Medical Ghost- and Guest-Writing as Corrupt Practices and How to Prevent Them

Abstract

This chapter analyses the corrupting influence of medical ghostwriting and its parallel phenomenon, guest-writing on medical and pharmaceutical research, focussing on important differences between ghostwriting in the ordinary sense of the word—in which the ghostwriter is basically an editorial assistant recruited by the apparent author and is subject to the latter’s authority—and medical ghostwriting in which the sponsor or the sponsor’s agent assumes the prerogative of choosing not only the ghostwriter(s) but also the guest-writer who is invited to sign on as principal author and researcher (and who is subject to being replaced). In addition to the misattribution of authorship and the obvious potential for funding bias, this type of situation involves a serious problem concerning proprietorship of and access to the raw data on which the conclusions are based. Under current laws (and the TRIPs Agreement of 1994), such data are considered to be the intellectual property of the sponsor and protected as a trade secret—a situation which is incongruent with the norms governing scientific inquiry and incompatible with concern for the well-being and safety of patients. Various strategies for preventing, reducing and remediating the harms associated with ghost- and guest-writing are discussed. Codes of conduct and agreed-upon best practices should continue to be followed by the editors of medical and scientific journals, including reinforcement of the requirement for declarations of conflict of interest by authors, as well as statements concerning funding, the identity of all contributors and the nature and extent of their respective contributions. Access to the raw data of published trials should be improved and in particular, should cease to be impeded by laws protecting intellectual property. The sanctioning and remediation of the harm caused by misleading articles subsequently discovered to have been ghostwritten can be affected by the use of both criminal and civil law. Universities, research institutions and faculty unions should assume their responsibilities in ensuring that guest-writing is not rewarded by promotion and that fraud, when it occurs, is associated with appropriate sanctions. The regularization of medical writing as a recognized profession as well as proposals for the detection and retraction of undeclared ghostwritten material in journal archives are also discussed and it is suggested that it is not desirable that medical research and continuing medical education should be the responsibility of the same organizations which are concerned with the manufacture and marketing of medical devices and pharmaceutical products.

This chapter is a re-worked and expanded version of a paper and slide presentation which was originally part of a Symposium entitled Combating Corruption in Health Care and Pharmaceuticals held at the Munk School of Global Affairs of the University of Toronto on 28 November 2016. See https://pharmacy.utoronto.ca/research/whocc/past-events/ and scroll down to the title. Some of the improvements to the original presentation are attributable to helpful suggestions and comments by professional ghostwriters who were in the audience.