July 13

Associated Press: JAMA says it was misled by researchers

In February, 2006, the Journal of the American Medical Association (JAMA) published a widely publicized article authored by 13 psychiatrists–all of who are paid by psychotropic drug manufacturers. However, the authors’ financial ties to industry were not disclosed to readers.  Such failure to disclose financial ties is a violation of JAMA’s
conflict of interest disclosure policy.

One has to wonder what value conflict of interest disclosure policies have if the editors of JAMA (and the other medical journals) fail to enforce that policy?
The 13 authors of JAMA article claimed that their findings showed "association of depressive relapse during pregnancy with antidepressant discontinuation .[1] That claim is contradicted all other credible studies advising pregnant women against taking antidepressants in late pregnancy because of severe risks for their developing fetus.

Had the authors’ financial interests been disclosed at the time of publication, their much publicized recommendation for pregnant women to continue taking the drugs–a recommendation contradicting the manufacturers’ warnings on SSRI drug labels–both physicians, the public and even the media that transcribed the news may have been less uncritical.
JAMA’s failure to enforce its conflict of interest disclosure policy–and its failure to disclose those financial conflicts all these months–raises serious questions about the journal’s role as a promoter of industry’s marketing agenda rather than a gatekeeper protecting the integrity of scientific and ethical standards in research.

Is it too much to ask of journal editors–especially editors of journals as well heeled as JAMA and the New England Journal of Medicine–to make the effort on checking authors through several data bases listing financial ties to pharmaceutical companies?  They do cite checks and ensure citation style comports with journal requirements, conflict of interest disclosure is at least as important.

The Associated Press report (below) reports that "The Center for Science in the Public Interest recommended Tuesday that editors adopt a three-year ban from publishing in their journals in failure-to-disclose cases."   The
editors of JAMA and the NEJM told the Associated Presss "that would be impractical and unnecessary."

However, failure to enforce conflict of interest policies or to hold authors accountable for failure to disclose financial ties or for concealing negative data from reports published by journals–such as withholding deaths and attempted suicide data–may open the door for journals to be subject to litigation as accomplices in the concealment of vital information, information  that may have prevented deaths.

1. See: Lee S. Cohen, MD; Lori L. Altshuler, MD; Bernard L. Harlow, PhD; Ruta Nonacs, MD, PhD; D. Jeffrey Newport, MD; Adele C. Viguera, MD; Rita Suri, MD; Vivien K. Burt, MD, PhD; Victoria Hendrick, MD; Alison M. Reminick, BA; Ada Loughead, BA; Allison F. Vitonis, BA; Zachary N. Stowe, MD, "Relapse of Major Depression During Pregnancy in Women Who Maintain or Discontinue Antidepressant Treatment," JAMA. 2006;295:499-507.

Contact: Vera Hassner Sharav

Wednesday, July 12, 2006
JAMA says it was misled by researchers

CHICAGO — For the second time in two months, the Journal of the American
Medical Association says it was misled by researchers who failed to reveal
financial ties to drug companies.

The studies’ validity – and the prestigious journal’s reputation – are at stake, and JAMA is tightening its policies for researchers as a result.

"This is costing us," said Dr. Catherine DeAngelis, JAMA’s editor-in-chief. "It’s costing us really good articles and God knows what it’s costing us in ads."

But DeAngelis said her main concern is the impact on readers, who she said need to know about researchers’ financial conflicts of interest to properly evaluate their studies.

The latest incident, disclosed in letters to the editor and a correction in Wednesday’s journal, involves a study showing that pregnant women who stop taking antidepressants risk slipping back into depression.

Most of the 13 authors have financial ties to drug companies including antidepressant makers, but only two of the them revealed their ties when the study was published in February.

Antidepressant use during pregnancy is controversial and some studies have suggested that the drugs could pose risks to the fetus.

"For readers to be able to make informed judgments about potential biases in this study, they should have been made aware of all of these associations and potential conflicts of interest," Dr. Adam Urato of Tufts University-New
England Medical Center, wrote in a letter to JAMA editors.

The earlier incident involved a study in the May 17 journal that said rheumatoid arthritis patients taking Humira or Remicade faced risks of developing several cancers and serious infections.

Study co-author Dr. Eric Matteson of Mayo Clinic has worked with Remicade’s maker in developing a similar new drug and he and co-researcher Dr. Tim Bongartz have been paid consultants to Abbott for unrelated work. The ties
were not disclosed until after publication.

Matteson called the omissions "errors of oversight," not an attempt to conceal, but journal editors asked the Mayo Clinic to investigate.

DeAngelis said it’s not the first time she’s reported authors’ omissions to their institutions, and she hopes it will help curb the practice.

"It would be wonderful if 100 percent of the authors understand that you have to disclose," DeAngelis said Tuesday.

The authors of the depression study defended their research in a separate letter to the editor published Wednesday. Lead author Dr. Lee Cohen, of Massachusetts General Hospital, who is on the speaker’s bureau for eight drug companies, disputed that such ties could influence the findings.

The business ties were not disclosed because "we did not view those associations as relevant" partly because the research was funded by the government, not industry.

Such conflicts are age-old problems haunting medical journals, which compete to publish the best research.

Dr. Jerome Kassirer, a former New England Journal of Medicine editor and an outspoken critic of doctors’ conflicts of interest, said it would be impossible for medical journals to reject all research with industry ties.

If industry ties were an obstacle to getting research published, "you’d have no research on drugs," Kassirer said.

Still, industry-funded drug research tends to have more favorable results than other studies, and those ties need to be revealed so readers can have "a healthy skepticism," he said.

The New England Journal of Medicine also requires financial disclosures from authors, although not before accepting an article for publication as JAMA is now doing, said Dr. Jeffrey Drazen, the journal’s editor.

The Center for Science in the Public Interest recommended Tuesday that editors adopt a three-year ban from publishing in their journals in failure-to-disclose cases.

But Drazen and DeAngelis said that would be impractical and unnecessary.

"Editors have very long institutional memories," Drazen said. "I think that’s adequate in this case."

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