In a recent eight-to-one vote, an FDA panel recently recommended approval of the diabetes drug Pargluva, despite concerns that it could cause potentially serious heart problems. Astoundingly, the decision was made without the help of a cardiologist, since the panel's lone heart expert declined to participate due to a potential conflict of interest.
The vote marked the second time in a one-week period that questions arose over conflicts of interest at the FDA. Prior to the advisory panel's recommendation on the Bristol-Meyers Squibb drug Pargluva, a separate panel, with some of the same members as the Pargluva panel, voted to approve Exubera, an inhaled form of insulin made by Pfizer in partnership with Sanofi-Aventis and Nektar Therapeutics.
Following the Exubera recommendation, an analysis by the Center for Science in the Public Interest showed three of the panel's nine voting members had previously consulted with or spoken for Pfizer or Nektar Therapeutics, and the panel chairman – although he voted against approval of the drug – held stock in Pfizer. Some of these same members participated in the panel that approved Pargluva, and despite their vested interests in the drug industry, one of the panel members was given a waiver that allowed him to vote on Pargluva. Two other panel members were granted waivers to vote on both Exubera and Pargluva, according to the CSPI analysis.
In addition to those who received waivers, another member of the Pargluva advisory panel declined to participate because of a potential conflict of interest. Dr. Jorge Plutzky, the Pargluva advisory panel's sole cardiologist, opted out of the approval process because he had conducted extensive research on PPAR-agonists, the type of drug subject to approval.
However, while Dr. Plutzky may have removed himself to avoid problems with conflict of interest, the fact that a conflict of interest existed in the first place posed problems, since his absence meant the panel lacked the expertise of a heart doctor. This is particularly troubling since the main argument against Pargluva is that it might double the risk of cardiovascular disease in diabetics.
An Oct. 20 article in the Journal of the American Medical Association, by Drs. Steven E. Nissen, Kathy Wolski and Eric J. Topol, points to the significant cardiovascular risks posed by Pargluva. After reviewing the same briefing documents presented to the advisory panel, the article's authors concluded that the drug more than doubled the risk of potentially fatal heart attacks (2.11 percent of diabetic patients taking Pargluva experienced cardiovascular problems like congestive heart failure, stroke, heart attack and death, compared to 0.81 percent of patients taking a placebo). The nature of these risks makes the absence of a cardiologist in the drug's approval process a significant concern.
In the wake of these and other FDA decisions that have brought conflicts of interest to light, the fiscal year 2006 Agriculture/FDA appropriations bill will allow for advanced public notice when a scientist with a conflict of interest is to serve on an advisory panel. According to an Oct. 27 CSPI press release, the bill will require the public be given 15 days notice when the FDA wants to put an individual with a potential conflict of interest on one of its 30 advisory panels. Waivers granted to scientists, along with their potential conflicts, must be published for public viewing. Up to now, these items have been kept secret from the public for years.
Although the CPSI hails the provisions of this new bill as a "step in the right direction," it also recognizes that it is not enough. While public disclosure gives the public the power to evaluate FDA activity more carefully, many argue that what the FDA needs is a group of scientists free from all conflicts of interest.
The CSPI continues to push for this, saying in the press release, "CSPI believes the FDA can find qualified scientists without conflicts of interest to serve on all of its advisory panels. That's why the waivers should be disallowed entirely. At the least, the present disclosure bill could have been made stronger by forbidding scientists with waived conflicts of interest from voting at the conclusion of a committee's deliberations."
After the Vioxx scandal left so many individuals questioning the legitimacy of the FDA's drug approval procedure, it is clear that the FDA has a long way to go in smoothing out this process. When advisory panels are tainted with conflicts of interests, it becomes difficult to trust the decisions these panels make, and this has major implications for public health. The bottom line is, there should be a divide between the individuals approving drugs and the companies making those drugs. Individuals with financial ties to the drug industry should not be approving drugs for public use. It should be important to all of us that the FDA find honest, independent scientists and researchers who work for the public, not the pharmaceutical industry.
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