The many problems with the FDA’s big menopause announcement

On Monday, the Department of Health and Human Services made an announcement that it promised would change the lives of millions of American women for the better: Hormone replacement therapy, the combination of hormone drugs that can treat the symptoms of menopause, was about to be depathologized.

The Food and Drug Administration (FDA) had decided to remove a black-box warning on the medication that cautioned patients that its use could cause cancer and stroke. HHS Secretary RFK Jr. and FDA commissioner Marty Makary said that the warning, which first appeared in 2003, had been based on an overblown interpretation of a decades-old study. “The FDA is announcing today that it will remove the misleading black-box warnings from all HRT products,” said Kennedy. “For the first time in a generation, the FDA is standing with science and standing with women.” 

The change was welcome news to many doctors who treat the often-debilitating and long-dismissed symptoms of menopause: hot flashes, brain fog, insomnia, and recurrent urinary tract infections, to name but a few. “This decision aligns with the latest evidence-based research and helps eliminate the unnecessary fear that this warning has long perpetuated,” the Menopause Advocacy Working Group, a group of physicians that promotes increased awareness around menopause, said in a statement on social media. (Two of the group’s members were among the speakers at Monday’s event.)

But the specialists with whom Mother Jones spoke said that Monday’s panel, which included doctors with robust social media presences, had at times overstated both the negative health effects of menopause and the science on the benefits of hormone replacement therapy. Spokespeople for HHS did not immediately respond to questions for this story.

Here are just a few of the more questionable claims they made:

Menopause causes divorce.

Dr. Kelly Casperson, a urologist and “expert and advocate for sexuality and hormones,” warned that “families fracture” if women don’t get treated for the symptoms of menopause. Dr. Makary listed “divorce” alongside well-documented symptoms like mood swings and hot flashes. For Adrian Sandra Dobs, a professor of Medicine and Oncology at the Johns Hopkins University School of Medicine’s Division of Endocrinology, Diabetes and Metabolism, this claim was “pretty ridiculous.” She continued, “It is true that there can be mood swings and this can affect a marriage,” but to blame a divorce on menopause is “really stretching it.” 

Menopause kills women.

“HRT has saved marriages, rescued women from depression, prevented children from going without a mother,” Dr. Makary said. “Menopause shortens women’s lives,” added HHS Advanced Research Projects Agency for Health Director Alicia Jackson. Dr. Esther Eisenberg, a Professor Emerita at Vanderbilt University Medical Center who is working on the American Congress of Obstetricians and Gynecologists’ (ACOG) forthcoming guide to menopause, called the notion that menopause kills women “absurd.” Menopause, she said, “has nothing to do with a woman’s lifespan.” Dr. Jen Gunter, a gynecologist and the author of the 2021 book The Menopause Manifesto, noted in a Bluesky post that, on average, women actually live longer than men.

HRT improves the lives of all women.

“We have the opportunity to add up to a decade of healthy years to the life of every woman that you love!” proclaimed Dr. Jackson. Except for, as Drs. Dobs and Eisenberg noted, the millions of women for whom HRT is contraindicated—such as those with a previous history of blood clots or stroke, certain blood conditions, and many of those with a history of breast cancer. 

Lifelong vaginal estrogen therapy helps breast cancer patients live longer.

“They need their oncologist to know that women with breast cancer who use it may actually live longer, and they need their primary doctors to know how to write the prescription, recommend it for life,” said panel member Dr. Rachel Rubin, a urologist and sexual medicine specialist. Dr. Dobs wasn’t so sure. “I can’t agree with that,” she told Mother Jones. “We shouldn’t be afraid of it, but I couldn’t make a statement that vaginal estrogen makes women with breast cancer live longer.” (Breast cancer patients and survivors are typically advised to avoid most forms of HRT, though emerging evidence suggests vaginal estrogen may be safer.) 

Doctors should test the estrogen levels of patients in perimenopause before prescribing HRT.

“We are sticking with our philosophy that the government is not your doctor,” said Dr. Makary. Nonetheless, he did recommend “having a doctor evaluate your estrogen levels to figure out when is the right time to start.” Yet the North American Menopause Society explicitly recommends against testing for estrogen levels in perimenopausal women because they fluctuate so much throughout a woman’s cycle. Instead, doctors should prescribe estrogen based on a woman’s symptoms. Of Makary’s advice for women to ask their doctors to test their estrogen levels, Dr. Eisenberg said, “that recommendation comes out of the sky.” 

Makary cast these claims as the results not only of “a robust review of the latest scientific evidence” but also of “listening to women who have been challenging the paternalism of medicine.” In a surprisingly feminist statement, Makary added, “A male-dominated medical profession, let’s be honest, has minimized the symptoms of menopause, and as a result, women’s health issues have not received the attention that they deserve.” 

Makary’s criticism of paternalism in medicine might strike some as being particularly ironic when considering some of the other recent actions the FDA has taken on women’s health, which have included adding warnings to medications already proven to be safe. Back in July, for instance, the agency convened a so-called expert panel to discuss the use of antidepressants by pregnant women. The event featured a majority-male panel, several of whom called for adding a black box warning to SSRIs for pregnant women, which reproductive health experts say could increase stigma for women who could benefit from taking the pills. The members of that panel mostly spewed misinformation while railing against the use of antidepressants during pregnancy, to such an extent that the president of ACOG promptly released a statement calling the meeting an “alarmingly unbalanced” event that “did not adequately acknowledge the harms of untreated perinatal mood disorders in pregnancy.” 

In addition, Kenedy and Makary confirmed in a September letter to Republican attorneys general that they would undertake a review of the safety of mifepristone, one of the two drugs used in medication abortion, even though more than 100 scientific studies have confirmed the pills are safe and effective—including when they are prescribed virtually and mailed to patients. Reproductive rights advocates are concerned that this “review” could lead to a decision to restrict access to the pills by recommending they should not be prescribed virtually and mailed to patients, or that they should not be used through ten weeks’ gestation, as the FDA currently allows. (Abortion advocates say the pills can be safely used later in pregnancy, and the World Health Organization guidelines note they can be used anytime in the first trimester.) 

The newfound enthusiasm for HRT has been building over the past few years, as awareness of menopause, its symptoms, and the myths around hormonal medications has increased. All the attention on menopause, though, has elevated a new cadre of doctor-influencers, two of whom were featured speakers at Monday’s event. Casperson, a urologist who hosts a podcast and has written two books about menopause and sex, has 435,000 Instagram followers. At her Bellingham, Washington clinic, which doesn’t accept insurance and instead offers memberships that start at $3,000 for 4-6 months of treatment. Casperson says she aims to help women “stop should-ing all over your sex life.” Rubin, also a urologist who doesn’t accept insurance, has 185,000 followers on Instagram. She trained under the controversial physician Irwin Goldstein, who advocated for the first-ever women’s libido drug, which the FDA approved back in 2015. 

Dr. Dobs cautions against relying on influencers selling supplements or claiming that HRT will solve all women’s health problems. “Unfortunately, nothing really keeps us young except things like stopping smoking, exercising, and lifestyle modification,” she said. “There’s a lot of hype to hormones—we think they’re going to cure everything, and they really don’t.”