← Duologue with Leslie Heaney
Duologue with Leslie Heaney
Why Testosterone Levels Are at an All-Time Low with Shalin Shah
00:41:58
Testosterone levels in men have declined more than 25% over the last two decades. And most people — men and women alike — have no idea why, what it means, or what to do about it. In this episode, Leslie sits down with Shalin Shah, CEO of Marius Pharma...
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- [00:03]
A
Hey, everybody, it's Leslie, and you're listening to Do a log with Leslie Heaney. So last year I was exhausted and had terrible brain fog. My husband pointed out the fact that I would stop speaking, apparently mid sentence. So I went to the doctor and it turns out that I had very low levels of testosterone. My doctor prescribed testosterone cream for me and it absolutely changed my life. I have more energy, less brain fog, feel stronger. It's been a real game changer. So my own life changing experience with testosterone led me to want to get an expert on the podcast who could explain the importance of testosterone to our overall health and who could speak to the epidemic of declining testosterone levels among men and women over the past 20 years worldwide. Thankfully for us, Charlyn Shah, who is the CEO of Marius Pharmaceuticals there, are the company behind Kaisertrex, which is a drug used to treat testosterone deficiencies in men with medical conditions. Charlin agreed to come on the podcast to tell us everything we need to know about testosterone. I should mention that Charlyn was also one of the expert panelists convened by the FDA last December to discuss the crisis of declining testosterone levels among men and women and what we can do to address it. So in this episode, Shailan provides a fascinating deep dive into why testosterone matters. We talk about the critical role that it plays in our cells function and our heart, bone and cognitive health. Charlin speaks about what we can do to improve our testosterone levels. We talk about the state of testosterone regulation in the US Today and where that's headed coming out of this FDA panel. And we talk what kind of treatments are out there if you do have low levels of testosterone or you are symptomatic. And he also talks about the importance of all of us getting tested and having a baseline, a testosterone level baseline, and what you can do to be treated if you do have low T. So this conversation is for all of us, really, all of us, men and women who are interested in learning more about how to have optimal health. I can tell you this conversation generally changed how I think about my own health, and I think I'll do the same for you. So with that, here's Shalin Shaw. Shailen, I'm so grateful to you for coming on the podcast. This is a subject of great interest to me as a woman, which we'll get to in our conversation too, about testosterone, but to men especially, obviously. And it's just interesting to understand and read that testosterone levels have declined dramatically over the past two decades. You obviously know this, this is your. This is your work Right. This is something that you are very, very intimately knowledgeable about. So tell us a little bit more about sort of the state of testosterone today. And then I want to get into side effects and treatments and all of that good stuff.
- [02:55]
B
Yeah, absolutely. So it's interesting. We have sort of a collision of worlds that are happening in. In testosterone because testosterone's been around for 100 years. This is not a new molecule in that sense. But you have a very significant past. Right. There's a lot of stigma, there's a lot of myths, there's a lot of misconceptions around testosterone throughout the last couple decades. And that has collided with, as you mentioned, this declining, this precipitous decline in overall testosterone levels. So, you know, again, there's more interest in the space, there's more quest for knowledge and to sort of correct or figure out what's real from what's not. Obviously, like health influencers today. Right. There's a lot of information out there, but as you mentioned, the bottom line is that testosterone levels have been dropping quite significantly in men overall. And this is a result of multiple issues that we can get into. And the other bit of that, the other side of the equation is that testosterone is a crucial metabolic hormone. There's an androgen receptor on every organ in the body. So it influences everything from your brain to your heart to your muscle to your bone to your libido, and the list goes on all the way down to your mitochondria. Right. A cellular function. So I think those are the two truths that we need to sort of address today and then get into all of the details to educate people. T levels have been declining and are at, you know, sort of new lows for men. And testosterone is a crucial metabolic hormone. So we need to address this issue with, you know, the right facts and then potentially the right treatments.
- [04:31]
A
Yeah. I think one of the misconceptions about testosterone, at least it was for me, is I think people kind of equate it with a male hormone that has to do with, as you mentioned, sort of your libido or, you know, people that are trying to build muscle, when, in fact, as you said, it is central to all these different processes in. In your body. Right. Not just bone and organ health, but cognitive health as well.
