Pregnant women are people too
September 26, 2008
Bioethicists ask: “Why aren’t pregnant women included in most clinical trials?”
Because the trial organizers are afraid of getting sued if something goes wrong, I’d say. But that’s not fair to pregnant women, who in fact experience the states of sickness and health while pregnant – sometimes even because of conditions unrelated to pregnancy!
In fact, one study estimates that half a million pregnant women each year have conditions that require treatment, but their doctors don’t have enough information to treat the conditions safely and effectively. Many clinical trials automatically exclude pregnant women, so the data just doesn’t exist.
“Our best predictions when it comes to dosing medications can be disastrously wrong,” says Lyerly. “This conservative stance doesn’t help anybody. Without adequate research on how drugs are metabolized during pregnancy, how they are absorbed, distributed in and excreted by the body, whether they cross the placenta or affect the fetus, we have little to no evidence on how to optimize the health of pregnant women or the fetuses they carry.”
Lyerly and her colleagues at Johns Hopkins University’s Berman Institute of Bioethics and Georgetown University clearly recognize the many challenges that need to be addressed in order to safely include pregnant women in clinical research. In fact, they are convening a meeting with officials from the FDA, NIH and leading experts in obstetrics, gynecology and maternal/fetal medicine next year to address these issues and come up with practical, public policy and moral solutions.
Read the press release: An ethical argument: include pregnant women in research