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Making the perfect the enemy of the good
Why banning industry consultants from FDA Advisory Committees hurts patients

Derek Lowe
Medical Progress Today
September 29, 2005

FDA advisory-committee members are supposed to provide expert opinion and guidance to the agency, and their meetings are designed to address the potential benefits and shortcomings of new drugs up for approval. The agency has traditionally granted conflict-of-interest waivers, because many of the experts that the FDA would want on these panels have worked with and often have financial ties to the companies involved.

This isn't surprising. Researchers who consult for pharmaceutical companies are often among the best scientists in their field, and both sides (and consumers) can benefit from the relationship. Academic consultants get access to cutting-edge therapies and techniques, and companies get access to the latest basic science. Normally, this wouldn't be controversial. But we are living in a new age: A.V., after Vioxx, and any tie to industry automatically makes scientists suspect.

Rep. Maurice Hinchley (D-NY), for instance, has argued that the FDA should be stripped of its power to grant conflict-of-interest waivers for members of its advisory committees. The political reasons for this are understandable, because it's easy to frame this practice as industry loading the deck in its favor. But what would the alternative be? Companies are looking for the best consultants that they can find, and Hinchley's ban could make that impossible. For some conditions, it could be hard for the FDA to find good people who haven't been approached by one company or another.

The implications of such a rule are troublesome. Must we assume that anyone who has worked with the drug industry has been corrupted? Someone with fifteen years of industrial research experience myself, I can't help but find that attitude offensive. Drug development, moreover, is expensive and risky enough that it's worth paying a lot for good advice. Paying just to have someone tell you what you want to hear, on the other hand, is not such a good investment. Consultants who think that all a company's ideas are good ones wind up costing those companies money-and putting themselves out of work. Consultants don't make money by kidding themselves or their clients.

Rep. Hinchley's grandstanding plays into some old rivalries between academic and industrial scientists. Academia often looks down a bit at industrial work. This reflects the old-fashioned order, in which scientific research was considered more elevated the further away it was from any application. Gentlemen, after all, don't lower themselves to make their living in trade. "Pure" research stays that way by seeking only knowledge, with merely accidental thoughts of utility.

By these lights, some academic researchers think that their pharmaceutical colleagues have too much money already and still think only of making more. For their part, the industrial types think that academics have no idea of how hard (and expensive) it is to bring a drug to the market in the real world-which is, after all, the only way that real people with real diseases get helped.

Stereotypes aside, there actually is room for trouble when the two research worlds come together in drug development. The problem isn't outright bribery, despite what Rep. Hinchley and other conspiracy theorists might think, and despite any number of television and movie plot lines. It's a more intellectual form of persuasion, a high-octane variety of wishful thinking. People want their experiments to work, and companies want their drugs to make it to market. But that's a danger that pharmaceutical researchers have to wrestle with even when they're working alone, and companies are well aware of it.

That's the second reason for double-blinding drug trials. People are familiar with the first one: if the patients know (or think) that they're getting an active drug, the placebo effect can partially mask the underlying efficacy of a drug. But the psychological dangers go both ways: if the clinicians know which patients are receiving the drug, they run the real risk of unintentionally treating and evaluating those individuals differently. With so much riding on the results of a clinical trial, disinterested observers become increasingly crucial. Does a given patient meet the criteria for entry into the trial? (While we're at it, do those criteria make scientific sense?) Was a particular adverse event related to the drug under study or not? These are all judgment calls, and judgment is (as always) at a premium.

Before the FDA advisory committee even meets, drug companies have to wrestle with serious and legitimate conflict-of-interest problems. The companies know that if their drugs hit the market, the real world will have the final say. The pharmaceutical industry would be doomed in the long run if it constantly coerced and paid off people to produce beautiful clinical numbers. (Not to mention that under such a system no drug would ever fail in the clinic-but most of them certainly do.)

What would a realistic policy look like? Outside consultants with significant financial stakes in the companies under review should recuse themselves.

Strict penalties and strict enforcement should be the norm for any suspected wrongdoing, since real corruption is deadly to both the scientific and regulatory efforts. Setting bright lines and enforcing them scrupulously should ensure sufficient objectivity for the FDA's advisory committees without depriving the agency of the best advice available.

But clearing the rolls of anyone who has ever accepted a consulting fee, or who has ever worked with the industry on the problems at hand, would purge many of the people whose expertise is most valuable. The thinking behind this policy seems to be more about how to strike the most virtuous pose than about how to best evaluate new drugs.

Derek Lowe received his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. He is also the author of a blog on developments in the biopharmaceutical industry called In the Pipeline.

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