WSJ: FDA Panelist's Vote On Glaxo Drug Raises Questions

23rd Jul 2010 22:41

By Alicia Mundy Of THE WALL STREET JOURNAL WASHINGTON (Dow Jones)--The Food and Drug Administration has asked investigators for the Department of Health and Human Services to look into whether there was a conflict of interest involving a panelist at a recent special meeting on the safety of the GlaxoSmithKline PLC (GSK, GSK.LN) drug Avandia. Endocrinologist David Capuzzi of Philadelphia told The Wall Street Journal this week that he is a speaker for Glaxo, though not on behalf of the diabetes drug. Capuzzi was one of only three members of the 33-member panel who voted July 14 to keep Avandia on the market without adding any new warnings. The group voted 20-12 not to withdraw Avandia, but most of those 20 wanted severe restrictions or stronger warnings. The FDA said before the two-day meeting of its advisory committee that it had vetted all members for any potential conflicts. The medicine has been linked to a risk of heart attack in a series of studies since 2007 and in recent FDA analyses. Glaxo has said that the drug is safe and fought efforts to remove it. The agency said in a brief statement Friday, "The FDA has completed its fact-gathering process and has referred the Dr. Capuzzi matter to the HHS Office of Inspector General." It added that it cannot release any confidential financial information. Capuzzi said in an interview Friday that since the news of his ties to Glaxo appeared late Monday, he has communicated with the agency several times. "I told them that I had given them all the information before, and I went over it again. I have nothing to hide." He said he did not think there was a conflict of interest, because he spoke on behalf of a separate Glaxo drug, called Lovaza, that can help lower triglycerides. A Glaxo spokesman said on Monday that Capuzzi spoke about Lovaza to doctors earlier this year and a few years previously, and received more than $14,000 from the company. Glaxo later added that Capuzzi had once served on an advisory board on Avandia, for which he was paid $750. Capuzzi said, "I don't remember that but it was probably eight or nine years ago when Avandia was just on the market, and I was talking about diabetes care." Avandia can lower blood glucose in diabetes patients. (END) Dow Jones Newswires July 23, 2010 17:41 ET (21:41 GMT)