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FDA Bars Critic From Meeting

Agency Cites 'Intellectual Conflict' in Removing Safety Expert

By Marc Kaufman
Washington Post Staff Writer
Saturday, November 13, 2004; Page A05

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advisory committee, was told Thursday that an invitation to participate in the panel's key February meeting had to be rescinded because of an "intellectual conflict of interest."

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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."

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.

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