The PGspot - Rethinking Menopausal Hormone Therapy: Insights from the FDA Roundtable

In this episode, we break down the key takeaways from the recent FDA roundtable where leading physician experts presented compelling data on the safety and efficacy of menopausal hormone therapy (MHT).

Tune in as we explore how decades of research are challenging outdated perceptions, what the latest evidence means for patients and providers, and why experts are calling for a more balanced, evidence-based conversation around MHT. Whether you're a clinician, patient, or simply curious about women's health, this episode offers a clear and timely summary of where the science stands today.

Topics covered:

• The evolving safety profile of MHT
• Misconceptions rooted in past studies
• Clinical guidance from hormone therapy experts
• What this means for the future of menopause care

If you want to learn more about sexual health, sexual dysfunction, or how to improve your sex life, follow me on Instagram at @thepgspot or check out my website at doctorpattyj.com for blogs and resources related to sex positivity and real talk about sexuality.  As as always, stay curious, stay empowered, and stay you.

Transcript

0:08

Welcome to the PG spot, where our goal is to take the X out of sex by breaking down the barriers that prevent open communication about sexual health. I'm Dr. Patty Jalomo, a dual certified nurse practitioner, pelvic floor therapist, and certified sexual counselor. I'm here to provide expert insights, debunk myths, and empower you to embrace your sexual wellbeing. Whether you're looking for answers or simply curious, join us as we open up the conversation around sex, intimacy and everything in between. I want to take this opportunity to acknowledge that some content may not be appropriate for all listeners. I'm a huge proponent of honest and accurate information regarding sexuality. But I'm also mindful that this should be age appropriate. Therefore, if you are under 18, this may not be the podcast for you. Additionally, some of the language used in this podcast may be offensive to some listeners. Please take these things into consideration before going forward with your consensual participation in this podcast. The opinions expressed by myself or my guests are just that, and these opinions are neither expected or required to be shared by all listeners. The information that is provided is for educational and entertainment purposes only, and should not be mistaken for individual medical advice if you do find the information that we cover in the PG spot. Helpful. Interesting or informative. Please rate and review the podcast wherever you're listening from. If you think this information is important, I would love for you to share it with your friends or family. This is a great way to get the information out to more people. So thank you for listening and let's get on with the show.

