Sunday, September 11, 2005

Conflicts of Interests Affecting More FDA Panels

The New York Times reported that the US Food and Drug Administration (FDA) expert panel that reviewed the new drug Pargluva (muraglitazar) had conflicts of interest, as did the panel with overlapping membership that reviewed the new inhaled insulin product, Exubera.
On the other hand, the Pargluva panel's one cardiologist did not attend the meeting, because he had a potential conflict of interest. Although I could find no controlled trials of Pargluva yet available on Medline, this summary of the panel's meeting indicates concerns about increased rates of congestive heart failure and cardiac death in patients who received Pargluva. (The cardiac death rate was roughly 0.3% in patients receiving Pagluva, but 0% in those receiving Actos during the time of observation, which was not stated. Similarly, the incidence of congestive heart failure [CHF] was 0.75% for Pargluva, and 0% for Actos. The absence of deaths or incident CHF cases in the comparison group suggests that the observation period was short, or that the patients were selected for low risk of cardiac disease.)
A list of conflicts of interest affecting the Exubera panel is available in this press release from the Center for Science in the Public Interest (CSPI).
As Merrill Goozner, director of the CSPI Integrity in Science project put it, "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."

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