Journals toughen disclosure rules
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Journals toughen disclosure rules
Writers: As industry-backed research grows, publications tighten their policies on conflict of interest.
By Julie Bell, Sun Staff
Originally published September 29, 2003
When Dr. Charles B. Nemeroff's review of mood disorder treatments was published in Nature Neuroscience last year, it should have been a feather in his cap. These widely read and trusted journals, especially the prestigious Nature family, can advance scientific careers. Collectively, they influence the direction of research, the drugs doctors prescribe, the profits and losses of drug companies, and the decisions of shareholders to sell, hold or buy.
So it was that the paper Nemeroff co-wrote ignited a controversy when scientists pointed out that the Emory University professor hadn't disclosed a patent, stock options and consulting fees from companies whose products he wrote about.
Why not? The journal didn't ask.
From now on, it will. As commercial backing for researchers grows, Nature and other top scientific and medical journals are redoubling efforts to safeguard the credibility that makes them some of the most influential magazines in the world.
Nature has broadened disclosure rules for authors beyond original research papers to include reviews, such as Nemeroff's, of earlier discoveries. Science is contemplating refinements of its rules, while it becomes more assertive about pursuing conflict disclosures from authors.
The Journal of the American Medical Association continues to take great care with commercially sponsored research. JAMA, for example, is asking authors of one potentially important paper to have their data reviewed and verified by at least one expert with no connection to the company that funded the research, said editor Dr. Catherine D. DeAngelis.
"There is a real issue of trust and public confidence in research," said Dr. Charles G. Jennings, executive editor of Nature Research journals. He acknowledges that criticism associated with the Nemeroff paper, first reported in the New York Times, was an embarrassment. Collectively, financial disclosure "affects the confidence of the public in the credibility of science," he said.
As industry-backed research has increased, some researchers wonder whether even the careful, expert review process most journals employ is sufficient to weed out subtleties in the design of medical studies that can cause bias.
In May, for example, a paper in the British Medical Journal reported that published studies sponsored by drug companies were more likely to have outcomes favoring the sponsor than studies with noncommercial financial backing.
The authors theorized that drug companies might be less likely to allow unfavorable results to be published. Or, the article said, company-backed studies sometimes compare their drugs with placebos, unequal doses of a competing drug or nothing at all.
Journals have tried to manage potential conflicts of interest by asking authors to disclose them - or by banning authors with financial ties to companies that make products they write about.
The New England Journal of Medicine, which has one of the strictest conflict policies in the business, tried the tougher approach for reviews and editorials, but loosened its policy in June 2002 because it wasn't getting enough submissions.
It now publishes reviews and editorials from authors as long as they don't have "significant financial interest in a company (or its competitor) that makes a product discussed in the article."
Research by Tufts University Professor Sheldon Krimsky, author of the new book Science in the Private Interest, shows that journals with conflict policies may not press authors for the information. He and fellow researchers found that 66 percent of peer-reviewed journals with conflict policies didn't publish a single conflict of interest disclosure in 1997.
But journals have become increasingly vigilant. Nature and its sister publications began encouraging authors to disclose conflicts in October 2001. They noted studies showing "that publication practices in biomedical research have been influenced by the commercial interests of authors."
While authors can refuse to disclose conflicts to Nature, the journal notes refusals when it publishes their papers. But until now, the policy covered only authors of original research articles, not those who wrote reviews of previously published research.
The change, announced in the October issue of Nature Neuroscience, comes after Washington-based Center for Science in the Public Interest and more than 30 researchers took Science and Nature to task in Aug. 21 letters posted on the center's Web site. They highlighted instances in which potential conflicts weren't disclosed. One was the Nemeroff paper. (A letter from the author in October's Nature Neuroscience says he intends to provide financial disclosure information to all journals in the future.)
In another case, the center said a scientist with research supported by Monsanto and other companies wrote an editorial in Science on licensing of genetically engineered plants without disclosing the connections.
Donald Kennedy, editor-in-chief of Science, said in an Aug. 22 letter that the journal is discussing whether to publish conflict of interest disclosures from editorial and op-ed authors. The magazine also is considering giving guidance to authors about what constitutes a conflict. Its current disclosure form allows authors to determine that for themselves.
"There's no question that the increasing amount of commercial sponsorship is cause for some concern," Kennedy said. But he said the journal's conflict policies largely have served it well. "I'm not concerned about where we've been, but I am concerned about where we're going."