- [04:53]
B
Correct? Yeah. Like, I mean, again, yeah. So it's not just sexual health and it's not just, you know, anabolic muscle building. Right. In a negative connotation. And that's what got it put as a controlled substance in 1990 by Congress. Right. That was a move that was done mainly as a response to doping in professional sports.
- [05:12]
A
Right.
- [05:12]
B
And you know, 30 plus years now, it's really created a big access problem that hasn't been corrected for modern science.
- [05:22]
A
Oh, that's really interesting. And I don't know if it was like, you know, the wwe, like the world, you know, everybody was bodybuilding in the 80s, right, or the Olympics or, you know, that, that sort of, you know, was sort of stigmatized. Testosterone is some bad hormone when, you know, as we just talked about, it's sort of central to the function of, of your body. And so when we talk about this decline in the levels, right. And, and as we mentioned it, it then has, has significant health effects. And we're gonna, we're gonna get into that a little bit obviously as well. But what, what are, what is this decline attribute it to?
- [05:57]
B
It's, it's two factors or two large buckets that I would put it into. So one would be, you know, let's call it endocrine disruptors. There are factors in the environment that are out of our control at large. Right. And think, think microplastics as one of the right. Top ones. Right. This is everywhere we've been, you know, we found, we have found microplastics in, you know, the human brain and across the entire body and even in populations that are far less sort of developed than, than here in the United States. Right. So this is, this is permeated everywhere. Know, you also have oils, scents, perfumes. All of these things actually are endocrine disruptors. Right. And, and have disrupted our systems. The second is really a lifestyle degradation, if you will. Right. Rising rates of obesity, rising rates of sedentary sleep is a big problem for our population. Right. I mean, we've, we've now been, let's call it addicted to devices. Right. How many people are on their phones, scrolling, you know, before they go to bed? And really what is the level of, you know, the quality of sleep that we're getting? Because that's when our body is creating hormones at night while we're sleeping. That's when we're releasing things. So if you have disturbed sleep, you almost surely will test low for your hormones the next day. Right.
- [07:17]
A
So that is interesting. I did not realize there was a correlation.
- [07:21]
B
There is between the two. And so again, like, some of these things are modifiable. And you know, I always advocate working on your sleep, stress, diet, exercise. Right. These are foundational layers that we know are integral to our health. But again, let's face reality. Not all of this is possible or to the degree that's needed. And that's really, again, why that combined with the environmental factors have led to these, you know, this drop in testosterone levels and, you know, the lowest levels that we've had in generations.
- [07:55]
A
So if people are listening and they're wondering, you know, whether or not they have a low. Low testosterone levels, men and women, are there certain side effects or symptoms that you could attribute to low T, as they say?
- [08:10]
B
Yeah, so, yeah, so it's a. It's a variety of symptoms, but, you know, they all, let's call it, generally look the same. Right. Fatigue is a big one. Loss of libido is another one that's quite common. The inability to put on muscle mass or the increased adipose fat around, let's say, the midsection. These are all. And some people chalk up things like general brain fog. Right? So they're very broad set of symptoms and they affect everyone differently. Right. So because our androgen receptors are everywhere and, you know, frankly, they operate differently for. For each individual. Right. Their sensitivity levels are different. The symptoms manifest in different ways and to different degrees for people. And that's why it's really important to get tested, right. Like this. Testosterone as a biomarker is the single best biomarker into your overall health because you are getting a view into your inflammatory state, you are getting a view into your glucose metabolism, your cardiovascular health. Right. You know, we test cholesterol, we test blood pressure, but we're not testing testosterone regularly. So rather than solely rely on symptoms to be the wakeup call, you know, there's a lot. There was a big FDA panel in December 2025, which I'm sure we'll talk about as well. It's important to test early and understand what your levels are as you travel through life, because that level is unique to everyone. And you really want to understand what is your baseline and where are you trending based on your journey.
