Pregnant Women and Clinical Trials
Reported September 30, 2008
(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 its 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 theres 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 theyre 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 doesnt 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