Marty Makary's Many Blind Spots about Menopause Hormone Therapy

His book is a master class in cherry picking

Roberto Moiola / Sysaworld/Getty Images

Dr. Marty Makary, the Commissioner of the Food and Drug Administration (FDA), has convened a panel on “Hormone Replacement Therapy” for Thursday, July 17, 2025. And while that might sound great, given his track record, I am concerned. To prepare for any fallout, I thought I would review the chapter on hormone therapy in his most recent book, aptly titled Blind Spots, because he has so many, to see what leadership and insight we might expect. I suspect the title of this post has given it away, and that going forward, we can expect things are going to be as bad for evidence-based menopause care as they are for evidence-based vaccines.

The chapter on hormones is the second one in the book, and is titled “OMG HRT: The Untold Story of Hormone Replacement Therapy.” I’ll look past the fact that “OMG” is incredibly cringy and start with the issue that Makary is using the outdated term hormone replacement therapy (HRT) instead of the preferred menopause hormone therapy (MHT). He also is using the outdated HRT for the FDA menopause panel. If he had read the 2022 Menopause Society Guidelines, which are written by actual American experts, he would have known to use the correct terminology for America (you can read about the importance of the correct language here). I assume Makary didn't read the guidelines, as they are not mentioned or referenced, then again, the guidelines contradict almost every claim he makes, suggesting that he is painfully unaware of his own blind spots. It’s also possible he read the guidelines and then decided to ignore them because he likes to see himself as a contrarian. Regardless, it takes a particular kind of arrogance to exclude guidelines from doctors and researchers who have spent the vast majority of their careers treating and studying menopause, a topic on which he has no expertise.

Makary’s chapter on MHT is an adventure in cherry picking. He never once seriously considers any research that disagrees with his assertions. It’s such a screed that it’s hard to know where to begin, but I’ll focus on three of his assertions to give you a general idea and save you the pain of reading it yourself:

1. His claims about the Women’s Health Initiative and breast cancer

2. His claims about MHT and cardiovascular disease

3. His claims about MHT and dementia

Makary is also wrong about MHT reducing the risk of colon cancer. I plan to address that in a future post, as this misinformation was also presented in Peter Attias’s recent podcast, and I have been asked about it a few times.

“OMG HRT”

The chapter begins with an explanation of the backstory behind the WHI, and I will not review the press conference and how the press approached MHT and inappropriately amplified the concerns. That is one of his only valid points in the chapter, and I have discussed it previously on The Vajenda and in my book, The Menopause Manifesto. What I am going to address is what Makary claims is the WHI “Kool-Aid,” that we in medicine and even the WHI researchers appear to be drinking. Using “Kool-Aid” this way is an offensive colloquialism, especially coming from a doctor.

We’ll focus here on the estrogen and progestin components of the WHI for simplicity.

The breast cancer results of the WHI are Makary’s “Kool-Aid.” He appears to assert that the WHI researchers are themselves unaware that their study doesn’t show that MHT is associated with breast cancer and that everyone has been bamboozled by a “Jedi mind trick.” This implies that almost every author on every WHI study (except a whistleblower or two) and almost every doctor and journal that has published outcome data for the WHI, missed a key statistical issue that that Makary and a few good men and woman caught. No really.

Makary’s “gotcha” moment with the WHI is the statistical measurement from the first publication in 2002 about the risk of invasive breast cancer. The results show a 26% increased risk with Premarin plus the progestin over placebo, and Makary’s issue is with the confidence interval (CI), which is a range of values that helps us understand the level of uncertainly of the results. The narrower the confidence interval, the better, and when a CI crosses 1, that suggests the results are not statistically significant. The CI from the original WHI study for invasive breast cancer is 0.83-1.92. Makary hammers this over and over again; the 26% increase in the risk of breast cancer is smoke and mirrors, he claims, based on this confidence interval crossing.¹

It’s crucial to point out that Makary is more than willing to accept the author’s statistical analysis of the breast cancer data for the estrogen-only arm, but if he genuinely believes the authors are incorrectly interpreting the statistics in one arm of the study, then how can you trust them with the other arm of the study? Except, of course, the estrogen-only arm shows what he wants to see–a reduction in breast cancer.

