Afaxys Candid Conversations in Public Health

What’s New in Menopause Care?

• Afaxys • Season 1 • Episode 7

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In our seventh episode of Afaxys Candid Conversations in Public Health, we discuss a truly “hot” topic—menopause. As a public benefit corporation devoted to serving safety net clinicians and their patients, Afaxys recognizes the disparities in menopause care for women seeking treatment at public health clinics, so we brought in world-renowned experts to talk about the ins and outs of menopause care, particularly during perimenopause. The esteemed Dr. Steven Goldstein and Dr. Lauren Streicher joined us for a lively discussion around the importance of individualizing treatment based on patient goals and medical history rather than following one-size-fits-all approaches. 

  • Dr. Steven Goldstein is Past President of the International Menopause Society, Past President of the North American Menopause Society, and Past President of the American Institute of Ultrasound in Medicine. He currently is a professor of Obstetrics and Gynecology at NYU School of Medicine. He has authored over 150 peer-reviewed articles and 60 book chapters. He authored the book Could It Be Perimenopause 27 years ago, as well as the first Textbook of Perimenopausal Gynecology 24 years ago.
  • Dr. Lauren Streicher is a clinical professor of Obstetrics and Gynecology at Northwestern University's Feinberg School of Medicine. She is also a Certified Menopause Practitioner of the Menopause Society and the founding medical director of the Northwestern Medicine Center for Sexual Medicine and Menopause. Dr. Streicher is a best-selling author of multiple books and the host of the podcast series “Inside Information” as well as “Come Again,” an educational audio series for patients and clinicians. She is a noted and sought-after authority in menopause and sexual health, having appeared on The Today Show, Good Morning America, the Oprah Winfrey show, and many other media outlets.

Disclosures:

Dr. Goldstein is a speaker for Bayer and Astellas, served on an advisory board for Astellas, and served on a safety monitoring board for Bayer and Mithra.

Dr. Streicher is a stockholder in Sermonix and gives educational lectures to healthcare professionals on behalf of Bayer Pharmaceuticals.

Resources:

Educational content only — not a substitute for professional medical advice. Opinions are those of the speakers and not necessarily of Afaxys. Visit Afaxys.com for resources.

SPEAKER_01

Welcome to Afaxis Candid Conversations in Public Health, a new podcast series from Afaxis, a public benefit corporation serving public health clinicians and their patients. Join us as we head to the front lines of sexual and reproductive health care, bringing you timely discussions with leading experts who are shaping the future of public health.

SPEAKER_04

Good morning and welcome to Candid Conversations in Public Health, an FAXA-sponsored program developed to bring together leading experts in the field of sexual and reproductive health to discuss relevant topics of importance to the public health community. Our topic for today, which is the seventh in our series of 10 podcasts, is on the front lines of menopause. We all know that this hot topic is such an important one, relevant to women, and without a doubt exploding in the news and on social media. In fact, we moved up this program within the series as the impact that it is having on women seeking and gaining access to treatments is quite intense and has been nuanced a bit recently. So it's a perfect time to have bona fide medical experts discussing this topic. I'm Dr. Beth Atias, and it's my pleasure once again to be moderating today's discussion. Dr. Felipin and I are joined today by two vibrant and accomplished guests who have made significant contributions to this field and are passionate about and committed to the work that they do each and every day. We are delighted to have with us today the dynamic menopause and sexual health and medicine expert, Dr. Lauren Stryker. Dr. Stryker is currently clinical professor of septics and gynecology at Northwestern University's Feinberg School of Medicine. And she is also a certified menopause practitioner of the Menopause Society and the founding medical director of the Northwestern Medicine for Sexual Medicine. This is only the tip of the iceberg of her accomplishments and accolades as she is a best-selling author, podcaster of two series titled Inside Information and Come Again. She is a noted and sought-after authority in the area of menopause and sexual health. We're equally delighted to have the renowned world leader in endometrial sonography and menopause, Dr. Stephen Goldstein, also on this podcast with us this morning. Dr. Goldstein is currently professor of obstetrics and gynecology at NYU School of Medicine. He has pioneered work in menopause and perimenopausal ultrasound and is one of the most highly recognized and regarded individuals in the field of vaginal probe ultrasound worldwide. Dr. Goldstein has also been president of the North American Menopause Society, now known as the Menopause Society, in addition to the International Menopause Society, and he wrote a layperson book on perimenopause 28 years ago. I loved it. This could it be menopause book, and the very first textbook of perimenopausal gynecology 24 years ago. So he has been charting the course for patients and HCPs for decades. He is also an author, speaker, and maintains a clinical practice. You have heard the expression, these folks wrote the books on this, but I'm absolutely knocking when I say that they actually have written the books on this, and in fact they still are. So we're so fortunate to have both of you joining us today. And thank you in advance for sharing your expert insights and perspectives. Our audience is in for quite a treat of knowledge, and I'm imagining a bit of entertainment as well. Before we begin, do either of you have any relevant disclosures?

SPEAKER_03

I don't really have any relevant disclosures, but I do have some stock in sermonics, and I give educational lectures on behalf of BARE.

SPEAKER_02

There's really nothing that I anticipate talking about that I would disclose, although I'm a consultant for Cook OBGYN, who make a Goldstein catheter for saline infusion sonohistorography. I do speak for BAER and Estellus and have been on an Estellus ad board in terms of these new NK3 receptor antagonists. I've been on the data safety monitoring board for BAER and Mithra. That's about it.

SPEAKER_04

Great, thank you. So, Dr. Stryker, I'd like to start with you first. And I'm sure that our listeners would enjoy hearing you share in your own words your background and your journey into your role and the work with which you're currently engaged in and excited about.

