Ghostwriting tarnishes medical ethics

U. TORONTO (CAN) — Academics who lend their names to medical journal articles penned by industry ghostwriters should be charged with professional and academic misconduct and fraud, according to a report by two law professors.

Published in the journal PLoS Medicine, the study suggests the practice has troubled the medical profession and editors of medical journals for years and raises serious ethical and legal concerns that bear on the integrity of medical research and scientific evidence used in legal disputes.

“Guest authorship is a disturbing violation of academic integrity standards, which form the basis of scientific reliability,” write Simon Stern, assistant professor of law, and Trudo Lemmens, associate professor of law and medicine, both at the University of Toronto. “The false respectability afforded to claims of safety and effectiveness through the use of academic investigators risks undermining the integrity of biomedical research and patient care.”

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Since medical journals, academic institutions, and professional disciplinary bodies have not succeeded in enforcing effective sanctions, a more successful deterrence would be through the imposition of legal liability on the guest authors, “and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO),” the paper argues.

Industry-sponsored articles, with only minor contributions from academic “guest authors,” have been published in leading medical journals, including articles on hormone replacement therapies, Vioxx, Neurontin, Fen-Phen, and various anti-depressants, and are often cited by the pharmaceutical sponsors to promote off-label use of their products.

“The same fraud could support claims of fraud on the court against a pharmaceutical company that has used ghostwritten articles in litigation,” the study says.

Such a claim could prevent the pharmaceutical sponsor of the articles from presenting them as evidence in court, and could also lead to sanctions against the lawyers who sought to treat the articles as legally valid evidence.

Ghostwriting by academics is “a prostitution of their academic standing,” Lemmens says. “And it undermines the integrity of the entire academic publication system.”

The research is supported by a grant from the Social Sciences and Humanities Research Council on the Promotion of Integrity in Biomedical Research.

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