Why aren't pregnant women included in most clinical trials?
Submitted by ruzik_tuzik on Sep 27th, 2008
That's the question posed by leading bioethicists at Duke University Medical Center, Johns Hopkins and Georgetown Universities, who say it's time to confront the challenges that have led to the exclusion of pregnant women from important research that could positively impact maternal and fetal health.
"Only in the last two decades did people recognize that women were being excluded not just from the risks, but from the benefits of research -- primarily because of their potential to become pregnant or because of concerns that female physiology - such as menstrual cycles - might complicate study results," says Anne Drapkin Lyerly, MD, an obstetrician/gynecologist and medical ethicist at Duke.
She is the lead author of a paper appearing online and then in print in the November 2008 edition of the International Journal of Feminist Approaches to Bioethics detailing the justifications for responsibly including pregnant women in research. "While we've made significant progress in correcting the gender imbalance, we have a long way to go in protecting the health and safety of pregnant women and the fetuses they carry."
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More than four million women give birth in the
"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
"It's not simply a matter of including pregnant women in studies," Lyerly explains. "We need to address what we need to do to ensure maternal and fetal safety, which diseases we should study first, and what we should do when pharmaceutical companies or institutions say no."