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- [00:04]
A
Welcome to the youe Are Not Broken podcast. I'm your host, Dr. Kelly Casperson, a board certified urologist, thought leader and conversation starter on midlife living, hormones and sexuality. Enjoy the show.
- [00:18]
B
Hey everybody. Welcome back to the youe're Not Broken podcast. Excited today to have on again Dr. Jim Simon, who you were previously on my podcast, episode 111. It's been a while since you've been here.
- [00:32]
C
It has. Thank you for having me back. It's very exciting to be here.
- [00:36]
B
Kelly, I think you should be here at least every hundred episodes, to say the least.
- [00:41]
C
Sure.
- [00:42]
B
It kind of sounds like a compliment.
- [00:44]
C
I can agree to that. Every hundred episodes.
- [00:47]
B
Right. So you practice in Washington dc. You're a gynecologist who specializes in hormones. And is this still true? The only doctor to be both president of Ishwish and Nams, the only physician. Only physician. So a PhD has done it.
- [01:03]
C
Yes. Cheryl Kingsburg.
- [01:05]
B
Cheryl Kingsburg has done it.
- [01:07]
C
Is the only other one that can claim those two. And yes, she's a PhD, but yes, only physician to do it.
- [01:16]
B
That's a pretty big deal. I mean, it's such an intersectionality of Ishwish and Nams and my go to in so many people ask me, where do I find a physician, where do I find a doctor, where do I. And I say Ishwish is the best because they're comfortable talking about sex and hormones. Because I think Ishwish has really kind of realized the importance of hormones in sexual health.
- [01:39]
C
Yeah. There's no question about that. Even though I'm here in Washington D.C. i've got a bunch of licenses across the country, so I can do some telemedicine visits for people in need or who just need to figure out who in their area can help them.
- [01:58]
B
Yeah. Especially the way, you know, both sexual health and menopause perimenopause is getting heard and seen and we're understanding the suffering. We need all physicians on board, all PAs, all nurse practitioners. 50% of the population is a ton of humans.
- [02:14]
C
It is. And they are coming of age. So it's that time.
- [02:20]
B
Yeah. I think what's really unique, first of all, I just read that Gen X next year, the oldest Gen x is turning 60. So they're really turning of age.
- [02:31]
C
Yep.
- [02:32]
B
And I think, you know, that generation, specifically the Gen X, is they're taking care of aging parents. They're really starting to consider aging. Well, how do we do this? Well, how do we stay functional? How do we keep doing what we love doing? And so I think there's a thoughtfulness to aging that we haven't had on such a big platform before.
- [02:54]
C
I think that's true. I think Dr. Peter Attia has really moved that needle toward healthy aging, healthy practice of medicine with the context of lifespan and healthy aging. And certainly hormones have a lot to do with that.
- [03:12]
B
Absolutely. I mean, I think Ashley Winter was the one who painted it out for me so nicely. She's like, hormones are the longevity movement in women. You can't have the longevity conversation without discussing hormones.
- [03:25]
C
I think that's probably, at least in part true.
- [03:28]
B
Absolutely. So you publish, and the paper that a lot of people go to because they say it's just done so brilliantly, is a paper called A Contemporary View of Menopausal Hormone Therapy. People can find it online, and it so well explains where we were and where we are now and maybe a revisiting of the current medications that we use and how they're different from the Women's Health Initiative medications. What motivated you to revisit and update people's current understanding of menopause hormone therapy?
- [04:00]
C
So I think that it was more serendipity than anything else. Dr. Barbara Levy, who's my co author on that article, and I have been working together at a recent American College of Obstetricians and Gynecologists meeting, and we noodled the idea that there are a lot of people online, writing, etcetera, who have ways to come up to what we used to believe in their current practice and their current pontifications, shall we say. And so Barbara and I hunkered down and decided, let's explain where we were, what happened with the Women's Health Initiative, where we are now and what people can do today. And we put that together, and she was very successful in getting it published in the Green Journal, the Journal of Obstetrics and Gynecology, which is the kind of Bible journal for your practicing obstetrician and gynecologist. And fortunately, it was very well received, got published, and I think it's factually incredibly accurate, yet conservative.
- [05:27]
B
Yeah. What have people told you about it as far as like, okay, I'm going to start thinking about this now, or where can I learn more? I just think it's so well done to lay out people's fears and to say, what we're doing now isn't what we were doing 20 years ago. This is actually different medicine and it's much safer.
