B (3:34)

Love you.

A (3:35)

Thanks for following. Please share this with friends.

B (3:38)

Welcome to the you are not broken podcast. I'm your host, Dr. Kelly Casperson, a board certified urologist, thought leader and conversation.

A (3:47)

Starter on midlife living, hormones and sexuality.

B (3:51)

Enjoy the show.

C (3:53)

50 to 70 million women have been denied the incredible short term and long term health benefits, including living longer, reducing the risk of heart attacks, which is the number one cause of death in women because of this dogma that was magnified by the FDA black box warning. The groupthink of modern medicine, it's mind boggling to me. Maybe one of the greatest screw ups of modern medicine in recent time. Okay, we're doing this. I'm here with Dr. Rachel Rubin and Dr. Kelly Casperson. Two experts in hormone replacement therapy have treated, I don't know, thousands of women that are perimenopausal with hormone replacement therapy. And this is around our new announcement on hr. Welcome to both of you. Great to have you here.

B (4:40)

Thanks for having us.

C (4:41)

Just out of curiosity, how many women have you treated with hormone replacement therapy in your practices?

B (4:46)

So I'm a urologist. I started with vaginal estrogen, cause vaginal estrogen's incredibly important for the pelvis. And now it's been thousands of patients.

D (4:54)

Again since I graduated fellowship in 2016. This has been a primary focus of mine. Thousands and thousands of patients, but also teaching thousands of clinicians how to do it.

C (5:04)

And I know you're both big into the education piece of this. Go ahead and start off by educating our listeners about what we did today at the fda. We took action following a public comment period going through the proper process of having our subject matter experts re review the entire body of scientific literature and made the decision to remove the black box warnings around hormone replacement therapy for postmenopausal perimenopausal women, specifically around breast cancer warnings and thromboembolic events and the other things that have really contributed to the fear machine over the years. All of those issues are discussed in nuance, in detail in the Package insert on the label. But we are getting rid of that fear machine black box warning on hormone replacement therapy that is estrogen or estrogen plus progesterone.

B (6:00)

It's a really monumental week. Like, this is a very big deal. And I want people to understand that this is a long time coming. Right. We had a citizens petition in 2016, there was a petition for the FDA to change it. 2018, Dr. Rubin went back 2024. So over and over saying, we have data, we have research, we have treated thousands and thousands of women and published the data. To say that this, the sanctity of the boxed warning needs to reflect the actual risk and to adjust that accordingly now for the safety of the American women is monumental. And I think this is just going to be the next step in normalizing healthcare and safe medications.

C (6:39)

So look, we are. I've. This is outside of my personal area, right. I'm not a candidate for hormone replacement therapy around the time of menopause. This is a women's health issue. But in my view, people ask me, why are you so passionate about this? Women's health issues have not gotten the attention, the funding, the education, the appreciation that those issues deserve. And this is like number one, this is almost like a case study. What kind of damage? So first of all, we heard the voices of all of you and the experts in the field. We reviewed the literature, we went through the process, we took this action today. But what kind of damage did that black box warning do, Dr. Rubin, over the years, ever since that milestone and tragic announcement in 2002?

D (7:31)

Yeah, so in 2002, they did a press conference before papers were even published that said hormones are dangerous, they cause breast cancer, cardiovascular disease. No one had seen the data. And now we know the data actually looked pret good. It actually looked really hopeful. And there's so much benefits of hormone therapy, but the cat was out of the bag and they couldn't put it back in. And the messaging for 20 years has been hormones are dangerous. And the catastrophic event that happens because of that is an entire generation of clinicians have no idea how to talk to their patients about this or how to write prescriptions. There is a handful of brilliant, pioneering sort of warriors in the menopause groups that have done this work for decades. This is over half the population. This must be changed. And we have so much work to do to teach every clinician who takes care of women why this is important and how to do it.

C (8:26)

So I think what you're referring to just to add a little color, because I Did look into this in detail is that when the Women's Health Initiative, the largest study ever in the world at the time, a billion dollar NIH funded study, went to ask whether or not hormone replacement therapy causes breast cancer for women and what the other health outcomes were. It was tragically flawed in its design. The average age that it was that women initiated treatment was I think 63. There was, there were a lot of issues in the cohort and the inclusion criteria. And then, and, and it's well recognized that you need to start at what, within 10 years of the onset of perimenopause or 10 years from the onset of menopause and generally before age 60. Is that generally correct?

