Last year, Laurence J. Hirsch, a former spokesman for the pharmaceutical manufacturer Merck, wrote an 11-page commentary titled Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals. The article, which looked at the relationship between medical journals and physicians who work on behalf of trial attorneys was published by the journal Mayo Clinic Proceedings, along with a correction and was also accompanied by a editorial by William L. Lanier, the publication's editor in chief.
In response to the commentary, Mayo Clinic Proceedings received a large number of letters to the editor and other communications in response to the commentary by Hirsch and the accompanying editorial by Lanier. Below is a summary of the comments the journal received .
Jeffrey R. Garber, MD, President of The American Association of Clinical Endocrinologists (AACE) acknowledged the various “interests” that physicians have and stated that “there is no inherent conflict of interest in the working relationship of physicians with industry and government. Rather, there is a commonality of interest that is healthy, desirable, and beneficial.”
Dr. Garber further emphasized that “monitoring and regulating physician interaction with industry is the key to ensuring integrity has yet to be supported by balanced scientific evidence.” As a result, he supported Hirsch’s “cogent argument that disclosure requirements for journal editors who are entrusted with accepting or rejecting manuscripts or who publish their own manuscripts should be as rigorously scrutinized as those being aggressively promoted for the medical community at large–perhaps no more, but certainly no less.”
Patricia K. Baskin, MS Executive Editor, Neurology, along with her colleagues, criticized Hirsch’s article for misrepresenting the “importance of the intellectual contribution of first drafts of manuscripts.” They make this claim based on the assumption that “a common industry practice is to use a professional writer to generate a first draft of a manuscript to facilitate the engagement of a “guest” academic author.” In fact, the editors of this journal felt that Hirsch’s essay showed a “desire to cover up the work of professional writers.”
In response to their criticism, Dr. Hirsch noted that there was no suggestion of cover up of authors but rather, that “others often do less and should simply be acknowledged, case-by-case.” As a result, he concurred that the contributorship model of attribution may be preferable to current approaches” but, “whether one approach is “better” than the other remains to be seen.”
One of the more powerful comments in support of Hirsch’s article came from numerous clinical researchers and educators dedicated to the treatment of multiple myeloma. These physicians wrote their response because they recognized that one important factor has been missing from the discussion about the increasing scrutiny and regulation of the relationship between clinical educators and investigators and industry and the continuing medical education (CME) providers:
“a concerted response from those who have worked with the pharmaceutical industry and providers of CME to present the opinion that these interactions are in fact of real value.”
These clinicians are also worried about the valuable relationship of industry and CME because “evolving institutional and national trends now in the public domain may seriously curtail the interactions between clinical educators and investigators, industry, and CME providers.” If such interactions are prohibited or hurt, they assert that it “will diminish clinical investigation and education alike, with a consequent negative effect on patient care.”
Even more detrimental to patient care, the group noted, is that “many institutions are considering the adoption of a “zero involvement” policy, which would substantially limit physician involvement in CME activities and new drug development.” They noted that “although some rare abuses have occurred and that the risks in this interaction are real,” the medical community should avoid “overzealous, ill-judged, and restrictive regulations that will curtail the current constructive interaction.”
Specifically, clinicians emphasized that such partnerships “resulted in unprecedented advances in myeloma, with a subsequent dramatic improvement in patient outcome, and to impede this progress in the treatment of multiple myeloma would be a disservice to their patients and their families.” The group then went on to assert that:
1. Synergistic interactions between physicians and the pharmaceutical industry have contributed to the development of safe and effective therapeutics that have improved individual patient outcome and thus have contributed to the greater good of society.
2. The overwhelming majority of interactions between academia and industry have been positive, productive, ethical, mutually respectful, and driven by the shared desire to bring better treatments to patients with multiple myeloma.
3. Conflict of interest concerns in these relationships have been exaggerated and diminish the integrity of physicians and coworkers engaged in clinical research in the public eye.
4. The evidence points to the overwhelmingly positive aspects of clinician-industry interaction and that a “confluence of mutual interest” exists.
5. That industry-academia interactions, conducting shared research under commonly agreed upon guidelines characterized by full disclosure and clear transparency, are in the best interests of all, and in particular our patients.
6. Enforced disengagement of such partnerships will help no one and hurt many.
7. The support provided by industry for professional meetings and publications designated to promote and foster research as well as education is a major factor in contributing to the clinical development and subsequent deployment of effective therapies in a timely manner.
