Health Longevity Secrets
A podcast to transform your health and longevity with evidence-based lifestyle modifications and other tools to prevent and even reverse the most disruptive diseases. We feature topics including longevity, fasting, ketosis, biohacking, Alzheimer’s disease, heart disease, stroke, cancer, consciousness, and much more so that you can find out the latest proven methods to optimize your life. It’s a mix of interviews, special co-hosts, and solo shows that you’re not going to want to miss. Hit subscribe and get ready to change your life. HLS is hosted by Robert Lufkin MD, a physician/medical school professor and New York Times Bestselling auhtor focusing on the applied science of health and longevity through lifestyle and other tools in order to cultivate consciousness, and live life to the fullest .
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Health Longevity Secrets
How Kyzatrex Transforms Testosterone Therapy
Discover the future of testosterone replacement therapy as we welcome Shalin Shah, the visionary CEO of Marius Pharmaceuticals, who has made the bold leap from an investment background to the forefront of medical innovation. Shalin shares his journey and unveils Kyzatrex, the FDA-approved oral testosterone that promises to change the game by sidestepping the liver toxicity risks associated with earlier oral options. With Kyzatrex’s novel lymphatic absorption method, we showcase why this advance is the answer to the pressing demand for safer and more convenient testosterone treatments for both men and women. Full disclosure: I use Kyzatrex with my patients who need testosterone at our Gatlan telemedicine practice.
Explore the intricate world of testosterone replacement therapy side effects, particularly how different treatments impact hematocrit levels. We tackle the significant health risks linked to high-dose testosterone injections, such as erythrocytosis and polycythemia, and how Kyzatrex may offer a safer alternative. Delve into the potential benefits like maintaining endogenous testosterone levels, which could minimize risks of testicular atrophy and infertility. This episode is a must-listen for those wanting to understand the delicate balance involved in hormone therapy and the critical importance of patient education to avoid unintended health consequences.
Lastly, immerse yourself in the transformative goals of the Testosterone Project, a nonprofit initiative championing routine testosterone testing for individuals over 40 and spotlighting testosterone's vital role in women's health. Shalin stands firm in his belief that the descheduling of testosterone could lead to better public health outcomes. This episode is packed with resources and insights into the evolving world of testosterone therapy, urging listeners to rethink conventional approaches and embrace innovative treatments. Join us in this critical conversation that promises to reshape how testosterone is perceived and utilized in healthcare.
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Bluesky: ...
Hey Shalane, welcome to the show. Welcome, thank you, thank you, Ron.
Speaker 2:It's a pleasure to be here, Really really excited to be here talking to you about chisotrex and testosterone today.
Speaker 1:Yeah, I'm so excited about this area. I can't wait till we get into it because it's really the world is changing now. Now there's some real breakthroughs here. But before we do, let me just ask you to maybe tell our listeners how you got interested in this area and kind of your journey here.
Speaker 2:Sure, sure, so again for everyone.
Speaker 2:I'm Shalan Shah. I'm the CEO of Marius Pharmaceuticals. We are the manufacturers and makers of Kaisertrex. So how did I get into this? It's kind of funny, right? I have an investment background. I spent years in private equity and hedge funds, looking at all sorts of companies, whether it's consumer, whether it's industrial, energy and so forth and this testosterone asset came across my desk in around 2015 timeframe. It was actually local I'm from the Raleigh, North Carolina area and it was actually being developed here as well. So came across the desk back then and, interestingly enough, this is around the same time the FDA made some changes to the testosterone labels.
Speaker 2:There were a couple of faulty studies that had come out citing cardiovascular risk and a lot of lawsuits popped up right Again. A lot of lawyers said, hey look, this is a great opportunity jumped on that bandwagon and the space got hit severely. So I think testosterone was growing tremendously. And then when that happened even though for the wrong reasons, really set it off its course. And that's when we got involved and got interested, because we looked at this thing and we said, you know, the more and more research we did said, hey look, if testosterone was discovered today, it would be the most valuable molecule in the world. It is responsible for so many things in the human body. But it doesn't seem like that to the FDA or some of the pharmaceutical companies out there. So basically put a team together and took control of the drug and brought it through phase three trials and eventually FDA approval in July of 22. And now we're here marketing Kysotrex.
