The modern wellness conversation has a familiar rhythm. A molecule becomes popular, early stories travel faster than the evidence, and people begin asking whether it belongs in their the benefits of recovery practice. Peptides sit directly inside that tension.
We're in an era where everyone just wants to optimize and sometimes at any cost. When you have someone coming in, they want to talk about peptides, that could mean any number of things and it could be something that has randomized clinical trial data or it could be something that's only been studied in preclinical, you know, miring or animal studies. The variability of the evidence is just astounding. 503A can be accredited, so that's good. 503A not accredited. Be a little careful. And then there's the underground. And when you have no ability to compound 503A or 503 molecules, the underground just goes crazy like they are with peptides. But that's when you get unregulated bacteria, heavy metals. You know, the research use only compounds. It's kind of like buying gas station sushi, man. Like you might have like a gas station that's got some great sushi and you just knock it out of the park, but hey, maybe you get a bad batch the next week. All right? Because there's not a lot of regulation or oversight there. You're really taking that risk into your own hands as a patient. Even if you have a pharmacy that has the best practices and manufacturing and being able to compound the medication, sometimes those initial ingredients that you're getting from chemical suppliers can be contaminated. There can be heavy metal contaminants. The ways that these are going to interact, you may not have the the same source um uh ingredients and molecules, the potency can be different. They may not store as well. I get it. You want to optimize your health and not just avoid disease. That's why peptides are exploding in popularity. But as one of my guests puts it, getting peptides from unregulated sources is kind of like buying gas station sushi. You might get lucky or you might not. I'm Dr. Reena Malik, urologist and pelvic surgeon. Welcome back to the Reena Malik MD podcast, your trusted guide for leveling up your health, relationships, and sex life with evidence-based tools. Today, I'm having a critical conversation about the peptide revolution sweeping through medicine with three leading experts in men's health and hormone optimization. Dr. Alex Tatum, internationally recognized expert in men's sexual health and prosthetic urology based at the Men's Health Center at Urology of Indiana in Indianapolis. Dr. Mohit Cara, professor of Baylor College of Medicine in Houston, a leading academic men's health authority and past president of
health authority and past president of the Sexual Medicine Society of North America. Dr. Kevin Campbell, assistant professor of urology at the University of Florida College of Medicine, specializing in men's sexual and reproductive health. All who trained under the same mentor in peptide therapy. now navigating this rapidly changing landscape. We're covering what peptides actually are, why the FDA banned 19 of them overnight in 2023, the difference between compounding pharmacies and research use only sources, and specific compounds like BPC 157, CJC1 1295, and the explosive growth of GLP-1 medications. This is about understanding what's actually in your body, the safety concerns no one's really talking about, and how to make informed decisions in an unregulated market. Thank you guys for being here. I would love to talk about peptides. So, what are peptides? The way that I explain it to patients is that peptides are just chains of amino acids. And so, think of amino acids as the Legos that kind of make us us. And the way that it works is that you start with amino acids. Same thing that you've eaten a protein supplement, same thing that makes up your chicken. And then whenever you connect those together, you get a peptide. And then whenever you keep connecting it together and you go above, let's say 40 amino acids, it becomes a protein. And so peptides are just an intermediate step between amino acids and proteins. I agree. You know, when patients come in, they say, "I want a peptide." They don't realize that's a loose term. Like they don't know that, you know, GLP-1s are peptides and Zolex is a peptide, but they're talking about those CJC, BPC. So it's a different brand of peptide that we're talking about specifically whether it be growth hormone or sexual. So I think you have to be very specific when you say what is a peptide. Yeah. You look at the biochemistry and you go down to a cellular level and there's so many peptides. It's like saying I want a carbohydrate or I want a fat molecule. You know if you're looking at this as basic building blocks just like you're saying Alex Lego is a really good term because uh you start breaking it down and like there's so many amino acids there's so many peptides that break or make those up and then you go into proteins and so on. Yeah. So there's obviously this this resurgence of interest in these
resurgence of interest in these peptides, BPC 157, so on and so forth. So why now? Why has this become sort of a culturally relevant phenomenon? You know, we're kind of experiencing prohibition 2. 0 No, because what happened is that in 2013 we had this terrible catastrophe with the New England compounding center where a bunch of patients were unfortunately really hurt up to I believe it was 66 67 patients died due to a fungal menitis outbreak due to compounding in you know terrible conditions and so previously the state governments had governed compoundingies and you know the federal government was like hey like we need to have some sort of guidance over this and so they uh started the uh DQS I say was the act that Obama signed in November of 2013 came into effect in 2014 and it basically told compounding like hey listen like you can make drugs that are on this uh specific on a what's called a USB monograph if they're already FDA approved okay but then we've got these other things which are kind of special that you've kind of been making for a while that are not in a commercial product and what we're going to do is we're going to give you something called interim guidance that will subdivide these into what fits where and what we're going to say is hey we're going to call one category one these are things that we we haven't seen any bad safety signals. We think they're safe. You can go ahead and make these. And the majority of peptides landed in that segment, at least the peptides we're talking about now. Category two is, hey, we've seen some adverse safety signals. You can't make these. And then category 3 is well, we just don't have enough information and these are kind of in legal limbo. And what happened is in 2023 uh in September on a random Friday the FDA under the Biden administration decided to upload a PDF file on their website just unilaterally moving 19 of those peptides are previously in category 1 to category 2 with no explanation and actually even a subsequent lawsuit from the compounders association where they demanded asking for signs of adverse you know patient outcomes adverse safety signals the government was unable to provide it and so all of a sudden you ban and this tell patients they can't have it. You have the advent of social media. You have Tik
the advent of social media. You have Tik Tok and then you've got GLP1's changing the conversation around peptides and then that all whipped together into the firestorm that we see today. Yeah, I agree with Alex. I mean, we all trained with the same mentor and he taught us how to do peptides and he's very good at it and uh we started prescribing peptides, the three of us did. But in 2023 when they banned them, that was tough. Um, and so essentially what happened was the black market just picked up because these underground, you know, you can get it for research purposes. That's what people are doing. So those skyrocket because they saw an opportunity. 503 can't make it. We're going to start making it. We're going to ship it out to patients and charge some money. So that really picked up the number of patients that are using the the medication. But I think that, you know, this brings up a safety concern that you mentioned. The FDA put them on category 2. And category 2 means it's dangerous to use. Um and come this July, next two months, we're going to see which one of those will be put in category one or actually on a 503 bulk list. Yeah. And the in in the most pedantic detail, what I learned the other day and you know because again it's challenging to keep up with this because it's a rapidly changing space. But what RFK actually did and the HHS did is they actually removed 12 peptides from category 2. So they're no longer in category 2, but they're not in category 1 yet. And so what's going to happen in July, like you mentioned, is that's where the pharmacy compounding advisory committee, the PCAC, is going to meet and they're going to consider the first seven out of that 12 and they're going to make a recommendation. Now, the FDA doesn't have to follow that recommendation. They don't have to add those compounds back to category 1, but generally speaking, they do, but it's not an overnight process. So even if they rule favorably unrecommend those seven, we're probably not going to see these available for compounding for many many more months in the quickest possible time frame. Yeah. And that's really when we've seen a lot of the explosion in the interest. And you can even see the interest going back 20 plus years. You look at even something simple as like Google trends and you see 2004, you start looking at all the the some of the individual peptides and you start seeing them start to track up on their interest. And you