- [05:46]
C
Yeah. I think it opened people's eyes by addressing the past and addressing the kind of Elephant in the room. The Women's Health Initiative, not as a bad study, but as a good study, but largely misinterpreted. Putting that into context and then bringing it forward and trying to move practitioners to rethink their fears and the benefits of hormone therapy for their own patients.
- [06:19]
B
Yeah. What are the big misperceptions that you see that still persist?
- [06:24]
C
So I think the biggest one, and it's the one that many, many, many patients fear, is the impact or lack of impact of hormone therapy on breast cancer. And that's the fear that many women have. There's a real difference between the effect of hormones on the breast, the effect of hormones and their risk of breast cancer. And then the fact that many treatments for 80% or so of breast cancers are hormone reducing or hormone sapping or hormone manipulating. Those are all completely different things where there's a lot of nuance between them. And that's what a real menopause practitioner or hormone specialist needs to clarify in the minds of patients so they can make their own educated decisions. But educated with the proper information.
- [07:31]
B
Yeah. One thing I see super common is my aunt, my sister, my mom had breast cancer, so I can't take hormones. How do you address that one?
- [07:42]
C
So certainly family history of breast cancer is extremely important and I think in some cases prompts a deeper investigation of that woman's personal risk of breast cancer. For example, if her mom, her aunt, her cousin, whoever we're talking about, had their breast cancers before menopause, that's a big red flag that maybe they have a genetic undercurrent or predisposition for breast cancer. We need to check that. We can check that. It can be investigated and maybe it'll be reassuring for her, but maybe it will say, hey, listen, maybe you need to have a prophylactic mastectomy. Maybe you need more aggressive disease reducing or disease preventing therapies of which there are plenty underutilized, by the way, but plenty. And we can have an educated decision. But then, then again, maybe aunt and mom and cousin had their breast cancers when they were 95 and they died of heart disease. And we can pretty much put the information in the chart and then ignore it in terms of her risk of breast cancer. Different strokes, different folks. But we need to tease those differences out.
- [09:14]
B
Yeah, very well said. One thing I see over and over on the social media is we want to simplify. We want to make black and white. And so much of medicine goes back to individual risk, individual benefit, informed consent. Nothing's 100% safe. Nothing's 100% risky. But we just want to draw these lines in the sand and we can't.
- [09:39]
C
That's a fool's errand to even try. On the other hand, as opposed to when I started practicing, we now have really good risk estimators, we have genetic testing, we have other ways to balance the risks and benefits so patients can really make an informed decision. Decision where in the past we were kind of flying by the seat of our pants.
- [10:07]
B
Yep, yeah, totally. Where do you see the future of hormones evolving at this point with the new research that's coming out, with the safety data that's coming out and specifically in the arena of prevention now looking at I'm taking this hormone because in 20 years I want to be healthier. Where do you see that conversation going?
- [10:26]
C
So I know that there's a lot of research going on behind the scenes to try and figure out an evidenced way to answer that question. I do think this is me, my crystal ball. It's not scientifically based, it's me answering a very good and provocative question sitting as I see it now, I think we will have testing that will be able to segregate women into buckets, let's say low risk, moderate risk, high risk of any hormone related risks and low, middle and high benefit from hormone therapy. And we're going to find out that the benefits outweigh the risks in probably 2/3 to maybe 80% of women. And we will put all of them on hormone therapy for the remainder. We will say look, we have a family history of this, a personal history of that. You're better served in terms of your longevity for that 20 year time horizon by not putting you on hormone therapy. And further, these are the reasons why I'm going to lay that down and you'll still be around 20 years from now. I won't be likely.
- [11:53]
B
God willing, maybe I'm even older than
- [11:57]
C
I look than I look. Although my dad's 97 and he's still living alone. So maybe there's hope for me.
- [12:07]
B
Maybe there's a little bit of hope for you. Yeah, I mean I think it's really exciting and I think that's the question people are starting to ask. The more we get the data of listen, hormones aren't going to treat disease. Hormones shine best in prevention of disease. Okay, now we know that we gotta kind of turn the medical paradigm on its head. Cause we're really good at treating disease. And so it's kind of introducing a new way of thinking to say we don't have many things that we Take for prevention. We don't put everybody on baby aspirin. We don't put everybody on a statin. Right. It's a very high bar to say everybody should. And. And I don't think we're going to get there with hormones and the. Everybody should. But I think if you have an informed conversation, you understand risks and benefits and you choose that it's right for you, I think you should be supported in it.
- [12:58]
C
So let me just tell you what my uncle, my father's brother said before he passed away. Had nearly 100. He was a general surgeon and very active as a surgeon until pretty late in life. He said, doctors are getting paid all wrong. And I asked him, I said, well, what do you mean they're getting paid all wrong? He said, we should be paid for keeping people healthy and alive, not for treating their disease.