D (9:17)

That's what the guidelines say.

C (9:18)

Okay. So they took a very different cohort, a very different formulation that is a drug that is not commonly recommended today that I don't think you, you use it as first line. That was horse estrogen. It's very different from the estrogens today that are being used. And they went to the media with the story that it causes breast cancer. Even though the study which later came out in jama never showed a statistically significant increase in breast cancer rates in the hormone replacement therapy group versus the control group.

D (9:51)

And you remember that the estrogen only arm. So if you didn't have a uterus, if you don't have a uterus, you don't always need progestins with your estrogen, had a decreased risk lower getting and dying from breast cancer. Not just dying, but getting it was reduced the risk. And so women don't know this. Their everyday woman thinks estrogen causes cancer, it's gonna fuel a cancer. And that is a misconception. And so it, we, we, we aren't messaging this correctly because we are. What are the risks of taking hormone therapy which now you're putting in your label in the packaged insert so people can read the risks. But what are the benefits? What are the benefits of hormone therapy?

C (10:28)

Twist of irony that it reduced the risk of breast cancer in that estrogen only subgroup.

B (10:34)

Reduce the risk of breast cancer, all fracture, not just osteoporosis, colon cancer.

C (10:39)

We're talking about other long term.

B (10:40)

Right, Right.

C (10:41)

All right, let's go through the list. Yeah.

B (10:42)

All CA mortality in between the ages of 50 and 60, mostly because of reduced heart disease. And the other thing I really want people to know because we throw around the word estrogen like estrogen's estrogens. Estrogen, this was oral synthetic estrogen to the currently transdermal estradiol. What Our ovaries naturally make. That is now gold standard, first thing to start with. So we're saying risks with apples that weren't actually that bad are not risks.

C (11:09)

The horse estrogen, the horse estrogen, the estrogen today, that's close to your body's natural.

B (11:14)

So the oranges got this label on them, right? And that's what this is doing is it's clearing up. These are different medications, different doses, different routes of administration. Clinicians know that. But the lay population, estrogens, estrogen, estrogen. And we're here to say apples aren't oranges. We need accurate labeling for the oranges. We studied apples, right? And the apples ruined the oranges for everybody.

D (11:35)

But the challenge here is clinicians don't know this. Your regular clinician, your family practice doctor, your primary care doctor, your neurologist, your orthopedic surgeon, anyone who takes. They don't know the safety and the benefits, benefits of hormone therapy. And they've never studied it because of that Women's Health Initiative press conference back in the 2000s. And so now you have a whole generation. They didn't learn it in medical school, they didn't learn it in their residency programs. Even gynecologists do not get this training routinely and, you know, systematically. So again, you women are hearing my friends on podcasts, they're reading their books, they're reading your book and they're getting excited and they go to their doctor and they said, I read, you know, I read Dr. Makary's book, the chapter two, oh my gosh, this is safe. And they say, they look at them like they have six heads and it's a 10 minute visit. And so, and they don't know how to help them. And so they either change the conversation or they tell them it's dangerous. And that and, and that they, you know, and just dismiss them.

C (12:34)

Easy way to dismiss. Somebody is telling them they could die from something.

D (12:37)

Yeah, make them scared, right? And the box labeling helped to make them afraid. They're afraid of the doctors are afraid of getting sued. They're afraid of being not in their lane. And they don't know how to do this. Everyone's lane is women's health. Everyone who takes care of people. Their lane should be women's health.

C (12:52)

The black box warning fed the fear machine that began with that press conference the media ran with the story Char T became synonymous with breast cancer. I remember I was a resident. All of a sudden, this medication that helps women feel better, live longer, improves all kinds of health long term. Health outcomes. And we'll go through that list one more time. All of a sudden, HRT became a carcinogen on that day, even though we didn't have the study. Study comes out later. Hey, wait a minute. No. Statistically significant increased risk of breast cancer in that study. And those who got estrogen alone had lower rates. But that fear machine took on a life of its own. And the FDA piled on the next year by slapping the black box warning across the class of products.

A (13:37)

Yes.

