AfterShoxx - Pharmaceutical Executive


Merck's withdrawal of blockbuster Vioxx blew a $2.5 billion hole in its revenues and stirred up a storm of suspicion and speculation accompanied by a chorus of wild laments. Some perspective, anyone?

Pharmaceutical Executive

Talley says the best argument "to get around the 'drug was approved by the FDA so we can't be liable' defense has been, 'Yeah, but you lied to the FDA. It wouldn't have been approved if they had known the truth.'" A big piece of this puzzle, Talley says, "is whether Merck did anything to mislead the FDA—are there smoking gun memos or studies that weren't provided to the FDA?" But a recent Supreme Court decision known as Buckman seems to undercut that argument. It appears to say you cannot sue someone simply for lying to the FDA because, as Talley says, "it's the FDA's job to punish people who lie to them." Defendants have tried to expand Buckman—which involved a consultant to a medical device company—to pharmaceutical companies. They want to claim, "'You can't sue us because you're preempted by the FDA's decision to approve the drug, and you can't sue us for lying to the FDA to get it approved because the Supreme Court says so.'" But the fallacy of Buckman, says Talley, is the FDA "doesn't have the manpower or time to know when they're being bamboozled or things are being spun."

COX-2 Inhibitions The real question in the public's mind now—not to mention the minds of Merck's competitors—is "to what extent are problems identified with Vioxx applicable to all COX-2 inhibitors," Wofsy says. He predicts FDA "is going to move very slowly in the area of approving new drugs with similar biology." Ryan agrees, saying, "the bar for new COX-2s has been raised," and adding, "There's no data yet for the existing drugs to come off the market. As the placebo controlled trials for Celebrex (celecoxib) come in, that data will be very important."

What about the next-generation COX-2s? Says Ryan: "We didn't think, even before Vioxx got pulled, that Arcoxia (etoricoxib) would ever get approved because we thought it had cardiovascular signals—and because of the debate over Vioxx for the last five years. Now, unequivocally, we don't believe it will be approved." She's also dubious about Pfizer's Prexige (lumiracoxib), which, she says, "has liver and kidney issues."

Risks and Regs From a public health perspective, the Vioxx recall "won't have a major impact," Wofsy says. "There were no medical conditions for which it was the only option." But if Vioxx is not an essential medicine, don't its risks—in conjunction with its widespread usage—constitute a public health problem of some sort? Says Wofsy: "It is fair to ask if this could have been recognized and stopped before people were hurt." Ryan is doubtful. "I'm not sure that the kind of data existed prior to this to suggest a move such as what happened," she says. "It is easy to say that there were many hints. By the same token, the data that existed in the public domain since 1999 on Vioxx left even experts arguing both sides. I don't think you can go back and say it was clear and we should have done this or that, because I don't think it was clear. We live in an imperfect world and we know what we know when we know it."


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