Speaker 1:Yeah, and so just to put this in perspective, kysotrex is a oral testosterone game-changing drug, I believe, and we're going to talk about it, why it's game-changing and how it compares to other ways of delivering testosterone replacement and full disclosure. You work for a company that makes the drug, but we're going to be balanced and full disclosure. I, along with Josh Duhamel, we're working on a company that is going to be selling, among other things, this particular drug. But you know, put that aside, we're going to take an honest look at it and I'm super excited about it. Otherwise I wouldn't be involved with it. So, all right, so maybe just take a. Take a step back. So this, this, uh, kaisertrex it's an oral form of testosterone in. In the past, the only oral form of testosterone really was the, the methylated testosterone, right, right, which had the liver damage and everything. This is completely different, right? Why is that.
Speaker 2:So yeah, completely different. I think we're still shedding that old image. So actually refer to you know again, kisotrex is FDA approved next generation oral testosterone, because Kisotrex is testosterone on decanoid and this is lymphatically absorbed, so it's absorbed by the small intestine. So there's actually no liver toxicity that's been demonstrated with the drug whatsoever.
Speaker 1:Yeah, and we're going to. Testosterone replacement is a huge subject for not only for men, but even for women in certain cases, and we're going to we're going to cover that in further episodes today, in further episodes later Today because we have a limited time and Charlene's with us we want to talk specifically about this new, game-changing oral version of testosterone replacement. So let's put it in perspective, charlene, just do. What are the other alternatives to testosterone replacement? Let's say I have low testosterone, for you know, for a reason, and as many men do, you know as they get older.
Speaker 2:It's a growing problem, right, I think. If you look at environment, you look at lifestyles. There's multiple factors here which have driven overall male testosterone levels significantly down over the past few decades.
Speaker 1:And much of it is related to metabolic disease too. With obesity, testosterone drops with other metabolic factors, so they're synergistic and getting your testosterone in order is really necessary to get your metabolic health in order and vice versa. So we can't overlook testosterone. Now there are replacement methods. Maybe you could just summarize those for our audience so they kind of see how Kysotrex fits into what is generally available now.
Speaker 2:Sure, yeah, absolutely so in terms of modalities, right, I think the most common form that you'll see today is injections. So this started out in terms of intramuscular injections, where people would take deep injections into the buttocks, for example. Now that's moved to sub-Q, which meaning they're usually just under the skin, you know, often in the abdomen area, but that's probably the most primary form. And then you'll see gels and creams, right, gels, creams, and actually there are pellets as well for men. So gels and creams have been used from some time, probably since the early 2000s. They have, you know, although sort of convenient at the beginning they presented their own issues with absorption and then the ability to shower, for example, or transference to partners. You know they do have a host of issues there, but I think the variability is actually a big one. And then, of course, you have pellets too. Pellets are a form used, and then of course you have pellets too. Pellets are a form used, albeit small, in the male population and used over a multi-month period. Pellets can be inserted by your provider.
Speaker 2:But what we see there is there's certainly convenience in this thing that set it and forget it. But if you look at sort of long term physiological nature of the drug, that may not be the case. So actually something interesting as it relates to chisortrex and oral. I think we have the spectrum of options out there for males. What we like to think about is what is the most physiological way to replace testosterone?
Speaker 2:So our bodies produce testosterone every day, right? This often is. This is when we're sleeping throughout the night and then you're peaking in the morning and then and then going going down throughout the day. So if we are going to replace this into our bodies, one would think replacing it as close to that manner as possible might yield the best effect. So, and that's what we're actually starting to see today, as Kaiser Frex is used more and more, we are mimicking, or more closely mimicking that natural diurnal rhythm and I think the results are speaking for themselves. Patients are having a very good experience and we believe and anecdotally when we hear from providers that this replication is helping achieve that.
