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Update on the Conflict of Interest Policy for the ARCHIVES
Joseph T. Coyle, MD;
Stephan Heckers, MD
Arch Gen Psychiatry. 2006;63(11):1178.
The issue of financial conflicts of interest in biomedical research and scientific publishing has been a thorny one with which JAMA, the ARCHIVES, and academic medicine have wrestled for nearly 2 decades.1-3 Pharmaceutical, biotech, and, increasingly, medical device companies make major investments in sponsoring research in medical schools and pay for consultations with basic scientists and clinical investigators from academic medicine because of the expertise that they can bring to bear on therapeutic innovation. Many of the advances in the treatment of cancer, heart disease, and infectious disease are the fruits of these highly productive relationships. However, financial relationships between medical faculty and industry may not be obvious, unlike the identification of an individual as an employee of a particular company. Such financial relationships include participation in industry-sponsored clinical trials, membership on scientific advisory boards, stock or stock option ownership, consulting, and participation in "speaker bureaus."
Most individuals involved in these financial relationships are presumably ethical and try to exercise their best judgment in making treatment recommendations in their scientific publications or in the peer review of manuscripts. However, unconscious biases may intrude as one involved in treatment development can have intellectual as well as financial stakes in the success of a particular treatment. Thus, the media and the public are increasingly suspicious of scientific neutrality when the financial stakes can seem so large. While $40 000 per year in consulting fees from industry may not seem excessive to an academic physician, it represents the annual income of half the population of the United States and thus may be perceived as a substantial motivator toward bias.
What to do? It would not be reasonable to banish from the ARCHIVES all authors and reviewers who have perceived financial conflicts of interest. This strategy would exclude important clinical research and scientific expertise from these pages. To the contrary, the leading medical journals and the ARCHIVES routinely publish the results of clinical trials that are organized and paid for by pharmaceutical companies, provided that they pass rigorous peer review. This is how information about innovative treatments is disseminated to physicians. Therefore, we have chosen a more measured response in an attempt to achieve greater transparency. Authors will now be required to disclose in the Financial Disclosure portion of the manuscript all financial relationships that might be perceived as creating a financial conflict of interest so that reviewers and ultimately the readers can take this information into account. The criteria and procedures for reporting financial conflicts of interest are now described in a revised and updated Instructions to Authors.
We view "perceived conflict" in the broadest sense. A recent example of an overly narrow disclosure concerned an article on a National Institutes of Health–funded study that demonstrated that maintenance of antidepressant treatment in pregnant women with depression reduced the risk of recurrence. The authors did not disclose financial relationships with pharmaceutical companies that market antidepressants because no industry funds went to support the study. However, concerns were raised that their recommendations, albeit based on significant research findings, could be viewed as being supportive of their industrial ties. Thus, we recommend full disclosure of all financial relationships, even when the relevance may seem tangential.
It is ironic that in the recent incidents of undisclosed conflicts, it is the journals and their editors that received the brunt of the criticism in the media. The reputation of the journal and its editorial integrity are thus called in question. Should we sanction those who violate the disclosure policy? We believe that this would place the editors in the untenable role of "policing" publications and evaluating intent and culpability of authors. Rather, when undisclosed conflicts are discovered, the ARCHIVES will approach this problem in the spirit of transparency by publishing a corrigendum that reports the conflicts and that will subsequently be linked to the offending article in PubMed. We hope that this policy of increased transparency about perceived conflicts of interest will foster greater confidence in the scientific rigor of the articles appearing in the ARCHIVES.
AUTHOR INFORMATION
Correspondence: Dr Coyle, Department of Psychiatry, Harvard Medical School, 115 Mill St, Belmont, MA 02478 (joseph_coyle{at}hms.harvard.edu).
REFERENCES
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1. Coyle JT. Beginning year 4. Arch Gen Psychiatry. 2005;62:14.
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2. DeAngelis CD. The influence of money on medical science. JAMA. 2006;296:996-998.
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3. Flanagin A, Fontanarosa PB, DeAngelis CD. Update on JAMA's conflict of interest policy. JAMA. 2006;296:220-221.
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