Congratulations on becoming the new commissioner of the FDA.
Under your leadership, I hope the FDA will help lead the way toward the MAHA goals of more vibrant health, transparency and evidence-based medicine. May we all witness a rapid decrease in rates of chronic disease in the US, and a world-wide trend back to physical, emotional and spiritual well-being.
Your book, Blind Spots: When Medicine Gets It Wrong, and What It Means for Our Health, is an inspiring call to action. Within, you encourage lifestyle practices over symptom suppression, a focus on disease prevention before profit, and a return to open scientific dialogue.
However, your chapter on menopause, OMG HRT, takes a disappointing and conventional allopathic approach. In the spirit of making America (and the world) healthy again, I would like to challenge your conviction that HRT offers long-term health benefits to most women.
Your book was published as we witnessed a new HRT “revolution” spread across the US. Traditional and social media are currently awash with influencers promoting HRT – illegally, since the promotion of prescription-only medicine must adhere to guidelines, which are not being met.
Should we be wary when a multi-billion-dollar segment of the pharmaceutical industry has celebs lined up to promote its products?
You make the claim that HRT protects a woman’s heart, bones, brain and more. Yet, why would women need pharmaceuticals to remain healthy?
Is there a design fault in woman?
Or has your analysis of HRT trials failed to pick up on how data are often presented with bias, in particular when we should be differentiating between the needs of women who journey through natural menopause with a uterus intact, and the needs of women who have an underlying condition that led to a hysterectomy, often with ovary removal?
From written history, we know that women have always lived beyond menopause. Before the modern era, high rates of infant and child mortality kept average life expectancy low – it’s not that women (or men) routinely dropped dead as they approached the age of 50.
There are doctors who argue that women need HRT because "we never used to live this long." It’s a shame these doctors have failed to read the data correctly. And it’s a shame that more of the discussions around menopause don’t look to the Blue Zones for inspiration and proof that women don’t need HRT to live long and healthy lives.
There’s a lot that can go right with health from lifestyle interventions. Indeed, in your book, you suggest that we treat Type 2 diabetes with cooking classes instead of prescribing insulin. You’d like to see an improvement in school lunch programs instead of giving children Ozempic. In addition, you’d be happy to focus on healthy communities to overcome loneliness instead of promoting the use of antidepressants.
However, you seem to suggest that rather than primarily promoting lifestyle interventions to ease a woman’s journey through midlife change and preserve her health in the years that follow, we should instead rely on HRT.
Are menopausal and post-menopausal women beyond the needs of a more holistic approach? Why would our bodies not know what hormones we need and when?
The rocky history of HRT
HRT first emerged as a treatment for menopause symptoms at a time when medicine believed it was in a superior position to manage milestones in a woman’s lifecycle. For most of the 20th century, hormone therapies were pushed out on women journeying through natural menopause without a single large randomized controlled trial having been completed to test its efficacy and safety.
Before the 1970s, estrogen-only therapy was given to women who still had a uterus and women who had undergone a hysterectomy. In 1975, two important studies were published in the New England Journal of Medicine, which concluded that among women who took menopausal estrogen while their uterus was intact, the risk of developing endometrial cancer was up to five times higher than normal rates, and 14 times higher than normal rates if women took estrogen for more than seven years.
By 1978, more than 30 years after the FDA first approved estrogen therapy for the treatment of menopause symptoms, the FDA mandated that all estrogen products contain a warning message that estrogen had been proven effective only for hot flashes and vaginal dryness, and that estrogen therapy carried risks of cancer and blood clots. One could say that estrogen therapy didn’t appear to be the “medical miracle” that many claimed.
In 1980, a research paper published in The American Journal of Public Health estimated that in the US, more than 15,000 cases of endometrial cancer had been caused by replacement estrogens during the five-year period 1971-1975. This, argued the paper’s authors, created one of the largest epidemics of disease that had ever occurred in the US as a result of medical intervention.
Following this scandal, progestin was added to estrogen, to protect the uterus. Without any large randomized controlled trials, this new combined HRT was prescribed to women who had not undergone a hysterectomy.
Is HRT needed to protect women from disease?
In your book, you claim that prior to 2002, studies found that women on HRT were “less likely to develop Alzheimer’s and bone fractures, and they had a 50% lower risk of dying of a heart attack when they started HRT within ten years of menopause.”
