Ruth Faden, PhD, MPH, is director of the Johns Hopkins Berman Institute of Bioethics and a senior research scholar at the Kennedy Institute of Ethics at Georgetown University. She was co-recipient of PRIM&R’s Lifetime Achievement Award in 2011 with her husband, Tom L. Beauchamp.
When I was pregnant with my first child more than 30 years ago, I developed a serious medical problem (deep vein thrombosis) and was put on heparin, a blood thinner. With every injection, I worried about whether I was doing the right thing, for me and for my baby. My wonderful physicians tried to be reassuring, but there was precious little by way of evidence or data to back up their claims. It was a difficult, sometimes scary experience.
I wish I could say that a lot has changed in the intervening years, but, sadly, it has not. Although it is widely recognized that the pregnant body is in many respects biologically unique, there is still little known about how pregnant women respond to most drugs for most diseases. This makes doctors hesitant to prescribe them, creating a cycle of no-information-so-no-new-information that has proved difficult to break. In the US alone, that lack of knowledge leaves hundreds of thousands of pregnant women in the lurch every year.
The good news is this is a solvable problem! The solution lies in shifting the current research ethics framework from a focus on the risks that pregnant women and their fetuses face from medical research to the risks they face without medical research. It’s time that pregnant women are treated justly by the medical research community, and it’s time that the health interests of pregnant women are given their fair share of resources and creativity.
That is why I’ve worked with fellow bioethicists Margaret Little and Anne Drapkin Lyerly to found The Second Wave Initiative, so named to reflect a connection to the “first wave” of widespread inclusion of women in medical research in the late 1980s.
Since its founding, Second Wave has established its role as an advocate for the inclusion of pregnant women in medical research. Other colleagues have joined us in leading the effort, and many more are actively working on its behalf. In 2009, we made sure pregnant women were part of the discussion around the H1N1 vaccine. More recently, we sent a letter to the Department of Health and Human Services (DHHS) to urge specific changes to regulations governing research with pregnant women, as part of our response to the DHHS Advanced Notice of Proposed Rulemaking (ANPRM), and we worked to secure congressional support for this effort.
In January, 36 members of the House of Representatives responded to our call by sending a letter to the Secretary of DHHS, Kathleen Sebelius. “It is critical that we understand how to safely and effectively treat pregnant women,” the letter states, calling the lack of knowledge a “public health issue.”
As DHHS prepares to revise the “Common Rule,” all of us in the Second Wave Initiative are hopeful that the changes will be positive for pregnant women, following the recommendations we’ve made. As the congressional letter says, “It is imperative that these regulations encourage the gathering of this critical information in safe and appropriate ways.”
Regardless of what happens with the “Common Rule,” however, progress can be made. The ethical and legal challenges to research involving pregnant women are real, but they are not insurmountable. Under the status quo, any number of valuable research projects that pose no or minimal risks are not undertaken or even contemplated, at least in part because researchers and funders don’t want the headache of trying to have research involving pregnant women approved. Those of us in the PRIM&R community could do a lot to alleviate these concerns. At Second Wave, we are all about starting with the (ethically) low-hanging fruit—epidemiological and pharmacokinetic studies, and the like. Please think about what you can do; with today’s science, there is just no excuse for pregnant women still to be facing what I faced all those decades ago.
For more information on Dr. Faden, visit the Johns Hopkins Berman Institute of Bioethics website.