The embarrassing FDA panel on menopause and HRT

The FDA recently hosted an expert panel on Menopause and Hormone Replacement Therapy for Women. The panel was co-chaired by Dr Marty Makary, the FDA commissioner.

Six months into the Make America Healthy Again (MAHA) era, we might have expected presentations with gold-standard science, and an honest and open debate on how best to support women through perimenopause and menopause.

Ahead of the event, we were also promised that a range of opinions would be shared.

As the panel discussion unfolded, the speakers converged on a single message:

Medicate your menopause transition, or be doomed!

A few days later, Dr Makary co-chaired an additional FDA panel to investigate SSRI use in pregnancy. This event brought together experts who had opposing opinions on the risks and supposed benefits of SSRIs for pregnant women. Some panelists even questioned how we currently diagnose depression.

In the areas of mental health, pregnancy, birth, pediatrics and metabolic health, Dr Makary has warned against over medicalization, recognizing the risks of complications that often arise. He has also called for a refocus on lifestyle interventions.

However, when it comes to menopause, Dr Makary has become a champion of pharmaceutical interventions. It’s as if menopausal women have a design fault, and we need to be saved by modern medicine.

To promote the idea that women should be medicated from midlife on, Dr Makary and the panelists relied on a combination of old and weak science, and the misrepresentation of data.

Here are seven embarrassing lowlights from the FDA panel on menopause and HRT:

1. MAHA had left the building.

One of the MAHA movement’s main objectives has been to free federal agencies from corporate capture.

With this in mind, why did so many panelists have conflicts of interest? And why were one third of the panelists also members of a menopause advocacy working group in an organization supported by Pfizer, Bayer and other pharmaceutical companies?

Dr Mary Jane Minkin, a panelist, member of the working group, and consultant for numerous pharmaceutical giants tried to explain: “I consult for a lot of people … but they don’t listen to me anyway, so it doesn’t make any difference.”

Oh, that’s alright then!

Another main objective of the MAHA movement is to create better health through lifestyle changes. Unfortunately, during the two-hour panel discussion, diet, movement and stress weren’t mentioned once. Instead, medicating perimenopause, menopause and beyond was promoted as the ONLY path to healthy living for women.

Most menopausal women with symptoms will have noticed how, for example, stress makes their symptoms worse. Lifestyle improvements, which help reduce stress and therefore lessen symptoms, also offer long-term health benefits with zero negative side-effects. Isn’t it worth discussing how women can help ease their journeys through midlife change for free, without relying on a pharmaceutical supply chain?

The FDA is aware that the US is in the middle of a chronic disease epidemic. Why didn’t anyone mention that low states of health make sensitive times of hormonal flux more challenging?

And why shouldn’t a MAHA demand be that every clinical trial include not only a placebo group, but also a few lifestyle intervention groups for comparison?

2. Dr Makary exposed his personal blind spot, again.

Dr Makary opened the panel discussion by declaring that when a woman takes HRT within 10 years of the onset of menopause, there’s “roughly a 25% to 50% reduction in fatal heart attacks and cardiovascular disease.” He added that additional research has shown that HRT could reduce the risk of Alzheimer’s by 35%. 

In his book, Blind Spots, Dr Makary provides the references that supposedly back his claims. In my post MAHA, Menopause and HRT: An Open Letter to Dr Marty Makary, I review his references and explain in detail how Dr Makary misrepresents the data.

Whether Dr Makary is discussing women’s heart, bone or brain health, he consistently displays an inability to grasp the difference between research on women who had a pre-existing condition that led to a hysterectomy (often with ovary removal), and research on women who journey through natural menopause with their uterus and ovaries intact. Dr Makary takes data from research on the former group of women and makes the mistake of assuming relevance for all women.

The former group have a higher risk of disease from the health imbalance that led to the surgical procedures, and the procedures themselves. In a clinical trial, this group would be given estrogen-only therapy, which research has shown can mitigate some risks.

The latter group (women in natural menopause) are on a different health trajectory and the combination of estrogen and progesterone (or progestin) that they would be given in a clinical trial shows different outcomes.

Conflating data from the two groups of women is bad science. While discussing different types of HRT, Dr Barbara Levy, who appeared on the panel, stated: “To classify all hormones as the same, either the benefits or the risks, is completely inappropriate.”

Telling women in natural menopause (most women!) that HRT reduces the risks of disease and even early mortality is NOT backed by data (JAMA 2017, JoAnn E Manson et al).

