Connect with us

News

Doctors push back on ‘data-free’ ruling on menopause hormone therapy

Published

on

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.”

News

Bridging the metabolic wealth gap: The telehealth platform bypassing insurance to democratise care

Published

on

As weight-loss treatments remain locked behind prohibitive paywalls, a new direct-pay initiative is cutting costs in half for low-income patients, and it could provide a new blueprint for health equity.

It is one of the most persistent, frustrating paradoxes in modern healthcare: the medical innovations most capable of addressing widespread chronic conditions are overwhelmingly priced out of reach for the populations most vulnerable to them.

Nowhere is this more evident than in the current landscape of metabolic health and weight management.

As state governments and insurance providers increasingly restrict coverage for advanced weight-loss medications due to skyrocketing costs, a stark dividing line has emerged. Clinical need is no longer the primary factor in who receives treatment. Affordability is.

This financial barrier disproportionately impacts women, who not only face high rates of metabolic conditions but also frequently serve as the primary caregivers in their households.

For a single mother managing childcare, grueling work hours, and the relentlessly rising cost of living, personal well-being is often the first casualty of a tight budget.

These patients are forced into a holding pattern, watching their conditions progress year after year while highly effective, life-changing treatments remain separated from them by a paywall.

Now, a telehealth platform called Amble Health is attempting to dismantle that wall by bypassing the traditional insurance apparatus entirely.

A Structural Shift for Access

Today, Amble Health announced the launch of the Amble Cares Program, a national initiative designed to cut the cost of medical weight-loss treatments in half for low-income Americans.

The programme arrives at a critical inflection point.

Today, roughly one in eight U.S. adults have utilized advanced metabolic medications, according to a recent KFF Health Tracking Poll.

This surge in adoption has driven a fundamental shift in preventative care, but the distribution of that care has been deeply uneven.

Through the Amble Cares Program, eligible patients can access comprehensive medical weight-loss programmes, which may include prescription medications if clinically appropriate, at up to 50 per cent below standard rates.

To ensure the discounts reach the intended demographic, eligibility is determined by an independent, third-party verification partner, based on verified financial need.

The programme explicitly prioritises individuals and families with limited disposable income, including parents and guardians whose financial flexibility is tied up in providing for dependents.

Once verified, patients are connected directly to licensed clinicians to begin treatment immediately, stripping away the friction of waiting periods.

“Healthcare should not be a luxury item,” said Joey Stiver, CEO of Amble Health. At Amble, we believe that a patient’s zip code or income shouldn’t dictate their metabolic health outcomes.

“The Amble Cares Program is our direct response to the cost of living crisis, moving beyond talk of ‘affordability’ to actually delivering it to the people the traditional system has left behind.”

The Direct-Pay Trade-Off

However, this rapid, lower-cost access comes with a significant structural trade-off.

To achieve these price reductions and eliminate the administrative delays, denials, and red tape associated with traditional healthcare, Amble Health operates strictly as a direct-pay platform.

This means participants cannot use outside coverage. The programme does not accept Medicaid, Medicare, commercial insurance, or even HSA/FSA funds.

For some patients, being entirely locked out of utilizing their existing health benefits may present a new kind of hurdle.

But for those who have already found themselves abandoned by traditional coverage networks, facing outright denials, unnavigable prior authorisations, or insurmountable deductibles, the direct-pay model offers a predictable, transparent alternative to a broken system.

Ultimately, the Amble Cares Program is making a bold bet: that the most efficient way to deliver equitable healthcare to disenfranchised populations isn’t to fix the traditional insurance system, but to innovate entirely around it.

Continue Reading

Motherhood

Natural birth pressure harming new mothers’ mental health, research finds

Published

on

Pressure to have a natural birth can cause lasting psychological harm when labour does not go to plan, new research shows.

The study found that the messages women receive during pregnancy are directly linked to the shame and self-blame many feel when those expectations are not met.

For the first time, the research provides an explanation for why unmet birth expectations contribute to psychological harm.

Several women involved in the research said they felt they had not given birth “properly”, even when medical intervention had saved their lives.

