Center for Gynecology & Cosmetics
Mon - Thur 9:00AM - 5:00PM, Fri 8:00AM - 3:30PM

Two Saturdays a month 9:00AM-12:00PM

(312) 574 - 3434

info@cgcchicago.com

312 N May Street, Suite 110

Chicago, IL 60607

Women’s Health Evolution: Dr. James Simon on HRT, Cognitive Function, and Heart Health

Women’s Health Evolution: Dr. James Simon on HRT, Cognitive Function, and Heart Health

Do you ever wish that your hormonal health and menopause journey were clearer and better understood?

On today’s episode, join me in welcoming Dr. James Simon as we dive deep into the impacts of hormone therapy on cardiovascular health, bone health, and overall well-being during menopause. 

This conversation sheds light on pivotal findings from the Women’s Health Initiative, which revealed that early use of estrogen or hormone therapy close to menopause significantly benefits cardiovascular health. 

Dr. Simon shares compelling patient cases where hormone therapy decisions were guided by coronary artery calcium scores, lipid profiles, and cardiovascular risk factors. I explore the potential of estradiol for easing perimenopausal symptoms and brings up ongoing studies, emphasizing the importance of evidence-based practice.

We discuss the emerging molecule, estetrol, a naturally occurring fetal estrogen. This hormone is showing promising results in not just birth control but also in vaginal estrogen products and treatments for menopausal symptoms like hot flashes and night sweats. Estetrol’s benefits on bones, blood vessels, and heart health make it a potential game-changer for menopausal therapy.

We also touch on the broader problem of cookie-cutter medicine and the importance of individualized treatment plans. Dr. Simon dispels the myth around hormone therapy and breast cancer risk, citing the Women’s Health Initiative’s findings. 

I also talk about the need for tailored treatment, especially given the high prevalence of heart disease and diabetes in specific populations, such as the South Asian community. 

Highlights:

Cardioprotective Benefits: Early hormone therapy near menopause can offer cardiovascular benefits. Delaying it may increase risks.

Breast Cancer Survivors: Shared decision-making in hormone therapy post-treatment shows emerging evidence of safety after a period.

Brain Health: Hormones might help reduce or prevent Alzheimer’s and dementia by affecting brain energy metabolism.

Testosterone Therapy: Dr. Simon advocates for the benefits and safety of testosterone therapy in menopausal women, although an FDA-approved product is still awaited.

Patient Advocacy: Dr. Simon provides tips on advocating for yourself in healthcare, finding menopause experts, and staying informed.

If you enjoyed this episode, please like, share, and give us a 5-star review on Apple! Who else would you like us to interview? This podcast exists to ensure you are educated and can advocate for yourself. 

Join us, stay informed, and continue the journey of health advocacy and empowerment with Gyno Girl Presents: Sex, Drugs and Hormones.

About our Guest:

Dr. James A. Simon is Clinical Professor of Ob/Gyn at George Washington University in Washington DC. A board-certified obstetrician-gynecologist, reproductive endocrinologist, and AASECT-Certified Sexuality Counsellor, Dr. Simon’s private medical practice, IntimMedicine Specialists® (www.IntimMedicine.com), focuses on complicated gynecology,reproductive endocrinology, menopause, and sexual health. 

Dr. Simon’s extensive and pioneering experience utilizing both hormonal and non-hormonal therapies for menopausal symptoms and sexual problems (i.e., reduced sexual desire/blunted arousal, and weak or absent orgasm, pelvic and sexual pain) have resulted in his receiving numerous awards.

Beyond his clinical work, Dr. Simon is an experienced clinical researcher having completed more than 400 clinical research trials, while receiving grants, contracts, and scholarships from a wide range of sponsors, including the National Institutes of Health (NIH), The American Heart Association (AHA), The Heinz Foundation, and the pharmaceuticalindustry. 

Dr. Simon was Sprout Pharmaceuticals’ Chief Medical Officer (CMO) during the development of the first FDA-approved medication for women’s sexual health. Dr. Simon is the only physician to serve as President of both the North American Menopause Society (NAMS now The Menopause Society), and the International Society for the Study of Women’s Sexual Health (ISSWSH).

Nicknamed “The Menopause Whisperer” by Washingtonian Magazine, a short-list of Dr. Simon’s other honors and achievements includes being selected to “Top Washington Physicians,” “America’s Top Obstetricians and Gynecologists,”

“Super Doctors of Washington DC-Baltimore-Northern Virginia,” and “The Best Doctors in America.” Dr. Simon is a recipient of the NAMS-Leon Speroff Outstanding Educator Award and the ISSWSH-Distinguished Service Award.

He is an author or co-author of more than 800 articles, abstracts, chapters, and proceedings, including several prize-winning papers, as well as the paperback book: Restore Yourself: A Woman’s Guide to Reviving Her Sexual Desire and Passion for Life.

Connect with Dr. James Simon

Website

Licensed in:

Colorado

District of Columbia

Maryland (pending)

Michigan

Ohio

Tennessee

Virginia 

Instagram

Get in Touch with Dr. Rahman:

Practice

Instagram

Youtube

Transcript

Dr. Sameena Rahman [00:00:01]:

Hey, y'all, it's doctor Samina Rahman. Gyno girl. I'm a board certified gynecologist, a clinical assistant professor of Ob GYN at Northwestern Feinberg School of Medicine, and owner of a private practice for almost a decade that specializes in menopause and sexual medicine. I'm a south asian american muslim woman who is here to empower, educate, and help you advocate for health issues that have been stigmatized, shamed, and perhaps even prevented you from living your best life. I'm better than your best girlfriend and more open than most of your doctors. I'm here to educate so you can advocate. Welcome to Gyno Girl presents sex, drugs and hormones.

