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FDA to Reassess Outdated Recommendations Against Menopause Treatment

Posted on July 18, 2025 by Devon Herrick

Menopause can be pretty rough, affecting some women more than others. I won’t list the symptoms but you can find a list of menopause symptoms at the Mayo Clinic website. Hormone replacement therapy (HRT) was routinely prescribed to women seeking relief from menopausal symptoms 25 years ago. This all changed in 2002, when the Women’s Health Initiative released a report suggesting HRT increased the risk of blood clots, strokes, breast cancer and possibly dementia. The number of women using HRT fell nearly 80% overnight.

The New York Times began writing about the miserable state of menopause care a few years ago, here and again here. Critics often complain that health care providers dismiss menopause symptoms as minor and inevitable. Some women have even said when they shared their concerns with heath care providers, their doctors responded with irritation, embarrassment, indifference, or dismissal. It is probably not because their doctors were unsympathetic. Rather, it was because their doctors have been trained – indoctrinated if you prefer – to believe HRT is dangerous and no competent doctor should prescribe it. Women with extreme menopausal symptoms, willing to take their chances with HRT, were often unable to find doctors willing to prescribe hormone therapy. 

Today women who want hormone therapy often must turn to concierge or boutique medical practices with doctors who specialize in HRT. Some practices that specialize in HRT includes YouTube influencer Mary Claire Wellness, Institute for Hormonal Balance, The HRT Club or other (mostly) online HRT telemedicine clinics. Also keep in mind that concierge and boutique medical practices can be expensive, something insurance does not always reimburse. 

In the intervening 20 years since the Women’s Health Initiative report attitudes have been slowly changing. Medical experts have begun increasingly calling into question some of the conclusions of the Women’s Health Initiative. The following is from The New York Times:

Hormone therapy for menopause has become the focus of intense debate among women, with many arguing that a landmark trial may have exaggerated its harms, dissuading physicians from prescribing it and leaving patients without relief from troublesome menopausal symptoms, even as other advocates for women’s health contend there are risks to long term use that are being minimized.

U.S. Food and Drug Administration (FDA) commissioner Marty Makary recently announced he will convene a panel to “set the record straight” about hormone replacement therapy. More from The New York Times:

But proponents like Dr. Makary say there’s evidence that hormone therapy — approved for the treatment of symptoms like hot flashes — may prevent cognitive decline, heart disease and some cancers, in addition to conferring benefits that are not in dispute, like reducing osteoporosis-related fractures.

Dr. Makary has dismissed findings of a heightened risk of breast cancer in women who took combined estrogen and progestin, saying the research caused a “breast cancer scare” that has deterred women from getting a useful treatment.

“There’s probably no medication that improves the health outcomes of a population more than hormone replacement therapy for women who start it within 10 years of the onset of menopause,” except perhaps antibiotics, Dr. Makary said on a podcast.

“Women live longer, feel better. The benefits are overwhelming.”

The FDA is not the only one demanding a change in menopause care. Legislatures in more than a dozen states considered laws around menopause care and training for doctors this most recent legislative term. 

From New York to California, lawmakers are weighing whether to support more menopause training for clinicians or mandate comprehensive insurance coverage for menopause treatment. Advocates of such legislation argue that these changes could improve access to care and reduce the risk that menopause symptoms will be dismissed by providers.

At least two dozen bills have been introduced across 15 states this year, according to data from Jennifer Weiss-Wolf, executive director of the Birnbaum Women’s Leadership Center at the New York University School of Law, and her colleagues who have been tracking menopause legislation.

The FDA’s willingness to champion HRT will undoubtedly benefit many women. The FDA’s backing of HRT should also help more doctors to feel at east prescribing hormone therapy. There will remain some Nanny State public health advocates who criticize the FDA’s new stance. Women should be free to make their own decisions about risk and benefits. 

Read more at NYT: F.D.A. Panel to Reassess Hormone Therapy Warnings

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For many years, our health care blog was the only free enterprise health policy blog on the internet. Then, when the NCPA closed its doors, the health blog stopped as well.

During this five-year hiatus no one else has come forward to claim the space. So, my colleagues and I have decided to restart the blog in connection with the Goodman Institute. We invite you and others to use this forum to share your views.

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