B (13:38)

So when I see patients, I have to say, now, now, what this says, and if you go home and you read the label, I need you to know that this part's not true. Probable dementia. It doesn't even say possible dementia. It says probable dementia, which is a stronger word, right? Heart disease, clot risk, stroke. That's not true. And what I'm asking you to do is you have to decide between me and the FDA on who's truthful here. And, you know, we kind of joke about it in the clinic, but that's what I have to say is you're gonna go read things that I'm telling you aren't true. And now we're in alignment. Now we're a partnership on it. And I have stories where a woman will come in vaginal estrogen for pain with sex. Her husband will read the label at home, and he'll say, it's okay, honey, our sex life is not that important. It's not worth you dying over.

C (14:22)

Were you telling me, Dr. Caspersen, about patients who are prescribed that maybe you've prescribed estrogen to. And then they go home and read the black box warning, and they're like, oh, my God, I'm not taking this.

D (14:33)

This is.

C (14:34)

That sounds like the scariest thing on earth.

B (14:36)

So there's a published study done by Dr. Una Lee and her team. Team, looking at if a woman's lucky enough to get a vaginal estrogen prescription, right? So she goes in, somebody who's trained in general urinary syndrome and menopause, who knows that it's safe, that knows it's effective. She's lucky enough to get a prescription, she then goes home. 30% of those women will then choose not to use the product because of the incorrect label.

D (14:59)

And so talk about what this is for. And I think the revolutionary thing that your team did is that they changed the labeling so that vaginal hormones, like local low dose vaginal hormones, are very different than whole body systemic hormones. And those are different. The transdermal and the oral options and the synthetic options are different from each other. And so what we've been advocating for, for all of these years, long before you are in this job, we've been advocating for vaginal estrogen, which treats the genital and urinary symptoms of menopause, should not have the same warning labels as an oral synthetic hormone therapy for hot flashes. They're different indications, they're different things. And so we're so grateful because our community every day has to warn, this is microdosing estrogen. It is safe for your great grandmother in the nursing home who has leakage and urinary tract infections and she's gonna die from those urinary tract infections. And so many women are not being offered this vaginal estrogen therapy. Cause they have a 10 minute visit and how am I possibly going to explain to grandma that this box labeling doesn't apply to her?

C (16:03)

It's amazing. You know the sentiment out there. You talk to doctors, I talk to friends, they have no idea what the truth is. They just know about this black box warning, the fear machine, the stuff that you' saying that's not supported by evidence. That is this black box warning of probable dementia not supported by any evidence. Right. And so you have women who have come in to their doctor for help, either not offered hormone replacement therapy when they're great candidates or they ask and they are dismissed, or they're the fear machine is used to dismiss their question, or they beg for it because they've listened to other experts, maybe from social media or other platforms and they're told, well, we really don't want you to take it. Take a tiny, as small of a dose for as short a time as possible. 50 to 70 million women have been denied the incredible short term and long term health benefits, including living longer, reducing the risk of heart attacks, which is the number one cause of death in women because of this dogma that was magnified by the FDA black box warning, the groupthink of modern medicine. And it's mind boggling to me. Maybe one of the greatest screw ups of modern medicine in recent time.

B (17:18)

Yeah. And now what we have to do is we have to catch the clinicians up. We have about a million physicians in this country, we've got about 400,000 nurse practitioners and advanced practice practitioners. And we have 80 million women over the age of 40. And what we're doing from the grassroots, we're educating the people, right. They're hungry for information, they love body literacy information. And we'd have to tell them, you're going to go in, you might be More trained than your physician on this right now. And I'm sorry, but this is the way you turn a very large boat, right? As we have to train the clinicians. The interesting thing, after the WHI came out, 10 years after, about 10% of women in this country were on hormones as a backup in the 1990s, 40% of women were on hormones. Ten years after, 10% were. Twenty years after the WHO, only 5% were, it's getting worse. We're like, why is it getting worse? Well, there were clinicians 10 years after who still knew that hormones were good and that hormones were safe and that hormones helped women. They've all since retired. And we're not teaching it in the medical residencies.

C (18:21)

Generally don't. I mean, I only speak for my own medical education, but there are studies looking at OB residencies, how they don't even teach about menopause, let alone hormone replacement therapy.

