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Editors are on safer ground when they prohibit such conflicts of interest altogether rather than attempt to manage them by establishing flexible guidelines and negotiating with authors. That is why, despite the changing environment, I am not fully persuaded of the need to modify the Journal's policy.
Arnold S. Relman, M.D., Editor-in-Chief Emeritus
Channing Laboratory
Boston, MA 02115
arelman{at}rics.bwh.harvard.edu
References
Bodenheimer cites several instances in which industrial funding may have influenced the conclusions of published articles.1 Angell and Kassirer2 decried the publication of an editorial in the Journal that presented a favorable risk–benefit analysis of antiobesity drugs after it was revealed that the authors were paid consultants for the companies marketing dexfenfluramine. Gerard Piel, editor of Scientific American from 1948 until 1986, reviewed the chief scientific advances of the 20th century in the book The Age of Science but consciously omitted the topic of health care. He wrote, "The intrusion of market forces compromises work in the life sciences especially. Whole university medical-school departments now operate as subsidiaries of pharmaceutical companies."3
Nowadays, corporate affiliations are more common than academic titles. Academic physicians may not be willing to criticize their sponsors, whose final responsibility is to shareholders, not to patients or physicians.4
John A. Bittl, M.D.
Munroe Regional Medical Center
Ocala, FL 34474
jabittl{at}aol.com
References
A residual issue is whether this approach ought to be applied to all submissions. Currently, medical journals have a liberal policy with respect to authors of other types of articles. Journals publish good-faith disclosures of conflicts of interest supplied by the authors but do not determine whether a conflict is important enough to result in the rejection of an original-research article. Yet, subtle biases can distort the design, analysis, and reporting of original research. Why not extend the policy of managed conflicts of interest to all submissions, while applying clear rules for determining whether a conflict is a disqualifying one? The threshold for disqualification would doubtless be lower for editorials and review articles, but the same processes could nonetheless be applied to all submissions.
Lorraine E. Ferris, Ph.D., C.Psych., L.L.M.
University of Toronto
Toronto, ON M5S 1A8, Canada
lorraine.ferris{at}utoronto.ca
With respect to the question of whether "acceptable" payments will be disclosed to readers, it is unsettling that the Journal editors seek to maintain control over whether financial associations are disclosed. It is rather for the readers ultimately to decide the extent to which a report is biased by conflicts of interest. To do that there must be complete disclosure, and such disclosure should be automatic rather than discretionary on the part of editors. Otherwise, editorial bias may influence our perceptions of the objective validity of a paper.
Stanley K. Korenman, M.D.
UCLA School of Medicine
Los Angeles, CA 90095-7041
skorenman{at}mednet.ucla.edu
To the Editor: Dr. Relman acknowledges that some revision of the Journal's policy was necessary but is concerned that our new guidelines are neither strict nor explicit. Our revised guidelines are strict and explicit; they are in agreement with the well-accepted community standard set by the National Institutes of Health and the Association of American Medical Colleges. These organizations represent the physician-scientists whose original research we publish. Our policy sets a strict ceiling on financial interests. We do not negotiate with authors. In each case, we make an independent assessment and may choose not to consider an article by an author whose financial associations are within the limits of the policy if we believe that the associations could preclude objectivity on the part of the author or give that appearance. This is a time-consuming task that we take very seriously.
We would prefer that therapeutic research not be funded directly by commercial entities, but we are not the decision makers in this matter. We encourage the initiation of an informed national debate on this subject. However, as long as companies serve directly as research sponsors, medical journals will need to have policies to safeguard against conflicts of interest. There is no perfect policy. We have a "zero-tolerance" approach in that our guidelines are clear and we have no leniency for authors who fail to disclose their financial associations fully. However, the solution favored by Drs. Relman and Bittl would exclude from the Journal the views of some of our top researchers and would instead favor authors who are not actively working in the field. For editorials and review articles, we prefer a policy that sets a clear de minimis for financial interests but allows editors to exercise judgment within that explicit boundary. We disagree with Dr. Ferris, however; we believe that editorial decisions on original-research reports should be based on the quality of the research, not on the type of sponsorship.
In response to Dr. Korenman, our policy is explicit and sets the de minimis level at $10,000 per commercial entity per year. To ensure transparency, we disclose all relevant financial interests of authors, regardless of the amount.
Jeffrey M. Drazen, M.D.
Gregory D. Curfman, M.D.
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