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Doctors push back on ‘data-free’ ruling on menopause hormone therapy
Medical experts say the FDA bypassed standard procedures to remove black-box warnings from hormone therapy without adequate scientific evidence.
The US Food and Drug Administration commissioner Marty Makary announced the removal of broad black-box warnings from oestrogen-related menopause medications last week, claiming the treatments could prevent heart disease, osteoporosis, Alzheimer’s disease and death.
Black-box warnings are the strongest safety alerts the FDA requires on medications, highlighting serious or life-threatening risks. The 2003 warnings on hormone therapy cautioned about increased risks of cardiovascular disease, breast cancer and dementia.
Menopause specialists said the decision to remove warnings makes sense for local vaginal oestrogen products but raised concerns about systemic oestrogen treatments and the scientific process behind the ruling.
To make that blanket statement that every woman should take this to prevent heart disease – it’s not true,” said Lauren Streicher, clinical professor of obstetrics and gynaecology and founding medical director of the Center for Sexual Medicine and Menopause at Northwestern University school of medicine.
The FDA used a roundtable panel instead of its typical expert advisory committee process, marking the first time the agency has relied on this format for regulatory decision-making. The panel was not open to public comments in advance.
Makary called hormone therapy a “life-changing, even life-saving treatment” and positioned the announcement as a “medical breakthrough”. Robert F Kennedy Jr, secretary of the US Department of Health and Human Services, claimed hormone therapy was “extending the lives for as much as 10 years”.
“There may be no other medication in the modern era that can improve the health outcomes of women on a population level than hormone replacement therapy,” Makary said at the press conference.”
However, researchers said there is no evidence that hormone therapy provides benefits for the wider population of menopausal women beyond those experiencing symptoms such as hot flushes, insomnia and joint pain.
Pauline Maki, professor of psychiatry, psychology and obstetrics and gynaecology at the University of Illinois college of medicine, called the “data-free” decision “harmful” and confusing for women seeking accurate information.
“Women are trying desperately to get the truth, and they’re having a really difficult time,” she said. Regarding hormone therapy for dementia prevention, her area of expertise, “the harm is maybe real, but certainly it’s not showing benefit.”
Streicher, who initially agreed to participate in the July panel, withdrew after preliminary meetings. “It became very clear to me that this was not going to be a scientific panel. This isn’t the scientific approach,” she said. “I said: ‘I’m out. I don’t want any part of this.'”
The evidence on hormone medications is nuanced. Local vaginal oestrogen, typically delivered as creams, tablets, inserts, suppositories or vaginal rings, treats symptoms like dryness, irritation and recurrent urinary tract infections safely. “Those products are really totally safe,” Streicher said, noting they never should have carried the warning.
Systemic oestrogen presents more complexity. Different preparations carry varying risks. Oral oestrogen increases blood clot risk, while transdermal patches do not. Synthetic progesterone carries a small increased breast cancer risk. The medications are unsuitable for people with histories of breast or uterine cancer.
Maki’s research on menopause and dementia illustrates the complexity. She once believed memory issues could be linked to oestrogen loss during menopause. Initial research suggested women using hormone therapy for menopause symptoms saw memory improvements.
However, when Maki conducted a large randomised study among a broader group of menopausal women, not just those with symptoms, results differed significantly. “Far from showing benefit, it actually showed a trend toward harm,” Maki said. Three other large randomised trials produced similar results.
Maki now believes treating menopause symptoms, whether with hormone therapy or other medications, is key to improving memory. Using hormone therapy for dementia prevention more widely is “just not based in science”, she said.
An HHS spokesperson said “randomised studies show that women who initiate HRT within 10 years of the onset of menopause (generally before age 60) have a reduction in all-cause mortality and fractures”. The HHS did not respond to questions about officials’ statements on purported protection against dementia or provide evidence for wider use of the medications.
During the press conference, officials positioned the decision as challenging “medical group think” and “medical dogma”. Kennedy said “the label was designed to frighten women and to silence doctors” and accused the American medical establishment of turning its back on women.
Makary said the decision was “challenging the paternalism of medicine”, but then stated hormone therapy “has saved marriages”, suggesting marital satisfaction as a key outcome of the medication.
“It was not only scientifically wrong, but it was offensive,” Streicher said.”
The FDA opted for the panel format because advisory committee meetings are “bureaucratic, long, often conflicted and very expensive”, Makary said. He indicated more panels with guests who “speak [their] mind passionately” will occur in future.
