As of Nov. 10, the Food and Drug Administration announced that the “black box warning” will be removed from menopause hormone therapy drugs, also known as hormone replacement therapy. “Black box” warnings are the FDA’s highest safety-related warnings for prescription drugs. This decision subverted typical FDA approval processes and faced backlash from many medical professionals. The Trump administration claimed it is promoting women’s health, yet their policies have eviscerated access to healthcare and other basic needs for millions of women. Moreover, the history of MHT in the United States is marked by sexism and medical racism.
Women’s health or corporate wealth?
The “black box” label for estrogen-containing MHT drugs stated that estrogen can increase the risk of “endometrial cancer, cardiovascular disorders, probable dementia and breast cancer.” This includes both oral and vaginal medications. According to the FDA, that label was “fearmongering,” while the removal of the “black box” warning is a “historic action to restore gold-standard science to women’s health.” However, while healthcare professionals are mostly in agreement that oral estrogen therapy for symptoms of menopause is beneficial in some cases, the medical community is divided on whether it is safe for all women.
From the 1940s-1970s estrogen was one of the most widely prescribed drugs in the U.S., but after 1975 studies raised alarms about links to endometrial cancer, its use plummeted. The “black box” warning was based on the findings of a 2002 study called the Women’s Health Initiative, which ended early due to increased breast cancer risk among participants. As a result, MHT use plummeted in the U.S.. Many ob/gyns disagree with the methods of this study and the way the results were framed, but the data cited by the Trump administration also relies on misreporting science.
In their press release on the decision, Department of Health and Human Services director Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary stated that MHT reduces the risk of cardiovascular disease by 50%, reduces the risk of Alzheimer’s disease by 35% and can extend women’s lives by ten years. “We do not have that data,” said Dr. Jen Gunter, a Canadian ob/gyn. According to Gunter, their evidence was “cherry-picked from ancient studies, most of which are observational and some that sounded completely made up.” She added, “If menopause shortens women’s lives, then why do women have a longer life expectancy than men?”
A chief finding of the WHI was that MHT is not an effective treatment for preventing heart disease, stroke, or cognitive decline. According to Dr. JoAnn E. Manson, this conclusion is still valid today. Typical FDA approval processes involve advisory committee meetings, but the change was made based on an “expert panel” convened by the FDA earlier this year, where only MHT advocates were present.
Under the new guidelines, potential risks will be outlined on a less visible label, which critics say denies women the right to make informed health decisions. “Removing the black box and putting warnings in a lengthy label that many doctors and most patients will not read is taking women’s health backward,” said Diana Zuckerman, a scientist and president of the National Center for Health Research.
Dr. Alicia Jackson, director of the HHS’s Advanced Research Projects Agency for Health, called the decision to remove the “black box” warning “an incredible step forward to empower millions of women.” Dr. Jackson is the founder and former CEO of a menopause telemedicine company called Evernow. Without the “black box” warning, it will be easier for MHT to be prescribed in virtual appointments, which will increase profits for telemedicine corporations. “I do think this is being a shill for the telemedicine companies,” said Gunter.
The root of the confusion around MHT lies in chronic underfunding for research on women’s health, which contributes to the lack of definitive medical data on MHT. If the Trump administration wants to promote women’s health, they should fund quality scientific studies and expand healthcare access. Instead, they have defunded health research across-the-board, denied healthcare to millions of people, and the HHS under Kennedy has repeatedly come under fire for spreading all kinds of medical misinformation.
“Feminine Forever:” the sexist roots of MHT
“For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear,” stated Dr. Makary. Ironically, the historical popularity of MHT was rooted in fearmongering towards women.
MHT for menopause entered the market in the 1940s, but not to promote women’s health. Estrogen therapy was introduced as a solution to women becoming less “attractive” as they age. In the 1966 book “Feminine Forever,” gynecologist Robert A. Wilson stated that with HRT, women’s “breasts and genital organs will not shrivel. She will be much more pleasant to live with and will not become dull and unattractive.” Selling MHT drugs relied on portraying menopause as a disease that afflicts aging women rather than a natural process.
The first MHT drug Premarin was marketed as a “cure” for menopause, and this outdated framing is echoed by the Trump administration today. Over a decade ago, practitioners replaced the term “Hormone Replacement Therapy” to “Menopause Hormone Therapy” because the former implies that decreasing estrogen levels must be replaced.
Hormone therapy is not appropriate for everyone, nor is it the only treatment for the discomfort women experience during menopause — other effective treatment options include other medications, Cognitive Behavioral Therapy and lifestyle changes.
Although some women will benefit from increased access to MHT, the administration’s framing of estrogen therapy for menopause must be understood in the context of their crackdown on women’s rights. “If your ultimate goal is to take away rights from women…then it’s very useful to say that women are too hormonal and they must be on medication, especially medication associated with femininity,” said Gunter. Trump’s sexist track record includes numerous sexual assault allegations, his relationship with Jeffrey Epstein, a laundry list of misogynistic comments and upholding anti-abortion laws. He aligns itself with openly sexist far-right pundits who advocate for “traditional” women’s roles. As they remove barriers to hormone therapy for menopause symptoms, the administration is simultaneously eviscerating estrogen access for transgender women.
The dirty history of hormonal drugs
FDA approval processes for estrogen-containing medications for women have a racist history. Hormonal oral contraceptives (birth control) were first tested in the 1950s, but popular backlash prevented researchers from testing it on women in the mainland United States. Researcher Gregory Pincus moved the human trials to the U.S. territory of Puerto Rico, where a lack of regulatory laws, lower education levels among women, and seclusion from white mainland populations ensured that he would face no barriers to his experiments. The government greenlighted the efforts due to concerns about “overpopulation” in Puerto Rico.
At the time, forced sterilization was the preferred method of population control, so birth control seemed benign by comparison. Puerto Rican women were lured into the study without being informed that they were taking part in a clinical . Nor were they clued into potential side effects. When on-the-ground doctors reported high levels of nausea, vomiting and headaches among the study participants, Pincus dismissed them as “psychosomatic.” Three women died during the trials, and the causes were not investigated. Despite the exploitative and unethical methods of the trial, Pincus’s pill received FDA approval and the first oral contraceptive entered mainland markets in 1960.
From forced sterilization of Indigenous women to ongoing medical racism towards Black women, U.S. policies have revoked autonomy from poor women of color for centuries. There is no room for medical racism and imperialist exploitation in women’s health.
Real solutions for women’s health
What does it really look like to promote women’s health? We need universal healthcare, so that people of all ages can access gynecological resources, which are often life-saving. The profit motive must be taken out of healthcare, so that decisions about medication options are based solely on the specific needs of each person. We must expand healthcare access for trans people. We must end medical racism, which includes expanding healthcare facilities into underserved communities and offering free medical education so that more women and people of color can become doctors. We need to end the imperialist system that treats Global South women as medical guinea pigs and creates public health crises through endless war. We need to redirect money towards scientific research on women’s health. Advocates for women’s health must unite to demand an end to the exploitative capitalist system, which stands in the way of a just future for all people and the planet.
Feature image: Robert F. Kennedy Jr. speaking at a campaign rally in 2024. Credit: Flickr/Greg Skidmore (CC BY-SA 2.0)
