FDA Once Again Packs Its Advisory Committees

The Food and Drug Administration yesterday and today held advisory committee meetings to discuss the safety and efficacy of two new drugs for diabetes. In each case, one-third of the committee's nine members had financial ties to the drug manufacturers that submitted the new drug applications, or their competitors.

Why does the agency persist in inviting conflicted scientists to serve on its panels? Last June, Rep. Maurice Hinchey (D-NY) attached a rider to the FDA appropriations bill that would ban the practice. Nearly three dozen Republicans joined with most Democrats to pass the measure 218-210. The bill is slated to come before the Senate, probably next week. Aides to Sen. Richard Durbin (D-IL), its sponsor, hope that the concern on both sides of the aisle about the agency's safety record will translate into a positive vote.

This week's sorry performance suggests that despite the political pressure the agency still doesn't get it. At today's advisory meeting, for instance, which considered a Bristol Myers-Squibb/Merck oral drug for diabetes, the agency appointed a University of California at San Francisco endocrinologist named Thomas Aoki to serve on the panel. Aoki, who hasn't published an article in the medical literature since 2001, has a patent on a technology that's been licensed to several start-up firms that would make insulin easier to use and potentially more effective. This would obviously undercut the market for oral drugs, which don't work as well as insulin. Obvious conflict, right? They appointed him anyway.

Yesterday, the agency allowed three scientists with direct ties to Pfizer or Nektar Inc. to evaluate those companies' joint application for an inhalable form of insulin (Nektar makes the inhaler). Again, this would give diabetics a much easier way to use insulin (what would you rather do, inhale or give yourself a shot?).

Sounds like a real breakthrough, right? Unfortunately, there are serious safety concerns for many diabetics who might use inhalers. Smokers wind up inhaling much more of the drug per dose. Some people lose breathing capacity. Existing lung diseases can be exacerbated. Clearly, if you've got an ax to grind for or against Pfizer/Nektar's petition, you could easily find data to support your case.

In the end the final vote was 7-2 in favor of the inhaler with one of the three conflicted scientists voting against. The Bristol-Merck drug got an 8-1 positive vote, with Aoki voting along with the majority. So it can't be said that the conflicts of interest determined the ultimate outcome.

But the public's faith in the integrity of the entire process is undermined when the FDA persists in appointing scientists with ties to industry to its advisory panels. How will this week's appointments look if the inhaler turns out to be the next Vioxx? Congress would be well advised to pass its measure and force the agency to mend its ways.

Posted by gooznews at September 9, 2005 09:38 PM