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

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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.”

Mental health

Neuroscience-backed journaling for women’s mental health

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AI-powered journaling app Véa is supporting mental health by helping women to understand their thoughts, triggers and behavioural patterns. 

Winner of the Brain and Mental Health Innovation Award at this year’s Femtech World Awards, Véa is designed to address the emotional gap in women’s health technology.

The journal – which has been built by a female team and trained on women’s health papers – tracks inner states, provides personalised insights and somatic practices, and utilises AI to explain complex neuroscience in relatable terms.

Described by its founders as a “protector, seeker, and sculptor”, Véa provides a longitudinal map of women’s emotional journeys, integrating journaling with therapy and both in-person and online community support.

The journal’s goal is to improve women’s mental health without replacing professional care. 

Zahra Bhatti, co-founder and CEO and Katrina Zalcmane , co-founder and growth lead speak to Femtech World about the technology, winning a Femtech World Award and their plans for the future.

Women’s health and wellbeing technology has grown so rapidly over the last few years, but is largely focused around physical health. What was the emotional gap that you saw that inspired you to create the journal? 

“Women’s health has been focused on reproductive health and physical health, but it is all one ecosystem – it always starts with the mind,” says Zahra.

“Whatever you feel down here, you feel up there too, and the hormones reflect that. 

“With Véa, it was actually built from our own personal experience of burnout. 

“We wanted to make a space where women could feel safe and were able to reflect what’s on their mind, but also understand their mind the same way that women understand their hormones. 

“Women need to understand what happens in our minds. Véa helps women to understand cognitive distortions, why they feel the way they feel, black and white thinking – we wanted to really surface that for them. 

“For example, when you’re in your luteal phase, your serotonin levels drop, so that means you’re going to be a bit more nervous. 

“You’re going to be more reactive. You’re going to be taking things more deeply, and that’s something that your rational mind wouldn’t normally do if you’re in your ovulation phase. 

“So that’s what Véa does – she reflects that back to you, so you understand your body and thought processes.”

Véa describes itself as a journal that’s designed for the female mind. What does that mean in practice, and how does the experience differ from using traditional journaling?

“The majority of our team is female, so Véa has been built from all of our lived experiences, and the AI itself is trained on women’s health papers,” says Katrina. 

“It takes into account what having a certain condition means for individuals. For example, if you have endometriosis or PCOS, We’ve trained our AI on womens health data and research, which gets reflected back to the woman in a simple and effective way

“We have a clinical board, who are all also women, who look through the AI and the language. They ensure that all outputs are evidence based, ethical and take into account the various therapies which are proven to work for women.

“We also have somatic practices which are focused on women which we call “rituals”. We have a self-inquiry ritual, a confidence mirror ritual, or we have one of our psychotherapists on the board who does therapy through novels, for example. 

“These aim to make you the protagonist of your story. 

“Generic journaling apps are one size fits all, but women are not one size fits all, and that’s what we’ve made sure to put in the forefront of Véa.”

Instead of conventional mood tracking, you are focused on the inner states of women. How do you develop that approach, and what kind of insights has it revealed about how women reflect on their emotions? 

Katrina says: “Mood plays a part in our inner state and Véa checks in on that. 

“It allows you to have a journey across time. For example, on a good day, maybe their “protector” aspect is good at setting boundaries, but on a bad day, it could be really closed off. 

“It’s a richer approach, and these inner states are tied to specific prompts which are then linked in the journaling.”

“As women, we are fluid,” adds Zahra. 

“We are not one entity. 

“For example, you might be in a state where you’re really overthinking, but actually, you’re seeking new perspectives, and that’s why within Véa, the inner state is called a “seeker”. 

“When you converse with Véa in your seeker mode, she will challenge you in a Socratic way.

“However, the next day, you might be a “protector”, and then Véa will adjust her voice for a reflective and exploratory tone compared to when you were a seeker.

“Another state which I love is the “sculptor” which is when you’re feeling confident. 

“When you’re a sculptor, Véa will talk about how you can be creative, asking questions such as ‘what did you create today?’ ‘How did that make you feel?’ and ‘How would you describe that if you could put a shape to this color, this feeling?’, for example. 

“Véa goes into all of these different modes, and it builds a longitudinal map of the woman as well. So, throughout weeks, months and years, you can see how you’ve changed across time.”

How did you approach designing an AI companion that feels supportive without replacing human connection or professional care? 

“For the past six years, I’ve been a product manager. So I’ve seen how all of these web apps and applications have been built, and I’ve worked quite deeply with AI so I knew what was missing and like what women truly needed,” says Zahra.

“The key thing for us is that we want to bring “URL to IRL” [in real life]. 

“We have a community that goes alongside Véa. This includes a WhatsApp community and events. 

“We turn the rituals inside Véa into in-person workshops at our events with our clinical board and with professionals in the space. 

“We are not neuroscientists, but there are neuroscientists who have helped us build the app, and we make sure that AI is there to support you, but AI will never replace that human touch.

“That’s something that’s very close to us, and we want to make sure we connect people together and help people reflect in a safe space. 

“As well as AI, there is the option to talk to the clinical board, to use their rituals, to reflect with the community, and go to our events.” 

Katrina adds: “The key is that whatever the touch point is, whether it’s the app or it is an event or even our online community, we don’t want women to feel alone. We want them to feel together, grow together, and process together.”

People may often start journaling with good intentions, but struggle to stick with the practice. What have you learned about building habits and how those insights have shaped the experience of your product? 

Zahra says: “I think everyone wants to gamify things – what helps us is the community aspect. 