D (18:31)

And this is the lived experience. So we have been teaching and teaching. I was education chair of an international society for the study of women's sexual health. We do advanced training in hormone therapy. I have spoken at the American College of Physicians, where you have a conference of 20,000 primary care docs, and there were no, no meetings, courses, or anything on menopause and hormone therapy. I. I got to talk about sexual health, which, of course, I talked about hormone therapy and menopause. And I got a standing ovation from the clinicians. You don't get very many standing ovations, you know, for giving a medical talk. And the comments, the comments all said, oh, my gosh, I learned something actionable that I can take to my clinic. They're starving. They were. They love. I've never seen such glowing evaluations. So when I do things like the Peter Attia podcast, I got so much, so many clinicians who showed up and said, thank you. My practice has now changed. I, I really. I can't believe I didn't learn this. How can I learn more? And so these clinicians are so hungry to know not just why hormones are safe, because the data is overwhelmingly showing us the benefits of hormone therapy, and everyone's talking about it, but how do we actually teach clinicians? Well, what dose of estrogen do you start with and pharmacy do you use? And what are the tips and tricks?

C (19:48)

Hormone replacement therapy in postmenopausal women relates to almost every single organ system and specialty in all of medicine, all 81 major specialties in medicine. Almost every cell in the body has an estrogen receptor. If I were to, you know, take A. A gander at it. And so if I were to have told my colleagues I was interested in diabetes and pancreas and publications, hey, I'm going to be doing some research on hormone replacement therapy as it relates to these, they would have laughed at me. Why are you doing that? There's no NIH funding for it. That's a dead subject. It's a carcinogen. Why would you look at the possible benefit? Let's talk about the possible health benefits from the literature for a second. Let's look at the list. Short term and long term benefits. I would guess hormone replacement therapy is known more on sort of a broad scale for the short term benefits. What blows me away are the long term benefits.

D (20:48)

Well, well, let's talk about the on label sort of what do. So this is really important because I was very involved with the development of guidelines for genitourinary syndrome of menopause. And there are guidelines from the menopause society sort of about when we give hormone therapy and sort of how it's changed and it has evolved. Guidelines evolve when new data comes out, just like warning labels should evolve when data comes out. And thank goodness that we're getting there. So, so if we talk, talk, there's the on label sort of or on guidelines and then there's sort of what we, what we see every day, right. I and Dr. Casper will talk about sort of what the guidelines say. But as a urologist trained in sexual medicine, I never thought I would treat so much joint pain in my life. Patients come to me every day and say, oh my God, I wake up without feeling like an old person. I can move my joints again because hormones are like brake fluid. So they help with dryness everywhere. Your skin dryness, your eye dryness, your itchy ears. But your joints, your plantar fasciitis, your frozen, frozen shoulder, right? It can help with the lubrication of your joints. But there is sort of the. By the guidelines, you know, what, what do we do? Right?

B (21:52)

Yeah. And I think that's where, where people, they rely on what has FDA approved and what happens when things get FDA approved is insurance coverage gets validated, right? There's so much that hormones cover because it's in every single cell that is not reflected in because you, you can't. How do you approve every single organ, right. As a use for estrogen. But if there was a drug, and I joke with my patients, I'm like, if there was a drug that you could take in pre diabetes, you're pre diabetic and you take a drug versus placebo. It decreases the risk of getting diabetes by 30%.

C (22:22)

And that study's been done.

B (22:23)

It's been done. That's an estrogen patch, right? I'm like, that would have two super bowl ads that year, right? It's an estrogen patch again, looking at prevention of dementia, prevention of depression in perimenopausal women. Placebo versus estrogen patch, Significant decrease in getting depression by one year. Because mental health changes that. Not feeling like myself, which is 40 to 60% of women in midlife. This is huge. This is relationships, this is jobs. This is how well you parent. This is how much you feel like going to exercise. This not feeling like myself, which I joke. I'm like, you can't X ray that. How, how do I know that Dr. Makary doesn't feel like Dr. Makary? And a woman's doing, but it's vitally important.

C (23:02)

And a woman's going through the symptoms of perimenopause, they're more likely to get an antidepressant than they are hormone replacement.

D (23:10)

So actually the Menopause Society meeting is happening right now and there was a study that came out that said, said if you go to see an OB gyn, you're more likely to get a hormone prescription, but still not, it's not that high. And if you're likely to go to a primary care doctor, you're more likely to get an antidepressant. And it's not because the primary care doctors just don't know how to write the hormone prescriptions. They don't understand. And there's no education on even perimenopause. So they don't realize that this is starting in the 40s. This is all your 40 old women who are coming saying, I'm dying because I wake up with drenched in sweat. Right? You would think of cancer as a, as a cancer doctor, right? I'm drenched, drenched in sweat. My weight is changing. I, I am so anxious. I'm, I'm depressed, you know, like I'm hot all the time.