Typically, expert advisory committees hold public discussions on evidence before making recommendations to the FDA, which subject-matter experts at the agency, rarely the commissioner, may accept or reject. The July panel included researchers who have published on menopause and doctors with large social media followings, but no oncologists.
Makary’s most recent book includes a chapter on hormone replacement therapy arguing that it has been shown to “increase a woman’s longevity by three years”. The more accepted medical term for treatment for women over 40 is menopause hormone therapy.
Streicher expressed concern about precedents set by the decision, noting the agency is also re-examining medications like mifepristone, a safe and effective abortion medication.
“Hormone therapy is safe and effective for those with menopause symptoms,” Streicher concluded. “But do I tell every single woman who goes through menopause that she needs to be on hormone therapy? Absolutely not.”
A new Female Health Hub launched by the English FA will support women and girls in grassroots football in England with trusted advice on health issues affecting play.
The hub brings together expert-backed guidance, practical tools and player insights in one place, giving women and girls practical advice and reassurance on female health in football.
It has four core aims: to help women and girls better understand their bodies and how female health affects performance and participation, to educate players on key health topics and when to seek further advice or support, to provide practical strategies to help navigate common female health challenges, and to help break down taboos and normalise conversations around female health in football.
Users of the hub will also be able to hear directly from members of the England women’s national team, who share their own experiences of navigating female health matters while playing at the highest level of the game.
“Our ambition is to create a game where women and girls can thrive,” said Sue Day, the FA’s director of women’s football.
“To achieve that, it’s essential that players feel supported in environments that understand and respond to their female health needs.
“We’ve heard directly from grassroots players that they want better information and support around female health, but that they often don’t know where to find it.
“The launch of the Female Health Hub marks an important step in changing the landscape.
“We want every player to feel confident in her own skin and supported without judgment, so she can feel empowered by her body, rather than held back by it.”
The platform was launched following research conducted by the FA that highlighted the need for better education and support around female health in football.
According to the FA, 88 per cent of adult players surveyed said their menstrual cycle has an impact on their ability to train or play, but 86 per cent reported they had never received education about the menstrual cycle in relation to football performance and training.
The research also found 64 per cent of women experience issues related to sports bras or breast health while playing football, despite sports bras being considered one of the most important pieces of playing kit.
Players also expressed strong interest in learning more about injury prevention, at 87 per cent, nutrition, at 84 per cent, and mental health, at 77 per cent, in relation to female health.
The first phase of the Female Health Hub focuses on three of the most requested topics: menstrual health, breast health and injury resilience, with further content to follow, including nutrition and pelvic health guidance.
The Royal College of Midwives (RCM) has referred to the women’s health strategy as a ‘missed opportunity’ to address maternity services.
The renewed strategy was released by the government this week, with the aim of putting women’s experiences at the centre of care and ensuring they are “better heard and served”.
However, the government stated that because of ongoing investigations into maternity services across the country, the strategy “does not seek to address safety in maternity and neonatal services”.
The RCM described this as a “missed opportunity” and urged the government to ensure that, following the inquiries, maternity is placed “at the very heart” of the strategy.
Gill Walton, RCM chief executive, said the college was “deeply disappointed” that maternity services “do not feature as a headline priority” in the renewed strategy.
She said: “This is a significant missed opportunity and one that is very difficult to understand.
“Pregnancy, birth and the postnatal period are not a footnote in women’s health – they are one of the most significant and consequential phases of a woman’s life.
“A strategy that treats maternity as an afterthought is not truly a women’s health strategy at all. It is exactly the kind of thinking that has allowed maternity services to reach the point they are at today.”
Walton acknowledged that the strategy contained commitments on ensuring women’s voices shape their care, on supporting families through pregnancy loss and on the principle that services should be held accountable when they fail to listen to women.
She added: “But a strategy that addresses one part of women’s health while leaving maternity care behind is only doing half the job.”
Walton urged the government to ensure that this is addressed when the ongoing investigations into maternity care conclude, with any recommendations placed “at the very heart of this strategy with the seriousness and urgency that women, families and midwives deserve”.
In the foreword to the renewed plans, health and social care secretary Wes Streeting referred to the ongoing independent National Maternity and Neonatal Investigation as action being taken by the government to improve safety in maternity services.
The strategy also refers to the new National Maternity and Neonatal Taskforce, chaired by Streeting, which aims to help deliver “safer, more equitable care” for women, babies and families.
