transcript

Speaker 1:
[00:00] Here's something that will surprise you. The compounds being sold right now as peptide therapies for healing, for performance, for longevity. Most of them carry a label that says, for research purposes only, not for human use. And yet people are injecting these anyway by the millions. Today, I'm talking to someone who understands better than almost anyone, what that label actually means, and what it means that we're ignoring it. Dr. Leigh Baxt has a Ph.D. in Microbiology and Immunology from Stanford, and she leads drug development at Memorial Sloan Kettering Cancer Center. She is by no means anti-peptide, but she does have questions, and so should we. With that, please enjoy my conversation with Dr. Leigh Baxt. You've been pretty vocal recently on social media about all things peptides. At a high level here, to begin this conversation, what's going on, what's concerning you? Why did you take to social media to share some of your thoughts?

Speaker 2:
[01:09] Well, I think a little background on kind of why I'm even on social media in the first place would help. I'm a mid-40s mom of two, I'm a scientist. My parents were a scientist and a doctor. They're both retired. My husband is a scientist. So this is very much a world that I've grown up in. And I've never seen anything happen in this world like is happening now. I've never been through political administration that impacted my life and the way this has. Last year alone, my husband had four out of his five NIH grants frozen or canceled. My not- the not-for-profit I worked at was actually shut down. I was able to find a new role. I was very lucky. But those types of things are just causing this kind of dystopian, like existential crisis in science. I've never seen anything like it. I think as scientists, we have a responsibility to explain science in a way that's accessible to everyone. Instead of reading depressing articles or seeing things every day, I thought it was a better use of my time to use what little free time I have to try to educate. Because I do teach as part of my job, and I think I work in a particular niche that's unique and I have something to offer. Even within the scientific community, there's a lack of understanding about how we really make new medicines and I've learned that process from people who've worked on a lot of drugs that are on the market. I don't work in pharma. I don't have any financial ties to pharma. It's just a process that I really enjoy and want to tell people more about. The reason it's relevant in the peptide craze we're seeing is that there seems to be this thought process that peptides are like this new invention and this incredible thing, but all a peptide is is a description. It's just a small piece of protein. You get DNA, then you get mRNA, then you get protein. Well, you get peptides and those peptides are assembled into proteins. So it's not something new. We have lots of FDA approved drugs that are peptides. The peptides that I'm hearing about now are peptides that don't have a lot of human data. We don't have mechanistic understanding for how they work, and people are sourcing and injecting them, and importantly, they're also being marketed as having all these incredible properties that aren't supported by human data. That concerns me.

Speaker 1:
[03:09] Why does that concern or scare you?

Speaker 2:
[03:12] It scares me because when we make a new drug, there are times where we start with a target, there are times where we find a property of something that we like. But regardless of whether we start with the property or the target, there's a mechanistic understanding that you develop in the early preclinical stages of drug discovery, which is what I do. We understand what our target is that our molecule is interacting with, how it affects it, why that's important, and we have a whole process that we go through to understand something before we can assess whether it's safe or even going to have the effect we want in the disease. That process hasn't been done for most of these peptides. So they're promoting a lot of different pathways, pathways that are also often dysregulated in cancers. I'm not saying any of those peptides are going to give you cancer, of course. I like to have a better biological understanding of what I put in my body.

Speaker 1:
[04:02] You said that you don't work for Big Pharma, but you are involved in drug development. So for someone who's confused, that thinks drug development is kind of the same thing as Big Pharma, and it is the pharmaceutical industries, the companies that are doing drug development. Can you help clarify that?

Speaker 2:
[04:23] Yeah. So I actually work in a sort of a unique role. The group that I work in is almost like a biotech that's embedded within academia. So I worked at a not-for-profit that was recently shut down. Now I work for a smaller group of that same, it's a subset of that original group doing the same type of work. What we do is work with academic researchers, who are the experts on all these different biological pathways. I focus predominantly on oncology now, but I've worked across many disease areas. So we work with the scientists who are the leaders in each of these biological areas, and they have ideas for new medicines. But because they're basic scientists who spent their careers studying biology, they don't know how to make a medicine. So they need people who actually understand that process. We help them move from the basic science into the first steps of developing a new medicine.

