Consideration of women’s health has been notably absent from recent efforts to cut, reorganize and begin to implement policy proposals designed to restructure and “modernize” the National Institutes of Health. Regardless of political ideology, improving the health of women is important and should be included in efforts to make America healthy. Healthy women mean healthy families, which means healthy communities, and a stronger nation.
Although the mission of the NIH is to improve human health through research, women have long been understudied. In 1887, when the NIH was founded, the default human clinical research participant was a 154 lb. man. Women were excluded from clinical research for over a hundred years as the 27 institutes and centers that make up today’s NIH were created and grew. Monthly hormonal fluctuations and the possibility of pregnancy were believed to make women’s bodies too unpredictable to be useful subjects for accurate scientific assessments.
It wasn’t until 1993, with the passage of the NIH Revitalization Act, that inclusion of women in federally funded clinical research became a requirement. And it was less than 10 years ago that the NIH began to expect pre-clinical research include female and male cells and animals when studying conditions that affect both men and women.
The historic omission of women from research left critical scientific gaps in our understanding of disease. Most standard therapeutic interventions in use today were never tested for safety or efficacy specifically in women. Today, although women are routinely included in federally funded clinical research and more basic science research includes male and female animals, research specifically addressing the health needs of women remains rare. There is still no scientific consensus on basic female phenomena, including what initiates labor during pregnancy, which immune cells populate the uterus, or how to define menopause.
In 2021, I joined NIH’s Office of Research on Women’s Health to lead a review of NIH’s portfolios on women’s health research that had been mandated by Congress. The ensuing report detailed profound gaps in the agency’s investment in women’s health research.
For the next few years, momentum built around improving women’s health research. President Biden signed a historic executive order directing federal attention toward women’s health research in March of 2024. In December 2024, the National Academies of Science, Engineering and Medicine released a report, commissioned and paid for by Congress, calling for transformative change in the NIH’s approach to women’s health. The report confirmed the staggering reality that over the last 10 years, less than one-tenth of the NIH budget has focused on women’s health, and despite increases in the agency’s overall budget, that proportion has declined over time.
Conditions that disproportionately impact women like autoimmune diseases, migraines and mental health continue to receive inadequate attention, contributing to delayed diagnoses, ineffective treatments and worse health outcomes. Female-specific conditions, such as hyperemesis gravidarum, pelvic floor disorders or abnormal menses fair even worse — with investments so small they are not even counted or publicly reported.
Proposed in this report were several solutions, including the allocation of an additional $15.7 billion to double the NIH’s investment in women’s health. Although this funding increase appears far-fetched given ongoing reductions in the size and scope of the federal government, several other recommendations are feasible.
A home within the NIH for research on female physiology and genetics, the influence reproductive milestones on overall health, and female-specific conditions can be identified and supported. Expertise in pregnancy and female-specific conditions within the NIH can be identified in order to foreground this science. Women’s health evaluation criteria can be incorporated into the NIH scientific review process within the agency. NIH-wide opportunities supporting investigators in training interested in pursuing careers in women’s health research can be prioritized.
Leadership is required to make transformative change in NIH’s approach to women’s health research. The new NIH director will need to identify the opportunities to advance the health of women that align with his vision and direction for the organization. Each institute needs a women’s health champion to incorporate the study of how female biologic factors influence the development, trajectory and outcomes of the diseases and conditions included within their mission. Further a gynecologist or obstetrician does not hold a senior leadership role in any NIH institute, center or office, including the Office of Research on Women’s Health. This gap in expertise must be filled.
We cannot afford to continue treating women’s health with a 19th century mindset: as a niche issue within the biomedical research ecosystem. Women make up over half of the population and have unique health needs. Women live longer than men, but spend more of their lives with chronic disease, disability and in poor health. As the NIH undergoes fundamental changes to align scientific resources to public health needs, women’s health needs must not continue to be overlooked.
Sarah M. Temkin, MD, is former associate director for clinical research at the NIH Office of Research on Women’s Health.
