Financial Ties to Industry Cloud Major Depression Study

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Major Depression Study Researchers Hide Ties to Pharmaceutical Manufacturers

At Issue: Whether It's Safe For Pregnant Women To Stay on Medication. JAMA Asks Authors to Explain

(July 11, 2006) - For pregnant women considering whether to continue taking antidepressant drugs, a study in a February issue of the Journal of the American Medical Association, or JAMA, contained a sobering warning: Stopping the medication greatly increases the risk of relapsing into depression.

The study authors -- most of them leading psychiatrists at Massachusetts General Hospital, the University of California Los Angeles and Emory University -- said their results challenged a common assumption that hormonal changes during pregnancy protected expectant mothers against depression. In their article, they predicted the findings would prompt some women to stay on their depression medication through pregnancy. That was good news for the makers of big-selling antidepressants, who have recently faced growing questions about the safety of their medications when used during pregnancy.

But the study, and resulting television and newspaper reports of the research, failed to note that most of the 13 authors are paid as consultants or lecturers by the makers of antidepressants. The lead author -- Lee S. Cohen, a Harvard Medical School professor and director of the perinatal and reproductive psychiatry research program at Massachusetts General Hospital -- is a longtime consultant to three antidepressant makers, a paid speaker for seven of them and has his research work funded by four drug makers. None of his financial ties were reported in the study. In total, the authors failed to disclose more than 60 different financial relationships with drug companies.

Dr. Cohen and some of his coauthors subsequently hit the lecture circuit, telling physicians about their findings while also spotlighting flaws in other recent studies that have found increased risks to babies born to mothers who use antidepressants.

The work of these academic researchers highlights the role of "opinion" or "thought" leaders coveted by drug companies because of their ability to influence not only the practice of doctors, but popular opinion as well. In the case of antidepressant use during pregnancies, the industry-paid opinion leaders have become dominant authorities in the field. They help establish clinical guidelines, sit on editorial boards of medical journals, advise government agencies evaluating antidepressants and teach courses on the subject to other doctors. In some cases, the financial ties between industry and these leading researchers are not disclosed.

The researchers, including Dr. Cohen, maintain that their financial links have no bearing on their research work or what they say about antidepressant use during pregnancy in interviews or lectures. The pharmaceutical companies say the academic researchers they work with provide important expertise that benefits patients. "It is important to remember that this is a partnership with the mutual goal of advancing science and enhancing patient care," says a Pfizer spokeswoman.

But such ties are prompting a growing debate in the medical community. Some physicians say they worry that it's hard to get unbiased information about treatment options for depressed pregnant women and that safety concerns about the use of antidepressants during pregnancy are being wrongly discounted.

"Whether or not to keep taking an antidepressant during pregnancy is a critical question for pregnant women suffering from depression," says Adam Urato, a Bradenton, Fla., obstetrician and perinatologist who publicly questioned Dr. Cohen and colleagues about their industry relationships during a recent online training session. "What these pregnant women and the providers who care for them need is expert advice that is free from pharmaceutical industry influence or the suggestion of bias that results when these experts are being paid by so many antidepressant manufacturers."

JAMA says its policies require that authors of studies disclose financial ties to the medical industry. JAMA's editor-in-chief, Catherine D. DeAngelis, says the journal wasn't aware of the relationships Dr. Cohen and some co-authors of the February article had to drug companies. "As soon as JAMA found out that they didn't disclose, we contacted the corresponding author, Dr. Cohen, and asked for his explanation," she says. "We have one and it will be published very soon in an upcoming issue of JAMA."

Dr. Cohen said his industry relationships have no influence on his research work or public comments on the issue. He added that the drug companies "tend to pick people who are expert in this area." He declined to specify what he does in his consulting role for the companies or how much he is paid, other than to say "we are not talking about megabucks."

Dr. Cohen said "it didn't seem relevant" for him and several of his co-authors to disclose their industry relationships in the JAMA paper in part because the study was funded by the government, not drug makers.

Big Ramifications

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Whether or not pregnant women continue or stop the use of antidepressants has big ramifications for makers of those drugs. Women are twice as likely to suffer from depression as men and have a 25% risk of developing depression during their lifetime, according to U.S. government estimates, with that risk peaking during childbearing years. The American Medical Association estimates that over 1% of pregnant women in the U.S., or more than 40,000, are taking antidepressants. Sales of antidepressant drugs in the U.S. last year exceeded $12.5 billion, according to IMS Health, which tracks prescription-drug sales.

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Last updated: 7/06

Source: WSJ

Major Depression Study Researchers Hide Ties to Pharmaceutical Manufacturers

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