[This is an update of an earlier story.] At the Avandia panel last week the FDA said it had carefully reviewed disclosure statements from all potential panel members and that all 33 voting members had no relevant conflicts. But two panel members, it now turns out, had received speaking fees, one from GlaxoSmithKline and one from Takeda, which makes Actos (pioglitazone), an Avandia competitor.
According to reports in the Wall Street Journal and Pharmalot, panel member David Capuzzi, an endocrinologist at Thomas Jefferson University, received over $14,000 in recent years for speaking about Lovaza, GSK’s omega-3 pill. In another report in the Wall Street Journal, panel member Abraham Thomas gave two Takeda-sponsored talks about Actos between September 2007 and September 2008.
Capuzzi was one of only three panel members who voted in favor of keeping Avandia (rosiglitazone) on the market with no additional restrictions. Abraham was one of the 12 committee members who voted for the withdrawal of Avandia.
Capuzzi told Pharmalot that “in the past, I’ve spoken for another drug, Lovaza, but the FDA doesn’t consider a different product for the same company to be a conflict of interest.” He said the FDA did not ask him if he had received money for GSK. “No, nobody asked me that question that way. I’m new (to the advisory committee). But I have nothing to hide. I believe in full disclosure. I just wasn’t asked that question.” However, a GSK spokesperson told Pharmalot that at least one talk Capuzzi gave was for Avandia.
Abraham told the Journal that he had disclosed his relationship with Takeda to the FDA.
Interesting story. Very consistent with what Montori and Stelfox showed with glitazones and CCBs respectively (NEJM and BMJ). Vote followed COI precisely.