- [13:28]
B
Yeah.
- [13:29]
C
And that was probably 35 years ago.
- [13:33]
B
He was ahead of his time in
- [13:35]
C
a lot of ways.
- [13:36]
B
Oh, I love that. So you. I mean, you have to have these women come to you. They're the boomers who. If the boomers are paying attention. The boomers were turning 55 when the women's Health Initiative came out. Roughly.
- [13:50]
C
That's absolutely correct. And a challenge because they were either in the thick of their menopausal symptoms or they were challenged to either stay on the hormones that they had been on with the data from the Women's Health Initiative, which suggested only risk. It didn't talk about benefits very much.
- [14:12]
B
Yeah. Not in the beginning. Not in the first pass through. So a boomer comes to your office. She's healthy, she's still active in the political. I'm making somebody up active in the political scene in D.C. like, likes her brain, likes her bones. Not the idea of her bones staying healthy. Right. And she's like, Dr. Simon, I didn't get hormones or my hormones were stopped in 2002. It's been 15 years. Can I start? Because I think there's a very large group of boomers who are like, we missed the window. What do you got for me? Is it still safe to start? Where do you go with those women?
- [14:49]
C
Yeah. So I have those women in my office every single day. They've read all the good news of late. They. They've read my paper, probably, and they want to ask exactly that question. They may be 60 or even 70 years of age, and there is no easy answer for them either. And here's how I explain it to them. I tell them that at their age, whatever it is, the answer is yes. Can Be yes or no or maybe. Remember, we put people in these buckets. Well, we need to figure out which bucket they're in. And I think that the standard answer is nope, you've passed the window of opportunity. It's too late. Forget it. That's the pat answer. My answer is let's investigate a little further to see if you've passed that window of opportunity or not. And sometimes even after I do that testing, I don't know. I'll give you an example from last week. One of my go to approaches for cardiovascular risk. After I look at their cholesterol profile and their exercise and their weight and other loose measures of cardiovascular risk, I'll get a coronary artery calcium scan. And I had a patient just last week who had a coronary artery calcium score of 0 in all of her major vessels except one where she had a score of 500 in one vessel. What do you do? I don't know what to do. I'm going to reach out to some of my cardiologists and ask what do I do? But in general, I have patients that either have high scores or low scores or age appropriate scores. High scores means to me, hormones might not be the best plan for you. Low scores mean okay, what are the benefits you're looking for? Maybe you're a good candidate and intermediate scores are. Well, we need to make a value judgment. You get to help me make that judgment, but I'm not pushing one way or the other.
- [17:19]
B
Informed consent.
- [17:20]
C
Exactly. Informed consent for her and shared decision making. I mean, I think in the political arena, more in the reproductive area than in this one. We've got all kinds of politics about who controls a woman's body. But I'm focused on here. You want to do something. Here are the risks, here are the benefits. My opinion might be, but you get to weigh in too. What is your opinion? What do you see for yourself? Knowing what I've just told you about risks and benefits, let's make this decision together.
- [18:00]
B
Yep. And certainly with the higher cardiac risk, transdermal is probably going to be preferred. And then I get comfort in the secondary prevention data. It's older studies now, but hormones didn't make things any better for the secondary prevention, meaning women who'd already had heart disease or a cardiac event, but they did no worse than placebo, cardiac wise. And so to me I'm like, I've got secondary prevention data. So that's women with known heart disease that we put on hormones compared to placebo to see how they did. They did no Better, but they did no worse.
- [18:37]
C
And there may be an alternative to hormones in that setting where they would do better. So, for example, statins and lowering of cholesterol has a pretty bad rap online. But if you look at the data, there are millions, and I mean millions of both men and women who take statins and have no adverse effect on whatsoever. And the benefits of cholesterol lowering in that setting is more than just cholesterol lowering. Those agents have major anti inflammatory effects in a variety of organ systems, including the blood vessels. That may really be one of the major benefits of them. And we commonly just gloss over it or ignore it when we shouldn't be.
- [19:34]
B
Yeah, I mean, you bring up a good point of it shouldn't always be hormones or not. It should be the whole human. What else? If we're getting scans that are saying you should optimize things, how's the diet, how's the exercise, things that are. It always comes back to there's more than just hormones that's going to get you that healthy longevity.