Makary interviews two key members of the WHI, who he claims are wishy-washy about the breast cancer risk. Since we don't have the transcript, I have no idea how faithful his retelling is, but he says that no trial has ever shown that “HRT was associated with an increase in mortality due to breast cancer.” At this point, the reader is left to think the WHI investigators are nice but incompetent.

It’s critical to add that death is not the only important outcome here. Management of breast cancer has improved dramatically, which it an important consideration. But also, biopsies, mastectomy or lumpectomy, radiation, chemotherapy, hormone therapy to stop estrogen production, never mind the worry, all matter. Or to me anyway, I guess not to Makary.

There are many issues here, and I suspect some of them may be due to Makary's unfamiliarity with the WHI and its follow-up studies, because much of what he is saying is missing the necessary context.

The WHI was designed to determine if oral Premarin plus a progestin, the most popular form of MHT at the time, reduced the risk of cardiovascular disease without increasing other risks, such as breast cancer. The study had a predetermined safety threshold for breast cancer as there was data going into the study showing an increased risk of breast cancer with MHT (many people conveniently forget this). If the incidence of breast cancer crossed this threshold in the WHI, the study would be stopped. The WHI investigators used a global index to put risks in context, because while some risks might be raised by MHT, others could be lowered, and this would be important to weigh in the final disease prevention hypothesis. This global index looked at coronary heart disease, invasive breast cancer, stroke, pulmonary embolism, endometrial cancer, colorectal cancer, hip fracture, and death. Consider the global index as a net good or bad.

When the study was halted, the global index for the Premarin and the progestin arm was an additional negative outcome for 20/10,000 women/year (or 0.2% of women per year). In the original paper, the authors write:¹

During the 5.2 years of the trial, the number of women experiencing a global index event was about 100 more per 10,000 women taking estrogen plus progestin then taking placebo.

A medication to prevent disease can’t result in a net harm of 1% over 5 years. Makary does not mention this key point at all, and chooses to focus on breast cancer only, but it wasn’t just the rise in breast cancer that stopped the study and affected how those of us who are evidence-based practice medicine, it was this rise in combinations with the other findings and in the context of disease prevention. When the WHI was stopped, the risk of invasive breast cancer had met the acceptable preset threshold, and considering the increase in cardiac events, it was evident that continuing the study couldn’t possibly achieve the primary goal of protecting the heart with a net positive effect.

Makary’s gotcha moment about the confidence interval is bizarre because in the study, the investigators write that the increase in breast cancer was within expectations, and “almost reached nominal significance.” Notice the word “almost.” Stopping the WHI wasn’t just about breast cancer; it was about the sum of the overall results.

Makary inappropriately dismisses the follow up WHI data as problematic, but in reality they are problematic for his predetermined conclusions. If he had discussed the follow-up data, he would have had to inform the reader that a WHI paper from 2010 (about 11 years of data) indicated a 25% increased risk of invasive breast cancer vs. placebo and the confidence interval was 1.07-1.46, and breast cancer deaths were greater in the MHT group.² After 20 years of follow up, the increase in invasive breast cancer remained increased and statistically significant, with a CI over 1.³ Most of Makary’s “concerns” about the original WHI study and follow up studies have been addressed by the researchers in peer-reviewed literature, but you would not know that from reading this cherry picked chapter.⁴

My biggest issue with the original WHI paper is that they said the risk of breast cancer and cardiovascular disease were “substantial,” and the public and press might think that is think something like 20% or more (as in one out of every five women), but of course, the risk of breast cancer was 8/10,000/year overall or 6/10,000/year for women ages 50-59. In general, that level of risk is considered rare. If you want to know more about the original paper and long term follow up, check out this post.

