It seems that the drug industry’s lobbyists have been hard at work to disrupt Congressman Waxman’s Committee on Oversight and Government reform hearing on Avandia before it even began!
It all began congenial enough and it even appeared that witnesses would be allowed to talk without first being attacked by members of the committee.
Alas, that was not to be.
Waxman at first announced that witnesses would be heard without any opening statements from Committee members. But then he opened up a can of Whump by inviting one committee member to speak on the special need for minority involvement in the regulatory process.
Then, all hell broke out when a Republican member attacked the NEJM for publishing “anecdotal” evidence. He also implied that ranking members of the Committee were in cahoots with Dr. Nissen, the scientist who lead the Avandia meta study, the results of which were published in the NEJM.
Von Eschenbach went on the usual FDA defensive and talked about team approach, process improvement, blah, blah, blah. At least his testimony was short.
Waxman then laid into him with a littany of instances when the FDA was warned about Avandia’s cardiovascular problems, but did nothing. “Missed opportunities,” he called them.
Von E emphasized the need to get drugs approved more rapidly and claimed FDA was engaged in post-marketing surveillance of Avandia.
But Waxman would have none of that. He wanted to know if FDA asked for special studies on CV effects.
Von E then handed the argument off to an underling, the scentist (Dr. Jenkins) that headed up the FDA approval team for Avandia. FDA had to admit that it did not ask for a study specifically for CV effects of Avandia. Meanwhile, the Europeans asked for such as study — the RECORD study. But Dr. Jenkins hinted that the FDA had “more data.” This data probably exists in the same vault as the data Bush has about Iraq’s weapons of mass destruction.
Another Reuplican committee member Davis asked about surrogate endpoints. The basis of approval of Avandia was based on its ability to lower blood sugar, not prevention of death. He allowed Von E to state that if a preventioon of death outcome was used as a basis of approval, it would have taken 25-30 years to get approval and in the meantime thousands of people would have died. Neither Von E nor the Congressman mentioned that diabetes patients have other drugs that they could have taken.
More later…