Rebecca Matthews, lead author and PhD researcher at the University of Reading, said: “These women were not failed by their bodies, they were failed by the messages they were given.

“Birth trauma does not begin with birth. It begins in the ideology sold to women throughout pregnancy.

“For the first time we can explain precisely how, by showing how birth culture creates a moral standard for women that defines what a good mother does and then leaves them to blame themselves when birth does not match that.

“Until we reform the way we prepare women for birth, we will keep seeing the same devastating consequences for mothers and their babies.”

The researchers interviewed 21 first-time mothers in the UK whose births did not go as planned.

From NCT and hypnobirthing classes, to social media to midwives, the researchers heard how women are surrounded by messaging that frames natural, unmedicated vaginal birth as the “gold standard”, not just medically preferable, but as a mark of being a good mother and the first test of maternal worth.

Research shows around half of women report their birth differed significantly from their expectations, and for the women in this study, all of whom experienced exactly that, the psychological consequences were profound.

Women judged themselves against the internalised moral standard that this ideology had created.

The researchers are calling for antenatal education to stop treating one kind of birth as the goal and to present all birth outcomes as equally valid routes to motherhood.

They also call for better postnatal screening for women whose births did not go as expected, specifically targeting the shame, self-blame and identity disruption that this research identifies as mechanisms underlying birth trauma.

The findings align with and extend the conclusions of the Kirkup, Ockenden and Birth Trauma Inquiry reports, all of which documented how the institutional pursuit of “normal birth” contributed to preventable harm.

This research provides the first theoretical explanation of how that ideology generates individual psychological harm and points to antenatal messaging as the primary site of such preventable harm.

Continue Reading

Fertility

AI patch could detect hidden hormone disruptions behind unexplained infertility

Published

on

Even when standard clinical tests show normal hormone levels, men and women may have hidden problems in how their reproductive hormones are timed and coordinated, potentially affecting fertility, new research suggests.

The findings suggest reproductive health may depend not only on hormone levels in the bloodstream but also on the rhythm, timing and synchronisation of hormone changes across hours, days and the menstrual cycle.

Researchers said a wearable skin sensor patch, combined with artificial intelligence, could help detect endocrine dysfunction earlier and support more personalised fertility care.

Unexplained infertility affects about 15 to 30 per cent of couples and is diagnosed when standard investigations reveal no clear cause.

In men, current tests for infertility or hypogonadism, defined clinically as low testosterone, often include a single morning serum testosterone measurement.

In women, fertility assessment typically examines menstrual cycle characteristics and reproductive hormones such as luteinising hormone, follicle-stimulating hormone, oestradiol and progesterone.

However, reproductive hormones are not static markers. They are dynamic biological signals that rise and fall in regulated patterns throughout the day and across the menstrual cycle.

Testosterone, for example, follows a diurnal rhythm, meaning it changes across the day, while female reproductive hormones act through coordinated feedback loops involving the hypothalamic, pituitary and ovarian systems.

A single blood test may therefore miss clinically important disruption in hormonal timing.

In one study, Dr Tinatin Kutchukhidze, from the University of Oxford, examined 102 men in Georgia and the UK.

The participants were aged 22 to 38 and had normal morning total testosterone levels, measured at 12 to 35 nanomoles per litre, with or without infertility or symptoms of hypogonadism.

Hypogonadism is a condition in which the body produces too little testosterone or other sex hormones.

Kutchukhidze and colleagues used wearable AI-enabled skin sensor patches to measure testosterone levels every 15 minutes across four days.

The team found that men with symptoms had significantly disrupted testosterone rhythms, despite standard laboratory tests showing normal testosterone levels.

These previously undetected rhythm abnormalities were also associated with reduced sperm concentration and symptoms of androgen deficiency.

Androgens are hormones, including testosterone, that play an important role in reproductive health.

Kutchukhidze said: “For the first time, we have been able to track androgen patterns in real time across several days with a novel, non-invasive, continuous, AI-driven testosterone monitoring patch, compatible with Android and iPhone mobile devices.

