That FDA Pledge

At a Center for Science in the Public Interest forum yesterday, Scott Gottlieb, the deputy commissioner of the Food and Drug Administration, promised to revamp the agency’s rules for granting conflict-of-interest waivers when physicians with ties to drug manufacturers sit on its advisory panels. I look forward to seeing the new guidance when it actually comes out. If I understood the intent correctly, the FDA will start excluding those docs who are actively engaged in marketing drugs and devices, but continue to put them on committees if their relationship with the companies was purely scientific – as in having done clinical trials.

The announcement drew major news coverage (see here and here, for instance). Since I have been a major proponent of a total ban on granting conflict-of-interest waivers to scientists who have ties to industry in any capacity, let me lay out once again why I think this proposed new rule doesn’t go far enough.

First, there are plenty of people out there who don’t have any financial ties to firms who can provide just as good advice as the FDA is currently getting from folks on industry’s payroll. There are 125 medical schools in the U.S. About a third of all clinical trials conducted in the U.S. are sponsored either by government – primarily through the National Institutes of Health – or health charities and non-profits. Those trials require all the same skils as industry-funded trials: physicians to enroll patients, biostatisticians, data safety monitoring boards, etc. Why can’t the FDA find experts from that crowd? Either they’re not trying or they don’t want to.

Why does it matter? Isn’t an industry-funded clinical trialist just as “objective” as someone who has not worked for industry? I think not. When one has been part of a study that comes up with a certain result, one becomes intellectually committed to that result. It is only natural to defend your previous conclusions, even when confronted with new evidence. Sometimes the new evidence becomes overwhelming and anyone who is intellectually honest eventually changes their mind, but letting go of previous conclusions takes time – it’s only human. Can that happen in the course of a one-day meeting at FDA where the clinical trial specialist is not only hearing contrary evidence but is hearing evidence presented by the company?

It’s the rare scientist who would arrive at anything other than their pre-conceived wisdom under that scenario. If these advisory committees are going to be real science courts that weigh the evidence, the FDA needs to appoint jurors who don’t have preconceived opinions about the new drug or device under consideration. Period.

That is the theory. Now to the practice. The New York Times Science section this morning has a pretty good
commentary analyzing the machinations of the hired brains behind the Cyberonics Vegus Nerve Stimulator for severe depression. Harold Sackeim, a professor of psychiatry and radiology at Columbia, told the paper that if device makers could not hire the field’s top experts, effective new devices would never be approved. “This is not like pharmaceuticals, where the companies are much bigger and have their own experts,” he said. But a few paragraphs down, we learn that:

Now the company has focused on promotion, as have some of its consultants. At an American Psychiatry Association meeting in May, Dr. (John) Rush sat in the Cyberonics booth, describing the benefits of the therapy to curious psychiatrists. In one of several presentations about the device, doctors reviewed its use for obesity, anxiety and Alzheimer’s disease, purposes for which it is not approved.

This isn’t science, it’s marketing. If the FDA does in fact come out with the new guidance promised yesterday, and it does in fact end forever the inclusion of such scientists on its advisory committees (whether their promotional activities take place for the company with a new drug up for approval or one of its competitors), then it will be a major improvement over the current rules and I’d applaud it. Hopefully, we’ll get to see the new rules sooner rather than later.

Posted by gooznews at July 25, 2006 06:43 AM