By Maryanne Demasi at Brownstone dot org.
On July 15, the FDA convened a two-hour expert panel to review its longstanding guidance on hormone replacement therapy (HRT) for menopause.
At first glance, it appeared to be a genuine opportunity to revisit the legacy of the landmark Women's Health Initiative (WHI), engage with clinical experts, and improve public messaging around hormone treatment.
But beneath the surface, the event raised uncomfortable questions. There was no dissent. The risks of HRT were downplayed, and women were left with the impression that they were jeopardising their health by not taking it.
What unfolded was a lineup of pro-HRT advocates, many with industry ties, in what often felt more like a public relations campaign than a balanced scientific discussion.
Selling the Benefits
FDA Commissioner Dr Marty Makary opened the session with several bold claims.
Hormone therapy, he asserted, could reduce cognitive decline by up to 64%, cut bone fractures by 50%, and lower the risk of heart disease - the leading cause of death in women - by 25%.
"Better than a statin," he said.
Makary went further, claiming there was no other medication in the history of modern medicine that could improve women's health on a population level more than HRT "if started within 10 years of the onset of menopause."
He lamented that too many women remained unaware of newer data reanalysing the WHI and suggested that outdated fears had left them suffering in silence.
"We've failed them," he said.
From the outset, Makary set the tone. The WHI had, in his view, cast a dark shadow, discouraging doctors from prescribing HRT and leaving women confused or untreated.
Speaker after speaker echoed this sentiment. The WHI was described as a catastrophic misstep that had misled millions - "the day the music died," as one expert put it.
Panelists portrayed the study as a rupture in women's health education. They argued the WHI had studied the "wrong women" - too old, too far past menopause, unrepresentative of those typically seeking relief - and used the "wrong type of oestrogen."
Its findings, they said, were overstated, misleading, and plain wrong.
The result?
Millions of women flushing their HRT down the toilet.
Some panellists made extraordinary claims. One doctor said a patient on testosterone therapy had experienced improved mathematical abilities, and described another who was able to recall a foreign language learned in childhood.
Oestrogen was described in near-miraculous terms - preserving bone density, boosting cognition, enhancing mood and sexual function, staving off ageing, and protecting the heart.
Declining levels of oestrogen were framed as a medical emergency. One that, if left untreated, would rob women of vitality, resilience, and longevity.
Several speakers advocated for starting HRT "at least 10 years" before menopause - even in women without hot flushes, mood changes, or sleep disturbances.
What Was Missing?
Absent from this enthusiasm was meaningful engagement with the potential harms. The WHI, published in 2002, remains one of the most rigorous, publicly funded randomised trials ever conducted on hormone therapy.
Involving more than 160,000 postmenopausal women, it was funded by the National Institutes of Health to examine whether hormone therapy could prevent chronic disease.
At the time, it linked oestrogen-progestin therapy to increased risks of breast cancer, stroke, and cardiovascular events.
These findings weren't outliers.
The Heart and Estrogen/Progestin Replacement Study (HERS), published several years earlier, also found that hormone therapy failed to reduce cardiovascular events - and increased the risk in the first year of use.
Then came the UK's Million Women Study - a prospective cohort involving more than a million participants - which found that combined oestrogen-progestin therapy significantly increased the risk of breast cancer.
Despite their size and scientific weight, these studies were scarcely menti...