“We’ve created a tribe through the community, and because it’s so hyper personalised, you help shape the app, the app doesn’t shape you. You have full control, which makes people want to come back. 

“Véa remembers what you said yesterday as well as six weeks ago, and she will surface that. 

“We do have “streaks”, but our streaks are very gentle – every time you get a streak, you get a neuroscience fact along with it. 

“Something else we have built in that helps retention is “breakthroughs”. When Véa detects a shift in language, and will highlight, for example, that you have shifted from overthinking to certainty.”

“I think people are sick of data, they’re sick of data that they can’t interpret from. Véa interprets for you. 

“Soon we will evolve even more and add more features such as cycle tracking, wearable tracking and hormone tracking, to build out that ecosystem.”

What does success look like for Véa and how do you see the app and the community evolving as you move forward? 

“We want to launch across so many different markets. Our next target is the US,” explains Katrina.

“We want to bring our events over there as well. We do a lot of corporate events too. We have one with NatWest coming up – we know that work stress is a big thing, especially amongst females. 

“I think there’s a real space for that in the corporate world, so that’s one of our key focuses.”

Zahra adds: “Growing in markets and keeping going with our communities. We have just launched a supper club which sold out in three days in Manchester, which is absolutely amazing. We’re doing some in London and Amsterdam as well in the next few months. We are focused on growth, growing our board as well, and keeping the female mind at the center.”

What does it mean to win the Femtech World Award? 

Katrina says: “When you are so passionate and truly believe in something, you do it for that reason, but that external validation of seeing that it also matters for others in the wider space means so much. 

“Especially, in Femtech – it is a whole category that has been growing, but when it comes to funding and recognising women’s issues, there is still a lot of awareness that needs to be raised. 

“Being recognised gives us that fuel to continue and drive forward, and that it really does matter.”

“We want to be at the forefront of women’s mental wellness as a whole, and have put many sleepless nights into developing the app, so it is a big testament to that,” adds Zahra.

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Features

Gender gap in treatment persists even when men and women have same condition

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Women with the same medical conditions as men were less likely to receive the same treatment across several specialties, a global research review found.

The review found differences in care for conditions including cardiovascular disease, kidney disease and Parkinson’s, with women less likely to receive some active treatments.

Of 38 studies analysed, 33 found women were less likely than men to be offered active treatment.

Researchers at the University of St Andrews found women with myocardial infarction, heart failure or an irregular heartbeat were more likely to receive medication, while men were more likely to undergo coronary bypass surgery, stenting or other surgical treatment.

Women were also less likely to be prescribed statins.

Men with Parkinson’s were more likely to be referred for deep brain stimulation.

Men with liver failure were more likely to receive a transplant, while women with kidney disease requiring dialysis were less likely to receive permanent access and spent longer using a catheter.

Women were also less likely to receive opioids for pain management.

The researchers found no significant difference between women and men in treatment for stroke or diabetes, while women were more likely to receive treatment for dementia.

None of the studies identified clinical guidelines recommending different treatment based on sex.

Researchers said this suggested the differences could not be explained by the need for different clinical approaches to women’s health.

Dr Andrew O’Malley, who co-led the study, said: “For clinicians, the findings are a prompt to check whether treatment is being offered on clinical grounds rather than assumption.”

He said studies showed doctors more often attributed women’s symptoms to anxiety and made more diagnostic errors with female patients, even when test results were positive.

Dr Miriam Veenhuizen, honorary lecturer in the School of Medicine at St Andrews, said: “While the direction of the findings was not a surprise, the consistency was. The same pattern appeared in cardiology, surgery, transplant medicine and emergency care, and it survived statistical adjustment in most studies.”

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Pregnancy

Women with multiple health conditions face higher pregnancy risks, study shows

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Women entering pregnancy with multiple long-term health conditions face higher risks of miscarriage and other complications, a UK study found.

Those with two or more pre-existing physical or mental health conditions had a 20 per cent higher risk of miscarriage than women with no long-term conditions.

They also had more than twice the risk of venous thromboembolism and around four times the risk of antenatal anxiety and depression.

The UK-wide research team analysed 2,225,701 pregnancies and birth events recorded between 2000 and 2022 across five datasets covering England, Scotland, Wales and Northern Ireland.

Women with multiple long-term conditions had a 69 per cent higher risk of nausea and vomiting during pregnancy and a 42 per cent higher risk of pre-eclampsia.

The women also had a 32 per cent higher risk of placental abruption and a 26 per cent higher risk of gestational diabetes.

Risks rose as the number of existing conditions increased.

Among women with three or more long-term conditions, the risk of venous thromboembolism was more than three-and-a-half times that of women with no long-term conditions.

Researchers said the findings had implications for maternity services, where care pathways are largely centred on individual conditions and may not adequately meet the needs of women with multiple long-term conditions.

Dr Kelly-Ann Eastwood, joint senior author and honorary lecturer at Queen’s University Belfast and consultant obstetrician at St Michael’s Hospital, Bristol NHS Foundation Trust, said the results “help define” the urgent clinical challenges facing women entering pregnancy with multiple long-term conditions and the clinicians caring for them across the UK.

“These findings highlight the pressing need to restructure existing maternity services to improve antenatal outcomes,” she added.

The authors cautioned that the study was observational and relied on routinely collected health records, meaning some conditions and outcomes may have been under-recorded, while residual confounding could not be excluded.

The researchers plan to examine birth and child outcomes and identify which combinations of long-term conditions carry the greatest risk.

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