to track up on their interest. And you take that out to about now and you start seeing the the early 201s, it just starts skyrocketing on individual peptides and as a collective there's a greater interest that's growing because I think as a as an audience it's just expanding. It's our patients, it's our providers and it's our referral basis. So I think it's uh just going to continue on especially as we see things that are happening in public policy. We have to realize people are are ready to optimize our care people. I mean that's a big deal. People want to if if they're good they want to be better, right? And that's a and sometimes at any cost. Yeah. Right. So, you just have to be careful. We're in an era where everyone just wants to optimize and and they feel like we're withholding information or that people are out to get them and and they're not like giving them these great things and and that, you know, that they're not available to them, but they they have to figure it out their own way, which to some degree they should advocate for themselves, but I think with the appropriate knowledge. Yeah. Absolutely. Yeah. I mean, I think that a lot of people have realized that, you know, whenever they're coming to see their doctor, let's say in their, you know, late 30s, 40s and 50s, you know, they don't feel like they did whenever they're in their 20s and early 30s. And then, you know, often, you know, in medicine, we've been trained to diagnose specific pathologies. You have diabetes, you have high blood pressure, here's your medication for that. And it can be very disconcerting as a patient. We're like, man, I feel like I am dragging. We've seen this in the testosterone world, right? Because for many years, you know, testosterone was like this forbidden topic and so it wouldn't be treated, wouldn't be addressed. And now we've reached the point where we're starting to address that as a population of physicians more effectively, but patients still, they don't want to just not be sick. They want to be the best versions of themselves. And slowly what I feel like, you know, we're being called to do as physicians is transition from a model of sick care to a model of true health optimization, which is, you know, kind of our wheelhouse, you know, as specialists in this field. Yeah. Especially if you start in if you're in the testosterone business, that's what you started with. People want to have improved quality of life and peptides are a nice adjunct sometimes to that. But testosterone has
sometimes to that. But testosterone has been proven safe and peptides still are the verdict's out. Yeah. And it's different for every peptide, right? You know, because again, peptides are a structural class of medications whereas testosterone is a single defined molecule. Yeah, I'm glad you made that distinction because, you know, when you have someone coming in, they want to talk about peptides, that could mean any number of things and it could be something that has, you know, randomized clinical trial data or it could be something that's only been studied in preclinical, you know, miring or animal studies or, you know, the the variability of the evidence is just astounding. So, we really got to be uh responsible when we do it. Yeah. I think for for the average person, they may not understand the difference between getting it from a compounding pharmacy versus a research lab only. They may think that they're the exact same thing. So what is the difference? Compoundingarmacies uh as a general rule okay operate under there are two main paradigms. There is what most patients are probably familiar with which is 503A okay and they have to make their medications according to USP standards. All right USP is not a government body. It is an industry body. But think of USP standards as when you solve a math problem. Did you get the final answer correct? Okay. And if you did that, okay, well you got the problem right and you're you're doing okay. Then you have 503b. 503b are actually known as outsourcing facilities and these are large complex operations that will make medications for hospitals and clinics and they actually have to follow the same uh manufacturing guidelines as commercial pharmaceutical companies which is called good manufacturing practices which is not just did you get the right answer to the math problem but did you show your work? Did you do show the mathematical proof? Did you get to there the right way? And so these are very highly regulated bodies that are required to have regular inspections to make sure that not only you getting what you're paying for, but there are no contaminants. And the challenge is is that none of that exists in the research useon space. And so the analogy I give patients is like, you know, the research use only compounds, it's kind of like buying gas station sushi, man. Like you might have like a gas station that's got some great sushi and you just knock it
some great sushi and you just knock it out of the park, but hey, maybe you get a bad batch the next week. All right? because there's not a lot of regulation or oversight there. All right? And so you're really taking that risk into your own hands as a patient. And that's why I advise patients, this is a great time to learn about these compounds. Okay? It's a great time to kind of, you know, take your notes, but I would not recommend pursuing them until you can get them from a reliable source like a 503A compounding pharmacy. Um, I was going to say, yeah, that's an excellent point because even if you have a pharmacy that has the best practices and manufacturing and being able to compound the medication, sometimes those initial ingredients that you're getting from chemical suppliers can be contaminated. There can be heavy metal contaminants. Uh, and then also, you know, the the ways that these are going to interact, you may not have the the same source um uh ingredients and molecules. The potency can be different. They may not store as well. So, it's going to see some differences downstream. Yeah. I look at like a hierarchy. 503b, as you mentioned, is the most regulated, right? 503A can be accredited. So that's good. 503A not accredited, be a little careful. And then there's the underground. And when you have no ability to compound 503A or 503 molecules, the underground just goes crazy like they are with peptides. But that's when you get uh unregulated bacteria, uh heavy metals. I mean, you don't even know. Sometimes if they tell you this is the ingredients, this is the milligrams. It doesn't mean that's the milligrams. It could be a variance of 50% to 150% or zero. and you have no way of knowing, right? And so that's a little risky, you know, uh when you start using underground. That's what we're using for peptides for most of the peptides now. So let's talk about some of the individual peptides. Which ones are you seeing that gives you the most pause that you're like, wait, I really think we need to hold off on I mean I I personally I think that the peptide that I have the most questions about is actually something called melanotan 2. Okay. And the reason for that is that this is a melanoorton receptor agonist. So these are the receptors that tell your body to tan. But they also have important signaling in the role of in the realm of sexual
in the role of in the realm of sexual function. There's a derivative of melanotan 2 called PT-141 or brolanotide that we are very familiar with and that we prescribe in our practice with a fair amount of uh regularity. Um but there have been some occasional case reports of potential melanomas that have been linked to melanotan 2 usage and again there has it that's not a definitive link right okay it could be a correlation not a causation but I think that there are definitely some questions that need to be answered there before that's something that we start routinely recommending in clinical practice. Yeah, I I would agree. Meanitan, I mean, Melanitan's actually up for consideration in February of next year, so I'm hoping they're not going to I mean, I don't know what they're going to do, but nausea, uh, severe nausea, uh, hyperpigmentation of the skin, um, melanoma. So, that one I have significant concerns about if that one got through. Yeah, I I concur with all that. And I actually to kind of even go a different direction with it. One of the ones that that gives me pause and I'll sit down and actually talk a little bit more and have discussions with uh, with my patients about is going to be BPC 157. Not because it's yay or nay, but just because I think it requires a little bit more counseling because it's it's very close to um a lot of other medications that we prescribe because it's got some uh initial phase one studies. It's got phase two studies that just haven't been really reported as much as we'd like to see. It's been a contender for some inflammatory bowel conditions and and we've seen it also in in some oral therapies as well. And so it seems like it's going to have some really good immunom modulatory anti-inflammatory properties, but the concern is that it's got some uh some of the molecules components. It has these epitopes that are recognized on some of your body's proteins. And so you can get some cross reactivity. So now anytime you introduce a molecule into your body, your body sees it and can produce some sort of autoimmune response. And so if you introduce it now, you are having the same sort of crossover the to a lot of your natural proteins. Well, now you can potentially induce an autoimmune condition. So I think it remains to be seen in larger populations. We've seen in some subsets it seems to be safe. Anecdotally it's safe and has a lot of uh benefit. Um but it's the one that
uh benefit. Um but it's the one that I'll I'll take more pause with when actually truly taking a pause and discussing. And I think what you know what's so challenging about these compounds is because we're used to the paradigm where we have a promising drug candidate that a pharmaceutical company will then pursue and they will take it all the way through to market. But in reality that is a1 to2 billion exercise going from the benchtop to market and uh the pass rate is about 9. 7%. And the unique challenge with the majority of the peptides that we're talking about today that are popular is that they are found in our bodies naturally. Okay. So and this is distinct because if you look at let's say the GLP-1 drugs yes simaglutide and tzepide are commercialized patent products but they are distinctly different from endogenous or natural GLP-1 and that's important because natural GLP1 only lasts for 2 to 3 minutes not a great compound to actually use as a therapeutic but the reason why it's significant from a patent law perspective is because in 2013 the company Myriad Genetics was taken to the Supreme Court over their patent on the brocha 1 and broa 2 genes. So they identified these cancer genes that at the time we knew were incredibly important for differentiating different types of breast cancer risk and ovarian cancer risk. Uh but since we've learned also affects prostate cancer risk, right? But they own that intellectual property and their tests were very expensive. And all of a sudden that was challenged like hey you can't own that. It's part of the human body. And believe it or not it was a unanimous decision from the Supreme Court decision saying actually no you're right. You can't actually patent anything that's derived naturally. So there is no incentive from commercial pharmaceutical companies to pursue these as potential drug candidates, okay, to take to market because they can't protect it with a patent. And even if they could come up with, let's say, a super version of BPC57, like a more potent version, well, okay, why would I patent the more potent version if the natural version works well enough and that's readily
