Healthy Skepticism Library item: 5498

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Publication type: news

Armstrong D.
JAMA to Toughen Rules On Author Disclosure
The Wall Street Journal 2006 Jul 12
http://online.wsj.com/google_login.html?url=http%3A%2F%2Fonline.wsj.com%2Farticle%2FSB115266504840504116.html%3Fmod%3Dgooglenews_wsj

Full text:

JAMA to Toughen Rules
On Author Disclosure
By DAVID ARMSTRONG
July 12, 2006; Page D2

The Journal of the American Medical Association says it will toughen the disclosure demands it places on its writers, following a series of embarrassing cases in which authors of research articles in the publication failed to disclose financial ties with drug makers.

The journal also issued a correction to set the record straight on a prominent study it published in February that reported pregnant women who stopped taking antidepressant medication were much more likely to suffer a relapse of depression than those who continued taking medication. The correction says that seven of the 13 authors had relationships with drug makers that weren’t disclosed in the February publication. The undisclosed relationships were reported yesterday1 by The Wall Street Journal.

Under the journal’s new guidelines, its authors — often medical researchers from top-flight universities and hospitals — are instructed to more broadly report their connections to drug companies and medical-device makers. Some critics say the measures don’t go far enough and called for a publication ban on authors who fail to disclose they are receiving money from industry.

The seven authors cited by JAMA, who came from the Massachusetts General Hospital and the University of California Los Angeles, failed to report more than 60 financial relationships with a broad array of drug makers. Several of the Mass General researchers are also Harvard University professors.

The authors of the study, in a letter also published in this week’s edition of the journal, said they concluded there was “no inherent conflict of interest” because their study was funded by the government and didn’t evaluate any particular drug. The authors, however, said they regret failing to disclose industry ties, since the main study findings indicate pregnant patients received a benefit from antidepressants.

The new JAMA disclosure guidelines instruct authors to be more inclusive in reporting ties to industry. In one hypothetical example, JAMA says authors of a paper on high blood pressure should report financial relationships they have with all manufacturers of products used in the management of high blood pressure, not just relationships with companies whose specific products are mentioned in the study.

“Authors should err on the side of full disclosure,” the new policy states. JAMA has experienced at least three cases this year where authors failed to disclose industry ties.

The Center for Science in the Public Interest, a Washington, D.C., advocacy group, published a report two years ago that found JAMA had the highest rate of nondisclosure of conflicts among four medical journals studied. Merrill Goozner, who studies scientific integrity for the center, said the JAMA changes were inadequate and urged the journal to adopt penalties such as a three-year publishing ban on authors who don’t disclose industry ties.

“It’s clear that [JAMA] does not evaluate conflict-of-interest disclosures when articles are submitted,” Mr. Goozner said. “As a result, some authors with blatant conflicts of interest apparently feel they can ignore the journal’s policy with impunity.”

Mr. Goozner said the International Committee of Medical Journal Editors, a group including the editorial heads of the most prominent journals, should agree to apply a ban by one of its members to all of its members.

Adam Urato, a Florida physician who alerted JAMA that the depression-and-pregnancy-study authors failed to disclose drug-company relationships, also called for tougher sanctions in a letter to the JAMA editor.

“It seems wholly inadequate that your policy should be that disclosure is absolutely mandatory and if it does not occur then only a correction in small font will be placed in a publication of JAMA several months later,” wrote Dr. Urato. “What teeth does that policy have?”

Catherine DeAngelis, JAMA’s editor in chief, says she is averse to a publication ban, but she rejected the idea that offending authors go unpunished. She says in several cases where researchers failed to disclose industry ties, she asked the medical schools where they work to investigate their behavior. In some cases, those probes resulted in sanctions, she said.

“We take this very, very seriously,” Dr. DeAngelis said, but added she is “not an FBI agent” and “there has to be a certain level of trust” between the publication and authors who publish their research in it. “The day that certain level of trust disappears, I will hang it up,” she said.

Write to David Armstrong at david.armstrong@wsj.com3