Was the FDA Advisory Panel on Avandia Tainted by Conflict?
It's been an eventful summer for GlaxoSmithKline (GSK) and its diabetes drug, Avandia. First, the New York Times dropped its bombshell that secret company testing in 1999 indicated the increased risk of heart attacks associated with Avandia. Yet, the company may have hidden its own test results, while reaping billions of dollars in revenue continuing to market the drug.
Then, this month, an FDA Advisory Panel met to discuss the future of the drug. When the panel voted, 29 of the 32 members voted either to remove Avandia from the market or change its warning label in light of the medical issues. Only 3 members voted to do nothing and 1 member abstained. Now, we hear that one of the 3 members who defended Avandia and voted to do nothing may have a significant conflict of interest. In fact, the FDA has even referred this serious issue to the Inspector General of the Department of Health and Human Services for further investigation.
The investigation into this potential conflict of interest is still ongoing and the facts are not yet clear. However, it now appears that the panel member under investigation may have received more than $14,000 as a paid speaker for another GSK drug. It is unclear as to whether the panel member disclosed his advocacy of a different GSK drug to the FDA before serving on the panel. If he did, then the FDA may not consider that issue to present a conflict since it did not involve Avandia. While the FDA may not consider such advocacy of a different drug by the same manufacturer to be a conflict if disclosed, it still does not sit well with me.
However, the issue goes beyond the panel member advocating one of GSK's other drugs and whether he properly disclosed his relationship to the pharmaceutical giant. More troubling, GlaxoSmithKline has now revealed that the same panelist may have actually received money for sitting on an Avandia advisory board. Did this person have a prior relationship with the company concerning the very drug that he was considering as an FDA panel member? If true, this undisclosed conflict would certainly present a troubling picture.
The government agencies that protect consumers and the public at large have important roles. It is essential that the difficult investigations and decisions of these agencies be free from conflict. In the recent few months we have clearly seen the results of a system where the same people responsible for our safety are tainted by money and relationships to the very companies they are regulating.