well enough and that's readily available, you know, to the public via compoundingies? And so, we don't have the appropriate funding and support to get that data as of this moment. Yeah, I agree. So, my understanding is BBC 157 doesn't have any randomized control data as of yet, rodent studies, I mean, but patients do tell you that they do feel better in terms of recovery. You know, it's a gastrop peptide. They tell you they feel better. You combine it with something called TB500, like you put it together. So, I I agree, you know, that there's, you know, you need to be cautious, but anecdotally, a lot of them have reported significant improvements in recovery. You know, we do have phase one data just looking at drug tolerability and safety. It was in a very small population though, and there were two different attempts to do phase 2 trials. And one of them by one company was the really the casualty of multiple acquisitions. This was a uh Croatian company that was bought and sold like twice in a row and the BPC57 project fell off. And then uh the PhD who has made BPC 157 his life's work Pedrag Sikurich uh ended up working with another company that tried to do a phase 2 study in Tijana and they managed they registered it on clinical trials. gov of and they actually submitted some data to the FDA but then they retracted it afterwards and so its current clinical status you'll look up is unknown and so again like that makes you raise your eyebrows all right but at the same time we've seen you know millions of doses now administered in between 2014 and 2023 from like licensed 503 compounders and who knows how many doses from the black and gray market and so far we have not seen an overriding concerning safety signal. I mean, I think it's tough, right? Because it's, you know, without there's obviously placebo effects in terms of like it could be safe, but it could also be doing nothing and there could be a a large placebo effect or it could be dangerous or it could be or could it could be it could cause something down the line or this autoimmune could these autoimmune
this autoimmune could these autoimmune conditions could arise 20 years from now. Right. I do think it is important to have context though because one thing that's very concerning is you know for BPC57 the concern is could this you know be a uh pro-N uh oncologic agent could this cause a cancer and then people will throw out what is the risk over years and years. Well unfortunately if you look at the data most even phase 2 and phase three trials don't go for many many years. You're looking at something that will go for maybe 6 to 24 months. And so the truth is we don't actually have long-term data on any new drug that's coming to the market if our time horizon is years. And at the same time, you know, what I try to tell patients is that we just truly don't know. But an example would be in 1990, we had the Anabolic Steroid Control Act that was introduced that put unique criminal language around the off label prescription of growth hormone. So yes, we're all familiar. Schedule one drugs are drugs like heroin. Okay, they have no medical use in medical practice. Schedule two, like narcotics, they've got a purpose, but they've got really, really high risk. Schedule three, where testosterone is right now. I don't think it should be there, but that's where it is right now. Saying there's less risk, but it exists. But now we have this one drug that is not scheduled, but has unique criminal language saying that if I prescribe this as a doctor, I could have criminal liability if the patient doesn't have a documented growth hormone deficiency. And that was primarily done out of concern that high schoolers were going to be using steroids and that this could be a long-term cancer risk. And what we've actually seen is there's been a profound use of growth hormone in the underground over decades and decades. Have we seen risk? Absolutely. We've seen acromegaly. We've seen type 2 diabetes. Uh changes in insulin sensitivity. Okay. We've seen water retention. Lots of concerns. But we've never seen cancer from it. Okay. Which I think is interesting. So just because something has the potential to improve blood flow or potentially regenerate tissue, it doesn't necessarily push it into the oncologic ter realm. Yeah. But but the safety problem is compounded. You're first trying to ask myself, for example, is BP57 safe or
myself, for example, is BP57 safe or not? And then you compound that problem with did the compounder make it safely? Is it contaminated? Is there bacteria? We see up to 20 to 80% will adulterate this other material in there. Right. So I have to worry about is the drug safe or not? And then I got to worry about was it made safely? Um and I don't know which one it is. So you got to be very very careful. Yeah. And Mo, I know that you, me, and you know Kevin have all gone and we've actually toured the high volume compoundingies that that we use because we rely on them. And so we have to have that confidence like we see how the the soup is made. And you know, I I just but I don't think that's the standard for, you know, a lot of clinicians. I don't think they've ever visited some of the compounders that they use. And that's concerning. Yeah, information is power here. And I think the common theme is that we're all all excited about about this the opportunity and we want more information you know and then that's uh speaks to it going touring the facilities hearing patients and their feedback and then also using that to make best decisions when prescribing. So what about these uh sort of peptides that are help secrete growth hormone like epimeor CJC1295 MK677 what are you guys thoughts on those? So, we used a lot. I mean, that's who we trained with who taught us how to do a lot of those peptides and they're growth hormone peptides analoges. And uh can they help? There's three main indic. I mean, they can help with increased muscle mass, decrease fat deposition, and some improvement in sleep. That's it. Some people say, "I heard it helps with libido." No. I heard it helps with this. No, those are the three things. Fat, muscle, and sleep. They have some risks. You got to be like MK67 677. You have to be worried about insulin resistance. It can cause um uh if if too much of it, it significantly creates appetite on all of these. So you have to be very careful. Some people get up at night, wake up at night and go down and eat because they can't control their hunger. Um so you know, but the benefit is they don't really suppress um indogenous production. Um so it keeps that that rhythm. But um I think they're good. I think that they can be beneficial in certain patients. Yeah, it's a very interesting tale when you go back and you look at how the discovery of these uh GHP Agnes and the and Grelin
of these uh GHP Agnes and the and Grelin mimedics came about because you find the the molecule, you find growth hormone, you find the receptor and then you start reverse engineering different iterations of each of these so you can try to then get a higher potential on that receptor. And so you start seeing things that come out like that ibutam and MK677 and you start actually seeing them come to trial. So it's an actually a true uh benchtobedside progression. And then you start seeing some of the things that come out like in the original oban trials like you would see um canines who had their limbs uh restrained end up still having some hypertrophy. Uh but then when you move it into a um a human population you start seeing some increased safety signals with CHF and and so it's a it's something that um uh stopped in in um pursuing the next steps with trials but it's also something that we we still have available. So um it's a really interesting phenomenon the advent of these something we wish we had available because you know Ibutamin CJC and Ipamorin you know they all took a dive back and forth they're not on the list to be reviewed. No they're not exactly yeah which is interesting. So uh CJC and Morland were taken off of category 2 and then they were going to be considered by the committee then they weren't and now they're in this like regulatory gray zone. So there are and I will just say and we all know this sitting here there are compoundingarmacies out there that are kind of riding the lightning a little bit making those compounds right now okay for prescription and again it's questionable like what the legal status of that is there are also some compounders out there that are actually making some of the peptides that are still up for consideration in July and I think that that's something that patients should be aware of that okay yes is that potentially better than getting it from a research use only like a site potent potentially, but you have to understand you're working with a company that's already, you know, kind of riding that line of legality, and that should raise your eyebrows a little bit. Okay. So, I mean, we're going to see what comes from this. Um, but going back to your original question talking about the growth hormone secrets, I mean, I think they're
