Curiouser and Curiouser
Stephen J Bensman
notsjb at LSU.EDU
Mon Jan 16 17:33:08 EST 2006
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January 16, 2006
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REVIEW & OUTLOOK
New England Journal of Politics
January 16, 2006; Page A14
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."
Any journal has an obligation to demand honest studies. Yet the facts of this case suggest that is exactly
what it got. In November 2000 the journal published a Vioxx study funded by Merck, which was ostensibly
looking for gastrointestinal problems. In the course of the study, the researchers also discovered that
participants showed a somewhat higher risk of heart attack from taking Vioxx as compared to another widely
used painkiller, naxopren -- a fact they included in the published results.
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.
Dr. Curfman declined to discuss the case on the record, save for the following statement: "The editors of the
New England Journal of Medicine expect that a manuscript submitted for publication will provide a complete and
accurate description of the study that was done, and that certain data will not be withheld."
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.
* * *
Some of this behavior may, in fairness, be a response to criticism the journals themselves have received from
the political left. Many have come under fire as stooges of Big Pharma because they get advertising revenue
from drug companies. But in recent years the leadership of these publications has also taken an ideological
turn.
Former New England Journal of Medicine Editor Marcia Angell has become a leading advocate of national health
care (a la Canada's waiting lines) and drug price controls. Medical journals such as the Lancet bow to
environmentalists by running reviews bashing the chemical DDT, despite its proven ability to save lives from
malaria. The journal Science has refused to run research from noted academics questioning the theory of
manmade global warming. Nature, Science and the Lancet have also declared war on genetically modified food;
Nature published one study that was so shoddy it later ran a retraction.
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."
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