Makary’s points about menopause not being taught in many medical schools and residency programs are valid, and I am sure the WHI played a role, but many things are not taught. For example, I didn’t learn about back pain in medical school, and that’s a major health concern. And I learned nothing about pain with sex during my residency, so I quickly remedied that after graduating. Doctors are responsible for continuing their education post training, everything can’t be spoon fed to us and the point to graduate with the brain power and skills to continue a life of learning. Anyone could have availed themselves of the Menopause Society guidelines over the years to learn how to put the risk of the WHI into perspective for their patients.⁵ That’s what I did. They put the first one out in 2003, I believe. I also found opinion pieces from experts who I trusted and read those.

Unfortunately, doctors heard the words "breast cancer” and just stopped prescribing estrogen and women heard it and were scared. It’s also important to point out that fear of lawsuits was real. I’m sure that once the increase in breast cancer pushed the net harm over the threshold, there was legitimate concern that if they didn’t stop the study, there could be lawsuits. And based on how Wyeth faced thousands of lawsuits for breast cancer causing MHT and hiding information from women, that concern seems valid in retrospect. Makary conveniently omits this, which is crucial for the context at the time. Imagine if the trial hadn’t stopped when they knew they couldn’t achieve their primary goal, and the breast cancer risk was at or had passed the predetermined threshold? You can see the lawsuits and the headlines now: “Government Hormone Study Gave Women Breast Cancer; The Investigators Knew, But Hid It For Years.” Imagine how hard it would be to get subsequent government funding for anything in menopause.

Makary’s gotcha moment about the WHI is non-existent, and I'm left with the impression that he has not availed himself of the wealth of other data that provides a more complete narrative. He’s right to be angry about the press conference and the press, and doctors who didn’t stay up to date, but those are the only arguments of his that hold water.

“Prevents Heart Attacks”

Makary claims that “HRT” reduces the risk of death from cardiovascular disease and the risk of heart attacks by 50% and that it is better than statins. The studies he refers to are oral estrogen, so perhaps he is unaware that oral estrogen and HRT are not synonyms. One is a 1991 review article, which is based primarily on observational studies, as well as an observational study from 2000.^6,7 We cannot make cause-and-effect conclusions with observational studies. He also cites the Danish Osteoporosis Prevention Study (DOPS) to support his claims; however, this is not an unblinded study, so women knew if they were taking hormones or not. It was also not designed to provide outcome data on cardiovascular disease, and the control group was older, which makes its findings somewhat problematic.⁸ Most evidence-based healthcare professionals agree that the DOPS should not be used to conclude that cardiovascular disease is reduced with MHT.

In a feat of stunning cherry picking (or yet another Makary blind spot), he completely ignores the two randomized, double-blind trials (ELITE and KEEPS).^9,10 These studies are important because they evaluated different formulations of estrogen early in menopause for the primary prevention of heart disease. In KEEPS (the Kronos Early Estrogen Prevention Study), a randomized controlled trial comparing oral Premarin with a 50 mcg transdermal estradiol patch and cyclic progesterone to placebo, there was no change in the primary endpoint with either hormone regimen compared to placebo. With ELITE (Vascular Effects of Early versus Late Postmenopausal Treatment with Estradiol), which evaluated oral estradiol and vaginal progesterone with placebo, there was a slight difference in slowing the progression of carotid intima-media thickness (CIMT), which is a good thing, but “no significant differences in post-treatment coronary-artery calcium and cardiac CT angiographic outcomes between the estradiol and placebo groups in either postmenopause stratum with a mean 6 years of follow up.” The meaning of the slight improvement in CIMT is unknown, given that the other markers showed no change.

Makary also makes a big deal about the 2015 Cochrane Review, again claiming this supports hormone therapy for prevention. It’s a review of clinical trials of oral estrogen versus placebo, so it cannot be generalized to transdermal regimens, which are more common today.¹¹ This is a crucial point that can easily be overlooked by someone with only cursory knowledge of MHT. The Cochrane review also doesn’t include any data from KEEPS or ELITE, which were published later, so it is not up to date.