hormone secrets, I mean, I think they're fantastically interesting compounds. Uh, I personally was prescribed MK677 uh to stimulate my hunger, you know, whenever I was, you know, like borderline kectic. And you know that was a huge like lever you know in my life and conveyed a lot of benefit. But guess what my A1C went up a little bit and I held on to the fluid and you know after about like 6 weeks walking wasn't so much fun and so like upstairs and I was like so we're going to ratchet this back a little bit. So you know everything that you mentioned these are things that we have to be mindful of you know as prescribers whenever we start to consider patients for these compounds when they become available again. Yeah, but let's I agree, you know, let's be there are um growth peptides that are available like legally prescribed sharellin tessimarelin and they're very good. I mean testolanin is fantastic for lipodistrophies used for HIV lipodrophy. It helps can cut the fat abdominally. Um it's expensive if if you don't get it compounded but sturlin also used for children for growth deficiency. So there are legal peptides that you can get that are very good. Yeah. And a lot of these they were used until they just got usurped by something else. So like you know when why why try to induce endogenous production in some one who needs ketchup growth when you can just give some you know some some actual uh synthetic growth hormone. So it's you've kind of seen some changes in the prescription patterns. So what about using those off label for people who want to get more muscle? You can. So I mean someone says I want more muscle decrease my fat and I want to help me sleep. And I say well there's two of them that are uh you can use it off label. It's HIV lipodistrophe in children but you can use it off label. We use drugs off label for many things, but you know it's safe. It's approved by the FDA. They put it on a category. It's a 503 bulk list, which means you can make it. It actually has a monograph. So they I feel very comfortable prescribing those and they're effective. And what are the side effects that people need? You get joint pain, you get water retention. Um, in some of these patients, I think those are the most ones that I see. Yeah. And you changes your insulin sensitivity. You can see your glucose spike too. Let's talk about brimotide which is the one an FDA approved peptide
which is the one an FDA approved peptide that we all prescribe. What what exactly? It's on label for female hypoactive sexual desire disorder but certainly we use it off label for men. So what is your experience using it and what does it do? Are you asking about my experience personally? Well I mean if you want to share by all means you're welcome. I you [laughter] know I I will tell you this as as someone who's you know like my own YouTube channel is like dedicated to brutal honesty you know I will say that you know PT-141 or brelanotide is a really fascinating compound because we're used to oral medications like Viagra and seialis for increasing nitric o nitric oxide release you everywhere but particularly in like penile tissues for erectile dysfunction. But when you hit the melanoortin receptor and you hit it as hard as bremalanide does, you really get that full body release. And the truth is is that you know whereas Viagra and Seialis actually can convey a benefit when it comes to clitoreral blood flow in women. Well, yes, just because bermolanide is prescribed or is FDA approved for females, it's actually effective in men as well. And so, you know, what I counsel patients is that you're going to experience, you know, a much more uh heightened version of what you might experience with an oral PD5, but some other new things like you are going to experience probably some nausea. Okay? You're going to have a lot of flushing. You should expect that. Okay? Stuffy nose, headache. That's something else that come along with it. Also, for men, you have to counsel them that they are going to get a really potent erection. And so, this is something that is great for your patients that have erectile dysfunction. All right. But for a young man who doesn't have erectile dysfunction, that erection is going to be bordering on the line of priapism. Okay. Now, it's a different mechanism. You know, priapism being an erection that lasts too long where men need to go to the emergency room. But the the mechanism of how that uh develops is different. I've never seen an actual priism that needs to be treated. But you have to let patients like, yeah, you think it's a lot of fun, but you know, this could be uncomfortable for you. So, this is, you
uncomfortable for you. So, this is, you know, what you should be aware of, you know, whenever you uh whenever you use this compound. Yeah. So you it's very effective in women I agree and but it's also off label in men and there are studies in men actually have been studies showing that it is beneficial in men uh to use I agree that the nausea is pretty significant we give them zopran with the medication just to make sure and we ask them to inject hours and hours before 6 to 8 hours before because we find that it tends to be more effective than doing it 45 minutes before um and you have to tell them you can't do it more than eight times a month because it's in the package insert because you get increased hyperpigmentation so there's certain nuances but you know if someone is maxed out on p5 inhibitors or maxed out on the testosterone and you need something else. This may be the something else that you can offer them off label. That's a really good point because you know after a certain while we kind of exhaust the different options that we have for PD5s and and incorporal injections you have um you know we have a lot of therapies that are aimed at the end organ just at the penis but here you're actually going central you're hitting the biggest sex organ in the body with the brain. Yeah. I've also people they get um as uh atrocious from compoundedies uh because I find some people they get less of those nausea side effects with with those and I found those any other things that you guys have used that you found useful nasal or yeah I haven't found the nasal spray to be super agree I don't the nasal has not been we've tried it it just didn't work um yeah it's kind of placebo at that time I think with the intraasal yeah I mean I I think that what seems to be the most effective for patients is what you know Mo mentioned which is you know administering uh subq injection before but you know I'll even I I will underdose my patients to start trying to make sure that they don't have a bad experience the first time cuz I tell them like you can always go up but you know if you end up like kind of burning that experience or having a really negative one or you know something else that you have to account for is that if you have a bad time and then your partner sees that you're having a bad time like that may just ruin that medication as an option for you moving forward and so low and slow and slowly working your way up much like we do with some of our uh injections for ED D is a decent strategy to take. How does it improve penobility? What is
How does it improve penobility? What is the mechanism by which it does that because it's working centrally? I think it significantly increases one's libido and when your libido goes up that you know there's a central component to erections, right? And so uh it improves a central component uh which will then increase blood flow. I I don't have any other better mechanism or explanation. Yeah, that's kind of the extent to which we know. Yeah. Well, as somebody who's, you know, taken it for a spin, you know, a couple of times, I will tell you that, you know, what I perceived was basically just a very amped up version of what you might experience with a full dose Viagra or Seialis. And so, I didn't perceive anything centrally as far as like increased sexual desire or anything along those lines. That just wasn't my experience. Um, but everything that I described to patients was absolutely what, you know, I experienced. And so, you know, again, I I do not think that doctors need to make it a habit of trying all the medications that they prescribe to patients. But, you know, the truth is is that, you know, I kind of fit the target demo for a lot of the guys that come into my clinic. And so, sometimes having that experience is helpful whenever you're talking to guys and giving them a frame of reference of what they might be able to expect. Let's talk about a couple other um sort of peptides that have come up recently with um intraasal CAX and dhexa which are supposedly supposed to help with cognition and performance. What are your thoughts on those? I mean I think CAX has some promise but you got to be careful. It's mainly in rodent studies as well and so um it's a Russian medication that they've developed and it may have some benefit but very limited data on both of those actually. Yeah, it's uh it's a segment for adrenic corticotropit hormone and there's some Russian literature but we're still we don't have much clinical uh western data that we'd like to review. Yeah, it's up for but in July it's up. So no in February but is there any that was July? That's one of the first ones. So it's so we've got BBC57, TB500, MC, KPV, Epylon,
MC, KPV, Epylon, uh Cmax and then Dhexa or DEP. Sorry D. Yeah, you're right. As those are going to be the the seven that go up. Yep. And do they have any ongoing clinical does this does CMX and Dexa do they have any ongoing clinical trials? I'm not aware of we don't see anything unlisted on clinical trials. Yeah. And what about DIP and epithelon? Yeah. So DIP has some you know uh interesting preclinical data about in potentially improving delta sleep waves is where it gets its name. delta sleepind inducing peptide and [snorts] you know epialon has kind of gotten the reputation in the biohacker circles as being the quote fountain of youth which you know I think is a gross oversell of it um but it's actually interesting because it does address you know improving tomeores activity tomeores being the enzyme that helps repair the tail end of DNA that kind of gets damaged when it gets replicated again and again. So think of it as whenever you photocopy a piece of paper, you know how it gets like you copy it again and it gets a little bit harder to read or maybe at the edges, you know, that's what tomeores is supposed to improve that. Uh so it does have some evidence of potentially improving the health of the pineal gland which is helpful for sleep regulation. And so as someone who has not slept since my first child was born six years ago, you know, I mean, you know, you look at that and you're like, man, I mean that could see that being pretty compelling for a lot of people. I mean, it's interesting because I think with without abundant data, like is it going to be better than a sleep aid of, you know, another type of sleep aid? Yeah. I mean, you know, the problem with a lot of sleep aids though is they can result in, you know, kind of dependency. And so, you're kind of looking at more of a band-aid than a long-term fix. And so, being able to potentially heal your body or heal your pineal gland and assist with that, that can be a little bit more compelling than, oh, I take melatonin every night and my body's actually dependent on it because I've suppressed my own natural endogenous production. and you're talking to somebody that whose vitamin cabinet, you know, is bigger than, you know, most people's like drinkware cabinets. And so, you know, we have a lot of really cool options when it comes to helping with sleep. Glycine is a great option.
