Financial Ties to Industry Cloud Major Depression Study

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Financial Ties to Industry Cloud Major Depression Study

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Recently, new concerns have been raised about the safety of antidepressants during pregnancy, mostly among the large class of drugs known as selective serotonin re-uptake inhibitors, or SSRI's. Eli Lilly & Co.'s Prozac, Pfizer Inc.'s Zoloft and Glaxo SmithKline PLC's Paxil are all SSRI's. Some studies have found an increased risk of a potentially fatal breathing disorder and an increased risk of seizures and fetal death among infants born to mothers using a broad spectrum of SSRI's, including these drugs. And two studies have found an increased risk in cardiac malformations in babies born to Paxil users.

Drug makers say patients need to decide with their physician if taking an antidepressant during pregnancy is the right thing to do. "It is obviously a weighing of benefits and risks between the patient and their physician," says GlaxoSmithKline spokeswoman Mary Anne Rhyne. "We try to be as transparent as possible in providing information to factor into that analysis." Most antidepressants carry warning labels that explain the potential risks to the unborn baby.

For physicians, it is becoming increasingly complicated to balance the risks posed by antidepressant use by expectant mothers against the dangers associated with depression during pregnancy. Several studies have linked depression to premature birth and developmental delays. Depression during pregnancy is also associated with an increased risk of postpartum depression, which some researchers believe affects parenting and can result in developmental delays and behavioral problems for children.

The Cohen study was published around the same time that another study appeared in the New England Journal of Medicine warning of an alarming increase in a dangerous breathing problem among babies born to mothers using antidepressants.

The study of 1,213 women, led by Christina Chambers, a pediatric researcher at the University of California San Diego, found a sixfold increase in the rate of persistent pulmonary hypertension of the newborn, or PPHN, among babies born to mothers who used SSRI's late in their pregnancy. About 10% to 20% of babies born with the condition do not survive. The condition, which is marked by severe respiratory failure, normally occurs in about one or two infants per 1,000 births. For babies exposed to antidepressants late in pregnancy, the rate of occurrence rose to six to 12 births per 1,000, according to the study.

Dr. Chambers and another author receive research funding from several generic drug makers to study the safety of drugs taken during pregnancy to treat rheumatoid arthritis and other auto-immune diseases. The study itself was funded by government grants.

In an accompanying editorial, James Mills, a senior biomedical research scientist at the National Institute of Child Health and Human Development, wrote that the association between SSRI use and the breathing problem was "very unlikely to be due to chance" and that women considering whether to use antidepressants during pregnancy should take the new findings into consideration.

After the study, Dr. Chambers says she heard from women across the country who took antidepressants and had babies born with the condition. Alexis McLaughlin of Dayton, Ohio, says she took 20 milligrams of Paxil daily during her pregnancy with her fourth child. She didn't take an antidepressant when pregnant with her other children. Mrs. McLaughlin says her depression began after the birth of her third child. "I couldn't stop crying," she says. "I couldn't sleep. I looked like I was falling apart." The Paxil was effective in treating her depression, she says.

She says her daughter started to experience difficulty breathing soon after coming home from the hospital. Within days, the baby was back in the hospital in the critical care unit, where she needed a respirator to breathe. After several days, the baby was diagnosed with PPHN and transferred to the children's hospital in Cincinnati. After treatment there, the baby began to get better and eventually recovered.

The results of Dr. Chambers's study are being questioned by industry-paid experts in the field. In a recent online symposium for doctors, Adele C. Viguera, the associate director of the Massachusetts General perinatal psychiatry program and professor at Harvard Medical School, said of the Chambers study: "We were very surprised by those findings because it really didn't jibe with our clinical experience." She went on to say that Mass General "informally surveyed" colleagues across the country and that none of them had ever seen the problem identified by Dr. Chambers. "So I think it really underscores this point that we can't let one study dictate our clinical care."

Dr. Viguera is a member of the GlaxoSmithKline speaker's bureau. Dr. Viguera says she is paid to talk about Lamictal, another Glaxo drug that is used to treat bipolar disorder. She says she does about a half dozen of those talks a year and is paid $2,000 for each.

Her comments came during a May 17 lecture sponsored by the Massachusetts General Hospital Psychiatry Academy. The event carried the stamp of the Harvard Medical School and bore the slogan "CME you can trust." The initials stand for continuing medical education -- a certain amount of which is required of doctors annually by state medical-licensing boards. Doctors received CME credit for the May 17 event.

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The panel of experts for the session on "Psychotropic Drug Use During Pregnancy" was comprised entirely of psychiatrists with financial ties to drug makers. The Mass General psychiatry academy itself is funded by six drug makers, including two antidepressant makers. These relationships were disclosed.

During the hour-long Web broadcast of the panel session, Dr. Chambers appeared in a 90-second videotaped clip to explain her findings and respond to some of the criticisms from the panel.

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Last updated: 7/06

Financial Ties to Industry Cloud Major Depression Study

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