(Ivanhoe Newswire) -- For years, being pregnant meant you probably would
not be enrolled in a clinical trial.
Now, bioethicists at Duke University Medical Center, Johns Hopkins and
Georgetown Universities, say it’s time to change that because pregnant women are
being excluded not just from the risks of research, but from the benefits, too.
Since 1994, the Institute of Medicine has recommended pregnant women be
“presumed eligible” to participate in research. But the authors of a new paper
say the “delicate condition” is still the reason pregnant women are almost
automatically excluded from research, even though there’s a need for more
effective treatment for them.
More than four million women give birth every year in the United States – many
of them need to be treated for medical conditions they have while they’re
pregnant. Common diseases during pregnancy include chronic hypertension and
diabetes, psychiatric illness, cancers and autoimmune diseases. But without
research on how medications work in pregnant women, the authors say doctors are
often left guessing about how to safely and effectively treat patients during
pregnancy.
“Our best predictions when it comes to dosing medications can be disastrously
wrong,” lead author, Anne Drapkin Lyerly, M.D., Duke University, was quoted as
saying. “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.”
The authors acknowledge there are many challenges that need to be addressed in
order to safely include pregnant women in clinical research and are meeting with
health officials to discuss the issues and come up with solutions.
SOURCE: International Journal of Feminist Approaches to Bioethics, published
online September 26, 2008