- [09:44]
A
That's really interesting, you know, because one of the things that I was reading in preparation for this conversation is that testosterone declines with age. So to your point, like having that baseline and kind of understanding where you are, whether you're having symptoms yet or not. Right. It would be helpful to kind of see what you could attribute those symptoms to one year down the line, five years down the line, 10 years down the line. I think what's. What's difficult is that, as you mentioned, it's not part of a regular. I don't believe it's part of a regular, you know, general practitioners Panel, it's more something you would need to get through endocrinologist or maybe are there other new ways?
- [10:25]
B
Right. There's at home testing. Right? At home testing has really exploded onto the market, as you've seen in direct to patient or direct to consumer advertising. But no, your GPA should be able to order your testosterone test. The only thing is, again, like, you know, most physicians don't treat testosterone deficiency, so there is a concept that physicians won't order tests that they don't necessarily want to treat. Right. So if I own your testosterone level, then I got to do something about it if it's low. And again, not to blame the provider in this scenario. I have seven minutes with you, and you probably have two or three other issues that I need to tackle as well. Can I really afford to add another one to that list?
- [11:05]
A
Yeah, yeah.
- [11:06]
B
So that's part of the problem, right? That is part of the problem. And again, it's just the general awareness of how important it is. Some more standardization of the blood panels. You know, that's why we advocate for actually the US Preventive Task Force to include this. Because, you know, just like colonoscopy screening, ages have moved down, Right. Over the, the last couple decades from, you know, 50 to 45 to 40, similar to this. Right. If they. You have an organization that's advocating for that, then it will become regular and the doctors will understand, they will order it and they will also understand and learn how to treat as well.
- [11:41]
A
How to treat it. So what is it you mentioned that's called the U.S. preventative Task Force Task Force. Is that part of the FDA or what hh?
- [11:51]
B
Yeah. So it's a separate body. It's an independent, you know, committee that reviews potential preventative treatments and, and testing.
- [12:01]
A
Okay. And so, and then there, the outcome of whatever their decisions are would be recommendations to doctors about what kind of things should be part of sort of the standard.
- [12:11]
B
Correct. And even insurance carriers. Right. Because again, that's a bad thing. People want to make sure that their insurance covers things. Right. So it would. It would effectively, you know, it doesn't mandate, but you will see adoption quite quickly if that happened.
- [12:25]
A
So you mentioned that everybody has their own baseline. Right. And that there isn't sort of a number like cholesterol. Right. To use another example, there's sort of a range which is considered healthy and maybe a range or normal, and then a range that's considered optimal. Is there a normal range for men or an optimal range in terms of levels?
- [12:46]
B
So there is, but it's it's wide. It's very wide. Right. So that, okay, you know, generally regarded the normal range is 300 nanograms through 1,000 nanograms per deciliter. And again, as we mentioned, that the levels have been declining. That range has also been declining, the lower end. Right. So it used to be 400 and 350, then 300. Now a lot of normal ranges are considered at 264 nanograms per deciliter. Right. So if I walk in and get a testosterone test today and say I'm 270 nanograms per deciliter, there's a decent probability that I would be regarded as normal, whereas that wouldn't have been a case a decade ago. And that's problematic.
- [13:28]
A
Oh, because the bar has, the sort of. The bar has changed or the bar has lowered.
- [13:32]
B
Our population. Right. Reference ranges are a reflection of your population. So if we have lower averages, then they're going to reflect that in the ranges. And again, normal is going to continue to be lower and lower.
- [13:45]
A
Interesting. You know, my husband gets, I get it must be through his panel. He does get his testosterone levels checked and he loves to go home and brag that he, you know, I've got, I've high tea, I've got like a. I think it's like a 700 or he's got something that's like, he claims he's like a 26 year old and not a 53 year old. But you know, it's interesting because it, I guess it all depends on, you know, maybe he had a level that was much higher 20 years ago and that's not sort of.
- [14:11]
B
And there's also, there's also nuance because there's, you know, total testosterone is that number that we're, we keep talking about. What we really need to focus on is free testosterone. And free testosterone is the, is the amount of testosterone that's actually bioavailable for your body to use because in between total and free tea, there's a protein called SHBG and that binds to your testosterone, making it unusable. So most of that. So, you know, you mentioned your husband's 798% of that is unavailable. Right. Actually, 2, 1 and a half, 1% of that total T number is actually your free T. And what's bioavailable? So again, there's a little. Introducing a little more nuance here, but that free T test, free testosterone number is actually the one that matters.