SPEAKER_03

Like a lot of physicians, my road was not a straightforward role. Lots of pivots along the way. I was actually an English and dance major as an undergrad that inexplicably landed in medical school, general OBCYNs, lived a few thousand babies, did lots and lots of surgery, which was my true area of interest, minimally invasive surgery. And a lot of those surgeries included ouperectomies, particularly for young women who maybe had a genetic mutation and required prophylactic surgery, women with endometriosis. And I found that I was ill-equipped to help them navigate their surgical menopauses because I had not had a lot of background in that. So I decided it was time to educate myself, joined what was then the North American Menopause Society, learned from experts, read a lot, ultimately became so involved in that world that I began giving lectures, left private practice and went over to Northwestern to become a full-time academic where I founded the Center for Sexual Medicine and Menopause. What I'm working on now, I really divide my time between my academic hat and doing research and lecturing and teaching, and my consumer hat of getting out there and talking to women to try and get them some real information with real science behind it. And to that end, I have these podcasts. I'm writing books. I have a new book coming out on menopause in 2027. So lots of projects along those lines. Fabulous.

SPEAKER_04

That's great. What an interesting journey. And thank you for sharing that. And Dr. Goldstein, could you likewise share your background and journey into your role, including how you, as an expert in sonography, then also became involved so deeply in the CERM and perimenopause and menopause arena, and maybe also share what's exciting to you about these arenas currently.

SPEAKER_02

Well, I could go back to first grade when I helped my older brother's class collect soap and toothbrushes to send to Dr. Tom Dooley in Southeast Asia for his jungle hospital. That's when I decided I wanted to be a doctor. But I think I'll cut to my first value after finishing training was in gynecologic ultrasound. I wrote the second book ever on transvaginal ultrasound and the first gynecologic ultrasound book and spent much of uh the early part of my career teaching the world how to do this new modality because nobody knew which end was up. In 1994, I described an unusual appearance in the uterus of patients on tamoxifen. Tamoxen makes a lot of funny-looking uteri and not that much pathology. People were getting DNCs and all kinds of biopsies. As a result of that, in 1995, a guy from Eli Lilly asked me if I would help them prove that a new compound turned out to be reloxifene or vista was not tamoxerin-like in the uterus, because they already knew it would be as a sermon anti-estrogen in breast, but estrogenic in bone. And if it wasn't tamocin-like in the uterus, it was a very interesting compound. And as a result of being on what was known as the reloxifene heavyweight team, started to learn all kinds of things about menopause because that drug came out initially as a bone drill. That got me involved with the help actually of one of my mentors, Dr. Lila Noctigall, in NAMS, now known as the Menopause Society. And I rose through the ranks and became president of the Menopause Society. Having previously been president of the American Institute of Ultrasound and Medicine, uh, had made some observations about the endometrium, became known as the endometrium guy. Every time there's a serum and they want to prove it's not tamoxa, like I get called to help them decide the uterine safety studies, and just became more and more interested. And it was actually my interest in bleeding that led me to stumble onto what I observed to be perimenopause. You know, now almost 30 years ago, we were doing a large study on women between 35 and menopause who had any irregularity to the bleeding cycle. 79% of them had no structural abnormality, what other doctors call hormone imbalance. When you talk to these patients, the number of these patients who were having inability to concentrate, free-floating anxiety, boot swings, uh, not feeling like themselves, that they were being told, oh, you didn't get the promotion you deserved, your youngest is going to college, your husband had an affair. Here, try this Prozac. And when she straightened out their hormonal fluctuations, and we'll talk about that, I think, later. The improvement in many of these women was dramatic. Some of these women needed the Prozac, but some of them just needed their hormonal situation straightened out. And that's what caused me to stumble onto that layperson book. There really wasn't enough medical information then to write a medical textbook. And it wasn't until about five years later that enough information had garnered where Nanette Santor and I edited the first textbook of perimetablesal gynecology and been off and running and doing this now for close to three decades.

SPEAKER_04

Fantastic. I've known you for a long time, but hearing that journey, there's definitely nuances to it that I wasn't aware of. So thank you both for sharing this tremendous roads that brought you to where you are today. And Dr. Kristen Feldman, could you also introduce yourself and share a little bit about your background and also a faxis for our listeners who might not be familiar with who a faxis is?

SPEAKER_00

Sure. Thank you, Beth. I feel as though I should start off by saying I have not written any textbooks nor regular books. I am a practicing gynecologist. I've been seeing patients in various types of facilities for about 20 years now. I'm also the VP of medical affairs at Aphaxis. And Afaxis is the name you get when you combine affordable plus access. We are a public benefit corporation and we specifically serve safety net clinicians and their patients. We have a pharmaceutical arm, a drug development arm, and a group purchasing organization. And we try to bring public health clinicians all the products and services they could possibly need to care for their patients.

SPEAKER_04

Great. Thank you. And Kristen, maybe you could also share. We have gone through a number of topics or considered a number of topics for these podcasts. But could you share with our listeners why you felt that it was an important topic, this topic menopause, from an Faxis perspective, perhaps?

SPEAKER_00

Yeah, it was interesting, Beth. Um a couple of years ago, we reviewed some internal data and some IQ via data and noticed that SafetyNet Clinics prescribed menopause treatments at a much lower rate than private practice clinics. And as always, when a clinical question is put in front of me, I think to myself, hmm, I'd like to know more about that. And then also, this disparity in care was recently mentioned to me by a member of our health equity steering committee. And since I'm a scientist at heart, I did what I always do, which is dig into the data. And it turns out that women of color and women with lower incomes do use hormone therapy at lower rates than the general population, even though, for example, women of color experience more frequent or severe menopause symptoms for a longer duration. And I know there are complex reasons for these disparities, but one of the reasons could be just simply lack of awareness or hesitation to provide menopause care at public health clinics, which tend to be more primary care oriented. So I thought that having menopause experts like Dr. Goldstein, Dr. Stryker would be a great first step in raising clinician awareness and education.

