Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals

Abstract

In recent years, Mayo Clinic Proceedings has published a variety of articles dealing with important, broad-reaching matters of societal interest that impact medicine and patient care. Topics included ideal physician behaviors, gender and medical career mentoring, advance directives and end-of-life issues, physician involvement in capital punishment, and, germane to this article, institutional conflicts of interest (COIs), as well as the journal's approach to publication of industry-sponsored clinical research.1-15 Equally important to the well-being of patients and of medicine is the legitimacy of interactions between industry sponsors of research and investigator-authors who communicate the information and the journals/editors who review and ultimately determine publication of the material. In this age of transparency, disclosure of COIs has assumed great prominence in medical journals. However, transparency is not always clear, disclosure policies are varied, and their implementation (by journals and medical societies) is asymmetric and biased. This commentary examines some prominent recent actions by consultants to plaintiffs' attorneys and a series of publications in 3 top-tier general medical journals that illustrate selective and incomplete disclosure of conflicts—both financial and otherwise. In my view, these events call into question actions by a medical specialty society with one of the consultants and, more broadly, the editorial practices at the journals concerning COIs. Specific recommendations are offered to address the latter. In April 2008, the Journal of the American Medical Association (JAMA) published a “research” article by Ross, Hill, Egilman, and Krumholz16 that was based on materials obtained through legal discovery; the authors claimed that Merck & Co, Inc (Whitehouse Station, NJ) previously hired professional writers (termed ghostwriters) to draft papers concerning clinical trials of rofecoxib (Vioxx) and invited academic physicians to accept authorship of them (without acknowledgment of the compensated writing) to increase their credibility. These guest authors supposedly made little contribution to the research, analysis, or interpretation of the data, an unacceptable practice. Many of the articles were from the mid- to late 1990s. JAMA issued press releases and an accompanying editorial17 that berated medical product companies broadly for manipulating clinical research, with resulting widespread media coverage. Some other journals opposed JAMA's posture.18 Several direct responses to JAMA by authors of publications listed in the article pointed out lapses in the report by Ross et al and mistaken inclusion of their publications in the analysis, with predictable rejoinders by the authors and editors.19-25 One letter23 suggested that “an author's declaration of financial dealings with industry is only meaningful if the monetary value received from each company over a preceding period (perhaps the past 2 years) is clearly stated,” a point to which I will return. I have worked in both academia and industry, including more than 17 years through 2006 at Merck, primarily in clinical drug development. From 2001 to 2006, this included management of a department of medical writers, support staff, and statisticians who worked with Merck scientists and external investigators to publish many (although not all) articles related to mid- and late-phase clinical trials sponsored by Merck. We adhered to the authorship criteria of the ICMJE (International Committee of Medical Journal Editors) and acknowledged lesser contributions to manuscripts by persons who did not meet those criteria. (The ICMJE states that, “Authorship credit should be based on (1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; (2) drafting the article or revising it critically for important intellectual content; and (3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3.”)26 These criteria are widely used in biomedical research, although by no means universally. Speaking only for myself, and in no way as a spokesperson, this is not a defense of Merck or of actions related to Vioxx. However, readers may have a different perspective concerning the report of supposed authorship misconduct by Merck when they learn what was not disclosed by Ross et al or by JAMA. That article16 (and the others discussed subsequently) illustrates the far-reaching influence of the American tort bar,27 now impacting the content of important medical journals to further its litigation interests, abetted by journal editors who appear biased against industry. For editorial comment, see page 771