with sleep. Glycine is a great option. Okay. Uh Ashwagandha can actually reduce, you know, cortisol and reduce stress. So, uh we have a lot of gapurgic, you know, compounds. Um but the idea that you could take something for a period of time and improve your natural, you know, health, I think that's really compelling to patients. Yeah, I agree. I think the challenge is that you, as you mentioned earlier, like it's going to be there's not a lot of people who are going to be interested in running these clinical trials, right? Because they can't patent it. So, the safety concerns because if you're not going to run a clinical trial and you're still going to make it, yeah, who's going to study it and some of the sleep aids have been studied, you know, and some of them that are prescription have been studied, you know, safe, but this is a a version that has not been studied and you have to just be cautious, I think. Yeah. Especially when like something like a sleep cycle relies so much on tachieaxis and hitting a threshold to to then fall asleep and it's based on all of our visual cues and our preoptic nuclei signaling, hey, it's time to go to sleep based on sunlight. And now we're flipping that on its head and saying now we're going to go at a certain time. I mean, you you wonder if that's going to retain or if it's going to be even a heightened threshold then to further have difficulty sleeping when you return it. I am so glad I have such smart friends. Preoptic nuclei signaling. Golly. [laughter] Yeah. you know, yeah, you you can tell. So, like the way that like our our training worked out is that, you know, obviously Dr. Kira trained with Larry, you know, uh some time ago. And then me and Kevin, we were separated by what, two years. Yeah. You could tell that he like got fried with me. He's like, I need someone smarter. I need some academics here. Yeah. I was calling you for tips. [laughter] I was like, just increase the testosterone dose. It's always the right answer. [laughter] [gasps] Well, you know, I and then that's what makes me worried. think that like for example there's so much that goes into sleep and I think we as a society are spending so much time doing things that sabotage our sleep right constantly looking at phones or looking at blue screens and we're stressed all the time and we're not allowing ourselves downtime to even you know turn our brains off and like things that we just did before because there wasn't so much distraction and so that's what really
distraction and so that's what really makes me worried like people are looking for these hacks or these things that can help them and optimize but like yeah they oh I'll work on my sleep, I'll work on my diet, but they're not dealing with their stress or they're not sleeping or you know that they're just not doing all the things and and so it's it's a challenge, right? Because we want to optimize, but we don't want to enable people to keep doing their bad behaviors. They're looking for the magic pill to help them sleep better as opposed to following sleep hygiene like going to bed early, not eating within 3 hours, keeping the room cold. Um they're not going to exercise, they're eating things that are going to spike. There's a lot of alcohol, let's be honest, you know. So then they say, "I can't sleep." Well, the reality is if you made some lifestyle modification changes, uh, you probably will sleep. And a lot of these sleep ages, remember, they will increase the keep the amount of time that you're asleep, but your efficiency doesn't go up. In other words, your deep sleep and REM sleep actually stay lower, but you do sleep longer, which is not really beneficial. Yeah, I'm glad you would point that out because a lot of it is uh our job is to be educators and and be able to expand this uh information base to to our patients. And so some of it is probably just a marketing and branding issue on on our part and the information is coming across because we have lots of biohacks. We have lots of them. That's what we do on a daily basis. It's just how you want to say it. Diet, sleep, stress reduction, exercise. Um Um they're just not sexy. Yeah, [laughter] they aren't. But they lead to good sex indeed. Yeah. Health. I mean it's funny if you're sleep deprived. I mean your libido just goes through like through the floor and we know that. Same with stress. So does your testosterone. Absolutely. Yeah. Well, my testosterone comes out of a bottle, so I'm good there. But, you know, but the thing is [clears throat] is that, you know, I have patients come in and they'll often complain about, let's say, oh, doc, I think I need to go up on my dose of testosterone because I don't have the same libido, okay? Or, you know, I'm not seeing gains in the gym, etc. And then, you know, again, you know, like talking to them as a man diagnosed with low testosterone who's on testosterone, I'll tell them, I'm like, listen, I can look at your testosterone levels. Those
look at your testosterone levels. Those are excellent. All right? So, okay, I will tell you as a man who's on testosterone, I have days where I feel like a dumpster fire. And why is that? It's because I didn't get good sleep. It's because I haven't been in the gym. Okay, so let's start talking about those lifestyle, you know, issues that haven't been adequately addressed because I could dose you through the ceiling with testosterone, but you can't outmedicate bad sleep. You can't outmedicate a bad exercise or bad diet. That's just not how we work as human beings. And so honestly, sleep, diet, and exercise are the fundamental pillars that make up all health and then literally everything we do as doctors is just in addition to that. But if those are disrupted, man, we are behind the eightball. That's a good point. You know, you look at the stats and half the people in the NFL have obstructive sleep apnnea and they are, you know, they're some of the fittest people in the world. And so you fall asleep and all that soft tissue then collapses your airway. You know, you're not going to get good sleep, you're not going to get restorative sleep, and you're going to wake up feeling tired. And so that's one of the things that we also screen for. There was a really good study I saw that actually showed decreased lean tissue acrruel in patients that, you know, get poor sleep and at least for, you know, my patients that are very active in the gym and that sort of thing. That's been the best motivator. I'm like, bro, you're leaving gains on the table and they're like, I'm going to get that sleep study tomorrow. And so, you know, it's about finding what the right motivator is for the right patient. Yeah. I I think, you know, these patients come in, they say, give me the pill, give me the testosterone, and I want to feel better. But they say, look, I said, if you keep eating potato chips and sitting on the couch, it's not going to work. The reality is the patients that do the best are the ones that do the diet, exercise, sleep, and stress, and use the testosterone. They're synergistic, right? But if you're just coming in for the magic pill, you're in the wrong place. Yeah. One thing I I have done a handful of times, I'm very lucky to have some really incredible patients that are very open and they are okay with me mentioning this, but I have a patient of mine who uh owns a gym in Indianapolis. Steven Jentelli owns an amazing gym called Indie City Barbell. I've worked with him for years. And if you look at him, I mean, the guy is an absolute stud. He looks like a Viking. He's 270 pounds, lean muscle. And what's funny is that I'll have patients come in and they'll bring in a picture of, let's
they'll bring in a picture of, let's say, Chris Bumstead or something like that. Like, you know, oh, I feel like I have low testosterone. This is something I want to look like, that sort of thing. And they start trying to negotiate their testosterone dose. And it's funny because I'm like, hey, you see this guy here, you know, my buddy, you know, down downtown who owns a gym. He's on less testosterone than you are right now. Okay, but what's the difference? Decades of training, sleep, okay, and appropriate diet. Like, that's what's actually going to make the difference. You can't just inject muscles. If that were the case, then everyone would be walking around like a Mr. Olympia, which is not reality. Are there any besid We'll talk about GLP1s, but any other peptides that you think we should talk about? GHKCU is pretty popular for the skin. I mean, uh, there's the transermal and then the injectable and that's going to be coming up in February to look at and, uh, you know, the transermal was on category one. For some reason, they pulled it off. Um, but I do think that there could be some benefit. If you overdo it, it can be a problem, but some I think there may be some potential there for skin. I'm really interested in MSI personally. uh because the idea that you could you know in inject a mitochondrial peptide that could upregulate amk pathway I mean that's pretty fascinating that you could elevate basil metabolism uh that way and you know I think that there's some synergy to be found there with GLP1s with fat loss with adding in an appropriate patients testosterone I think that it's a new lever for us to pull and so I find that really compelling yeah I'm looking forward to u more more research coming out on thymus and alpha. You look at this is one of the peptides that actually has uh very robust data it's uh when the company was bringing it to market uh they really market in Southeast Asia and so it's it's approved in 35 countries and there's randomized clinical trials there's level three evidence but we just we don't have it here just due to the um not going through the FDA yet. So that's the one that I'm really looking forward to being able to prescribe patients and what is the efficacy of that one? So that one's it helps with uh hepatitis from uh hep and hep. So it's got a a real um imunogenetic uh property
