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FDA Removes Panel Member from Drug Review (from ATSNN)

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posted on Nov, 12 2004 @ 06:27 PM
A researcher who publicly questioned the safety of a popular arthritis medication 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 Furberg said he was told by the FDA that his invitation was rescinded because he was quoted in the New York Times as saying Bextra appeared similar to Vioxx and that Pfizer sought to suppress that information.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.

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 Vioxx was withdrawn from the market in September by Merck following a clinical trial showing that after 18 months, patients taking it had a higher risk of heart attacks and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.

Please visit the link provided for the complete story.

After the withdrawal of Vioxx from the market due to elevated risk of heart attack and stroke, Dr. Furberg made the mistake of publicly stating that the drug Bextra seemed to produce the same elevated risks. Pfizer, Inc., the makers of Bextra, called his findings "unsubstantiated," and a spokesperson claimed that the company had nothing to do with the FDA's decision to exclude Furberg from the Cox-2 investigations.

The president of Pfizer, Hank McKinnell, recently donated $100,000 to the Bush/Cheney inaugural fund.

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ATS: Merck and Vioxx: A Twisted Tale of Cover-ups, Pork and Profits

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