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Conflict on drug reviews
The Star-Ledger, 2-28-05

“The Center for Science in the Public Interest analyzed the allegiances of scientists on the FDA panel at the request of the New York Times. Of 32 panel members, 10 had been consultants or paid speakers for Merck, and two other big COX-2 firms. The FDA said that it doesn’t matter, that there were no conflicts. That point of view is part of the problem. Anyone with financial ties to the products under review should not have been on the panel.”

But past ties to industry do not translate into present ties to the products under review. Furthermore, it is eminently arguable that scientists who study these drugs and consult with industry on their development know them better than anyone else.

In the final analysis, we have to get back to the objective science.

Was this a class of drugs (painkillers) worth creating given the limitations of existing treatments? Yes. Do they serve a valuable purpose for a real group of patients. Yes.

Were these drugs over prescribed? Most likely. Therein lies the real problem, but it’s a much tougher nut to crack than simply decrying industry influence at the FDA.

The Star-Ledger suggests that the unholy influence of industry on the FDA can only be broken if “people who have accepted money from pharmaceutical companies are not on panels reviewing those companies or their competitors.” Is this true?

We respectfully disagree. There is no reason to expect that the best scientists in academia should recuse themselves from financial gain from their research, and nothing to gain by forbidding them to do so. Medical progress depends on close cooperation between industry, government, and academic scientists and bottle-necking cooperation between any two of those groups will have perverse consequences for the entire enterprise.

If we want to improve safety at the FDA, we should concentrate on improving the science and technology it uses to evaluate new drugs and monitor drug safety because only that knowledge will really enable us to save lives.

Otherwise we will lose sight of our goal in an impossible quest to weed out that most nebulous of human factors: “influence.”

Project FDA.
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