- [15:00]
A
Shailen, when you were saying earlier about the testing and home testing kits you know, if you did go to your GP and they don't order that, and I mean, it's really interesting. Sometimes you'll go to a doctor and they'll sort of say, oh, you don't need that, or you're not, you know. But if you really want to sort of explore this for yourself, are there tests that you recommend or certain companies that do good testing or are convenient for people to use?
- [15:21]
B
I think there's a. There's a range of them, to be honest. Right. I don't think there's anyone that's. That's necessarily a leader in that space. And everybody's integrated testing into their treatment platforms. Right. Because treatment, you have to go through testing. So if you put in, you know, at home testosterone tests, you're going to get like 10 options easily. But, okay, good thing is for, you know, patients, consumers, that price keeps dropping. So, you know, it's becoming less and less expensive to do this at home.
- [15:50]
A
So even though there is no. Well, I guess you mentioned that 267 seems to be the, quote, normal range, but, you know, even though there is no sort of like set levels that indicate that you're in a healthy range, if you're feeling symptomatic or you just want to understand it so that you have a baseline going forward, you just want to get that number and then a year later, kind of see or whenever. See. See what? Where levels are going up or down. You know, I think one of the sort of misconceptions about testosterone is that it's just. Just a male hormone and that if women take testosterone, they're gonna be bodybuilders or we're gonna grow beards or, you know, there's just a misconception, I think, around it. Would you sort of speak, you know, you talked about the importance of testosterone for men's physical health, Bone, organ, cognitive, just the function of their bodies. Would you speak a little bit about that as it relates to women?
- [16:47]
B
Yeah, absolutely. So, yeah, testosterone is both a male and female hormone, much like estrogen is also a female and male hormone. Right. So these, these core sets of hormones are, are applicable to both sexes. And in a female body, testosterone physiologically affects many of the same places. Right. There are androgen receptors everywhere. So you're talking brain, heart, bone, muscle, et cetera. So you have a very similar pattern. Right. And now it is becoming better known, right. Like 2025 was a very big year for female hormone therapy. Black boxes came off the. The existing therapies and much attention was paid to the role of hormones in health. Right.
- [17:32]
A
Yeah.
- [17:32]
B
As it relates to brain and, and, you know, cardiovascular and sort of that list goes on. Again, females are no different. So and, and it's also important to know, you know, females often, you know, premenopause make three to four times the amount of testosterone as they do estrogen. So they actually have more testosterone in their body than they do estrogen.
- [17:52]
A
Interesting. Right before meta, right before menopause.
- [17:57]
B
Through.
- [17:57]
A
Okay.
- [17:58]
B
It's only really at menopause that that those numbers shift. So it's again, it is, it is, it is a female hormone. It needs to be addressed. I think more of the discussion is finally there. And, and you know, practitioners as well as patients are bringing it up and discussing it, but there's still a big gap to close.
- [18:18]
A
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- [22:02]
B
Absolutely. We've developed a product called Kaisertrex. It's an FDA approved oral testosterone. And yes, currently it's indicated for men 18 plus who have testosterone deficiency due to certain medical conditions. Right, that's the medical.
- [22:17]
A
Okay, right.
