainly want to show they have advisors more critical than the clowns who gave the "thumbs up" to Vioxx. I guess I'm unsophisticated.


I just saw Marcia Angell, who is the former editor of the New England Journal of Medicine, at a conference this past weekend. She has this great new book out called "The Truth About the Drug Companies." She pointed out that FDA review gets half of its funding from drug companies themselves. They essentially control the clinical trials and much of the academic research of their own products, doing things such as cherry-picking participants so that certain side-effects won't show up, and suppressing negative results. Vioxx is just the newest example.

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