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The reason? Pregnant women are usually excluded from clinical research and medical trials. A 2014 study in the American Journal of Obstetrics & Gynecology found that of the 213 new pharmaceuticals approved by the Food and Drug Administration between 2003 and 2012, only 5 percent included research on pregnant women. And a recent review of nearly 36,000 “pharma­cokinetic” studies—research that analyzes the way drugs move through the body—found that less than 2 percent involve pregnant women. Only a handful of medications, all for conditions of pregnancy like morning sickness and preterm labor, have been explicitly approved by the FDA for use by expectant mothers. Meanwhile, a 2011 study in the American Journal of Medical Genetics found that of 172 drugs approved by the FDA between 2000 and 2010, risk to the fetus could be determined only 2 percent of the time. Yet despite these unknowns, the FDA considers all drugs approved for women of reproductive age to also be approved for pregnant women—unless manufacturers determine that the risks of the drug outweigh the therapeutic benefits. That leaves the pregnant women considering whether to take medication with little sound information to go by. Catherine Spong, an OBGYN and the former deputy director of the National Institute of Child Health and Human Development, says it’s a conversation she has every time she sees a patient. “There’s always the risk-benefit ratio of trying to figure out when it is better to take a medication, because not taking it could be far worse,” she says. “Someone who is depressed or suicidal, not taking that therapy is going to be far worse.”

“The pharmaceutical companies or the biotech industry folks, they don’t really have an incentive to include pregnant women in their research,” says Ruth Faden, the founder of the Johns Hopkins Berman Institute of Bioethics. “People are nervous.” She points to the controversial drug thalidomide, a popular sedative and morning-sickness medication developed in Germany and used by pregnant women throughout the world in the 1950s and ’60s. The drug caused serious congenital deformities, primarily in the arms and legs of children whose mothers took it. The manufacturer eventually paid out tens of millions of dollars to the families affected. Beyond potential liability, federal regulations require that researchers do extra work when getting participation consent from pregnant women, including, in some cases, an okay from the father. The path of least resistance for researchers, in other words, is to not include pregnant women.

…continue reading ‘The Case for Giving Pregnant Women More Drugs’

Thumb image via Mother Jones

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