Officials at Pfizer, who had called the Bextra paper by Furberg and his colleagues "unsubstantiated," said this week they played no role in his removal from the panel.
FDA advisory panels, made up of recognized experts in their fields, meet when the agency wants scientific guidance about controversial, complex or highly technical issues. The panels usually register their views about specific scientific questions by voting at the end of a meeting, and those votes carry considerable weight within the agency.
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The February panel is considered an especially important one because it will examine whether the cardiovascular problems found with Vioxx are specific to that drug or a feature of the entire class of COX-2 inhibitors. Celebrex, a COX-2 drug made by Pfizer, is one of the largest-selling drugs in the world.
Furberg said he had been invited onto the COX-2 panel on Oct. 25 and had begun researching information about the drugs to prepare himself. The panel is made up primarily of arthritis specialists, and Furberg said he was brought in as a drug safety expert. News that Furberg's invitation had been rescinded was first reported by the Wall Street Journal.
Peter Pitts, who until recently was in charge of the FDA advisory committees as associate commissioner for external relations, said the decision to remove Furberg from the committee was "unusual but not unprecedented."
He said that advisory panel members are "usually trained not to be public with their opinions about matters in front of their committees," and that a decision to remove someone would be based on how outspoken he had been.
Furberg has been a member of the FDA's Drug Safety and Risk Management Advisory Committee since it was formed in 2001. A professor at Wake Forest University and former chairman of the Department of Public Health Sciences at Wake Forest University Baptist Medical Center, he has been a vocal advocate for more aggressive monitoring of drugs already on the market.
In 1995, he and several colleagues discovered that a class of drugs used to control high blood pressure, called calcium channel blockers, sharply increased the risk of heart failure rather than preventing it, as had been widely accepted. Their work was published in the Journal of the American Medical Association and drew angry protest from the drug industry. But a large, federally funded trial that Furberg chaired confirmed a dramatic increase in heart failures with one prominent calcium channel blocker.
The issue of prescription drug safety, and whether the FDA and drug companies are properly monitoring dangerous side effects of drugs already on the market, has become a politically charged one in recent months.
The Vioxx withdrawal in particular has become a lightning rod for criticism, in part because possibly harmful side effects were first noted soon after Vioxx was approved by the FDA in 1999, and in part because aggressive direct-to-consumer advertising quickly made it a blockbuster drug.
Sen. Charles E. Grassley (R-Iowa), a vocal critic of the FDA, plans to hold a hearing Thursday on the Vioxx withdrawal.