Our Unscientific FDA

Recently it has become common in my consulting practice for one of my clients to say, "I can't believe that so-and-so wasn't a member of that recent FDA advisory committee." So-and-so being a renowned expert in the field. The reason for this person's absence was his or her ties to the pharmaceutical industry coupled with the FDA's emphasis on preventing potential conflicts of interest in advisory committees.

The FDA is supposedly a scientific organization that makes decisions based on empirical data. A drug company can't simply approach the FDA and say, "Theoretically, this should work," and expect FDA approval for a new drug. The FDA wants to see empirical evidence. Unfortunately, the FDA applies this standard to other groups, like drug companies, but not to itself. When it comes to potential conflicts of interest among advisory committee members, the FDA has simply rounded up the usual suspects and declared them guilty without so much as a trial. Why would the FDA need empirical evidence when the problems with conflicts of interest are so obvious?

Well, I do happen to have some empirical evidence in this arena and it comes from Sidney Wolfe, one of the pharmaceutical industry's most vehement critics. David R. Henderson and I wrote an article about it in early 2009.

In a 2006 study to look at potential conflicts of interest, where outside FDA advisors had ties to industry, Wolfe and four other authors published an article in the Journal of the American Medical Association that drew on 76 product-specific meetings of FDA advisory committees that involved yes or no votes on individual drugs.

Their findings? None of the 76 voting outcomes would have changed had voters with supposed conflicts of interest been excluded. That didn't stop the authors, and later the FDA, from reaching a conclusion that contradicts these findings: "Ideally, all panels of scientific experts advising a federal decision-making body would be free of financial conflicts of interest with the affected companies." So much for objective, evidence-based policy.

It is difficult to be a renowned expert in a medical field and not have drug companies clamoring to pay for your expertise. Yet that doesn't necessarily make you biased, and we have the evidence to prove it. By ignoring this evidence, the FDA has divulged its own unscientific prejudices.

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