While the overall conclusion for the Cochrane Review was “little benefit” from MHT for primary or secondary prevention of cardiovascular disease, much has been made of the subgroup analysis of women who started hormone therapy less than ten years after menopause, which is also what Makary does. In this group of women starting MHT early there was a reduced rate of coronary heart disease (which included death from cardiovascular disease and non-fatal heart attacks), with a relative risk of 0.52, and Makary uses this subgroup analysis to drive home his point that for women less than 10 years from their last period, MHT reduced by 50% the rate of “death from cardiovascular causes and non-fatal myocardial infarction.” ¹¹

This does sound impressive; however, he conveniently doesn’t mention that the authors had to combine data from trials with different oral estrogens and progestogens to perform the subgroup analysis for those starting hormones within ten years of menopause, which is problematic and weakens the conclusions.¹¹ Even if we accept the results as true, which hormones are involved? Which doses? Unknown, and this only applies to oral.

Not only does Makary cherry-pick articles, but he even cherry-picks within the Cochrane review! He neglects to tell his readers that the authors stated the results for women who start hormone therapy within 10 years of menopause are only “significant due to the DOPS 2012 trial, that has high risk of bias…had the DOPS not been there, the metanalysis would not be significant.” ¹¹ Kind of an important point. Taking out DOPS, the problematic trial we discussed a few paragraphs above, negates all the benefits of MHT for the heart for women within 10 years of menopause.

I asked Dr. Martha Gulati, MD, MS FACC, FAHA, MASPC, FESC, FSCCT, what she thought about using MHT for the primary prevention of cardiovascular disease. She is the Director of Prevention & Associate Director of the Barbra Streisand Women's Heart Center, as well as the Immediate Past President of the American Society for Preventive Cardiology. Unlike Makary or me, she is an actual expert in the prevention of cardiovascular disease in women. She told me, “Menopausal therapy may be necessary for some women due to menopausal symptoms, but it should not be considered as a cardiovascular preventative therapy.”

“Reduces Cognitive Decline”

Again, Makary starts with a bold claim that women taking estrogen have a “35% lower incidence of Alzheimer’s.” Wow, the reader might think, this is amazing, except that once again he is relying on outdated and observational data, this time from 1996.¹² His other reference is a narrative review from 1997, so it is not even a study as suggested in the book.¹³ Historically, women who take MHT have been at lower risk for dementia for several reasons, including higher levels of education and better access to health care. Additionally, this review paper draws conclusions about the potential of estrogen as based on rodent studies, laboratory experiments, and observational data. The author concludes that clinical trials are needed. I mean, come on.

Makary also claims that women who take MHT have improved memory, and cites a 2023 study, “Hormone replacement therapy is associated with improved cognition and larger brain volumes in APOE4 carriers.”¹⁴ I wrote about that study here, and this study DOES NOT prove that taking MHT improves memory. The study is cross-sectional and observational, which means it cannot establish a cause-and-effect relationship between hormone therapy and memory. It showed a smaller loss of brain volume and fewer memory issues for those who took menopausal hormone therapy and who were also APOE-4 positive versus those who didn’t. Makary neglects the point that no effect was seen for women who were not APOE-4 positive.

Makary also uses a small study of 343 women to support a wild claim that even just 2-3 years of MHT reduced the risk of cognitive impairment by 64%.¹⁵ “Wow,” he writes, but this study should not be used to support these claims due to statistical flaws and the trial's design. Women were randomized as part of osteoporosis trials, and there were no baseline tests for cognition. You cannot examine women 2-3 years after starting hormones, and then use a test to measure cognition, and if there is a difference, assume it is from hormone therapy. A baseline evaluation is needed. Someone who understands research would know this.

