You Are Not Broken 344. BONUS Episode! Historic FDA Label Change!
Nov 11, 2025
In a groundbreaking discussion, Dr. Marty McCary, an FDA commissioner, and Dr. Rachel Rubin, a menopause and HRT expert, delve into the pivotal removal of boxed warnings on hormone replacement therapy (HRT). They unveil the positive implications for women's health, debunk myths that have caused unnecessary fear, and stress the long-term benefits of HRT, including reducing heart disease and osteoporosis risks. The conversation highlights the need for better clinician education and informed consent, empowering women to make knowledgeable health choices.
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Boxed Warning Misapplied To Different Estrogens
- The boxed warning reserved for life-threatening risks was misapplied to varied estrogen therapies, creating decades of fear.
- FDA reassessment removed misleading boxed warnings to align labels with evidence for different estrogen types.
Regulator Calls It A Major Medical Mistake
- Marty McCary called the WHI-driven fear a major modern-medicine mistake that denied 50–70 million women benefits.
- He described it as possibly one of the greatest screw-ups of modern medicine in recent time.
WHI Cohort And Formulation Differences Matter
- The WHI trial studied older women using different formulations and dosages than modern estradiol therapies.
- Applying WHI results to current transdermal, oral and vaginal estradiol was comparing apples to oranges.
