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Medical Journal Relaxes Conflict-of-Interest Rules
Last June the New England Journal of Medicine, one of the country's premier medical journals, ended its practice of not soliciting review articles or editorials by authors who have relationships with drug companies. Review articles and editorials summarize published articles and synthesize their conclusions but do not present original research.
Formerly, the journal insisted that authors not have any financial interest in a company that makes a product discussed in an article. The new policy advises that authors should not have a "significant" interest in such a company. According to the journal's editors, they could no longer find authors without ties to drug companies who could provide comprehensive, up-to-date information, especially on recent advances in therapeutics. "In the past two years we have been able to solicit and publish only one drug therapy article on a novel form of treatment," they wrote in a June 13 editorial in the journal. "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."
Moreover, they write, not all financial associations are the same: "Honorariums for occasional lectures sponsored by biomedical companies, . . . may be appropriately viewed as minor and unlikely to influence an author's judgment. . . . 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." Under the new policy, authors can receive up to $10,000 a year from a drug company before a relationship is automatically considered significant. "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," the editors wrote. They noted that information about financial relationships below the $10,000 limit but relevant to an article will be disclosed in the journal.
"The editors made a wise decision dictated by necessity," says David Korn, senior vice president of biomedical and health sciences research at the Association of American Medical Colleges (AAMC). Korn, who monitors conflict-of-interest issues, believes the journal's new policy reflects the "profoundly changing environment of academic biomedical research." He explains that the journal's $10,000 threshold matches current regulations for federally sponsored research as well as the recommendations of AAMC task forces that have studied conflicts of interest among individuals and institutions conducting clinical research involving human subjects. He expresses regret, however, over the lack of an informed public discussion about the "effect on the future of medical research of the increasing intertwining of academic and commercial biomedical research and the private appropriation of research findings historically deposited freely in the public domain."
The journal's policy on presentation of original research was set in 1996 and remains unchanged. The editors will continue to disclose information about the sponsorship of studies and relevant financial relationships between authors and biomedical companies. In fall 2001, the New England Journal of Medicine joined the editors of other medical journals, including the Journal of the American Medical Association, in announcing revisions to the ethics section of a widely used biomedical publishing manual on which the journals rely. The revisions include a requirement that authors of published articles disclose all financial and personal relationships that "could be viewed as presenting a potential conflict of interest."
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