Across the country, women entering menopause often find themselves in a great battle – biological, emotional, and psychological – accompanied by a cascade of disruptive symptoms including hot flashes, brain fog, insomnia, and mood swings. These changes can be life-altering, yet theyre too often met with minimal support from their doctors.

Instead of real solutions, many women are offered platitudes: Try yoga, drink more water, maybe take an antidepressant. Hormone replacement therapy (HRT) – once a common standard of care – is rarely mentioned, and when it is, the treatment is often portrayed as too risky or outdated to consider. After already suffering from menopause symptoms, many women dont hear about HRT from their physicians. More often they learn about it from a friend or online, and then must bring it up with their doctors themselves.

Despite mounting evidence that HRT can significantly improve quality of life and long-term health outcomes, the therapy remains stigmatized – the result of decades-old fears rooted in a single, controversial government study. Tens of millions of women have been misinformed, turned away, or left untreated, according to the most recent evidence. New FDA Commissioner Marty Makary calls this failure one of the greatest public health mistakes of the modern era.

In a small, crowded conference room at the Food and Drug Administration last month, a panel of experts quietly initiated what could become one of the most consequential reversals in American medicine. Convened by Dr. Makary personally, the July 17 panel reviewed decades of data on hormone replacement therapy for menopausal women – and concluded that a 20-year-old fear-based narrative has deprived millions of women of a profoundly effective therapy.

“People are hungry for this information,” Makary told RealClearPolitics. “When they come to their doctor asking about HRT – for hot flashes, mood swings, or night sweats – theyre often told not to take it, or to take the least amount for the shortest time. Meanwhile, many of those same doctors have patients who thrive on long-term HRT.”

That contradiction lies at the heart of what Makary and many physicians now call a colossal public health failure – one fueled, in part, by the press. After a 2002 government study – known as the Womens Health Initiative – found elevated risks of breast cancer and heart disease in some postmenopausal HRT users, a media firestorm ensued.

Prescriptions plummeted. Doctors stopped initiating the therapy. And women were left suffering in silence. But in the two decades since, the scientific understanding has changed – and the consensus has shifted.

The WHI findings were based on systemic estrogen-progestin therapy in women well past the onset of menopause, many with existing risk factors. Later analyses revealed that age and timing matter: Starting HRT within 10 years of menopause not only alleviates symptoms but may reduce the risk of cardiovascular disease, cognitive decline, osteoporosis, and even all-cause mortality.

Makary doesnt mince words. “The number one cause of death in women is not positive mammogram findings. Its heart disease,” he said. “If HRT improves heart and brain health – and reduces Alzheimers risk by 35% – we have to ask: Why are we still scaring women away from it?”

He points to the fear-based messaging that followed the WHI as a “tragedy,” adding that theres “no greater therapy that improves the health of women at a population level.”

Evidence backs that up. A meta-analysis of randomized trials found a 39% reduction in all-cause mortality and 32% lower heart disease risk in women who began HRT before age 60 or within 10 years of menopause onset. The long-term Danish Osteoporosis Prevention Study reported similar outcomes, including a 52% drop in cardiovascular disease.

HRT has also shown powerful benefits for bone health. As estrogen levels decline during menopause, women experience accelerated bone loss, increasing the risk of osteoporosis and fractures. The North American Menopause Society and WHI data indicate up to a one-third reduction in hip and spine fractures, with a 20-40% reduced risk across bone sites overall. Improved bone density is consistently observed within two years of treatment.

The FDA panel brought together cardiologists, neurologists, OB/GYNs, and urologists to reassess the infamous black box warning that still accompanies estrogen products. While the experts acknowledged that risks cant be dismissed entirely – particularly with certain systemic therapies – they argued that low-dose vaginal estrogen and transdermal options carry minimal risk and significant benefits.

Their recommendation? Remove or revise the black box warning, particularly for local estrogen treatments. The panel cited extensive evidence that these therapies do not significantly raise the risk of breast cancer or cardiovascular events when used appropriately.

“The science has evolved,” one panelist said. “So should the label.”

The FDA is expected to open a public comment period before proposing label revisions. Makary emphasized that the agencys role is to empower – not dictate – healthcare decisions.

“We want to provide information so people can make their own choices,” he said. But he also made clear that current labels are contributing to confusion among clinicians and missed care for women. “This is one of the most understudied, underfunded areas in medicine. Thats changing now.”

For many advocates and physicians, the HRT controversy isnt just about data. Its about how womens health has been treated for decades – with caution, neglect, and stigma.

Makary agrees. “This fear comes from a male-dominated medical culture that has dominated for hundreds of years. Groupthink and misinformation shut this therapy down. Were just now starting to set the record straight.”

If that happens, millions of women may finally get the care – and the clarity – theyve been denied for far too long.

Much of the stigma around HRT stems from a misunderstood breast cancer risk. While some WHI data linked combined HRT to a small rise in incidence, no study has shown increased breast cancer mortality. Estrogen-only therapy, used in hysterectomized women, has even shown neutral or protective effects in some analyses.

Makary summed it up simply: “We always say, as a doctor: treat the person, not the test result.”

Adair Teuton is a 2025 intern with RealClearPolitics.