In a quiet but consequential gathering, U.S. health regulators reconvened a long-dormant debate this Thursday that may reshape how millions of women navigate menopause. The subject: Hormone Replacement Therapy (HRT), a treatment once widely prescribed to ease the often-disruptive effects of menopause, but which has since become a lightning rod in modern medicine.
At the heart of the discussion lies a paradox — a treatment both hailed as liberating and vilified as dangerous.
HRT, designed to replenish estrogen lost after menopause, was once a near-standard offering to women experiencing symptoms like hot flashes, sleep disruption, and vaginal discomfort. Yet its reputation was dramatically altered in the early 2000s, when the Women’s Health Initiative — a landmark clinical trial — triggered alarm bells by linking the therapy to higher rates of stroke and breast cancer. Prescription rates collapsed in the aftermath.
More than two decades later, the federal government is now reconsidering whether those fears were overstated, and whether the pendulum has swung too far in the other direction — depriving women of a potentially valuable tool.
FDA Commissioner Dr. Marty Makary, a long-time proponent of re-evaluating HRT, called this week’s expert panel to reexamine what he claims is an outdated narrative. “We’ve let one trial silence decades of clinical experience,” Makary said ahead of the meeting. “What we’re discussing isn’t whether HRT is risk-free — it’s whether we’ve let fear outpace evidence.”
Makary and others argue that newer research, particularly when the therapy is started earlier in the menopausal transition, suggests potential protective effects — against osteoporosis, cognitive decline, and even heart disease. These benefits, they say, have been buried under the weight of legacy stigma.
Still, not everyone is convinced. The American Journal of Physicians this week published a counterpoint, warning that recent re-analyses do not erase longstanding concerns. “Menopause isn’t a pathology — it’s a stage of life,” the editorial noted. “Medicalising it risks turning a natural process into a pharmaceutical opportunity.”
The FDA’s own labels remain firm in warning of serious risks: endometrial cancer, breast cancer, and potentially fatal blood clots among them. Delivery methods for HRT — whether oral, transdermal, or vaginal — may affect these risks, but clarity remains elusive.