SPEAKER_04

Great. Thank you for that interesting overview of the rationale, which is fantastic. So I'd like to start with a level-setting question. Dr. Stryker, can you shed some clarity around perimenopause and postmenopause, how these terms are utilized and what they mean and why it's important to distinguish between them?

SPEAKER_03

I'm going to start with your last question first. It's important to differentiate between peri- and postmenopause because while the symptoms are very often the same, as Dr. Goldstein will tell you, the treatment approach is completely different. But that is not what we're seeing out there in the world. So let's start with menopause and postmenopause because this is pretty straightforward. The official definition is 12 months without a period. We've all heard that. But that's a very problematic definition. A lot of times we are dealing with women who perhaps had a hysterectomy but have not had ovary removal. They're not having periods. Women who have a levanogesterol IUD, women who have had an endometrial ablation. So there are many, many women who do not fit that official definition. So the more simple way of thinking of it, which is accurate, is your body's no longer producing estrogen or progesterone. It may be because your ovaries are no longer functional, or maybe they've been surgically removed. And from a practical point of view, what we're hearing from our patients is oh, I'm done with menopause. And it's so important that we have to point out to our patients, well, maybe you're not having hot flashes anymore, but you're not done with menopause. You're done with menopause when you die, because menopause means that you are no longer making estrogen and you're never gonna make it again. Which brings me to perimenopause, the time leading up to menopause. And perimenopause of women, the ovaries are still pumping out some estrogen, but the levels are erratic. The symptoms come and go, the periods come and go. The only thing predictable about perimenopause is that it's unpredictable. And the biggest myth out there that our patients and even some clinicians think is that the symptoms from perimenopause are a consequence of low estrogen. That's not true. The symptoms that people have are a consequence of the changes in estrogen because we have estrogen levels that are bouncing around more than the stock market, including surges that are higher than what's seen in young women. So that's a problem because people need to be educated in that being the case, which is going to, of course, inform how we treat these symptoms. And the other thing that's out there, and we're hearing again and again and again on social media is that perimenopause typically starts in the 30s. And that's not true.

SPEAKER_04

Great. Thank you for that clarity. A follow-on question for you. In one of our planning sessions, we said that a lot of women don't know what pause they are in, which I love that expression. But how do you make the diagnosis for women?

SPEAKER_03

You know, unfortunately, by the time the woman gets to a doctor's office, she's already done a home menopause test, maybe multiple home menopause tests, and she's prepared to ask you to do hormone levels. Neither of these are appropriate, neither of these are necessary, and in many cases, they're misleading. The diagnosis of perimenopause and postmenopause is in most cases a clinical diagnosis that someone with expertise in menopause is able to determine based on menstrual history, the patient's age, medical history. Is it ever helpful to do a blood test? Yes, it is, but it is certainly not done routinely, and blood tests need to be done in the hands of an expert that knows what tests to order and how to interpret them. Thank you.

SPEAKER_04

I'm sure our listeners appreciate that information. Dr. Goldstein, you've been a strong advocate for appropriate and individualized therapy for patients, you know, based on a variety of variables. How do you approach treatment for women, both peri- and post-menopausal? What variables do you consider? I mean, how do you decide what is appropriate therapy for patients? And I know that this could be a week-long CME course. So it's a it's a tough question. Um being given a high-level view.

SPEAKER_02

First of all, uh, I think that understand something. Although we we follow guidelines, guidelines are created for populations, not for individuals. And so anytime you're going to treat somebody, you sort of have to ask yourself, could she be an outlier or is there you want to individualize? You know, when you when you have certain standards that you adhere to and never want to break, so to speak, you I think you really shortchange some people. Having said that, a great segue into what Dr. Stryker was talking about. If people are perimenopausal, by definition, their ovaries are still functioning. It is erratic, it is pulsatile, it is the change in estradiol with often a lack of progesterone or diminution of progesterone. It's these annovulatory cycles, you know, with an comes from the Greek without. The key to treatment in perimenopause is not replacing estrogen. So many newcomers to our field are giving so-called HRT to perimenopausal women. By definition, they don't need replacement. They're making estrogen. And as Lauren pointed out, often, and that's been very elegantly shown in perimenopause, estradiol levels can go up before they go down because you don't recruit a dominant follicle. You have a lot of follicles. And sometimes these estradiol levels are even higher than they were initially. So the key in perimenopause, not replacement, is suppression of ovarian function and substitution of a stable amount of estrogen and progesterone all month long. And we accomplish that if there's no contraindication with hormonal birth control, whether it's birth control pills, birth control patches, birth control rings. In addition, in those patients, you don't want to have them come off for four to seven days at the end of the cycle. That was a fake period that was built into pills. That was one of the more paternalistic things they ever did to women. John Rock, who invented these things, was a devout Catholic. He thought he could fool the Catholic Church into not realizing this was contraception. There is absolutely no medical reason to get this fake withdrawal bleed at the end of a package or the end of a cycle. And if you're giving this to women whose hormones are fluctuating, you don't want them to withdraw a hormone for four to seven days. So I'm at a point where it's interesting. Or as Lauren points out, many women are not bleeding at all because they've they've had a uterus removed or they've had an ablation or an IUD. But if the symptomatology seems to be perimenopausal and there's no contraindication, what I have finally gotten to the point of saying is I'm not sure how much of how you feel is hormonal. But I know how to find out. If you will let me turn off ovarian function for two months, substitute a stable amount of estrogen and progesterone all month long, you will tell me. Because if symptom A, B, and C are 80% improved, that was hormonal. Symptom D didn't get touched, that wasn't hormonal. It's a therapeutic trial. Now, we all know there are certain contraindications to hormonal contraception, clearly, but there are few. The problem is there's a total misconception out there about birth control, whether it's pills, patches, or rings. And I think a lot of that misconception emanated from extrapolation from the women's health initiative. In other words, in the women's health initiative, they educated women that the estrogen and progesterone promoted breast cancer, might increase heart disease initially. What's in a pill? Estrogen and progesterone. So it's understandable why a woman might think, why would I put this in my body? But what isn't explained is in pre-menopausal women, that's going to suppress ovarian function. So that hormone is not on top of what she's making. It now becomes instead of what she's making. When I was a student, pills came in 80 and 50 microgram strength. By the time I was a resident, they were 50 and 35. Most of my career, they've been 35, 30, 25, and 20. Now we have a 10 microgram pill.