got a a real um imunogenetic uh property to it. And what's crazy is I I think that we and I'll I'll save this because if we're getting into the GLP1s, but uh what we're seeing from a population level and from a population level experiment of retatride is mindblowing. Yeah. That's I'm excited for that one. I think it'll be really interesting. I think it is going to be the world's first trillion dollar drug with a T. Um, but it depends. There's a lot of really fascinating legal battles that are going on right now in an Indiana courthouse just a couple uh blocks from my house that I think would radically change uh how solvent Medicare is going to be in a couple of years versus drug access. Um, I don't know. I'm kind of teased. I'm gonna go into this. Are you okay if I just dive into this? Let's go for it. All right. So for for our audience, you know, we have right now two main GLP-1 drugs. Okay, we actually have some we have like llutide and some others that were legacy GLP-p1s main ones. Simiglutide owned by Novodorisk and then we've got Tzepide which is owned by Lily just down the street from where I live. And right now Lily is working on their next drug reat. And what separates semiglutide from tzepide from reatride is what receptors they hit. Semiglutide just GLP-1. Trazepide GLP1 and GIP. Retatrutide adds in glucagon receptor activation and so what that does is it actually pulls glycogen and sugar stores out of the liver and then once that becomes depleted it actually pulls fat out of it and so much like I mentioned Matsi is interesting because that's going to upregulate basil metabolism we've actually seen an upregulation or what we perceive to be an upregulation in basil metabolism primarily manifested through changes in heart rate but retatride we're seeing 25% change in phase 2 phase three clinical data and overall body weight like absolutely mindblowing numbers. But what's crazy is that typically again you go through this uh process of phase 1, phase 2, phase three comes to the market and then people start using it. Well, fun fact, part of the patent process in order for Lily to, you know, own this drug and to have patent protection is they have to
have patent protection is they have to submit the amino acid sequence to the FDA, which is publicly available. And so what's happened is now that we have widespread peptide manufacturing that's become you know again the peptide manufacturing that's been used to be making BPC57 and TB500 in these Chinese labs that are making right now you can use that exact same technology for making reatride and so now we've had for over a year an explosion of retatride use in the population amongst bodybuilders and biohackers to a very high level I won't say who but I was talking to one of our colleagues whose spouse is using retatride and she's a physician. Okay. And so there is an incredible experiment where going on where we're seeing people you like regular civilians walking around using a drug before it's even available or going as it's actually going through FDA phase two and three trials which blows my mind. And what is I find really compelling or challenging on the regulatory side is that the FDA years ago defined a peptide as being 40 amino acids or less. Okay? And anything above that is considered to be a complex biologic. This is a huge deal because anything less than 40 uh peptides that is treated as an IND or a standard new drug application. And that means that you get 5 years of exclusivity due to a law passed called the Hatchwaxman Act. Okay? And then you end up if you cross that line, you have 41 amino acids, all of a sudden that's a biologic. Biologics get 12 years of exclusivity. And more importantly than that, if you're ever going to make a biologic, even after it goes generic, okay, it has to be done by a facility with what's called a BLA, okay? Which means a biologic license uh application. uh which fun fact no compounding pharmacy has ever obtained because the cover charge to apply for that is somewhere between 80 to $ 150 million. And so this is the case. Lily tried to use some logic. They have two it's a 39 amino acid uh compound in the
it's a 39 amino acid uh compound in the alpha chain which is what the law defines. Okay. But they tagged on two other amino acids on the side to the side chain to make 41. Don't know if that was necessary for the molecule. don't know if that's just happen stance. And so Lily's lawyers told the FDA, "Oh, no. This needs to be a biologic." Fun fact, I know a guy who knows a guy who had to write the BLA application for the FDA. It's a small world in Indiana. And what happened is the FDA said, "No. You guys can't bend the rules. It's 39 amino acids." Well, that got appealed. And so right now there is a knockdown dragout fight happening inside a small Indiana courthouse that is not only going to determine whether or not you get access to reatrite. It's going to determine price point. It's going to determine time of exclusivity. And guess what? Because this is so effective. It's going to have to be available. But if it's a biologic, they're going to be able to price it through the roof, which is going to bankrupt Medicare. Okay? Because all of a sudden we're looking at semiglutinide and tzepite alone which are already going to be somewhere between a 55 and 60 billion dollar business in just 2025. We already have one out of eight people on a GLP1 projected to be four out of eight people by 2030. And if we end up having this become a biologic then it will never ever be available via compoundingies. So it will forever be out of reach to the majority of Americans. And this is a small technicality that is being debated in a small Indiana courthouse that is going to have profound ramifications in the United States, but then that gets duplicated in every other market in the EU, in Australia, in Asia, and this is going to, I think, change the face of modern medicine. So, we'll see. That's crazy. We'll see. So, the question is, Alex, when you when you're when they're doing the Netflix documentary, who's going to play you? [laughter] [laughter] I don't know. I mean, but I will tell you it is uh you know, it is a little spooky because the truth is is that you
spooky because the truth is is that you know that you'll have like oh this is a mining town, okay? And like the the company pretty much owns the town at that point. Well, you know, Lily briefly crossed the trillion dollar valuation. You know, first farmer company to do that, okay? Lily owns the state of Indiana. Okay. And so the amount of influence that they wield on a political level is absolutely unprecedented. And again, this is not being debated in a federal courthouse. this is being debated in an Indianapolis, you know, courthouse. And so, you know, that's an incredible amount of pressure to be put there. And so, you know, I have true concerns for the uh impartiality for whatever that decision ends up being on this appeal. Man, that's crazy. It's like mind-b blown emojis over all of our heads. Let's talk about the GOPs we have right now. What are your thoughts on how GLP1's are affecting I mean, obviously they're doing great things for overall health. Um, but in terms of sexual health, what are you guys seeing? So we're actually seeing some really good evidence uh towards hypogonasm and the treatment of uh that just with some of the GLP-1s. There's some studies that have come out of Italy and Croatia that have looked at looking at primary hypogonasm giving just some of these GLP ones and then following them up 3 months, 6 months and you see the testosterone go up almost significant like they're taking a daily testosterone gel. And this is not when they're on testosterone. And some of the interesting things I still want to see more studies on and I'm very excited about is that secondary outcomes for some of these studies they looked at sperm counts and you see some, you know, on testosterone you're going to see sperm usually be suppressed. Not everyone, it's not a contraceptive, but on most men it's going to come down. It's go to zero, but on on the guys who are on um on their GLP1s, you don't see it suppressed. You actually start to see it come up uh almost uh at the same level as if you were giving someone the hormones that tell them to make sperm and testosterone. So if we're talking about kind of some biohacking and and really tapping into some of this HPG access, uh, I think it's got a lot of good potential. Yeah, I think on the testosterone front, you're, you know, absolutely. You know, when people lose weight, they raise their testosterone. So, 10% loss in body weight, 85 nanogram, 15% body weight, loss, body weight, 250 NOG. So, it makes
