Editorial
Financial Associations of Authors
N Engl J Med 2002; 346:1901-1902June 13, 2002
- Article
Information published in medical journals helps shape diagnostic and therapeutic decisions. For a journal to be of value, it must publish authoritative, up-to-date information that is free of commercial influence. For nearly two decades, the editors of the New England Journal of Medicine, along with the editors of other journals, have set policies to ensure that the financial associations of authors are disclosed and that published articles are not influenced by those financial associations.1-9 These important editorial policies have raised awareness about conflict of interest in medical research and have helped prevent bias — and the appearance of bias — stemming from authors' financial interests. Because relationships between authors and biomedical companies are growing, it is important to reemphasize the principles that underlie the Journal's policies on financial associations. In this editorial we reiterate those principles and introduce revisions to our policies that are intended to enhance the depth and breadth of the Journal's content while ensuring that the articles we publish are not influenced by financial interests.
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
References
1
Relman AS . Dealing with conflicts of interest. N Engl J Med 1984;310:1182-1183
Full Text | Web of Science | Medline2
Rennie D ,Flanagin A ,Glass RM . Conflicts of interest in the publication of science. JAMA 1991;266:266-267
CrossRef | Web of Science | Medline3
Koshland DE Jr . Conflict of interest policy. Science 1992;257:595-595
CrossRef | Web of Science | Medline4
Kassirer JP ,Angell M . Financial conflicts of interest in biomedical research. N Engl J Med 1993;329:570-571
Full Text | Web of Science | Medline5
Smith R . Conflict of interest and the BMJ. BMJ 1994;308:4-5
CrossRef | Web of Science | Medline6
Angell M ,Kassirer JP . Editorials and conflicts of interest. N Engl J Med 1996;335:1055-1056
Full Text | Web of Science | Medline7
The politics of disclosure. Lancet 1996;348:627-627
CrossRef | Web of Science | Medline8
Campbell P . Declaration of financial interests. Nature 2001;412:751-751
CrossRef | Web of Science | Medline9
Davidoff F ,DeAngelis CD ,Drazen JM , et al. Sponsorship, authorship, and accountability. N Engl J Med 2001;345:825-826
CrossRef | Web of Science | Medline10
Relman AS . New “Information for Authors“ -- and readers. N Engl J Med 1991;323:56-56
Full Text | Web of Science11
Angell M ,Wood AJJ . Authors' conflicts of interest: a disclosure and editors' reply. N Engl J Med 1999;341:1618-1619
Full Text | Web of Science | Medline12
Public Health, 42 C.F.R. ch. 1, § 50, subpart F (2000). (Accessed May 21, 2002, at http://grants2.nih.gov/grants/compliance/42_CFR_50_Subpart_F.htm.)
13
Task Force on Financial Conflicts of Interest in Clinical Research. Protecting subjects, preserving trust, promoting progress — policy and guidelines for the oversight of individual financial interests in human subjects research. Washington, D.C.: American Association of Medical Colleges, December 2001. (Accessed May 21, 2002, at http://www.aamc.org/members/coitf/firstreport.pdf.)
14
Kelch RP . Maintaining the public trust in clinical research. N Engl J Med 2002;346:285-287
Full Text | Web of Science | Medline
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