Patty 1:47

Hey everybody and welcome to the PG spot. This is your host, Dr. Patty Jalomo, and today I want to talk about a video that I just finished watching for the second time on YouTube that you all can go on and find on your own, but if you don't wanna sit through. Two hours of research. I really just wanted to summarize it in today's episode. So some of my favorite people were on that video and basically there was a group of physician experts that went to the FDA to really pitch for removing the black box warning off of especially vaginal estrogen, but also just really presenting data that. Showed some of the pitfalls of the Women's Health Initiative study in 2002 that really just changed the lives of. Perimenopausal and menopausal women in the US and the world over the past two decades. So today we're going to dive into what was discussed in that video. Again, if you all really want to sit down and listen to it and watch it. It was really informative and they all did a great job in presenting their case. So you can just really just search for the FDA panel on menopause on YouTube, and you should be able to watch that. But let's get started. First of all, Dr. Marty McCarey, he's the FDA commissioner. he started off the round table by presenting some data and a little bit of a personal story of his own. The first thing that he mentioned was that in the 1950s, the Mayo Clinic researchers looked at women who had their ovaries removed and found that they all went on to have early heart disease, which was very suggestive of a powerful protective cardiovascular effect of intrinsic estrogen that's made in the ovaries. There were other studies that went on to show that when a woman starts getting estrogen or estrogen with progestin or progesterone, as we prescribe now within 10 years of menopause, There's a roughly 25 to 50% reduction in fatal heart attacks and cardiovascular disease, And that is actually comparable to, or even greater than the risk reduction of a statin medication. Cardiovascular disease is the number one cause of death in women. I know a lot of the women that I see in my practice, their first response to hormone therapy or the first fear that they express to me is that of breast cancer. And I always find that interesting because nobody talks about cardiovascular disease and. With early introduction of menopausal hormone replacement, that can be reduced by 25 to 50%. So I think that's a huge takeaway that I really want my patients and everybody to start thinking about. He also mentioned in 2015 there was a finished study that Showed when women who were taking menopausal hormone therapy stopped the risk of fatal heart attack actually increased by 26% in the first year that they quit taking the, their hormones. So the Women's Health Initiative which was a big study back in 2002, it really was looking at the question was. Do we start everybody on hormone replacement for the preventative benefits of cardiovascular disease. And so the aim of that study was to enroll a wide variety of women. So the average age of initiation of hormones in that study was 63. what we now know, and really what we got from that study as well, is that the best time? To initiate menopausal hormone therapy is within that first 10 year period of becoming menopausal, or approximately age 50 to 59. That's not to say that women who are 60 and over or that are 10 years out from menopause can't be started on menopausal hormone therapy. It really is a very nuanced conversation and certainly something that you would wanna talk to your provider about. But that's what the WHI in 2002 showed that average age of initiation was age 63. And then in a 2017 re-analysis of that study by Manson and all in JAMA found that in the group under age 60, there was a decrease in all cause mortality in women that took hormone therapy. And then we reminded that in the Women's Health Initiative, it was suggested that menopausal hormone therapy caused breast cancer. And that really caused many women to go off of hormone therapy. People were just flushing their hormones down the toilet. However, in that paper there was actually no statistically significant increase in breast cancer mortality. Then Dr. McCarey went on to tell a story of his mother, who was subsequently not offered menopausal hormone replacement due to the WHI, and then went on to have bone fractures hip fracture. And we know that estrogen reduces the risk of bone fracture by up to 50%. that came from data that was included in a randomized controlled trial that was published in the New England Journal of Medicine. And also studies show that there's a decrease in the risk of cognitive decline by up to 64% and Alzheimer's by 35%. So then it started with our panel of expert physicians and Dr. Heather Hirsch was the first physician who presented, they each had five minutes to present on something that they were passionate about and something that they wanted to get out to the FDA and to the public. Dr. Heather Hirsch said history got it wrong. The distinction between topical. Local or vaginal estrogen versus systemic menopausal hormone therapy was really something that she wanted to stress and pointing out that vaginal estrogen does not get into the bloodstream and is therefore pretty much safe for all women. Vaginal estrogen actually has an FDA approval for treatment of genital urinary syndrome of menopause or those. Vaginal vulvovaginal changes that occur due to lack of estrogen. However, the FDA has a black box warning, which is a highest safety warning on vaginal estrogen, stating that it causes endometrial cancer, breast cancer, cardiovascular disease. Stroke, blood clots and a host of other scary things, and this is causing people not to use it. We can get the prescription. They