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J Thorac Cardiovasc Surg 2006;131:771-772
© 2006 The American Association for Thoracic Surgery
Editorial |
Drexel University College of Medicine, Philadelphia, Pa.
Received for publication February 13, 2006; accepted for publication February 13, 2006. * Address for reprints: Andrew S. Wechsler, MD, Drexel University College of Medicine, 245 North 15th St, Room 6415, Philadelphia, PA 19102-1192. (Email: jtcvs{at}drexelmed.edu).
In recent weeks, your Editor became involved in a lengthy series of E-mails and telephone conversations with a reporter from The Wall Street Journal. It seems that three articles were published by us in which the authors had clear conflicts of interest (COI) that we did not report. In one case, we failed to transmit potential conflicts disclosed by the authors. In the other two instances, my interpretation is that serious potential COIs were withheld from the Journal at the time of submission. One author had an important financial relationship with AtriCure (Cincinnati, Ohio) that he chose not to disclose. In the other instance, far more complex relationships existed that ranged from consulting agreements by some authors to authors having control over financial investments that might have profited from increased value of AtriCure stock. Both articles, regardless of how egregious the violations of our policy, survived careful peer review and generated work deemed meritorious.
As a result of this experience, I was forced to reconsider the Journal's COI policy and refresh my own knowledge of the issue. It is not my purpose in this editorial to explore the many facets of the COI controversy because the issue has been discussed at length by scientists, ethicists, politicians, national medical leaders, and the press. The evidence seems pretty strong to me that important financial interests in the outcomes and interpretations of studies can influence those interpretations. For the time being, I do not subscribe to the philosophy that these conflicts invalidate the work. I do, however, believe that reviewers and readers have a right to be forewarned that a potential bias might exist. I also believe that determination of whether or not a conflict exists should not be in the hands of the potentially conflicted.
Richard Smith, former Editor of the BMJ (British Medical Journal), has written thoughtfully on this topic. I like his conclusive statement that "conflict of interest is a condition not a behaviour." That being the case, asking an author to determine whether she had a COI is analogous to the adage that "a doctor who treats himself has a fool for a doctor." We do not ask authors to manage their COI nor to declare one. We ask only that they disclose to us all their relationships with industry and those of their coauthors. We accept the responsibility for using those disclosures to unveil a potential COI; that is, we use the objective disclosures to make a diagnosis and, as a remedy, we publish the existence of a relationship that could be construed as a COI.
My editorial staff, associate editors, reviewers, and editorial board members are not police officers. We assume that authors are inherently honest and forthcoming with required information. We assume that their institutions have policies that manage COI before research, human or otherwise, is allowed. What we have never done is to punish authors who violate our disclosure policies, and I was astonished to learn that no systematic penalties exist for such devious behavior. Thus, at its last Council meeting, The American Association for Thoracic Surgery agreed with a proposal from me to deny authors who violate our disclosure policy the privilege of publishing their work in our Journal for some period of time, probably one to two years. This solution is not perfect but it is practical. In some instances, we will be punishing our readers as much as sneaky authors. I think, however, that the message is clear: We take disclosure of relationships that might influence article content very seriously.
As does every student of the issue of COI, I know that this approach is not enough. What about our reviewers? Are they in competition with the author of an article they review? Does personal animosity exist? Is there potential gain to the reviewer by looking favorably on certain work? How can a pragmatic approach to running the Journal be balanced with these incredibly complex issues?
I have decided to make two important changes in Journal policy to try to manage these issues. First, we will ask all reviewers that which we should not ask of them: "Does this article in any way raise the potential of a conflict of interest?" We are also going to incorrectly allow the reviewer to manage that potential conflict by stating that he or she does not believe any potential conflict prohibits him or her from providing a good, scientifically valid review. Ultimately, all reviews are judged by me and my associate editors in the context of other reviews and of our own impressions of the submitted work.
Second, and more important, we have established a formal system for managing disclosures. Led by our ethics editor, Dr Martin McKneally, we are convening a panel whose members will review the disclosures of all authors as they relate to any article accepted for publication. When the ethics panel believes a conflict exists, we will publish the disclosures of the authors.
Finally, we must acknowledge that every system remains at the mercy of our authors and of our belief in the inherent honesty and desire to "do the right thing" that has been a hallmark of our profession and specialty over the years. We assert the belief that our authors are persons of character and accept the notion that character is doing the right thing when no one is looking. If an author offends us by displaying a lack of character, we believe our disciplinary action is appropriate.
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