We all stood by and watched the figures from the famous 2002 Women’s Health Initiative study prove, categorically, that artificial hormone replacement therapy was dangerous and led to excess incidence of breast and other cancers, AND increased death and morbidity from cardiovascular disease CHD (strokes, pulmonary embolism from clots, etc.)
Good job. No arguing. Doctors like me were not surprised at the finding, given that the patients studied were asked to take a mixture of equine estrogens (extracted from horse urine) and synthetic progestins (fake progesterone). Pharma shills and underperforming doctors have always argued that these fake hormones are exactly the same as Mother Nature’s version!
But it is not so.
The women taking the active drug combination were being hurt. On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic made it clear that the risks exceeded any potential benefits.
In more precise wording, the researchers stated: The risk-benefit profile found in this trial is not consistent with the requirements for a viable intervention for primary prevention of chronic diseases, and the results indicate that this regimen should not be initiated or continued for primary prevention of CHD (coronary heart disease).
In other words even the trial was dangerous and too many women were being hurt by the hormone combo, so any further investigation was stopped. The findings were quite clear and you can read them here, published in JAMA:
https://jamanetwork.com/journals/jama/fullarticle/195120
It’s all very obvious and straightforward. The FDA issued warnings, Big Pharma howled with protest that the game was rigged (obviously) and, in due course, the dangers of these drugs were added to black box warnings in the package insert.
I remember watching with relief as prescribing of these drugs fell and fell and fell, BECAUSE WOMEN REFUSED TO TAKE THE MEDICATIONS. They were rightly frightened of blood clots, breast cancer and other complications, which had been deliberately played down.
Prescriptions dropped from 22.4 million prior to publication of the study, to 15 million at the beginning of 2003 (32% decline) and eventually down to 12.7 million by the end of 2003 (nearly halved).
This decline was particularly dramatic for Prempro (combination conjugated equine estrogen + medroxyprogesterone acetate, exactly as used in the trial), which fell by 80% by the end of 2003.
This HRT reduction persisted over the long term, changing clinical practice and lowering hormone therapy prevalence among menopausal women.
And you know what? There was a sharp drop in deaths due to breast cancers in women the following year!
[https://www.nejm.org/doi/full/10.1056/NEJMsr070105]
Hooray!
So you can imagine my surprise when the FDA walked back on all this. The FDA in late February approved label changes for six hormone replacement therapies (HRTs) that remove boxed warnings for cardiovascular disease, breast cancer, and probable dementia.
One way or another, you’ve got to admit the FDA are stupid or crooked: either they were wrong to say there was a problem and there wasn’t, or there is a problem and they are wrong to say there isn’t!
[Never mind the science, which shows conclusively there IS a problem]
Notwithstanding, following what they claim was a comprehensive literature review (they always say that and it’s meaningless), the agency initiated the process for the labelling change in November 2025.
The FDA has received criticism for how it approached the change. Over the last year, the agency has convened fewer advisory committee meetings while holding a handful of what critics call “look-alike” panels. In this case, rather than convene a typical advisory committee of thoroughly vetted experts, Commissioner Marty Makary, MD, MPH, handpicked a panel of experts who largely already agreed on removing the boxed warnings.
These panels have been criticized a being improper, unbalanced and possibly even illegal.
“The public needs to understand that these are not true advisory committees like the FDA has held in the past,” C. Joseph Ross Daval, JD, and Aaron Kesselheim, MD, JD, MPH, both of Brigham and Women’s Hospital and Harvard Medical School in Boston, told MedPage Today in an email. “True advisory committees make recommendations the FDA doesn’t know in advance. Sometimes FDA overrules them, which can be controversial. The system isn’t perfect, but on balance it works pretty well. It promotes transparency and accountability. These expert panels offer none of that.”
It appears that expert panels may be failing to meet requirements of the Federal Advisory Committee Act (FACA), such as opening meetings to the public, publishing relevant documents, and announcing meetings in advance, Daval and Kesselheim noted. FACA also contains language aimed at ensuring that committee membership is fairly balanced and that advice “will not be inappropriately influenced by the appointing authority or by any special interest, but will instead be the result of the advisory committee’s independent judgment.”
[https://www.medpagetoday.com/washington-watch/fdageneral/119868]
What’s even more disturbing is that 29 drug companies have (so far) submitted proposed changes to HRT safety labelling at the FDA’s request!
I mean, what’s going on? Didn’t we all believe Makery was sympathetic to the MAHA cause? Now we should worry has he been “hacked” by Big Pharma. It’s an old story: the commissioner passes all sorts of bad judgements or even patently criminal approvals and then goes to a highly paid sinecure with one of the drug companies.
The move to ease the restrictions is apparently backed by the Menopause Society (TMS), which said the boxed warning “may have been a deterrent to the use of the low-dose vaginal estrogen, which is a safe and effective therapy for a condition that affects most menopausal women.”
But this is not about low dose vaginal estrogen; the concern is doctors going back to ladling out powerful and dangerous synthetic HRT. Out of 41 million eligible women ages 46 to 65, only an estimated 2 million received an HRT prescription in 2020, according to the FDA. Big Pharma obviously wants its profits back. They don’t waste money on research; they spend it on bribes to get what they want.
So the FDA produced a wimpy excuse:
“Today’s action will allow women, working with their healthcare professionals, to make better-informed decisions about their treatment plan for menopause symptoms.” Which is a bald manipulative lie; women are now less well-informed, by deliberate intention.
Oh yes, the warnings will still appear in the drug’s labeling, but lower down in the prescribing information where they probably won’t be seen!
What’s Better?
Bioidentical hormones, of course. That means hormones which are EXACTLY what your body secretes, nothing tricky, no added side chains, and NOT patented. There are lots of people swimming in the market and trying to sell you “bioidenticals”!
But a better idea, in my view, is my own “HRT” – herbal remedy from Thailand! (joke)
It’s called Pueraria mirifica. Mirifica means miracle, and it is! On Vivien’s suggestion I labelled ours as “PurificaTM” (very clever Viv) and you can check it out here.
To your good sense and good health,
Prof. Keith Scott-Mumby
The Alternative Doctor
