July 16, 2010

I spent three days at the FDA Advisory Committee hearings this week. The first two days were devoted to Avandia for type 2 diabetes. The third day consisted of a review of the anti-0besity medication, Qnexa, made by Vivus Inc.

The committee voted to keep Avandia on the market in spite of long term studies, meta-analyses and observational studies all pointing to an increased risk of heart attacks. And this in a field where there are multiple classes of drugs which enhance glucose control. The evidence was there (in my opinion) but the committee stuck with the drug.

On the other hand, in reviewing Qnexa, the evidence was there that it met the FDA’s requirements for approval. What the committee had was higly speculative fear that it might be approving another phen-fen. (Never mind that Qnexa’s two components – phentermine and topirmate – have been used for decades.) Fear trumped evidence when it comes to obesity products.

Most of the audience at the hearing felt stunned when the vote was announced. Most had expected easy approval as the effectiveness data was very clear and the safety issues were well-addressed, small and mainly speculative. Hopefully, the FDA will look at the company’s two year data in September and approve Qnexa.