One phrase that gets lip service in medical training is, “Women are not just small men.” Meaning that women are different from men and may need sex-specific adjustments to their care. But practice often hasn’t matched that principle. Women were excluded from clinical research by official policy until 1993, and though heart disease is the leading cause of death in women, nearly three-quarters of cardiovascular trials still under-enroll them. Whether by design or default, medicine was built around the male body and women bore the consequences in side effects and missed diagnoses.
First Lady Melania Trump’s women’s health initiative promises to put women’s biological needs at the center of federal research priorities. In doing so, it addresses what should be an uncontroversial first principle: studying women’s health starts by acknowledging that biological sex is a defining characteristic of the population being studied.
The Biden administration’s approach to women’s health was structurally incompatible with that approach. This was not just a single policy choice but a coherent and systematic framework. Taken as a whole, it redefined “women” for federal purposes in ways that made biological, sex-based research impossible.
The framework began on President Biden’s first day in office, when he issued an executive order that extended Title IX’s sex discrimination protections to cover gender identity, importing employment protections into other federal programs, including medical research. The March 2021 executive order establishing the Gender Policy Council further embedded gender identity as the administration’s priority. The 2021 National Strategy on Gender Equity and Equality and the 2024 Title IX regulations provided further reinforcement. Women’s health research in theory was expanded, but from a practical standpoint, it did not exist outside of a focus on gender equity. It was funded and evaluated through a lens that deliberately disregarded any acceptance of biological differences between women and men.
The Biden NIH’s Office of Research on Women’s Health should have been an institutional home for biological, sex-based research, but from the start it focused on including “gender-diverse people” in its mission. Two NIH funding opportunities illustrate the challenge this framing created. A call for HIV prevention research in women explicitly requested studies on prevention for both biological and transgender women. A related solicitation went further: studies that did not consider transgender women in addition to (or instead of) biological women would not be considered for review. At best this was an approach that decentered the unique needs of women; at worst it meant that studying only transgender women, aka biological men, could meet the requirements for federal funding.
The Biden-era approach to Title IX and women’s health initiatives missed the point of why they were so important: opportunities for women-specific funding grants were created because studying men had been the default. The progressive reframing took those corrective actions and redefined the term “woman” so research would once again center on male bodies. This is why revoking the Biden-era approach to women’s health is so necessary. Studying biological men who identify as women might be a worthy goal, but it will never explain why women have different symptoms when they have heart attacks, and it definitely will not help save their lives.
Biological sex differences in HIV prevention, cardiovascular disease, drug metabolism, and immune response are driven by just that: differences in biology. Biology dictates real differences between men and women. Differences in hormones and anatomy aren’t just incidental characteristics most women share. Pretending the differences aren’t real isn't equity, and it certainly isn’t science. Two plus two will never equal five, no matter how many times it’s repeated.
The new executive order makes it clear that biological sex is the operative category for women’s health research. It is nonsensical to study endometriosis in people who have never had a uterus, or to focus maternal health resources on people who can’t get pregnant or give birth. Biological considerations are not optional in women’s health. They are the central research question, one that the First Lady gets right.
Dr. Monique Yohanan, MD, MPH, is director of the Center for Better Health at Independent Women.