Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles

Abstract

There are persistent concerns about the influence of the pharmaceutical and device industries on the medical literature, and particularly on the reporting of clinical trials, which can include the distortion of the true evidence base of medical interventions and overestimation of the clinical benefit of a drug used to treat patients [1]. An especially problematic issue involves the industry practice of publishing studies prepared by hired medical writers but signed by academic “guest authors” who are invited to add their names without fulfilling authorship criteria. In this case, “guest authorship” is accompanied by “ghostwriting,” which occurs when a published article fails to acknowledge the original writer or writers' contributions [2]–[4]. Ghostwriting can also occur when an academic research group uses a professional writer to draft an article based on data generated by the group. When the research group retains control of the data and the final analysis, however, there is less of a concern about possible bias in the reporting of the results, and the appropriate remedy in that case is to report explicitly the role and contribution of the medical writer in the article. Here, we concentrate on ghostwriting and guest authorship in industry-controlled research, where several examples have revealed the use of ghostwriters to insert concealed marketing messages favourable to a company's product, and the recruitment of academics as “guest” authors despite not fulfilling authorship criteria [5]–[9]. Commentators have condemned the practice as unethical and unacceptable and have discussed the harms resulting from this form of medical ghostwriting, recommending that journal submissions be policed more aggressively and that the “guest authors” be suitably sanctioned by journals, academic institutions, and regulatory agencies [1]–[14]. However, these recommendations have not yet been widely embraced by the academic institutions, medical journals, and medical licensing organizations that would seem to have the most at stake in curbing this practice. Here, we discuss some of the reasons for this lack of response and suggest that the law may offer a solution, given these other institutions' failure to impose sanctions.