The foreword said that, because of ongoing initiatives, it was “important that this work continues without restriction and that the government can properly respond to the findings”.
It added: “This renewed women’s health strategy therefore does not seek to address safety in maternity and neonatal services other than that related to women’s health before and during pregnancy and the actions we are taking immediately to improve maternity and neonatal care.”
The strategy does, however, include plans to prioritise health education in schools, communities and healthcare settings to “empower women” with the “knowledge and tools they need to help control their fertility” and “prepare for the best pregnancy outcomes.
It also promises to provide women with access to “safe and high-quality contraception, abortion care, fertility services, preconception care and support after pregnancy loss in convenient settings.
Article produced in association with London Pregnancy Clinic and Jeen Health
For the majority of couples planning a pregnancy, genetic testing is not something they think about until a problem arises.
Pre-conception genetic carrier screening challenges this approach by identifying risk before pregnancy begins.
As panel sizes have grown and at-home testing options have become widely available, carrier screening is transitioning from a niche clinical referral into a mainstream component of reproductive planning.
What Carrier Screening Tests For
Being a carrier of a genetic condition means carrying one copy of a variant in a gene associated with that condition, without being affected by it.
In most cases, carriers are entirely unaware of their status.
The clinical significance of carrier status emerges when both members of a couple carry a variant in the same gene: in this scenario, each pregnancy carries a one in four chance of resulting in a child who inherits two copies of the variant and is affected by the condition.
The conditions most frequently included in expanded carrier screening panels include cystic fibrosis, spinal muscular atrophy (SMA), fragile X syndrome, sickle cell disease, and a range of metabolic and enzyme deficiency disorders.
The Beacon 787 carrier test, offered by Jeen Health, screens for 787 conditions from a single sample, making it one of the most comprehensive panels currently available to UK families.
Who Is Most Likely to Benefit
Any couple planning a pregnancy can consider carrier screening. It is particularly relevant for:
- Couples with a family history of a known inherited condition
- Those from populations with higher carrier frequencies for specific conditions, including Ashkenazi Jewish, South Asian and African communities
- Couples pursuing fertility treatment, where genetic information informs treatment planning
- Those who wish to have the most complete picture of their reproductive health before conception
Importantly, being a carrier of a condition does not mean a child will be affected. It means there is a defined statistical risk that can be quantified, discussed and planned for with appropriate clinical support.
How the Test Is Performed
Carrier screening is typically carried out on a blood or saliva sample.
For at-home options such as the testing offered by Jeen Health, a cheek swab collection kit is dispatched to the patient, the sample is returned by post, and results are delivered digitally within a defined turnaround period.
In-clinic carrier testing may use a blood draw and provides the advantage of immediate access to a clinical consultation at the point of result delivery.
London Pregnancy Clinic offers genetics counselling through its partnership with Jeen Health, allowing couples to receive and contextualise carrier test results with expert support.
Genetic counselling before and after testing is recommended by Genomics England as a standard component of any genomic testing pathway.
What Happens If Both Partners Are Carriers
If both partners are identified as carriers for the same autosomal recessive condition, they are typically offered further counselling to discuss their options.
These may include proceeding naturally with an awareness of the risk, using prenatal diagnosis (CVS or amniocentesis) during pregnancy to test the fetus, or pursuing preimplantation genetic testing (PGT) in the context of IVF, which allows unaffected embryos to be selected before transfer.
The purpose of identifying carrier status before pregnancy is to give couples time to consider these options without the added pressure of an ongoing pregnancy.
Knowledge of carrier status does not remove reproductive choices; it expands the information available when making them.
The Role of Pre-Conception Services
Carrier screening sits within a broader category of pre-conception care that includes fertility assessments, general health optimisation and, where relevant, management of existing conditions before pregnancy begins.
London Pregnancy Clinic offers pre-conception services encompassing fertility investigations, genetics counselling and carrier testing as part of an integrated 0th trimester approach, allowing couples to address genetic and clinical risk factors before their pregnancy starts rather than after.
Disclaimer: This article is produced for informational purposes only and does not constitute medical advice, diagnosis or treatment.
Clinical guidance referenced reflects published NHS, NICE and RCOG standards as at March 2026. Individual circumstances vary; readers are advised to consult a qualified healthcare professional before acting on any information in this article.
This piece was produced in association with London Pregnancy Clinic and Jeen Health, which provided background clinical information for editorial purposes.
Hyperlinks to external sources are included for reference only and do not represent an endorsement of any product, service or organisation.
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