SPEAKER_03

I mean, this is here for a second, because I think one point that to what you're talking about, which is so important, is I hear from women all the time who say, he or she just wanted to put me on a pill and they feel dismissed. And I think that it's important for clinicians to understand that you need to not only do the right thing, but you need to give your patients the kind of explanation that you just heard. Because that's what's not happening. And when I tell people, no, that actually was the right thing to do. And let me explain why, it takes on a whole different feeling for the patient because she's not feeling dismissed. And I tell women the exact same thing you do based on your script. And what I tell them is, we're not going to treat you. First, we're going to do a test to see what kind of treatment you need. And I'm going to put you on a special form of hormone therapy for a couple of months that happens to also be used as birth control pills. And it changes the conversation.

SPEAKER_02

Exactly. And we're doing it in a very inexpensive generic way by using low-dose birth control pills because that's the lowest dose that will suppress ovarian function. You see, an estrogen patch and prometrium generically do not suppress endogenous ovarian function. And that's part of the problem. But in addition, you're right. You have to explain to people and give them a comfort level. Not only is there an inappropriate extrapolation from the WHI, the second thing I talked about About is there are those people who don't want to take hormonal contraception because they say it's not natural. So then you explain to them, well, wait a minute. We are higher order primates. Nature thought you'd have eight children. You would have to nurse them all for 15 months. There's no bottle or formula in nature. Do the math. Most women have 40 years of reproductive life, 13 lunar months in a calendar year, that's 520 cycles. Modern women are having 480, 500. Nature thought at most you'd have 250. And 26 years ago, Malcolm Gladwell, the famous author of Tipping Point, wrote a beautiful article in the New Yorker magazine called John Rock's Era. John Rock was one of the inventors of birth control pills, where he talks about the fact that they should have brought these things out as cancer-reducing agents. There's great science that women who take pills have less ovarian cancer, less endometrial cancer, and in the doses that we're using today, almost certainly less breast cancer. And then there is some good stuff that came out of the UK in 2021 from their quarter million women in their national register where they compared every users with never users of pills, and there were huge reductions in some of these gynecologic cancers that people are unaware of. And so I think you're 100% right. If you're going to suggest this therapeutic trial to see how much of your symptomatology is hormonal, you have to educate patients about these myths. And it's amazing how when you go through what I just went through, how many people are shocked to learn this about hormonal contraception.

SPEAKER_03

And the last myth that I think it's worth throwing out at this time is a lot of women have this idea that birth control pill is low dose because they're called low dose birth control pills, but menopause hormone therapy is high dose, which is also why they're so afraid of it. And when I tell someone it's time to go off your birth control pills and switch you over to menopausal hormone therapy when they're in their 50s, and they'll say, oh no, that's dangerous, thinking that it is actually higher dose.

SPEAKER_02

That's a great point. And but I will say when we talk about blood tests, that's one place where I do do blood work. In other words, I've got a ton of patients who are on a low-dose birth control pill in perimenopause, they feel great. In fact, I sometimes call them my pill junkies because they don't want to come off. They feel so good. And they get to be 51, 52, and depending on any comorbidities or you know, Patsy Sulak, who wrote the chapter in our original book on birth control, said keep everybody until 55, because by then 95% of the population would be menopausal. I've never really bought into that because if I did that, I'd be treating a sizable number of people for one, two, three years of menopause with birth control because I don't know that they're menopausal. If you want to transition somebody from pills to perhaps menopausal hormonal therapy, you need to be off those pills for some period of time. Some people use seven days, I use 14 days. But then I will measure estradiol and fsh because I say it works 100% in one direction and about 70% in the other. What do I mean by that? If two weeks off of pills, somebody's estradiol is up and their FSH is down, they're not menopausal. And they might as well go back on these pills for another six or 12 months. If, however, FSH is high and estradiol is low, I never tell those women you're menopausal. I say your blood work was in a menopausal range. Because depending on their age, in my experience, 25-30% of them three months later will call you and say, I swear I just got a period, because there's erratic ovarian function. And so when that happens, I give everybody a slip and I say, if you bleed in three months, go do blood work first, then call me. Because what happens, I think, in the real world is if you've got menopausal numbers on the chart and three months later the woman has an episode of bleeding, she's going to get a full-blown workup for postmenopausal bleeding. And if you can document that she bled because she had a blast of some endogenous ovarian function, you don't have to work her up for postmenopausal bleeding because she's proven that she bled because she made some endogenous estrogen. That's a place where I do use FSH and esperdiol, where I find that to be helpful, but you have to understand its limitations.

SPEAKER_04

Fantastic discussion. We've focused on perimenopause and treatments, but I'd like to ask both of you in women who are post-menopausal, how do you individualize therapy to those patients?