- [19:51]
C
Yeah. And the other thing that I have to stress over and over again, let's take the long view here. You need to lose some weight. How much do you want to lose? Oh, I want to weigh what I weighed in high school. Well, let's forget that. Let's get real here. Okay. Likelihood of that happening is very low. But let's talk about what's a realistic weight for you at age 60 and where you want to be. No, you can't lose that amount of weight in two weeks to fit into your new bathing suit in this fall season. Let's take the long view. Then it becomes a very doable and quite realistic, you know, if you only want to lose a half a pound a week, I know you can do that. I know you can do that. Whether you need to lose 5 pounds or 50 pounds, let's take a proper time horizon as a variable and get to work on it because it becomes doable.
- [20:51]
B
Yeah, I mean, I think the same thing about fitness too. Right. It's like you've got to incorporate all of this into the, the healthy longevity of. You know, somebody asked me today, they're like, would you go so far to say we have enough data for testosterone supporting muscle growth in women? And I'm like, I don't think we have that much data. And I can give you hormones and you will not grow any muscles if you don't feed them properly and, and weightlift them properly. Hormones don't work in a bubble.
- [21:19]
C
You gotta have resistance Training as part of exercise. It's one of my go tos. And there's pretty good data that resistance training is underutilized, undervalued and underdone in women in particular. Men, not so much.
- [21:35]
B
Yeah, yeah. No, there's no drug that does what waits do. That would be a blockbuster for sure. Let's talk about the newer drugs for hot flashes that work in the brain on the candy receptors, Fezilinitant. And now help me out. Lizonatant is the new one.
- [21:54]
C
Elinzanatant.
- [21:56]
B
Elinzanatant is very. Is that even out yet?
- [22:00]
C
It is not out. The data on it was just published this past week in jama.
- [22:07]
B
I saw your Nate, your name was on it.
- [22:10]
C
Yeah, it is, but it too is a central nervous system receptor antagonist. And the answer really is that we Only recently, since 2005 and in the history of science, 2005 was yesterday, discovered how hot flashes are controlled in the human brain. And we now have one drug on the market, thezolinitant, and it's available. You can buy it, your practitioner can write a prescription for it. And this newer one, Elinzanatant, which is not on the market yet, but hopefully sometime next year, will be obviously subject to FDA review and approval. And then we'll have. Actually we have two, but not only two, but we'll have a third option for how to treat hot flashes and night sweats and to some degree disturbed sleep in women who are in the perimenopause or menopause. And that's great news because there are clearly some women who cannot or should not use hormones and they have those hot flashes, night sweats and disturbed sleep.
- [23:40]
B
To me, I'm like, I can, I want to take the upside on this. Why are there three coming out? They're all incredibly expensive. Are they all hoping they're going to get on somebody's insurance and then be covered? But like, I know it's a huge market, but these drugs are pricey. Is the fact that there's going to be three of them, is that going to be helpful? Because you think the price will go down?
- [24:00]
C
Yeah, competition is good. When drugs are brand new, the free market doesn't work that well. But once they're established and on the market and there's competition, it tends to push prices lower. One of those companies will want theirs to be the exclusive on a particular formulary or on a particular health plan. The other will want to do the same and let them fight it out for lower prices, hopefully. But yeah, choice is good. More choices are typically better. And I'm all for more development in this arena so that women have choices. I want to correct one thing I didn't mean to say. There'll be three candy neuron modulators. We have an FDA approved non candy neuron modulator called Brizdel, which is a very low dose of paroxetine Mesylate, an antidepressant that is also FDA approved for for the treatment of hot flashes and night sweats. And it's been on the market for a while.
- [25:19]
B
My understanding is it's kind of pricey too. I mean, compared to an estrogen patch, oral microns progesterone.
- [25:25]
C
I cannot tell a lie. You are absolutely correct, Dr. Caspersen.
- [25:31]
B
I care about prices. I mean these aren't like a five day course of antibiotics. This is a you gotta keep taking em for them to keep working sort of medication.
- [25:40]
C
Yes, it's true. And I'm just hopeful that for people that really need them, they will be able to access them and for women in the future that there'll be competition and driving those prices down. One of the things that I'm on a little bit of a soapbox about, Kelly, is that drugs in the US are really overpriced compared to the rest of the world. But it's not because necessarily they're overpriced generally, but because companies have to hurdle such a big barrier with the FDA that other countries kind of defer to us. If it's approved over there, we'll give it a big old rubber stamp and we don't have to spend a lot of money or a lot of work to get it approved over there. And so we, the people in the US that buy the drugs here, overpay for those treatments to subsidize the rest of the world, quite frankly, which good for them, bad for us. But I do think that balance has to shift and change going forward because we just can't keep doing it. And we all want new and innovative therapies to advance the state of the art. So something's got to give.
