The FDA removed the black box warning on hormone replacement therapy for menopause, a change Dr. Haver and others had advocated for decades, citing overstated risks from the 2003 Women's Health Initiative study.
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Perimenopause, which can last up to 10 years, is finally getting research attention, with only 7,000 articles to date; Dr. Haver's upcoming book 'The New Perimenopause' aims to fill the gap, and she highlights a doubling of depression/anxiety rates during this transition.
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Workplaces are beginning to offer menopause benefits, and telemedicine companies are emerging to address the shortage of trained clinicians, especially in rural areas.
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Private funding, like Melinda French Gates' $100 million commitment, is stepping in where federal investment has stagnated for women's health.
Protocols
Concrete recipes — what, when, how much, and why
3 items
Hormone therapy for perimenopausal mental health
WhatConsider hormone therapy to stabilize mood and cognition during perimenopause before resorting to antidepressants or anti-anxiety medications.
WhenDuring perimenopause, especially when depression or anxiety symptoms emerge.
For whomWomen in perimenopause experiencing mood or cognitive symptoms.
WhyPerimenopause is associated with a doubling of depression and anxiety rates; stabilizing hormones can yield better cognitive and mental health outcomes than psychotropic medications alone.
CaveatsNot explicitly stated; should be done under medical supervision.
Dr. Haver notes that many perimenopausal women are misdiagnosed with primary psychological conditions and placed on antidepressants, when in fact hormonal fluctuation is the root cause. She cites emerging research showing that hormone stabilization can improve outcomes more effectively than starting with psych meds. This approach challenges standard practice but is gaining traction as the neuroprotective role of estrogen becomes clearer.
Mechanism
Estrogen receptors in the brain influence mood regulation; fluctuating and declining estrogen during perimenopause can destabilize neurotransmitter systems.
Personal experience
Dr. Haver states that in her practice treating only perimenopause and menopause patients, she observes these benefits firsthand.
By stabilizing their hormones through the transition, they are having better cognitive outcomes and better mental health outcomes than rather starting them with an antidepressant or anti-anxiety medication first.
Also said
“One of the biggest findings we see is a doubling in the depression and anxiety rates across perimenopause.”— Quantifies the mental health burden that the protocol addresses.
Vaginal estrogen for local menopause symptoms
WhatUse vaginal estrogen products for local genitourinary symptoms of menopause.
WhenWhen experiencing vaginal dryness, discomfort, or urinary symptoms due to menopause.
For whomWomen with local menopausal symptoms.
WhyVaginal estrogen is not systemically absorbed, so it carries minimal risk and should not have carried the black box warning.
Dr. Haver emphasizes that the black box warning was particularly unjustified for local estrogen because it does not enter the bloodstream in meaningful amounts. The removal of the warning should reassure women and clinicians about the safety of these products.
Mechanism
Acts locally on estrogen receptors in vaginal and urinary tissues without significant systemic absorption.
For vaginal estrogen, for local estrogen products, there should be no warnings whatsoever because it's not systemically absorbed.
Telemedicine for menopause care in underserved areas
WhatSeek out telemedicine companies that specialize in perimenopause and menopause care when local providers are scarce.
WhenWhen living in a rural or underserved area with limited access to trained menopause clinicians.
For whomWomen in perimenopause or menopause, especially in rural or underserved regions.
WhyThere is a nationwide shortage of providers educated in menopause care; telemedicine can bridge the gap.
Dr. Haver points out that even in major cities it's hard to find an educated provider, and in rural areas it's next to impossible. She sees telemedicine companies focused on menopause as a promising solution to expand access.
These telemedicine companies are being developed specifically to serve women in perimenopause and menopause, and I think that's going to go a long way to help women get the care that they need.
What's new
Personal practice updates, fresh positions, predictions
5 items
FDA removal of black box warning on hormone replacement therapy
The FDA removed the black box warning on HRT for menopause, stating benefits outweigh risks for most women. The warning was added in 2003 after the Women's Health Initiative study but was an overcall, especially for local vaginal estrogen.
Why this matters: This reverses a decades-long barrier to HRT prescribing, driven by advocacy and re-analysis of data showing the original warning overstated risks.
Background
The black box warning was added in 2003 due to the Women's Health Initiative study, which initially raised concerns about HRT risks. Over time, multiple factions of that study were walked back, but the warning remained until now.
Dr. Haver explains that the black box warning was an overcall, particularly for vaginal estrogen, which is not systemically absorbed and should have had no warnings. For systemic HRT, the labeling still includes risks and benefits, but the dramatic black box has been removed. She notes that advocates had been asking the FDA through multiple administrations to remove it, and the change finally happened this year. The removal is significant because it reduces fear-based avoidance of a therapy that can greatly improve quality of life for menopausal women.
The big black box warning, which was dramatically overstating concerns, has been removed.
Also said
“For vaginal estrogen, for local estrogen products, there should be no warnings whatsoever because it's not systemically absorbed.”— Highlights the specific case where the warning was most unjustified.
“When we look at the nuance of the actual data, having this black box warning was really an over call.”— Emphasizes that the decision was data-driven, not political.
