On November 10, 2025, the United States Food and Drug Administration quietly did something it almost never does: it reversed itself.
The FDA announced the removal of what it described as “misleading warnings” on hormone replacement therapy, stating in language that should be read carefully by every woman over forty in this country that “estrogen is a key hormone for women’s health where every single part of a woman’s body depends on estrogen to operate at its best — including the brain, bones, heart, and muscles.”
That sentence took twenty-three years to come out of a federal regulatory agency. Those twenty-three years have a body count — not of deaths from hormone therapy, but of preventable fractures, preventable cardiovascular events, preventable cognitive decline, and an incalculable accumulation of unnecessary suffering by women who were told, on the authority of science, to stop their treatment. Or to never start it.
The story of how this happened is the kind of story this publication exists to tell. It involves a landmark study whose design was unsuited to the question it was used to answer, relative risk inflation dressed up as settled science, a medical establishment that moved faster to alarm than to correct, and a generation of women who paid the cost. (See link for article)
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**Comment**
Hormones are huge. Huge.
Besides helping virtually everything physiologically, they are also drivers of behavior (or lack thereof). However, due to all the xenoestrogens in plastics, pesticides, and personal care products, our society is typically estrogen high – and the wrong, synthetic form at that, disrupting hormonal balance and affecting health negatively. Just watch a film made in the 70’s or 80’s and then compare the bodies in it to the average population now.
BTW: I’m not a fan at all of equine estrogen due to the horrible way it is made, and I’m not a big fan of synthetic hormones created in a lab often from animal sources (unless for rare special circumstances). In my opinion, bioidentical hormones that are chemically identical to the hormones naturally produced in the human body are more bioavailable as well as safer.
The sad truth is that the Women’s Health Initiative (WHI) was stopped early due to a small but statistically significant increase in breast cancer, cardiovascular events, and stroke in the hormone group compared to the placebo group. From that point on, hormones were branded as killers and avoided like the plague by mainstream doctors.
Weiler points out the following problems with the study:
- the average age of participants in the trial was 63
- many had pre-existing cardiovascular risk
- many were put on hormone therapy for the first time years AFTER their estrogen collapsed
Further, there’s the sticky problem of absolute risk – a problem discussed regarding the COVID jabs as well, and a widely used technique to get a study to say what you want it to say.
The absolute risk increase for breast cancer in the combined hormone group — the number that actually describes what happened to real women in real terms — was approximately eight additional cases per ten thousand women per year, compared to placebo. That is a relative risk increase that translates, in absolute terms, to a risk that is smaller than the baseline absolute risk increase associated with drinking one alcoholic beverage per day, or with being sedentary, or with being obese.
Weiler further adds that while breast cancer is devastating and must be included in the conversation:
relative risk, stripped of its denominator, is a rhetorical instrument. When the baseline rate is small, a relative risk of 1.26 can be presented as a twenty-six percent increase in breast cancer — which is how it was widely framed — or as eight additional cases per ten thousand women per year in a specific, older population — which is what it actually meant. These are not equivalent framings. The first drives panic. The second permits informed decision-making.
The risks became headlines but the significant benefits in reduced hip fractures, colorectal cancer, and relief from vasomotor symptoms became the footnote. This is how you rig a study.
Researchers now understand that there is a critical window regarding HRT and the benefit-risk profile is different depending on when it is initiated.
I short, women who begin HRT within a ten year window of the onset of menopause (or before age 60) have cardiovascular outcomes that are neutral to favorable. Women who start HRT a decade or more after menopause show a less favorable profile because the vascular and neural adaptation to estrogen withdrawal have already occurred.
Who benefits from this travesty?
Big Pharma of course
Women who stopped taking HRT switched over to individual pharmacological agents targeting individual symptoms – and there’s a bevy of them! Since the systemic solution of hormone therapy that would have solved all the symptoms was maligned, Big Pharma now had a collection of targeted interventions bringing in separate revenue streams!
Weiler then drives the message home by showing the HRT saga is not an isolated event but a documented pattern of what happens when:
a large, expensive, federally funded study conducted on a population that does not match the clinical target using a formulation or intervention that does not match the clinical practice being evaluated, producing findings that are communicated in relative rather than absolute terms, and whose findings are translated into guidelines and clinical practice with a speed and thoroughness that is never matched by the subsequent corrections.
And this, right here, is why I’m against ANY large, expensive, federally funded study for Lyme disease – and for the same reasons.
The WHI results changed clinical practice within months but took a decade and a half to change – yet, are still not uniformly reflected in practice.
For more:
Madison Area Lyme Support Group 