Marty Makary and the Truth on Menopausal Hormone Replacement

In a recent podcast with Megyn Kelly, Dr. Marty Makary says there is no clinical trial of hormone therapy showing increased mortality from breast cancer. This is not entirely accurate and omits important information regarding the carcinogenicity of synthetic progestins, such as medroxyprogesterone acetate (MPA). This is the synthetic progestin used in the famous NIH funded study, the Women’s Health Initiative (WHI). MPA is also commonly used by conventional mainstream medicine in menopausal hormone replacement. Note: RCT is randomized controlled trial. Note: Marty Makary is a Johns Hopkins pancreatic cancer surgeon and current FDA commissioner. Header Image: courtesy of Megyn Kelly podcast with Marty Makary.

The Women’s Health Initiative (WHI) used Carcinogenic Progestin

The information Dr. Makary is leaving out is the carcinogenic progestin, medroxyprogesterone (MPA) given in combination with Premarin to menopausal women in the first arm (2002) of the WHI study. Why does Dr. Makary say there are no studies showing HRT increases mortality from breast cancer when the 18 year follow up of the first arm of the WHI study (2002) using Premarin and MPA showed HR=1.44, a 44 per cent increased mortality from breast cancer in the hormone treated group compared to placebo (61 HRT deaths vs 40 for placebo). However, this was NOT Statistically significant ! (1-2)

Breast Cancer Mortality in Both Arms of WHI – 18 Year Follow-Up

The 18-year follow-up of the WHI data was published by Dr. JoAnn Manson in JAMA (2017).(1-2)

First Arm Breast Cancer Mortality
CEE+MPA = 61 deaths vs. Placebo = 40 deaths

Hazard Ratio (HR)=1.44 meaning a 44% increase in breast cancer mortality.
Note: This is not statistically significant.

Second Arm Breast Cancer Mortality
CEE-alone = 22 deaths vs. Placebo = 41 deaths
Hazard Ratio (HR)= 0.55 = 45% reduction in breast cancer mortality.
Note: This is statistically significant.

Why was the data NON-Significant?

Why was the increased breast cancer mortality from synthetic progestin (medroxyprogesterone) in the WHI study not statistically significant?  The answer is this: the non-significant result (HR = 1.35, 61 vs. 40 deaths) was because the total event numbers for deaths were small and the intervention time was short (5.6 years of hormone treatment). The P value was greater than .05 and the confidence interval (CI) included 1.0

What If?

What if the study population was larger, and the intervention time longer? Would this transform the breast cancer mortality from INSIGNIFICANT to SIGNIFICANT? Let us ask our artificial intelligence program, Elon Musk’s “Grok” which you can read below).

Grok says: It is highly likely that an HRT study with CEE+MPA in menopausal women, would show a statistically significant increase in breast cancer mortality. This is supported by observational studies such as the Million Women Study.

This is the Question posed to AI (GROK): Isn’t it highly likely that if one does a hormone replacement study in menopausal women using Premarin and medroxyprogesterone with enough patients and long enough exposure time, the results will show a statistically significant increase in breast cancer mortality in the hormone-treated group?

Answer from GROK (Artificial Intelligence Program):

Conclusion (from Grok): “It is highly likely that an HRT study with Premarin (CEE) plus MPA in menopausal women, designed with a large enough sample size (e.g., 30,000–50,000 women) and long enough exposure (10–16 years), would show a statistically significant increase in breast cancer mortality, assuming the HR remains ~1.35–2.0 and event rates scale with exposure. The WHI’s non-significant result (HR = 1.35, 61 vs. 40 deaths) was limited by low event numbers and short intervention (5.6 years). Observational studies (e.g., Million Women Study) support increased mortality with prolonged HRT, but modern treatments and ethical constraints complicate replication in RCTs.”

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The Truth About Long-Term Benefits of Hormone Replacement Therapy For Women, with FDA’s Marty Makary and Megyn Kelly Podcast Exerpt.