Surge in perimenopause research and attention
Perimenopause is finally receiving research focus, with article counts surging, though still only ~7,000 compared to 98,000 on menopause. Dr. Haver is publishing a new book on perimenopause next year.
Why this matters: Perimenopause has been severely understudied; the recent increase signals a shift that could improve diagnosis and treatment for millions of women.
Background
Historically, menopause research centered on hot flashes, while perimenopause—the transition lasting up to 10 years—was largely ignored, leading to misdiagnosis and inappropriate treatments like antidepressants.
Dr. Haver contrasts the 1.2 million articles on pregnancy with only 7,000 on perimenopause, underscoring the research gap. She notes that she checks new publications daily and sees a surge, estimating the field is about three years behind the menopause conversation. A key finding is a doubling of depression and anxiety rates across perimenopause, and many women find that stabilizing hormones improves mental health outcomes more than starting psychotropic medications. This is driving a re-evaluation of standard care for midlife women.
Personal experience
Dr. Haver says, 'now that I just treat perimenopause and menopausal patients,' she sees these patterns clinically.
When you look at perimenopause, we only have about 7000 articles.
Also said
“One of the biggest findings we see is a doubling in the depression and anxiety rates across perimenopause.”— Provides a concrete statistic that underscores the mental health impact.
“By stabilizing their hormones through the transition, they are having better cognitive outcomes and better mental health outcomes than rather starting them with an antidepressant or anti-anxiety medication first.”— Challenges the common practice of prescribing antidepressants as first-line treatment.
Workplace menopause benefits
Large companies are beginning to add menopause benefits to employee care packages, including access to specialized care, time off, and resources.
Why this matters: This represents a cultural shift in recognizing menopause as a workplace issue that affects productivity and retention.
We're seeing large companies starting to add menopause benefits to their care packages.
Private funding for women's health innovation
Melinda French Gates committed $100 million to women's health innovation, and other private entities are stepping up as federal investment stagnates.
Why this matters: Highlights a shift toward private philanthropy filling the gap left by underfunded federal research on diseases that primarily affect women.
Background
A McKinsey report found that diseases mainly affecting women receive far less research funding than male-dominated diseases, and federal investment is stagnating.
Melinda French Gates committed $100 million to women's health innovation.
Also said
“A lot of private entities are stepping up to start to fund women's health, because when we have healthier women, we have a better population overall.”— Frames the investment as a societal good, not just a women's issue.
Shift in menopause research focus to cardiometabolic and neurologic impacts
Research has moved beyond hot flashes to investigate how estrogen loss affects cardiovascular disease, visceral fat, insulin resistance, bone loss, cognitive aging, and Alzheimer's risk, driven in part by women sharing symptoms on social media.
Why this matters: Broadens the understanding of menopause from a reproductive event to a whole-body transition with long-term health consequences.
Background
Previously, menopause research was narrowly focused on vasomotor symptoms. The discovery of estrogen receptors in every organ system has prompted a wider lens.
Dr. Haver explains that estrogen receptors exist in all organ systems, so the loss of estrogen at menopause affects the heart, brain, metabolism, and more. Social media has amplified patient-reported symptoms like frozen shoulder, palpitations, and tinnitus, which researchers are now investigating. This patient-driven data is helping to identify under-recognized manifestations of menopause and is spurring new studies.
There are estrogen receptors in every organ system of our body. And all of these organ systems are affected.
Also said
“The discussion around frozen shoulder, the discussion around palpitations, the discussions around having tinnitus or ringing in the ears really has led a lot of researchers to say, hey, let's dig into the research.”— Shows how patient advocacy on social media is directly influencing research agendas.
Recommendations
Products, supplements, and tools mentioned in the episode
1 item
Telemedicine companies specializing in perimenopause and menopause care
Service
Emerging services designed to provide accessible, expert menopause care, particularly for women in areas with few trained clinicians.
These telemedicine companies are being developed specifically to serve women in perimenopause and menopause.
Lines worth pulling out — contrarian, specific, or perfectly phrased
6 items
Women are owed centuries of research in diseases that primarily affect women.
A powerful, memorable indictment of the historical underfunding of women's health, quoted from Dr. Lisa Mosconi.
The big black box warning, which was dramatically overstating concerns, has been removed.
Succinctly captures the significance of the FDA's decision and the advocacy behind it.
When you look at perimenopause, we only have about 7000 articles.
Starkly illustrates the research gap compared to pregnancy (1.2 million articles).
One of the biggest findings we see is a doubling in the depression and anxiety rates across perimenopause.
A specific, alarming statistic that underscores the mental health toll of the transition.
By stabilizing their hormones through the transition, they are having better cognitive outcomes and better mental health outcomes than rather starting them with an antidepressant or anti-anxiety medication first.
Challenges the standard of care and offers a hormone-first alternative for mental health in midlife women.
There are estrogen receptors in every organ system of our body. And all of these organ systems are affected.
Explains why menopause is a whole-body event, not just a reproductive one, and justifies the broad research agenda.
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Educational summary of the cited expert source — not medical advice. Open the source recording linked above and consult a qualified physician before acting on any protocol.