Medical Ghostwriting is Scientific Misconduct – More Regulation Needed to Ensure Full Disclosure of Authorship in Prescription Drug Studies

This week, open-access journal PLoS Medicine features a discussion on medical ghostwriting by leading scientists, denouncing ghostwriting as “scientific misconduct” which poses a threat to patient safety by misleading the medical community and general public.

As we have mentioned on the blog from time to time, it is not uncommon for drug companies to hire professional ghostwriters to produce prescription drug studies, and pay reputable scientists to then put their names on research in which they have actually played little or no part. Evidence in the Merck lawsuits over the painkiller Vioxx showed that the company repeatedly lied to both the FDA and respected medical journals about who was conducting and writing up the results of purportedly “scientific” studies of the drug. While Merck named respected, ostensibly impartial doctors and researchers as the authors of Vioxx studies, these studies were actually done by Merck company employees, and written up by ghostwriters working for professional writing firms. Similarly, Wyeth—the maker of Phenergan, recently in the preemption spotlight for causing gangrene when administered improperly—was found to have paid ghostwriters to produce medical journal articles praising its female hormone replacement therapy Prempro, and to have kept the ghostwriters’ role in the articles a secret from the medical journal editors and readers.

In PLoS Medicine, Peter Gøtzsche (Director of the Nordic Cochrane Centre, Copenhagen, Denmark) argues that ghostwriting is a form of scientific misconduct which should be formally treated as such. His suggestions to decrease the prevalence of medical ghostwriting include:

· Most importantly, all journal articles should list the contributions of the authors. This would make it far easier for authors and editors to object before publication, and to document cheating after publication.

· Editors should explain in their “Instructions to Authors” that ghost and guest writing is scientific misconduct and will be exposed if detected, possibly alerting the authors’ academic institutions, and identifying the commercial companies. Editors’ associations, such as the Committee on Publication Ethics, the Council of Science Editors, the International Committee of Medical Journal Editors (ICMJE), and the World Association of Medical Editors (WAME), should develop policies that recommend ghostwriting be deemed scientific misconduct.

· Editors should ask authors to specify who wrote the first draft of the paper (and for research studies, who wrote the protocol and did the statistical analyses), and should contact these people to confirm their contribution if they are not authors. Editors should be particularly careful when manuscripts concern drugs or medical devices.

· Editors should not accept meaningless statements in the Acknowledgments such as “We thank XX” (without specifying for what) or “XX provided editorial assistance” (a euphemism, usually without affiliation, for “XX from Company YY wrote the paper”).

In the same article, Jerome Kassirer (former editor-in-chief of the New England Journal of Medicine) argues that although ghostwriting “debases the fundamental tenets of the medical profession,” the extent of the problem is not fully known. Accordingly, “[w]e must be careful not to impose excessive regulations to solve problems that may not be threatening.”

A group of professional medical writers also weigh in on the legitimacy of medical ghostwriting, calling ghostwriting “dishonest and unacceptable,” but arguing at the same time that when a medical writer’s contribution to a publication is fully disclosed, “the communication expertise and health care knowledge” of such a professional can greatly improve the quality of the publication. They propose that a standard checklist divulging medical writing assistance should be included with any manuscript submission.