Synopsis: This personal reflection from Daved Rosensweet, M.D. marks the FDA’s November 10, 2025 removal of the black box warning based on misreported Women’s Health Initiative data where Premarin alone actually showed reduced breast cancer risk and the Prempro arm’s 1.26 relative risk was labeled “statistically insignificant” meaning no conclusion should be drawn, yet terrified the hormone therapy user base from 18 million to under 2 million with documented increased deaths and devastating health consequences. It traces Dr. Rosensweet’s decision to never stop prescribing compounded bioidentical hormones—molecularly identical to human hormones unlike the synthetic Premarin/Prempro used in flawed studies—and argues the FDA decision is just the beginning of restoring access, training, insurance coverage, and trust after irreversible harm to millions.
Top 5 Questions Answered:
- What did the WHI study actually show versus what was falsely reported about hormone therapy risks?
- What does “statistically insignificant” mean in medical research and why was reporting it as increased risk false?
- What health consequences and increased mortality did women experience after stopping hormones in 2002?
- How do compounded bioidentical hormones differ molecularly and clinically from the synthetic hormones used in WHI?
- What systemic changes beyond FDA warning removal are needed to restore access, training, and trust?
On November 10, 2025, the FDA removed the black box warning from hormone replacement therapy.
After 23 years.
I felt deeply grateful when I heard the news.
Because warning women and healthcare providers that estrogen was unsafe was absolutely false. One hundred percent different from what the science shows and has always shown.
The Numbers Tell a Devastating Story
In 2002, 18 million American women were using hormone replacement therapy.
After the Women’s Health Initiative study and the subsequent black box warning, that number dropped to under 2 million.
The fear spread like wildfire. And it was based on false reporting of a deeply flawed study.
I’m a medical doctor. I graduated from the University of Michigan Medical School in 1968. I’ve been in practice since 1971. I’ve seen plenty of untoward events take place in the medical world.
But this one was different.
I was appalled by the false representation. I was uncomfortable with what I knew would follow for millions of women.
What the WHI Study Actually Showed
The principal flaw in the 2002 Women’s Health Initiative study was false reporting.
Here’s what actually happened:
The study had two arms. The first used Premarin alone—horse urine-derived estrogen. Not my favorite, but it certainly did a lot of good for a lot of women. That arm actually demonstrated a reduced risk for breast cancer.
The second arm combined Premarin with medroxyprogesterone acetate (Prempro)—a very flawed molecule of progestin.
The researchers reported a 1.26 relative increase in risk. Immediately associated with that statement was another statement: that this 1.26 risk was “statistically insignificant.”
In medicine, we know what statistically insignificant means. It means don’t draw any conclusion.
Yet they reported it as increased risk. That was false.
By 2006, continued follow-up showed a 1.0 relative risk with the progestin arm. That means no increased risk at all.
Then, in 2017, the original study committee eventually published in the original journal that after 18 years of follow-up, there was no increased risk of breast cancer, heart attack, or stroke.
Very few healthcare providers or women heard about that retraction.
The Human Cost of Scientific Misinterpretation
Scientific papers documented what happened to women who stopped using hormones after 2002.
They showed very significant health compromises. Including increased death.
In my practice, I didn’t see evidence of that devastation because I have a wonderful demographic. Women who are very intelligent and highly motivated. They kept coming to me for treatment with compounded bioidentical hormones.
I didn’t drop a beat.
After reviewing the WHI articles and many scientific papers that had already been produced on the safety and efficacy of bioidentical hormones, I didn’t stop treating women at all.
Even though I had some concern after the WHI study, I reviewed everything in depth—myself and with trusted colleagues. Then I just kept treating women as I always had.
I found the treatment of women with hormones very important for the hugely significant health and life benefits. The WHI study that terrified everyone actually showed reduced risk for breast cancer with Premarin alone. And it showed a statistically insignificant effect on breast cancer even in the women with the progestin arm.
The science was there. It just got buried under false reporting and regulatory fear.
Why This FDA Decision Matters Now
I’m deeply grateful for the removal of the black box warning.
I think it could make a major difference. I’m hoping it’s sufficient that it will be embraced by traditional mainstream medicine. That there will be a revival of treatment of women with ovarian hormones.
I’m hopeful.
I’m also aware that things are often slow to change. There’s concern among many that this particular FDA administration is not behaving according to traditional methods. It’s a complex political issue.
But I really hope this changes the minds of traditional medical providers who treat women in menopause. Organizations like the North American Menopause Society and the American College of Obstetrics and Gynecology.
Yes, I sure hope this makes a major difference.
The Distinction That Changes Everything
The WHI study used synthetic hormones. Premarin and Prempro.
I’ve spent decades teaching medical professionals about compounded bioidentical hormone replacement therapy (cBHRT). Through The Institute of BioIdentical Medicine, I’ve trained thousands of practitioners in proper hormone optimization protocols.
The distinction between synthetic and bioidentical hormones isn’t semantics.