Dr. Sameena Rahman [00:00:47]:

Let's go. Hey, all, it's me, doctor Smeena Rahman. Gyno girl. Thanks for joining another episode, an exciting episode of Gyno Girl presents sex, truth, drugs and hormones. I'm super, super excited to have an amazing doc here with me today, doctor James Simon, who is like, really the OG when it comes to menopause. He's the menopause whisperer. I'm going to put all of his information in the show notes, but whenever myself and my colleagues think about who knows the most about menopause that we know, we always think of Doctor Jim Simon here. He is a professor of Ob GYN at George Washington University in Washington, DC, a board certified OB GYN REi specialist and an ASEC certified sexuality counselor.

Dr. Sameena Rahman [00:01:36]:

He has his own private practice called intamedicine, and he focuses on complicated gynecology, rei, menopause and sexual health. He's really a pioneer when it comes to stuff. Has published more publications than I can probably count, but it's in the hundreds. And the same with, you know, the amount of shows that he's been on and, you know, magazines and all the good stuff. So if you think about who knows menopause, it's really Doctor Jim Simon. So we're excited, excited to have you here today. My tagline is always, I'm here to educate so you could advocate for yourself. So hopefully women will be able to gain some information additionally and advocate for themselves.

Dr. Sameena Rahman [00:02:14]:

So thanks for coming on board, Doctor Simon.

Dr. James Simon [00:02:17]:

It's really my pleasure. I'm happy to be here. So excited to be working with you on this gyno girl podcast. So great.

Dr. Sameena Rahman [00:02:27]:

It's really picking up. So that's good.

Dr. James Simon [00:02:29]:

It's, it's fantastic. And, and I hope that we, you and I, can create some great content for your audience so that they can advocate for themselves and have a better fund of knowledge to advocate from.

Dr. Sameena Rahman [00:02:44]:

Absolutely. And, you know, I met Doctor Simon, I met Jim, like, way long ago at Ishwish for the first time. I think it was like eight years ago when I first started coming. And he was giving all the menopause talks and he was past president of the International Society for the Study of Women's Sexual Health, which I always talk about on this channel as well. And so one of the best speeches I remember you making is the one about how the us government has conspired and the media has. I don't know the exact title, but has conspired against women. And it's not a conspiracy theory. This actually is like, you know, things that were done to women by the us government and the media to prohibit them from accessing the medicines they need.

Dr. Sameena Rahman [00:03:28]:

But I think that's online. Right? Your thoughts?

Dr. James Simon [00:03:31]:

It's on my website. And it really was a conspiracy, not in, like, making up stuff, but in the way it evolved. And then there were so many entrenched concepts and ideas and so much money behind those that the truth really was hidden and to women's detriment, actually.

Dr. Sameena Rahman [00:04:00]:

Absolutely. Absolutely. We all know, and I've spoken about the WHI before, the study that probably ruined so many women's ability to gain access to the hormones they need for their health. And so that whole lecture that you gave is on that and it's online. It's wonderful. It really talks about the nuances of the women's health initiative and where they got it wrong. And I guess maybe where they got it right, too.

Dr. James Simon [00:04:27]:

And some things right. And we learned from that. The message was basically wrong.

Dr. Sameena Rahman [00:04:33]:

Right. Because that's all people remember from it, that it's hormones cause breast cancer, which, you know, I want to dive into some myths about hormones, but first I want to hear about your journey into menopause. Doctor Simon, if you could tell us, like, how you came. I mean, you've been doing this for a while. You've taught, you know, me a lot from everything that I've ever learned about you, from all the conferences I've attended. And I just. I want to know how you came to, because it's not something that, like, I know a lot of REI doctors can cut capacity, but it's not something that's wholly offered, I think, as a. As a specialty.

Dr. James Simon [00:05:07]:

So I don't think it's that complicated. I was trained as an obstetrician, gynecologist, and then a reproductive endocrinologist was actively involved in the early years of developing in vitro fertilization, even before trans vaginal ultrasound. Now that's. Yeah, exactly. But as my own patients got older and were, after all the reproductive issues of pregnancy and childbirth and miscarriages and the usual subjects that ReIs deal with on a regular basis, they stuck around, or they came back to me with questions about aging and menopause and hormones and sex. So I just made sure that I was up to date and stayed ahead of the game and did research and wrote on these subjects, which I've just continued to do as I've gotten older. And interestingly, as an older male person, women who are older take my wisdom, if you will, more seriously than when I was much younger, because, you know, they. I guess they see their partners or their friends in me more than some younger guy.

Dr. Sameena Rahman [00:06:35]:

Yeah. Yeah. No, I can believe that, too. And just the fact that you've done so much research and, you know, educating on this topic is amazing. But let's talk about your newest article that just came out in the Green Journal, which is our Ob GYN journal with doctor Barbara Levy. And it's the contemporary view of menopausal hormonal therapy, which I think is such an important article for. And I know you guys wrote this for the general practicing ob GYN who doesn't know what to do. They see these patients and what do we do about it? But tell me how this paper evolved, and then we can get into it a little bit.

