When it Comes to Women’s Health, We Have Not Come a Long Way, Baby: Hormone Therapy Label Change Reflects Women’s Health as a Priority

Hormone Therapy Label Change Reflects Women’s Health as a Priority

US Food and Drug Administration Commissioner Marty Makary recently announced the removal of the black-box warning on hormone therapy in women. It turns out that the black box warning was the result of studies on a restricted population of women and ignored benefits in other populations.

For thirty years, the official story has been that women are now “fully included” in medical research. We hear that randomized controlled trials are the gold standard, that guidelines are “evidence‑based,” that women’s health has finally caught up.

Look past the slogans, and a harder picture appears.

For most of the modern drug era, women of child‑bearing age were literally written out of early‑phase trials. When they were finally let back in, the studies were still designed on male templates. Diseases that mainly disable women were quietly underfunded. Pregnancy was treated as too risky to study properly. Menopause was turned into a decades‑long scare story after one over‑interpreted trial.

The National Academies now say bluntly that the lack of data on chronic conditions in women is itself harming diagnosis, treatment, and prevention.

That is the backdrop for today’s Department of Health and Human Services, led by Secretary Robert F. Kennedy Jr., and for US Food and Drug Administration Commissioner Marty Makary’s decision to tear up the old black‑box warning on hormone therapy. They are not tinkering with details. They are attacking a research culture that has treated women’s bodies as an afterthought.

This is the long view of how we got here—and why this HHS is saying that reversing bias in the evidence is now a central priority.

Built on a male template

In the late 1970s, the Food and Drug Administration told clinical researchers to keep “women of childbearing potential” out of early‑phase drug trials. The idea was to avoid another thalidomide‑style tragedy. In practice it meant that any woman who could possibly become pregnant—married or not, on contraception or not—was treated as a legal risk and excluded.

For the next decade and a half, those cautious memos quietly hardened into habit. New drugs were tested mainly in men. Early‑phase safety, dosing, and side‑effect profiles were built on male physiology. When women showed up in clinics, doctors often assumed the data would “transfer.”

It took an act of Congress to begin to undo that. The NIH Revitalization Act of 1993 finally required that women and minorities be included in NIH‑funded clinical research “in adequate numbers,” and that trials be designed so you could actually analyze whether treatments affected women differently from men.

On paper, that sounded like a turning point. In reality, it was the start of a very slow correction.

Analyses of NIH‑funded trials years later found that simply opening the door did not guarantee women showed up in meaningful numbers—or that the data were ever examined separately by sex. A 2018 review in Journal of Women’s Health found that even after the Revitalization Act, many trials still failed to meet inclusion goals, and sex‑specific results were often missing or underpowered.

By 2015, NIH had to issue yet another policy, known as “Consideration of Sex as a Biological Variable in NIH‑funded Research”. Grant applicants were told they were expected to factor sex into study design, analysis, and reporting, and to justify any proposal that used only one sex. That policy exists for one simple reason: the earlier rules did not produce sex‑aware science on their own.

Even today, large reviews still find that women are under‑represented in important areas like cardiovascular trials, and that pregnant and breastfeeding women are almost completely left out. The basic template of the “typical patient” is still male, unless researchers are forced to do otherwise.

So yes, women are in the room now. But they are still being squeezed into a structure that was never really rebuilt around their biology.

What we chose not to study

Even when women are technically “included,” the next question is what research receives serious money.

Arthur Mirin’s 2021 analysis in Journal of Women’s Health looked at NIH funding relative to disease burden, using disability‑adjusted life‑years for dozens of conditions. In nearly three quarters of diseases that primarily affect one sex, he found that the funding pattern favored male‑dominant diseases. Where a disease mostly affected women, it was more likely to be underfunded relative to how much disability it caused. Where a disease mostly affected men, it was more likely to be overfunded. The gaps were roughly twice as large when they favored male‑dominant conditions.

A 2023 Nature feature drew the same picture visually. When you rank diseases by NIH dollars instead of by how much suffering they cause, conditions that mainly affect women—migraine, chronic headache, endometriosis, anxiety disorders—visibly drop down the chart.