8. The support provided by industry to commercial CME providers, with independent review of content for fairness and balance, has resulted in the development and implementation of a variety of educational events directed toward physicians, patients, and allied health care personnel, which has improved their understanding of the disease, the benefits and risks of different treatment strategies, and the existence of additional resources to help in patient care. Through these educational events, the quality of care delivered to patients with myeloma has improved. By accelerating deployment of new therapies, lives have been prolonged and toxicities of treatment decreased.
9. We believe that this learning activity is of high value to the recipients of such education, especially to patients. As such, remuneration to experts of content and presentation for their time (often spent away from family) is reasonable, necessary, and professionally acceptable.
10. Consulting and participation in advisory boards by highly informed specialists with first-hand experience of novel therapeutics, both clinically and preclinically, are important activities of high value to industrial partners during the development of safe and effective new drugs. Optimal sharing of this knowledge occurs with investigators who care for patients and are engaged in clinical research, thus representing a bona fide exchange of information; remuneration for this work is reasonable, necessary, and professionally acceptable.
One commentator recommended that a 10-year moratorium should be used for any expert who would sit on FDA or related advisory committees and severing all financial ties at least 2 years before volunteering for these committees through 5 years after the guidelines have been implemented. In response, Dr. Hirsch noted that such an idea is “precisely the kind of damaging forced disengagements between industry and physicians, academia and medical associations that Fonseca et al warn against and which are not supported by analyses of several hundred Food and Drug Administration Drug Advisory Committee deliberations.”
Joseph S. Ross, MD, MHS, of Mount Sinai School of Medicine, and Harlan M. Krumholz, MD, SM, of Yale University School of Medicine, also commented on Hirsch’s article, and criticized him for misstating facts. Hirsch defended his assertion about Ross and Krumholz’s articles because “there was no mention of any of the authors being compensated, nor of appearing as expert witnesses in court, etc. The disclosure statements in the 2 other publications mentioned that the authors had been compensate.” Dr. Hirsch did note a correction to a statement about compensation.
A clinician who treats patients with AIDS commented that “had great opportunity for profit not motivated the owners of these companies, AIDS drugs may never have been developed.” He further emphasized that “had the owners of these companies not paid the researchers adequately, they may not have been able to retain and engage the type of people who have led to these wonderful breakthroughs and advances in drug developments.” Consequently, he referred to the present trend as an evolving “witch hunt against pharmaceutical companies.” He called for judging the work of physicians and researchers on the “basis of what they do and what they accomplish, not on the basis of who pays them or how they are paid; on the basis of its quality and honesty, not by who writes the paycheck of the investigators.”
Conclusion
In the end, Hirsch acknowledged that he had received dozens of e-mails from readers in the United States, United Kingdom, Europe, and Latin America after publication of his commentary and Dr Lanier’s editorial. He noted that, “with a single exception, roughly 90% were supportive.” As a result, he asserted the need to stop the indiscriminate use of the term “conflict of interest, and instead use the more neutral term “competing interests.” Dr. Lanier added that, the overwhelming majority of communications were supportive as well. In fact, he noted that many comments dealt with the fact that journals, editors, and policy makers were using a one sided idea dealing with the ills introduced by financial COI, instead of discussing the larger “risk-benefit equation as it relates to the discovery, invention, and introduction of drugs and medical devices.”
Such support reaffirms the notion that “within the proper boundaries of full disclosure and compensation at fair market value for the effort involved, these interactions should not be limited, but rather encouraged with appropriate guidance and within agreed upon guidelines.” Moreover, the relationships with industry and physicians should be strengthened to further improve outcomes for patients,” because hindering the progress of such collaboration will only be to the detriment of all, in particular patients.
It is also important to remember that “we should not simply assume that because someone is paid either more or less or by one person or another person, that the quality of his or her work or his or her integrity is either better or worse.”
With that in mind, we agree with Dr. Lanier that “the long-established, sustaining principles of scientific method, peer review, and medical publishing do not need to be abandoned or undergo major revision in the current era … because these traditional rules can be used appropriately for the advancement of knowledge and the benefit of society.” In fact, “collaborations with industry by experienced clinicians, educators, and researchers are indeed beneficial and advance the state of health care.”
Rather than “close the door to evidence, debate, and proper decorum,” by excluding the involvement of industry and “mocking the core of science,” the medical community and public must “appreciate the enormous amount of high-quality research funded by industry to develop drugs and demonstrate their value.”
Comments