Investigation Launched into Conflict on Avandia Panel

The U.S. Department of Health and Human Services’ Office of the Inspector General has been called in to investigate whether a member of the recent FDA advisory committee, which recommended that a recall of Avandia not be issued, may have failed to disclose a conflict of interests after it was discovered that he had been a paid speaker for the pharmaceutical company that makes Avandia.

The FDA announced on Friday that it has finished their own internal investigation on endocrinologist David Capuzzi, who was one of only three members of the advisory panel who voted that no further actions were needed to warn the public about potential heart side effects of Avandia. While the FDA has not indicated what it found from its investigation, the matter has been referred up the chain to the HHS’s OIG for further investigation.

Capuzzi was one of the strongest defenders of Avandia on the 32-member panel that met earlier this month to consider whether an Avandia recall was necessary given the risks compared to other available diabetes treatments. While 12 members voted for the drug to be removed from the market, the majority of the panel voted to allow the Avandia to stay on the market despite the finding that it appears to be more dangerous than older diabetes drugs. Of those who felt a recall of Avandia was not necessary, 10 voted to add stronger warnings and restrict its use, 7 voted to just add new label warnings and three voted to do nothing. One member abstained from the vote.

Concerns about Avandia conflicts of interest on the panel arose last week when it was revealed that Capuzzi received $3,750 from GlaxoSmithKline for speaking engagements from April 2009 through March 2010. Before that, he was paid $8,000 for speaking on the company’s behalf, and since March he’s received about another $3,000.

The investigation announcement came after GlaxoSmithKline, the manufacturer of Avandia, revealed that Capuzzi had been paid to serve on an Avandia advisory board, contradicting earlier statements by Capuzzi, who said he had only spoken about other drugs for GlaxoSmithKline. FDA officials said they were unaware at the time of the vote that Capuzzi had spoken for GlaxoSmithKline in any capacity.

Avandia has come under harsh criticism in recent months by a number of experts, including some FDA drug safety reviewers, who have estimated that Avandia may be responsible for more than 100,000 heart attacks and deaths since it was approved. Critics have argued that Avandia should be recalled, as there is no reason to put patients at risk with the drug when there are alternative treatments that do not appear to carry the same heart attack risk as Avandia.

The current issue of the New England Journal of Medicine contains an editorial urging the FDA to take strong action on Avandia, saying that the agency should either recall the drug entirely or put a system in place where patients being given Avandia have strong informed consent about the drug’s dangers, going well beyond the traditional “black box” warning that is considered the limit of FDA drug warning power.

Amid the ongoing controversy, the FDA announced last week that it was suspending new enrollment in an on-going Avandia clinical trial. The agency is in the process of reviewing whether continuing with the trials is ethical, given the risks associated with the drug.

Another advisory board member, Dr. Abraham Thomas, was also revealed last week to have once been paid by Takeda Pharmaceuticals to talk about Actos, a drug in direct competition with Avandia. The FDA has not made any announcement regarding an investigation into his activities. Thomas was one of the committee members who voted to recommend an Avandia recall.