SPEAKER_03

Dr. Strike, let's start with you, and then we can have Dr. Goldstein come in. The key word is individualized. What we have is a world where everyone has this idea that there is a best form of menopausal hormone therapy or that everyone should get a patch or everyone should get, you know, fill in the blank. And can you imagine if someone went to their internist with high blood pressure and the internist said, I put everyone on the same antihypertensive? That wouldn't happen, yet that's what's happening in the hormone therapy world. So when we look to what the appropriate treatment is, you first need to look at what are the goals, what are the symptoms, what is that person's medical history? And then based on that, you be you come to a determination if first of all they would benefit from hormone therapy as opposed to a non-hormonal option for basal motor symptoms if that's their only symptom. Um you then look at medical situations that might say, okay, this person really needs to use a transdermal product. Maybe they have a history of a blood clot, maybe they have liver issues versus someone who might do much, much better on conjugated equine estrogens because they are at risk for developing breast issues. We know that that's going to be the most protective. You have to look, you know, if they're triglycerides. We know that oral estrogen increases triglycerides, a transdermum will not. So you get the point that there is no one best treatment. This really comes down to what are the person's goals, what's their medical history? And then you get into the practicalities of what is this person's personal preference? What is their insurance going to cover? But this is personalized medicine, just as every other indication for treatment in medicine needs to be personalized.

SPEAKER_02

Boy, did Lauren nail it. I mean, so what she said is exactly 100% what I do and what needs to be done. I sometimes use the analogy with my patients. If I were a psychopharmacologist, I would absolutely understand the nuanced differences between, well, butrin affects or Prozac. To me, they're all antidepressants. I don't prescribe these things. And but when it comes to different hormonal preparations, different birth control pills, I understand the nuanced difference between these things. And unfortunately, so many of our colleagues are what I call one-trick ponies. You know, they've got like one thing that seems to be used for everybody, as Lauren just uh alluded to. And this is truly, truly unfortunate because, you know, and especially you realize when I was president of NAMS, for years the membership hovered at 2,000. This year it surpassed 12,000 healthcare practitioners. And so many of these new people put everybody on a transdermal patch and natural progesterone, the only arrow in their quiver. One of the reasons why the patch is on back order for so many people. There are certain people who will do much better on oral estrogens. Conjugated equine estrogen has some benefit, especially in hysterectomized women. It's been shown to reduce breast cancer and breast cancer death. Estradiol's never been shown to reduce breast cancer and breast cancer death. There's a non-progestin combination, TSEC, that combines conjugated estrogen with a CERM out of your institution, Lauren, the promise trial in women with DCIS. The use of that product reduced KI67, you know, with 28 days of administration compared to the placebo group.

SPEAKER_03

Yeah, and just to expand on that just for a second, because it is such an important trial, is that they were given uh the duavase, the trade name, it's a combination, as they said, conjugated equine estrogen and basodoxifen. And this was a multi-center trial that was done by breast surgeons. So we have breast surgeons that give patients with biopsy-proven DCIS estrogen with basodoxifen, wait a period of four to eight weeks, rebiopsy the area to see what the activity is in some of these tumor markers. And it was honestly, it was astonishing to see that the activity had dramatically, dramatically decreased. And it's the combination of not just the basodoxifen, which we know is a CERM, which is going to inhibit uh estrogen receptors, but also conjugated estrogen, which Dr. Goldstein has pointed out so many times, has CERM-like uh qualities.

SPEAKER_02

Not astonishing. In other words, uh ever since it came out in 2013, I've been telling people that if they did the 40,000 per$2 billion five-year study, I would bet my retirement fund that this combination would reduce breast cancer compared to placebo. It's in science, it's in some of the data on files that they show key opinion leaders. It's even in the nuanced of the trials where there was no increase in breast density or breast tenderness compared to E plus P, which increases breast density and tenderness. And now you've got this promise trial, which is a phase 2B multi-center randomized placebo-controlled trial. It begs the question: how much evidence do you need for it to be evidence-based medicine?

SPEAKER_03

In other words, and I just want to throw one other trial out there that just got published was in women with a BROCA mutation that were given hormone therapy after their prophylactic oophorectomy, and they had different formulations and they followed them for seven years. And in the seven-year follow-up, there was no increase in breast cancer in any woman on any hormone therapy formula, but the combination of conjugated equine estrogens and basodoxifin, they had a decrease in breast cancer. Well, that's all of the other formulations. And if that doesn't tell you something, in the most high-risk group that exists, women with a BRCA mutation, and that people are all out there asking for a patch when I'm thinking, whoa, well, you know, the I really knew this data, not to mention less bleeding and good for your bones, and you know, we can go on and on. And I don't work for these people. I'm just saying this is what the data shows.

SPEAKER_02

I don't work for these people either. And it it's I wish I did.

SPEAKER_03

I wish I'd stuck, you know.

SPEAKER_02

And what's really disturbing is I'm aware there was divulging too much, aware of a person who went to their local doctor with horrendous menopausal symptoms, was told you don't want hormones because uh they cause cancer. So, you know, and she had gone onto my website because she was one of the staff people for the American Institute of Ultrasound Medicine, and one of the people who wrote chapters in my book said, you should check out Goldstein because he's not just ultrasound, he's menopause. So she was armed with the notion that she wanted to go on this combination, this branded Dewey. And she went to an MSCP that she found on the website. That's Menopause Society Certified Practitioner. The practitioner had never heard of Dewey. How scary is that? Everybody gets a patch in progesterone. There are certain advantages. I mean, there's certain people who absolutely should be on transdermal, but there are other advantages to oral estrogen, and you need to individualize, you know, but you're basically a healthy 51-year-old who has virtually limited, if no risk, really, of deep vein thrombosis, may benefit from some of these other forms of oral. So it's not one size fits all. And that's the most important take-home message I could give you.

