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Old 06-13-2002, 02:11 PM   #1
antiquity
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Major U.S. Journal Loosens Conflict-Of-Interest Rules

Major U.S. Journal Loosens Conflict-Of-Interest Rules
Thu Jun 13, 1:32 PM ET

NEW YORK (Reuters Health) - Editors at The New England Journal of Medicine ( news - web sites), one of the most prestigious medical journals in America, announced on Wednesday a change in journal policy that would allow experts to comment on the effectiveness of a drug or device, even when that expert has a financial tie to the maker of the product under review.

The move could leave the journal open to criticism that drug companies and other private entities could wield more influence in the publication process.

According to Journal Editor-in-Chief Dr. Jeffrey M. Drazen and Executive Editor Dr. Gregory D. Curfman, the new rules do not apply to "original articles"--articles presenting new data on the causes or treatments of various conditions. In those cases, the journal discloses the study's funding and the financial interests of the researchers, and that won't change.

But they are changing rules applying to "review articles," where noted experts in a particular field provide commentary on new study findings, and editorials, in which experts are asked to comment on new findings.

Drazen and Curfman believe previous rules barring experts with any financial ties to private companies linked to drugs reviewed in journal articles were too restrictive, limiting their ability to publish.

"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," they write, adding that while the avoidance of conflict of interest is important, "our silence does not serve our readers."

According to Drazen and Curfman, the NEJM editorial board "concluded that our ability to provide comprehensive, up-to-date information, especially on recent advances in therapeutics, has been constrained" by a policy which stated that the authors of review articles and editorials "will not have any financial interest in a company (or its competitor) that makes a product discussed in the article."

The policy has now been changed to read that the authors of these types of articles will not have any "significant" monetary ties to private companies that might stand to gain from a review article in the Journal.

"The addition of the word 'significant' acknowledges that not all financial associations are the same," Drazen and Curfman write. For example, experts who simply have invested in a mutual fund that might contain a drug company linked to the product under review will now be allowed to write a review article on that drug for the Journal.

And the editors base their definition of "significant financial interest" on guidelines issued by the US National Institutes of Health ( news - web sites) and the Association of American Medical Colleges, which set the amount at $10,000 in any given year.

Experts who stand to gain larger sums--either through stock, stock options or patents--will still be barred from penning review articles for the journal. Also barred are researchers who get a major portion of their funding from companies that stand to profit.

The goal, Drazen and Curfman explain, is to allow a wider range of experts to write for the Journal, including those who have received small amounts of monies from private sources that "may be appropriately viewed as minor and unlikely to influence an author's judgment."

"We regard these revisions as guidelines, not rigid rules," the editors add, stressing that authors for review articles will be selected on a case-by-case basis. But a loosening selection criteria will help "bring the best scientific and medical information to the Journal."

SOURCE: The New England Journal of Medicine 2002;346:1901-1902.
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