3. The science of “Let’s say it’s safe!”

Dr Heather Hirsch claimed she wanted to provide “concise and logical information in support of the safety of menopausal hormone therapy.”

Dr Hirsch led the call to remove the FDA’s black box safety warning from vaginal estrogen. She stated that this type of estrogen is “categorically safe for all women, period.” She forgot to mention that since there are no long-term clinical trials that have tested the safety of vaginal estrogen, any claims of long-term safety are assumptions based on observational data only.

Another panel member, Dr James Simon, attempted to confirm the safety of vaginal estrogen by referencing an observational study, which was carried out by the leading pharmaceutical manufacturer of vaginal estrogen.

Conflict of interests? Don’t ask!

4. The menopause horror show: fear of life without estrogen

Fear and health don’t mix. However, some doctors seem to believe that they’re doing humanity a favor by promoting natural menopause as a horror show.

Dr Philip Sarrel chose from the beginning of his remarks to use the term “menopause estrogen deficiency” to describe the supposed diseased state all women enter at midlife.

Dr Sarrel claimed women’s brains become “disturbed” with postmenopausal levels of estrogen. It’s as if women’s brains can only function normally when our bodies produce the levels of estrogen needed for reproduction.

Where have we heard a similar theory before?

Many centuries ago, there was a belief that when a woman wasn’t reproducing, her womb could start wandering and disturb the brain, leading to hysteria.

Isn’t it time we moved on from this misogynistic nonsense?

Relying on data from research published in 1990, on estrogen-only therapy given to women with a pre-existing condition that led to a hysterectomy (often with ovary removal), Dr Sarrel claimed that estrogen was the solution needed to alleviate brain disturbances, including sleep disturbances, cognitive disturbances, mood disorders and angry outbursts.

Dr Sarrel painted a picture of how when women aren’t given estrogen, they lose their self-worth, and there’s chaos in the home and workplace. In addition, he claimed unmedicated menopausal women create a broader societal burden: increased health spending.

Just when female viewers might have started fearing how their menopausal brain would ruin their lives and society, the fear of death was to come next in Dr Sarrel’s presentation.

According to the doctor and his team at Yale, in the US, almost 50,000 women died post-hysterectomy between 2002 and 2012 because they avoided estrogen, following the publication of the Women’s Health Initiative (WHI) in 2002.

Dr Sarrel first published this claim in The American Journal of Public Health, in 2013. At the time, it was disclosed that Dr Sarrel had served as a medical consultant for Noven Therapeutics (a manufacturer of estrogen therapy).

The calculations that Dr Sarrel and his colleagues presented in the research were disputed at the time by WHI Investigators, who described them as “oversimplified conclusions.”

Dr Sarrel’s attempts to associate menopause with early mortality make even less sense when we remember that women outlive men, according to all available data throughout history and across all cultures.

In addition, how does Dr Sarrel explain the average life expectancy of women who live in Blue Zones? These women live longer and healthier lives than the average American woman, without supplemental estrogen.

Just like every other member of the panel, Dr Sarrel failed to point out that when a woman undergoes a hysterectomy with ovary removal, she increases her risk of early death.

Prior to introducing his controversial calculations of “death without estrogen,” Dr Sarrel made the claim that 30% of women in the US will have had a hysterectomy by age 50.

According to data from the National Center for Health Statistics (2021) rates of hysterectomy stand at 22.1% of women between the ages 45–64. Was it an innocent mistake that Dr Sarrel exaggerated rates of hysterectomies? Was he trying to normalize this risk-filled procedure to make women appear more prone to malfunction? Was he trying to make his disputed calculations appear more relevant?

With the overall benefits of hysterectomies and oophorectomies in dispute, shouldn’t we discuss how rates of these surgical procedures can be reduced to improve women’s health, rather than normalized?

Instead, to end his presentation, Dr Sarell tried to hit home his point about menopause by referring to experiments on octopuses. An octopus is not a mammal and it doesn’t go through menopause. Could the clown show stop?

5. Fearing a woman’s future brain

The attack on the female brain didn’t slow down. Dr Roberta Diaz Brinton was up next. She just happens to be the founder and president of a company that claims to have a few brain protecting products in the pipeline, including a phytoestrogen product for menopausal women, which is currently in clinical trial.

