Authors of JAMA Study on Antidepressant Use During Pregnancy Did Not Disclose Relationships With Drug Companies

Most of the 13 physicians who co-authored a study regarding depression relapse risk for women who stop taking their medication during pregnancy -- published in the Feb. 1 edition of the Journal of the American Medical Association -- did not disclose more than 60 financial relationships to pharmaceutical companies, the Wall Street Journal reports (Armstrong, Wall Street Journal, 7/11).

The study, funded by the National Institute of Mental Health, questions the commonly held belief that hormones produced during pregnancy protect women from depression. Lee Cohen, director of Massachusetts General Hospital's Center for Women's Mental Health, and colleagues 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, 2/2).

According to the Journal, the study did not disclose that Cohen is a consultant to three pharmaceutical companies and a paid speaker for seven drugmakers or that some of his research is funded by four such companies. The second listed author of the study -- Lori Altshuler, director of the Mood Disorders Research Program at the University of California-Los Angeles -- is a consultant or speaker for at least five drug companies, affiliations that were not disclosed. Adele Viguera, associate director of MGH's perinatal psychiatry program and co-author of the study, did not disclose that she is a member of GlaxoSmithKline's speakers bureau. The study did disclose the financial ties to drug companies of two of the authors, Zachary Stowe and Jeffrey Newport of Emory University.

Previous Studies
The study is the first major research paper to establish a relapse risk for pregnant women who stop taking antidepressants, the Journal reports. Previous studies have questioned the safety of antidepressant use during pregnancy. One study found an increased risk of an infant experiencing a potentially fatal lung disorder if the woman takes a group of antidepressants called selective serotonin reuptake inhibitors during pregnancy, and two other studies found that use of GSK's Paxil during pregnancy could cause cardiac fetal heart defects. The results of those studies are being called into question by industry-paid experts in the field, according to the Journal. JAMA, Authors'

Reactions
JAMA said that its policy requires study authors to disclose all ties to the medical industry, the Journal reports. JAMA editor-in-chief Catherine DeAngelis said the journal was not aware of the relationships some of the study's authors had with drug companies, and "[a]s soon as JAMA found out that they didn't disclose, we contacted ... Cohen and asked for his explanation." She added, "We have one and it will be published very soon in an upcoming issue of JAMA." According to the Journal, the researchers "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." Cohen said that "it didn't seem relevant" for him and other co-authors to disclose their financial ties in part because the study was funded by a federal health agency. He declined to describe his consulting role to drug companies or how much he is paid for the role, but he did say that drug companies "tend to pick people who are experts in this area" and "we are not talking about megabucks." Viguera said that because of the way the study was designed, he does not "see how any kind of relationship [the researchers] have with a pharmaceutical company plays a role in that." He added, "I don't believe there is a conflict of interest." Other Reaction

According to the Journal, "industry-paid opinion leaders have become dominant authorities" in the field of antidepressant use during pregnancy, and they often assist in developing clinical guidelines, are members of journal editorial boards, provide counsel to government agencies and teach courses to other physicians. "Whether or not to keep taking an antidepressant during pregnancy is a critical question for pregnant women suffering from depression," Adam Urato, a Bradenton, Fla.-based obstetrician and perinatologist who has questioned Cohen and his colleagues about their financial ties, said, adding, "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 many antidepressant manufacturers." A Pfizer spokesperson said, "It is important to remember that this is a partnership with the mutual goal of advancing science and enhancing patient care." Nada Stotland, a professor of obstetrics and psychiatry at Rush Medical College in Chicago, said pharmaceutical companies have the resources needed to fill a research void on the effects of antidepressants during pregnancy, but they often "only do what they are required to do" by FDA. She added that there are few studies that examine the effects of antidepressant alternatives, such as psychotherapy, on treating depression among pregnant women. Alan Gelenberg, head of the psychiatry department of the University of Arizona and editor of the Journal of Clinical Psychiatry, said less than 5% of his income comes from consulting work with pharmaceutical companies, adding, "The problem is if you want an expert on antidepressants in pregnancy, most of us have taken some industry money." Gelenberg said the answer to industry-funded experts is increased funding from government and independent sources (Wall Street Journal, 7/11).

Courtesy of kaisernetwork.org

Bonnie - it is unconscionable that they did not reveal their association with Big Pharma, especially in light of all the revelations concerning this same issue over the last few years. If the authors claim that the association had no bearing on the study's outcome, then why did they not state their associations?

This has to stop and must be dealt with much faster than it is now.