Dr. James Simon [00:07:11]:

Yeah. So this was a true collaboration. Barbara Levy, who used to be an executive at ACOG, and I have been colleagues and friends for decades, and we felt that there was a big gap between the knowledge base that we had and the average practitioner, because the average Ob GYN and even primary care practitioner had a long time with no education or the wrong education on the women's health initiative, hormone studies, or they got no education whatsoever on those studies and the issues. And we thought it was time for an updating and reintroduction and a little primer, if you will, on where we are and where we are going forward for people in the trenches, for average Ob gyns, nurse practitioners, pas, et cetera, in the Ob GYN or gynecology space to just bring them up to the current state of affairs.

Dr. Sameena Rahman [00:08:26]:

Wonderful. It's really a wonderful article. I like how you go into all the different hormones, and I like in the beginning where you guys talk about how just like, no one blood pressure or one seizure medication is the same. The same is true for the hormones that we have available for women in peri and post menopause that you wouldn't just prescribe lisinopril to everybody. So why would you just prescribe one of the estrogens or conjugated estrogen? So I liked that comparison a lot.

Dr. James Simon [00:08:57]:

I think this is a big problem in medicine, not only in this space or for these kind of hormones. And that is we are so busy in the clinic or in the office that we have these algorithms. We now even have AI telling us what we should or shouldn't do. And we have pressures, cost and time wise, to homogenize what we use for treatment. And I think that's just the opposite of what we should be doing. We should be seeing every woman as an individual with her own risks and benefits and desires and concerns, and try and tailor something that's pretty unique and special, personal to her, rather than just, you know, McDonald's every everything the same way, because it's inexpensive or easy to do or satisfies the big, broad audience rather than the individual audience. So that's my focus, and that's why I think Barbara and I put this article together in a nutshell.

Dr. Sameena Rahman [00:10:10]:

Yeah, I love it. And I think that is consistent with the theme of last year's menopause conference, which was precision medicine. Like, we really have to practice with each individual patient in mind and not, this is not cookie cutter medicine. This is not like one size fits all. I really like that approach as well. So let's talk about some of the myths that touched on some of these in other podcasts. But I want to hear from you. So let's talk about the myths around breast cancer, which is the biggest concern always, and the hormones, obviously, using estrogen and medroxyprogesterone acetate versus other synthetics, progesterone.

Dr. James Simon [00:10:49]:

First is the most important thing. I think we showed this in our article that even in the women's Health initiative, the active treatment of conjugated equine estrogens and medroxyprogesterone acetate actually didn't increase the risk of breast cancer. It was a statistical aberration that led to that finding that really changed the world, and I would argue unnecessarily. So whether or not hormones increase or decrease breast cancer risk in an individual was not actually shown in the biggest study that contended that that was the case. And in this paper, we review why that was a mistake and erroneous and what those judgments served and how they served anybody, I don't know, but they were incorrect in my judgment and doctor Levy's as well as many other people. In addition, we also show that there may be ways to have less impact on the breast, less potential increase in risk of breast cancer by using what are commonly referred to as bioidentical or body identical hormones that are both less estrogenic and less strong as progestational agents or progesterone like agents. And so, taken together, not only was it not true that hormones increase the risk of breast cancer, but there may be ways to even reduce the risk further. And so if you have that as an opportunity, why not take it?

Dr. Sameena Rahman [00:12:50]:

Why not take it? Yep. And I think that it's important just to know, we all know that the women's health initiative was, you know, conjugated equine estrogen with hydroxyprogesterone acetate, a synthetic progestin. And, you know, I think premarin has gotten such a bad rap over the years. I actually, I feel like one of the conferences, I met somebody that is, like, involved with, like, the farms that these people, like, raise these horses in, and he was like, these horses get treated so well, actually, people really get worked up about how they might get treated.

Dr. James Simon [00:13:22]:

So I think there's choice. And I think that conjugated equine estrogens, whether given alone or with medroxyprogesterone acetate, probably have the largest amount of data in american women of any compound available. So if you want certainty of what you're using, what you're going to get, both risks and benefits. We actually know that lots of times we think of bioidentical or body identical hormones as being better or safer, but there are big gaps in our knowledge. And so that may be better on paper, but not better with actual data on american women. And american women are different than women in Southeast Asia or in Asia or even in Europe in a lot of ways, diet, exercise, body weight, body fat, et cetera. So we never really know exactly unless we're talking about american women. That isn't to say that conjugated estrogens should be used for everyone, but the answer is, we at least know what to expect, right? I'm not a big conjugated equine estrogen proponent, but it is clearly a well documented, well studied option, and there are some advantages for women which we can talk about.

Dr. Sameena Rahman [00:14:50]:

Sure. Yeah, we should get into that, because we all, I think many of us that find people with progestin sensitivities or if they're concerned about breast cancer, I've turned to combination of the conjugated equine estrogen with benzelfs base dua, have a is the trade name, but yeah, it is a cirm plus the conjugated equine.