Speaker 1:
[05:09] And what were your particular, I guess, academic qualifications? What did you study to become an expert in that?

Speaker 2:
[05:18] So actually, it isn't my training that has given me the expertise. I think that the training you go through in science, when you get a PhD and you do a postdoc. So you spend, you know, you need an undergraduate degree in biology. So I went to Brown. I did research every summer. I spent my whole senior year doing research. I went to Stanford for a PhD in microbiology, because that's something I love and I have a lot of background in. I also did a postdoc, which is another five years of training in that. So I spent, you know, more than a decade doing primary research myself at the bench, in the lab, designing experiments, running and analyzing them. That skill set is what you need to learn in grad school and postdoc. You can apply it to any area you want. And what I love about what I do is that it's not asking the biological question. It's actually more like assembling a puzzle, understanding which pieces need to happen in which order to take somebody from an idea to a potential drug.

Speaker 1:
[06:10] We'll come back to what that drug development process looks like. One thing that you and I bonded over when we were going back and forth was a willingness to say, I don't know. And for our listeners here, I think it's important to understand where your expertise in peptides lies, and where's the edge? Where does it not extend to?

Speaker 2:
[06:31] So I'll be the first to tell you, I am not a peptide expert. I do not work on peptide therapeutics. I work predominantly on small molecules, and I work on biologics, which are the two sides. Peptides actually fall right in the middle. It's kind of a unique area. That being said, the process that you need to go through to go from an idea to a drug, is the set is, it's not identical, but it's very similar across different drug modalities, whether those are small molecule chemicals like ibuprofen or a GLP-1 agonist, which is a peptide.

Speaker 1:
[07:00] And you just alluded to this, but I just want to make this clear for our audience. When we spoke, you said that these compounds, they may turn out to be amazing. We just don't have the necessary data to say that. So would it be accurate to say that overall, your position towards peptides or feelings towards peptides is pro-evidence? It's not anti-peptide as such.

Speaker 2:
[07:26] I would say that I'm neither pro nor anti-peptide. I'm not pro-peptide for myself. I'm not using them. I don't have any plans to use them. I think if people would like to use things like this, that they should be able to do whatever they want, as long as things are being sourced according to whatever regulatory guidelines exist, and people are being careful about what they're using, making sure it is in fact what's supposed to be in the vial. They may be amazing. I guess we don't have the data yet. We don't have the data. So I wouldn't say that I'm for or against. I just believe in the process of understanding the biology behind something before we use it as a therapeutic.

Speaker 1:
[08:01] And just to be really clear here, there's a distinction between peptides like GLP-1 receptor agonists that people may be hearing about that have gone through a regulatory process versus some of these other peptides in the wellness community that are currently, I guess, sold underneath this kind of for research purposes only label peptides like BPC-157 or CJC or ipamerelin. These are peptides that people may have heard of. So can you just underscore that distinction again?

Speaker 2:
[08:36] So I would actually give, I'd say, almost three different classes. There are the FDA-approved drugs. Those would be things like the GLP-1 agonists. There are other medications that are peptides. Insulin is technically a peptide. Then there's sort of this class of people making copies of the GLP-1 agonists and selling those on the gray market, which I'd put in kind of like a middle bin. And then there are these for research use only peptides that don't have, I won't say they don't have human data. Some of them have very minimal human data. They don't have a drug development process that has occurred for them. They have not been mapped molecularly to understand what the target is, what the process they're causing to be perturbed is. And we don't know exactly what they do in a body. And we don't have human data. All of the claims you see are largely based on cellular and animal studies.

Speaker 1:
[09:27] Okay, so let's say I come to you with a peptide that I'm interested in. And I say to you, I want to get this drug approved, such that doctors across America can prescribe it to patients. What does that process look like?

