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PostPosted: Sun May 14, 2006 11:10 am 
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FDA Removes Panel Member From Drug Review

By ANNA WILDE MATHEWS and SCOTT HENSLEY
Staff Reporters of THE WALL STREET JOURNAL
November 12, 2004; Page A8

A researcher who publicly questioned the safety of Pfizer Inc.'s painkiller Bextra was removed from a Food and Drug Administration advisory panel that will review it and similar products next year.

Curt D. Furberg, a professor at Wake Forest University, Winston-Salem, N.C., said he was informed by the agency that he no longer will participate in the meeting in which the committee will examine the safety of Cox-2 inhibitors, the class of drugs that includes both Bextra and Vioxx, a painkiller that Merck & Co. recently withdrew from the market. Dr. Furberg said he was told by the FDA that his invitation was rescinded because he was quoted in the New York Times as saying Bextra appeared similar to Vioxx and that Pfizer sought to suppress that information.

"They'd said because I had taken a public position, I was disinvited," Dr. Furberg said. He added that he felt he wasn't biased, and he was "trying to be evidence-based" in making findings about Bextra from an analysis of data. "I collected the information to get evidence to contribute to the debate, I drew a conclusion, and I'm off," he said. Dr. Furberg said he still is on the FDA's drug safety and risk management advisory committee, but won't be part of the February Cox-2 meeting.

Sandra Kweder, acting director of the FDA's office of new drugs, said the agency routinely screens advisory committees for possible conflicts, including intellectual as well as financial interests. "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," she said. Dr. Furberg still could speak before the panel as part of the public-comment period, she said.

The panel is set to review the safety of Bextra and Celebrex, another Pfizer drug, as part of an examination of Cox-2 inhibitors. Vioxx was withdrawn from the market in September by Merck following a clinical trial showing that after 18 months, patients taking it had a higher risk of heart attacks and strokes.

Dr. Furberg was quoted in coverage of an analysis he helped to do that found that patients taking Bextra might be at higher risk for heart attack or stroke.

Pfizer called the findings "unsubstantiated." A Pfizer spokeswoman said the company had nothing to do with Dr. Furberg's departure from the panel. "Pfizer would never intervene in any way with the FDA's regulatory process," she said.


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PostPosted: Tue Nov 09, 2010 3:18 pm 
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