Dr. James Simon [00:15:17]:

Estrogen, which so du vi in the US, an ex US that's called dua viva. Oh, same combination. But these agent, this combination of conjugated estrogen without progesterone or progestogen, but using an antiestrogen, basodoxifene, as the progesterone like agent in the combination provides estrogenic effect and a safe endometrium for which we used, usually use progestogen with no progestogen. So you said it, Samina. I mean, in someone who's progesterone sensitive, what does that mean? Someone that has premenstrual like symptoms when they're on menopausal hormones, bloating, breast tenderness, fluid retention, menstrual like cramps, et cetera. She's not going to be very happy even if her brain is happy and her bones are happy, if she feels really bad. And this combination therapy allows her to be on estrogen doses, we know amounts we know a product we know without being on any progesterone or progesterone and still having uterine safety. And for her, it's incredible.

Dr. James Simon [00:16:48]:

The other place that we, that at least I like this particular combination is in that woman who's on estrogen and progesterone, and she wants to be on bioidentical or body identical hormones, but has spotting, staining, bleeding, spotting, staining, bleeding all the time and has otherwise a normal uterus. This combination therapy really has an incredible bleeding profile, which is to say women don't have spotting, staining and bleeding on it. And so that could be really such a game changer for her that she won't have to have spotting, staining and bleeding. And not to put too strong a method or a point on it, but there are a group of women, and many of them are in your audience and thinking, maybe they're one of these women who either for religious or ethical reasons, refrain from sex when they have spotting, staining or bleeding. Absolutely.

Dr. Sameena Rahman [00:17:55]:

Yep.

Dr. James Simon [00:17:56]:

Or they really require oral genital contact to get their orgasm, and they won't engage if they're spotting, staining and bleeding. And here's a life changer for those groups of women, because it has very, very little spotting, staining and bleeding associated with it.

Dr. Sameena Rahman [00:18:20]:

Yeah, no, that's wonderful. That's a very good point, actually, since you were talking about, you know, you brought up the South Asians and you know, my audience, I have a lot of South Asians that come see me in downtown Chicago. And, you know, and you're probably aware that although we make up like a quarter of the world population, we make up like 67% of the world heart disease or something really astounding. So we have. We carry a big burden of heart disease and diabetes. So when I have, you know, a midlife brown woman in my office, I'm really trying to push her for, you know, sometimes, unless, you know, like, I'm perimenopausal, unless they're sort of in the same sort of, you know, philosophy that I'm on, many of them won't use it, but I'm. I try to use the cardiac, you know, angle to try to get them in, to try to potentially go on the hormones. Can we talk a little bit about the cardio benefit of.

Dr. Sameena Rahman [00:19:07]:

Of being on estrogen?

Dr. James Simon [00:19:09]:

So this is somewhat controversial, but is one of the primary learnings we got from the Women's Health initiative. And that primary learning, in just raw terms, is that use of estrogen or hormone therapy early, close to menopause, versus starting late years after your last menstrual period really defines a group of women who will benefit and cardiovascular benefit from hormone therapy versus those that will have risk from hormone therapy. So what I like to say is early on and long use really gets you most of the benefits, brain, bone, heart, metabolic, etcetera, versus starting late gets you mostly, if not exclusively, risk. And that's a fundamental change that we learned in the women's Health initiative. But your idea of starting women on hormones early after their menopause or even in the late perimenopause for cardiovascular prevention and metabolic benefit, I'm 100% with you on that.

Dr. Sameena Rahman [00:20:33]:

Right. And although technically it's not an indication. Right. For hormone therapy, but I think most people also will have vasomotor or concerns about bones and all that stuff. So you can always negotiate that. But I think for them to understand the cardioprotective benefit is really important.

Dr. James Simon [00:20:50]:

Right. The other thing, and I think it's a subtlety that we're just learning about, is that most people outside the US and outside western Europe, even those that were, that are living there, but that their ancestry is outside, have millions, if not tens of thousands of years of diet that's largely carbohydrate based, and that there's nothing wrong with that diet as long as the amount of total calories and expenditure that you got is consistent with that mostly agrarian history. But move that person to the US, where hunting and gathering calories doesn't require very much expenditure at the Safeway or whatever your local grocery store is. Now you've got a lot of car. A lot of car and not much expenditure, and that's really bad for your cardiovascular health.

Dr. Sameena Rahman [00:22:02]:

Sure. No, that makes sense, actually. But I think that benefit for early perimenopause or early menopauses should not be understated for some patients that are really concerned about their cardiovascular health. And so I think we touched on a little bit on the heart stuff. There was the article that came out, I wanna say, a few months ago, about starting hormone therapy in patients over the age of 65 or something like that, and how we should restart. And I've actually had a number of patients come in that I treat for GSM who are like, did I miss my chance? Like, what should I do, Doctor Aman? I'm like, I'm in good health, and they have really good numbers. Cholesterol, blood pressure. Sometimes I'll have them get that coronary artery calcium score and see what it is.

Dr. Sameena Rahman [00:22:52]:

But these are the kind of things that I kind of look at when I'm considering. We both know that we try to do things based on joint decision making with a patient. So if a patient is well aware of the potential risks, benefits, then they can understand that. But tell me what you do when you have, like, a 70, 75 year old patient come in and say, hey, you're giving me all this good vaginal estrogen. But what about me? I got left out of the picture.

Dr. James Simon [00:23:17]:

So I think it's a particular problem in this timeframe, because women who went through menopause around 20 years ago, when the women's health initiative first set of hormone data came out, were taken off or were not allowed to go on. And now they're 70, you know, 20 years after age 50 is 70. And they really do want to know, is that window of opportunity for cardiovascular benefit that we just talked about? Is that window now closed?