 

Dr. MArty Makary says: “No clinical trial has ever shown that hormone replacement therapy for perimenopausal women increases the likelihood of dying of breast cancer.: endquote

Megyn Kelly talks about natural progesterone improving sleep.

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Notice in the video above , neither of them mentions MPA, the carcinogenic synthetic progestin used in the WHI study, and the reason why the 18-year follow-up showed a 44 percent (nonsignificant) increase in breast cancer mortality in the MPA treated group. 44 per cent! 60 vs 40 deaths.

Dr. Makary failed to mention there is a 29 percent increase in breast cancer in the MPA/Premarin group compared to placebo. This was statistically significant. Would you want to take a synthetic progestin that increases the statistical risk for breast cancer, and increases risk of dying from breast cancer (nonsignificant). Even though not significant, it is highly likely this increased mortality from breast cancer would be significant if the study had been powered to detect this.

Transcript of Megyn Kellly and Marty Makary

Megyn Kelly: There’s so much misinformation on this on HRT and even amongst my friends, they they don’t know what to do because there is a general belief it’s bad for you, you shouldn’t do it. And then women there are other women who say, well, I don’t have hot flashes, etc., so I’m not going to do it. And what I gleaned from your panel and your book for that matter is there are other reasons. It’s not it’s not going to cause breast cancer.
in in these numbers that we were told in 2002, it’s a very very minimal risk. And secondly, it’s got a lot of really good benefits.

Dr. Makary: Well, that’s right. Uh look, women have been confused for good reason. The medical establishment has doesn’t even they’re not even all on the same page. And the misunderstanding around the studies has created a lot of dogma that you should not take hormone replacement therapy because of an increased risk of dying of breast cancer. Now, it turns out when you look under the hood, no clinical trial has ever shown that hormone replacement therapy for perimenopausal women increases the likelihood of dying of breast cancer. Um, now there are importantly two different areas of benefit and I
should just point out there are contraindications. Some women cannot take hormone replacement therapy. The vast majority of women going through perimenopause can have not only short-term benefits, but long-term health benefits. And often when people talk about how it alleviates hot flashes and night sweats and helps with mood swings and better
sleep quality and um helps prevent some of the weight gain associated with
permenopause. They’re really only talking about the short-term benefits. Now, I’m not here to say they’re uh, you know, more important or less important than the long-term health benefits. I’m not a woman. But look at the studies on the long-term health benefits. Cutting the risk of heart attacks in half in some studies or 25 to 50% reduction in
other studies. That’s the number one cause of death in women. and it may
prevent Alzheimer’s, reduces the risk of cognitive decline by up to 64%, reduces
osteoporosis risk and the risk of bone fractures, cutting that risk in half. Uh
those are some of the serious long-term risks that can take the life of an older
woman is uh risks of bone fractures and hip fractures. So there may be no other
medication in the history of modern medicine that can improve the health
outcomes of women on a population level than hormone replacement therapy when
started within 10 years from the onset of perimenopause. Maybe with some rare
exceptions. I might cite antibiotics as one of those exceptions. But the incredible
health benefits of hormone replacement therapy described by the experts at the
FDA expert panel uh uh just recently um have been in the bucket of things in modern medicine that have been underappreciated, underrecognized and underfunded probably because it deals with women’s health and that it is something that needs to come to the
surface. every woman needs to know about the real data on this topic and not follow dogma for dogma’s sake.

Megyn Kelly: The thing that’s great about I mean preventing dementia, hello, everybody
wants to prevent Alzheimer’s or dementia, but the thing about HRT too is it’s estrogen and progesterone and progesterone helps you sleep better in the short term even which if you have terrible sleep, we’ve talked about this with a number of experts that actually
increases your risk of getting some form of dementia. So, it’s got like double
protection there where you start to get better sleep immediately and then
longterm it can have I guess maybe for other reasons uh the effect of of
helping prevent some forms of dementia.