“Previous research suggests that a normal morning testosterone level is sufficient to exclude clinically significant androgen deficiency. However, our findings challenge that assumption by demonstrating that men with normal serum testosterone may still exhibit marked disturbances in hormonal rhythmicity associated with reproductive dysfunction.”

According to the abstract, the study compared 54 men with infertility or hypogonadal symptoms with 48 age-matched healthy controls.

Mean morning serum testosterone did not differ significantly between symptomatic men and controls, at 22.4 ± 3.1 compared with 23.1 ± 3.5 nanomoles per litre.

Continuous AI-assisted monitoring, however, revealed significant differences in androgen dynamics.

Men with symptoms had lower diurnal amplitude than controls, at 5.2 ± 1.1 compared with 8.7 ± 1.4 nanomoles per litre.

The AI-derived rhythm indices predicted subclinical dysfunction with an area under the curve of 0.87, compared with 0.61 for static serum testosterone testing.

In diagnostic research, the area under the curve is used to assess how well a test distinguishes between groups, with higher values indicating stronger discrimination.

A second study by Kutchukhidze’s team examined female reproductive hormone rhythms.

The researchers developed an AI-driven metric called Endocrine Rhythm Integrity to assess whether reproductive hormones were changing in the correct pattern, at the correct time and in the correct relationship to one another across the menstrual cycle.

Endocrine refers to the hormone system, while endocrine dysfunction means hormones are not being produced or regulated in a typical way.

The team analysed data from 312 women aged 18 to 22 who had self-reported regular menstrual cycles.

Participants included fertile controls and women with unexplained infertility.

The researchers assessed key reproductive hormones during the luteal phase, including luteinising hormone, follicle-stimulating hormone, oestradiol and progesterone.

The luteal phase is the part of the menstrual cycle after ovulation. Ovulation is the release of an egg from the ovary.

They also incorporated physiological data such as basal body temperature, heart rate and sleep patterns.

Basal body temperature is the body’s resting temperature and can shift slightly around ovulation.

The study found that women with unexplained infertility had lower Endocrine Rhythm Integrity scores even when conventional hormone levels appeared normal.

Lower scores predicted infertility and were also associated with a higher incidence of implantation failure, when an embryo does not successfully attach to the womb lining.

Kutchukhidze said: “Our study reveals that a woman may have a seemingly healthy menstrual cycle and normal hormone levels but still experience hidden endocrine dysfunction that affects her ability to conceive.

“Rather than analysing hormone levels as isolated values, Endocrine Rhythm Integrity evaluates whether reproductive hormones are changing in the correct pattern, at the correct time and in the correct relationship to one another across the menstrual cycle.”

In the female study, mean cycle length did not differ significantly between fertile and infertile groups, at 28.9 ± 2.3 compared with 28.9 ± 2.5 days.

Endocrine Rhythm Integrity scores, however, were lower in the infertility group, at 0.61 ± 0.12 compared with 0.78 ± 0.10.

Disrupted endocrine rhythm integrity was observed in 64 per cent of infertile participants despite hormonally normal mid-luteal progesterone levels.

The metric independently predicted infertility status after adjustment for age, body mass index and anti-Müllerian hormone.

Anti-Müllerian hormone is made by reproductive tissues and is best known as a marker of ovarian reserve, meaning an estimate of the number of eggs remaining in the ovaries.

Receiver operating characteristic analysis indicated that Endocrine Rhythm Integrity identified infertility more effectively than cycle length or single-time-point progesterone assessment.

Lower Endocrine Rhythm Integrity scores were also associated with a higher incidence of implantation failure.

Kutchukhidze said: “Our AI-driven rhythm analyses were significantly better at identifying subclinical reproductive dysfunction than conventional testing, suggesting that both female and male endocrine disorders may not simply be disorders of hormone quantity, but rather disorders of hormonal timing, synchronisation and biological rhythm.”

The team will next assess whether the tool can reliably predict fertility outcomes across different reproductive conditions in larger and more diverse populations.

Continue Reading

Trending

Copyright © 2025 Aspect Health Media Ltd. All Rights Reserved.