Your reference for the heart disease claim is a study entitled Estrogen and Coronary Heart Disease in Women, which was published in JAMA in 1991. This research (not a large randomized controlled trial) looked at the impact of estrogen-only therapy given to women with a pre-existing condition that led to a hysterectomy.
In the US, hysterectomies remain shockingly common – more than 20% of women between the ages of 45-64 have had one. That number is worthy of an investigation. A hysterectomy can negatively impact hormonal regulation, bowel and bladder function and sexual satisfaction. When the surgical procedure is combined with ovary removal, the risks multiply, and include an increased risk of cardiovascular disease, rapid bone loss and early death.
Some risks appear to be mitigated with estrogen therapy, but studies into the impact of estrogen-only therapy on women who’ve had a hysterectomy (with or without ovary removal) cannot be assumed to be relevant for women who are journeying through natural menopause with a uterus and ovaries intact (most women!).
A woman’s uterus and ovaries play important roles in her overall health, far beyond their central role in reproduction. A woman’s organs should not be assumed to behave like machine parts with a single function. Rather, they are intricately connected to the body’s greater intelligence.
The authors of the 1991 study on HRT and heart disease that you referenced called for large randomized controlled trials (RCTs) to test their hypothesis. The Heart and Estrogen/Progestin Replacement Study (HERS), which was published in 1998, and the Women’s Health Initiative (WHI), halted in 2002, were the RCTs needed. They both concluded that HRT did not prevent heart disease.
Another observational study that you referenced to strengthen your argument about heart disease prevention actually concluded:
“Clearly, alternatives [to HRT] should be considered that promote healthy aging and pose no risks, such as physical activity, a healthy diet, and smoking cessation.”
The Cochrane research from 2015 that you referenced on the same topic similarly concluded:
“Our review findings provide strong evidence that treatment with hormone therapy in post-menopausal women overall, for either primary or secondary prevention of cardiovascular disease events has little if any benefit and causes an increase in the risk of stroke and venous thromboembolic events.”
Regarding the claim that HRT promotes longevity, you cite research from 2004, entitled, Mortality associated with hormone replacement therapy in younger and older women: a meta-analysis. This paper, like others, conflates data of women who have undergone a hysterectomy, entered surgical menopause and women who journey through natural menopause. No conclusions can be drawn from this paper about longevity for all women.
Furthermore, the longevity claim was debunked in 2017 by research published in JAMA, entitled Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality, by JoAnn E Manson et al. Over a period of 18 years, researchers compared the mortality rates of women who took hormone replacement therapy for a median of six to seven years with women who received a placebo. The research found that women who received hormone therapy were no more or less likely to die of any cause than the women who received a placebo. The study’s authors concluded that they would not support the use of hormone therapy for reducing chronic disease or mortality.
When this research was published, it caused an earthquake in the menopause world – perhaps you missed it. The North American Menopause Society (NAMS) was forced to update their policy document on hormone therapy and remove the prevention of heart disease from the list of benefits attributed to HRT. Most of the other menopause societies in the world endorsed the new policy document. In addition, menopause doctors in the US who, before 2017, had felt very comfortable talking about supposed disease prevention and longevity benefits from HRT, suddenly had to stop sharing this made-up story. In the context of natural menopause, it’s inaccurate to declare that “HRT saves lives.”
Currently, the only disease that NAMS claims HRT can help prevent is osteoporosis. However, improved bone health is not a benefit that most women who journey through natural menopause can expect from HRT.
A healthy woman going through natural menopause will rarely experience significant bone loss at midlife. If she takes HRT during the menopause transition, she can experience an increase in bone density, however, her bone density will return to pre-treatment levels once she stops the HRT. Because of the known risks associated with long-term use of HRT, women are advised to take it for less than 10 years. Any increase in bone density experienced in midlife will not have a knock-on effect decades later, when osteoporosis would be more of a concern.
Rather than promoting a false sense of security around bone health and HRT, it would be best if from midlife, if not before, women became aware of how exercise, clean diets, low stress and time spent outdoors can protect our bones over the long term.
For women who undergo surgical menopause, the situation is different because of the risk of rapid bone loss. This risk increases when the surgery is carried out on a woman well below the average age of menopause. The immediate risk of osteoporosis in such cases can be reduced via estrogen therapy.
