Annie Drapkin Lyerly, MD, MA, professor of social medicine and obstetrics and gynecology, and associate director of the UNC Center for Bioethics, published an article in Scientific American on the medical ethics of including pregnant women in drug trials.
“Fifteen years ago, the claim was audacious: that the best way to assure the health of pregnant women was to make sure they were included in experimental research on drugs and vaccines.
For years bioethicists and scientists had assumed the opposite—that exposing a fetus to a drug under study was ethically unacceptable. Oversight committees routinely required provisions that minimized the likelihood of pregnancy in almost all clinical studies. They insisted on pregnancy tests and contraception. A woman who became pregnant during a study had to be removed, and asked to discontinue use of the experimental drug. Such caution has had an unintended and harmful consequence: profound knowledge gaps around the safety and use of medications in pregnancy.
In recent years, however, researchers and policymakers have turned this ethical frame completely around. They have begun to recognize that ethics do not preclude research in pregnancy but rather require it.”
Read the rest of this Scientific American article.