Makary offers nothing but cherry-picked lower-quality studies and reviews, and ONCE AGAIN, ignores the higher-quality data, because there are four randomized, double-blinded, placebo-controlled trials examining MHT for cognition that he conveniently doesn’t mention. These studies have investigated different hormone regimens, including oral and transdermal therapy, as well as Premarin and estradiol. The studies are COGENT, ELITE, WHIMSY, and KEEPS, and all show no benefit for cognition.^16-19

In addition, Dr. I-love-me-an-observational-study Makary doesn't mention that four recent observational studies from multiple countries suggest a small increased risk of dementia from taking menopause hormone therapy.^20-23

(Don’t panic over the observational studies, unlike Makary, I want to reassure you that they are not proof of cause and effect, just evidence that we need more randomized studies with longer follow up).

I have written extensively about MHT and dementia elsewhere, so I won't review all the studies here. Dr. Pauline Maki, PhD, a world expert on hormones and the brain, says that the 2022 Menopause Society Guidelines hold, and that MHT is not indicated for the prevention of dementia.

Makary is Wrong About a Lot of Things, Not Just MHT

You are shocked, I know, simply shocked. And probably exhausted at this point. Me too!

For those of you who don’t know, he was one of the co-authors on an abomination of a paper that claimed medical errors are the third leading cause of death. The paper is perhaps one of the best (or worst, depending on your perspective) examples of a flawed analysis, and you can read a critique here. Makary has a very problematic track record regarding COVID-19, and if you are interested, you can read this post, or this one, or Dr. Jonathan Howard’s book, “We Want Them Infected,” (exceprt here). He believes that the CDC website, which calls the fluoridation of water “one of the greatest public health achievements” of this century, is “misinformation.” The American Dental Association, a group that knows a fuck ton more about fluoride than Makary and who are the actual experts, disagree. And he has said about seed oils that ”generally, they’re believed to be pro-inflammatory.” Also, spectacularly wrong.

And Makary is a forced birther who has regurgitated the fetish about fetuses moving away from abortion instruments.

I could have just started with that, because you should never, ever, ever, trust a doctor who is a forced birther, because they excel at cherry-picking for cruelty and are misogynists.

Makary appears to have built a career outside of the operating room as a cherrypicker of data, and his interest in menopause hormone therapy (learn the fucking name, Makary, I swear I'm going to call him Marty Macaroni until he can get it right) does not bode well for evidence-based medicine. If you are going to present an argument in good faith, you present the data and then make arguments against it. You don’t just dismiss them out of hand and present the data you like, as he does in his book.

In my opinion, Makary is unqualified to lead any discussion about menopause hormone therapy. Honestly, he is unqualified to lead the FDA. Based on this chapter and his general abuse of facts and actual expertise, I am concerned that Makary will make Thursday’s meeting an evidence-free zone and the FDA will produce a document that cherry picks the data and ignores the meticulously crafted recommendations from The Menopause Society. After reading his book, I think he may focus on MHT and the heart. I’m also worried that something will happen to the hormone arm of the WHI. I know some people are hoping that he will remove the black box warning from vaginal estrogen, and that will be good if that happens, but I am always wary about deals with forced birthers.

This meeting will also provide Makary with the illusion that he cares about women’s health, which he can then use to buffer himself from criticism if he eventually restricts mifepristone. Already there are several menoinfluencers putting Makary in a good light, giving him great prehab for his image (preventative rehab), so if he turns around and restricts mifepristone, there will be less blowback. It’s really hard for me to get excited about a meeting when the person in charge has expressed such biased and unscientific views, not just on menopause hormone therapy, but on so many things.

I hope I’m wrong, but considering cherry picking science for political agenda is the Makary special, and trusting him to get it right about menopause hormone therapy feels like trusting RFK Jr to get it right about vaccines.

I will do a Substack live tomorrow evening with a recap from the panel for subscribers, assuming I can digest it all and formulate my thoughts.

References

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