(120) Beyond the Black Box: How Evidence and Advocacy Reframed Menopause Hormone Therapy

Abstract Introduction In 2002, the Women’s Health Initiative (WHI) research study dramatically changed the landscape of menopause hormone therapy (MHT). Although the study evaluated systemic estrogen-progestin therapy, its findings were broadly applied to all formulations of hormone therapy, including transdermal and vaginal preparations. This led to widespread fear among clinicians and patients, effectively halting access to MHT prescriptions nationwide. In 2003, the FDA issued a so-called “black box warning” on MHT, the most serious of all prescription drug warnings, stating that estrogen-containing hormone therapies lead to an increased risk of heart attack, stroke, and breast cancer in some women. Objective To outline the key scientific, clinical, and advocacy milestones that led to the FDA’s expert panel and removal of the boxed warning on MHT products. Methods We developed a timeline summarizing pivotal research, professional society statements, and advocacy efforts from 2002 to 2025. Key sources of information include position statements from the North American Menopause Society (NAMS), ISSWSH, and the American College of Obstetricians and Gynecologists, along with peer-reviewed evidence on the safety and efficacy of MHT products, and advocacy groups such as Let’s Talk Menopause. Results Over two decades, mounting evidence has increasingly demonstrated that MHT is a safe and effective therapy for many perimenopausal and menopausal women. In parallel, advocacy groups and multidisciplinary experts worked to translate this evidence into public awareness chiefly via social media. The unified stance of major medical societies and sustained advocacy efforts ultimately led to policy change, with the FDA’s expert advisory panel and subsequent removal of the boxed warning. Conclusions The journey from the WHI to the FDA illustrates the power of evidence-based advocacy. It demonstrates persistence, collaboration and clear communication to correct long-standing misconceptions. The effect of social media on advocacy efforts and policy change was paramount to the restoration of equitable and effective menopause healthcare. Disclosure No.