Conflict and Balance on Federal Advisory Committees

Peter Lurie, Sid Wolfe and colleagues at Public Citizen published a paper in the current Journal of the American Medical Association that found only a tenuous connection between Food and Drug Administration advisory committee decisions and their members' financial ties to drug companies whose products were up for approval.

No shock there. Anyone who has ever sat through one of those meetings knows that serious differences on the committees are rare no matter who sits on the panels. Having attended plenty of these meetings, I've come to recognize that the core problem isn't financial conflicts but the fact that most of these committees lack overall balance. They are almost always made up of clinicians who treat patients and/or conduct clinical trials. They are usually on the lookout for the next new and hopefully better drug or device for their patients. It's only natural.

What the committees usually don't include are epidemiologists skilled in ferreting out the responses of groups that do not fare particularly well on the new drug. Or they don't include safety experts who are on the lookout for problems that have only been hinted at in the limited trials conducted for new drug approvals.

The Federal Advisory Committee Act, which was passed in 1972, requires that these panels exclude scientists with conflicts of interest (although it allows for waivers in case a person's expertise is needed, which the FDA uses liberally). It also requires that the panels be balanced.

Historically, the FDA, along with most other agencies of the government and the National Academy of Sciences, have interpreted that latter requirement to mean inclusion of the range of experts needed to get the job done. At the FDA, that might mean including a bunch of clinicians who treat patients, a biostatistician who can interpret data, a consumer representative and an industry rep, who usually doesn't vote. But the Government Accountability Office, in a critical review of advisory committees published in 2004, said that the balance requirement also refers to opinions, especially when the subject being discussed is controversial.

At tomorrow's Cardiovascular and Renal Drugs Advisory Committee meeting, which will discuss labeling antihypertensive drugs (see this GoozNews for a rundown of the issues), I will raise this point with the FDA during the public session (I'll post my full comments in the afternoon). The real problem with this committee is its lack of balance.

Late this afternoon, FDA officials sent me an email indicating that the chairman of the committee, whom the Center for Science in the Public Interest exposed as having conducted clinical trials on hypertension drugs for Bayer Pharmaceuticals, will not take part in the meeting, nor will another scientist whose research for drug companies directly pertained to aspects of the labeling controversy. Yet the pared down roster still does not include any of the physicians who played key roles in conducting the best antihypertension research of the past decade (the so-called ALLHAT trial) or participated in writing the National Institutes of Health-funded clinical practice guidelines for physicians treating people with hypertension.

FDA advisory committees should not be confabs of the like-minded. They should be a forum where the best minds in a field can openly debate the pressing issues daily practitioners face. No matter what the committee decides tomorrow -- and I'm hopeful that despite the myriad conflicts of the members who remain that they will suggest significant changes to the FDA proposal -- the FDA needs to do some serious rethinking about how it chooses its outside advisers.

Posted by gooznews at April 25, 2006 11:14 PM