- [27:02]
B
Yeah, no, I agree and I really appreciate you bringing that point up because I don't think it's often talked about. I think one of the big frustrations for women is how many FDA approved testosterone doses for men do we have? How many decades have we have tons of safety data on testosterone, but the hurdle to get an actually appropriately dosed testosterone for women, it's generic, you can't charge a lot for it. If you do get a product where you're Going to charge a lot for it. We'll still just use the male dose and buy the cheaper stuff. Right. Like, it's a hard ask to actually get a female dose testosterone in this country for a couple of reasons.
- [27:39]
C
Yeah. I've been on that soapbox for 40, count them, 40 years. That is a continuing challenge. But I haven't given up and I can't spill the beans. But I think that there's a little teeny glimmer of hope in the future and I'm optimistic that's going to happen in my lifetime.
- [28:02]
B
Yeah, no, I think it's going to happen soon. But again, if it'll be priced and then when it's FDA approved for low libido insurances will say, we don't cover sexual dysfunction meds.
- [28:14]
C
And I would ask every person in your audience if that happens to rise up in protest, storm the FDA and
- [28:26]
B
make them change 100%. 100%. It's amazing how many people are like, I'm angry. What should I do? And I'm like, get loud. Get loud to the insurance companies. Get loud to the fda. Get loud to your legislatures. Let them know that you care about this because everybody else is getting loud about everything else.
- [28:45]
C
I'm angry about this. And I vote you want to keep in that seat about six minutes from here where my office is. You better get on it there.
- [28:58]
B
Oh, I love it. Thank you so much for helping support that because I think so, so many women just feel like their voices don't matter. And to hear that they'll be supported when they speak up is very powerful.
- [29:10]
C
Yeah, absolutely. I'm in on that 100%. And quite frankly, given my location, which is, let's shall we say, five blocks from the White House, I can honestly say I've seen some of the most powerful vaginas in the world.
- [29:31]
B
Yeah. And they're, they're middle aged and they care about these things. So let them know that you all like that. The people also care about these things. I saw another paper that your name was on. You did a meta analysis in the menopause journal in 2023 talking about Ospemifeme for GSM. Osphena is the brand name. My question to you, is this an underrated med? Are we not using it enough? And maybe I should back up to explain. Or you can explain. What is this medication for?
- [30:00]
C
Sure. I'm happy to explain it and I will answer your question. So Osphena or ospet is a medication that was originally being developed for osteoporosis however, osteoporosis development is extraordinarily expensive. Hundreds of millions of dollars expensive. We already had reasonably good agents on the market or coming to the market at the time Osphena or ospemiphene was being developed for osteoporosis. And the company noted that in the early tests for osteoporosis patients that their vaginal symptoms of menopause, dryness, pain with sex, et cetera, were being alleviated by the use of omiphene. And it turns out that it's an estrogen in the vagina, it's an anti estrogen in the breast and an estrogen in the bones. So it kind of hit this nice complementary number of targets. And so the company developed it for the treatment of vulvar and vaginal atrophy due to menopause, typically dryness and pain with sex. And there's tons of data on it and it looks to be safe, it's definitely effective. And we also published another paper in a European journal showing that it actually reduced the risk of breast cancer recurrence in breast cancer patients who are using it for their vulvas and their vaginas. So you take that whole picture together and your question is it underutilized? I think definitely underutilized. The other piece of that puzzle, going back to our prior discussions, is it's very cost effective and patients tend to like it because it's a pill. Now that might be also why it's underutilized. You know, we don't think think of taking a pill for a targeted treatment of the vulva or the vagina. We think about putting something in it, putting something on it, but not taking a pill for the great down there, so to speak. And so we don't think of it in our head. So we don't prescribe it when we have a patient. But the answer is it works, it's effective, has some off target benefits. And the paper that you brought up is about its safety and it's extremely
- [32:58]
B
safe side effect of hot flashes because of how it's an antagonist also in some parts of the body. Uterine safe.
- [33:06]
C
Uterine safe, which is what that meta analysis is about. We forget that women that have hot flashes, not all, but many of them, they're right around the time of their menopause, a little before their last period, or in the first three to five years after the last menstrual period. During that time, their ovaries are still making some estrogen, still making some testosterone, and their vulvar and vaginal symptoms tend to be much worse in the second half of their 50s, 55 to 60 or beyond, when their hot flashes are much better. So this product fits right in that vein. Late 50s, after the hot flashes and when the vaginal and vulvar symptoms are kicking in.
