News Report Links Avandia Panelists to Drug Makers

From Heartwire

Michael O'Riordan

July 21, 2010 (Rockville, Maryland) — A US Food and Drug Administration (FDA) advisory panel member who voted to keep rosiglitazone (Avandia) on the market without any labeling changes received financial compensation from GlaxoSmithKline, the maker of the controversial diabetes drug, according to a report in the Wall Street Journal.

Dr David Capuzzi (Lankenau Institute for Medical Research, Philadelphia, PA) earned $14 750 as a member of the company's speaker's bureau, but received the money related to talks about Lovaza, an omega-3 polyunsaturated fatty acid approved by the FDA to lower triglycerides, and not for rosiglitazone.

"I have not given any talks [to doctors' groups] promoting Avandia," he told the Journal.

In a statement released Tuesday, panel member Dr Abraham Thomas (Henry Ford Hospital, Detroit, MI) said that he was also paid twice to speak, in this case for Takeda Pharmaceuticals, the makers of rival pioglitazone (Actos). Again reported in the Journal, Thomas said he was paid between $2000 and $3000 in 2007 and 2008 as part of Takeda's diabetes speakers' bureau, and disclosed this information to the FDA. Last Wednesday, Thomas called for rosiglitazone to be removed from the market.

Capuzzi received $3750 from the company between April 2009 and March 2010, as reported on the GSK website, and received an additional $8000 in speaking fees prior to that period. He earned another $3000 in second quarter of 2010. A GSK spokesperson told heartwire that Capuzzi was paid to serve on a rosiglitazone advisory board prior to 2008.

In an emailed statement provided to heart wire , FDA spokesperson Karen Riley said the agency is currently investigating the issue. "At this point, the FDA plans to conclude its investigations by the end of this week," wrote Riley. "Until then, we cannot provide any detail on future actions."

As reported by heartwire , Capuzzi was one of three doctors to vote for the drug to stay on the market without any labeling changes. As part of the complex recommendations, 12 of 33 voting panelists from both the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee felt the safety risks were too great to allow rosiglitazone to stay on the market. Of the remaining 20 votes--one member abstained--panelists said the drug could stay on the market with severe restrictions, while some believed the drug could remain with increased warnings.

The FDA told the Journal they are trying to determine if there was disclosure regarding Capuzzi, and if there was, why it wasn't conveyed to the committee.

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