- [22:18]
B
Due to medical conditions. There are again. And what was what was really unique about this is, is that oral testosterone in a lot of ways was considered the holy grail or is because previous versions were all liver toxic. So old versions were tried and, and they failed because they were toxic to the liver. Or what Kaisertrex is, is a lymphatically absorbed vehicle. So that means your small intestine actually absorbs it and it has, you know, all our data, you know, shows no liver effect, which is really promising for what is this, this shift. Right, again in metabolic health. So if you have, you know, right now there's 25 million men in the US that are hypogonadal or low testosterone. Only 2 million or so, 10% of that mark market is on, on therapy. Given all the initiatives that are behind and, and understanding of this, we see that that population growing to 10 million men. Right, right. Two to eight, two to 10. But what, what modality can they use, right? Like, where are you going to see the greatest adoption? And frankly, that's a pill, right? That's just, it's the easiest to do, easiest to incorporate into the routine, most approachable. Right. Injections are otherwise the dominant therapy, right? They're cheap. Yes. They work. They get into your, your blood, you know, very quickly and, and spike levels. But that's also part of the problem, right, with this, again, this is the dominant therapy. But most people are taking an injection either once a week or once every two weeks. And that leads to a roller coaster in your levels because you get super physiologic levels right after your injection and for those first couple days and then you're coming crashing down on the second half of your treatment. Yeah, exactly. So that's not good, right? That's not how we make our hormones. We make our hormones every day. So what you can, if you can replicate that on a daily basis, that would be the most ideal from a physiologic perspective. Right? And then also you have some other, you have some, you do have some safety issues when you have these super physiologic levels that you should not have. Whether that means high hematocrit, that's your red blood cells, or you get higher estrogen conversion because again, your body's like, whoa, I got all this testosterone, what am I supposed to do with it? Right?
- [24:30]
A
Yeah.
- [24:31]
B
The goal is not. Testosterone therapy is not something where it's like simply the higher the better, right? You want to be in a physiologic range. You do not want to overdo that. And that's important. Right? So again, back to Modalities, you know, injections are the main, main modality outside of what is a growing oral market. Then you have creams or you have gels. That was Androgel back in the day for men. But you know, that has transference issues. You know, you have to worry about transferring that to your partner or to your kids or to your pets. Interesting, that sense. And it's just the absorption is quite variable so it's really just not as effective. So that's really a small portion. You see maybe older guys that are on that today. But yeah, we see that all transferring to, to the oral market.
- [25:19]
A
Natural ways to boost testosterone levels.
- [25:22]
B
Right. Goes back to the basics. Right. Diet, sleep, stress, exercise, these are all things. But you know, again, everything is a balancing act. I mean diet at large is just for your general health. Sleep and stress, I think are, are bigger ones for your hormones. So those are, those are important. I would focus on exercise.
- [25:40]
A
Shailen, is that because you're make, if, if you're, if you're stressed or you're not sleeping, you're not making healthy levels, you're not producing healthy levels.
- [25:48]
B
Exactly. You're not getting proper. Yeah. You're not, you're not getting proper sleep. So you're not producing. Yeah. Appropriate levels. And stress is sort of a, you know, it's a silent killer in our body. Right. For what it does to cortisol levels. And I, and I, I personally believe there's a lot of unmeasured implications of stress that don't even reflect in court. It's not like stress is related to cortisol and that's a one to one and that's going to tell you the whole story. I think there are so many silent aspects of stress that are wrecking our bodies for sure. And then, you know, like I said, exercise is good for your overall health and being, of course, but overdoing that too can lead to deficiencies. Right. So there are a lot of endurance athletes, hardcore athletes, etc, that over train and have crushed their testosterone levels.
- [26:35]
A
What about strength training?
- [26:38]
B
Strength is important.
- [26:41]
A
There's not. So building muscle doesn't help increase your
- [26:43]
B
testosterone because I mean, it's an, you know, testosterone will help that muscle synthesis process, but active muscle tissue is not playing a role in creating testosterone.
- [26:54]
A
Okay, interesting, interesting. So sleep, stress, are your two big recommendations on ways to help boost your levels naturally?
- [27:04]
B
Yep.
- [27:05]
A
Okay. What, when you said that 2 million of the 25 million are getting treatment.
- [27:11]
B
Yep.
- [27:12]
A
And that Kaisertrex is sort of is targeted towards, you know, help helping address These lower testosterone levels in, in men with medical conditions. What kind of medical conditions are you talking about obesity? Or is it other conditions that.
- [27:28]
B
It's on our label. It's it regarded to things like, you know, pituitary tumors, like primary hypogonadism is
- [27:35]
A
the technical term, okay.