Speaker 1:Okay, this is a really good point and I want to get more into that. But before we do, let me just summarize what you've said. See if it makes sense. So there are a number of ways to deliver testosterone. First of all, you mentioned gels and creams.
Speaker 1:But the problem is they're not consistent in their absorption, certainly between people, or even the same person can have a different absorption. So it's like giving a dose and you don't know what the dose is. So it's problematic for many, many reasons. So if we put gels and creams aside, then we're left with injectable forms, either with a needle sub-Q or IM or with pellets underneath the skin. And the thing with the needle most people don't want to inject themselves on a daily basis, or even multiple times during the day, in order to simulate what you described as the normal testosterone diurnal rhythm, you know, sort of circadian rhythm that all, all men have, and so instead, what you're faced with is that the most common injection now is once a week and you get you get a big dose and then it it tapers off until the end of the week and then you give another big dose.
Speaker 1:So it's it's not just a matter of the way it's delivered, you know, under the skin versus through the mouth. It's, as you say, the physiology of it, because giving a shot once a week, as somebody once said, it's like caffeine. Right, I like my caffeine, I want it. You know, I have a cup of coffee every day. Well, I could take it once a week and drink 10 cups of coffee in a row and then have it for the week, or I could just have a cup of coffee every day, like I do now. It's much more physiological.
Speaker 2:It's a great example there, I think, in kind of demonstrating again what one thought to be sort of a normalized process, right, until the right tool came along to then show you you know what you should do right. And I think something also important, robert, is again, by taking this single dose, as you're saying, like you know, like 10 cups of coffee or 20 at one time to cover you for the week, you know, what happens then is that's really when you see a lot of the negative side effects with testosterone replacement therapy that frankly give it a bad reputation as well, because now you have these concerns which again, frankly don't have to exist if you could dose it differently. So I think that's really what's important and patients will start to see, as they discover, you know, the newer modalities, next generation modalities. Here is avoiding a lot of the side effects that are not necessary on testosterone replacement therapy.
Speaker 1:Yeah, it's a great point. So it's not just the convenience of an oral pill versus a shot, but it's much more than that, is. We're recapturing the physiology of the body and then in the process, it may allow us to avoid the complications that the once a week injections, the reputation that testosterone has.
Speaker 1:Let's talk about some of those complications Polycythemia, erythrocytosis red blood cells, people of erythrocentosis, red blood cells people, many people on testosterone treatment Routinely. They donate blood just to lower their hematocrit because of the effect of this testosterone treatment. This is people on, again, standard testosterone treatment where they do the 10 cups of coffee once a week or 20. You know it's the super high dose. It gives you super physiologic levels of testosterone and then it tapers off during the week. So you're really only in a sweet spot in the middle of the week and the beginning you're like hyped up too high and at the end of the week you're too low. So is there any evidence for Kisotrex and effect on erythrocytosis and polycythemia, because one would expect that maybe we wouldn't see this. What is the evidence?
Speaker 2:So if you look at the phase three trial data, we had sub 2% of patients experience a hematocrit above 54. 54 is usually the standard cutoff that clinicians like to use as saying okay, time to maybe give blood or maybe we need to adjust your dosage or whatnot. So during our trials this was a sub 2% case rate of erythrocytosis. If you look at literature you know that's been published today some folks in the urology space including, say, dr Mohit Khera. They took a look at all forms of modalities and the rates on erythrocytosis. Actually in their study injections were near 60% actually the rate of erythrocytosis. So if you look at that comparison again, this is not head to head data, but if you look at independent, literature and what these incidence rates are.
