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New England Journal loosens its rules on conflict of interest

by Scott Gottlieb, New York

The New England Journal of Medicine is relaxing its longstanding rules on conflict of interest so that it can publish evaluations of new drugs by researchers with financial ties to the manufacturers because it cannot find enough experts without financial ties to drug companies.

In an editorial, the journal's editors say the change means its readership will be better and more promptly informed about drugs that are just coming on the market and have been studied only in trials funded by industry. Editors concede there is a risk that the objectivity of authors may be compromised, but say that otherwise doctors might have to rely on pharmaceutical companies for information about new treatments (New England Journal of Medicine 2002;346:1901-2)[Full Text].

From 1990 until now, the journal's rule was that nobody who wrote a review article or editorial could have any financial interest in a company that made a product discussed by the article, or in any of its competitors. Under the new policy, the journal will prohibit researchers from evaluating drugs for publication only if they have "significant" financial interests in manufacturers of the products, or their competitors.

The new policy pertains only to review articles and editorials. Researchers with company ties have always been permitted to present original data as long as their financial connections are disclosed.

The journal defines a significant financial interest as holding company stock, stock options, or patent positions, or having received more than $10000 (6800; 10600) from the manufacturer in the two years before the review's publication.

Lesser financial ties, such as ownership of publicly traded mutual funds or honorariums for educational lectures sponsored by drug companies, "may be appropriately viewed as minor and unlikely to influence an author's judgment," said the editorial, jointly signed by the editor, Jeffrey Drazen, and the executive editor, Gregory Curfman. Such ties will be disclosed to readers.

The change in policy was criticised by Dr Sidney Wolfe, the director of the Public Citizen Health Research Group, one of the country's largest medical consumer groups. He said: "If a doctor is doing that kind of business [evaluating drugs] with four or five companies, he or she can get as much [as] $40- to 50,000 a year and not violate the new New England Journal policy.

"The bias introduced by drug companies paying writers of review articles a large amount of money can have the consequence of slanting articles and influencing physicians in a way that isn't really in the best interests of their patients," he added.

But Dr Drazen defended the loosening of ethics rules, arguing that in the two years that he has run the journal he has been able to commission and publish only one review article about a new drug. He called that a disservice to readers as well as to contributors.

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