loss, body weight, 250 NOG. So, it makes sense on the GLP1s if you're losing weight, you're going to raise your tea levels. The only caveat is this. So when we lose weight, our SHPG levels will start going up, right? So your free tea is going to kind of come down, right? So just remember, it's not this beautiful just rise in total tea. Free tea is going to come down a little bit. And so we thought that it was a weight loss mechanism, but at this meeting where we're at the AUA meeting, uh the Mayo Clinic, uh to Toby Kler's group have shown that the GLP1s can actually cause um an improvement in testosterone level independent of weight loss, And they had it was of 1, 600 patients. And so what's the mechanism? And the mechanism theoretically is that the GLP1s uh we know directly affect latic cell production affect the latic cells. So they can actually induce the latic cells to produce more testosterone. And there's some data to suggest that the GLP1s can centrally uh induce the kissepin pathway to improve LH secretion as well. So maybe maybe it's not just a a weight loss. Maybe in and of themselves they can raise tea levels. Yeah, I will tell you that the central effect of GLP-1s is something that you know is pretty remarkable. You know, not just from a food noise perspective, right? How much are you thinking about food? You know, I did a trial of Tzepide for a little over four weeks and I perceived and again that's super subjective, right? But I perceived a degree of mental clarity that, you know, I had not appreciated, you know, before then. And you know, there are GLP-1 drugs that are currently in drug development that are designed to actually cross the bloodb brain barrier to specifically treat things like alcohol use disorder, chronic opioid usage uh disorder. And so I think that the idea that oh GLP-1s just work by reducing calories and that's it. Like I think that we have fairly thoroughly disproven that and there's a lot more to this than just eating less food. What about So it it obviously decreases your desire for food, but what about it? You know, we see that it's helping people with alcohol use, maybe
people with alcohol use, maybe compulsive behaviors like gambling or shopping addiction or whatever. What about sex? Well, we know that in some patients it decreases libido. Yeah. Right. So because sexes can be compulsive, right? So in some patients you see a decline in libido. Um but the early studies on GP1's erectile function were a little bit mixed. shown negative, but the newer ones have suggested that there may be a positive effect in the studies looking at preventing erectile dysfunction over time. So, we do think that the GLP ones may have a positive effect on ED. It may have a negative effect on libido. Um, and more to come. Yeah, it tough to sus those twos out, right? Like libido versus erectile function, right? Because they're so closely tied, but they're different. Yeah. They're put in the same bucket and you just you really have to separate them to be able to really hone in on what's attacking wish. kind of like ejaculation, emission, orgasm, climax, all these things kind of get lumped in, but we got to separate them out. Yeah. Absolutely. And also, I think that um when you're looking at um metabolic health is going to be better, right? So, obviously, you're going to have better erections and better all those things, but desire, as you mentioned, is is so separate and and I think that it's probably going to affect people differently, like especially on different doses, right? Like when you're on a higher dose, it may be more strong, but then at the same time, you may have better body image, you may feel more confident in your body. Like there's other factors that may play a role, but it is interesting because I think there's there's a lot of discussion about how it changes your dynamic in your relationship. Absolutely. And you know, some of these guys too, they can become sarcopenic. You know, I think the the stats like 10% or so can become sarcopenic. So, it's definitely a population that also keep an eye on and when they're in my clinic on their testosterone as well. That's a really important point for our audience. You know, sarcopenia being a a deficit in lean tissue mass. a loss of muscle to the point that it's a metabolic problem because muscle is the largest metabolic organ metabolically active organ by volume and so if you lose muscle with fat like that's not a good thing which you know now pharmaceutical companies are actively pursuing with the development of these myostatin and actin inhibitors and so
myostatin and actin inhibitors and so we've got beagrammab that's actively undergoing I believe phase two right now with Lily if I remember correctly and that's going to be an actin inhibitor and then you alo also have Travogumab and Gerrett's Mab which are owned by Regeneron and they've completed phase 2 data and I believe they're going into phase three and so that's they get they cause nosebleleeds but besides that it looks great. Okay. Um but again it's going to be a challenge because those are going to be complex biologics right and so it's going to be interesting to see how they come into the market and what commercial availability actually looks like for patients. Yeah. So they both have a very important point because they're telling you that you're losing 30% of muscle mass. 30% of muscle mass if you start this medication. So you can prevent it by increasing your protein intake and working out and that will may help but not all the time. You can use as myostatin inhibitors which are very helpful. That's in the future. And now they're also using SARMs. So there's a phase 2 study looking at SARMMS uh you know so novasarm just to see if we can give something like testosterone to help decrease the muscle mass loss. Um but but I think that's going to be very important because if you don't uh inhibit the muscle mass loss, you're going to see a negative change in the demographics. Yeah. And if people don't change their nutrition, even though they're eating less, if they don't modify their nutrition or they don't work out, they're going to lose potentially even more than 30%. Absolutely. So, you can't just look at the scale. I think that's the big thing. You know, if you're just going by weight loss, then you can be missing things. Yeah. I I'll tell you, Mo, I looked at that clinical trial looking at an NOSAM and man, I I am not a big fan of SARMMs. I think because we've all been very uh you know, kind of gunshy based off of what we've seen in patients. And so I really hope that these androgen independent options like myostatin inhibitors get across the finish line um because you know again I always want patients to have options but I think that we truly underestimate the long-term consequences of of SARMMS. Yeah, I agree there and I agree. And also STS have apat toxicity there and they've never made it by monotherapy into the market. So they're still not available. But there are companies also looking at giving testosterone even oral
looking at giving testosterone even oral testosterone in combination with um GLP-1s. And what's unique about testosterone is that you know the more you give the more you upregulate muscle and you can potentially but only fear is if you're giving a young guy who's yugenatal testosterone you're running into trouble. And and then we get but but then we get into like oh can we do oral testosterone and inclenine to like try and like protect pat right like so yeah I mean like there it's an exciting field to be in because everything is developing rapidly and it's cool to be in this space because it's all evolving out of you know what we were trained in and it's kind of having this cultural zeitgeist moment and so I would joke with friends I was like it's kind of like I being really into like Pokemon and like that's just like your thing right or like Warhammer 40k like I just do this on my own I paint miniatures and that sort of thing. You just wake up one day and all of a sudden everybody like loves Pokemon Warhammer 40k. I'm like you guys used to make fun of me for this, right? And now like this is the cool thing. Oh crap. It would have been you could have been nicer to me in seventh grade. Gosh. [laughter] So let's round up this discussion. If you were to design a clinical trial today for peptides, which peptide would you want to study and and how would you design it? I would be really really interested as someone who has you know and I this is the same for both Mo and Kevin you know I see a lot of patients uh that are post-radical prostatctomy and part of what's called our survivorship program so these are men that have been diagnosed with prostate cancer and undergo radical prostatctomy their prostate is removed surgically in order to cure their cancer but the drawback of that or the challenge those patients face is both with leaking urine okay and with losing their sexual function losing their erections And we have some therapies that are available that can help maximize their chances for recovery. So uh for example, we start patients on oral medications like uh Viagra and Seialis. We have them do pelvic floor physical therapy. I have patients use a vacuum erection device to keep the penile tissues stretched and limber and healthy as they recover. But the thing is is that we've all had
