Women make up 51% of the population but account for only 22% of clinical trial participants in cardiovascular research. That single statistic explains why heart disease—the leading cause of death for American women—is still routinely misdiagnosed in emergency rooms across the country.
This isn't a minor oversight. It's a systemic failure that has been compounding for half a century.
The Origin of the Gap
In 1977, the FDA issued guidelines excluding women of "childbearing potential" from early-phase clinical trials. The intention was protective. The result was catastrophic.
For the next 16 years, medical research was conducted almost exclusively on male subjects. Drugs were tested on men. Dosages were calibrated for men. Symptoms were documented based on how men presented.
It took until 1993—1993—for Congress to mandate women's inclusion in NIH-funded research. And even now, three decades later, we're still playing catch-up.
"We don't have a women's health problem. We have a research equity problem that manifests in women's health outcomes."
The Numbers Don't Lie
Consider what the research gap has produced:
- Cardiovascular disease: Women are 50% more likely to be initially misdiagnosed with a heart attack. Why? Because "classic" symptoms like crushing chest pain are based on male presentation. Women often experience fatigue, nausea, and jaw pain—symptoms still dismissed as anxiety or stress.
- Autoimmune diseases: Women suffer from autoimmune conditions at 2-3x the rate of men. Yet funding for autoimmune research represents less than 3% of the NIH budget.
- Depression: Twice as common in women, but most antidepressant efficacy data still skews male.
- Hormone therapy: Decades of stigma and underfunding despite clear evidence of benefits—because women's hormonal health wasn't considered a serious research priority.
Why This Matters Now
I spent six years at Biote Medical working to change this. Hormone optimization therapy—bioidentical hormone pellet therapy specifically—had been helping patients for decades, but without the research infrastructure to prove it at scale. The medical establishment dismissed it because the studies weren't there. The studies weren't there because no one funded them. No one funded them because women's hormonal health wasn't considered a serious research priority.
We built that research infrastructure. We funded the studies. We published the evidence. Not because it was the easy path—it wasn't—but because the alternative was continuing to fail millions of women who deserved better.
What Needs to Change
Scientific equity isn't just about including women in trials—though that's the minimum bar. It requires:
- Sex-disaggregated data as a standard requirement, not an afterthought
- Funding mechanisms that prioritize understudied conditions affecting women
- Medical education that teaches providers to recognize sex-based differences in disease presentation
- Regulatory pathways that don't penalize companies for studying women's health
- Cultural shift away from dismissing women's symptoms as "hormonal" or "psychological"
The Business Case
For those who need a business rationale: women make 80% of healthcare decisions for their families. They control $10 trillion in consumer spending in the US alone. Companies that solve women's health problems well will win in the marketplace.
But more importantly: this is simply the right thing to do. Medicine exists to help people. Half of those people are women. It's long past time we designed our research—and our treatments—with that basic fact in mind.
Terry Weber served as CEO of Biote Medical from 2019-2025, where she led efforts to advance evidence-based hormone optimization therapy and women's health research.