Podcast Summary: The Neuro Experience

Episode: The FDA Just Removed a 22-Year-Old Warning | ft. Dr. Mary Claire Haver

Host: Louisa Nicola & Pursuit Network

Guest: Dr. Mary Claire Haver (Board Certified OBGYN, Menopause Society Certified Practitioner)

Date: November 18, 2025

Overview

This episode unpacks the recent FDA decision to remove a 22-year-old black box warning from local vaginal estrogen products, exploring its impact on menopause care, the persistent knowledge gaps in medical education, and the social, psychological, and neurological aspects of hormone replacement therapy (HRT). Dr. Mary Claire Haver, a leading menopause expert, joins Louisa Nicola to discuss historical context, patient and clinician confusion, evolving research on HRT and dementia, and how culture and misinformation shape women’s health.

Key Discussion Points & Insights

1. FDA Removes the Black Box Warning

• Significance: The FDA’s move aims to reduce fear and misinformation surrounding hormone therapy, especially estrogen, for menopausal symptoms.
  • “It is gonna take away some of the fear and the panic that has been associated with hormone replacement therapy.” – Dr. Haver [00:04]
  • The warning label scared approximately a third of women away from using the medication, despite its localized use and lack of evidence for serious risks. [02:03–03:13]
• Context: Before the 2002 Women’s Health Initiative (WHI) study, there was no black box warning for estrogen.
  • “Black box warnings are meant for dangerous products like cigarettes... This isn't cyanide, this is estrogen.” – Dr. Haver [00:45, 03:18]

2. Divided Medical Community

• There’s a generational divide among clinicians regarding menopause care and HRT:
  • Doctors trained before 2002 routinely prescribed HRT; those trained after are much more hesitant due to the WHI’s impact.
  • “That one study really defined their understanding of menopause and what we could do for a woman.” – Dr. Haver [00:15, 05:57]
• Menopause care remains a minor part of OB/GYN training and certification, leaving many practitioners ill-equipped. [05:57]

3. Underutilization of HRT

• Only about 4–8% of eligible women use FDA-approved or compounded HRT products—dramatically less than might benefit.
  • “Well less than 10% of women who are eligible.” – Dr. Haver [03:40]

4. Anecdotes and Gender Bias in Medical Training

• Women’s menopausal symptoms have often been dismissed historically as psychological or insignificant.
  • Dr. Haver recounts being taught to categorize complex female symptoms as “whining women” (WW):
    • “If you can't figure out what's going on with her, it might be in her head.” – Dr. Haver [08:17, 10:14]

5. Research Gaps & SSRIs

• No large-scale clinical studies have focused exclusively on perimenopause treatments. [01:05, 11:02]
• Instead, the default intervention has been the prescription of SSRIs and antidepressants, which spike in use during menopause.
  • “The average prescription practices are about 10% of women are on an SSRI or one of the antidepressants right across the menopause transition. That doubles to 20%... by the time you're 65, it goes up to 25%...” – Dr. Haver [13:33]

6. Symptoms and Diagnosis of Perimenopause

• First and most universal symptom: “I just don’t feel like myself.” [15:33]
• Other common symptoms: brain fog, cognitive decline, insomnia, word-finding difficulties, loss of resilience, diminished alcohol tolerance. [16:22]
• Diagnosis remains clinical, based on listening to women’s presentations rather than objective laboratory findings.

7. Critical Window/The Timing Hypothesis

• Starting HRT within ten years of menopause or before age 60 provides the clearest evidence of benefit, particularly for heart health and potentially lower all-cause mortality.
  • “Before the age of 60 or within 10 years...the benefits outweighed the risks...” – Dr. Haver [17:35]
• Most research (especially WHI) used older women and outdated formulations (Premarin), which clouds present recommendations. There’s a need for modern RCTs; however, lack of financial incentives hinders this progress. [17:04–19:47]

8. HRT and Disease Prevention

• Undisputed benefit is osteoporosis prevention: “We can prevent her about 50% chance of having an osteoporotic fracture.” – Dr. Haver [20:25]
• The link between HRT, dementia, and Alzheimer’s is still being researched; evidence is promising but inconclusive.
  • Host Louisa notes: “Are we seeing that hormone replacement therapy is actually the cause of lower dementia incidence, or is it the...vasomotor symptoms that’s helping?” [21:11]