- [27:36]
B
That relates to, say, pituitary tumors or other pituitary things which prevent you from, you know, creating enough testosterone. And then there are, is secondary hypogonadism, which is, you know, more related to. It can be related to obesity or other sort of comorbidities. But what's interesting now is because all the data that's been created throughout history is really on testosterone deficient patients in general. No specification of why they have testosterone deficiency. Much like again, if you have cardiovascular disease or if you have high blood pressure or high cholesterol. Yeah. Your doctor asks about your family history and tries to understand a little bit of the nuance of maybe the why. But that doesn't prevent therapy. Right. It doesn't matter why you have high cholesterol, they're going to treat that. Why do you have high blood pressure? It doesn't matter. They're actually going to treat it. Why do you have low vitamin D? Doesn't matter. You're going to treat it. Testosterone deficiency is the only thing that's been singled out in a way that the concern has been more around why do you have it versus the need for therapy. And I mean, frankly, that's a disservice to patients. And we see that changing as a result of that FDA panel that occurred in December 2025 is, you know, actually 12 years ago or so. Labels included, language that said part of the indication was idiopathic, meaning it, you know, you don't know where it comes from or it comes from an unknown place. Because what the research has shown is that the testosterone deficient person benefits from therapy regardless of why they have it. It's important. Like, like, okay, you know, I'm here, I'm testosterone deficient because maybe I have a pituitary tumor, right. But my best friend who's sitting next to me has it because he has obesity. It doesn't matter.
- [29:27]
A
You should still be treated.
- [29:29]
B
And by the way, because the negative implications are the same.
- [29:32]
A
So in the, in that group of 25 million, because they have one of these other conditions, they obviously have been tested to see what their levels are. But I think what you're saying is that the market's 25. You know, there's that 25 million, but there's Probably a heck of a lot more. They just don't know what their test. Right. They don't know what they're.
- [29:53]
B
There is again, that is a conservative number based on the comorbidity profiles and the prevalence rates and so forth. We think it's. We think it's actually a significant. Higher. Significantly higher.
- [30:03]
A
So you, you touched on this a little bit, but there was this expert panel that presented before the FDA this past December of 2025, and it was really talking to the FDA more about to loosen or to reevaluate their restrictions on testosterone recommendations and usage. Can you talk a little bit about, you know, that panel, the discussions that you had and what the outcome was of those conversations?
- [30:30]
B
Correct. So you had 13 experts who have spent their entire careers, you know, on testosterone therapy. You know, these are the folks that have been in the trenches, done the research and treated patients. Right. This is not in some sort of vacuum without clinical experience. Right. I've treated tens of thousands of patients, so the range was quite wide in the sense that it focused on testing. Right. Every man should be tested for their testosterone levels. Right. And this could be argued, you know, from a younger age or certainly men over 40, because of the downstream implications. Right. Lower testosterone is associated with all cause mortality. Right. A simple state or simple understanding of that. Meaning if you are going to have a higher propensity of death if you have low testosterone. Right. So test it like we're talking about should be on every blood panel. And then part of it is the restrictions, right. The controlled substance bit. And what kind of hurdles this is created for therapy because doctors have to be registered in a database and have to register their patients in a database when prescribing testosterone, the pharmacies have to have special protocols for carrying it and dispensing it. Right. So there's a hurdle at introduced at every step of the way, which reduces the likelihood that that patient gets on therapy. Right. So you're going to lose a lot of patients because of that.
- [31:50]
A
The black boxes around the use of estrogen, you know, was sort of based on this flawed study. Right. Is there any sort of study that was. That has given testosterone a bad name or is it more just the use of it in ways and in public ways? Right. Whether it's through sports or. I don't know why I keep going back to Hulk Hogan. But you know, that group, Right.