Bioidentical hormones are molecularly identical to what your body produces naturally. They’re compounded specifically for each patient based on their individual needs, symptoms, and lab results.
That’s what The Menopause Method is all about. It’s not just hormone replacement. It’s hormone optimization—an art informed by science, not a one-size-fits-all prescription.
Over 12,000 women have been successfully treated with cBHRT using this protocol.
What This Means for Access and Training
The FDA’s decision has broader implications for the compounding pharmacy industry, which has faced regulatory threats for years due to the controversy around hormone therapy.
Because of the threats from various commercial and political entities, I co-founded the Coalition for the Protection of BioIdentical Hormones. We’ve been fighting to protect access to compounded bioidentical hormone therapy.
But removing the black box warning is just the beginning.
Insurance coverage remains inadequate. Many physicians remain untrained in proper hormone optimization protocols. And the FDA’s decision still doesn’t fully recognize the validity, safety and efficacy of bioidentical hormones.
We would like the medical community to step up. Now is the time to master proper cBHRT protocols. To understand that hormone optimization goes far beyond simply writing prescriptions.
Women deserve access to safe, effective, bioidentical hormone therapy administered by properly trained physicians and nurse practitioners.
Rebuilding Trust After 23 Years
How do we rebuild trust with women who were denied treatment?
Women who lost careers, marriages, mental health, and quality of life to untreated menopausal symptoms because their doctors told them hormones were too dangerous?
Some of those consequences are irreversible.
The best we can do now is ensure this never happens again. That means:
- Better education for medical professionals about the safety of hormone treatment for women
- Continued evaluation of medical practices based on evidence, not fear
- Protection of access to compounded bioidentical hormones
- Training the next generation of practitioners in proper hormone optimization
- Advocating for insurance coverage that reflects the value of this treatment
The FDA’s decision is a watershed moment. But it’s not the end of the story.
It’s the beginning of a new chapter where women’s health is finally treated with the respect, rigor, and individualization it has always deserved.
A Message to the Medical Community
For the medical professionals who dismissed this work for decades: I understand.
The medical establishment operates on consensus. When a major study raises alarms, the instinct is to protect patients by restricting access.
But this case shows what happens when medical science, mis-interpretation and mal-reporting leads to egregious consequences.
Millions of women suffered unnecessarily.
The lesson here is clear: we must continuously evaluate medical practices based on deeply scrupulous examination of the evidence.
What Women Should Know Now
If you’re considering hormone therapy post-FDA decision, here’s what you need to know:
Find a properly trained practitioner. Look for someone who is specializing in hormone treatment of women, who understands hormone optimization, not just hormone replacement. Someone who will customize your treatment based on your individual needs, and someone who is trained in treating women with compounded bioidentical hormones: my best suggestion.
Understand that this is an art informed by science. Your hormone levels, symptoms, medical history, and goals all matter. Oversimplified approaches don’t work.
Don’t accept “you just have to suffer through menopause.” You don’t. Safe, effective treatment exists.
The black box warning is gone. And, your responsibility to be an informed patient remains.
Looking Forward
I’ve been in practice for over 50 years. I’ve trained the first nurse practitioners in the United States. I’ve been called to testify before The National Academies of Science Engineering and Medicine on the safety and efficacy of bioidentical hormones.
I’ve written books, organized national summits, founded educational institutes, and for the last 33 years have specialized in treating women in menopause and men in andropause with compounded bioidentical hormones.
This FDA decision validates what my absolute favorite and most respected medical colleagues and I have known—and what the science has shown—all along.
The goal always has been and is the best hormonal care possible for all women: the opportunity has just increased.
The goal is a medical community that embraces evidence-based hormone optimization. That trains practitioners properly. That protects access to compounded bioidentical hormones. That advocates for insurance coverage. That rebuilds trust with the millions of women who wound up suffering unnecessarily.
The black box warning is gone.
The Great Work continues.
And I’m deeply grateful to be part of it.
Daved Rosensweet, M.D.
Dr. Rosensweet graduated from the University of Michigan Medical School in 1968. He has been in private medical practice since 1971, and has had offices in New Mexico, California, and Colorado and is currently in practice in Southwest Florida. Dr. Rosensweet was the clinical physician involved in the very first Nurse Practitioner training program in the U.S.A. and in charge of health promotion for the State of New Mexico. He teaches health professionals about the treatment of women in menopause with bio-identical hormones.
– Nationally known lecturer. Just named “One of the Biggest Names in Anti Aging Medicine” by A4M
– Principle Investigator for a scientific study of female hormones sponsored by Metametrix Clinical Laboratory
– Author of the books Menopause and Natural Hormones and Happy Healthy Hormones: How to Thrive in Menopause
– Organizer of a National Summit Committee on the Treatment of Women in Menopause with Bio Identical Hormones
– Founder of The Menopause Method, i wonder, doctor…, The Coalition for the Protection of BioIdentical Hormones, and Brite.