Speaker 2:There's a huge gap of what's happening on oral medication versus injections, and then you start to come down from there. Then you'll see pellets at a rate a little bit lower than that, and then you'll see gels and creams, but again now, new to the game wasn't there when Dr Karama did those studies, but again our data is showing a sub 2% rate and I think that's really significant and really really helpful for providers, who then don't have to think about this as much and tell their patients to go dump blood or remind them to go do so. And then patients themselves, which are getting that inconvenience removed from their you know routines and also some of the downsides that come with having to donate blood too much, like decreased iron levels. They don't have to worry about some of those downstream anemic effects that may happen if they have to donate blood too often because of that hematocrit issue.
Speaker 1:Yeah, and just to be clear, you know people may say, well, so I have extra red blood cells, I have extra hematocrit, that makes me better. It can affect the viscosity of your blood, coagulation of your blood and and be at risk for, you know, thrombosis, you know stroke, heart attack, those kinds of things. So it's, it's very, it's very serious. You need to need to keep an eye on it. So, but yeah, it is as bad as that is. There's else worse. That's another complication or another association with testosterone replacement therapy up until now at least, and that is by replacing the testosterone in the body with an exogenous source. The endogenous testosterone, the testes decrease production, so that can lead to infertility and amazingly, you know, some patients who are on testosterone treatment haven't even been told that. You know they're not even. You know, sadly.
Speaker 2:Yeah, it's scary, right, and that's a mistake. Yeah, I think that's the problem You're going to be infertile, but maybe you can speak to that.
Speaker 1:So the more physiologic use of this oral testosterone you know, twice a day, mimicking the actual testosterone, it benefits the erythrocytosis and polycythemia. What effect does it have on testicular atrophy that you see with regular testosterone replacement or even fertility, or can you speculate?
Speaker 2:on that. Yeah, so no, we have some interesting data as it relates to that and we're actually doing more research as well. So, again, from our, from our studies, we have not seen testicular atrophy. So this is really hypothesized in the sense that because your body's flushing testosterone from your system every day and potentially allowing some of your own production to stay online, or at least the brain telling the testes, hey, we have work to do.
Speaker 2:Whether they're functioning or not may be a different story, but what we see is two parameters that come out in terms of LH and FSH, which sort of show the level of activity. Those parameters, although they decrease on Kisotrex, they stay at the lower end of normal. So again, conversely, not head-to-head data If you look at literature for injections, talk to patients, talk to providers at large, those parameters are going to zero. On injections, there's going to be no LH or FSH signal going on in that body Because, as you mentioned, you are going to a super physiological high for days on, days, before that comes down in your body saying, hey, look, we might have to get to work, and even before that happens again, you're likely taking your next dose of injection. So what we see is those parameters staying at the lower end of normal, which is good.
Speaker 2:We don't see the testicular atrophy, at least reported in our data. And then, as that relates to fertility, again I don't want to sit here and say, hey, kaiser Trek can help you maintain your fertility, but we are running, or we have an investigator initiated study around fertility and there was actually an abstract that was presented last month at the Sexual Medicine Society of North America and this was an initial look into the data just by patients and completed so far. They were measuring semen parameters at baseline three months and six months, I believe, and four, I think, encouraging from the fact to understand more what this daily rhythm does to the body and what does that mean for long-term implications.
Speaker 1:Yeah, and and I guess we should we should cover the these. This testosterone undecanolate kisotrex. It seems like it has decreased side effects compared to the other replacement therapies. Based on the physiology, it's just more like our body's experienced testosterone. Let me ask you this Are there any side effects of Kisotrex or oral formulations like this that we don't see with injections or anything? Is there anything specific to the oral meds that we need to watch out for?
Speaker 2:Good question? Frankly no, and again I think it's a nice thing to be able to tell.