SPEAKER_04

Yeah, we often hear stories either from our friends or you know, others, sinners and things, of their wanting hormones and go, especially over the last several years, their physician, they can't get them and aren't prescribed, which, you know, is why I think we saw in the menopause arena that influencers other than physicians and bonfide experts are very quickly becoming the doctor for these women, you know, especially in the hormone arena, whether it's contraceptive or menopause. And so I'm curious how each of you navigate the conversation with your patients in your office. If they've heard of something from an influencer who's now doctor influencer, and come to your office asking for certain things or requesting or quoting information that isn't accurate, you know, how do you navigate that conversation?

SPEAKER_03

I have a little history with this because the original influencer was Suzanne Summers, when she was out there selling her book about everyone should use, you know, quote, bioidentical, which is a made-up term, a marketing term, compounded hormone therapy. And I was on the Oprah Winfrey show with Suzanne Summers to be the voice of science, and it did not go well. You know, I'd always wanted a do-over of that. Because what I now really appreciate is the reason that women were talking to Suzanne Summers while they were following her, while they were reading her book, and why people are going to influencers now is because their own doctors are not helping them. Because at the end of the day, most women do trust their doctors, particularly in OBGYN, if they deliver their children, if they've had a long-term relationship, which we don't necessarily see in other doctor-patient relationships. And I appreciate the fact that it's very frustrating for doctors when someone comes in and they have a limited amount of time and they say, I've learned from XYZ that this is what I should do. And will you write me a prescription? And the onus really is on the doctor to say that's not the approach that I take. And this is why. And number one, don't be afraid to set up another appointment. A lot of women come in for their annual exams and they get 15 minutes and they think that you're going to do a comprehensive menopause consultation in that time, and that's not realistic. So the doctor has to acknowledge that this is important. I have a lot of information to give you, and I need you to come back. And just as important, the two of us have been going on and on about how nuanced this is and how you can't just have one size fits all. Not every doctor has to do this. It is perfectly legitimate to say, I don't do menopause. It's gotten to be very complex because there are so many options and there are so many nuances. And I'm going to refer you to a menopause expert, just like you would to a fertility expert or anyone else or high-risk obstetrician if it was something beyond what you would do, and help you navigate this field. So, you know, you can spend all day long trying to counteract the influencers, and it's not a good use of anyone's time. So that's my approach. Practical suggestions. Dr. Goldstein, you know, approach it.

SPEAKER_02

Yeah. I mean, it it is frustrating. I mean, the medical system in many respects, as you know, is broken. Uh, many patients are fed up with big health systems, you know, 15-minute visits, 20 years of medical people not getting good information about menopause because of the women's health initiative publicity and the black box warning not being taught. And now all of a sudden it's big business. You know, I mean, like I said, 12,000 people in the menopause society, many of whom, you know, now have a credential after their names, although that's that's a low-hanging bar for sure. And it's frustrating. And so why so many women turn to social media, why so many women turn to, you know, telehealth visits out of frustration. We do what we can. People like Lauren and I, we teach, we give our time, we lecture, we're involved in societies, we're involved in creating materials, but I feel like the train has left the station. And sometimes you really feel like it's really hard.

SPEAKER_03

And there's so many doctors who do want to know, who do want to understand this. These are the doctors that are listening to this program. These are the doctors that even my stuff, which a lot of it is geared really towards the consumer population. 50% of my audience in terms of Substack and my podcasts and all of that are clinicians. Because while I make it consumer friendly in terms of language, it's all based on data. It's all based on science. And not only are you fighting the influencers, the menopause influencers, but you are also, when I say, you know, Steve and I are also fighting the doctors who are listed very often as menopause uh certified clinicians, that they took the test so that they could put it out there that they're certified, and then they're pushing pellets and they're doing other things which are not appropriate care for menopausal women, and in fact, can be dangerous, but because they have that certification. So there's a lot that we're up against in terms of trying to get the right information to women. And this is exactly what doctors who do have good information need to navigate. They can come in and they want those pellets, and we have to be the ones to burst that bubble and say, yeah, you really don't, and this is why. Right, right.

SPEAKER_04

Dr. Feldman, since you're a practicing physician and also leading medical affairs at a Faxis, uh it's really help safety net clinicians. And I know that educational tools are important to you and something that you mention, you know, frequently on these podcasts. Do you have any resources that you'd like to share with clinicians seeing menopausal patients that could, you know, potentially help them with some of these issues that we were just discussing?

SPEAKER_00

Yes, I was just thinking that I was loving the direction the conversation was going, talking about you know, resources for clinicians who do want more information about caring for menopause patients. And so I just wanted to bring up a couple of different things. For one, Dr. Stryker has uh 30 audio episodes, supplementary materials and training courses. And uh this package is entitled Come Again for Healthcare Clinicians. And this is going to help clinicians to augment and help set up their own sexual health practice. So menopause care adjacent, shall we say. And then also her um Substack, excuse me, that she mentioned. I will put that in the show notes because it sounds like that's a great resource for clinicians as well, even though it is really geared more towards patients. Um, if you've got 50% of your readers being clinicians, then you're doing something right in your special forum.

SPEAKER_03

It is very gratifying to me when I go to the Metaplaus Society and people run up to me and tell me how much they've learned from my podcast and my substacks. And now I'm getting that kind of feedback from Come Again, which the way you get that that's not a podcast, it is a product. And that can be found on drstriker.com.