You state in your book, “HRT lowers the risk of a fracture by 50 to 60% according to a randomized trial,” as if this applies to all women. It doesn’t. This figure is taken from research on estrogen-only therapy, published in 1980. Once again, the needs of women who have entered surgical menopause or had a hysterectomy cannot be equated to the needs of women in natural menopause.
The Women’s Health Initiative (WHI)
With regards to the data from WHI (2002), a lot has been made of the press conference that advanced the breast cancer scare. The increase in breast cancer for the 50-59 age group may not have been statistically significant (as you argue in your book), yet something spooked the researchers.
Before it became a pharma talking point to focus on the above-mentioned press conference, most criticism of WHI pointed to the fact that women who were decades beyond menopause were included in the study and therefore skewed the results, making HRT appear riskier for all age groups. This criticism ignores the fact that when WHI was designed, many in medicine believed that taking HRT for life was safe, which is why older women participated in the clinical trial.
In the meantime, by 2012, Pfizer had paid and set aside approximately $1.2 billion to settle 10,000 HRT breast cancer lawsuits associated with their product, Prempro. Did the courts read the data incorrectly? Did Pfizer not employ intelligent enough lawyers to protect their product’s reputation and the company’s funds?
When we put the WHI results in the context of pharmaceutical messages of the time, a different scandal becomes more obvious. In addition to encouraging women to take HRT for life, women were being told that combined HRT would prevent disease, with the focus on the prevention of heart disease.
The WHI data revealed first and foremost that women had been lied to. Perhaps this should have been the headline that came out of the famous press conference. In addition, women deserved an apology.
An analysis of the Women's Health Initiative randomized trials by JoAnn E Manson et al, published in JAMA in 2013, stated:
“Absolute risks of adverse events (measured by the global index) per 10,000 women annually taking CEE plus MPA [estrogen plus progestin] ranged from 12 excess cases for ages of 50-59 years to 38 for ages of 70-79 years; for women taking CEE alone, from 19 fewer cases for ages of 50-59 years to 51 excess cases for ages of 70-79 years. Quality-of-life outcomes had mixed results in both trials.” Where adverse events include coronary heart disease, invasive breast cancer, stroke, pulmonary embolism, and more.
HRT and dementia
I’m sure you’ll agree that the decision to take any medicine must come with an understanding of risks versus benefits. Today, women are being convinced to take HRT to prevent dementia. Is there any robust research to back up this claim?
The fact that more women than men experience dementia, is often blamed on menopause. It’s as if when comparing the life of an average American woman to an average American man, the end of a woman’s menstrual cycles is the only variable that could have an impact on a woman’s brain!
Shouldn’t we consider the possibility of negative influences from hysterectomies and oophorectomies, the contraceptive pill, other pharmaceutical interventions more often given to women, low fat diets, toxic skin care, toxic cleaning products, the breakdown of the extended family leading to changing roles of elders, and more?
In your book, you cite a number of studies to back your claim that HRT can prevent cognitive decline. The first study you reference Estrogen Replacement Therapy and Risk of Alzheimer Disease was published in 1996 in Archives of Internal Medicine. This study only examined the use of estrogen therapy which, once again, when given without a form of progesterone, suggests that the women included in the study had undergone a hysterectomy.
The Mayo Clinic cohort study, which was analyzed in the 2009 research paper you referenced, observed the health of women who had undergone a bilateral oophorectomy (surgery to remove both ovaries) and were thus exposed to higher than average risks of disease than women in natural menopause. The research stated: “The risk-benefit balance of prophylactic oophorectomy versus ovarian preservation remains uncertain and controversial.”
The research also stated, “Approximately 600,000 women undergo bilateral oophorectomy in the U.S. every year, many before reaching natural menopause.” With the risks of this surgery so high, who is profiting from this situation?
Of the three additional studies you cited, two examined women who had a pre-existing condition that led them to have a hysterectomy. The third examined women who were considered to be at high risk of Alzheimer’s, but the study’s authors could not establish causality between HRT and a lower risk of dementia.
It’s not that more robust research on women in natural menopause has not been carried out.
Dr Lisa Mosconi teamed up with Dr Matilde Nerattini et al to publish 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 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 observational studies that investigated the use of estrogen-only therapy in women post-hysterectomy.
Unfortunately, the least significant data point from this research (observational studies of estrogen-only therapy) has been used to convince all women that HRT prevents dementia.
