Reform FDA's Advisory Committees, Too

The Institute of Medicine report calling for reform of the Food and Drug Administration got a strong boost today from the New England Journal of Medicine. The journal's editors called on Congress to take prompt action to enact the more far-reaching elements of the report.

There is "a crisis of confidence" at the agency," they wrote, and the growing problems with drug safety are "a mounting public health crisis. . . The critical issues of financing, transparency, and independence must be addressed."

Unfortunately, the editorial makes no mention of the issue that the Center for Science in the Public Interest (where I work) helped bring to the fore: the FDA's overreliance on outside advisers with financial ties to the drug industry. The IOM report called for a "substantial majority" of those advisers to have no ties to firms the agency regulates.

Could it be that the NEJM editors disagree? If so, they would find strong support from the American Enterprise Institute, whose leading drug scholar, John Calfee, today published a ringing defense of the FDA's current practices.

Feel free to read it for yourself. But before you do, allow me to point out the arguments that Dr. Calfee ignores.

First, he argues that the "best and brightest" among the nation's academic physicians work for the drug industry. If the FDA cut them out of the advisory process, it would deny the public the best help. Hogwash. The nation's 125 medical schools, the National Institutes of Health and leading health delivery systems like Kaiser Permanente and the Mayo Clinic are filled with experts who are equally qualified as those academicians and scientists who advise industry. Given the chance, these scientists would gladly serve the public by evaluating the safety and efficacy of new drugs that come before the FDA.

Indeed, many committees have few advisers with conflicts of interest. Is the FDA and defenders of the status quo arguing that these people are somehow unqualified or less qualified? If not, surely there are more where they came from.

Calfee also argues that few if any votes are swayed by the ballots cast by conflicted advisory committee members. He points to the Public Citizen study in the Journal of the American Medical Association that turned up that unremarkable statistic. An FDA re-analysis of those numbers showed that most conflicted scientists actually work for competitors of the firm with a drug application before the agency. Since most advisers with conflicts of interest vote to approve new drugs, they are, in fact, voting against their supposed self-interest.

Alas, Calfee fails to address the central point, which I'm sure he is aware of because he heard me present it at a conference last week at Hofstra University. The core problem with larding advisory committees with conflicted members is not that there is some crude quid-pro-quo behind their votes.

Their presence creates an ideological imbalance. Scientists and clinicians who serve industry are biased toward approving drugs, whether it is their sponsor's drug or a competitor's drug. They do not cast a cold eye on the underlying data. They do not hunt for signals in the data that hint at a safety problem down the road when millions of people -- not the few hundred or thousand in a clinical trial -- are taking the drug. By continually drawing from the same crowd of scientists with long-standing ties to industry, the FDA fails to balance its committees with scientists who have these critical skills and perspectives.

No one argues that ending conflicts of interest on FDA advisory committees is a panacea for what ails the agency. But the presence of so many scientists with financial ties to the firms the agency is supposed to regulate casts a pall over the entire process. When it comes to the agency charged with overseeing the health and safety of the American people's food and drug supply, appearances matter.

If the new Congress takes FDA reform seriously, ending conflicts of interests on the FDA's advisory committees will rank high on its agenda. The other reforms in the IOM report are, quite frankly, more important. They will give the FDA the tools it needs to do a better job. But ending conflicts of interest will send a clear signal to the public that a new day has dawned at the agency. That's a signal worth sending.

Posted by gooznews at October 11, 2006 10:06 PM