New England Journal of Trial Lawyer Supporters

Speaking of tarnished brands, the image of the New England Journal of Medicine (NEJM) as an objective purveyor of medical and research information has been badly damaged by the Merck-Vioxx trial flap.

In an editorial Monday, The Wall Street Journal explains (requires subscription; bolds are mine):

Merck scored a court victory late last month, convincing all but one federal juror that it acted responsibly in developing and marketing its Vioxx painkiller. What makes the outcome more notable is that it came despite the efforts of Merck’s latest accuser, the New England Journal of Medicine.

Accusations aren’t the usual fare of august medical journals, so it’s worth trying to understand the publication’s self-insertion into the Merck litigation. Its extraordinary decision to publish a critical statement about a Vioxx study it ran years ago is being hailed by trial lawyers as the best evidence yet that Merck played fast and loose with its data. Another way to say this is that the New England Journal is joining the ranks of academic publications risking their reputations as non-partisan arbiters of good science in order to rumble in the political tarpits.

The facts and timing of the Merck ambush certainly suggest as much. Late last year the New England Journal published an “Expression of Concern” about a Vioxx study it carried in 2000, baldly accusing researchers of omitting key data to make the painkiller appear more safe. The statement curiously appeared just as jurors began debating the latest Vioxx verdict. In case anyone missed the point, Executive Editor Gregory Curfman followed with his own attack on Merck, telling reporters he was “stunned” that the researchers had “allowed” his journal to publish a “misleading” article. In response to Merck’s explanation, Dr. Curfman bluntly noted: “We’re not buying into that.”

….. What has Dr. Curfman in a dither is the fact that three more participants also suffered heart attacks — though only after the cutoff date that had been determined by an outside safety panel for the study. The three heart incidents were included in an early draft of the paper, but they had disappeared by the time it went to press. The not-so-subtle accusation is that Merck manipulated the data.

In fact, as prominent scientists have since attested, the authors were simply following the rules of science. “If the outcomes truly occurred after the close of the study, then they don’t belong in the study,” Brian Strom, an epidemiologist at the University of Pennsylvania, told Nature magazine. As to a grand Merck cover-up, the company provided the additional information to the Food and Drug Administration, publicly released it not long after the journal’s article, and included information about the additional heart attacks when it sent out marketing materials that included the published study.

The New England Journal clearly knew all this, and as an esteemed professional body presumably understood the scientific rationale behind the omission. Yet it nonetheless chose to use the Vioxx trial as an opportunity to join in the latest political and legal tarring of Big Pharma as greedy profiteers.

….. Unfortunately this attack on Merck isn’t isolated, but is part of a growing trend among scientific journals that have joined business-bashing and other liberal campaigns. Last year a group of medical-journal editors joined in a partisan battle over “disclosure,” refusing to publish studies unless companies had first registered at a federal clinical trial Web site.

As FDA Deputy Commissioner Scott Gottlieb noted in a September speech, this is ironic considering that the journals “bottle up” important research in overly long peer-review processes and enforce their own “strict embargoes” on key studies so as to elevate their own publishing franchise. There’s also the question of proprietary drug data that no company is eager to share with competitors. “Disclosure,” after all, counts for little if no company sees a financial reason to explore a drug in the first place.

….. The worry here is that the health community and broader public will soon have one less place to find legitimate “science.” These publications have viewed themselves as the gold standard in research, using their peer review processes to build reputations for careful and unbiased science on the leading issues of the day. Any suggestion that these publications have an axe to grind — whether against corporate America, private markets, or specific drugs — undermines their standing as neutral arbiters. That in turn makes it that much harder to separate good science from the “junk” version. And that truly warrants an “expression of concern.”

I for one will not take anything I hear from the NEJM with the same level of faith I have previously had. They do not seem to appreciate the potential destructiveness of the fire they are playing with.
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UPDATE: Another one that got past peer review, courtesy of EU Rota and Amy Ridenour (don’t remember who I saw first; in case of ties, both places get links).
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Previous posts:

• Jan. 10 — Three Monumental Hoaxes, One Common Thread
• Dec. 30, 2005 — An Insider’s Assessment of Medical Journals and Peer Review
• Dec. 17, 2005 — What Does “Peer Review” Mean?