The Biggest Medical Mea Culpa In Modern History
After two decades of fear and confusion, the FDA has officially removed its black box warning on hormone replacement therapy for menopausal women. The decision follows new evidence showing that estrogen, when used appropriately, does not increase breast cancer mortality. For millions of women, it’s the long-overdue correction of a narrative that never should have happened.
Dr Peter Attia's Powerful Words — The Lost Generation Of Women
Longevity physician Dr Peter Attia didn’t hold back when 60 Minutes host Norah O’Donnell asked him about the fallout from the original 1990s hormone therapy trial.
“An incredible mistake was made 25 years ago, and the amount of cognitive dissonance that is brewing and that has led to an inability for people to acknowledge those mistakes and to undo them has been glacial at its pace.
You’re talking about hormone replacement therapy for perimenopausal and menopausal women.
That’s correct. Where tens and tens of millions of women every year are not getting the treatment that they need.
You know, it’s hard to not sound hyperbolic when you talk about it, but if you’ve watched your mother and your mother-in-law and many of your patients go through this being a part of what I call the lost generation of women, the women that entered menopause at the turn of the century, it’s very hard not to be distraught, and it’s very hard not to argue that this is the greatest single failure of the modern medical system, the inability to treat women with hormone replacement therapy.
Look, you want to take the most charitable approach to interpreting the actions of others. I try to steel man as opposed to straw man cases. So they designed a trial in the ’90s to test a hypothesis, but they really, really screwed up the interpretation.
And even on the subsequent analyses, in other words, when you follow these women and repeated the analysis, estrogen given to women in this setting was not causing breast cancer, and yet the narrative just didn’t change.
And we’re actually seeing right now that the FDA is finally, after two decades, going to remove a black box warning to that effect.
And how important is hormone replacement therapy, specifically for women, going to extend not only lifespan but healthspan?
I think that’s the part that just gets missed, and I think that’s another great example of where Medicine 2.0 runs amok. I’ve had many debates with opponents of HRT, and they will go off in the weeds about, ‘Well, even if you concede that the benefits of HRT in terms of diabetes and colon cancer and heart disease, they’re not that big, and besides, you really have to be worried about this risk of breast cancer, etcetera, etcetera.’
But when you turn your attention to bone density, when you turn your attention to vasomotor symptoms, when you turn your attention to sexual side effects, they say, ‘Well, again, that doesn’t show up on lifespan, so we’re not really going to pay attention to those metrics,’ although many of those do.
For example, lower bone density dramatically factors into lifespan, because women are at an enormous risk for fractures if they fall, as are men, but women are disproportionately more so because of the estrogen deprivation.”
Attia’s words landed like a gut punch for anyone who has watched a mother, sister or friend suffer through avoidable symptoms because of outdated science. His take is clear, the real danger wasn’t estrogen, it was inertia.
Photo Credit: ITV News - Hormone replacement therapy products including Oestrogel, Evorel 25 and Sandrena estradiol gel - examples of transdermal estrogen treatments commonly prescribed for menopausal symptom relief.
Main Image Photo Credit: Images: 60 Minutes / CBS News; Robert F. Kennedy Jr. and Dr Marty McCary via Daily Express US - Robert F. Kennedy Jr. speaks alongside FDA Commissioner Dr Marty McCary, with Dr Peter Attia and journalist Norah O’Donnell appearing in 60 Minutes coverage on the FDA’s decision to remove the hormone-therapy black box warning.
Dr Marty McCary — The FDA Finally Admits It Got It Wrong
Then came the FDA Commissioner himself, Dr Marty McCary, confirming that the agency is formally erasing the warning label that kept millions of women from treatment. Speaking to CBS News, McCary described it as one of the most consequential corrections in modern medicine.
“I do think it’s one of the biggest mistakes in modern medicine.
That mistake, according to FDA Commissioner Dr. Marty McCary, is the conclusion from a government study more than 20 years ago that suggested hormone therapy leads to an increased risk of breast cancer.
There’s no statistical significance, and no subsequent clinical trial has ever shown an increase in breast cancer mortality. And look at the long-term health benefits, the reduction in cognitive decline, in heart attacks, in bone fractures, in other conditions, including cancer and diabetes that have been suggested in some studies.
First on CBS News, McCary, a former cancer surgeon at the Johns Hopkins School of Medicine, explains the FDA’s decision to remove the black box warning:
‘We now have a more nuanced understanding, and we want to put that fear machine in its proper context.’
In fact, you say hormone replacement therapy can be a breakthrough for women.
‘Arguably, with the exception of vaccines or antibiotics, there’s no medication that can improve the health of women on a population level more than hormone replacement therapy.’”
For once, the FDA isn’t playing defense. McCary’s statement signals a genuine pivot from fear to function; a long-overdue green light for evidence-based care.
Robert F Kennedy Jr — Restoring Trust In Women’s Health
The announcement was backed by US Health Secretary Robert F Kennedy Jr, who used his address to speak directly to women.
“For too long, women have been told to fear their biology. We’re turning that page. The science is clear... for women who are medically cleared and guided by their physicians, hormone therapy is not something to fear but a pathway to health and dignity. No woman should have to suffer in silence because of outdated warnings or institutional inertia.”
For women who have been dismissed, gaslit or told to “just push through it,” this moment feels like long-delayed validation.
Who Needs To Be Cautious
While this marks a huge win for women’s health, HRT is still a prescription therapy that must be approved and monitored by a qualified doctor.
You should proceed with caution or consider non-hormonal options if you have:
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Fibroadenomas, fibroids or other hormone-sensitive conditions
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A personal or family history of breast or ovarian cancer
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Untested genetic risk such as a possible BRCA1 or BRCA2 mutation
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Unexplained breast lumps or abnormal imaging
Get tested, get cleared, then move forward with confidence. BRCA screening and a full breast and pelvic review are essential before starting HRT. For women who are cleared, discuss delivery options such as transdermal patches and localised estrogen often have lower systemic risk.
Find A Functional And Integrative Clinic
If you’re ready to explore your options, talk to a practitioner who actually understands hormones.
Visit the Functional & Integrative Clinics Directory to find doctor-led centres specialising in menopause, hormone balance and longevity medicine. Every listing is vetted, evidence-based and pro-woman.