Dr. Makary: Yeah, it’s pretty cool how the importance of good quality sleep is now being recognized as a central component to so many aspects of health. And it poor sleep may help drive some of these chronic diseases, including dementia and perhaps even Alzheimer’s in some studies, including one study I was a part of at John’s Hopkins in my previous career. So, uh, we’re learning more and more that good quality sleep, a healthy
microbiome, uh, and, uh, what we eat is so central to health. We have had a health care
system, Megan, entirely focused on drugs and operations. And we’ve got to ask, why is Alzheimer’s going up every year? It’s not just because we have older people in America, as I was taught in medical school. We have early onset Alzheimer’s that has tripled in the last few decades. What’s going on here? Two thirds of the cases are in women. What’s going on here? Turns out there may be an association with the hormonal access. When a woman takes estrogen uh starting around the time of permenopause, that risk of Alzheimer’s
goes down by up to 35% in some studies. So I’m not look I’m not in in the business of being someone’s tell a doctor or or ex telling them what to do but the data on this area of medicine has been so massively misunderstood and misrepresented and you you you saw the fear machine come out 23 years ago talking about you know such a sensitive topic like breast cancer to women demonizing hormone replacement therapy. People need to know the facts and one place to help get good information in my opinion is the FDA expert panel that’s available online for women to watch.

Megyn Kelly: Yes. So you talked about this when you came on before your new job and in your book you get into this about how it all the misinformation was rooted in this uh 2002 study called the women’s health initiative. The lead author was Dr. Jacques Russo and you when writing your book went to him to say I’ve looked at your information. I don’t see
the correlation between what you said was HRT and breast cancer because he came out in the middle of doing that women’s health initiative and said the risk is so high for breast cancer from HRT. We need to stop the study right now. We need to stop doing this to
women. and women all across America said, “I’m out.” and threw away their their hormones, the the estrogen and and the progesterone. But you actually went to him and found some remarkable I mean got some remarkable admissions.

Dr. Makary: Well, the most amazing thing, Megan, was that he acknowledged to me that the little tiny bump in uh breast cancer cases that they observed in the study was not statistically significant. You have to run statistics in these large trials to know whether or not something is a random occurrence, whether or not it’s noise in the data or whether or not it’s a true association. If you don’t run statistics, then we don’t have science. All of a sudden, snake oil works and cures cancer and we don’t have science anymore. So, he actually acknowledged to me that the observation of breast cancer in one of the looks of the data was not a statistically significant finding. And by the way, subsequent studies have found no statistically significant increase in dying of breast cancer. So what does that tell you? It is amazing. It it really is amazing because when that announcement hit and you know he feels that the media got ahead of his results when I when I had talked to him. But when that those headlines hit that hormone therapy causes breast cancer, man, women flush their pills down the toilet. Doctors were calling and scaring all the patients in their practice saying, “Get off of this. There’s been new data.” And I honestly I don’t even know if some of them had actually read the the numbers in the study and noticed that there was no statistical significance.

Megyn Kelly: So you this is from your book. It’s amazing. Uh you write I asked Dr. Russo point blank. Was the breast cancer link in his study statistically significant? He answered quote it touched on significance but wasn’t quite significant. It was nominally significant. It was not significant after being adjusted for multiple looks at the data. What? And uh and based on this, people ran for the hills. And I know this is personal for you because you feel like your own mom could have benefited from this, but didn’t.

