Addressing the Limits of Women’s Health Research in the United States

Though women, on average, live longer than men, women disproportionately suffer from a variety of health conditions and diseases that can lead to premature death and lower their quality of life. Heart disease, for instance, which is common in the United States regardless of sex, is the number one killer of women. Research has also revealed that when a nonsmoker dies of lung cancer, the person is twice as likely to be a woman.

The recently announced White House Initiative on Women’s Health Research aims to address these disparities through a $100 million investment to achieve scientific breakthroughs and strengthen our ability to prevent, detect, and treat disease among women.

Women also suffer from conditions and diseases that don’t affect men. For example, ovarian cancer, one of the leading causes of cancer in women, claims thousands of women’s lives each year. According to the American Cancer Society, in 2024 alone, 12,740 women are likely to die of ovarian cancer. Cervical cancer, according to the Centers for Disease Control and Prevention (CDC), claims approximately 4,000 women’s lives each year.

Some of the illnesses that affect women are chronically underdiagnosed because of a lack of health screenings. Endometriosis, a painful disease that causes tissue similar to the lining of the uterus to grow outside of it, for instance, can take as long as 10 years to be diagnosed.

Yet too few heart disease and lung cancer studies focus on women. Research on cervical and ovarian cancer is poorly funded for how common the conditions are and the number of lives they claim. Diseases like endometriosis are rarely the focus of medical research. The recently announced White House Initiative on Women’s Health Research aims to address these disparities through a $100 million investment to achieve scientific breakthroughs and strengthen our ability to prevent, detect, and treat disease among women.

Research Discrepancies Hinder Progress on Women’s Health

Including women only in the later stages of research treats women as an afterthought rather than a focal point.

At first glance, the statistics on women’s inclusion in clinical trials suggest parity in health research between the sexes. In 2024, at 58.5 percent, women comprised more than half of the people in the National Institutes of Health-funded (NIH) clinical trials. More medical trials focused exclusively on women than their male counterparts.

However, despite the current statistics on clinical trial participation, biased research practices have created a knowledge gap on diversity among women, as well as their differences from men. From a biological and hormonal perspective, too little is known about women, which leads to confusion about why women respond to treatments differently than men do. Research, including research in high-prestige medical journals, doesn’t typically separate data on men and women. Without data disaggregation by sex, scientists simply can’t analyze data on women.

Additionally, women are still underrepresented in key research areas, such as cancer trials, where they make up only 43 percent of volunteers. Cell lines used in the early stages of research are typically drawn from men, and the animals used in clinical research, including lab mice, are predominantly male. Women’s exclusion from the initial phases of research is important because this is when research questions are solidified, and ideas that guide the rest of the research process are formulated. Including women only in the later stages of research treats women as an afterthought rather than a focal point.

How the White House Initiative Plans to Advance Women’s Health  

The White House Initiative on Women’s Health Research seeks to improve women’s health by pushing to drive innovation in women’s health and close research gaps. The initiative will be led by Jill Biden and the White House’s Gender Policy Council and directed by Carolyn M. Mazure, PhD, who currently directs Women’s Health Research, a center at Yale School of Medicine. The initiative’s key components include:

• Interagency Collaboration

The legislation will require coordination between the US Department of Health and Human Services, the Department of Defense, the Department of Veteran Affairs, and the White House. NIH will also be involved in the effort, with the NIH Office of Research on Women’s Health (ORWH) directing the agency’s efforts.

• Developing Concrete Recommendations

Within 45 days of the initiative’s start, the agencies and actors involved will recommend concrete actions to advance women’s health research. According to briefings from the White House, the recommendations will include guidance on how the nation can maximize its investment in women’s health research. Addressing inequities within women’s health research is another key issue the recommendations will tackle.

• Creating a Targeted, High-Impact Approach

After recommendations have been gathered, the initiative’s members will prioritize investments with the potential to be transformative. According to the information currently available from the White House, these investments could be related to anything from menopause to heart attacks among women.

• Scientific, Private Sector, and Philanthropic Community Engagement

As part of their engagement strategy, the initiative will build public-private partnerships that serve as the foundation for collaboration between private and philanthropic leaders. Within this approach, these cross-sector groups of leaders will serve as drivers of innovation that ensure the combined power of public, private, and philanthropic sectors advances research on women’s health. External stakeholders, such as researchers, philanthropic leaders, and others who work for or with women’s health organizations, can also provide input on the initiative.

Obstacles Remain 

The federal government has strategically invested in women’s health research since the late 1980s. In fact, NIH’s first policy on women’s inclusion in clinical research was enacted in 1989. Then, in 1993, Congress cemented the policy by writing it into the NIH Revitalization Act of 1993. By 1994, the Food and Drug Administration (FDA) created the Office of Women’s Health (OWH).

Yet despite this policy infrastructure, the research landscape continues to fail women, due at least in part to a lack of action by the offices and agencies responsible for women’s health research and continued regulatory failures that endanger the health of women and girls.

Since significant disparities remain despite past investments in women’s health research, there is reason to question how much progress will be achieved by the White House Initiative on Women’s Health Research. In an article by the Guardian, Nanette Wenger, who helped develop the initial NIH policy that was later signed into law, explains why she believes the NIH fell short of its initial aims. According to Wenger, the law was never a mandate; it was merely a recommendation and, therefore, had no teeth.

Likewise, the FDA’s OWH served a grantmaking and communications function but, problematically, doesn’t participate in reviews of specific medical products, nor does the office have a role in evaluating FDA data or making approval decisions. Consequently, rather than intentionally shaping the nature of research on women when it comes to developing medications and medical devices, OWH is largely indistinguishable from similar efforts by offices of women’s health at the CDC and the Health Resources and Services Administration. The new White House initiative opens itself up to criticism on similar grounds.

The initiative’s structure, as outlined by the White House, doesn’t include any rulemaking or approval authority. It also doesn’t include information that indicates how it will collaborate with other agencies, which could continue to result in duplicative rather than impactful work on women’s health research.

In the same vein as previous efforts, the initiative may not address one of the most prescient problems facing women’s health: the FDA’s role in vetting therapies and regulating medical products for women. According to the Food & Drug Law Institute, women are still treated as an “other” when it comes to FDA regulations. The FDA’s lack of emphasis or consideration for women has resulted in confusing and incomplete labeling of women’s medications and sparse information on the effects of common drugs and medical devices on their health and safety, especially for pregnant women.

Forging a New Path

There is, indeed, a knowledge gap when it comes to understanding the biological and hormonal aspects of sex as well as how gender identity and the social conditions of women and girls play into health disparities. But, of equal or more importance, is a failure to act on this information and to create a political and regulatory environment that goes beyond sharing information on women’s health and merely recommending scientists conduct better research.

Without persistent monitoring and accountability, researchers may not treat gender as a distinct analytic category or examine why women respond to treatments differently than men. Without solid data that speaks to the unique needs of women, girls, and other feminine persons, research on women’s health could continue to move at a near-glacial pace despite significant investments in the research.

Until the leading government agencies responsible for health research create more stringent guidelines for incorporating women and include intra-sex differences as a key measure of the inclusivity of studies on women’s health, we will continue to have a healthcare system where women die in large numbers from preventable and treatable diseases.