Trial Lawyers Politicize Science

By April 17, 2008General

The placement of the Washington Post story yesterday, page one, caught our eye. And the accusations against Merck were certainly pumped up to full volume.

Two teams of researchers with access to thousands of documents gathered for lawsuits over the painkiller Vioxx allege that Merck waged a campaign of deception to promote its drug, moving slowly to warn of possible hazards while at the same time dressing up in-house studies as the work of independent academic researchers.

The reports in today’s Journal of the American Medical Association in effect accuse one of the world’s biggest pharmaceutical makers of various forms of scientific fraud.

Oh, the prestigious, fact-based, peer-reviewed JAMA, so it’s an allegation that must be taken seriously, right?

To those who follow media coverage of civil litigation and tort reform, the story immediately stood out as a hit job, one that can only be seen in the context of the multibillion-dollar wave of lawsuits against Merck for claims against Vioxx. After the jump to an inside page — always after the jump — Merck gets a brief chance to respond: “A spokesman for Merck’s legal team dismissed the JAMA authors as ‘people in the pay of trial lawyers.'”

We know lots about media coverage, but not enough about the ins and outs of the Vioxx litigation to fully judge the story. But Ted Frank of the American Enterprise Institute certainly knows the issues, and here’s his PointofLaw take on the JAMA study that the Washington Post gave such prominence to:

The latest issue of Journal of the American Medical Association publishes two pieces by plaintiffs’-side experts (including the infamous Dr. David Egilman (e.g., Oct. 2007; Dec. 2005; Jul. 2005) slamming Merck over Vioxx studies. Ross/Hill/Egilman/Krumholz accuse scientists of ghostwriting studies for Merck, but as Merck and Reuters note, Egilman et al. are smearing dozens of scientists without factual basis.

And…

How unbalanced and unfair is the Psaty/Kronmal piece? The entire piece is about Protocols 078 and 091 (the “Alzheimer’s trials”), but nowhere does it note that the very same Alzheimer’s trials data found that Vioxx was less likely than placebo to result in cardiovascular events. (Indeed, it was the results of Study 078 and 091 that led Merck (and the FDA) to mistakenly believe that the adverse cardiovascular results in VIGOR were the combination of the cardioprotective effects of naproxen and random chance. See Martin Report 58-60.) There was no scientific reason to believe that Vioxx was causing fatal heart attacks (or car accidents) while simultaneously preventing heart attacks. This sort of for-hire hit-piece is appalling enough when presented in a court of law masquerading as scientific evidence; it’s utterly shameful that a political piece has the endorsement of a medical journal.

See, it’s all part of the trial lawyer shakedown. JAMA is the enforcer carrying the baseball bat of bad publicity. And the Washington Post is the little weasely guy standing next to the muscle, saying, “Yeah, yeah, that’s it. Hit ’em harder.” Because the real point of enforcement is scaring the next victim who might not pay up.

Also, Merck news release: “Merck Responds to Journal of the American Medical Association Articles.”

And politicization of medical journals is not a new phenomenon. Michael Fumento wrote about JAMA in 1999 in the Wall Street Journal, “Medical Journals Give New Meaning To ‘Political Science’.”

Join the discussion 4 Comments

  • David Egilman says:

    Could the real Emil Gilels please email me if you are not a lawyer. (degilman@egilman.com)

    No one from Merck has ever come forward.

  • David Egilman says:

    There was an increase in cardiac events on Vioxx in the AD trial 078.

    The published article misrepresented the cardiovascular outcomes of the trial. Although the study protocol stated that the primary endpoint would be an ITT analysis, the published paper did not report any such analysis. Merck presented the on-drug and off-drug data separately and disaggregated fatal and nonfatal myocardial infarctions and cardiac arrests. When combined, the results indicated that Vioxx treated-volunteers had suffered a statistically significant increased rate of MI/SD (sudden death)* of 2.16 (CI 1.12, 4.35). In addition, there was a statistically significant increase in adjudicated CV/T deaths RR = 4.72 (CI 1.59 – 14.00). These volunteers used prophylactic anti-thrombotic medications, including Plavix and aspirin. (Thal LJ 2005). Aspirin’s anti-thrombotic capabilities may have concealed the negative cardiovascular effect of Vioxx, thus acting as a significant confounder.

    Merck did not give the FDA the ITT analysis and there is no evidence the FDA never calculated the above from the data or the paper. The FDA missed a few other things like the death excess (sat on this for six months), the fact that Merck removed the planned DSMB after the study was approved by the FDA & the IRBs and of course the death excess.

    Had the FDA reported all their misses they would have looked worse than they did. It is hardly a surprise that the FDA did not report these events after the drug killed and injured so many. Of course that is part of the point. The FDA is, as Merck research lab presidents Drs. Peter Kim and Edward Scolnick stated, “overworked” and look like “grade D high school students.”

    From the “infamous” David Egilman MD, MPH. Knowledge can make you a dangerous infamous person.

    * Sudden death was considered a myocardial death. This is how most studies characterize SD.

  • Ted Frank says:

    Emil, I’m working off of FDA analyses of the Merck studies, including one done in 2005, http://www.fda.gov/OHRMS/DOCKETS/ac/05/briefing/2005-4090B1_02_MERCK-Vioxx.pdf, when they would have had every incentive to criticize Merck to divert unfair criticism of the FDA approval of Vioxx. If your claim was true, we’d see Psaty/Kronmal trumpet it as further evidence of Merck perfidy in these two studies, but they made no such claim. So if you’re aware of something that Psaty, Kronmal, the FDA, and I all missed, please drop me an e-mail, and I’ll correct my analysis.

  • Emil Gilels says:

    This statement:

    “the very same Alzheimer’s trials data found that Vioxx was less likely than placebo to result in cardiovascular events”

    is actually false.

    It is true if you look at
    what Merck published, but that’s because Merck
    never published the as-randomized analysis
    that their data analysis protocol called
    for. That analysis shows a vioxx cardiovascular
    problem very similar to that in the APPROVe study
    that led to the withdrawal of vioxx in 2004.

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