go home, they open the box, and they see this black box warning that says that it causes, all of these horrible things. And they think that we're trying to kill them, so they throw it away. Now, the FDA has the same black box warning on systemic estrogen. However, no study has ever shown an association between estrogen and breast cancer mortality. The other thing that she pointed out was that, there is an important difference between hormone replacement therapy and menopausal hormone therapy. So HRT is indicated for and medically necessary for women going through menopause before age 40 to 45. So early or premature menopause. it is essential that these women do receive hormone replacement therapy until. At least the average age of menopause, which is about 52, and possibly further, but menopausal hormone therapy or MHT is estrogen or estrogen in combination with a progestin or a progesterone, with or without testosterone, and there's important nuances in safety considerations based on the route, the formulation, which is the chemical structure and the timing. She also went on to say that 50 million women between the ages of 40 to 60, due to a gap in training and unwarranted fears resulting from the women's health initiative, many of these women are not offered this life altering hormone therapy. The next presenter was Barbara Levy and her main point was not all hormones are the same. So Dr. Levy differentiated between hormones used in the Women's Health Initiative, which was a. Medication called Premarin, which is conjugated equine estrogen. And the progestin component was hydroxy progesterone acetate which is a synthetic progestin, and it's not what is considered natural to human, which would be progesterone. Additionally the estrogen that. We now typically prescribe that is considered natural to humans is 17 beta estradiol. So two very different combinations of hormones that were used in the WHI as compared to what is typically prescribed now. And these are different chemical structures and they bind to receptors differently. As I stated the purpose of the WHI asked the question, do we start all women on hormones to prevent cardiovascular disease? therefore, women of all ages were involved in a study with an average age of 63 and those that had other comorbid conditions, so either previous cardiovascular disease, a lot of the women in the study were smokers and obese women. So data from that study was specific to the conjugated equine, estrogen and a progestin, which is again, Yeah. Much different than the hormone therapy that is used today. Yet it all gets slumped into one category. So one of Dr. Levy's points was that we really need studies that stratify to age, dose, and chemical structure instead of just bunching all of these things together because of the data that got out in the WHI. Menopausal hormone therapy was also put on the Bears list. Now the bears list is a list of medications that are considered to be dangerous for those over 65. So obviously. N going into your provider's office as a woman who is say 67 and they're on hormone therapy, a lot of the providers in the past have said, oh no, you've been on that too long. You need to get off of that. It's on the beers list. So that's something that really needs to be addressed as well. The next presenter was Dr. Joanne Manson. And, can't remember if it was Dr. Manson or Dr. Pinkerton, but they basically presented for both of them. And so the information that was presented by Dr. Manson was data that showed that estrogen alone has different effects. Then the estrogen progestin combination. In the WHI, in the 50 to 59 age group, Estrogen alone showed a decreased risk of coronary heart disease, stroke, breast cancer, colorectal cancer, all cancers, all fractures, diabetes and all cause mortality. In the estrogen progestin arm of that study, it showed a slight increase in coronary heart disease, stroke DVT, or deep vein thrombosis and breast cancer risk, but no increase in breast cancer mortality. So she presented data that showed those slides, and then Dr. Joanne Pinkerton went on to speak about genital urinary syndrome of menopause and the increased incidence of urinary tract infections or UTIs. Again, she stated that the boxed warning on vaginal estrogen Says that it can cause breast cancer, endometrial cancer, cardiovascular disease, blood clots and stroke, and a probable risk of dementia. There is an absence of randomized controlled trials or consistent observational evidence linking vaginal estrogen to any of these things. Then Dr. James Simon, spoke on class labeling. So class labeling basically says that if there is, for example, estrogen in a product, that same label goes on any product containing estrogen. So again, that's why the vaginal estrogen has the same warnings as say, an oral estrogen which. Because it's a different route. It's a different, it's used to treat different things. It's a different dose. It has very different potential side effects. So his main point was that the FDA really needs to be consistent with product data that is presented in also consistent with the scientific literature. He stressed that the label for the product must be fair and be consistent with other products that are used for the same issue. So he is the example of DHEA, which is a precursor basically to estrogen and testosterone. But it is available in a brand name. Medication called OSA that can be used for genital urinary syndrome of menopause. And then he compared that to another option which is an estradiol called brand name Ivey. That is a little al that is inserted into the vagina again for genital urinary syndrome and menopause. So two different options of treatment. Basically they both are estrogen products. The DHEA converts to estrogen, but