Speaker 2:
[09:44] So I work at the beginning of what's usually, I don't know, a 10 to 15 year process, depending on what drug modality you're working in. I work in the first maybe two to three years of that process. So we go from the idea up to intellectual property, ideally a patent as well as animal proof of concept data. After that, you still have another probably three years of preclinical development before you can even apply for permission to go into clinical trials in humans, which is like an IND application. If you work in small molecules, for example, after you get that IND, that would give you the permission to go into clinical trials, to do phases one, two and three, followed by applying for FDA approval. If you look at the entire continuum from I have an idea to an approved drug, more than 99% of ideas fail. I've worked on, I don't know, probably 60 targets in the last 10 years and I've seen like maybe five that might make it into the clinic. And that doesn't mean make it to the market, that just means make it to the clinic. And these are for things like cancer. So if you work on this process from the inside and you understand just how complicated and challenging it is, it seems amazing that we can even make medicines from my perspective. So the idea of taking something that hasn't gone through any of that process, that we really only have basic research on, that hasn't followed any of those regulatory standards, the idea of putting that into my body is scary.

Speaker 1:
[11:07] So what's happening here, particularly when there might be a signal, let's say in basic research in animal studies or in cell studies, why are these compounds, these drugs not making their way through all the way to the end of this drug development process?

Speaker 2:
[11:23] There's a lot of ways that drugs can fail. Because I work in the early stage, I see a particular type of failure or different types of failure that you see if you work in the clinical stages. They can fail because the biological hypothesis doesn't hold up when you actually have a molecule to test what you want to inhibit. A lot of times when we validate drug targets, that's using genetics where we actually delete the gene and that often does not behave the same way as if you inhibit the protein that gene makes. The genetics doesn't always match what we call pharmacology. There can also be issues where you don't translate to humans. For people working in oncology, the joke is that we've cured tons of mice of cancer, but not all of those cancers are curable in humans yet because animal models don't always translate to humans. I'm sure you've heard there's a lot of pushes towards trying to bring in more non-animal models into the drug development process and rely less heavily on animal-based research.

Speaker 1:
[12:16] Is the final part of this process, when you say approval, is FDA approval, is that what we're talking about here?

Speaker 2:
[12:25] Okay.

Speaker 1:
[12:25] Which means that that drug has gone through the basic science, then gone into these different phases of human clinical trials. Overall, that tells us that we understand the efficacy and the safety, the risks associated with this compound for a specific population of people. Therefore, through that knowledge, we can approve it as something that doctors can prescribe.

Speaker 2:
[12:52] Yeah. We understand the risk benefit. We understand what risk it poses, what benefit it can bring, and whether that risk benefit ratio is appropriate to the population in question. So something that's a cancer medication for someone with a fatal cancer is going to have a different kind of risk benefit tolerance than something that's being given to healthy people.

Speaker 1:
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Speaker 2:
[15:58] Frustrated, worried for people. I don't think, we have such an issue with trust right now, trust in science, trust in medicine for a large variety of reasons. But things like that, which I think are somewhat disingenuous, not saying what data does or doesn't support a claim that you're making, I don't think that helps the situation. You're trying to sell something. You have a financial incentive to sell that product. So of course, you want to make it sound appealing. If you come to me and you say, oh, you're in your mid-40s, you're probably starting to hit perimenopause, you're probably tired, maybe it's hard to feel as active as you used to, maybe your hair is thinning, I have these peptides that you can take and they're going to help all of that. They're going to give you more energy. You're going to feel like you're 30. And all you need to do is pay $300 a month and we're going to send you these vials and you can inject it yourself at home and it's totally safe and it has all these incredible properties. Oh, by the way, they have to save for research use only because they haven't been tested in humans for that. They're not FDA approved drugs. There's always a legal disclaimer. That scares me. Like the fact that so many people are looking for help for different situations, whether they have, you know, I've been working on a series with Unbiased Science on autoimmune diseases. My mom has an autoimmune disease as does my aunt. It's something that I've learned a lot about over the years. A lot of these kinds of diseases takes so many years to get diagnosed because they are so complicated and they don't have a single diagnostic test that you can take on its own and say, yes, you have this disease. So there's a lot of people who feel like they're not listened to by their doctors or they're ignored by the medical ecosystem and they're looking for other help, which I completely understand. Certain populations, parents, people in the fitness industry, women going through menopause, there's so many populations you can target. And as a woman who is in that perimenopausal space with a mom who's got an autoimmune disease, and I'm a parent too, seeing that type of marketing, understanding that what data does and doesn't exist just makes me scared for the people who are going to buy those things and use them.

