Tuesday, December 12, 2006

Updated: Torcetrapib & Big Evil Pharma

An interesting take and a challenge from the soon-to-be-unemployed Derek Lowe of In The Pipeline:

I mean, think it through: Pfizer spends hundreds of millions of dollars, only to find that their drug has unexpected toxicity. Not the horrible, chemical-weapon toxicity that the conspiracy mongers talk about, mind you: 11 deaths per thousand versus 6 deaths per thousand. But development stops immediately, as it should, the very day that Pfizer's executives get the news. Two days after trumpeting the compound as the biggest thing in their pipeline, they pull it and walk away from the billions of dollars that could have been.

How, exactly, does this fit the Evil Conspiracy worldview?

(My usual disclosure: I do a small amount of consulting work for pharmaceutical companies in products liability litigation.  Pfizer is not presently one of them.)

Update: Blog 702 responds: "Did Pfizer figure out that it would be difficult to yell "junk science" in a potential hailstorm of litigation, given that clinical trials showed a reported 60% increase in deaths among patients taking torcetrapid and Lipitor, over patients taking Lipitor alone?"

Well, maybe, but if you listen to the plaintiffs' experts in any given mass tort litigation (you can take your pick), the data are just as compelling in all of those cases.  Rezulin, HRT, diet drugs, Baycol, Vioxx -- in all of them, according to the plaintiffs, the warning signs were just as stark as they appear to be here.  But here the development stops.  Is it a different standard being applied or were the purported warning signs different in kind in the prior cases?

(Incidentally, given the indication of these drugs, it may well be that the numbers of lives saved by the combination of LDL reduction and HDL increases would exceed the number of fatalities from side effects.  (I think it probably wouldn't be, but depending on the treatment population, it's certainly not impossible.  Probably still the right thing to stop development, but it's interesting to consider.))

http://lawprofessors.typepad.com/tortsprof/2006/12/torcetrapib_big.html

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Comments

Well, the side effects here were precisely the cardiovascular problems that HDL increases were supposed to reduce, so this isn't really a case of tradeoffs. HDL is a means to an end of better cardiovascular health, not an end in and of itself. Torcetrapib was counterproductive, while there may be a population of people where Vioxx's benefits exceed the risks.

I think the significant-to-three-standard-deviation indication for torcetrapib is unambiguous, unlike the evidence in the COX-2 scenarios, where the evidence is sufficiently ambiguous that only Merck has withdrawn the drug. Of course, since the plaintiffs' bar puts profits in front of people, they're focusing on the one company that did withdraw a drug when the evidence started to become less ambiguous.

Posted by: Ted | Dec 13, 2006 9:05:01 AM

But the data from the study so far do not necessarily show that the drug would be counterproductive. They showed (as I read the reports, anyway) that certain short-term CV risks were increased. HDL increases are beneficial long-term. We don't know how it would come out long-term. And the standard-deviation calculation addresses the interim data in a trial that wouldn't have ended until 2009.

The side effects also are not "precisely" the same. They are both in the region of CV risks, but it appears (again from what I've seen so far) that the risks that led to the end of the trials were blood pressure-oriented, not cholesterol-related. The benefits of cholesterol improvements could outweigh the harms from blood pressure increases in terms of overall mortality.

All that said, I'm not saying it was a mistake to stop the trial (obviously Pfizer's folks thought about this more than I did) -- only that if the clinical trial had gone through its planned end-point, the overall mortality outcome may well have been much less clear and possibly even positive.

Posted by: Bill Childs | Dec 13, 2006 10:28:04 AM

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