She reminded us that 2/3 of Americans with Alzheimer’s are women. Why does this occur? According to Dr Brinton, it’s because the disease starts earlier in women – during the menopause transition. By referencing brain scans carried out in collaboration with Dr Lisa Mosconi, Dr Brinton suggested that a menopausal brain looks different, with a build-up of beta-amyloid deposits.

If menopause was the trigger of Alzheimer’s, we‘d see similar rates of Alzheimer’s across all populations. We don’t. If beta-amyloid deposits were a sign of early Alzheimer’s, surely people with significant beta-amyloid buildup would not be able to remain cognitively healthy. Some do.

Dr Brinton has her mind set on blaming female biology. Meanwhile, we should be studying other variables, which could negatively impact women’s brains, including hysterectomies and oophorectomies, hormonal birth control, toxic skin and hair products, SSRIs and other medicines more often prescribed to women.

Dr Brinton argued that the use of HRT is “associated” with a reduced risk of neurodegenerative diseases, such as Alzheimer’s and dementia. When her research to back this claim was published in 2021, none of the menopause societies changed their policy documents on hormone therapies to list long-term brain health as a benefit of HRT. Furthermore, after her research became the central piece of “evidence” in a UK primetime Channel 4 documentary on menopause in 2022, which encouraged women to take HRT to avoid dementia and Alzheimer’s, the British Menopause Society issued a statement which included the following clarification:

“HRT should not be initiated for the purpose of reducing the risk of dementia in postmenopausal women and at this time, there is not enough evidence to support prescribing HRT for prevention of dementia.”

While relying on Dr Mosconi’s brain scans, Dr Brinton forgot to mention that Dr Mosconi co-authored a systematic review and meta-analysis on the impact of HRT with regards to Alzheimer’s disease and dementia (Frontiers, 2023). This research found that randomized controlled trials (RCTs) conducted with postmenopausal women with a uterus, aged 65 and older, showed an increased risk of dementia with estrogen-plus-progestogen therapy use when compared with a placebo, while other RCTs found no significant effects of estrogen-only therapy when given to women who had undergone a hysterectomy.

A reduced risk of dementia was only seen in weaker observational studies that investigated the use of estrogen-only therapy in women post-hysterectomy.

6. Fast-tracking the approval of testosterone for women? A disaster waiting to happen.

Dr Kelly Casperson called to fast-track the approval of testosterone for women, even though there’s an absence of long-term safety data from clinical trials. Currently, every woman taking testosterone for more than a year is the experiment.

“The science is solid,” Dr Casperson declared, while suggesting that women’s brains, bones and even ambition could be enhanced by testosterone. Her presentation relied mostly on personal anecdotes.

The world’s leading authority on testosterone for women, Professor Susan Davis, has publicly stated that although clinical trials have been carried out to test if testosterone could positively impact mood, cognitive function, bone health, sexual function and more in women post-menopause, in all cases apart from sexual function, the results were inconclusive. Or in other words, for most of the supposed benefits that Dr Casperson chose to promote, the science is NOT solid at all! With regards to sexual function, Prof Davis has stated that although clinical trials have shown a moderate improvement in “most women,” from her decades of experience of prescribing testosterone to women in Australia (one of the few countries where testosterone is licensed for women), a majority of her patients don’t experience a change significant enough to convince them to carry on taking testosterone beyond six months.

Known common side-effects of testosterone for women include excess body hair, acne and baldness.

There’s a devastating history of pushing out hormone treatments without long-term safety data in place. Will the FDA authorize another mass experiment on women?

7. The worst for last

During Dr Rachel Ruben’s presentation, she stated:

“Menopause is a castration event.”

Perhaps Dr Ruben thought some viewers would consider her description of menopause as edgy and original.

In the book Feminine Forever (1966), written by Robert A. Wilson MD, funded and marketed by the main estrogen therapy producer of the time, Wyeth, we find the following:

“It is the untreated [postmenopausal] woman – the prematurely aging castrate – that is unnatural. That which is common is not necessarily normal. The mere fact that such women castrates are prevalent – and getting more so every day as the world fills up with elder women – does not make them biologically natural.”

Pharmaceutical companies have an HRT play book rooted in a deep mistrust of the female body. HRT sales are driven by the promotion of fear and the promise of a quick fix. In every generation, pharma finds useful doctors to relay their messages, on repeat.

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A similar version of this article also appeared as a guest post on Sanity Unleashed, the Substack of Dr Jonathan Engler, who uses his knowledge and experience working in medicine and pharmaceuticals to expose where "The Science" is not science at all.

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