SPEAKER_00

Awesome. Yep, and I'll put that in the show notes as well. And then for Dr. Goldstein, he is uh leading a CME course in April, which is from world-class CME. It's entitled Survival Skills for Women's Health. Experts Teach menopause. And that's going to be in April in New York. And I believe he mentioned one other um course in July, and I will link those in the show notes as well because, like I said, I really love resources that can help clinicians give better care to their patients. One other resource that I want to bring up is a platform that's called Dhamma Assist, and it's launching this month. So I am an unpaid medical advisor for DAMA, and I was able to beta test this tool. And it's an AI clinician support tool. It's specifically trained on menopause guidelines and scientific literature, and so it's reliably sourced in a way that ChatGPT, for example, is not. But I have found it helpful in answering clinical questions for those, you know, more complex patients. And I see this as a useful tool for clinicians to keep up with the data, keep up with guideline changes, almost like a curbside consult. So I'm gonna bring up a patient scenario because I think it will be helpful for our uh next discussion topic. So I recently saw a 62-year-old patient. She'd been a menopausal for 12 years. She had a family history of severe osteoporosis. She herself had some dental issues that made her wary of bisphostenates. And she had and has had zero menopause symptoms. But she said to me, I feel like I missed the boat on estrogen. And now the black box warning is gone. Should I start estrogen to protect my bones? And so, you know, these are some of the tricky clinical questions that are not on the guidelines that we are being presented with in um clinical circumstances. And so, Beth, I think you had a question specifically on this topic.

SPEAKER_04

Yeah, absolutely. I mean, I wanted to ask, you know, each of you and Dr. Golstein, maybe we could start with you. You know, for those patients who come in and do say, whether directly I missed the boat or what can I do now, you know, how do you think I hear you?

SPEAKER_02

And first of all, this concept of age 60 as some sort of magical number is a totally inappropriate extrapolation from the Women's Health Initiative, where over the age of 60, in that study, the incidence of cardiovascular side effects started to go up, and over 70, it went up even more. We have to first of all distinguish between starting MHT and continuing it. Those are two very different issues. And even in the idea of starting it, I mean, I look at the total picture, look at the comorbidities. I've had patients that are 55, they're overweight, they're pre-diabetic, they quit smoking a year ago, they don't exercise. I'm nervous, even though they're under 60. I have other people like the one you just described, you know, who exercise five days a week, have normal blood pressure, normal weight, didn't even smoke a cigarette in the eighth grade with the other girls in the bathroom. But that's called individualization and judgment, not 59 and a half yay and 60 and a half nay, you know, taking into account any other factors and not just her own personal history, but I think as Lauren sort of alluded to before, why does she need MHT? In other words, if she's got a family history, low bone mass, those are good reasons. Does she just think it's gonna keep her young forever? That might not be as good a reason. In other words, you've got to weigh her, what she brings to the table with her family history, her personal history, the absence or presence of any comorbidities in making a synthesis of what's right for that particular woman.

SPEAKER_03

And just to add to that, you know, a lot of patients actually think it is somehow illegal to take hormone therapy after a 60. When they really come to you with, they say, Well, I know it's against the law. It's like, no therapy, it's not law, but they say that. They say that. And then remind people, as Dr. Goldstein just said, in the women's health initiative, over and people who were taking an oral, which we know has, you know, more complications than transdermals in terms of blood clots and cardiovascular, that's still over 97% of women in that in that study did just fine. So this idea that something horrible happens at age 60 simply isn't true. But having said that, you have to say to someone, okay, aside from your past medical history and your risk factors, which we'll discuss, what are your goals? Because there's a big difference between someone who says, I am still flashing and I am still can't sleep and my joints ache. And, you know, I really want to see if this would benefit me. And then you evaluate their cardiovascular status and other risk factors to see if they're a candidate, as opposed to the woman who says, Oh, I feel fine, no problems, but I hear it's going to prevent dementia down the road, or I hear I'm gonna live longer. You know, those are the kinds of things that need to be discussed. And even when it comes to bone health, most women who are at risk for osteoporosis lose most of their bone during perimenopause and early postmenopause. That's when it's lost. And if they walk in and they're already osteoporotic in their 60s and they think that estrogen is gonna turn it around, it's not. So, you know, there's I mean, we really need to be realistic about what are your goals and what is this gonna do for you. And then we get to and is it safe and appropriate, and what's the best way to administer hormone therapy if we find that that's a reasonable option.

SPEAKER_02

I hate to occasionally disagree with my. Okay, go ahead.

SPEAKER_03

What I think it's gonna help.

SPEAKER_02

Well, no, I have to say that I think there's good evidence that estrogen is probably the best bone drug there is, other than perhaps the anabolics. If you look at something like Fosamax or residuate, lendrinate or residuenate, in order to show a reduction in hip fracture, they had to cull out the highest risk women. They took women who not only had osteoporosis, but at least one pre-existing vertebral fracture. And only in that group was there a statistically significant reduction in hip fracture. In the women's health initiative, they weren't picked for bone. 30,000 women in the two arms. Some had normal bone, some had osteopenia, some had osteoporosis. So they were not a high-risk chosen group. There was a statistically significant reduction in all fractures, including hip fracture, in that study. That's how good estrogen is.

SPEAKER_03

So let me ask you that.

SPEAKER_02

And but yet it never they'll never get into the label because nobody's going to do a fracture prevention.

SPEAKER_03

We don't care about the label anyway. We treat to the data. However, let me ask you this then. 65-year-old woman walks into your office, no risk factors. She's otherwise an excellent candidate for estrogen. Her only issue is that she has osteoporosis. She's already had a fracture. Her other doctor wants to put her on an osteoporosis drug. She doesn't want to take it. Are you going to give her estrogen for her osteous?

SPEAKER_02

Well, I guess no, once again, that's a little too, there's more nuance here. You're telling me she's got osteoporosis and a pre-existing vertebral fracture. She is almost certainly a candidate for an anabolic injectable agent. So I wouldn't give her estrogen in lieu of that. But the woman who's got uh a frax that wants to be treated or has just crossed the threshold into osteoporosis, uh, would I give her estrogen rather than, let's say, denosinab or reclass, you know, like xolidronic acid? Possibly.