Dr. Makary: Look, my mom is one of the 50 million women over the last 23 years never offered hormone replacement therapy or the many potential health benefits associated
with it because of this study. And it became dogma in the medical field. And man, they pounded this message into primary care doctors and doctors all over the medical field. It just became this dogma that it causes breast cancer. Therefore, don’t prescribe it. And by
the way, medical schools never even taught about menopause because why teach about all the symptoms of menopause if there’s nothing you can do to treat them. So, you don’t even need to teach about menopause. So, we didn’t we got almost no education on menopause. There was this dogma. But my mom was one of the 50 plus million women never offered
it. She should have been offered it. She was would have been a great candidate. And you know, HRT reduces the the chance that you’re going to break a bone if you’re in a car accident or if an 80-year-old woman falls later in life. There’s like a 50% increase the risk of
of breaking a bone is cut in half if you’re on hormone therapy. Well, my mom
broke her bones twice in in two different falls, you know, and one of them I remember showing the X-ray to an orthopedic surgeon friend of mine and I said, “Does she really need surgery with screws and pins and and and this, you know, my mom is uh not, you know, you
you put an older woman through something like that, it sets them back. It’s debilitating. They’re non-ambulatory and sometimes that sets up older Americans for a cascade of events that can result in their demise. So, I didn’t want to see her non-ambulatory. Well, the
orthopedic surgeon said it’s really on the border as to whether or not these fractures require surgery, but in my opinion, I think she does need surgery. Well, if it was if that much of a you know borderline call, certainly a hormone replacement therapy would have helped her avoid that bone fracture and all of the cost and pain and debilitation associated with that
long lengthy lengthy physical therapy. And she’s that’s just my mom and and I’m putting these pieces together from what I’ve done for my research. Think about the 50 plus million uh women. An 80-year-old woman has a one in three chance of having a hip fracture and a
quarter of women die within a year of a hip fracture. So these are real issues that are never talked about. END Transcript

What is Dr. Marty Marary Not Telling You?  MPA is Carcinogenic.

Conclusion:

How do we know MPA is carcinogenic? MPA reliably causes breast cancer in wild type mice, as shown in 2009 by Dr. Claudia Lanari. Preclinical studies show MPA activates oncogenes Cyclin D1 and c-Myc which increases breast proliferation and is carcinogenic. MPA is an androgen blocking endocrine disrupting drug (EDC) that abrogates the breast cancer preventive action of testosterone in women as demonstrated by multiple studies. The message is that MPA is carcinogenic and should not be used. How do we avoid using MPA? Simple. Use natural bioidentical progesterone instead. Natural progesterone is breast cancer preventive. This is what Dr Makary is not telling you. For more on this, see my new book, Bioidentical Hormones 101, Second edition (2025). (3-4)

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Video of the FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women was held on July 17, 2025, at the FDA White Oak Campus in Silver Spring, MD. (below)

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Free Video Introduction to Book

Introduction Video to Bioidentical Hormones 101 Second Edition (2025)

Bioidentical Hormones for Breast Cancer Survivors  Video Presentation

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Hormone Replacement for Breast Cancer Survivors Part One

Hormone Replacement for Breast Cancer Survivors Part Two

Estrogen Metabolism, Iodine, 2MEO Part Three

Testosterone for Breast Cancer Prevention and Treatment

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Jeffrey Dach MD
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Links and References:

1) Manson, JoAnn E., et al. “Menopausal hormone therapy and long-term all-cause and cause-specific mortality: the Women’s Health Initiative randomized trials.” Jama 318.10 (2017): 927-938.

2) Bluming, Avrum Z., Howard N. Hodis, and Robert D. Langer. “The WHI’s Continued Misrepresentation of its Breast Cancer Claims: a Critique and Evidence.” Current Obstetrics and Gynecology Reports 14.1 (2025): 15.

3) Lanari, Claudia Lee Malvina, et al. “The MPA mouse breast cancer model: evidence for a role of progesterone receptors in breast cancer.” (2009).

4) Dach, Jeffrey. “Bioidentical Hormones 101 Second Edition” (2025) Medical Muse Press

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Jeffrey Dach MD
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my blog: www.jeffreydachmd.com 
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Menopausal Hormone Replacement, Health Benefits
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Published on July 23rd, 2025 by Jeffrey Dach MD