Dr. Sameena Rahman [00:23:52]:

Yeah.

Dr. James Simon [00:23:53]:

Is there a way to reopen it? Is there some, you know, intermediate way of judging whether it's closed or open? And I do a variation on what you just mentioned, but I've been very surprised, both positively and negatively. And I'll give you those two examples. Patient, exact same patient. She's now 65 to 75 years of age. She'd like to go on hormones, mostly for her bones because her hot flashes are done or not a big problem. She's already on vaginal estrogen because she's having penetrative sex or recurrent urinary tract infections, etcetera. And I got to decide, is it safe for you to go on hormones for your bones or not? And so I think cardiovascular risk is the real limiting step there. And assessing her coronary artery calcium, her lipid profile, her blood pressure, typical cardiovascular risks, maybe even checking to see what the thickness is of her carotid artery intima.

Dr. James Simon [00:25:07]:

This is what was used in the elite trial, some global measurements of her cardiovascular risk right then as a 70 year old or older woman, and then making a judgment on risks and benefits with her joint decision making once we get those scores back. And just recently, I had a woman in the office this week had a terrific cholesterol profile with hdl cholesterol. Above 60 was actually above 80. Long family history of longevity, et cetera. But she, for whatever reason, had a high coronary artery calcium score.

Dr. Sameena Rahman [00:25:51]:

Oh, really?

Dr. James Simon [00:25:52]:

Yes. It was a big surprise to everybody, including her cardiologist.

Dr. Sameena Rahman [00:25:56]:

Like in the hundreds kind of thing?

Dr. James Simon [00:25:58]:

Yes, in the hundreds.

Dr. Sameena Rahman [00:26:00]:

Oh, my God. Not kidding.

Dr. James Simon [00:26:03]:

This week.

Dr. Sameena Rahman [00:26:04]:

Wow.

Dr. James Simon [00:26:04]:

And so we decided jointly that we were going to put her on some hormones in spite of her calcium score. Her cardiologist already put her on a statin, already put her on a baby aspirin, and she had been on them stable. Everything fine for a while, but proof was in the calcium score, and it was pretty high, but we went ahead and did it anyway.

Dr. Sameena Rahman [00:26:30]:

And she was already on a staff. Wow. That's crazy.

Dr. James Simon [00:26:32]:

And we already did it, knowing full well that she was at increased risk. But that all documented and we'll see. That was just this week. But in general, I've had that same patient, 65, 70, even 75 years of age with a coronary arteries calcium score of zero. And for her, risks should be pretty darn low. And she can do what she wants, and I'm happy to help her with that.

Dr. Sameena Rahman [00:27:03]:

Oh, great. And you said you get a carotid.

Dr. James Simon [00:27:05]:

I mean, endothelial carotid artery intima media fitness. It's a CIMT is the abbreviation. It's an ultrasound test, so there's no radiation involved, but, you know, it has to be done by somebody that knows what they're doing, and it's an indication of plaque formation. But in the carotid arteries, it's better associated with stroke than it is with heart attacks, so.

Dr. Sameena Rahman [00:27:37]:

Right, okay, wonderful. I'll just start doing that, too. Okay, well, that's good to know, actually. And that's a really good example, I think, of somebody that you wouldn't. You would. You were, you were shocked to see had an elevated coronary artery calcium score. So yeah.

Dr. James Simon [00:27:53]:

So you have to ask the questions and get data with someone's kind of outside the norm and the mainstream. And, you know, sometimes you're surprised for the better, sometimes surprised for the worse.

Dr. Sameena Rahman [00:28:08]:

Exactly. You know what? I was going to ask you something else. I put myself on Nextelis because e four has so much good. There's so much good data on the use of estratriol when it comes to perimenopausal symptoms. And I heard there's data coming out use using it in menopause. Are you do, are you on that study? Are you on that study?

Dr. James Simon [00:28:32]:

So there are investigations that haven't been fully published yet, so don't. I hope your audience doesn't get too far ahead of the data.

Dr. Sameena Rahman [00:28:42]:

Right.

Dr. James Simon [00:28:42]:

On the use of estetrol, which is a naturally occurring fetal estrogen, but we're using it now in birth control pill, pills and trade name stellis. Correct. And it's being tested in vaginal estrogen products for genital urinary syndrome of menopause, pain with sex, urinary tract infections, etcetera. And it's also being tested for its benefit in hot flashes and night sweats. But I think it's a little premature to either endorse it or trash it because the data is not really out there in the public domain yet.

Dr. Sameena Rahman [00:29:28]:

Okay. Can we just talk about why it's being studied, though, like, with the uniqueness of it?

Dr. James Simon [00:29:32]:

Yeah. So estetrol is, as I mentioned, a fetal estrogen. All of us, male fetuses, female fetuses, we are literally bathed in it when we're in utero, and moms are exposed to it when they're pregnant because it's in such high concentrations in the baby that it kind of leaks into the mother's circulation. So we know it's safe. We know it's something that occurs naturally. And it can be now manufactured, in the pharmacology logic way to be used in birth control or in vaginal creams, tablets, etcetera, or for pills for hot flashes. And it has a very neutral effect outside of the central nervous system. It's probably beneficial on the bones, it's probably beneficial on the blood vessels, and it's probably not detrimental or maybe has no effect in the breast, which makes it really good for menopausal patients, good for the heart, good for the bones.

