Vioxx, the FDA, and Preemption: The Power Grab
Early during my training as a psychotherapist, I was told a one-liner that has proven to be useful: "Paranoids are always right." The idea is that paranoids may lose perspective on the wider context of particular events. But, in every case, they are on to something that is genuinely true, even if they make mistakes of scale.
So allow for the possibility that what follows is a paranoid view. Some of it is true. Some of it may be out of proportion. And, of course, much of it may be dead on.
Virtually everyone agrees that Merck's recent settlement offer on Vioxx will be a victory for the company if it is approved by the requisite 85% of plaintiffs. Of course, Merck continues to face civil and criminal charges on state and federal levels. So this is not the end of the line.
Still, it is obviously a significant moment. The $4.75 billion figure is roughly what Vioxx made in two years. Given that its use should almost certainly have been strictly limited after the 2000 VIGOR study (which is what happened in Canada in, a bit later, in the states of Oregon and Washington Medicaid formularies), Merck got about two years of "freebie" blockbuster sales out of the drug even after you subtract the $5 bil. In the meantime, there were several thousand deaths and injuries that could and should have been prevented (and were largely prevented in Canada and Oregon and Washington).
(Parenthetically, the preemption gang loves to talk about an infernal "chaos" that would result from different safety drug standards co-existing with the FDA's. But I am still waiting to hear about anyone in Idaho or northern California who ever so much as sneezed as a result of the different standards set in their neighboring states.)
In any case, Merck made few attempts to use preemption to get summary judgment dismissal of Vioxx cases. I do recall New Jersey's Judge Higbee referring to the 2007 preemption preamble as a "purely political document," so there were rumblings in that direction. But it was clearly not a central strategy pursued.
In the meantime, pharma managed to get Congress to pass the FDA Amendment Act which, at core, does nothing substantial to change the FDA. PDUFA remains in place. Fines for false and misleading advertising, if they are levied at all, are pats on the wrist. Direct-to-consumer advertising remains unchanged, even during the first two years a drug is on the market (what the industry calls the "evidence-free zone"). No independent office of drug safety – which has been supported by independent reviews of the FDA for forty years – will be created. In short, despite Vioxx's taking out 50,000 people and seriously injuring twice that number – FDA reform did not happen. And all the talk by Grassley, Kennedy, Dodd, Dingell, and Waxman turned out to be that. They caved.
Still, the illusion of reform served the preemption gang well. Even before the new law was out of the oven, they enthused about how now no one can complain the FDA is "not strong enough," "needs more resources," "cannot keep us safe," yadayadayada. For them, the nothing that Congress passed became something indeed. The Emperor got clothes.
Now add a final piece. Consider the FDA preemption cases headed to the Supreme Court in a context in which the thousands of Vioxx cases are still out here. Imagine the noise it would make if, at the stroke of a pro-preemption pen, all those highly publicized Vioxx cases suddenly went up in smoke. Would that headline catch folks' attention? I've given up on predicting what catches folks' attention. But that is, indeed, a fair amount of smoke. No, not a reinstatement of racial segregation. Not a repeal of Roe. Not even Bush v. Gore. But some potentially serious business. And maybe more.
Thus, from a pro-preemption perspective, both passing sham FDA reform and getting all the Vioxx cases off the table is very convenient stuff. Very convenient indeed.
A couple of years ago, I attended a Federalist Society program on FDA preemption which featured Dan Troy as the main speaker. The panel also included two other preemptors and one "moderate" to provide something resembling a difference of opinion. The "moderate" was, indeed, nuanced and careful in his comments. The whole thing came off as reasonable and decorous as such events are supposed to be.
When it was over, the "moderate" and I chatted a bit. He needed no encouragement. It was obvious he needed to spill. "Forget what I said on the panel," he almost hissed, "FDA preemption? It's just an f'ing power grab."
My professional opinion is that this guy was as sane as guys get.