Speaker 2:You know the listening population here Again, if you look at our label, for example, you know we have a few cases I think it was four or five cases of hypertension. This was a 2.6% of the population that experienced hypertension. On average it was a 1.7 millimeter increase in mercury and systolic blood pressure, which you know a lot of clinicians will tell you is equivalent to walking up the stairs. So you know your providers can make what they need to in terms of that increase. And then, like I mentioned, actually it was a sub 2% level that had that hematocrit increase, and those per label are the only things that show up there. What I'll say to this is taking a step back is testosterone. It's been used for almost 100 years now, right, and it's had these ups and downs where, as I mentioned, it was sort of, you know, believed to be a miracle molecule that something might come out, maybe for right or wrong, and it kind of gets reset and so forth. I think we're finally at a place now where the Traverse study so this was the largest randomized, controlled study on cardiovascular risk and testosterone therapy, because this was a big debate, even clinicians also, despite not being good evidence to say there was risk, still believe this. So the FDA mandated the industry conduct this study, but unequivocally, you know, the study came out and said look, there is no increased cardiovascular risk on testosterone therapy. So I think that has been put to bed. And that was the same with prostate cancer too. So these two myths have really been put to bed.
Speaker 2:As it relates to testosterone therapy, the issue is that the label that has been put on these products the FDA has not revised the label yet, despite this overwhelmingly positive evidence and no real literature citing anything else. Right, there's been multiple studies that support the safety profiles of the therapy the anything else right. There's been multiple studies that support the safety profiles of the therapy the entire class, right. But again, the FDA has kept a lot of these things on the label, a lot of the side effects and so forth. So I think what I'm getting at is I think it's an amazing time for really a fresh look at the therapy. People can put a lot of these concerns behind them and really look at the therapy. People can put a lot of these concerns behind them and really look at the benefits. What does testosterone therapy mean to me and for me? Right, again, it's indicated.
Speaker 2:Kisotrex is indicated for low testosterone, right? Individuals that have, you know, actual hypogonadism. But I think the research now can really be focused on what are the benefits of this therapy? Right, similar to you know our GLP? Glp ones are being studied every day and you see an article almost every day. Can it be used in fatty liver? Can it be used in cardiovascular health? Can it be used in cognitive health as well? Right, I think a lot of those things could be replaced with testosterone. The word testosterone could be, you know, glp-1 could be replaced with testosterone, and you can, really. I think, then, research and medicine can look at what are the different ways that we can use this to help.
Speaker 2:As you say, this is metabolic health. This is foundational. You really can't have good health when your hormones are in decline. There's actually many studies that have shown decreased levels of testosterone are directly tied to all cause mortality. Your lifespan will be shorter if you have a testosterone deficiency. That's what these studies say, right? So, again, now we can focus on how do we use this molecule, how do we study this molecule for the benefit of patients?
Speaker 1:So for patients who've never had testosterone therapy, this is a new alternative that potentially gets rid of, or at least lowers the incidence of, some of the other side effects that we're seeing with conventional therapy. We mentioned the polycythemia, the hypertension, this kind of thing. But how about for patients that are currently on IM or sub-Q testosterone therapy or gels or pellets? What sort of resistance are you seeing with them? I mean, it seems like this is a no brainer, right? I mean, unless maybe they're in the habit of doing it once a week and injection, they don't care about the side effects. But what are the dials there for people moving back and forth between this? Is everybody going to shift to this or?
Speaker 2:what I do believe. I do believe that god tracks will be the standard of care, in, in, in, in a few years time frame, right, not only for the convenience that we talk about. I think we look at the efficacy profile, which I'll talk more about. Uh, free testosterone in in a bit here, but but the efficacy profile and then the safety profile, but, but in terms of the let's call them the switchers, right, I think you know your easiest level are the guys that really don't want to inject, right?
Speaker 2:They're saying, look, I've had no other choice so I will do this to get what I need to out of testosterone therapy. I think those folks and the folks that have left therapy right. The adherence rate if you look at literature studies based on the adherence rate to injections after 12 months, it's sub 10%, which is incredibly low. So people are really giving up very early on this therapy. So I think there are probably honestly a few million guys that have rolled off of T injections in the last five years because they have not been able to keep up with the routine. So I think those are going to be guys that definitely want to.