C (23:54)

Million dollar workout, right? You do, you don't even think about.

A (23:57)

And they tell you you're fine after.

D (23:59)

Your million dollar work and they tell you you're fine and they give you no solutions. Oh, it's just aging. But this idea of like we have to be having these conversations in the 40s, not after one year of no periods. Your period doesn't actually matter. You can be cycling fully and still need and benefit from either a contraception or menopause. Hormone therapy, nuanced discussion of do you need contraception, do you need hormone therapy? Or you know, do you need something else? Like what is it that you do? You need bleeding control. And if we don't have people able to have high level conversations and rate how many menopause society sort of specialists are there? Not enough for the 85 million women who are having problems. But on label, right, you're looking at prevent like stopping and treatment. The best treatment benefits outweigh the risk for vasomotor symptoms, which is hot flashes, night sweatshirt, sweats, irritability.

B (24:50)

Right?

D (24:50)

All of those vasomotor symptoms, hormones, benefits outweigh the risks by the guidelines. How about osteoporosis prevention? So that's not a symptom. So if you go to your doctor and say, hey, I'm really afraid of getting osteoporosis. My grandma was 91 in the nursing home with dementia and osteoporosis. My grandfather gave her a hug and broke all her ribs. Okay, that's not how I want to age. I really want to prevent osteoporosis, but it's not a symptom. My bones are not telling me that I have a symptom. And so. And we know the genital and urinary symptoms of menopause. And it's not just dryness and pain with sex, although it is. It's urinary urgency, frequency, leakage and recurrent urinary tract infections. As urologists, we see daily. Women have recurrent urinary tract infections in their 30s, in their 40s and beyond. And it gets worse and worse and worse without the very, very safe local vaginal hormones.

C (25:43)

You're both clinicians, you have a lot of experience treating patients, which is why I invited you after the expert panel. You were both part of the FD expert panel on HRT that everybody should watch. Everybody who is a woman or knows a woman should watch it. That should be the universe of human beings on planet Earth. By the way, what the US does sets the standard for the world. So I'm proud of what the FDA has done here, proud of what all of you has, have said and voiced in your passion. That came out in the expert panel. I was moved by it. I do want to share that. So first of all, it's not a, it's not a one size fits. All your periods stop and you, then you start. You've got to sit down with a clinician. There's lots laboratory indicators that are much better indicators of when you could initiate. You want to initiate the right type, you want to ensure that you don't have one of the rare contraindications which some women have. So that's why it's so important to talk to a clinician. That's why I'm sitting here with both of you. I remember as a medical student, somebody came in with symptoms of menopause. Hot flashes, night sweats, a little abdominal pain, dryness, mood swings. Some of the classic clinical, classic short term symptoms. When I say short terms, they can on average, I think last eight years. You know, we were told in medical school some women have perimenopausal symptoms, but they're really short. They just go a couple years and they're very. And they're mild. Well, not true. 80% of women plus have symptoms. Many of them are unrecognized. The average duration is eight years. And for many women, they're severe. They're severe. I mean it destroys marriages, all kinds of stuff. Well, we had a woman come in with the classic short term symptoms and nobody just put the basic pieces together. And this is like the most Basic Women's Health 101. These were classic symptoms of menopause. Screaming at the docs, but they didn't see them. And they ordered a million consultations and tests and giant workup. And then a medical student, a female medical student I think it was, popped in and said, hey guys, this is menopause. These are the symptoms of menopause. So we talked about the short term symptoms of, of menopause. Those symptoms are alleviated by hormone replacement therapy. Maybe not a hundred percent, but significant relief for the vast majority of women. But then there's the long term health benefits. You're talking about osteoporosis, you're talking about heart disease. Let's enumerate them one by one. Reducing the risk of feeding fatal heart events, that is heart attacks by 25 to 50% in different studies. Reducing cognitive decline by up to 64% in some studies I've seen, in the 30 percentage point range, I've seen up to 64%. Preventing bone fractures because it prevents Alzheimer, prevents osteoporosis, by the way, also found in one study to reduce the risk of Alzheimer's by 35%. What else does that?

B (28:47)

Nothing.

C (28:47)

I mean, statins don't even reduce your risk of fatal heart attacks as much as hormone replacement therapy for women in, in some of the studies about reducing cardiac risk. And then the bone fracture risk thing, massive reduction in bone fracture, over 50% reduction in bone fracture. And women die of bone fractures later in life.

