12:00 AM
Aug 25, 2008
 |  BioCentury  |  Politics, Policy & Law

Sacred vs. profane

Medical journal editorials routinely attack the pharmaceutical industry, alleging drug companies corrupt the practice of medicine through inappropriate and overly aggressive marketing, while also criticizing doctors for allowing themselves to be influenced. The journal publishers themselves, however, play a key role in encouraging the behaviors their editors criticize via advertising, sponsored subscriptions and the promotion of reprints of company-sponsored clinical trials.

The latest example of this double standard came in the Aug. 19 Annals of Internal Medicine, which featured a paper based on documents uncovered in litigation against Merck & Co. Inc. According to the authors, the findings demonstrate that a study comparing Vioxx rofecoxib to naproxen, published in the Annals in 2003, was “an example of marketing framed as science.”

The new paper is by Kevin Hill, a psychiatrist at McLean Hospital, which is affiliated with Harvard Medical School, and three other physicians who were paid consultants to plaintiffs who sued Merck.

According to an accompanying editorial signed by Annals Editor Harold Sox and Drummond Rennie, deputy editor of the Journal of the American Medical Association (JAMA), “institutional review boards, researchers, physicians, and patients” need to be challenging the hypothesis behind a study in order to uncover trials that do not resolve unsettled questions and are simply being conducted in a way to engage investigators as advocates for a drug.

Last week’s editorial did not criticize Annals editors for publishing the original paper describing the ADVANTAGE (Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness) trial, although the new paper by Hill et al. concludes that based on the plaintiff’s evidence, ADVANTAGE was done primarily to support marketing and did not provide important medical or scientific information.

For example, in an internal e-mail, Edward Scolnick, head of the research division at Merck Research Laboratories, characterized ADVANTAGE as “intellectually redundant.”

Indeed, the litany of ADVANTAGE’s failings cited by the Hill paper suggest that a critical reading of the manuscript might have led the editors to question its merit.

According to the American College of Physicians, which publishes the journal, Annals accepts only 7% of submitted research papers. In this case, according to last week’s editorial, the editors “published the study because we thought that physicians would be interested in the low discontinuation rates for both drugs and the small difference between them.”

With benefit of hindsight, the editorial notes, “no one told Annals the true purpose of ADVANTAGE.”

By the same token, the editorial did not address how the journal could have profited from reprints of ADVANTAGE and other studies.

For example, it did not mention that Merck could have paid to sponsor subscriptions to Annals for physicians, who could have received a specially modified edition with a cover advertising Vioxx or another Merck drug.

While Annals did not respond to calls for comment, its business practices are far from unique. For example, discovery in the Vioxx litigation disclosed that Merck spent over $600,000 on reprints of another VIOXX study published in the New England Journal of Medicine(NEJM).

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In a JAMA editorial on April 16, Editor in Chief Catherine DeAngelis and Executive Deputy Editor Phil Fontanarosa issued a warning: “The profession of medicine, in every aspect - clinical, education, and research - has been inundated with profound influence from the pharmaceutical and medical device industries. This has occurred because physicians have allowed it to happen, and it is time to stop.”

They added: “When integrity in medical science or practice is impugned or threatened -...

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