Dr. James Simon [00:30:55]:

Not no effect in the breast, maybe good for the vagina. Uh, you know, these are good for hot flashes. This is sounding pretty good.

Dr. Sameena Rahman [00:31:04]:

Yeah. So we'll have to see.

Dr. James Simon [00:31:06]:

We'll have to see. Yeah, that thought. Until the date is in.

Dr. Sameena Rahman [00:31:10]:

Yeah. So you guys, you know, stay, stay on what you're on right now, but I use nextelis as a form of like, contraception and, you know, helps with my perimenopausal symptoms.

Dr. James Simon [00:31:21]:

Yeah, absolutely.

Dr. Sameena Rahman [00:31:23]:

Not all of them, but most of them. Okay. I wanted to also talk about breast cancer survivors. I had Doctor Corinne Min on for one of my episodes, and she's a big fan of yours as well. And so she was talking to me about how frustrated so many of her patients that she sees through allo in her own practice are, who are really remote from breast cancer and just aren't getting the help they need from a hormone status. So can you tell me how you address breast cancer survivors in your office?

Dr. James Simon [00:31:54]:

So this is another controversy of shared decision making that really needs to be shared because the dogma, I didn't say the science, I said the dogma is once you've had breast cancer, you can always get a recurrence. And theoretically that is absolutely true, but after a long period of time or after early breast cancer or both, the likelihood of a recurrence is extremely remote. It's not zero, it's never zero, but it's extremely remote. And many times women finish their aromatase inhibitor or their tamoxifen, those adjunctive treatments to their primary surgery or lumpectomy or radiation, and then they're not cured of their cancer. But their recurrence risk is very remote. But they don't have any hormones, they don't have any for their vaginas, they don't have any for hot flashes, they don't have any for their bones, etcetera. And the data is accumulating over decades that it's actually safe for them to go on hormones after a period of time.

Dr. Sameena Rahman [00:33:21]:

Right?

Dr. James Simon [00:33:22]:

That period of time is not entirely clear. Not entirely clear which women with breast cancer or what types of breast cancer or what stages of breast cancer, but early stage breast cancer with no positive lymph nodes that have been treated properly and then deemed to be clean of their disease. I think we're being overly cautious with their hormones, and it's time to reevaluate and give women who need them or want them the hormones they deserve.

Dr. Sameena Rahman [00:33:58]:

Okay, great. That's what I was wondering from your perspective as well. But I knew you're on the same. Okay. And then I have to talk about the brain. Of course, it's very controversial too, in so many ways, whether or not it really is going to be a benefit of reducing your risk. Of dementia. But we know there's many types of dementia, vascular Alzheimer's, everything.

Dr. Sameena Rahman [00:34:18]:

So where do you stand when you talk to patients about the brain health?

Dr. James Simon [00:34:22]:

So I think this is likewise evolving. And like you say, there are many kinds of dementia just there, like there are many kinds of breast cancer. So we need to be a little careful about making generalizations. However, just last week I attended a magnificent, and I don't say that all that often, a magnificent lecture on the impact of menopause and hormones on Alzheimer's. It was given by doctor Roberta Brinton, who's a basic researcher, and she was speaking for both herself and doctor Lisa Moscone, who could not bake the lecture and who's written two very popular books, female brain and hormones in the female brain. But basically, she, Doctor Brinton, gave this beautiful, albeit complicated, overview of how hormones are likely beneficial in reducing or preventing Alzheimer's and other forms of dementia. And curiously, it's not in the typical way hormones work. That was the take home message for me.

Dr. James Simon [00:35:48]:

It was about energy metabolism in the brain that is facilitated by estrogens. And by virtue of that energy metabolism in the brain, the brain of the aging woman, not on hormones, doesn't have to reinvent itself for sources of energy. And when it has to reinvent itself for alternative sources of energy, there's a whole bunch of inflammatory, destructive and temperature raising changes that are all ultimately detrimental to cognitive function. So it's all about energy, energy metabolism and maintaining stability of that energy metabolism through the menopause transition and beyond that preserves cognitive function, not the typical estrogen binding to its receptor, and that making estrogenic changes like we have, for example, in the vagina.

Dr. Sameena Rahman [00:37:03]:

Oh, that's really interesting.

Dr. James Simon [00:37:04]:

Actually, it was fascinating. Tons of data, tons of references. I wish I had a podcast of her doing it again because she did such marvelous job of simplifying two decades of research into, you know, the average endocrinologist was, was in the audience.

Dr. Sameena Rahman [00:37:26]:

Oh, where was this conference? Or where was she?

Dr. James Simon [00:37:29]:

This is the endocrine Society annual meeting. It was one of the plenary presidential lectures, and it was spectacular.

Dr. Sameena Rahman [00:37:39]:

Oh, wonderful. Wow. Okay, well, we'll stay tuned to hear more about that at some point.

Dr. James Simon [00:37:45]:

Absolutely. But very positive in its potential for early prevention of cognitive decline with hormones at or around the time of menopause.