- [34:00]
B
Got it. When it came out, it was really expensive. And now the price of vaginal estrogen cream is it's like the only thing that's going down in price in the United States of America in the last five years. It keeps getting cheaper, which is fun to watch. But I should probably revisit the coverage for Ospenofeme now that it's been out for a while. I'm thinking, like my really older ladies that maybe can't be remembered to do a vaginal product twice a week. Maybe a pill is a better option for them.
- [34:32]
C
So a couple of things that you might not have thought of, and I'll probably get some hate mail on this, but according to Procter and Gamble, who make a ton of products for menstrual periods, about 15% of U.S. women, this is about five years ago, were too big to put a tampon in their vagina. They couldn't get their arms around their bellies or around their butts to do it, and so they use pads. My guess is that they didn't get any smaller after menopause. And so a pill for their vulvar and vaginal symptoms may be one of the few choices that they have and one which might be able to solve a very important symptom that otherwise will go untreated.
- [35:33]
B
My next question on this drug as the urologist is any data that the ospemifeme will decrease recurrent UTI risks or recurrent UTIs? It makes sense that it would, but do we have any data on it?
- [35:46]
C
Yeah, there is some data. It's not very good. It's secondary outcome data from the clinical trials which, as you suggest, did show a decrease. But the best way to show a decrease is in recurrent urinary tract infections is to study it in a group of women with recurrent urinary tract infections. And in these studies, these were typically women who did not have recurrent urinary tract infections to begin with, but it did have a signal that was a beneficial one.
- [36:22]
B
I mean, it makes sense mechanism wise. If it's improving moisture, maybe your microbiome,
- [36:30]
C
acidity of the vagina and epithelial integrity, it does all the right things. That's how it got approved. So as you would expect, it will reduce the content of pathogens in the vagina and the likelihood of urinary tract infections. But again, the data's secondary and pretty soft because the women didn't have a lot of urinary tract infections.
- [36:56]
B
Yeah. One more paper that I want to talk about because you're. We all get set in our ways of like the meds we go to because they work and, you know, blah, blah, blah. It's so nice to kind of be like, maybe I should re explore some of these things. You did a paper on the effects of flibanserin, brand name's Addie, on subdomain scores for female sexual function. And I think that's important to talk about because we talk that drug is FDA approved for low, low sexual desire or hypoactive sexual desire disorder is the medical term for it. But it's helping arousal, it's helping orgasm, it's helping quality of life in that domain. It's really kind of all domains of sexuality. And side note, 10% of its users are men. For a pill that's pink and marketed to women because it helps in their orgasm and desire and arousal as well. Anything you want to add about what you guys found when you looked at things besides desire for that medication?
- [37:52]
C
Yeah. So I think that we, the medical profession generally get overly focused on the label and the package insert. And this is on us. This is a problem of us focusing on what the FDA and the company have agreed to to be the primary test of their drug. And, and the primary label that an indication that they got for their drug. Cialis works in women. Why would you think it wouldn't?
- [38:27]
B
Right. It's a blood. It's a nitric oxide blood flow drug.
- [38:30]
C
Correct.
- [38:31]
B
Not specific to the penis.
- [38:33]
C
Correct. And the anatomy may be different, but not that different. And so my point here is just because a company chooses to develop a drug for a certain endpoint or for a certain population, in this case Flibanserin for women, doesn't mean that the only thing it works for is that endpoint or it won't work in men. To your point, same thing for testosterone. You mentioned that we got, I don't know, 30 different types dosing of testosterone for men. Women make tons of testosterone during their entire reproductive life. Why would we think that it wouldn't have an effect in them? It just doesn't. It's illogical.
- [39:25]
B
Right. Or for only one domain of libido and nothing else.
- [39:29]
C
Correct. So the companies typically went for the desired domain of sexual dysfunction because the other domains are really hard. So if you want to get to the market and use it for women, for whatever domain, you got to get it on the market. So you take the path of least resistance, as agreed to by the FDA and the company, or the path that's even affordable. And so we get these labels. But we, you and I need to fight for and against the insurance companies that want it pigeonholed just for that label. You know, we have to be logical and try it outside the label. If it works outside the label, if it's logically going to work outside the label, just fight for our patients to get the best care for whatever it is that their problem mandates.
- [40:28]
B
Yeah, I mean, it's ironic, right? Because the FDA will be the first to say we don't practice medicine. The FDA says that. And then insurance companies say we don't practice medicine. They'll be the first to say that. And then we say, well, we can only get this medication approved by your insurance for what the FDA approved it for. So who's practicing medicine here?
- [40:48]
C
Completely and 100% agree. And believe me, if more practitioners were vocal about that issue with the insurance companies. And we are getting there. We're getting there.
