FDA_Conflicts_of_Interest_and_VIOXX[1] - The FDA's Conflict...

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The FDA's Conflict Of Interest Problem Forbes.com Matthew Herper, 02.24.05, 7:05 PM ET NEW YORK - By all rights, the storm surrounding the arthritis drugs Celebrex, Bextra and Vioxx should start to dissipate now that a panel of 32 doctors voted that all three drugs have at least some place on the market. But what if some of these doctors convened by the Food and Drug Administration (FDA) are seen as having material conflicts of interest that might have swayed their votes? Normally, before an FDA advisory committee meets, a list of potential conflicts of interest is read aloud. Some experts with material conflicts, such as having received fees for lectures from drug companies or owning stock in them, are allowed to sit on the panel. But this occurs only when the doctor's expertise is considered irreplaceable to the FDA. In at least one case, a panelist owning tens of thousands of dollars in one drug firm's stock was allowed to give advice about a competitor. "The FDA has a pretty high threshold for conflict of interest," says Sidney Wolfe, of the watchdog group Public Citizen. "That is a serious problem. It isn't as if you can't find people." As the panel convened last week to consider the arthritis drugs, no disclosures were read. Instead, the panel's secretary read a statement explaining why they weren't necessary. "Based on the agenda," the statement said, "it has been determined that the topics of today's meeting are issues of broad applicability, and there are no products being approved. Unlike issues before a committee in which a particular product is discussed, issues of broader applicability involve many industrial sponsors and academic institutions." However, this panel was making decisions about whether medicines vital to two companies should be on the market, unlike a typical meeting to advise the FDA on what should be required to approve a drug for, say, gouty arthritis. The statement went on to say that waivers had been issued to the panel, and that these could be obtained by submitting a Freedom of Information Act request to the FDA. "The FDA acknowledges that there may be potential conflicts of interest," the statement said, "but because of the general nature of the discussions before the committee, these potential conflicts are mitigated." However, while it's certainly true that the panel addressed the future of some two-dozen painkillers, the main focus--from a financial perspective--was on three of these pills. On its earnings call in January, Pfizer (nyse: PFE - news - people ) several times pointed forward to the FDA meeting, saying it could not give earnings guidance until it was completed. "We need the FDA review in mid-February," Pfizer Chief Executive
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This note was uploaded on 09/07/2011 for the course BUS 682 taught by Professor Staff during the Spring '11 term at S.F. State.

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FDA_Conflicts_of_Interest_and_VIOXX[1] - The FDA's Conflict...

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