the thing is is that we've all had patients that you know surgically you talk to the oncologist they had a beautiful nerve sparing surgery been despite all of our interventions they still developing profound erectile dysfunction primarily through a mechanism known as venus leakage where the penile tissue becomes damaged somehow and loses the ability to trap blood effectively. And so what I would be really interested to see is could we develop a trial where we have our patients that serve as our controls undergo standard rehab and then could we have an arm of patients that receive let's say BPC57 TB500 okay maybe something like KPV adding in it as well you know or like the glow or the close stack as people have described and does that convey a meaningful benefit in not just how many men regain the urinary control and regain their sexual function but how quickly they regain gain those. Yeah, it's fascinating. Yeah. Cool. I'd be curious to see what we could do in some of the orthopedic uh literature. A lot of injuries. You know, we see um a lot of spinal cord injuries, but also a lot of femur fractures, you know, arm fractures. And all these guys when they come in, I'll I'll see them for refractory referred, you know, testicular pain, but um but they still have some lasting injuries, some lasting irritation. I'd be curious to see if he had, you know, you're giving one arm TB500 and IB warrant or excuse me, uh, BPC 157 and then the other arm just standard uh, rehab uh, pathways and PT and I'd like to see, you know, return of strength, functional uh, mobility and see if there is a difference. So then we can then incorporate it not just in restoration but also potentially improvement. Yeah, I'm focused still back on that GLP1 and muscle mass loss and anything I can do to like that seems like the biggest pressing issue and anything we can do to prevent muscle mass loss whether it be my statin which would be interesting if that works um or and even if you can get the SAMS to be a little bit safer something to prevent the muscle mass loss would be very important. Mo, you might be interested that there is, you know, data that would suggest that Matsi actually has a muscle sparing component to it through its interaction with the CK2 uh receptor. And so that could be an interesting adjunct to add in to GLP1's. Yeah. Which again, you again, you're
Yeah. Which again, you again, you're going to be helping by supposedly upregulating your basil meta metabolic rate, but is it going to convey? Let's do DEXA scans in those people. Let's see how much lean tissue they preserve. That could be interesting. Now we just have to get people to fund the trials. [laughter] [laughter] Yeah. Well, I mean, honestly, I think that this is a time where, you know, so many people are googling this and looking at videos, you know, online and trying to educate themselves. I mean, this is a time where a call to action to have people call their senators and to call their congressmen and to say, "Hey, we want the NIH to fund these trials." Okay? And you know I will tell people like hey like I try to use my platform my ability to shout from the rooftops but this is why like I need colleagues like Dr. Kira Dr. Campbell who operate in academic settings that are you know candidates to receive that kind of funding and to pursue these studies in a regimented and formal fashion so that not only do we get safety data like hey do we have any adverse events these people do okay but also like do these things really work the way that we think that they do or do they work even beyond that. And so I think this is a time where you know hey patients like need to educate themselves and need to be proactive but man take that extra step like and you know maybe this is us taking time to liazison with activists on the own lobbyists on the political side and try to like create form letters and have patients fill out or sign online petitions but this is where again people if you want to take control of your own health sometimes it's that extra step of actually contacting your you know uh legal representative and going from there. Yeah absolutely. Thank you guys so much for joining me on today's episode of the Reena Malik MD podcast. If you love this podcast, do me a solid favor and subscribe to the podcast. Make sure you go on wherever you're listening or watching this and subscribe. It's completely zero cost and a great way to support our podcast and our work. And as always, we're going to take care of yourself because you're worth
Transcript auto-generated by YouTube. Verbatim — duplicates intentionally preserved.
In this discussion, Dr. Rena Malik and her guests do something useful: they slow the conversation down. Rather than treating peptides as a single category, they separate evidence from enthusiasm, prescription medicine from research-use products, and informed care from unregulated risk.
A peptide is a short chain of amino acids. That definition sounds simple, but it covers a wide range of compounds. Some have randomized clinical trial data and clear medical indications. Others remain mostly supported by animal research, mechanistic reasoning, or anecdote.
That distinction matters. When someone says they are interested in peptides, the first question is not whether peptides are good or bad. The first question is which peptide, for what reason, with what evidence, and through what source.
"The variability of the evidence is astounding."
The conversation returns often to regulation because purity is not an abstract concern. A medication made under clinical oversight lives in a different world from a product labeled for research use only. With injectables especially, contamination, concentration errors, and impurities change the risk completely.
This is where health optimization needs maturity. Curiosity can be useful. But curiosity without quality control becomes exposure. The body is not a testing ground for unclear substances from unclear supply chains.
BPC-157 is often discussed for injury recovery, gut health, and tissue repair. The appeal is understandable. Recovery is personal, and people want options when pain or injury interrupts their life.
But the strongest claims around BPC-157 still lean heavily on preclinical evidence. Animal studies can guide research, but they do not automatically become reliable human protocols. The careful position is not dismissal. It is restraint.
Growth hormone secretagogues are sometimes framed as recovery or sleep enhancers. The mechanism is more complex. These compounds can influence hormonal signaling, which means the possible benefits and possible risks both deserve medical context.
For anyone drawn to deeper sleep, stronger recovery, or better body composition, the foundation remains less glamorous and more dependable: consistent sleep, progressive training, adequate protein, metabolic health, and deliberate restoration.
The discussion also touches GLP-1 medications. Unlike many wellness peptides, this category has substantial clinical evidence and medical oversight. That does not make it casual. It makes the conversation clearer.
Weight loss can improve metabolic health and, for some men, may support healthier testosterone dynamics. But rapid weight loss can also threaten lean mass if nutrition and resistance training are neglected. The outcome depends on the whole protocol, not the medication alone.
"When we talk about peptides, that could mean any number of things." — Dr. Alex Tatem
"You are really taking that risk into your own hands as a patient." — Dr. Kevin Campbell
Ask for the evidence level. Human clinical data, animal research, and anecdote are not interchangeable.
Clarify the source. Prescription oversight, accredited compounding, and research-use products carry different safety profiles.
Protect the foundation. Sleep, training, nutrition, and recovery remain the strongest first-line protocol for resilience.
Peptides may become a more precise part of medicine over time. For now, the most grounded approach is informed patience: respect the promise, respect the unknowns, and refuse shortcuts that make the body carry the cost of poor evidence.
