Financial Ties to Industry Cloud Major Depression Study

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Financial Ties to Industry Cloud Major Depression Study

continued

Warning Labels

The panelists were also critical of a recent action by the Food and Drug Administration to add new warnings about potential birth defects to the Paxil label. In December, the FDA issued a health advisory saying it determined exposure to Paxil in the first trimester of pregnancy may increase the risk of congenital malformations. The advisory said an as-yet-unpublished Swedish study of 6,896 women found a doubling of cardiac defects among infants born to mothers who use Paxil, compared with those in the general population. Most of the cardiac defects involved the failure of the wall between the left and right sides of the heart to completely develop.

Panelist Zachary Stowe, who directs the women's mental health center at Emory, described the recent FDA decision to change the warning label for Paxil as "driven by a single set of data that is unpublished, non-peer reviewed, and somehow this trumps the very nicely done prospective investigations that have really failed to find this risk." Dr. Stowe has served as an adviser and speaker for several antidepressant makers.

To further make that point, a videotaped interview with Gideon Koren, the director of the Motherisk Program at the University of Toronto, was played.

Dr. Koren said the data identifying a risk of cardiac malformation were "very low quality" and that regulatory agencies were "just throwing us statements, mostly for medical-legal reasons." Dr. Koren is currently conducting a study funded by drug maker Wyeth looking at the development of children exposed to the company's Effexor, a non-SSRI antidepressant. That relationship was not disclosed.

Beginning this fall, the Mass General psychiatry academy plans to conduct CME symposiums in a dozen cities across the country. Dr. Cohen is overseeing a segment on treating psychiatric disorders during pregnancy, according to material promoting the events.

Robert Birnbaum, the medical director for postgraduate medical education in the psychiatry department at Massachusetts General, said the panelists were chosen because they are nationally recognized leaders in their field. He said the academy curriculum is supported by a consortium of pharmaceutical companies, but that the drug makers have no input into the selection of faculty or program content.

Experts with industry ties were also heavily represented at a U.S. government-sponsored conference in Florida last month. The conference, sponsored by the National Institute of Mental Health, a government agency, drew hundreds of researchers from academia, industry and government.

A panel titled "Use of SSRIs and Mood Stabilizers During Pregnancy: Weighing the Risks" included Drs. Cohen and Viguera, as well as Alan J. Gelenberg, the head of the psychiatry department at the University of Arizona and the editor of the Journal of Clinical Psychiatry. The lone panelist without industry ties was Kathleen Uhl, the director of the FDA's Office of Women's Health. Her talk was largely a general discussion about how the FDA decides to assign various warning labels to drugs.

While the speakers made no mention of their industry affiliations during their presentations, conference attendees were provided a booklet when they registered that listed speakers and their financial relationships.

Dr. Gelenberg said at the conference "probably there has been an overreaction" to recent concerns about heart defects linked to Paxil use during pregnancy. Dr. Gelenberg reports numerous consulting and speaking arrangements with several antidepressant makers. In an interview, Dr. Gelenberg said less than 5% of his income comes from pharmaceutical company consulting work and that he no longer owns stock of antidepressant makers. He said he knows of academic colleagues earning six-figure incomes from those companies. "The problem is if you want an expert on antidepressants in pregnancy, most of us have taken some industry money," he said. The solution, he adds, is more independent or government funding of research work.

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Nada Stotland, a professor of psychiatry and obstetrics at Rush Medical College in Chicago, says there is a lack of good studies looking at the use of antidepressants in pregnancy. She says one problem is that pharmaceutical companies have the resources to do the studies that are needed, but "only do what they are required to do" by the FDA. She also says few studies look at non-drug alternatives to treating depression in pregnancy, such as psychotherapy.

Citing the conflicting and often confusing research on antidepressant use during pregnancy, the American Medical Association House of Delegates last month passed a measure directing the association to come up with guidelines concerning the treatment of depression during pregnancy.

The JAMA study by Dr. Cohen and others was the first major paper to establish a risk of relapse for pregnant women who stop antidepressant treatment. For many years, doctors were taught that pregnancy is a time of emotional well-being that protects women from getting depressed. The study was widely covered by print and television.

Wide Publicity

Headlines warned of the danger of stopping antidepressants during pregnancy, and many local television news stations broadcast, unedited, a "video news release" put out by JAMA reporting on the study. That release featured Dr. Cohen and one of his patients, Lisa Kirshenbaum of Cranston, R.I., who was a part of the study. Ms. Kirschebaum experienced a miscarriage when she went off her antidepressants, according to the video. When she became pregnant again, she took her medication and delivered a healthy baby, according to the release. The actual study, however, did not examine whether mothers delivered healthy or sick babies. It tracked only whether they suffered from depression.

The study reported financial relationships with antidepressant makers for two of the 13 authors of the study, Emory's Drs. Stowe and Jeffrey Newport. But at least seven others have relationships that were not disclosed. Among the most significant of the missing disclosures are those of the second listed author -- Lori Altshuler, director of the Mood Disorders Research Program at UCLA. She is a speaker or consultant to at least five antidepressant makers. An assistant says she is on sabbatical and unavailable for comment. Two of her colleagues -- Vivien Burt and Victoria Hendrick -- were also authors who didn't report financial relationships they have with antidepressant makers. Dr. Burt, in an interview, said "we all regret not having" disclosed those relationships and are "all genuinely interested in doing the right thing at all times." Attempts to contact Dr. Hendrick were unsuccessful. Dr. Cohen says JAMA has imposed an embargo on his letter until the journal publishes it, so he can't discuss the contents.

Dr. Viguera of Mass General was another author, and did not disclose her speaking relationship with GlaxoSmithKline. She said the study was designed in such a way that "I don't see how any kind of relationship we have with a pharmaceutical company plays a role in that. ...I don't believe there is a conflict of interest."

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Last updated: 7/06

Financial Ties to Industry Cloud Major Depression Study

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