Another Avandia panelist has confessed a potential conflict of interest. Dr. Abraham Thomas, who heads up the endocrinology and diabetes division at Detroit's Henry Ford Hospital, says he was a paid speaker for Takeda Pharmaceutical--which makes Avandia's direct rival Actos--in 2007 and 2008. And during last week's hotly contested advisory committee meeting, Thomas was one of 12 panelists who voted to withdraw the drug.
The news from Thomas comes after another panelist, Dr. David Capuzzi, was found to be a paid speaker for GlaxoSmithKline (NYSE: GSK), which makes Avandia. Capuzzi spoke on behalf of a different drug, Lovaza, but also served on a company advisory panel on Avandia sometime before 2009, the company says. At the committee meeting, Capuzzi voted to leave Avandia on the market with no additional warnings or restrictions--one of three panelists who did so.
At last week's meeting, the FDA's expert advisors heard evidence from all sides of the Avandia question, aiming to determine whether the diabetes drug is safe enough to stay on the market--and if so, whether it needs stronger warnings or restrictions. After the two-day confab, the panel voted 20-12 to keep Avandia, with most of the 20 advising additional warnings or restrictions.
Now, the FDA is investigating the Capuzzi situation, trying to figure out why his financial ties to GSK didn't come up during the pre-meeting vetting process. Presumably the agency will do the same on Thomas, but it hasn't commented officially. What the FDA does say is that it will weigh the evidence as it considers what to do about Avandia. "If any member of the advisory committee is found to have a conflict of interest," the agency tells the Wall Street Journal, "FDA can consider that information as we make our final decision on the status of the drug."
- read the WSJ piece