Sunday, July 25, 2004

The headline in the National Law Journal — “FDA strategy would pre-empt tort suits” — is all you need to know about why trial attorneys want to defund the office of the Food and Drug Administration’s general counsel, Dan Troy. What’s the public health when you are seeking to hit the legal jackpot?

Trial lawyers are hot about Mr. Troy because he aggressively pursues a settled legal doctrine: that federal law pre-empts state law with respect to what constitutes a safe and effective drug. Mr. Troy’s practice of filing amicus briefs in liability suits urging state courts not to second-guess the FDA-approved wording of warning labels is hurting lawyers’ ability to win scientifically dubious but highly lucrative verdicts.

As my Manhattan Institute colleague Walter Olson points out, the need for a federal agency to assert its authority is pretty clear: You can’t have individual juries defining for different reasons when a drug is or isn’t safe and effective. All of the living and former FDA general counsels, regardless of party, support Mr. Troy’s work and oppose the bill cutting his budget.

Their opinions were recently buttressed by a federal court decision upholding the legal basis for pre-emption. It agreed with the longstanding government position that the FDA’s decisions about what drugs are safe and effective were more scientific than any state court’s decision. The court also ruled that undermining pre-emption would harm public health by retarding research and development, would encourage “defensive labeling” by manufacturers to avoid state liability and would result in scientifically unsubstantiated warnings and underutilization of beneficial treatments.

This bill is part of a multi-front trial-lawyer war against the FDA. Trial lawyers are also attempting to force the release of unpublished safety and efficacy data so that private researchers can more effectively second-guess the agency. This also would let them use scientifically dubious information in their lawsuits.

The controversy over the refusal of the FDA to release unpublished data about Paxil is an excellent case in point. One trial lawyer, who represents thousands of one-time users of the anti-depressant Paxil in a suit against Paxil manufacturer GlaxoSmithKline PLC, is quoted in a recent National Law Journal article as saying that court-ordered discovery allowed her to see raw data on safety and efficacy, while the FDA saw only the completed write-ups.

Yet the Paxil data she saw was from a failed study: It showed that 70 percent of patients responded to the drug compared to a placebo, an unheard-of response rate. That raised serious questions about how patients were included, what criteria were developed to exclude patients and how they were treated. Nobody publishes failed trials with design flaws because they muddy the waters. The evidence can’t be scientifically interpreted. It would be irresponsible to even introduce this into the literature and even more irresponsible to introduce it into a courtroom.

Scientists and doctors with integrity are careful about the evidence they use. That’s why there are consensus panels and journals that work closely with the FDA to review credible studies. When they do, as they have twice already, they have found that there is no link between taking anti-depressants and increased risk of depression. Pre-emption seeks to preserve this scientific approach.

Which is why tort lawyers hate pre-emption and are — with the cooperation of some operatives associated with the campaigns of Sens. John Kerry and John Edwards and congressional allies — slandering Mr. Troy and cutting his budget. No one really cared about pre-emption until the Paxil lawsuits and New York Attorney General Eliot Spitzer came along. And no one began targeting Mr. Troy — who has taken this opportunity to reaffirm the FDA’s longstanding policy in this matter — until a former Edwards California-based campaign staffer (now working for Mr. Kerry) got involved. Is it a coincidence that three of the FDA amicus briefs were filed in California? Or that the congressman who is working to slime Mr. Troy and strip him of his budget received his second-largest single donation during the last election cycle from the trial lawyers’ association?

The anti-Troy bill sailed through the House without any fight from the House leadership. Let’s hope the Senate shows more guts. If Mr. Troy is sacked and the trial-attorney revolt wins, the public’s health will be the loser. Senators should ask themselves one simple question: Who would I rather have deciding which drugs are safe — scientists or trial lawyers?

Robert Goldberg is director of the Manhattan Institute’s Center for Medical Progress.

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