- [41:04]
B
You promise?
- [41:05]
C
I promise.
- [41:05]
B
I don't see light at the end of that tunnel. I will steal belief in your light if you see it.
- [41:10]
C
All right, well, we're working on that too.
- [41:13]
B
You live closer to the White House than I do. You know more.
- [41:17]
C
I definitely live closer to the White House than you do. But the answer is this narrow view of FDA labeling was never meant to be narrow. It was meant only to get drugs on the market. And as you're aware, we use tons and tons of drugs in all aspects of medicine off label. And they work.
- [41:41]
B
Birth control pills?
- [41:43]
C
Really?
- [41:47]
B
Everybody who's on a birth control pill is not on it just to prevent pregnancy.
- [41:52]
C
Really?
- [41:56]
B
And 80% of women at some point in their life have been on a birth control pill. I rest my case. We use off label stuff when it's convenient. All the time.
- [42:05]
C
All the time. All the time. And we need to push back and help our patients get what they need, even if it's not on the label.
- [42:15]
B
Yep. All right, so I've got a lot of Doctors, Nurse Practitioners, PAs who are moved by what you're publishing. They're moved by what they hear on the podcast. They didn't get taught how to prescribe hormones or sex med things in med school because you and I didn't either. Right. What's your advice to where? Who do you think is teaching clinicians the best right now in regards to hormones, in regards to sex, med, in regards to the things you care about.
- [42:44]
C
So the international menopause society outside the US Is doing a good job on hormone therapy for women. I think also menopause society here in the US Is being much more proactive about educating women about hormones. Apropos of your comment about sex and hormones and the intersection thereof, certainly ishwish has got a very good course and is teaching women about menopause and hormones. It's just that we have a huge uptick in the desire to learn about them because of the Gen Xers and the baby boomers either wanting to go on or wanting to stay on their hormones, that there's a little bit of a mismatch between the number of places in class and the desire to learn. So I would just say that there may be others who are doing teaching and education. It needs to come in the medical schools, in the residency and other training programs. That's coming along slowly. And I would argue, although I will get pushback for this, that we need to reach out with a helping hand to the internists and the family physicians who represent a huge swath of the United States that is not easily or adequately addressed by urologists or gynecologists. To bring them up to speed on this subject 100%. The problem is that they, while they can be taught to prescribe hormone therapy, they're never going to have it as the first 1, 2, 3, 4 things on their problem list because their approach and their mandate by their societies is hypertension, lipids, blah, blah, blah, blah, blah down the list. Not hormones or hot flashes. So there's a real challenge there in getting the knowledge into their hands in a way that they can utilize it in the context of everything else that they have to do.
- [45:15]
B
Yes. Do you know how many practicing gynecologists are in this country?
- [45:21]
C
I don't know. I think about 30,000 maybe.
- [45:25]
B
Not enough to take care of 50 million women.
- [45:28]
C
No. Let me give you a different statistic that's even scarier.
- [45:32]
B
Okay.
- [45:33]
C
And you should look into this for urologists also, because I suspect that it's not different. There are 50% of the counties in the United States that do not have a single gynecologist.
- [45:51]
B
I didn't know that's what urology is. Urology is even worse in the fact that I think it might be near 70%, but I didn't know it was 50% for gynecologists.
- [46:03]
C
Right. And in those areas, women are delivered by family physicians or they have to travel long distances to facilities where there is an obstetrician, gynecologist. So we have a distribution problem. We have not enough of us. And that makes for a bigger challenge that is being met by family docs, internists, nurse practitioners, PAs, midwives. Let's not forget midwives who, when they get a little longer in their career, may be doing more gynecology than obstetrics or midwifery per se. These are all people that need to be up to speed on this subject.
- [46:53]
B
Yeah, I love it.
- [46:54]
A
Man.
- [46:55]
B
That went an hour fast. You did a paper on sleep, which I love. I don't think there's been a lot of papers looking at the midlife sleep issues and the role of hormones. So if you want to either talk about that quick or I know you've got some exciting stuff in the pipeline, if you're allowed to talk about any of that today, to tease us for coming back in 100 more episodes, let's
- [47:15]
C
do sleep really quick because I learned a lot in doing that paper. And let's also plan to get together again in less than 100 episodes. So the issue of sleep in perimenopausal and menopausal women is quite complicated. But in our efforts to simplify everything, we attribute it all to hot flashes, night sweats and sleep disturbance due to them. But the challenge is that once those hot flashes and night sweats are cared for, a huge percentage of people with sleep problems still have sleep problems.