Speaker 1:
[18:04] There's been a recent news story in the United States around the categorization of these peptides and a recategorization. An RFK junior has come out and he mentioned on Joe Rogan a while back that he uses these and has had some terrific results.

Speaker 2:
[18:23] Yeah.

Speaker 1:
[18:25] And that's something we hear a lot of people say, so we might come back to that idea of the anecdote. But on the recategorization, I looked into this and my understanding is that the proposal is to move these from a Category 2, which means they're prohibited from compounding to Category 1, which means that eligible compounding pharmacies would be able to make these peptides. But they still don't require the full approval process that you're describing of going through Phase 1, Phase 2, Phase 3 trials. So I read these articles and a lot of people are sharing them to me, a lot of my friends saying, look at this, wow, this must mean there's a lot of evidence behind peptides. And I think that it's important for people to not conflate or misunderstand what this change actually represents. It doesn't represent all of a sudden, there's a huge amount of this human data, right, that all of a sudden exists out of nowhere.

Speaker 2:
[19:24] So I'll be the first to tell you that I am not a regulatory expert, that is not my space, intellectual property regulatory, that's not me. To do the job that I do, I need to have an understanding of at a high level of processes from end to end when it comes to making drugs. So I have a peripheral understanding of this, but I would never call myself an expert. The way I understand it is that the classification would make these basically exempt from sort of the FDA approval drug pathway, by classifying them as something different. There isn't new data. It's not like all of a sudden someone went out there, invested billions of dollars and did randomized human clinical trials for these. The designation they're giving them is not an FDA approved drug. It's something that's allowed to be compounded by pharmacies, and I think a doctor can prescribe it if they feel that it's indicated. The thing I don't understand is that doctors have malpractice insurance. I don't know how a doctor prescribes something that isn't a drug, and then what if it has a negative effect? Who's liable? Is it the doctor? Is it the compounding pharmacy? Do you have to sign a waiver? I don't know how that process would work, but it definitely is just a reclassification of something. It's not an indication that we've now gone and generated this data.

Speaker 1:
[20:35] It seems very confusing to me, and if I was to try and steal manner and think about someone here from the wellness industry, that's very pro-peptides what they might say, is that at least one benefit is that now you'll have these compounds under the control of pharmacists, making them as opposed to a gray market, where right now, quite frankly, a lot of Americans, Australians, anyone buying these on the internet, you're sourcing these from God knows where.

Speaker 2:
[21:04] Yeah, absolutely. I do think the little reading I've done on this topic, it sounds like what they're moving toward is an evaluation of the use of the peptide for specific medical conditions. They would be used therapeutically, but for a specific purpose and they have to demonstrate some kind of utility for that. The burden of data that they need to provide is not anywhere near what we would have for an FDA-approved drug, so let's be clear about that. But there's at least like, you need this to treat that, as opposed to like, there are no peptides where they're saying, we're going to test this for longevity or for wellness, or for increased energy. You know, the things that I've seen listed are like specific, like ulcerative colitis and specific medical indications. So sourcing them more responsibly, that's good. Having some level of data that you need to provide for some particular indication, also good. Making sure people are not taking some, you know, tainted vial, like I saw something shared by a clinician the other day. There's a bacteria related to tuberculosis called mycobacterium abscessus, and it can cause these horrific skin infections that are really hard to treat. And it was someone who had been injecting peptides into their leg muscle and got an abscessus infection and had this horrific like sore. We don't want that, right? So the safety aspect is good. I think people are going to use these peptides kind of whether we like it or not, you know, it's not my decision if they want to use it. I have no problem if people want to experiment on themselves. I just think people need to be informed about what they're actually getting. So when you're targeting someone with marketing and they don't know what data actually is out there, yeah, that's where it gets shady for me.

