Monday, October 20, 2008

There are many good reasons for the Supreme Court to uphold the authority of the Food and Drug Administration in determining what information should be included on the label describing the risks and benefits of a drug. A current case would challenge that authority, known as pre-emption, and hand it over to trial attorneys suing drug companies that, as part of any financial settlement, would be able to demand changes to the information a company would have to provide doctors and consumers.

Today’s Op-Ed by Tomas Philipson notes that vaccine investment dried up after litigation costs in the wake of a successful lawsuit. But higher prices are not the only result of overturning pre-emption. Nor are they the most costly. The litigation that found pertussis vaccines “caused” Sudden Infant Death Syndrome was conducted without any scientific basis for such a link. This has spurred a whole industry of trial attorneys and doctors on the take who have been willing to concoct the conspiracy that vaccines or their ingredients “cause” autism or other brain damage. That in turn has allowed science to be hijacked in favor of what one observer has called “judgments based on anecdotes and speculation.”

That observer was Marcia Angell, who, more than a decade ago, saw how fearmongering fed by courtroom antics and junk science shoved aside the FDA and caused a panic among women regarding silicon breast implants. It was a panic, as Dr. Angell noted back then, that had “no good scientific evidence for or against a link between breast implants and systemic disease of any kind.”

Today, it is even easier to supplant science and replace it with a state of fear. Fake blogs, journalists working closely with trial attorneys, and doctors and scientists on tort-lawyer payrolls create and spread specious theories and crank out statistical associations without any real evidence of cause and effect. Panic spreads and is reinforced in court-proceedings. As one theory is knocked down, such as the measles vaccine causing autism, another one - thimerosal - springs up.

And you only need one “study” to cause panic and launch a class-action lawsuit. (That and the visceral hatred of corporations Dr. Angell once found to be flimsy basis for silicon-breast-implant litigation.) But now Dr. Angell claims that the courts are the only avenue to establish the real risks of a drug because the FDA is merely a rubber stamp for drug companies. Forget the fact that the number of drug approvals have declined in the past few years and the number of late-stage drug flops has increased. So much for evidence.

Dr. Angell and the current editors of leading medical journals are willing to allow the trial bar to displace the FDA. This group is willing to forfeit the ability to target risk and benefit - where science is heading - and permit opinion and emotion to hold sway. As Dr. Angell noted, in the courtroom, the experts’ opinions are the evidence. It would seem now that Dr. Angell and others have drug companies in their sights, their opinion (and overturning pre-emption) is all that matters.

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