they don't have the same boxed warning. So that was something that he feels is important for the FDA to address and. Then lastly, he stressed that you can't measure vaginal estrogen in the blood. So in order to cause the problems that are listed on the box warning, the chemicals must travel in the blood to those organs. The endometrium would be the first stop. And again, that vaginal estrogen has a boxed warning saying that it could cause endometrial cancer. And when looking at the observational studies of 400,000 US women and 200,000 Denmark women, there is no effect on the endometrium. And so this is why the guidelines themselves don't even require progesterone. To be given in addition to vaginal estrogen for endometrial protection because it does not get absorbed in the blood system. It does not get to those organs, and therefore we really feel that those contraindications and those warnings need to be removed from that black box warning especially on vaginal estrogen. The next speaker was Dr. Phillips Sill, and he spoke on the negative effect of vasomotor symptoms on productivity and healthcare costs. So vasomotor symptoms are those hot flashes, night sweats. Those are some really common complaints in women who are menopausal. But again, over the past two decades, because we've been withholding hormone therapy for. The majority of women or the public has been scared about using hormone therapy. A lot of women have just suffered through that, and it really does have a profound effect on their productivity and even on healthcare costs. So he stated that estrogen is the master regulator of the brain, So he discussed a study that looked at insurance claims within a one year timeframe from two separate groups of women. Those women with hot flashes and those without hot flashes. And there were about 252,273 women in each group. And they all worked for Fortune 500 companies. So these were high functioning women. and this study found that the women. With untreated hot flashes had one and one half million more visits for medical care, and the cost for healthcare and work loss was$400 million more. So that is a significant difference and that tells us just how detrimental hot flashes and those vasomotor symptoms are to not only women's productivity, but overall healthcare costs. The next point that he made was that death that was attributed to avoiding estrogen was significantly increased. And by the age of 51 half of women in the US have reached menopause, and one third of women in the US have had a hysterectomy. So in 2011, the WHI reported that women aged 50 to 59 who received conjugated equine estrogen compared to women who received placebo, had 12 fewer myocardial infarctions, or heart attacks, and 13 fewer deaths per 1000 women. So the women who died were all under age 70.'cause this was a 10 year follow up. So they would've been in that 50 to 59 year age group during the original study. So he and his team at Yale used those numbers to calculate that almost 50,000 women in the US had died between 2002 and 2012 because of avoidance of estrogen. And then in the years since that original calculation, another 100,000 women have died in their fifties and sixties because they didn't use estrogen replacement after hysterectomy. At the rates of the 2002 data and more recent WHI data shows that women started on estrogen between. At the ages of 50 or 59, or within that 10 year window of initiation of menopause show decrease in all cause mortality by 32%. So these figures are completely different than what most of my patients come in knowing or thinking that they know about menopause. So very important to get this information, this correct information out there. The next speaker to present was Dr. Roberta Diaz Brenton, and she discussed the brain effects that come along with menopause. She said that two thirds of Americans with Alzheimer's are women, she looked at data from PET and MRI studies that show a decline in glucose metabolism and a coincidental rise in deposition of beta amyloid in the brain during menopause transition, and they also saw a loss of white matter. So white matter is important for its connections that enable communication across Neural circuits in the brain giving rise to symptoms such as brain fog and loss of words. The change in the mitochondria from efficient to inefficient results in brain changes that influence brain heat. And that's what causes the hot flashes. So those hot flashes originate from the brain. And then she also pointed out that menopausal hormone therapy is associated with reduced risk of Alzheimer's disease, Parkinson's disease, all cause dementia. Multiple sclerosis and a LS. So certainly during menopause, the brain is changing. There's a decline in glucose metabolism that activates a starvation response and that leads to utilization of accelerate fuels, which are provided by the white matter in the brain. And that's why on those PET and MRI scans, they showed a decrease in white matter. Our bodies are basically. Categorizing the white matter of the brain to get the energy that it needs. So menopausal hormone therapy initiated before these changes in the brain happen is what leads to decreased risk of these neurological diseases. Next. Dr. Vonda Wright, who is an orthopedic surgeon, came on to speak about bone health. So the statistics that she presented were that 40% of all women will develop osteoporosis, There's a 20% loss of bone mineral density at menopause, and 50% of these women with osteoporosis will suffer osteoporotic fractures, and that's expected to double by age 40. 