In 2024, the National Academies report Advancing Research on Chronic Conditions in Women opened by noting that women in the United States have a higher prevalence than men of many chronic conditions, including Alzheimer’s disease, depression, and osteoporosis, and that they also carry female‑specific conditions such as endometriosis and pelvic floor disorders. It concludes that research on these conditions is incomplete and that this lack of data is now actively hindering diagnosis, treatment, and prevention.

Translated out of committee language: diseases that disable women have been treated as low‑status topics. Their biology is “complicated,” their symptoms are “nonspecific,” and the path of least resistance has been to psychologize them instead of studying them properly.

The history of funding priorities make that choice visible.

When the data exist and the story is still wrong: Hormone Replacement Therapy

Hormone replacement therapy is the cleanest case where the data were there, but the story women heard was badly distorted.

By the late 1990s, menopausal hormone therapy was common. Then in 2002, the Women’s Health Initiative published the results of a large, randomized trial of one specific regimen: conjugated equine estrogen with medroxyprogesterone acetate in women who were, on average, sixty‑three years old—roughly a decade beyond natural menopause.

The trial found small but real increases in breast cancer, heart disease, stroke, and blood clots in that group, along with reductions in fractures and colon cancer. Overall, the investigators concluded that this particular combined therapy should not be used for the primary prevention of chronic disease in older women.

That is not how the findings were translated for the public.

Press releases and headlines boiled the nuance down to “HRT causes breast cancer and heart attacks.” The age of the women, the timing of when they started, and the specific formulation they used faded into the background. The estrogen‑only arm of the trial, which later showed lower breast‑cancer incidence and mortality in women with hysterectomy, barely registered at all outside specialist circles—despite long‑term follow‑up like Chlebowski et al. 2020 showing reduced breast‑cancer incidence and mortality with estrogen‑alone therapy.

In 2003, FDA responded with a boxed warning—the harshest type of label—on menopausal hormone therapies, flagging risks of heart disease, stroke, dementia, and breast cancer for essentially all users. Prescribing collapsed. Analyses over the following years showed that use of hormone therapy among US postmenopausal women fell from over a quarter to the single digits, even though extended follow‑up of WHI did not show an increase in all‑cause mortality with menopausal hormone therapy and suggested lower mortality when started in women in their 50s (Manson et al., JAMA 2017).

The problem is not that WHI was “fake.” It is that the trial’s narrow question—whether a single, older regimen should be used to prevent disease in women who were mostly well past menopause—was inflated into a blanket warning for every woman with hot flashes in her early fifties.

Over time, the literature filled in. Age‑stratified analyses of WHI and other studies showed that women who start hormone therapy near the onset of menopause look very different from women starting a decade later. Specialty groups like the North American Menopause Society began saying as early as 2012, and again in their updated statements, that for healthy women under sixty or within about ten years of menopause, the benefits of hormone therapy for symptoms and bone protection generally outweigh the risks when individualized.

Yet the black box on US labels never really changed. Doctors in primary care continued to see HRT as “dangerous,” and millions of women were never even told it was an option.

That is what FDA Commissioner Marty Makary is now calling the “fear machine.” In interviews and in his November 2025 JAMA Viewpoint, “Updated Labeling for Menopausal Hormone Therapy”, he describes how the WHI narrative was allowed to ossify into law, and how women “have been talked out of” therapy that could have relieved debilitating symptoms and reduced fractures, and possibly other risks, when prescribed appropriately.

On November 10, 2025, HHS and FDA finally moved. The department issued a press release and fact sheet—see “HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy”—explaining that the old warnings had driven under‑use of effective treatments and that new labels will present a more nuanced risk picture instead of a blunt scare.

Makary’s JAMA article, and a string of media appearances, framed it directly as a correction of “decades‑long misinformation” and an end to a “fear machine” around menopause care.

