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FDA bars critic from meeting

A prominent drug safety expert has been removed from a Food and Drug Administration advisory panel meeting on Vioxx and other arthritis drugs because of comments he made this week suggesting that the entire class of medications may be unsafe.
/ Source: a href="" linktype="External" resizable="true" status="true" scrollbars="true">The Washington Post</a

A prominent drug safety expert has been removed from a Food and Drug Administration advisory panel meeting on Vioxx and other arthritis drugs because of comments he made this week suggesting that the entire class of medications may be unsafe.

Curt D. Furberg, a member of the FDA's drug safety advisory committee, was told Thursday that an invitation to participate in the panel's key February meeting had to be rescinded because of an "intellectual conflict of interest."

Furberg, an acknowledged expert on assessing the risks of drug side effects, had commented earlier this week on an analysis he had just completed on possible cardiovascular risks from the arthritis drug Bextra. The drug is a COX-2 inhibitor such as Vioxx, which Merck & Co. took off the market in September because of a study showing that it increased the risk of heart attacks and strokes.

Furberg said yesterday he was concerned that "higher-ups" in the FDA wanted to silence him.

"I think they're trying to control criticism at the committee meeting," he said. "The fact that I've commented on the issue should be irrelevant. I've done research and some analysis here, and think I'm the most qualified to comment on the data, but now they're going to take me away. It doesn't make much sense."

‘These are tough calls’
Sandra Kweder, deputy director of the FDA Office of New Drugs, said it was not unusual for advisory panel members to be kept from participating in a meeting if they have clear financial interests or intellectual positions that could keep them from being objective.

Kweder said Furberg had said publicly this week that he thought Bextra, made by Pfizer Inc., was as bad as Vioxx or worse when it comes to cardiovascular risk. She said that made him unsuited for the advisory committee that would be weighing that question.

"For someone to be recused from a meeting because their words or their research show that their mind is made up, it happens," she said.

But she also said that "these are tough calls" and that the decision might be reconsidered, especially if the committee could not find another person with Furberg's expertise.

FDA spokeswoman Victoria Kao said the advisory committee's consultant staff first flagged Furberg's comments and raised questions about whether he should remain on the committee. Kao said their concerns were forwarded to the FDA's ethics division, which is part of the commissioner's office, for further evaluation.

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.

Significant 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.

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.