Speaker 2:You know, look at oral and understand now that they know it's available, or they're going to know that it's available and they can look at the profiles and so forth. They will switch, I think, some of your. I think there will be more injection switchers. What I do see, which we're exploring more as well, though, when you ask about hurdles, right, I think there's a concept of sort of the androgen receptor modulation, desensitization or a few ways to refer to it, right? Because again it goes back to these folks have been taking super physiological doses for extended periods of time. So you know, again, the way the body works in the sense is that your androgen receptor, which is on every organ of the body, only needs so much testosterone, right, it becomes sort of saturated or activated and then it starts working and doing its job. More is not always better, right? So over time, these injection folks may have effectively desensitized their androgen receptors. So then that's why you see them. They might say, hey, doc, it's been three years, four years, my dose is not working. Maybe it's been shorter than that, right, and they need a higher dose continuously to compensate for that down regulation. I think that's where you may see some struggle to adopt in oral, and they're just used to those high peaks, but that's not the majority, right At the end of the day, and I think, more importantly, there are millions.
Speaker 2:I mean, there's an estimate and this is conservative by the scheme of things that 20 million males in the US are hypogonadal, right? Remember the obesity rate 50% of obese patients are hypogonadal. 40% of type 2 diabetics, 70% of ED patients are hypogonadal. This is a massive, massive problem, not just here in the US, but this is a global phenomenon, right? We've exported our American diet everywhere and I think you've seen the downstream effects. So you have 20 plus million men here in the US. Only 2 million men are on therapy. You have a massive Delta of folks that that just have not not been on or or don't understand it, don't know about testosterone. So this is honestly a massive educational effort to really help people understand, and that's why we've created rethinktestosteronecom. It addresses a lot of the old things that people you know have thought and and really looking at and then also looking at the new research. So people really need to rethink testosterone and understand its role and hence rethink testosteronecom is a good educational source to get the basics down and then people can start asking more questions.
Speaker 1:And just to be clear, rethink. Testosteronecom is separate from the organizations we've been talking about now. It's a 5013C charity, but Rethink is a disease.
Speaker 2:State from Marius right. So actually, yeah, the 5013C happy to talk about that now.
Speaker 1:If people can talk about it Before we. Okay, I want to talk about it Before we do. You mentioned free testosterone versus total testosterone. Did you want to make a point about that?
Speaker 2:Yes, absolutely so. This is really important, right? So if you look at Kisotrex, what it does is it uniquely lowers something called SHBG sex hormone binding globulin. And what SHBG does is it binds to testosterone and makes it effectively unusable, right? So the amount of free testosterone in the body is normally only 2% of what your total testosterone is. So, but most people really only measure total testosterone most doctors and patients when they get their tests and whatnot, they really only think about that. But what the body can actually use is the free testosterone. This is the number that matters, right? So we're encouraging again patients, clinicians, to be checking this more often and using this as the yardstick for how a patient is doing. But what Kystrex does is it uniquely lowers SHBG.
Speaker 2:In our phase three trials it was 30% reduction in SHBG. In some of our abstracts and real world evidence we're seeing this up to 50%, right? So anywhere between 30 and 50%, you're seeing this reduction. And what does that do for free testosterone Effectively? Again back to the phase three trial. Free T doubled and this is preferential in some sense to total T, so your free testosterone can go up more on a percent basis than potentially your total testosterone. And then again, through these abstracts and whatnot, we're seeing this from two times to probably four times in real world data.