Dr. Sameena Rahman [00:37:59]:

That's wonderful. Well, that's exciting, actually. That's, every time I hear more of this information, I get super excited about the potential. Because for those individuals listening, I'm sure if you had a family member with dementia. It's very much of a struggle to kind of navigate that on many levels, and nobody wants to be that person for their kids. We're all on a nursing home prevention program.

Dr. James Simon [00:38:24]:

Yeah, yeah. Memory care prevention program. Exactly. But the point here is, again, just like hormones after breast cancer and personalizing and individualizing treatment plans, this is early research in terms of cognitive decline and hormones, but it's almost all positive and in the same direction, just still evolving. And so we need to be careful about over generalizing and treating everybody a certain way before the data.

Dr. Sameena Rahman [00:39:02]:

Sure. We should probably try to get her, for the menopause society to come talk. Are you on the committee?

Dr. James Simon [00:39:08]:

It would be fantastic.

Dr. Sameena Rahman [00:39:10]:

Maybe we'll talk to Lisa about that. Let's see if she can, you know. Great. Okay. And then I want to also talk to you about testosterone, because, you know, from ish. Wish I've heard you talk about testosterone. I think you were on some of the studies, the early studies, using testosterone in women for hypoactive sexual desire disorder. And testosterone obviously gets a lot of press.

Dr. Sameena Rahman [00:39:31]:

We all know we don't have an FDA approved testosterone here in the state states. Australia does. I remember learning that from you for the first time. But can you tell us how you feel the research on testosterone is going to, or if you know any new research where it's going? Because we know that right now for post menopausal or perimenopausal women, we use it for hypoactive sexual desire disorder. But I want to hear what your take is on.

Dr. James Simon [00:39:55]:

So this has been a lifelong goal of mine. And when I say lifelong goal of mine, I mean, over 45 years ago, I published on testosterone in women, and we still don't have a testosterone product for women in the US.

Dr. Sameena Rahman [00:40:15]:

Despite good studies. Right.

Dr. James Simon [00:40:16]:

Despite excellent studies. Let me summarize very quickly for your audience to give them some basics to understand. First of all, testosterone is a hormone in women. It's present in between four and ten times the amounts, as is estrogen. Even though we focus a lot of on estrogen. The reason that most practitioners don't appreciate that is that testosterone is, is expressed in blood work, for example, in different units than is estrogen.

Dr. Sameena Rahman [00:41:00]:

And when you first taught me that, my mind was blown. I was like, what? Cause we don't learn this in med school either. Like, it's not.

Dr. James Simon [00:41:07]:

No, we just know if it's normal or it's abnormal. And the answer is, we don't know the amounts. But if any of you or your audience has ever tried to teach a child the difference between seconds and minutes and hours. To a kid, it's all the same. You can't tell them the difference. I mean, it's just time. And to some degree, we practicing physicians, healthcare professionals of all types, we never really got the difference in the units either. So women make lots more testosterone every day of their reproductive lives, then they make estrogen.

Dr. James Simon [00:41:49]:

It goes down as women age. So the average 50 year old who's going through menopause, she's got about half the testosterone that she had rolling around in her veins that she had when she was 25. So it goes down and dramatically down. Now, if you lost half your thyroid or half insulin, we'd be jumping all over you to get on your thyroid or on your insulin, because you'd have problems and consequences from having half as much as you did when you were younger. And we just are ignoring women in the menopause in terms of getting them testosterone. Now, there is this product that's available from Australia that's approved for. For women, formulated for women in the US. Ish wish has taken the bull by the horn, so to speak, and decided that in the absence of a product that's approved, that there were some male products, male testosterone products, that could easily be adapted to use in women without making them bald or bearded.

Dr. James Simon [00:43:04]:

And that's what we've decided. And there is a guideline and instructions of how to do it, how to test, how to retest, etcetera. Not going to get into the weeds there, but I'm a believer that most menopausal women benefit from testosterone therapy added to their estrogen or their progesterone, or both, but could be used even in women who are not on estrogen and progesterone. And there's good studies for that. One of the more recent studies convinces me of the safety of that approach. And it was a study that was mandated by the FDA to be done in men. And those men in those studies were at high risk of heart attacks and high risk of prostate cancer. And they were given standard doses of testosterone, and they were on it for a prolonged period of time, and nothing bad happened to them.

Dr. Sameena Rahman [00:44:08]:

Right. I heard about this, yeah.

Dr. James Simon [00:44:10]:

And the doses that they were given were about tenfold more than we would be giving women.

Dr. Sameena Rahman [00:44:16]:

Right.

Dr. James Simon [00:44:17]:

Even though women are not one 10th the size of men, they're smaller, but they're not one 10th the size. And so it was very reassuring that a 10th of the dose, which is the proper dose for women, should be more than safe in women for breast, which is the comparable organ for prostate in the risk of cancer, if it exists, and cardiovascular disease, which is very similar in men and women in terms of the effect of hormones. So we have data from a couple decades ago when there was a testosterone patch being developed for women, never made it to market both on safety and efficacy. We have this new data on men at much higher levels than in women on safety. And we know that it works for women for low sexual desire, but it also works for strength, lean muscle mass, cognitive function in terms of math, problem solving and visual spatial function. Whole bunch of other things that it does for younger women that older women lose to one degree or another. And I just don't understand why we can't get the regulators, Health Canada, the US, to help move this forward a little for women when we have 30 plus products for men.