A large Danish study on HRT and dementia was published in the British Medical Journal in June 2023. Between the years 2000 to 2018, researchers investigated the medical records from all Danish women who were between the ages 50-60 in the year 2000. This covered the records of over 60,000 women. The study found a correlation between the occurrence of dementia and short- and long-term use of HRT. The data indicated that the longer HRT was used, the higher the risk.
Within the limits of this observational study, the Danish researchers concluded: “Further studies are warranted to determine whether these findings represent an actual effect of menopausal hormone therapy on dementia risk, or whether they reflect an underlying predisposition in women in need of these treatments.”
In other words, could women who experience more severe menopause symptoms (leading them to take HRT) also be more likely to experience dementia? Could severe menopause symptoms represent a valuable signal that there’s a source of imbalance in a woman’s life that can be corrected through lifestyle intervention, and thus dementia avoided?
If we embrace the researchers’ concluding statement, wouldn’t fewer menopause symptoms requiring less medical intervention be an ideal short- and long-term goal?
The price of pathologizing milestones in a woman’s lifecycle
In chapter 7 of your book, Blind Spots, you note how the risk of postpartum depression can be reduced by 50%, and the health outcomes of babies improved, simply by allowing the mother skin-to-skin contact with her baby immediately after birth.
Skin-to-skin contact is often denied to women whose birth is managed by a doctor in a hospital, since babies are regularly quickly whisked away for medical checks, even when the infant is not considered at risk.
Care given by a midwife during labor and birth is likely to create better outcomes overall than care given by an obstetrician in low-risk pregnancies delivered in a hospital.
During labor, medicine can be on hand for emergencies, but pathologizing birth and replacing midwives with doctors, increases the chances of unnecessary medical interventions and complications.
The time leading up to labor is also crucial. Women have better birth outcomes when they are knowledgeable and don’t fear the birth process. Relaxed birthing mothers birth best.
Similarly in perimenopause and menopause, a compassionate and empowering approach, which offers information without fear, will serve women better as they journey into their post reproductive years. The recent surge in “menopause awareness” has led to endless discussions about symptoms, disease and suffering.
Just as medical students can experience symptoms of a disease that they are studying (second year syndrome), what do we think the current depressing model of “menopause awareness” is doing to women’s experiences of their health at midlife?
Can you imagine if we pushed an equally fearful narrative about puberty and menstruation on pre-adolescent girls? Even though some teenage girls will have challenges in puberty, isn’t it better to focus on our innate well-being and how we can stay healthy so we can avoid medical management of menstrual cycles?
Prior to modern medicine, women not only found natural ways to cope with the menopause transition, they also, on average, lived longer than men, as they do today.
As you’re aware, the US currently has the worst health outcomes of OECD nations. The population is facing unprecedented challenges with obesity, chronic disease, stress and mental ill-health. However, almost no-one seems to want to join the dots between the health of American women and how they might experience the menopause transition. In all cultures, women’s hormones drop when their menstrual cycles end, yet there’s no single way to experience menopause.
Menopause is not a pathology and the compassionate midwife model of care is much better suited to these years of change, which like the journey into motherhood, represent a physical, mental and spiritual rite of passage.
Most doctors are not trained in what Plato described as medicine for the free. Squeezing menopause into the current “slave” model of medicine – take this pill, patch or cream and carry on – results, at best, in the type of symptom suppression that you seem to oppose in other areas of healthcare, in addition to exposing women to risks.
HRT is not a panacea
HRT prescriptions often commence a game of symptom “whack-a-mole.” Unlike other commonly prescribed medications where a doctor would not expect a high percentage of patients to return with side-effects, spend time where menopausal women hang out and you will hear endless stories of HRT helping certain symptoms while unleashing others. It’s common for women to have to return several times to a physician until the “right” type of HRT is found, if it can be found at all. This is frustrating for patients and doctors.
Even newer forms of bioidentical HRT come with a long list of common side-effects. Some side-effects, such as increased levels of depression, which according to product data is experienced by up to 20% of oral progesterone users, can easily be misdiagnosed as worsening menopause symptoms, leading to additional and unnecessary medication.
Nonetheless, some women do claim to feel better on HRT. In your book, you share that while you were a medical student, you encountered a female patient suffering from new-onset abdominal discomfort, palpitations, depression, numbness and tingling. You witnessed HRT work like magic but in an honest review of this case, is it possible to rule out a powerful placebo effect?