Speaker 2:So, again, very interesting because, at the end of the day, free testosterone is what your body can use. Again very interesting because, at the end of the day, free testosterone is what your body can use. And I think that's why, if you look at secondary or exploratory endpoints for us, whether that's, you know, energy, fatigue, sexual desire, these types of things they were all at large, significantly statistically significant increases in in data. Right. So what what? I think the hypothesis is that because the free t is able to go up by so much, you actually don't need total testosterone to go super physiologic to feel better. Right for the symptomatic relief. Why do patients come in asking for their testosterone? It's symptoms that's driving it right. So so I think what we're seeing there againBG, which for a lot of folks is elevated today, whether it's lifestyle, alcohol, just aging right Uniquely being able to lower that and get your free testosterone up, I think is showing to be a tremendous positive for guys' tracks this positive for kaisertrax.
Speaker 1:So just to summarize then one effect of kaisertrax we may see is that the total testosterone, which is the thing people often measure, just as a first pass may go up only a little bit, but the SHBG changes and basically drops. So the free testosterone, which is where the money is and the action is essentially as far as the benefits of it actually can go up. So that's another, arguably more physiological approach to testosterone management that we see, I guess yeah, no, absolutely Again.
Speaker 2:Yeah, just for clarification. Right, we've seen C-max. You know that max level of your testosterone generally in that 900, 1000 point, right, we've seen C-max. You know that max level of your testosterone generally in that 900, 1000 point, right. But, and again, for most people that's more than enough. I don't think you really want often to go much higher than that. But again, as you say, yes, the free tea where the money is that's where you see these increases and you know, frankly, the patient response has been fantastic.
Speaker 1:Right, yeah, and well, and now in our last few minutes, I'd love to hear about the initiative we spoke a little bit about offline, about this is the nonprofit I guess, about educating people. Yeah, tell us about that.
Speaker 2:Yep, absolutely. So. This is a nonprofit initiative. It's called the Testosterone Project. So this is a nonprofit initiative, it's called the Testosterone Project, and the Testosterone Project has three initiatives. The first is routine testosterone testing in everyone over 40.
Speaker 2:If you think about it, testosterone is a simple blood test and actually, if you look at the male side, so equivalently important for a female. But we test things like cholesterol, we test our blood pressure, we test our liver enzymes and so forth, but testosterone is actually the single best barometer for your overall health because it gives you an insight into your cardiovascular health. It gives you an insight into your insulin sensitivity. It gives you an insight into your inflammation in your body. So actually it's baffling that this is already not included standard on a blood panel. It's a cheap test. This is a $10 test. Why would you know the broader community not be looking at this in your annual physical? So this is critical. I think everyone should know where their testosterone level is.
Speaker 2:The second mission of the testosterone project is testosterone in females. Right so testosterone. Females, pre-menopause, have five times at least the testosterone in their body than estrogen Little known fact, right so they. And even it's even higher, as you know, in younger females. So testosterone is not just a male hormone, it is a female hormone and they they need that for a host of functions, same things that we've talked about. So to date there's no approved US FDA approved product for testosterone in females.
Speaker 1:There's only one globally, in Australia, but I think what we need to do is establish that this is a female issue as well, and how do we tackle that and improve the metabolic health for females. These drugs, including Kysotrex, or FDA approved for certain indications. This would be an unapproved indication, but it's off label and we frequently use FDA approved drugs for off label indications if it's the physician you know feels it's indicated. So that pathway is open. Right and now it's just a matter of educating people of the value of assessing testosterone in females and what role it plays.
Speaker 2:Right, absolutely. I think there's a great you know, again, clinicians have spoken up and there's great movements that are helping educate patients out there. Like you know, your show today. In that sense, and again, at the end of the day, I think patients have to be, you know, empowered and then be able to advocate for themselves, and they can only do that through education.
Speaker 1:Yes, and so that was two. What's the third? That's two. Third, one's a big one. All right, we'll save that for last, but yeah, we don't shy away from big challenges in that sense.
Speaker 2:So the third is to actually de-schedule testosterone. Testosterone today is a control three substance. This happened back in 1990. Congress scheduled it, which was the first time they had ever done that and they had actually, at the time, done it against the wishes of the FDA, against the wishes of the DEA and against the American Medical Association. No one wanted to do this but Congress.
