So, the big medical/science news yesterday was that the FDA plans to remove the “black box warning” on estrogen products designed for hormone replacement therapy in menopausal women. This is a topic i happen to know a lot about, because i spent an enormous amount of time researching it when i entered menopause and was debating taking estrogen. (Spoiler alert: i decided to do it, and I’m still wearing an estrogen patch.)
Some details about the issues and the research
The back story is that doctors have long observed that women have lower cardio-pulmonary rush than men until they enter menopause, when the risks become about the same. So they speculated that estrogen was protective, and ran a big study where they gave estrogen to older women with heart disease to see if it helped. (Actually, it was a huge study and probably didn’t just include women with pre-existing heart disease, i forget, i did this research five years ago.) Anyway, not only did it not help, it actually increased the risks of blood clots and strokes, as well as the risk of breast cancer. The study was halted early, and the black box label was created.
But here’s the thing: Hormone replacement therapy isn’t usually prescribed to women in their sixties and seventies (the average age of women in the study was 63), it’s usually prescribed around the time a woman enters menopause, which is typically around 50.
There were several good observational studies that had previously shown that women who took estrogen starting around menopause did well, and the estrogen was protective of overall health. And after the dust settled, it turned out that the data from that very study, a large, randomized, prospective study, found that when you stratified by age and years since onset of menopause younger women closer to menopause had a net health gain from HRT and older women had significant risks. It’s complicated, and estrogen increases the risk of breast cancer at all ages, but for younger women the total mortality of women taking estrogen was lower than for those not taking estrogen.
And there have been a lot of advances since that study was conducted. Women in that study took a funky version of estrogen purified from the urine of pregnant mares, and took it orally. Today most estrogen medications are estradiol, the version most prevalent in the blood stream, and it can be delivered via a patch or other routes that don’t get processed by the liver. This appears to mostly eliminate the risk of blood clots, as compared to oral premarin. And some estrogen products, like vaginal creams, are basically just topical, and have very little systemic impact. But they, too, carry a big scary warning.
And i left out some important stuff about progesterone and uterine cancer that you ought to understand if you are considering hormone replacement therapy, but it’s not really relevant to this announcement.
Anyway, based on modern understanding of the risks and benefits of hormone replacement therapy, women at high risk of breast cancer, and with certain other conditions, shouldn’t take it. And women who are over 60 and more than ten years past menopause shouldn’t start taking it systemically. Younger women with menopausal symptoms who aren’t at high risk of breast cancer generally can take it safely. And even older women suffering from vaginal dryness or urinary incontinence can probably use a topical estrogen product. Whether the overall risk is enough to justify a black box warning is a judgement call. But here are four articles about the FDA announcement:
FDA to lift warnings on menopause hormone therapy, potentially boosting access
https://www.washingtonpost.com/health/2025/11/10/hormone-replacement-therapy-menopause-warning-lift/
6 questions to ask about hormone therapy for menopause 6 questions to ask about hormone therapy for menopause : NPR
The NYT article opens by citing the big study that found estrogen use to be risky. Then it cited a single doctor, with the language “Dr. Makary, long a champion of the treatment, asserted”. All the arguments in favor of dropping the warning are attributed to him, and it also warns “Critics opposed to removing the warning, the strongest kind the F.D.A. issues, had urged Dr. Makary to convene a scientific advisory panel to carry out a careful assessment of the evidence before making any changes to the label.” It sounds like he’s some maverick ignoring medical evidence.
The other three are much more balanced. The WSJ one is shortest, also citing Dr. Makary, but adding "Makary cited several studies that showed some health benefits associated with the drugs, including reducing the risk of heart disease and slowing cognitive decline. "
The WaPo article is long and detailed, giving a lot of background, citing multiple doctors and referencing various studies, and also explains the politics of the decision and why it is controversial. They may have lost a large fraction of their their journalists, but they still have some excellent science journalists on staff.
The NPR article (there was a slightly different version over the air, but it’s in the middle of a longer news hour, and this seemed more accessible to a message board) mentions the FDA change, and then launches into a pretty good discussion of the risks and benefits of hormone replacement therapy, and the alternatives.
So, IMHO, the NYT article stands alone as being misleading and fear-mongering. And this isn’t a unique occurrence. I can’t imagine i can find it now, but during the covid pandemic, they published a graph showing a huge spike in risk for people aged ~30. But… The risk they were showing was something like the % increase in mortality. And people that age have a very low overall mortality, so the fact that their risk of death had increased (on as percentage basis) more than for people of other ages was basically meaningless. Someone took all the data (and i believe that the data was accurate) and massaged it every which way until they were able to produce a graph that looked like it said something scary about young adults. Damn it, there were plenty of real things to be scared of about covid, we didn’t need fake stuff muddying the waters.
And they frequently start graphs above zero so as to exaggerate the visual impact of a small change. (At least, when i objected to doing that at work, my boss described it as “the NYT style”, as he advocate for doing it.)
And they rarely actually link to studies, making it harder to track down the original. And I’ve seen them conflate correlation with causation too often.
Anyway, i distrust New York Times science reporting, and recommend that you do so, too.