70% of all hip fractures are in women, and after suffering a hip fracture, you have a 30% risk of death in the first year from complications and a 50% chance of never returning to normal function. Bone health is significant. The WHI found a 35% decrease in fracture in women on estrogen. And other studies show that this may be up to 50% reduction in osteoporotic fractures. So we know that estrogen plays a key role in the remodeling of bone. as much so that the FDA actually has approved estrogen for prevention of osteoporosis, yet only 4% of women in this country enjoy these benefits. Another thing that she pointed out was that estrogen must be used for 10 years to get the benefit, and within six years of stopping, bone loss will decline as if you've never had it at all. So this really plays into the question of how long do I stay on my hormones? And in the past, the recommendation was. To use the lowest dose possible to manage your symptoms for the shortest amount of time. We now know that there is no set time limit and the guidelines from the Menopause Society and even acog, the American College of Obstetricians and Gynecologists guidelines support that. So the next speaker was Dr. Kelly Cassper, and I love Dr. Casper. I listened to her podcast. You are not broken. She's got so much good information and she's funny as hell. So anyway, Dr. Casper is a urologist and she came on to speak about testosterone. She said that in a 2025 study, it showed that women that were given a female dose of testosterone were 50% less likely to need a cane or a walker after a hip fracture. Testosterone was first developed in 1935 and has been being used by women since the 1940s. In fact, as many women in the US as men use testosterone testosterone is approved for men for hypogonadism and. About one in five men are diagnosed with this, and that is when your body stops making enough testosterone. interestingly, the same thing happens to women in the sense of our ovaries shutting down. And nearly all women will experience this if they live long enough. So testosterone is a neural hormone, so it acts on nerves, muscle, bone, brain function. It has been stereotyped as a sex hormone or libido hormone, which it can help with libido, but the way that it does that is it works to improve libido because it acts in the brain and that involves improvement in dopamine and blood flow. And so then you're feeling better. And Obviously then you're gonna wanna have more sex. Interestingly, the FDA rejected two attempts of female dose testosterone for lack of safety data. However, that rigid requirement for safety data was not imposed on more than a dozen formulations that are FDA approved for men. They only required six months of safety data. A female dose would be much lower, And we've been giving trans males 10 times this dose for many years. So therefore women are forced to microdose testosterone and pay cash. There are four countries that have approved female dose testosterone available, and that is New Zealand, Australia, South Africa, and the uk. However, it is only approved for decreased desire, which then forces women to justify treatment only for sexual function, which is. Already stigmatized and in the US anyway. Oftentimes those things aren't covered by insurance. Also, she stated that dementia is a fifth leading cause of death in women and autopsy. Studies show that higher brain testosterone is correlated with less dementia, so another benefit of testosterone. So she basically had four asks of the FDA in regards to a female dose testosterone. Number one, she asked, let's fast track female dose testosterone under the new FDA commission's national priority voucher. Second, Clarify and simplify the regulatory guidance. Third, approve it for hypogonadism, not just low desire. And four, work with the DEA to declassify, low dose testosterone for women and get that off of the high risk list is considered a controlled substance based on the doping scandal from the 1980s Olympics. So let's get that classification off of testosterone and that way it would be easier to get this available for women. The next speaker was Dr. Mary Jane Minkin, and she is an O-B-G-Y-N, who spoke on the lack of training and education around menopause. in 2013, there was a study that showed that only 20% of medical residents reported getting training on menopause management. And in 2023 that had only increased 10% up to 30%. So as Dr. Minkin stated, on July 9th, 2002, when the Women's Health Initiative study came out, menopause education got cut. She really stressed the importance of healthcare providers getting better training and up-to-date and evidence-based menopause management. This includes not only just the gynecologists, but urologists, primary care providers, PAs, nps. We all need more education on menopause management. The next speaker was Dr. Rachel Rubin who I love Dr. Rubin as well. And Dr. Rubin spoke on genital urinary syndrome and menopause. So in 2014, a round table of experts that included Dr. Irwin Goldstein, who was one of the key. Founding members of the International Society for the Study of Women's Sexual Health or isw. And its first president actually got together and changed the nomenclature of what was then known as vulvovaginal atrophy to genital urinary syndrome of menopause or GSM. So this included a very important component of this inevitable consequence of menopause, and that is the importance of the urinary system. So symptoms of GSM include recurrent urinary tract infections, urinary frequency, urinary urgency, painful urination, urinary incontinence, vaginal dryness, painful sex, decreased lubrication, decreased arousal and And difficulty with orgasms, so it's a lot more than just vaginal dryness. In April of 2025, the American Urological Association developed new guidelines for the management of GSM. And this was actually not a, an overnight project. This was seven years in the making. And Dr. Rachel Rubin was a