In April 2017, Johns Hopkins School of Nursing (JHSON) students attended the Consortium of Universities for Global Health Conference, “Healthy People, Healthy Ecosytems,” in Washington, D.C. Students wrote blogs reflecting on breakout sessions and topics presented by experts and the current climate of global health. In part six, we look at the thoughts of JHSON student Katie Nelson and confronting pregnancy in infectious disease epidemics.
Pregnant women get ill, sick women get pregnant: Confronting Pregnancy in Infectious Disease Epidemics: HIV/AIDS, the Zika Virus, and Beyond
The story goes like this: pregnant women get ill, and sick women get pregnant. The recognition that women’s health impacts everyone’s health was a re-emerging theme at this year’s Consortium of Universities on Global Health Conference. However, as was pointed out in this particular plenary session, pregnant women are not simply women with wider hips and more hormones. We know that there are distinct physiological changes that occur in the maternal-placental-fetal unit during pregnancy, which can influence the pharmacokinetic process of drug absorption, distribution, and elimination. As such, pregnant women require distinct treatment, though, this requires the development of substantial evidence through clinical research.
“A practical and ethical nightmare” – Anne Lyerly, Associate Director, Center for Bioethics, University of North Carolina, Chapel Hill
Rigid regulatory requirements, a deeply rooted fear of teratogenicity, and in turn, liability issues, have notoriously left pregnant women, and even those with childbearing potential, excluded from clinical research trials. This has left clinicians with meager evidence and a troubling lack of knowledge on which to base their treatment of pregnant women. Researchers find themselves in a “catch-22”, as regulations are created to protect vulnerable populations from harm, yet excluding them from trials altogether does not yield any new knowledge about the treatment of pregnant women. The issue has significant implications, especially as the threat of infectious disease wagers on. A report by the Centers for Disease Control and Prevention (CDC) found nearly 1,000 pregnant women from 44 states who completed their pregnancies had some evidence of a recent Zika infection and were at risk of having a baby with Zika-related birth defects.
“Pregnancy does not affect a woman’s rationality” – Maggie Little, Kennedy Institute of Ethics, Georgetown University
Substantial work by the National Institutes of Health (NIH) in the 1990s urged the inclusion of vulnerable populations in clinical research trials, under which pregnant women have been included until recently. Policies were not explicit, leading researchers to err on the side of legality rather than a woman’s decision to participate in a trial. Champions on this issue have tirelessly advocated that this label be changed to something other than “vulnerable”, as pregnancy does not affect a woman’s rationality. An Institutes of Medicine (IOM) report concluded that pregnant women should be presumed eligible for research studies. Subpart B of the U.S. Department of Health and Human Services (DHHS) regulations (45 CFR 46) now states that pregnant women are a “scientifically complex” population, but are as competent as non-pregnant women to weigh the risks and benefits of participation in clinical studies. As the world begins to acknowledge the importance of women’s health, the paradigm of exclusion has slowly started shifting toward more inclusion of pregnant women in clinical research. Moving forward, this could have a significant impact on health outcomes as infectious diseases continue emerging.