9. Estrogen, Brain Metabolism, and Brain Fog

• Estrogen directly influences brain glucose metabolism; its absence can trigger the brain to use myelin as fuel (catabolize), leading to potential cognitive effects.
  • “The estrogen receptor can't shuttle in glucose...so the brain cell...starts to catabolize the myelin sheath in order to produce ketone bodies.” – Louisa Nicola [28:25]
• The hormonal chaos of perimenopause is a key driver of cognitive complaints, especially among high-performing women.
  • “It's Perry where we see the biggest drama.” – Dr. Haver [32:25]

10. Social Factors and Stigma

• Misinformation and stigma lead many women to reject HRT out of fear of breast cancer, though modern evidence suggests estrogen-alone HRT may actually lower risk in some cases.
  • “Women on estrogen only from the WHI had a 30% decrease relative risk of breast cancer versus placebo.” – Dr. Haver [33:30]
• Many women quit their jobs or struggle at work due to untreated cognitive symptoms of menopause; sometimes, menopause prompts empowerment and positive life changes. [35:44-39:54]

11. Modern Trends: Vaginal Estrogen, Rejuvenation, and Wellness Hype

• Local vaginal estrogen is safe and critically important to genital/urinary health, yet woefully underused due to misunderstanding.
  • “All vaginas need estrogen, all of them, and it's healthier with it.” – Dr. Haver [43:00]
• Trendy treatments (PRP, NAD, red light therapy) often have little evidence for efficacy in menopause compared to basics: sleep, diet, exercise, stress management.

12. Lifestyle vs. HRT

• HRT is not for everyone, and the decision must be made based on accurate information, not fear.
  • “Is this a decision based on facts and not fear?” – Dr. Haver [44:10]

13. Knowledge Gaps, Politics & Moving Forward

• “Women's healthcare is political because it has to be.” – Louisa Nicola [46:25]
• Future: Dr. Haver is optimistic that younger generations will be better informed and empowered to navigate menopause proactively. [49:01]
  • “The boomers are pissed. The Gen Xers are not standing for this. The millennials […] are wanting to get ahead of it.”

Notable Quotes & Memorable Moments

• “All vaginas need estrogen.” – Dr. Haver [01:33, 43:00]
• “Black box warnings are meant for dangerous products like cigarettes. This isn't cyanide, this is estrogen.” – Dr. Haver [00:45, 03:18]
• “There’s not been a single clinical study, large scale, on the treatment of perimenopause.” – Dr. Haver [01:05]
• “If you can't figure out what's going on with her, it might be in her head.” – Dr. Haver, relaying dated medical advice [08:17]
• “It's becoming part of their vocabulary. They're learning, they're not afraid. They are wanting to get ahead of it.” – Dr. Haver, on young women and menopause [49:01]
• “Not all my patients choose hormone therapy.” – Dr. Haver [44:10]

Timestamps for Important Segments

• [00:04] – Significance of removing the FDA black box warning
• [03:13] – Fear and discontinuation of HRT due to the warning
• [05:57] – Medical education gaps and generational practice differences
• [08:17-10:14] – Gender bias and “the whining woman” stereotype
• [11:02-13:33] – Lack of perimenopause research & rise in SSRI use
• [15:33-16:22] – “I just don’t feel like myself” and constellation of symptoms
• [17:04] – Women’s Health Initiative and the "timing" hypothesis
• [19:47] – Barriers to new RCTs, funding gaps
• [20:25] – HRT for osteoporosis prevention
• [21:11] – Uncertain link between HRT and dementia risk
• [28:25] – Estrogen, brain energy, and myelin catabolism
• [32:25] – Hormonal chaos of perimenopause
• [33:30] – HRT and breast cancer risk myths
• [35:44-39:54] – Cognitive fallout: job performance, divorce, empowerment
• [43:00] – “All vaginas need estrogen” and modern misconceptions
• [44:10] – Lifestyle interventions & patient autonomy
• [49:01] – The cultural shift and optimism for the next decade

Tone & Flow

The conversation is candid, evidence-focused, and as practical as it is hopeful. Both host and guest use direct language, mix personal anecdotes with scientific context, and address stigma and structural issues head-on. The tone combines professional authority, empathy for patient experiences, and a sense of humor (“bitches be crazy”, “whining woman”, “fluffy vaginas,” the “We Do Not Care Club”).

Summary Conclusion

This episode clarifies the roots and repercussions of the FDA’s black box warning on vaginal estrogen, the generational divide in menopause care, and the urgent need for better research, medical training, and patient education. Dr. Haver and Louisa Nicola call for nuanced, patient-centered discussions about HRT, broader awareness of menopause’s neurological dimensions, and a focus on both evidence-based basics and empowering women to make informed choices—setting the stage for a new era in women’s midlife health.