B (29:07)

There's more hospitalizations in America every year from bone fracture, hip fracture than stroke and heart attack combined. Let that sink in. Why do we not know about that? These are older women. They have no voice. They're not speaking up. But this is a huge problem. So when I talk to women, I say if men, if men had a drug that they could take between the ages of 50 and 60, that increase their life expectancy, said a different way, decrease their risk of dying, however you want to say that, do you think all the men would be on it? And everybody's like, yeah, all the men.

C (29:39)

Have been billions of all the beyond this.

B (29:41)

And I'm like, it's called estrogen.

D (29:44)

This is so challenging, right? Because even it's amazing what the menopause community has been able to do to really show benefit, to really to get patients on board and to help their patients individually, but it's not enough. And so we're so proud to be a part of that community and all the work they're doing and we fight, we all fight in our communities on the little details of Wait, that personage didn't show that, and that thing didn't show that. This is science and this is how science has always scienced, is that you have different camps, you have different people who believe different things. But here's the problem. This is a tiny community and yet it's over half the population. So this is a wake up call. Everyone wants to say, it's not my thing. This is not my lane, this is not my scope of medicine. And to have the head of the FDA say, if you take care of women, this is your lane is probably the most impactful thing that can change future funding, future research and our understanding of menopause and hormone therapy. But this isn't just about menopause. This is about which again, happens in your late 30s and fees. And we need more funding, we need more research, and we need more basic science and smart voices in this space. So this kind of platform is absolutely revolutionary because what it does is both the patients are watching, but the clinicians are watching, industries watching, the scientists are watching, and they can't say anymore, well, up there's a box label, this isn't my lane. This is too dangerous to be interested in. In fact, I love it. This cures my burnout because it gives me curiosity. And it's so fun because not every pat needs the same thing. Some patients only need vaginal hormones, some patients only want progesterone at bedtime. Some patients only need estrogen, you know, because they don't have a uterus. So you have to. But if your clinician doesn't know the difference between different types of hormone therapy, you should choose a different clinician because you have agency over who you go see.

C (31:35)

What percent of docs believe in hormone replacement therapy, they, they believe the benefits far outweigh the risk for the vast majority, but they just don't know how to proceed, describe it.

D (31:43)

We don't have the number. So as the social media has really menopause, everyone says is having a moment. This is not a moment, it's a movement. Right? We have this movement happening. So people are getting on board. We're doing these podcasts where people are interested. But again, there is not enough. Here's how to write the prescription, here's how to counsel your patient, and here's another big systematic problem is when I go to the doctor, it's a 10 minute visit. And we were trained. You get one problem. Mrs. Jones, are we talking about your hypertension today? Are we talking about your headaches or are we talking about your UTIs? You can't have all because we only have 10 minutes. So you have to pick one. You just got done saying that there are hormone receptors in every cell in your body. So when you go to the doctor because you are not feeling like yourself, you've got a lot of problems. You've got headaches, you've got joint pain, you're not sleeping, you're getting UTIs and your doctor says patient's just crazy or oh, patient has too many problems and, and you can't help them in 10 minutes. But if you understood that there actually really was one problem. But again, no one taught you. So now you're writing 20 different referral letters. Go see the neurologist, go see the urologist, go see. But no one's putting it all together.

B (32:48)

The average woman goes depending upon what data you look at. But the average woman has to see five to six different doctors to get her menopause symptoms treated. And we, we women, we're given a hard time for. You consume too many healthcare dollars, you're too expensive, you're utilizing too many resources. If we treated women in the first, first place and didn't have them go from doctor to doctor to doctor to actually get help, that number would come down.

C (33:14)

I mean, there we had a woman orthopedic surgeon on the expert panel at the FDA expert panel on HRT that was showing X rays of hip replacements that she did in women with Severe osteoporosis, where that osteoporosis was likely preventable had some woman been on. You think about the expenditure. You, you think about the fact that if a woman reaches age 80, one in three of them will go on to have a hip fracture. Bones, strength matters. It's essential to health. And then the one year mortality after a hip fracture, even with surgery, is like 22%.

B (33:48)

The wins are huge. The wins are because we talk about long term, this, long term, that all very me not dying, that's, you know, end of chapter, right? But the short term, I feel like myself again, which is not an ICD test. And we'll never get anything FDA approved for feeling like myself again saves.

