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The Journal's policies were last revised in 1996.6 With regard to Original Articles and Special Articles, we will continue to follow the policy that was restated at that time. In such articles, we disclose the sponsorship of the studies and relevant financial information about the authors. During the editorial process, we ask authors for details of their financial relationships with biomedical companies, such as consulting fees, service on advisory boards, ownership of equity (or options thereon), patent royalties, honorariums for lectures, fees for expert testimony, and research grants. In a statement in such articles, we report all relevant financial relationships; if an author has reported no relevant financial relationships, there is no statement. We apply the same policy to Sounding Board articles, Case Records, and Perspectives. Our purpose in publishing financial-disclosure statements is to inform readers of the existence of financial relationships that, in our judgment, are pertinent to the article, and to affirm that we had access to this information during our deliberations.
Review articles and editorials, which summarize published articles and synthesize conclusions but do not present new data, have fallen under a different policy. More than a decade ago, the editors became concerned about the possible influence of commercial associations on viewpoints and opinions expressed in the Journal.4,10,11 The policy is laid out in Information for Authors:
Because the essence of reviews and editorials is selection and interpretation of the literature, the Journal expects that authors of such articles will not have any financial interest in a company (or its competitor) that makes a product discussed in the article.
Over the past two years we have carefully assessed the pros and cons of this policy. We have evaluated its effect on the recruitment of authors and on the range and diversity of our editorials and review articles, and we have discussed the issue in depth with the Journal's editorial board. We have concluded that our ability to provide comprehensive, up-to-date information, especially on recent advances in therapeutics, has been constrained. For example, in the past two years we have been able to solicit and publish only one Drug Therapy article on a novel form of treatment. Certainly, if we publish nothing on a given subject we run no risk of promulgating a biased opinion, but our silence does not serve our readers. Without authoritative review articles written for scholarly journals by the best possible authors, physicians may find that pharmaceutical companies become their chief source of information about new therapies. This situation is not in the best interest of either physicians or patients.
Therefore, beginning with this issue of the Journal, we have modified the statement in Information for Authors to read as follows:
Because the essence of reviews and editorials is selection and interpretation of the literature, the Journal expects that authors of such articles will not have any significant financial interest in a company (or its competitor) that makes a product discussed in the article.
The addition of the word "significant" acknowledges that not all financial associations are the same. Some, such as the receipt of honorariums for occasional educational lectures sponsored by biomedical companies, may be appropriately viewed as minor and unlikely to influence an author's judgment. Others, such as ownership of substantial equity in a company, are of greater concern. It is our intent to focus on the financial relationships that, in our judgment, could produce bias, or the perception of bias, in an article. Our definition of a significant financial interest accords with that of the National Institutes of Health (NIH)12 and the Association of American Medical Colleges (AAMC).13,14 The key provision of the definition sets an upper limit on the annual sum that a person may receive before a relationship is automatically considered significant (the limit, currently $10,000, is referred to as the de minimis level). We also regard as a significant interest any holding in which the potential for profits is not limited, such as stock, stock options, and patent positions. Our policy includes both publicly and privately traded companies, making our definition stricter than that of the NIH and the AAMC. We do not consider ownership of publicly traded mutual funds to represent a significant financial interest. With respect to research grants, our policy will continue to require that authors of review articles and editorials, through their institutions, not have major research support or a major proportion of their funding from relevant companies. We consider interactions that occur within two years before the publication date of an article to be pertinent. Information about financial relationships below the de minimis level but relevant to the article will be disclosed in the Journal.
We regard these revisions as guidelines, not rigid rules. In the end, we as editors are responsible for weighing the available facts about each prospective author and for making the decisions we believe will bring the best scientific and medical information to the Journal. No Journal editor who makes these decisions has any financial relationship with any biomedical company. With these modifications in policy, we can prevent financial interests from infringing on the editorial content of the Journal, while at the same time acknowledging that some level of interaction between academia and industry may facilitate the dissemination of scientific knowledge and its application to patient care.
It is essential that our editorial policies allow the Journal to fulfill its mission to publish current, authoritative, and unbiased information about advances in medical research. We believe that the modification of our policy on the financial associations of authors of review articles and editorials will allow us to fulfill this mission more successfully. Patients, whose physicians are guided by the information in the Journal, will be the ultimate beneficiaries.
Jeffrey M. Drazen, M.D.
Gregory D. Curfman, M.D.
References
50, subpart F (2000). (Accessed May 21, 2002, at http://grants2.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm.)
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Related Letters:
Financial Associations of Authors
Relman A. S., Bittl J. A., Ferris L. E., Korenman S. K., Drazen J. M., Curfman G. D.
Extract |
Full Text |
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N Engl J Med 2002;
347:1043-1044, Sep 26, 2002.
Correspondence
This article has been cited by other articles:
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