The North American Menopause Society policy document on hormone therapy, published in 2022 with over 340 references to menopause and HRT research, offers no evidence that HRT can cure the symptoms your patient experienced.
A woman can often be caught off-guard by symptoms at midlife. Without knowledge of what to expect in perimenopause, a sudden onset of symptoms, such as palpitations, can help convince her that there must be something seriously wrong with her health. The woman can then develop health anxiety, which can lead to additional symptoms.
Once a woman is given a framework for her symptoms, assured that she’s not about to die, and given a promise of a hormonal “cure,” the placebo effect can indeed work like magic. I frequently come across social media posts where women declare HRT cleared up all their symptoms within days. Hormonal treatments don’t work that fast; the placebo effect does.
It would be wonderful if under your leadership at the FDA, the data from placebo treatments could become more easily available.
In the meantime, a placebo has been found effective in trials of HRT. For example, the Cochrane Library 2004 systematic review of HRT use for hot flashes found that in women who were randomized to receive a placebo treatment, a 57.7% reduction in hot flashes was observed between baseline and end of study. This figure emerged from trials with estrogen-only and estrogen plus progestogen therapies. Given what we know about the risks that are associated with hysterectomies and surgical menopause, the placebo effect observed in estrogen plus progestogen trials might be even higher.
Peri/menopause is a sensitive time.
All times of hormonal change in a woman’s lifecycle, including pregnancy, postpartum and peri/menopause, are sensitive times. Just as high stress and a poor lifestyle during the sensitive months of pregnancy and postpartum can rapidly lead to symptoms, so can a life lived out of balance rapidly lead to symptoms during the sensitive years of the menopause transition.
In your book, you have tried to convince the reader that HRT is a panacea for women. You have branded menopause as a hormone deficiency and cause of disease. However, what if we viewed peri/menopause as an intelligent sensitive time – a turning point in a woman’s life designed to bring her back to a harmonious path of good health? What if symptoms at this time, which are by no means inevitable and cannot be predicted through hormone testing, are signals designed to alert a woman that her life is out of balance?
Many doctors like to point to charts of increasing rates of chronic disease from midlife on and single out menopause as the culprit (even though similar charts exist for men). If we viewed symptoms as warning signals, rather than rushing to try and suppress them, could we improve health outcomes from midlife on?
Ten years ago, I was able to heal my perimenopause symptoms following an insight into how I could live with less stress, regardless of life’s circumstances. I witnessed my night sweats, frequent migraines, skin problems, two weeks of PMS every month, and more, all disappear, without any need to “fix” my hormones.
Since that time, I’ve helped hundreds of women have a similar experience. I teach women how they can remove internal chaos from their life and reconnect with inner peace. From that place, they often eat better, exercise more and follow their passions in life – a great recipe for symptom-free, long-term vibrant health.
However, I first have to help women regain trust in the wisdom of the body. If we believe in the myths that menopause is a malfunction and that we need HRT to prevent disease, we create obstacles to healing, and expose ourselves to needless risks from long-term medication.
You argue that a medical blind spot around menopause was created from the Women’s Health Initiative (2002). I would argue it happened long before. The first doctors who thought it was a good idea for all healthy menopausal women to be given HRT, also worked in medicine when the horrendous birthing practice of twilight sleep was standard, and breastmilk was considered primitive compared to “more scientific and advanced” formula milk.
All three medical practices – medicating women from midlife on, knocking women unconscious so doctors could birth babies, and discouraging women from breastfeeding – are rooted in the idea that a woman’s body cannot be trusted.
Since the 1960s, medicine has sought to convince women that menopause hormone therapy can relieve dozens of symptoms and protect them against disease. The most recent policy document on hormone therapy published by the North American Menopause Society states that the types of symptoms that HRT has been proven to treat only include vasomotor symptoms (hot flashes and night sweats) and the genitourinary syndrome of menopause. The research that you presented in your chapter on HRT, does not provide robust evidence that HRT can offer relief for additional symptoms or prevent disease for women who journey through natural menopause.
Menopause is not a biological mistake and our symptoms are not a sign of malfunction. Menopause symptoms offer us messages about our health and we have a choice – learn to listen to the body and allow it to guide us back to balance so we can be healthy and free, or enter slavery with the belief that from midlife on, our health is dependent on products dispensed at pharmacies.
PLEASE CONSIDER SHARING THIS POST so we can broaden the discussion on MAHA, menopause and HRT.
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