Tuesday, September 13, 2005
An FDA advisory panel has recommended approval of the diabetes drug, Pargluva, made by Bristol-Myers Squibb. On Thursday, another advisory panel with some of the same members voted to recommend another diabetes treatment, Exubera, developed by Pfizer with Sanofi-Aventis and Nektar Therapeutics. The panel in Silver Spring, MD, decided that Pargluva's benefits outweighed its potentially serious heart risks, even though no cardiologist was present for the vote, according to the N.Y. Times. One of the panelists who is a cardiologist skipped the meeting due to a potential conflict of interest; he conducted research on PPAR-agonists, the class of drugs being debated. The article says that "the absence of the only heart doctor on the Pargluva advisory panel is but one illustration of how conflicts of interest can affect the deliberations of F.D.A. panels, in which outside committees help the agency decide whether to approve new drugs."
In fact, an analysis by the Center for Science in the Public Interest says both panels raised conflict-of-interest issues. According to Director Merrill Goozner, "the public's faith in the integrity of the process is undermined when one-third of an advisory committee's membership has significant financial ties to the company seeking the product's approval." The center reports that three of the Exubera committee's nine members had previously consulted or spoken for Pfizer or Nektar Therapeutics. One member, acting as chairman, holds stock in Pfizer and voted against Exubera. Another panel member participated but did not vote as a result of his industry ties.
Currently, the Congress is addressing the issue of potential conflicts of interest by drug reviewers. The House has adopted legislation (HR 2744) that would bar scientists with drug industry ties from participating in FDA panels. However, Dr. Plutzky, the absent cardiologist panelists of the advisory committee, argues that the appearance of conflicts of interest is a complex issue due to the fact that the scientists most knowledgeable about drugs being reviewed are often those who have received research grants from drug companies: "Ultimately, the FDA needs to have a source of valid and rigorous information."
Thanks to Lindley Bain for help on this post. [tm]