- [32:15]
B
I'm sure there was some testosterone there. That's fine. But again, what's. As it relates to sports and. And so let's call them Doping scandals. It's not just testosterone. It's often a lot of other things that are being thrown in that mix. Testosterone alone is not going to do those things. Right. Like, right, I'm. I am on, you know, trt, right. I don't just not just jacked and like ripped because I start taking this thing. Right. That's not how it works. So it's a combination of things. I think it's those cultural things that you mentioned. But there were two faulty, two main faulty studies back in. I think it was between 2011, 12, 13 that caused, and this was around cardiovascular risk. That caused the FDA to change the labels and slap cardiovascular warnings on products. And that reversed in 2025 as well, because there was a major study that was released in 2023 called the Traverse Study. This was the largest randomized controlled study in history on testosterone therapy. And it showed there is no cardiovascular risk with testosterone therapy. So they fixed it finally. Right. But it was on the basis of two faulty studies. And same goes for that prostate cancer warning. The prostate cancer warning actually came from the 1940s, which was. It was interesting when you hear the story of, of. Of one of our key opinion leaders that kind of dug deep, deep into this. He also presented on, on the panel and he went down, you know, he was at Harvard. He went down to the, to the files and pulled this study, 1940, that, that caused all this, you know, 70, 80 years of prostate cancer, you know, hoopla. There was three people in the study. One was a female. Throw it out. There was two older men in the study. One got prostate cancer. Which old men do, right?
- [33:56]
A
Yeah.
- [33:57]
B
And that caused testosterone as the, you know, culprit. You know, they were taught then in medical school that, like, this is the fuel to the fire. You will kill your patients. When I had a conversation, and again, fast forward today. I was having a conversation with one of our providers last night, and he's like, yeah, I probably have 30 to 40 patients with active, active prostate cancer on testosterone therapy.
- [34:20]
A
Wow.
- [34:21]
B
And so, like, it's gone one.
- [34:23]
A
I mean, isn't that fascinating, though, that, that people, you know, doctors are making decisions based on studies that are either flawed or antiquated. Right. And so it's how, you know, thank goodness, right, that people are continuing to test these theories and to look at the science behind some of these decisions or these protocols. Right.
- [34:44]
B
So, and again, like, I, you know, sort of kudos to HHS and the FDA for convening this panel and shining a light on it. Right. Because we've never had a stronger regulatory environment behind this therapy and that makes a huge difference.
- [35:00]
A
So was the outcome, is it still being discussed? Is it, you know, the, there was a similar panel, you know, talking about HRT with estrogen for women and the outcome of that was the removal of those warnings or, or the removal of some of the warnings around the risk of breast cancer. You know, for some, for some people there might be a small group in there that might still be a slightly higher risk for taking hrt, but it's not sort of this, you know, kind of broader, doesn't have broader implications for everybody. And it's actually, in fact the benefits of taking it far, far, far outweigh any, any minimal risk of there being a, a associate a correlation with a hormone based cancer from taking HRT was at least my takeaway from what I understood from that, that panel. And was that the outcome of this
- [35:49]
B
panel sort of like the outcome is, is, is pending? Right? We had, there was a, there was the panel and then there was a public comment period which closed, I believe it was February 9th. So I, I, from what I understand there are active discussions around, you know, what is to come next. But I think the, the asks were certainly clear. Right. So label corrections, get rid of the, you know, the unnecessary warnings that are based on flawed data. You know, expand the indications which bring, which most of the patients who are off label today, even on the male side, back onto label. Which is important. Right, because again, a provider is going to be less inclined to treat a person off label than on label. So fix that and then deschedule. Testosterone. No other hormone is a controlled substance. Estrogen is not a controlled substance. Insulin is not a controlled substance. HGH amazingly enough, is not a controlled substance. Human growth hormone is not a controlled substance. And it's, and it's, it's, that's fascinating.
- [36:48]
A
Isn't that sort of the, isn't that the major driver and kind of juice, Is it juicing?
- [36:53]
B
Exactly. That's a much bigger driver than testosterone. So it's again, it's very, you know, it's, it's wild, honestly. But I think that's again, that's one of the major asks. So I think we're not too far away from potentially hearing more about this and I think it should be a win for patients.
- [37:11]
A
Oh, for sure. Is there any follow up coming up out of that panel? Is there another panel coming out? Is there a report being written?
- [37:19]
B
I think there will be decisions that are released by HHS and fda.
- [37:23]
A
Okay, and is there a time frame on that. Or.
