Medical Journals: Conflicts of Interest, The Tort Bar, and Editorial Oversight
An editorial published today by William L. Lanier, MD Editor of the Mayo Clinic Proceedings: Bidirectional Conflicts of Interest Involving Industry and Medical Journals: Who Will Champion Integrity? He reviewed a commentary, written by Laurence J. Hirsch, MD: Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals , “a part-time practicing endocrinologist, and former employee of Merck & Co, argues “that journals and journal editors have compromised their credibility as adjudicators of COI and, although likely unintentionally, have abetted plaintiffs’ lawyers to the detriment of the pharmaceutical industry.”
Dr. Hirsch further argues that that editors and plaintiffs’ attorneys selectively choose to portray certain information, and forget that “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.”
These editors also “sometimes use one set of COI standards for accepting or rejecting manuscripts when it suits their purposes and another set of standards when it does not.” Editors that apply these different standards “stifle creativity and productivity in the
When industry experiences great success, “journals should applaud strong drug and device companies” that “perform and publish high-quality research, and authors and industry should seek out journals and editors that demand high standards for publication but apply those standards equally to all parties.”
The pharmaceutical bio and device industries should also be recognized for their “direct participation in drug registration studies as legally required by the Food and Drug Administration.” Specifically, journals and editors should praise pharmaceutical companies for taking such proactive steps “when new drugs are being introduced or evaluated” because these companies want to have a say in how studies are designed, who conducts the research, how the data are analyzed, and how quickly a line of investigation moves from conceptualization to completion and publication.” Why? To make sure patients are safe, and treatments are effective, and to speed beneficial therapies to market thus making them available for patients.
For example, “pharmaceutical companies have collaborated to develop guidelines for proper conduct when pharmaceutical companies publish research findings and other information.” In addition, “many pharmaceutical companies reduce the production of manuscripts written by industry by using “contracts with groups of authors’ editors to help with the copy editing and formatting of manuscripts.”
While critics believe that making guidelines and manuscripts “is harmed by commercial
groups (e.g. “medical communication companies”) the greater majority of “drug companies seek out (for their original research efforts) investigators who are well versed in conducting clinical studies of drugs.”
Although some “investigators who contribute to these studies are increasingly viewed by the public as biased, the mere “affiliation of physicians with a drug company alone is not proof of any wrongdoing.” In fact, journals and editors that “exclude investigators and authors from public discussions” for such affiliations are problematic and only harm patients by preventing research.
Journal editors have changed their view of COI because they “do not use a single standard for all authors but instead selectively and excessively condemn authors who have drug company affiliation.” That is why Dr. Hirsch and others support a uniform system for COI disclosure policies for journals to use.
A policy such as JAMA’s requirement to use independent verification for industry trials “is a clear example of bias in manuscript review and provides no real benefit to its readers.” In fact, JAMA is so strict on COI disclosures that recently they issued a policy “requiring whistle-blowers to essentially agree to be gagged until JAMA completes its investigation of alleged COI.”
Editors also must not fall into the interests of plaintiffs’ “lawyers to the detriment of the pharmaceutical companies because “Journals can have financial and reputational COIs when dealing with COI issues” as well. Specifically, it is controversial that top-tier peer-reviewed medical journals would publish articles based on a unilateral presentation of legal discovery proceedings (Merck) without allowing a real-time response from the accused. Especially when Merck’s guidelines addressed the role of medical writers and disclosure of their contribution as well as criteria for authorship well before any journal adopted such a policy.
In response, Dr. Lanier noted that “it is curious that journal editors have acquired such a low threshold for publishing rules to address industry-related COI, yet have less interest in addressing other meaningful forms of COI that result in contamination of the medical literature.” As Hirsch rightly states, “pharmaceutical companies, authors, journals, and editors should be held to the same standards,” and “it is inappropriate for editors to apply one set of rules for one demographic group and another set of rules for others.”
When it comes to acceptable authorship practices there is consistent agreement among many organizations on 2 issues: (1) Medical writing is a valuable, accepted function that can assist in the timely, well-organized, clear communication of scientific studies. (2) Medical writing or editorial assistance that does not merit named authorship should be acknowledged, along with the source of funding support for such work.
The Association of American Medical Colleges also clearly states that, “Transparent writing collaboration with attribution between academic and industry investigators, medical writers, and/or technical experts is not ghostwriting.”
Regardless of who wrote the article, editors have a responsibility to inform their readers of the explicit role(s) played by and the extent of compensation received by authors in publications arising from legal proceedings. Readers must also have the opportunity to see both sides of a story and pass judgment about the actions of the company or individual, much as in a court of law.
While frequent calls for greater “transparency” on the part of industry ignore the major changes that have occurred in the past decade, they also ignore multiple Nobel Prizes awarded to scientists who worked with industry.
For example, Drs. Edward Kendall and Philip Hench “worked in concert with Merck & Co during World War II to discover and introduce cortisone.” The impact of such a discovery resulted in a Nobel Prize in Physiology or Medicine in 1950. Are their accomplishments “tainted” by a drug company?
Then there is Drs. Gertrude Elion and George Hitchings—employees of Burroughs Wellcome Company—who were responsible for the introduction of 6-mercaptopurine, trimethoprim, azathioprine, allopurinol, and acyclovir, and Dr. James Black, a former employee of the Pharmaceutical Division of Imperial Chemical Industries and later an employee of Smith, Kline, and French Company, who introduced propanolol and cimetidine. All 3 of these doctors shared the 1988 Nobel Prize in Physiology or Medicine “for their discoveries of the important principles of drug treatment.”
Conclusion
Conflicts of interest are not a behavior or misconduct. COIs are a state of affairs, that should be managed, rather than vainly attempting their elimination, and if disclosure is the method of management, it should be implemented consistently.
Ultimately, these overt restrictions on researcher communications in journals today are beginning to affect the willingness of prominent researchers to interact with industry in any manner that involves even minimal compensation for their time and efforts. For example, researchers such as Eric Winer, Professor at Harvard and Director of the Breast Oncology Center at the Dana Farber Cancer Institute, are no longer willing to “go to an advisory board meeting,” something he resents. This impact will have serious negative implications for the future of medical product development if top academic researchers are shamed into ceasing any type of compensated interactions with industry.
Americans must remember that “nearly all modern medical therapies that are taken for granted today have resulted from applied research and development by industry (often building on mechanistic basic research funded by government), done largely in collaboration with academic physicians."
The coverage of COI issues from Drs. Lanier and Hirsch confirm that physicians and medical scientists can provide objective, evidence-based reasoning even if supported by industry.
We encourage you to download and read these important papers and disseminate them amongst others in academic medicine who are fearful of the mighty journal editors both are a must read for the end of summer reading.
Laurence J. Hirsch, MD: Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals
William L. Lanier, MD Editor of the Mayo Clinic Proceedings: Bidirectional Conflicts of Interest Involving Industry and Medical Journals: Who Will Champion Integrity?