Law professors claim academics ‘guest authoring’ ghostwritten medical journal articles should be charged with fraud

Academics who lend their names and receive substantial credit as guest authors of medical and scientific articles ghostwritten by industry writers — even if the articles contain factually correct information — should be charged with professional and academic misconduct as well as fraud, according to two University of Toronto Faculty of Law professors.

In an article published recently in PLoS Medicine, professors Simon Stern, PhD, and Trudo Lemmens, LLM, DCL, argue “guest authorship is a disturbing violation of academic integrity standards, which form the basis of scientific reliability.”

“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,” they wrote.

In the article, 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 the imposition of legal liability on the guest authors.

“In the legal setting, peer-reviewed articles are credible sources of evidence that may be used in lawsuits to support claims about safety and effectiveness, and hence to determine liability,” the authors wrote. “Industry-controlled publications that are prepared by ghostwriters or that use guest authors may distort perceptions about current knowledge concerning a product’s safety and effectiveness.”

The authors went on to suggest that legal liability may be the most viable course to curb ghostwriting, as the institutional response thus far has been limited in strength.

Reference:

Stern S, Lemmens T. Legal remedies for medical ghostwriting: Imposing fraud liability on guest authors of ghostwritten articles. PLoS Med. 2011. doi:10.1371/journal.pmed.1001070.

Boy, it sure seems harsh to consider it fraudulent if the study is within acceptable standards of scientific research e.g. using the evidence based guidelines for prospective and/or retrospective case study material that is used elsewhere in peer reviewed literature. However, the author should have participated in the study to lend his name as a co-author as opposed to an internal "white paper" written by the industry researcher and then simply approved by the author who has a relationship with that industrial partner. Clearly, this latter scenario would be considered inappropriate and perhaps fraudulent.

— Jack M. Bert, MD
Orthopedics Today Business of Orthopedics Section Editor
Summit Orthopedics
Saint Paul, MN

Legal remedies for ghost-writing appear excessive. Tort liability, if any, should properly lie with the companies that indulge in such egregious conduct and falsely enhance the credibility and safety of their products. As for academic sanctions, those already exist. Peer-reviewed journals also have extensive disclosure requirements, and sanctions against authors who misrepresent or plagiarize work. I do not believe that legal sanctions are the appropriate remedy.

— B. Sonny Bal
Missouri Orthopaedic Institute
Columbia, Mo.

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