- [48:00]
B
That is such a good point because I've had those women. They're on their hormones, they're decent doses, they've got no other symptoms and their sleep is still horrible.
- [48:11]
C
So here's what I would think is relevant, quick and dirty that I learned from doing this paper. First, get those hot flashes and night sweats taken care of. We got good drugs for them, hormonal good drugs and non hormonal good drugs. That's the low hanging fruit. Let's get that taken care of. If sleep is still a problem, let's dump it into three buckets. An insomnia bucket. Falling asleep is a problem. Staying asleep is a problem. A restless leg syndrome bucket, where a person kicks or moves uncontrollably and that wakes them up or wakes their partner in bed up and then he or she wakes the kicker up. And then also an obstructive sleep apnea bucket. Those women tend to be overweight or obese. They tend to have other medical problems. But three easy buckets to identify. Didn't say fix, but where the process is Relatively easy and straightforward. And just pick off the buckets. And if you have a sleep person practitioner in your area, do not pass code, do not collect $200. Go directly to a sleep expert. Or if you've got a good primary care doc, he or she can make inroads in all three of those buckets. And if it's not enough, you got to sleep. Everybody's got to sleep. So again, don't waste time. Get help. And it's not that complicated. You just gotta think a little bit beyond hot flashes and night sweats.
- [50:01]
B
Yeah. I mean, I've had a couple of women where they're like, I know it's the hormones. I know it's the hormones. We push their doses up and up. And I'm like, can we just check an estradiol? Just see what this. And it's high. And I'm like, I don't think your sleep is from lack of estradiol anymore. It's time to keep looking at other sleep issues.
- [50:19]
C
Correct. It frequently unlocks anxiety disorders.
- [50:25]
B
Interesting.
- [50:27]
C
Which are highly prevalent in this age group. Again, what you said. They're worrying about caring for their aging parents. They've got kids that are going off to college. They're worried about them. They're worried about the finances of. Of that education. They're worried about divided attention between the older kids and the younger kids and their parents. They've got plenty of reason for anxiety. Not to mention they may have a partner that is a problem or their sexual issues. It's a challenging time for everyone. Anxiety is likely to come up. Let's get on.
- [51:10]
B
Yep. Absolutely. Oh, Dr. Simon, I love my time with you. You are a true experts expert.
- [51:17]
C
Thank you.
- [51:18]
B
Thank you for publishing the papers to me. I'm like, mad respect for people who can publish papers. I'm like, I'll write the books and do the podcast. Somebody's got to write the papers.
- [51:29]
C
I'm still having fun, Kelly, and it's been really great to spend some time with you.
- [51:35]
B
Are you going to be at nams?
- [51:37]
C
Absolutely. I get to present a couple of things and I get to see all my buddies, and hopefully you'll be there, too.
- [51:45]
B
It's my first NAMs. I hope they welcome urologists.
- [51:50]
C
We welcome everybody. It's a multidisciplinary society that benefits from different points of view, but they call it the Menopause Society.
- [51:59]
B
I know, I know. I haven't even gone to a conference, and I'm not calling it by the right thing. I should get my act together.
- [52:07]
C
So I was the President the year after the Women's Health Initiative came out.
- [52:11]
B
Oh, what a busy time.
- [52:13]
C
It was a challenge.
- [52:14]
B
That was a challenge. That's for another podcast episode. Thank you so much for joining us today.
- [52:21]
C
My pleasure. Really good to be with you.
- [52:23]
A
Thank you for listening to this week's episode of youf Are Not Broken.
- [52:27]
C
It.
- [52:27]
A
If you want to dig deeper with me, sign up for my Adult Sex Education Masterclass where you learn adult things like communication skills, anatomy lessons and desire types, and how to talk to your doctor about sexual health concerns. If you want the Adult Sex Education Masterclass for free, join my monthly membership for more in depth exclusive content, more time with yours truly. A private podcast, coaching and educational empowerment and you can watch my interviews live and get them immediately without advertising. Head over to www.kellycaspersonmd.com for the membership and Adult Sex Ed Masterclass members. Get the Masterclass for free. This podcast is presented solely for educational, entertainment and informational purposes only. I am a doctor but not your doctor in this format and all of my platforms and guests including on this podcast are not giving individual medical advice or practicing medicine. See and consult with your own care team for your individual needs and concerns. This podcast is not intended as a substitute for the care and advice of a physician, therapist or other qualified professional. This podcast does not constitute the practice of medicine, in case you were curious about that and no doctor patient relationship is formed. But I still love you. Using the information on this podcast or any of my platforms is at your own risk. Until next time, remember you are not broken.