Ghostwriting and guest authoring in industry-controlled research raise ‘serious ethical and legal concerns, bearing on integrity of medical research and scientific evidence used in legal disputes’

Toronto, ON) Two University of Toronto Faculty of Law professors argue that academics who ‘lend’ their names, and receive substantial credit as guest authors of medical and scientific articles ghostwritten by industry writers, should be charged with professional and academic misconduct and fraud, even if they contain factually correct information.

In an article published today in PLoS Medicine, Professors Simon Stern and Trudo Lemmens argue “Guest authorship is a disturbing violation of academic integrity standards, which form the basis of scientific reliability.” In addition, “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.”

In “Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles,” Stern and Lemmens argue that 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 authors continue: “The same fraud could support claims of ‘fraud on the court’ against a pharmaceutical company that has used ghostwritten articles in litigation.” 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.

Concerns about ghostwriting have troubled the medical profession and editors of medical journals for years.  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.  These articles are often cited by the pharmaceutical sponsors to promote off-label use of their products.

Lemmens, who is also cross-appointed to the Faculty of Medicine, has tough words for academics who participate in this guest authorship-ghostwriting dance. “It’s a prostitution of their academic standing. And it undermines the integrity of the entire academic publication system.”

PRESS-ONLY PREVIEW OF THE ARTICLE: www.plos.org/press/plme-08-08-stern.pdf

Author bios: http://uoft.me/sstern and http://uoft.me/tlemmens

PLoS Medicine: http://www.plosmedicine.org

Funding: 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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For further information contact:
Prof. Simon Stern
University of Toronto Faculty of Law
Toronto, Ontario, Canada
simon.stern@utoronto.ca
1-416-978-0293

Prof. Trudo Lemmens
University of Toronto Faculty of Law
Toronto, Ontario, Canada
Trudo.lemmens@utoronto.ca
1-416-978-4201
**Prof. Lemmens parle francais**

Lucianna Ciccocioppo
Director, External Relations
University of Toronto Faculty of Law
Toronto, Ontario, Canada
Lucianna.ciccocioppo@utoronto.ca
1-416-946-0334
www.law.utoronto.ca