Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications–4

Abstract

In September 2009, Mayo Clinic Proceedings published a commentary by Dr Laurence Hirsch1 that broadly attacked our personal and academic integrity on the false premises that we had not disclosed our COIs and that our research findings were flawed and biased. The criticism was directed at 3 of our published articles2-4 that described conflicted and unethical collaborations between physicians and industry that distorted clinical research and patient care, particularly acts by physicians and by Merck & Co (Whitehouse Station, NJ) during the development, evaluation, and promotion of rofecoxib (Vioxx). Of these 3 articles, 1 focused on ghostwriting and guest authorship4 and was particularly relevant to Hirsch, a former employee at Merck who oversaw medical communications related to Vioxx, including many of the clinical trial articles discussed in our articles. Although Hirsch repeatedly criticizes our lack of disclosure, it should be noted that he did not disclose the extent of his past role in the publication of Merck-sponsored clinical trials, including those of Vioxx, nor the extent of his current financial relationship with Merck with respect to company stock or options, after many years of employment at the company. To be clear, within the financial disclosure section of our articles, we not only disclosed our role in the litigation at the request of plaintiffs as a potential COI but also reiterated it within the articles' text. No reader of our articles would have been unaware of our relationship to the litigation. In addition, Hirsch repeatedly denigrates our research contributions. However, he provides no evidence for why he believes our case-study reviews of documents produced as a part of litigation against Merck do not represent research. Reviews of litigation documents have been previously used by other investigators to study issues at the intersection of litigation and health, particularly with tobacco5,6 and pharmaceutical7,8 products. Most importantly, Hirsch presents no evidence beyond hearsay to support his assertions or contradict our findings: articles related to Vioxx were ghostwritten and guest authored4 and a seeding trial was developed by Merck's marketing division to promote prescription of Vioxx.2 Finally, among several errors and misstatements, Hirsch declared that one of us (H.M.K.) had received more than $300,000 for work as a consultant at the request of plaintiffs in litigation against Merck & Co related to rofecoxib, suggesting it undermined our research integrity. This amount is inaccurate because it reflects the sum paid to him (H.M.K.) and several research assistants (including J.S.R.), which is clearly stated in Hirsch's source, a rapid response comment by a lawyer who was at that time paid to represent Merck in the Vioxx litigation.9 We regret that Mayo Clinic Proceedings did not provide us a lengthier opportunity to address the many allegations raised and errors made within Hirsch's extensive commentary and to defend our research and academic integrity, as it was purportedly published in “the spirit of opening the door to a discussion.”10