Intended for healthcare professionals


FDA bars own expert from evaluating risks of painkillers

BMJ 2004; 329 doi: (Published 18 November 2004) Cite this as: BMJ 2004;329:1203
  1. Jeanne Lenzer
  1. New York

    The US Food and Drug Administration has barred one of its own experts from serving on the panel considering the safety of cyclo-oxygenase-2 (COX 2) inhibitors after he made remarks indicating that valdecoxib (Bextra) may—like rofecoxib (Vioxx), which was recently withdrawn from the market by Merck—cause heart attacks and strokes.

    Dr Curt Furberg, a member of the FDA's drug safety advisory committee and a prominent authority on drug safety, was told his invitation to participate in FDA hearings on the safety of COX 2 inhibitors had been rescinded. This followed his being quoted in the New York Times on 10 November as saying that a study that he and his colleague performed “showed that Bextra is no different than Vioxx, and Pfizer is trying to suppress that information.”

    Larry Sasich, research associate with the US consumer association Public Citizen in Washington, told the BMJ that “Dr Furberg has an unimpeachable record as a scientist” and that his experience as a cardiovascular researcher and the lead investigator of the largest clinical trial on hypertension in the United States put him in a unique position to evaluate risks of drugs. “I don't understand the [FDA] claiming an intellectual conflict of interest in Dr Furberg's case when the reproductive drugs advisory committee has an adamant pro-life advocate, Dr [W David] Hagar.”

    Dr Hagar, known for his opposition to birth control for unmarried women and his writings suggesting that women with menstrual cramps should read the Bible, was appointed to the committee by President George W Bush.

    Victoria Kao, spokesperson for the FDA, told the BMJ that Dr Furberg's removal was the result of a routine review of all panel members for “financial and intellectual conflicts of interest.” When asked about the timing of Dr Furberg's removal, only days after his interview with the New York Times but months before the panel is to meet in February 2005, Ms Kao said that was because “it takes a long time” to do all the reviews.

    According to a September 2001 report by USA Today, 55% of all FDA advisory panellists had financial interests in the drugs they reviewed. A transcript of the most recent arthritis advisory panel meeting in June 2004 shows that seven of the 14 panellists, including the panel's chairperson, received waivers for financial conflicts of interest. Several of the arthritis panellists have written favourable reports on COX 2 inhibitors. When asked how the FDA reaches a decision to remove a panellist who has no financial conflicts while giving waivers to panellists who do have financial conflicts, Ms Kao said, “Each case is individual.”

    Dr Furberg's contention that Pfizer suppressed negative data has been publicly denied by Pfizer. Pfizer's spokeswoman, Susan Bro, told the BMJ that the company issued a news release on 15 October in which it warned about potential risks to patients having cardiac bypass surgery. When the BMJ first called Pfizer, on 14 October, however, Ms Bro denied that valdecoxib posed any cardiac risk. When asked about the negative outcomes seen in the two cardiac bypass studies, Ms Bro instead asked, “Who gave you that information?” and added, “We haven't talked about that.”

    Ms Bro said that other studies of valdecoxib, including a trial of over 8000 patients with osteoarthritis and rheumatoid arthritis, showed no increase in cardiovascular risk.

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