FDA Commissioner Marty Makary has acknowledged what he termed “possibly one of the greatest medical errors of modern times”: 23-year-old black-box warnings on hormone therapy that coincided with an estimated 91,000 premature deaths and the withdrawal of treatment from nearly 50 million women. How did a single flawed study, testing one formulation in women with a mean age of 63, produce class-wide contraindications that endured for more than two decades despite mounting contradictory evidence?

This manuscript traces how statistical framing amplified relative risk while obscuring absolute benefit, how regulatory structures favored restriction over reassessment, and how cognitive bias transformed caution into paralysis. Contemporary data now show that appropriately timed hormone therapy reduces fatal cardiovascular events by 25–50%,  cognitive decline by 64%, Alzheimer’s disease by 35%, and fractures by up to 60%.

Beyond diagnosis, the paper proposes five mandatory regulatory reforms, because when evidence shows policy causes harm, correction becomes an ethical obligation, not an academic exercise.