Speaker 1:I mean, what were the politics behind?
Speaker 2:that are just curious, yeah just again, politics always have their own uh you know, uh life and and breath, so no I think there was.
Speaker 2:There was a lot of outlash and outcry after, you know, the olympics, I think there was. There was obviously doping going on in the olympics. I think they looked at, okay, you know how is this affecting the youth of our country and their role models and whatnot. So they said, let's. You know there's some angry people out there, we're going to go and placate to that and they went ahead and scheduled it and it's been sitting there since you know 1990. We're talking about 34 years here which, frankly, again, it doesn't make sense.
Speaker 2:You know testosterone, especially oral testosterone, can't be abused. You know testosterone, especially oral testosterone, can't be abused. You know you take a certain amount. You're not going to have this linear reaction. You know your body can't absorb it all. And again, insulin is a hormone, vitamin D is a hormone, estrogen is a hormone. No other hormone is a controlled substance. So I think again, it has this bad rap.
Speaker 2:But I think that's why the education is so important, understanding how important of a metabolic hormone this is, all the things that it affects, from cognitive health to cardiovascular health, to bone health, to you know that includes frailty and things like sarcopenia. Yes, muscle health, right. Muscles finally being understood as a crucial organ, right, the biggest organ in our body, and not just vitality, but longevity and the importance, right, that's going to mean a lot for our aging population, and again, the list goes on. So this is truly that metabolic hormone that the body needs. We don't, we would not think twice, right? People don't think twice about replacing thyroid today. We would not think twice, right, people don't think twice about replacing thyroid today, for sure. So, again, I think, providers and patients, through the descheduling of this, it becomes an accessible molecule, and that's really important.
Speaker 1:If we're going to change, sort of frankly, the health of this country. Yeah, this is so fascinating. I want to have another conversation about this and go over some more stuff, but this has been great, and people today, I mean obviously this is available through their urologist, through their practitioner, or you know we mentioned a company that I'm involved with. We do it online. I'm sure the other ones that do this too so it's, it's available now. It's out there, right, and people can. Yeah, I'll say this, right.
Speaker 2:What we did, you know, marius, we we made Costrex a cash product, right, we know. I think, going back to the system and the challenges we see in health care in this country, we knew from day one that if we went through a typical insurance system, this drug was not going to be accessible. We would have to price it at over $1,000. We'd be rebating to PBMs and insurance companies and, at the end of the day, patients would not get it. So it would not be a success.
Speaker 2:So, frankly for us, we said, okay, let's price this at a reasonable cash level, let's get partners involved, like you know, again, urologist or primary primary care, telehealth, people that really are out there changing the landscape for patients, and, at the end of the day, it needs to be accessible, because that's the only drug that matters, is one that you can get. Um, so we took a very different path and, you know, one that we're proud of and, I think, one that's really blazing a trail here. I mean, we were going online, honestly, before Lilly Direct was there or any of these at large, right. So I think again that for us, what we want to see is patient access. That's truly important to us and that's the way that again we've made Kaiser Choice today.
Speaker 1:Oh, that's great. Well, Shalin, tell people how they can follow you, how they can find out more aboutcom. That is the URL for the nonprofit, Naturally, Kysertrex you know, w-w-k-y-z-a-t-r-e-x, kysertrexcom, and then rethinktestosteronecom.
Speaker 2:These are all great resources and different angles to get involved and educate and learn. And then again, you know, please reach out. We're always happy to chat.
Speaker 1:This has been great. It's so exciting that this whole testosterone space is changing for the better and it's really it's a new world for testosterone therapy that we, you know, we really have to start looking at it very, very differently because of these new options that are available. So thanks again, sheldon, for coming and being with us and thanks so much for the great work you do.
Speaker 2:Absolutely. Thanks for having me, Robert.