D (34:08)

Can I tell a quick story? I take care of veterans, and this week I had a veteran couple come to see me, and it was about his problems. And he's, he's got some problems, right, as we get older, right? 80% of 80 year olds have erectile dysfunction. 50% of 50 year olds. And he came to me for his problems. And what was so cool is he brought his wife of 35 years, this gorgeous woman who was with him. They were in love. You saw the way they looked at each other. They had deep connection. And we're talking about his problems. And I asked her, I said, I said, well, how old are you? And she said, oh, I'm, I'm, I'm 55. And I said, are you, are you feeling like yourself these days? And she said, no. I've got hot flashes, night sweats, I've got brain fog, sex feels like razor blades, I've got dryness. And every time we have sex, I get a urinary tract infection. And I spent the next 20 minutes talking to them, giving them books, podcasts, resources, guidelines, showing them my video at the fda, telling them about how it's actually not his problem. He just wants to connect with the woman who he has loved for 35 years. And he doesn't have the knowledge, the education, or the language to understand why they've been disconnected for all these years. But it's her biology, right, that is affecting their biopsychosocial relationship. And he cares deeply about her. He doesn't want to hurt her during sex. And so once he got that information and he realized it, you just felt the ether of the room just so much more hopeful and excited of, like, wow. But then it was, well, where do they go? She wasn't a veteran, so she couldn't be my patient. Like, like, where does she go? Where do I send her for medical care because there aren't that many people who can have these deeply nuanced conversations about risks and benefits and family history. So it is essential, right, that we actually pair all this new education and knowledge with the clinicians who can have these conversations.

C (35:57)

How many docs have we talked to where you say deprescribe hormone replacement therapy for postmenopausal women and they'll say ooh, I, I worry about that breast cancer risk. So I, I, I'm concerned, so I don't. The damage done by that Press release in 2002 from the WHI announcement without any data released and you know, let's, it, it's maybe the biggest screw up in, in modern medicine. It's had tremendous consequences. And I'm, you know, I'm thinking as you're talking, which, as we talk about these long term health benefits, there may be no medication in the modern era that can improve the health of women at a population level more than hormone replacement therapy. Arguably, maybe with the exception of antibiotics or something, I'm not thinking of, but the tremendous public health benefits.

B (36:49)

Well, Dr. Rubin published a paper that said if every woman who receives Medicare, So this is 65 and older just got vaginal estrogen, right. They're a low hanging fruit here. So that's just for genital urinary syndrome, menopause. If you mailed everybody on Medicare who has a vagina a tube of vaginal estrogen and they used it, which they're more likely to do now that we have correct labeling, it will save the government healthcare system 13 billion a year just in reduced urinary tract infections.

C (37:17)

Just in one outcome out of all the outcomes. Forget about the fewer hip replacements, fewer, fewer people taken to the cardiac surgery suite for a heart attack. Just the one outcome.

D (37:28)

Well so I think also the point is that we are not suggesting that every single woman on earth gets a hormone prescription tomorrow. We are suggesting that they are able to go to their clinician and get options and see the menu. And the menu may just look like vaginal hormone therapy to prevent urinary tract infections, which is guideline driven and every human on earth can take safely. Right. I, I truly believe that. And the data is only overwhelmin safe wheat. There's data that came out last year. 50,000 women with breast cancer, if they took vaginal estrogen, had less likely risk of dying than if they didn't. And so we have more data out there that shows mortality benefit from vaginal estrogen than any harms at all. So some women may just opt for nothing, which is okay. Like if as long as you're, it's all informed consent. If you know what the risk, the, the benefits are and the risks are and you choose to do nothing, that's a great option. But you deserve the dignity, the dignity to get to choose how you live your life. Because we are going to die, every single one of us. And the question is, how do you want to live? Do you want. Right, like, like what are the options and what do you choose to put in your body? Some people choose to smoke, some people choose to drink. And they take on those risks, but they aren't often sort of given the options. And that's what we're trying to change. And this labeling change is just the first step. It is the first necessary step to say, wait a minute now, now we have the hard work of training people to understand how to do this and how to message it.

B (38:54)

I write in my books, I say, I'm not here to tell you what to do. Women are smart. They once given good information, they can make excellent decisions. But I want you to make your decision based upon education and not fear. And for too long, fear has been driving the train.

