Reflections from the July 17, 2025 FDA Expert Panel on Menopause Hormone Therapy for Women
By Ben Gonzalez, MD
I usually take a little time, a few days at least, to reflect on conferences or big panel discussions before I post my thoughts and remarks. However, not this time. I am hoping that today’s FDA expert panel discussion accelerates what us physicians who are passionate about women’s health have been talking about.
For the first time in recent memory, a room full of doctors, researchers, and policy leaders came together to say what many of us in women’s health have been shouting into the wind for years: Estrogen is not the enemy. Today, the FDA convened an expert panel to address the clinical guidance, risks, and benefits of Hormone Replacement Therapy (HRT) and Menopausal Hormone Therapy (MHT), and it was nothing short of a paradigm correction.
I was there.
And what I witnessed was the public beginning of a necessary reckoning with two decades of harm.
The Weight of 2002
Let’s be clear: the 2002 Women’s Health Initiative (WHI) study caused an earthquake in women’s medicine. Millions of women were taken off hormone therapy either on their own or by their providers. almost overnight. Doctors, terrified of liability and confused by exaggerated headlines, told their patients to stop. Estrogen was vilified. And actually, any reference to many hormones had gone down by association.
But here’s the thing, the data never supported the hysteria. And today, we have the re-analyses to prove it. At least to move from the dogma.
In 2007, a follow-up published in JAMA showed that when initiated in women under 60 or within 10 years of menopause, estrogen therapy actually reduced all-cause mortality (Manson et al., JAMA. 2007;297(13):1465–1477). Let that sink in. A therapy that was once said to kill, may in fact help women live longer, when used properly.
Cardioprotection, Not Catastrophe
Dr. Rachel Rubin, a urologist and menopause specialist who has become a national voice for women’s sexual health, opened the discussion with a powerful reminder: estrogen protects the cardiovascular system. Data from observational and randomized studies (including Rossouw et al., Circulation, 2007;116(3):354–60) demonstrate that estrogen started early in the menopause transition reduces the risk of fatal heart attacks by 25% or more.
She reminded us that women who lose ovarian function early, whether from surgery or primary ovarian insufficiency, experience up to a 7-fold increased risk of cardiovascular disease—some suffering heart attacks as young as 28.
Panelist Dr. Howard Hodis reinforced this with compelling imaging data showing improved endothelial function in women on transdermal estradiol. Cardiologist Dr. Vonder Kelly Casper added that we would never withhold other useful medications based on outdated data, so why are we penalizing estrogen?
The Truth About Vaginal Estrogen
One of the most important clarifications came from Drs. Heather Hirsch and Barbara Levin, who emphasized the systemic safety of local vaginal estrogen, especially for genitourinary syndrome of menopause (GSM). Despite carrying the same FDA “black box” warning as systemic estrogen, vaginal estradiol cream, tablets, and rings do not increase the risk of stroke, heart attack, or cancer (Crandall et al., Menopause, 2022;29(6):651-660).
Yet women are routinely denied this simple, effective treatment, one that reduces urinary tract infections, restores comfort, and protects tissue integrity, because clinicians are scared off by regulatory language that no longer reflects the evidence.
As I’ve said in my lectures: “What’s the point of living longer if you’re doing it in diapers and with chronic pain?” Yeah, I said that 15 years ago at a trauma conference in Washinton D.C.
Bones, Brains, and Beyond
Estrogen does more than ease hot flashes. It is bone-protective, neuroprotective, and, yes, sex-protective. Panelist Dr. Roberta Diaz reminded the audience that estrogen reduces fracture risk by 50%, citing the NEJM trial (Anderson et al., 2001). For women over 80, hip fractures carry a 1 in 5 chance of death within a year. Yet we withhold the one treatment that could meaningfully lower that risk.
Neurologist Dr. Sarah Phillips shared sobering statistics: women are twice as likely as men to develop Alzheimer’s, and estrogen may reduce that risk by up to 35% when initiated near menopause. This echoes findings from the Cache County Study and recent metabolic brain imaging showing that the female brain undergoes a measurable decline in glucose metabolism during perimenopause, one that estrogen may reverse or slow (Mosconi et al., PLoS One, 2017). YES! I know these are not perfect studies. However, they show support, and we see clinical relevance in practice. I have certainly.
Testosterone and the Gender Double Standard
Sexual health was also on the table, finally. And this drives me crazy and I have pointed this out in lecture after lecture, year after year over the last 2 decades: More studies and availability of a hormone that declines with age in BOTH men and women, testosterone, is simply addressed for men only.
This hormone protects my wife’s heart.
Dr. Dorothy Fink, Deputy Assistant Secretary for Women’s Health, addressed the elephant in the room: men have 39 FDA-approved testosterone products; women have zero. Let that sink in. For women with hypoactive sexual desire disorder (HSDD), access to testosterone remains limited, off-label, and out-of-pocket.
As I’ve written before: “Men get Viagra and sympathy. Women get antidepressants and dismissal.”
A System That Still Fails Women
Look, 5000 to 6000 women enter perimenopause….EVERY DAY. According to The Commonwealth Fund, women of reproductive age in the U.S. are most likely to have multiple chronic conditions. Do you think those chronic conditions go away at menopause? They get worse and more add to them. Multiple panelists underscored a painful statistic: the average woman sees 5 to 7 clinicians before receiving appropriate help for menopause-related symptoms. Why? Because most medical education barely covers menopause. Because the Beers Criteria still list hormone therapy as “potentially inappropriate” in older women, despite overwhelming evidence to the contrary.
Because when women complain, we code it as anxiety.
What Comes Next
Here’s what I hope happens:
- The FDA updates its boxed warnings to distinguish systemic from local estrogen.
- Professional societies provide clear, consistent guidelines that reflect the evidence.
- Primary care and OB/GYN training includes meaningful education on menopause care.
- Insurance companies start covering women’s sexual health and menopause care with the same enthusiasm they cover men’s.
The meeting concluded with a call for public comment, the launch of a future roundtable series, and the commitment to place women’s real-world experiences at the center of regulatory reform.
I’ll be participating. I hope you will too.
Because menopause is not a disease. But the silence around it is.
References:
- July 17, 2025 FDA Expert Panel on Menopause Hormone Therapy for Women, Silver Spring, MD White Oak Campus.
- Manson JE, et al. Estrogen Therapy and Coronary Heart Disease. JAMA. 2007;297(13):1465–1477. https://jamanetwork.com/journals/jama/fullarticle/206274
- Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause. Circulation. 2007;116(3):354–360.
- Crandall CJ, et al. Safety of Vaginal Estrogen Use. Menopause. 2022;29(6):651–660.
- Anderson GL, et al. Effects of Conjugated Estrogens on Bone Density. NEJM. 2001.
- Mosconi L, et al. Menopause impacts human brain structure, connectivity, energy metabolism. PLoS One. 2017.
To Your Health!
Dr. G