Dr. Sameena Rahman [00:45:54]:

Do you think that there's going to be a new product to be tested or do you feel like the pharmaceuticals are done?

Dr. James Simon [00:46:00]:

I not ever giving up because I've been at this for 40 plus years. But I think that with the tremendous number of prescriptions for compounded testosterone products in women, and the use of this australian product here in the US for women, and the use of male products at lower doses, as we've recommended by ishwish in women, that I'm hopeful that the FDA will meet with the companies that would like to bring a product to market and come up with a rationale that's effective and safe and doable with a reasonable amount of financial resources to get products approved for women. I'm hopeful. I remain hopeful.

Dr. Sameena Rahman [00:46:53]:

I hope so. I mean, that would be wonderful because it's always hard to tell patient how to give. Take testim 1%, one 10th of the dose. I always say, tell them they can use a five cc syringe and use a half a cc today. You know, some people are just like, this is alchemy, right? Like.

Dr. James Simon [00:47:11]:

It is a bit like alchemy. But I use the. That's a similar approach to that. Just using drops of the testimonial in tubes. Drops in tubes, which works extremely well because the skin is a big equalizer. So you use a little too much one day, a little too little the next day, right. Exactly the right amount the third day, the skin is the great equalizer. And so women end up with the right amount.

Dr. Sameena Rahman [00:47:42]:

And my patients that I have on it, really, they're just like, you're not taking this for me. I'm sure you feel the same way.

Dr. James Simon [00:47:50]:

Yeah.

Dr. Sameena Rahman [00:47:50]:

Awesome. Well, I'm glad you've been doing all that work, and we all appreciate all the research and education that you've done. Tell us, tell. And I appreciate the time you've given me already, but I want to end on any advice you would give a patient who's not being heard by her clinician, who, you know, like, how can we help them advocate better? They have now, like the data and the information, but they're just totally getting gaslit. Like, how would you tell them to approach their clinician?

Dr. James Simon [00:48:18]:

So I would say a couple of things. First, they should advocate for themselves. They should try and find someone in their community who's an expert. They can find one of those people using the listservs for the menopause society or the International Society for the Study of Women's sexual Health. They can ask their practitioner, is there anyone in this community who might be an expert who could offer me an opinion, a second opinion? And, you know, a really good practitioner knows that he or she doesn't know everything, even if they're really great. And if they're certain in themselves that they have a relationship with the patient, they should be willing to offer getting a second opinion from somebody else. If that's not happening or it appears that there's not an expert in your community, then find one of us online or make, and make sure they have credentials and expertise and we can schedule a video visit. I have licenses in about a half a dozen different states.

Dr. James Simon [00:49:36]:

We can do a video visit. I can make suggestions to that person, even if I don't have a license, having to do with what questions to ask their doctor. And I've often back channeled with the doctor to say, listen, your patient reached out to me. I think that she's a candidate for this or that and, you know, try and help them all get the knowledge they need.

Dr. Sameena Rahman [00:50:03]:

Wonderful. Well, that's great to hear. Can you tell us the state you're licensed in for the listeners?

Dr. James Simon [00:50:08]:

Yes. So I have to refresh my memory, but Virginia, Virginia is one, DC, which isn't a state, but in DC, Ohio, Tennessee, Pennsylvania.

Dr. Sameena Rahman [00:50:26]:

We can list it in the notes too, the show notes.

Dr. James Simon [00:50:30]:

I'll send you the list so you'll have it. But I'm trying to expand that because there's been a big gap, as we've discussed, in the education of practitioners. That's catching up, but it'll still be a while before everybody's on the same page.

Dr. Sameena Rahman [00:50:47]:

You should start out like a masterclass, Jim, you know, for practitioners.

Dr. James Simon [00:50:53]:

So we do have masterclass for practitioners. Yeah, and we're trying to sell a group of master classes to health systems, to big employers, so that all of their practitioners, whether they're physicians or nurses, nurse practitioners, pas, can all benefit from those masterclasses. So we're working on that.

Dr. Sameena Rahman [00:51:18]:

Okay, awesome. Well, a lot of great stuff in the pipeline here, so you guys heard it here first. So anyway, thank you so much, Jim. I really appreciate you being here. It's always a pleasure to hear you speak and, you know, to bestow your knowledge upon the world. So thank you so much.

Dr. James Simon [00:51:34]:

It's really been my pleasure and I'll give you lots of ammunition for the notes and look forward to working with you further. Nanoparticle society and at ishwish and maybe seeing some patients that heard this.

Dr. Sameena Rahman [00:51:49]:

Absolutely. So thanks everyone for joining me today. This is doctor Samir Mangaino, girl. I'm here to educate so you can advocate for yourself. Please join me next week for another great episode. If you have a second, please subscribe to this podcast.

Dr. Sameena Rahman [00:52:05]:

I'd love for you to be a follower and learn as much as you can about the things that we're going to talk about with all the people on our journey. Please review us on Apple or Spotify or wherever you listen to podcasts. These reviews really help review us comment tell me what else you want to hear to get more information. My practice website is www.cgccago.com my website for Gynel Girl is www.gynegirltv.com. my Instagram is Gynell Girl so please follow me for some good content. Additionally, I have a YouTube channel, Gynell Girl TV, where I love to talk about all these things on YouTube. And please subscribe to my newsletter, Gyno Girl News which will be available on my website. I will see you next time.