C (39:10)

Yes, look, you dangle something as sensitive as breast cancer to women, that is a powerful fear machine. And look, the people, people who might disagree with us out there might say, hey, no, look, there was this one study that showed even though it was not statistically significant in its first publication in 2002, 1 in 10,000 women would experience a breast cancer diagnosis. No subsequent study has ever shown, no clinical trial specifically has ever shown an increase in breast cancer, more time mortality. And the initial finding was not statistically significant and a subgroup had a lower rate of breast cancer. I'm like you, I'm a regulator now. I'm a health official. I am part of the government. I'm not here to tell anybody what to do with their own health decisions. But I feel like by removing some of the black box warning dogma, we are clearing the air for a conversation around the evidence and getting away from the fear based mindset that has dominated this field for 20, 23 years. A lot of women now are saying, hey, why have these issues not gotten the attention they deserve?

D (40:21)

It's a very bipartisan discussion actually because everyone loves a woman in menopause. Everyone, everyone has a perimenopausal or menopausal person in their life. And it that spans beyond politics.

B (40:33)

We're living 30% to 40% of our lives post menopause Right. And people think it's all about the period. One third of women don't even have periods. Hysterectomies, IUDs, ablations. Right. It's not about the period. It's about outliving ovarian function.

D (40:46)

And.

B (40:46)

And this is for decades. Right. And so when I talk to women, I say, what do you want to be doing when you're 75? How functional do you want to be? What's your ideal day? Let's build you now so you can be that person. And once you get women thinking about the future, it actually is a lot easier to make that decision of, I want to be playing pickleball. I want to be able to get off the ground with my grandkids. I want to be writing my fifth book, whatever it might be. Everybody's different. But when you think, how do you want to age one? Well, hormones are part of that discussion. I always agree. When women are like, we need more research, we need more research. I completely agree. We need more research. But let's not forget about the research that we have. And a lot of this research that we have is actually old research, because the Iron Curtain came down in 2002 with the WHI.

D (41:31)

Right? The box warning.

B (41:32)

And the box warning. So we actually do have to go back and be like, we've been giving women hormones for 80 years. 80 years. Let's not forget all the research that we've done to show decrease in diabetes in pre diabetics, decrease in depression in people, you know, who are in perimenopause. We've got all these amazing studies. Yes, we need more. I will always say we need more. But let's not forget about what we have and then be able to make safe, wise decisions.

C (41:59)

Yeah, you know what students will sometimes ask me? What higher or advanced degree should they get? And almost invariably, regardless of what they want to go into, I tell you, tell them to get a degree that allows them to have a command of the skill set of critically appraising a study. Something that's almost a lost art. Now. We find studies that give us conclusions that we'd like, and we latch on and we cite them. Regardless of if the study's flawed methodologically or weak or. And vice versa. Study gives us an answer we don't like. Even though it's methodologically solid, we don't dismiss it. And that is sort of falling for this cultural trap that we have going on all the time. We have to, as physicians, objectively evaluate data with the same Appraisal of methodology, whether or not the results give or show it tell us what we expected or didn't expect.

B (42:52)

So here's what's crazy. The paper that was published in 2002, JAMA, the first WHI paper, it is free online, no paywall. It is available now. Now anybody's been able to read it ever since we've had an Internet connection and they put it up. So it's like because of the boxed warning and because of the fear that's in the ether and people can't even say where it's coming from, the actual paper is free online for anybody to read and interpret at any time. I was a medical student, third year medical student, doing my general surgery rotation. And the chief resident said, I don't know what we were talking about, but he said something that changed my life. He said, nobody is more in charge of your education than you. So it's like, listen to the thought leaders, listen to, you know, what people are saying. But at the end of the day, go read the paper if you want to. The crazy thing is that WHI paper is freaking free online and we still have so much work to undo the damage.

C (43:47)

Well, the boxed warnings that the FDA slapped on in the groupthink bandwagon pile on that happened in 2002, 2003, are now gone. And the only box warnings that are gonna remain are the basic warnings around systemic estrogen being given alone without progest in women who still have a uterus, which is an important principle that most clinicians should be giving guidance on. But the fear machine is hopefully going to end and we are going to now usher in a new era of education and research. And so thank you to both of you for coming in, for what you do, taking care of patients. I wanted to have just sort of an open conversation with both of you and this has been wonderful. So thanks.

D (44:26)

Thank you. Great.

B (44:27)

Thank you.

C (44:28)

Great. All right, folks, thanks so much for listening. We'll do it again.