JAMA Publishes Correction on Author Disclosure for Study on Antidepressant Use During Pregnancy, Tightens Disclosure Requirements

The Journal of the American Medical Association in its July 12 online edition published a correction saying that seven of the 13 authors of a study published in the Feb. 1 edition of JAMA did not disclose financial relationships with pharmaceutical companies, the Wall Street Journal reports (Armstrong, Wall Street Journal, 7/12). The Journal on Monday reported that the study, which was funded by the National Institute of Mental Health, did not report more than 60 financial relationships to pharmaceutical companies among the seven authors. Among the omitted relationships were that the lead author Lee Cohen, director of Massachusetts General Hospital's Center for Women's Mental Health in Boston, is a consultant to three pharmaceutical companies and a paid speaker for seven drugmakers. The study also did not note that some of his research is funded by four such companies. The study did disclose the financial ties to drug companies of two of the authors, Zachary Stowe and Jeffrey Newport of Emory University. Cohen and colleagues for the study between 1999 and 2003 monitored 201 pregnant women with a history of depression. The women were taking medications such as Prozac, Zoloft, Effexor and Paxil. Researchers found that 68% of the women who stopped taking antidepressants relapsed into depression during pregnancy. In addition, 26% of the women who continued taking their medication during pregnancy also became depressed (Kaiser Daily Women's Health Policy Report, 7/11).

Authors' Response
The researchers in a letter published in the July 12 edition of JAMA said they found "no inherent conflict of interest" with respect to their financial ties to drug companies because the study was funded by NIMH and did not examine any particular drug (Wall Street Journal, 7/12). However, they added, "[G]iven the implications of these findings relating to potential antidepressant use during pregnancy, we regret that we failed to include disclosures of the financial associations of all of the authors. Such disclosures would have provided utmost transparency with respect to potential conflict of interest, and we wholeheartedly support such a practice." The researchers' letter came in response to a letter to JAMA from Adam Urato of the Tufts-New England Medical Center. The researchers also responded to a letter written by Takeshi Terao of the Oita University Faculty of Medicine, as well as to a letter written by Arthur Rifkin of Zucker Hillside Hospital in Glen Oaks, N.Y., and William Rifkin of the Yale University School of Medicine (Cohen et al., JAMA, 7/12).

JAMA Conflict-of-Interest Policy
JAMA in an editorial said it is tightening its financial conflict-of-interest policy, telling authors to more extensively list potential conflicts of interest, the Journal reports (Wall Street Journal, 7/12). JAMA at the beginning of 2007 plans to require that authors list all disclosures in the acknowledgement section of their manuscripts when they submit them to the journal, according to the editorial by JAMA Managing Deputy Editor Annette Flanagin, Executive Deputy Editor Phil Fontanarosa and Editor-in-Chief Catherine DeAngelis. Researchers now make disclosures to JAMA through cover letters or by other means, the editorial says. The new policy says, "All authors are required to disclose all potential conflicts of interest, including specific financial interests and relationships and affiliations (other than those affiliations listed in the title page of the manuscript) relevant to the subject of their manuscript. Authors should err on the side of full disclosure and should contact the editorial office if they have questions or concerns" (Flanagin et al., JAMA, 7/12). Merrill Goozner, a scientific integrity researcher for the Center for Science in the Public Interest, said JAMA's policy changes are not enough and said the journal should enact a three-year publishing ban on authors who fail to disclose ties to the pharmaceutical industry. DeAngelis said she does not favor a publishing ban but said the journal often has asked the affiliated medical schools of authors who do not disclose to investigate their conduct. She said those investigations sometimes resulted in sanctions for the authors. "We take this very, very seriously," DeAngelis said. However, there must be a "certain level of trust" between the journals and the researchers who publish work in them, she added (Wall Street Journal, 7/12).