FDA Asks HHS To Probe Avandia Panel Member
1 CommentBy Ed Silverman // July 26th, 2010 // 7:08 am
Remember David Capuzzi? He was a member of the recent FDA advisory committee on Avandia who, as it turns out, has also been a speaker for GlaxoSmithKline, which sells the controversial diabetes pill. The FDA, apparently, was not aware of this relationship until it was disclosed last week (see here).
Capuzzi, who is a former professor of medicine and biochemistry at Thomas Jefferson University in Philadelphia was paid a total of $14,750 over the past several years, mostly for talking about Lovaza, including at least one engagement earlier this year. But there was once instance in which he spoke about Avandia, according to a Glaxo spokesman. When asked about this last week, the FDA issued a statement saying the agency “takes these allegations very seriously and is investigating the matter.”
Now, an FDA spokeswoman says the agency has completed its “fact-gathering process” and referred the affair to the Deparment of Human and Human Services’ Office of Inspector General. However, she adds the FDA is prohibited by law from releasing any financial details that Capuzzi may have disclosed to the agency or comment further about an ongoing investigation. There was no word on whether another panel member, Abraham Thomas, was also being probed. He was a speaker for Takeda Pharmaceuticals, which sells the rival Actos pill, although his talks were more than 12 months prior to the recent panel meeting. A failure to disclose within 12 months is a serious problem.
As for Capuzzi, last week he told us that he was confused by the FDA disclosure process. He said that he told the agency about speaking engagements concerning Lovaza, but did not specifically mention the relationship with Glaxo. “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.”
Doc
One of the last cash bastions that physicians can draw from pharma is the ever present “promotional program”, where the speaker uses a company supplied slide deck and talks on label unless off label questions are raised.
this lucrative position does skew physician prescribing and presentation of dat - no matter how often both speaker and pharma company says it does not.
Look at the vast majority of “promotional speakers” and they are high volume prescribers for that class of drug. With cut backs in re-imbursements, pharma dollars are viwed by many as critical to college costs for kids, etc.