Study note 1
Video Link DA Expert Panel on Menopause and Hormone Replacement Therapy for Women https://www.fda.gov/patients/fda-expert-panels/fda-expert-panel-menopause-and-hormone-replacement-therapy-women-07172025
I have recently posted two articles about the female sex hormone, primarily referred to estrogen. The new FDA administration has taken action to remove the labeled warning of exaggerated risks on estrogen medicines. This warning has frighten millions of women away from estrogen hormone therapy for the past 23 years. As I turned my attention to male sex hormone therapy, which is, equally a fascinating story, I came across the video recording of FDA Panel Experts on Hormone Therapy for postmenopausal Women. On July 17, 2025, FDA convened the national top experts in estrogen hormone for women’s health, to form a panel, discussing their views on issues of the policy regulations on female hormones. Those panelists are all titanic figures in this field. In the meeting, those physicians, professors had 5 minute to present their insight views and advises for FDA. The oceans of knowledges from their lifetime research, and experiences of treating patients had to be distilled into the insightful extracts. As so, their views presented in meeting are undoubtedly “cream of the crop”. After watching the video recording a few times, felt compelled to share their views with friends,” ladies and gentlemen who love their ladies”, a quote from a panelist.
Speaking to the government policy regulators, they criticized the established regulation. Labeling the exaggerated warning have made physicians unwilling to treat their patients with estrogen hormone therapy, so that “actually harm their patients under the name of protecting women!”. Their pinpointed what barriers for treatments have been, and called on the removals, so millions of women will not suffer bone fracture, heart attack , stroke and other diseases.
Speaking to physician audience, they gave instrumental treatment advises, such as who should receive the hormone therapy, what type of hormone formulation, the protocol of treatment.
Speaking to the patient audience, they suggested that patients have to take initiative in learning , and discussing the information to their physicians. In the consideration for the hormone treatment, ladies need to be “self- dependent” one panelist put it, seeking helps from physicians. It is because their physicians may still be hesitated, or willing to adapt estrogen hormone therapy, due to the risk warnings which had been posted for past 23 years, even though the risks have been proved false. Ladies should not wait on sideline, because there is the age window of 50 to 59 for the health benefits of this hormone therapy. Passing this age window, no benefits have been observed.
The fear of the risks of estrogen therapy have lingered in people’s mind for those years, it is just not easy to overcome. In the past, I have been told by pharmacy consultation courses to recommend fluoxetine or other SSRI antidepression drugs for women having postmenopausal symptoms, rather than estrogen. Such a recommendation has been unambiguously criticized by experts in the meeting. The sharp turn is 180 degree. Even after FDA has removed the black boxed warning in November 2025, people are still in doubts. The flip-flop change of regulatory stance of FDA leads to a simple question — “Are you sure?”. For medical professionals, studying the speeches of those experts helps tremendously in gaining confidence on this therapy. After learning about the huge health benefits of this therapy, ladies will still be uncertain with many questions. Most of their questions should have answers found in the speeches from the experts.
I have the transcript of this meeting posted in this website, as well as the internet link for its FDA video recording. The transcript is lengthy, and a little nerdy. You would find the details with emotional stories, data interpretation and mind-enlightening explanations.
Naturally, we would have questions as follows:
In the past, we had been told that estrogen hormone therapy increased the life-threatening risks of heart attacks, strokes, breast cancer, Alzheimer’s disease. How can now all the risks be not only concluded faks, but all those risks can be reduced with this same therapy?
Everybody knows that breast cancer have been treated with medications lowering the body estrogen levels, because estrogen stimulates growth of breast cancer. Now you are telling me that estrogen therapy reduces the risk of breast cancer, you are telling that estrogen therapy reduces the mortality rate of breast cancer. All I thought about that it is like gas on fire when estrogen is placed on breast cancer. Make me believe you!
Why do women starting estrogen hormone therapy at ages between 50 and 59 or within 10 years of menopause can be benefited from this therapy, other women at older ages are not? What is your logic?
There are different types of female sex hormone, synthetic or natural of estrogen and progestin, in combination or just one hormone alone, do they all carry the same health benefits? Any of them can be safely used to benefit ladies age above 60?
There are pills, injectable, transdermal patches, topical cream, vaginal gels, which one should be better used? Why?
…..
The FDA panel experts answered those questions in their speeches at this meeting, although the answers may be incomplete because each speaker was allowed 5 minute limit to talk. It would be my intention, if I have a chance, to explain questions/answers in more details in my future blogs, based on what I have learnt from the experts’ presentations.
Dr. Marty Makary, FDA Commissioner:
Great, thank you Sara, it’s so good to be here.
