Pregnant women have historically been excluded from the majority of medical research under the justification of protecting these women and their pregnancies from harm. But when new treatments are not tested in this population, we cannot know whether those treatments are safe and effective.
People who are sick or have chronic conditions can become pregnant, and those who are pregnant can get sick or develop health conditions. More than 90 percent of women take at least one medicine during pregnancy, and a significant portion are given recommended vaccines: the flu shot and Tdap, both of which protect not only the recipient but their family as well.
The COVID-19 pandemic is a prime example of why pregnant people must be included in research.
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Recent studies have shown that pregnant women are at increased risk for severe illness from the coronavirus. They are more likely to be admitted to the intensive care unit and receive invasive ventilation, and are at increased risk of death compared to nonpregnant women.
As a high-risk population, pregnant people clearly need access to vaccines and treatments for COVID-19. Yet, pregnant women are currently being excluded from COVID-19 research, meaning they are unlikely to have timely access to these critical interventions because we will not know whether they are safe for pregnant people.
To address these concerns, we must move toward protecting pregnant people through research, not from research. Fortunately, a federal task force has just released a plan on how to do this.
The Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) outlines steps for implementing 15 recommendations designed to address obstacles to the inclusion of pregnant women and breastfeeding women in research. The task force is made up of representatives from the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), clinicians, researchers and industry.
The PRGLAC implementation plan identifies roles for each of these stakeholders within the research and medical community, as well as for Congress, in the effort to overcome this harmful precedent of exclusion.
To integrate pregnant women and breastfeeding women into the national clinical research agenda, all agencies under the Department of Health and Human Services (HHS) need to be on the same page regarding rules, regulations and best practices around the inclusion of these populations in research. The PRGLAC plan recommends the creation of an HHS-wide guidance on ethical issues and strategies for designing studies that include these populations, as well as the establishment of a central committee or office to oversee work in this area.
The PRGLAC Task Force recommends expanding the workforce of clinicians and researchers with expertise in obstetric and lactation pharmacology and therapeutics. The task force also calls for communication strategies to supply health care providers with important information on research in people who are pregnant or breastfeeding. Medical professional societies such as the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) are well positioned to lead these efforts around the training, mentorship and career development of clinicians and researchers.
Congressional action could play a critical role in implementing many of the PRGLAC Task Force recommendations, including the potential for legislation similar to the Best Pharmaceuticals for Children Act, which provides financial incentive to drug developers for conducting pediatric studies on new therapies, and the Pediatric Research Equity Act, which allows the FDA to require drug developers to assess certain therapies in children. In addition, Congress will need to dedicate funding for the expansion or creation of federal programs and activities that will move this space forward. For example, existing NIH infrastructure and research networks, such as the Maternal Fetal Medicine Units Network, could facilitate much-needed research if provided additional resources.
Given the research challenges, ethical considerations and liability issues inherent to incorporating those who are pregnant or breastfeeding in studies, the pharmaceutical industry has historically limited its investment and work in these populations. The PRGLAC plan notes the importance of addressing liability issues and creating incentives to drive industry investment in this space. But pharmaceutical companies must also commit to ensuring the inclusion of those who are pregnant or breastfeeding in their drug development plans when appropriate, and the companies should work to design clinical trials that eliminate barriers that make participation difficult for these populations.
Finally, the PRGLAC Task Force recommends that all stakeholders—federal agencies, medical societies, industry and nonprofits such as the Society for Women’s Health Research (SWHR)—should band together to develop a public awareness campaign that explains the importance of research on therapeutic products in people who are pregnant or breastfeeding and that encourages the participation of these populations in research.
The inclusion of pregnant women and breastfeeding women in medical research is long overdue. With almost four million women in the U.S. giving birth each year, 80 percent of whom will breastfeed their infants, and about 74 million women of childbearing age in the U.S., it is time to include pregnant women and breastfeeding women in research. With a health pandemic raging across the globe, a rising maternal mortality rate and wide disparities in health outcomes, women are working every day to protect themselves and their families. We have a plan endorsed by experts—and although it will take work, women’s health will greatly benefit from these efforts.