SPEAKER_03

Because we're gonna put them both together to have a better chance of stabilizing whatever bone she gains from it.

SPEAKER_02

A little bit of belt and suspenders, but I'm I'm not sure that she needs two drugs, or I'm not sure she needs two drugs for her bone, but I'm saying don't underestimate the power of estrogen for bone as an anti-resorptive. The whole reason that we're even that they've invented all these other drugs was because women stopped making estrogen and they weren't taking hormone replacement therapy as it was called in those days. So they had to come up with these bone-specific drugs. So they're anti-resorptives. Yeah, they're anti-resorptives.

SPEAKER_04

The salient and important question that's a dynamic that has unfolded is the removal of the black box warning within the hormonal menopausal products. Could each of you comment, please, on that?

SPEAKER_02

When it comes to the removal of the boxed warning, which happened in November, all of the key opinion leaders would say that that was a well-needed, good thing that needed to be done. Because of the boxed warning, for 20 years, women who were great candidates for hormone therapy wouldn't take it because they were scared. Physicians wouldn't prescribe it. It wasn't taught in medical school and residencies. It was really a bad thing. What we're upset about was the way that it was rolled out, the kinds of claims that the FDA commissioner McCary made about 50% reduction in heart disease, 35% reduction in dementia, which divorce. Don't forget divorce. It decreases divorce. He said that which is I was there at the FDA. He said that. But I'm saying the removal of the box warning was a good thing. The way it was promoted was dangerous. And this is what women heard. So you have people coming in thinking, oh, I'm going to go on hormone therapy. I'm 72 years old because I want to prevent heart disease or I want to prevent dementia. And the data is just not there for that. And that's what I think upset so many of the societies and so many of the key opinion leaders.

SPEAKER_03

And also just to add on that, you know, there's a difference between a black box warning and a warning. And a black box warning is appropriate if there is a drug which is truly so dangerous that it may be life-threatening and you really want to weigh if it's appropriate or not. So getting rid of the black box warnings was, as Dr. Goldstein said, that was good and that was appropriate. That doesn't mean that there shouldn't be some warnings. Now, when it comes to the local vaginal estrogen products that we've not talked about today, there really are no issues with that in terms of safety. I mean, there's really no one who can't use them. There, honestly, you don't even need any warnings on that package as far as I'm concerned. When you look at systemic estrogen, just as we've been talking about all along, it is individualized and it is nuanced. And each one of these products individually needs to have appropriate warnings, whether it's a transurmal product or an oral product. And we have no confidence that that's going to happen because there was no scientific committee that was behind these FDA changes. And I actually did a podcast episode on that because I was asked to be involved in that. And then when I heard that it was not going to be a scientific committee, it was basically just going to be a PR campaign that they were going to decide to just take off these warnings. It leaves us in this position of, as Dr. Goldstein said, so they are out there saying things which are not scientifically true. And we have no idea what is ultimately going to end up on the label in terms of the systemic estrogens and warnings. So we may have to circle back to what actually happens down the road. But this is this is highly problematic.

SPEAKER_04

Absolutely. I'm glad that you brought that up because certainly it was always for breast cancer survivor patients who were having extreme vaginal atrophy, dryness, dysperunia, that black box warning for oncologists and for patients as it related to cancer clearly made it very much a barrier for them to use psychologically and otherwise. But again, to your point with the black box warning coming out of everything has really continued to fuel in this arena confusion and women coming in as we talked about and saying, wait, I missed the boat within this ever-changing, really complex environment now. And we've kind of alluded to this. If you just had to say in a nutshell, given all of the dynamics that we've talked about, what would be your advice to patients and also to healthcare practitioners? Although we've alluded to it throughout the discussion, kind of your your one-liner of advice. And Dr. Glostummy, we could start with you.

SPEAKER_02

Individualize, individualize, individualize. And if you're a healthcare provider who wants to take care of perimenopausal and menopausal women, just try to educate yourself as much as possible about the nuances of what's available so that you can individualize.

SPEAKER_04

Great. And we certainly will have those in the show notes as Dr. Feldman had mentioned. And Dr. Stryker, from your perspective, you know, what would be that and if we craced one-liner?

SPEAKER_03

We need to stop using the term longevity and instead substitute that with wellness. And this idea that hormone therapy is going to guarantee long-term wellness is simply not true. We have to look at other things which have been scientifically proven to prevent cardiovascular disease, which is the number one killer of women, to prevent dementia, you know, getting enough sleep, being active, having a healthy diet, being involved in community. So many women who feel like I'm, you know, screwed, I missed the boat because I didn't take hormone therapy, need to appreciate that that is just one piece of a very large puzzle that is going to speak to long-term wellness. And I just want to finish with looking to the blue zones, in that these women do not take a drop of estrogen therapy and they live very long and very healthy lives where they stay active and in community well into their 90s. So keep that in mind.

SPEAKER_04

Okay. So this has been such a rich and robust discussion. I'm quite certain that our audience has found it to be tremendously useful in understanding aspects of both diagnosing and treating women in both the peri and post-menopausal time. We definitely understand how tremendously demanding both of your schedules are, and we appreciate you taking the time to join us on this episode of a Faxis Candid Conversations in Public Health. I'd also like to thank our audience and listeners for joining us today, as we know that your schedules are also demanding. As Tristan mentioned, we'll have the resources mentioned in addition to the links to the relevant articles in our show notes, which we know that you always find very helpful. And so for that, we'll say thank you. Have a great rest of the day, happy Valentine's Day, and uh and a special thank you for our esteemed experts for joining us.

SPEAKER_01

Thanks for listening to Afaxis Candid Conversations in Public Health. To learn more about our mission and resources for clinicians, visit afaxis.com. Don't forget to follow or subscribe so you never miss an episode, and we'll see you next time.