On the heels of the November 12 Make America Healthy Again (MAHA) Summit headlined by U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. and Vice President J.D. Vance, news reports have described growing “rifts” in the MAHA movement and concerns among many followers that HHS “appears willing to collaborate with pharmaceutical companies, tech firms and other big corporations whose motives they don’t trust.”
The Associated Press quoted, for example, Summit observer Leslie Manookian, president of the Health Freedom Defense Fund, as stating, “I was not thrilled about some of the people who were there. I don’t think that we make America healthy again through pills, creams, injections, pharmaceuticals, chips, monitors, devices.”
MAHA supporters generally voice skepticism over vaccine safety, seek more natural alternatives to drug remedies, and demand greater transparency and accountability regarding food production and medicinal risks. At root are ethical standards regarding patient rights to informed consent, concerns over profit motives in drug production and marketing, and loss of trust in public health officials and medical providers following the COVID-19 pandemic.
In a move that suggests such concerns are indeed being dismissed by Kennedy and the Trump administration, only two days before the MAHA Summit, the U.S. Food and Drug Administration (FDA) announced plans to remove its “Black Box” warnings from Hormone Replacement Therapy (HRT) products for menopause symptoms. These products may contain estrogen only or combine 17β-estradiol (E2) or conjugated equine estrogens with micronized progesterone or synthetic progestins such as medroxyprogesterone acetate. Use of HRT peaked in the United States in the early 1990s but “plummeted,” per the FDA, in the early 2000s when the FDA applied Black Box warnings.
Those warnings emanated from findings of the national Women’s Health Initiative (WHI) study, which raised concerns about observed associations between use of HRT and increased risk of breast cancer, cardiovascular disease (heart attacks and strokes), and dementia. The FDA has opted to remove its Black Box warnings following an updated review of the scientific literature, an expert panel convened in July 2025, and a public comment period.
Principal results of the WHI study (1993–1998) were published in the Journal of the American Medical Association (JAMA) in 2002. At that time, the Writing Group for the Women's Health Initiative investigators explained that between 1993 and 1998, the WHI had enrolled 161,809 postmenopausal women between the ages of 50 and 79 years into a set of clinical trials designed to assess the major health benefits and risks of the then-most commonly used combined hormone preparation in the United States. The randomized, placebo-controlled clinical trials included trials of low-fat dietary pattern, calcium and vitamin D supplementation, and two trials of postmenopausal hormone use. The WHI also included an observational study at 40 clinical centers throughout the United States. Findings of the trial of combined estrogen and progestin in women with a uterus proved alarming, and the trial was stopped early based on the finding that health risks to users exceeded benefits over an average follow-up of 5.2 years.
A parallel trial of estrogen alone (“unopposed estrogen”) in women who had undergone hysterectomy was continued until February 2004. Today, investigators generally believe that combined (estrogen and progestogen) HRT increases breast cancer and cardiovascular risk, while the risks versus benefits of estrogen-only HRT among women with a prior hysterectomy appeared “more balanced” (the term used by the cited authors), with a slightly increased risk of stroke and venous thrombosis, decreased risk of hip fractures and diabetes, and decreased breast cancer.
Conclusions from the WHI trials might long be debated, as researchers note certain study design flaws, the variation in findings according to subjects’ ages and years past onset of menopause, whether HRT-users had undergone a prior hysterectomy, and what scientists have since learned about the advantages of bioidentical hormones versus synthetic progestins, etc. Writing for Natural Womanhood, Anne Marie Williams, RN, BSN, notes that, while both are created in a laboratory, synthetic hormones are made from chemicals that do not have the same molecular structure as a woman’s endogenous (natural) hormones, whereas bioidentical hormones are made from naturally derived ingredients (i.e., typically plant derived) and are “structurally identical” to those produced by the body. Williams’s article is an excellent summary of the rationale behind the recent FDA action and current options in women’s reproductive health.
Here it should be noted that the FDA is not seeking to remove the Black Box warning for endometrial cancer for systemic estrogen-alone products, which would be used by women who have had hysterectomies. (As Williams notes, a woman with a uterus will need progesterone along with estrogen). In 2016, a systematic review from Denmark of 527 published articles and ultimately 28 eligible studies concluded that all HRT formulations (with the possible exception of continuous combined HRT) increase the risk of endometrial cancer.
The recent FDA step was contemporaneous with the publication of a policy paper designed to provide scientific justification for the 5th edition of the European Code Against Cancer (ECAC5), which notes that, except for vaginally administered estrogens, all forms of HRT are associated with an increased breast cancer risk and possibly risk of serious ovarian and endometrial cancers. Accordingly, the ECAC5 recommends that any use of HRT should be preceded by a baseline assessment of breast cancer risk and thorough discussion with a qualified health care professional regarding individual risk-benefit analyses. Women should have ample opportunity to make an informed choice, and HRT should be used for the shortest duration as possible for the treatment of severe menopausal symptoms.
The authors of ECAC5, part of a special initiative of the European Commission, further note that “Management of menopausal symptoms should first be attempted using non-hormonal approaches.” Non-hormonal approaches might include, but are certainly not limited to, increased physical exercise and weight loss for some women, cognitive behavioral therapy, and dietary changes, including increased consumption of soy products and cruciferous vegetables such as broccoli and kale.
The ECAC5 paper is interesting in that its measured support “despite the carcinogenic potential of HRT” appears to be much more nuanced than the nearly exuberant tones of the November 10 press conference at which removal of the FDA Black Box warning was announced. At one point, FDA experts described the label action as “monumental,” a “breakthrough” in women’s health, and a major move to “stop the fear machine.” Such effusive language by FDA officials under scrutiny for failures regarding the copper IUD, Depo Provera, women’s health and MAHA generally seems to echo the Trump administration attempts to curry GOP favor with an increasingly dissatisfied constituency: women, especially young, educated, and urban women.
Ultimately, time will tell whether FDA removal of its Black Box warning leads to a resurgence in HRT prescriptions and sales. An estimated 31.7 million prescriptions for oral menopausal estrogens were dispensed in 1992. Overall, annual hormone therapy prescriptions rose from 58 million in 1995 to 90 million in 1999, representing approximately 15 million women per year, then remained stable through mid-2002. As noted previously, HRT use then “plummeted” after the sudden halt of the WHI estrogen-plus-progestin trial, and, along with it, promotional expenditures — meaning drug company promotional efforts such as product samples for physicians and direct-to-consumer advertising. Indeed, Majumdar et al. reported that in the single quarter alone before publication of the 2002 WHI report (April–June 2002), 71 million dollars had been spent on HRT promotion, or in annual terms, $350 dollars per year per U.S. physician. At its zenith, HRT accounted for promotional expenditures of more than $300 million per year in the United States.
One hopes that, as our European counterparts emphasize the importance of limiting HRT exposure to “as low a dose” and “as short a duration as possible,” American women will be guaranteed fully informed decision-making, including non-hormonal options for navigating perimenopause and menopause. Indeed, there are healthy, evidence-based options for more natural approaches to women’s reproductive health, not only as their fertility wanes, but also — and especially — in their fertile years. Toward this end, readers are encouraged to explore valuable resources such as Natural Womanhood, FEMM Health, and the Fertility Awareness Collaboative to Teach the Science (FACTS).
Teresa A. Donovan, MPH, is an associate scholar of the Washington, D.C.-based Charlotte Lozier Institute and former senior writer and editor of Presidential Messages & Correspondence for President George H.W. Bush. She has served more recently in higher education, including work focused on environmental and public health sciences at the University of Kentucky and the University of Cincinnati College of Medicine|UC Center for Environmental Genetics.
