Very few drugs are approved for use during pregnancy. Yet millions of pregnant women each year take prescribed medication to treat high blood pressure or depression or cancer, without meaningful data on whether the drugs are safe for them or their fetuses.
Many researchers have long considered including pregnant women in their studies taboo. But a push is on to learn more, amid fears that leaving serious health problems untreated could be more dangerous for pregnant women and their babies than taking an unstudied medication.
"I can't identify any other group that has been as systematically neglected" in biomedical research, said Ruth Faden, director of the Johns Hopkins Berman Institute of Bioethics.
Others worry that fetuses could be hurt by clinical research and that it would be difficult, if not impossible, to recruit enough pregnant women to participate. Many haven't forgotten the horror story of the morning sickness medication Thalidomide, which caused severe limb deformities in thousands of children after their pregnant mothers took the drug in the late 1950s and early 1960s.
"We can't throw [women] into studies who are pregnant just to see," said Dr. Hugh E. Mighty, an obstetrician/gynecologist at the University of Maryland Medical Center.
No one is suggesting women be included in every study of every drug. But Faden - who is co-hosting a conference on the subject this spring - thinks mothers and their children can be kept safe even as researchers find creative ways to study the risks, benefits and proper dosing of medications in pregnancy.
She wants to see review boards at hospitals and academic institutions, the gatekeepers to research, develop ethical guidelines for including pregnant women whenever possible.
"It's really controversial," said Dr. Donald Mattison, a senior adviser at the National Institute of Child Health and Human Development. "There are some groups who believe it's completely inappropriate, and others who are outraged that more hasn't been done."
In the meantime, Faden and others say, obstetricians and patients are often forced to make treatment decisions without all the facts.
"Pregnant women sometimes feel like they're put in a situation where they feel they have to choose between their own well-being and what's best for their baby," said Dr. Karen Feibus, who heads the maternal health team at the Food and Drug Administration's Center for Drug Evaluation and Research.