It’s so good to see everybody. So great to meet all of these experts in person. I have read the work of so many of you, so thank you for being here and contributing. This is a very important issue. In the 1950s, researchers at the Mayo Clinic noticed that women who had their ovaries removed in their 20s all went on to have early heart disease, including a fatal heart attack. Let me start over again.
I don’t know if you had that. I don’t know if you could hear me in the back. In the 1950s, researchers at the Mayo Clinic looked at women who had their ovaries removed, and they noticed that they all went on to have early heart disease, including one woman, who had a fatal heart attack at age 28, suggesting a powerful and profound cardioprotective effect of estrogen made in the ovaries.
Other studies went on subsequently to show that when a woman starts estrogen or estrogen plus progesterone, within 10 years of the onset of menopause, there is somewhere between roughly a 25
and 50% reduction in fatal heart attacks and cardiovascular disease.
Now, just to put that in context, that is comparable to the risk reduction or greater than the risk reduction of a statin, heart disease is the number one cause of death in women.
And a 2015 Finnish study found that when women taking HRT
stopped taking the hormone replacement, the risk of a fatal heart attack went up by 26% within that one year that they stopped taking it. What’s going on here? Well, there’s some significant nuance that is for women, who go without hormone replacement therapy for greater than 10 years or without natural intrinsic estrogen production
for more than 10 years, the benefit can turn into a risk because there may be progression, of atherosclerotic changes in the cardio vasculature. Some doctors recommend never prescribing hormone therapy in initiation of therapy after age 60. There are many different practice styles out there.
We’ll hear from the experts today, but there is nuance to affirm
this idea that if a woman is to start it, if they do not have a contraindicationm, or a relative contraindication, that it is important to start it within 10 years of the onset of menopause, or before age 60 roughly. Now, I don’t practice in this field.
I’ve been observing the medical literature, but this nuance was affirmed in the 2002 Women’s Health Initiative study where the average age of starting hormone replacement therapy was over age 60.
It was age 63 on average. That’s too late in the minds of many experts.
In fact, a 2017 reanalysis of this data by Manson et al and JAMA
found that in the group under age 60, there was a decrease in all cause mortality among the women that took hormone replacement therapy. Now, that 2002 Women’s Health Initiative study suggested that there was an association with breast cancer.
Doctors called their panel of patients to tell them to get off of it immediately.
The many benefits of hormone therapy were ignored as it was seen as a carcinogen.
Prescriptions for hormone replacement therapy plummeted in the United States. Women flushed their pills down the toilet. The amazing thing was that in that 2002 paper, there was no statistically significant increase in breast cancer mortality, amazing.
But as a result of the fear of breast cancer, 50 million plus women have not been offered the incredible potential health benefits of hormone replacement therapy because of medical dogma.
One of those women was my mother who went through perimenopause around that time.
She went on to have a couple bone fractures subsequent to that in the course of her older life.
So I was struck when I learned that hormone replacement therapy started within 10 years the onset menopause reduces the risk of bone fractures by up to 50%.
That’s a New England Journal of Medicine randomized controlled trial. And remember, when a woman gets over age 80, the risk of a fracture can be fatal. One in three women over age 80 will have a hip fracture,
and the one year mortality is 22%. Bone strength matters, and that of course is another well-established long-term health benefit, is the reduction in bone fractures.
It has also been found to reduce cognitive decline by up to 64% and in one study reduces the risk of Alzheimer’s by 35%.
And we’ve got billion drugs that are aimed at slowing the progression of Alzheimer’s.
But there may be a hormonal association whereby there may be a benefit in preventing Alzheimer’s at a much lower cost.
Notice I’ve only been talking about long-term benefits and not the short term alleviation of the symptoms of perimenopause experienced by many women. Symptoms that can be alleviated, including mood swings, difficulty sleeping, dryness and maybe 50 plus other potential symptoms of perimenopause. Today we are interested in learning and that is why Dr. Brenner and myself have convened incredible experts on this topic, well published with impeccable credentials to separate medical dogma from evidence.
So I look forward to learning from all of you. I would be very interested in your thoughts on what we discovered when we came to the FDAA few months ago.
Number one, there is a black box warning on vaginal estrogen.
Even though the North American Menopause Society and the American College of Obstetrics and Gynecology has called for removing it, we discovered that there is a black box warning
on systemic estrogen, even though no clinical trial has ever found
an association between hormone replacement therapy and an increase in breast cancer mortality.
So we want to learn from all of you, update us, teach us about the latest evidence and help guide us as we think through what should be done here at the FDA. Thank you very much for being here.