For Secretary Kennedy, this is not a side issue. HHS’s own press materials present the HRT label change as a flagship move in a broader plan to “advance women’s health” and to align guidance with current evidence rather than with institutional habits.

The HRT story shows what it looks like when women are not just excluded from research, but trapped inside a misread version of the research that already exists.

Mothers dying on their baby’s day—and the year that follows

The same pattern shows up in a place that should be unthinkable: childbirth.

The United States has the highest maternal mortality rates in the developed world. Analyses by CDC, NICHD, and independent groups like the Commonwealth Fund all document that US maternal mortality exceeds that of other high‑income nations. The NICHD fact sheet on maternal morbidity and mortality summarizes the trend, known well to Sec. Robert F. Kennedy, Jr., who has discussed this problem as a priority many times: rising maternal deaths, stark racial disparities, and large fractions of deaths judged preventable.

CDC reviews of pregnancy‑related deaths between 2017 and 2019 found that more than eighty percent of those deaths were preventable with changes in care at the patient, provider, facility, or system level.

The burden is not evenly shared. Analyses of pregnancy‑related mortality show that Black women are roughly three times more likely to die from pregnancy‑related causes than white women, with American Indian and Alaska Native women also facing sharply elevated risk. Population Reference Bureau and CDC data converge on that ratio.

We know the leading causes: heart problems, severe bleeding, infections, strokes, blood‑pressure disorders such as preeclampsia, and mental‑health‑related causes such as suicide and overdose. We also know that a large share of deaths occur before delivery or in the months after the baby is born, not only in the delivery room.

Yet pregnant and breastfeeding women are still among the most systematically excluded populations in clinical research. A 2024 National Academies report, Advancing Clinical Research with Pregnant and Lactating Populations: Overcoming Real and Perceived Liability Risks, concluded that pregnant and lactating people are frequently excluded from trials and that the fear of legal liability is often exaggerated. The committee found limited actual evidence of lawsuits tied to including them and warned that marketing drugs to pregnant women without good data may pose greater legal and clinical risk.

In plain language: we have decided that pregnancy is too risky to study properly, so we leave women and their clinicians guessing about how to manage blood pressure, diabetes, depression, and other conditions during and after pregnancy. That ignorance shows up in funerals and in babies growing up without mothers.

Due to Kennedy’s concerns on this issue, the current HHS has at least named the problem. Its maternal‑health portal now states that the United States has a maternal mortality crisis, that addressing it is a top priority, and that eliminating pregnancy‑related disparities is part of that mission.

Turning that promise into reality will require exactly what the National Academies called for: safe, ethical, but real trials in pregnant and lactating populations, and a commitment to fix the data gaps instead of hiding behind them.

I recommended pragmatic trials on integrative pathways to healthy and safe pregnancies, and a re-examination of the safety of influenza, TDaP, RSV and COVDI-19 vaccines during pregnancy.

Chronic conditions in women: the invisible burden

Beyond pregnancy and menopause, there is a whole cluster of conditions that most clinicians quietly recognize as “women’s diseases,” but that research portfolios have never taken seriously.

Autoimmune conditions are a classic example. Reviews of autoimmune epidemiology estimate that around 8% of the population, or about 25 million people have an autoimmune disease and that roughly three quarters of those patients are women. Fairweather & Rose, “Women and Autoimmune Diseases” describes that skew and the consequences for women’s health. Yet these diseases remain underfunded and poorly understood compared with their burden.

Endometriosis affects an estimated one in ten women of reproductive age worldwide, causing chronic pelvic pain and fertility problems, yet diagnostic delays of six to ten years remain standard in many countries. Patient‑advocacy and policy analyses, such as the Endometriosis Foundation’s facts page, detail how years of dismissal and lack of noninvasive diagnostics produce those delays.

The 2024 National Academies report on chronic conditions in women puts it starkly: women experience higher rates of many chronic illnesses and carry additional female‑specific conditions, but the research required to explain, prevent, and treat these patterns is missing. It calls for a coordinated, long‑term research agenda to close those gaps.