- [37:27]
B
Or my take is. My take is it'll be in the next, you know, couple months.
- [37:32]
A
Oh, okay.
- [37:32]
B
There's also. There's also a initiative for a national men's health office. So this is an initiative that HHS is, you know, sort of mandated to create a national office of men's health and close the gap on, you know, male mortality, if you will. Men die seven years younger on average than females.
- [37:52]
A
The life expectancy for men has also declined.
- [37:55]
B
Exactly, exactly. So, you know, there's, you know, I know nobody feels bad for. For men at large. You know, I get it there.
- [38:01]
A
I do. I have. I have two sons and a husband with high teeth. That's.
- [38:06]
B
That's awesome. I mean, but that's. There's. There's more advocates like that. And that. That was one of the advocates or one of the panelist members. Again, it is. Think about your husband, your brother, your sons, and you want them to be healthy, thriving. We have to address this issue because it is an epidemic in itself. And the more that we talk about it, I think, again, from a federal level and from a, you know, a trust perspective, that Office of Men's Health will do a lot of service for improving our healthcare.
- [38:34]
A
Yeah, for sure. For sure. Well, I just also. One of the things I think is so important about these conversations around hormones for both men and women is that there's a recognition, particularly on the. The women's side, of the fact that we are different and our bodies are different. You know, a lot of the studies that, you know, for just drugs in general were never. Were never tested on women.
- [38:55]
B
Absolutely.
- [38:55]
A
So. And just understanding that we have different physical makeups and constructs and that our hormones really play a part into our broader health besides just our sexual or reproductive.
- [39:06]
B
Yeah, that's a. That's a total. If, you know, sort of pigeonholing of the importance and. And it's. And it's. Yeah. Massive disservice to. To. To females and patients if that's what happens. It's not just about sexual health.
- [39:20]
A
Yeah, yeah, no, for sure. Listen, I feel I've got a spring in my step now, Shailen, with my testosterone.
- [39:27]
B
That's. Again, we have. We have. You know, we have n. We have n of one. We have thousands and hundreds of thousands of n of ones. Right. I think the data is there. We don't need to develop. Again, it's. The clinical data is there, so we shouldn't have to go through these long, arduous processes to get things approved for what we know works. And what we know is safe at physiologic levels. So I think that's the gap that we're trying to close.
- [39:52]
A
So for people that are listening and are wondering, like, gosh, my, my libido or my, my brain fog or my, my fatigue or even if they're not having any of those symptoms, I think your recommendation would be go get tested either through your general practitioner or through one of these home tests just to have a baseline.
- [40:12]
B
Absolutely. I mean, yeah, you want to know where these, these levels are and you want to be proactive about your health. Right. I think the best thing about where healthcare is in 2026 is that patients have really started to take ownership over this and they are more interested, invested in their health than ever before. And I think that that's powerful and that will lead to better outcomes.
- [40:34]
A
Oh, for sure. Well, Shailen, thank you so much. It was. I loved speaking with you. I learned a ton. I actually want to know what my level is. So just, I mean, I know that I'm on the cream and I know I feel better being on the cream, but maybe I, you know, and I would think the oral actually isn't even available for women.
- [40:51]
B
It's not available for women. And we're working on it. That is, that is one of our initiatives is to bring an FDA approved oral testosterone to the.
- [40:59]
A
That's terrific. Well, Shailen, thank you so much. I really appreciate you coming on and I know my listeners are going to be really, really, really interested in this subject and very appreciative too. Thank you for all the great information that you shared. That brings us to the end of this episode of Duologue. A huge thank you to Shawn Shaw for joining. I learned so much from my conversation with Shawn. I hope that you all did as well. Also, a big shout out to our sponsor, Cozy Earth. Don't forget to go run and check out their website, www.cozierth.com and use our promo code dualog at checkout to get 20% off all of their amazing products in time for Mother's Day. And a special thank you to you all for listening and for all of your support of the podcasts. If you enjoyed this episode, please rate or review us on Apple Podcasts or Spotify or wherever you get your podcasts. We release a new episode each Wednesday. So until next Wednesday, this is Leslie. And thanks again for listening to Duologies.