part of that as well. But these guidelines recommend vaginal estrogen as a first line treatment for GSM. She presented information and statistics that urinary tract infections cause 7 million hospital visits per year and make up 25% of the infections in adults, and The mortality rate of urinary sepsis is rising, and we all know that chronic antibiotic use is dangerous. Vaginal estrogen can prevent greater than 50% of urinary tract infections in women. In 2024 there was a publication by sexual medicine research team that was headed by Dr. Rubin, and this showed that. If all women in the age of Medicare use vaginal estrogen, which you can get it as a cash pay in a lot of places for around$13 a tube, that could save the government billions of dollars per year in decreased urinary tract infection costs. Local vaginal estrogen is safe, effective, and essential, but yet the FDA box label that was blanketly placed on all estrogen products in 2003 and has zero evidence, says that again, vaginal estrogen causes strokes, heart attacks, blood clots, breast cancer, and probable dementia. while in fact there are no studies in the literature that support this, and frankly, it just scares women. Dr. Rubin went on to tell the panel of a very personal story about her mother. She said that the FDA's boxed label tried to kill her mother, Her mother was in the ICU for six months, and while she was in a coma immunocompromised and with a catheter, the ICU team refused to start her home dose of local vaginal estrogen. They'd never even heard of it. They justified their answer by stating that the box said it would cause stroke. Heart attack and blood clots. So she brought in literature and evidence to the contrary and emphasized that U sepsis could quickly kill her mother. And so finally, she was able to help the ICU providers be able to write a prescription for her mother's vaginal estrogen cream. And then once they had the prescription, though, the pharmacy wouldn't dispense it because of a big warning sign that comes up on the computer saying the same thing. Finally after getting the cream in the room, her last hurdle was that the nurses didn't even know how to use it. So she stated that her and her family instructed them on how to use it. And basically her point is that if it takes that much for a hormone and menopause expert to get other healthcare professionals to get vaginal estrogen for their hospitalized loved ones, what then are other people to do? she handed her presentation by urging the FDA to remove the box label from vaginal estrogen, and she said that her family deserves better and everyone deserves better. Lastly, Dr. Howard Hodis really broke down data from the WHI. So in the first WHI manuscript, he said, the author stated that in the estrogen progestin arm of the study, breast cancer almost reached statistical significance. It never actually reached statistical significance and so then it should not have ever even been included in the paper. But unfortunately it was, and again, this then put the fear of hormones in everybody including providers and patients. He presented data from the WHI on outcomes from the estrogen alone arm and the estrogen plus progestin trials. On women that were started on hormone therapy prior to age 60. DVT in the estrogen progestin trial was the only adverse outcome to reach the rare threshold of one event per 1000 women per year. Other adverse events he said were rare and none statistically significant as compared to placebo, and that included breast cancer, all cause mortality and all cancer deaths. Colorectal cancer and all cancer types were reduced. Contrary to claims lung cancer was not increased by either arm of the hormone therapy, estrogen alone, or estrogen plus progestin. All fractures and diabetes were reduced in both trials and ovarian cancer was not increased with the E plus P, as was claimed. Alzheimer's disease and dementia mortality across all women was significantly reduced by estrogen alone after the 18 year follow up and breast cancer was reduced in the estrogen alone trial and still reduced after a 20 year follow up. He stated that a Cochrane meta-analysis had data consistently showing that hormone therapy decreases coronary heart disease by 50%, and all cause mortality by 30% in women starting hormone therapy. Prior to age 60 or within 10 years of menopause, women aged greater than 60 or greater than 10 years of menopause showed no benefit. Additionally, The study showed no effect on stroke. So that is just a brief overview on the main points that each of these providers, these physicians and menopause experts presented to the FDA in this round table discussion. Again, if you would like to really. Watch the whole thing and see their presentations and get all of the data. you can get on YouTube and just search for the FDA panel on menopause and that will come up. it was very informative. I watched it like three times and again, I just wanted to share that data with everybody on today's episode and just encourage everybody to really look at the data. Don't just go by what your cousin's mother told them or what you've heard. We really have to start looking at up to date evidence-based research So that's all I have for you today, I hope you enjoy the show and we'll catch you next time.

33:32

That's it for today's episode. Thanks for listening, and be sure to rate and review the podcast on whatever platform you're listening from and share it with your friends. That's a great way to help reach new listeners and make this a more sex positive world. Also, I'd love your feedback and questions, so send me a message. It's at email@doctorpattyj.com, and that's doctor spelled out, D-O-C-T-O-R-P-A-T-T-Y j.com. Until next time, stay curious, stay empowered, and stay you.