This is the “other data gap.” Women are not just under‑represented in trials; the conditions that shape their lives are under‑represented on grant review panels, in study sections, and on priority lists.

What is different about this HHS

None of these problems began in 2025. They were built over decades, under both parties, by people who often thought they were being cautious or neutral.

What is new is that the leaders of HHS and FDA are now saying, on the record, that the architecture itself is biased—and that fixing it is part of their core job.

In public speeches, Secretary Robert F. Kennedy Jr. has framed his agenda as “Make America Healthy Again,” with a heavy emphasis on chronic disease, transparency, and what he calls “gold‑standard, unbiased science.” HHS’s own press room now groups these efforts under a visible “MAHA in Action” banner, signaling that research priorities and regulatory decisions are meant to shift away from legacy narratives and toward disease burden and real‑world outcomes.

The HRT decision shows how that looks in practice.

The HHS press materials on removing black‑box warnings do something prior administrations never did: they admit in plain language that women may have been under‑using hormone therapies because of FDA warnings, and they tie the label change directly to updated evidence about who is actually at risk and who is likely to benefit.

Makary’s JAMA Viewpoint goes further, stating that previous messaging overstated risks for many women and calling the label change “decades late.” In a CBS interview he called the old warning a “fear machine” and “an American tragedy,” and on NPR he described women as having been “denied or never offered” hormone therapy despite clear benefits when used appropriately.

Together, Kennedy and Makary are not just adjusting a label. They are describing the last twenty‑plus years of official guidance on menopause as bad science and bureaucratic inertia, and they are willing to say that out loud under the HHS letterhead.

On maternal health and chronic conditions, the moves so far are more modest—elevating maternal mortality as a top priority, endorsing extended postpartum coverage, funding the National Academies’ work on chronic disease and on pregnant and lactating populations.

But the direction is clear: this HHS is explicitly tying women’s health to better evidence, not to inherited dogma, and is treating gaps in that evidence as a problem to be fixed, not as an excuse to say “we don’t know” for another generation.

Kennedy has been explicit that he wants trials and funding streams redesigned so that women—especially pregnant women and women in midlife—are no longer an afterthought. Makary has been equally explicit that he intends to use FDA’s labeling power to correct past distortions when the data justify it, even if that means breaking with long‑standing consensus.

That is what it means, in practice, to say that this HHS’s priority is to reverse the trends and ensure unbiased studies are done.

The stakes, in human terms

It is easy to treat all of this as a policy debate. But this is what it means on the ground.

When randomized trials are designed around men and pregnant women are excluded, a woman with lupus in her third trimester has to choose between her disease and her baby with almost no good data.

When NIH funding is skewed toward male‑dominant diseases, a woman with endometriosis or ME/CFS spends years being told that her pain and exhaustion are “in her head” because no one has funded the work that would let her doctor say otherwise.

When menopause is framed as a hazard to be managed with fear instead of as a stage of life that can be treated with evidence‑based tools, a woman in her early fifties lies awake night after night in drenched sheets because her physician is more afraid of a 2002 press conference than of her fractured hip at seventy‑five.

When eighty percent of pregnancy‑related deaths are preventable, but we still do not demand trials in pregnant and lactating populations, a woman dies of postpartum cardiomyopathy because “nobody really knows” how aggressive her treatment can safely be.

These are not accidents. They are the predictable result of how research was built, who was prioritized, and who was told to wait.

“We have not come a long way, baby” is not nostalgia; it is a diagnosis of a system that still treats women’s bodies as special cases and women’s suffering as acceptable collateral damage.

For the first time in a long time, the people running HHS are not just quietly adjusting those structures—they are naming them as problems and taking visible steps to unwind them. Kennedy and Makary are placing women’s health, and the quality of the evidence behind it, at the center of their agenda.

If they follow through, trial by trial and budget line by budget line, women will finally stop living in the gaps of other people’s data. If they do not, the slogans will change, but the funerals, the broken bones, and the sleepless nights will not.

Right now, at least, the department is saying the quiet part out loud: the way we have studied medicine has been biased against women and fixing that is now our job.