Speaker 1:
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Speaker 2:
[25:57] I think rather than giving you specific risks, what I'd like to do is kind of talk you through the chain that we think about when we think about developing a drug in terms of molecular understanding. So we have a target, a drug target. We have the thing that's interacting with that target, which causes some downstream effect, which we understand. That effect can be measured in an animal model with something we call biomarkers. So I can take my peptide, small molecule, whatever, dose an animal with it, and then I can look at the blood levels of that item and the effect in the animal and draw something called a PKPD relationship. That's pharmacokinetic, pharmacodynamic. Seeing that relationship tells me that when I give more of it, I have more of an effect. You can track everything from binding to a receptor all the way into seeing molecular mechanisms in animal proof of concept studies. We don't have that for this. So GLP-1s went through these processes. We understand exactly what molecular pathways are being affected. And yet with these GLP-1s that are already approved on the market and being used by millions of people, we're seeing things that we had no idea would be beneficial. There was an article, I think it was in The New York Times this week, where there was a woman with alopecia who was able to grow her hair back from GLP-1s, someone with a traumatic brain injury who had relief from these chronic migraines from GLP-1s. They weren't developed for that. So who knows what other benefits we'll find long-term, and they may be benefits, but there may also be long-term risks. And that's for a drug that went through the process. So when you're considering injecting something that we don't even understand the molecular pathways that it is affecting, what target it's binding or anything else, it's pretty much impossible to quantify the benefit or the risk. And a lot of the pathways that you see being induced are things like cell proliferation and angiogenesis, which is the growth of blood vessels. They're pathways that are often upregulated in cancers. If you had some predisposition that you didn't know about, like you could be lighting a fire under it.

Speaker 1:
[28:00] I think a couple of the pushbacks here from people, or things maybe that they've heard elsewhere, that they think, okay, I hope that they comment on this. The first one would be that, well, I've heard that a lot of these peptides are actually natural compounds. Your body is already producing them, so how can they actually be harmful?

Speaker 2:
[28:21] There's something we call the appeal to nature fallacy, which is the idea that anything natural must be safe, and this idea that these peptides are made in your body, so they must be safe, except a lot of these peptides are not actually made in your body in that exact form. BPC157 is a fragment of a larger peptide that does get produced in your body, but there is no BPC157 peptide of that sequence that gets produced in your body. The same for TB500, it's a piece of a smaller peptide. There's tons of research in the TB500 space, the parent peptide it comes from, this thymus and beta-4, there's lots of research on that, solid research from lots of different groups, but they're studying the full thing, they're not studying this fragment, so we don't have that PKPD relationship, where we can track molecular pathways for that fragment. For something like BPC 157, the research is coming from a really small number of groups in one very specific area, so you don't see scientific consensus from around the world where people are reproducing results, which is one of the things we always look for when we're thinking about a new therapeutic research project. How widely reproducible is this result? Do you see a lot of different experts who can reproduce the same findings? Are there lots of different animal models where you see similar doses having similar effects? Do you see a dose-response relationship? So when I give an animal a larger dose, do I see a larger effect? These are all types of things that we would look for, and in the absence of those, it would raise red flags when you would consider investing in developing something like that.

Speaker 1:
[29:53] The other pushback that someone might have here is, I hear what you're saying. However, these peptides have been around for 20, 30 years, and nobody is investing to do the studies that you're talking about. So right now I have whatever health issue it is, X, Y, Z. As you mentioned before, there are limits of the current medical system, and there are many people that are searching for answers and feel like they haven't got that answer, and they're living with pain or some type of condition, and they want resolution, reprieve, and I think that's understandable. And they hear this conversation, and they think, yeah, this is easy for you to say, but those studies are not coming down the pipeline, and they've heard that pharma, big pharma, is not going to research these peptides, these natural compounds, because they can't be patented, they can't be protected, and as a result, there's no money in it, so it never gets studied.

Speaker 2:
[30:49] This is actually pretty related to one of the videos I made that's got a lot of comments, kept me pretty busy. So patenting, there is, I am not a patent attorney, I do not do IP patenting. The space I work in, though, is generating intellectual property, and so discussing with patent strategists how we're going to patent, when we're going to patent, and what we're going to patent, is part of what I do. So it's something that I talk about a lot with people and understand the strategic aspects of it. The idea of finding a way to patent something is not generally challenging for the pharmaceutical industry. So when you take one of these naturally occurring peptides, except that they're not really naturally occurring, so we've established that, you take one of these, let's say, somewhat natural peptides, the properties of that peptide may not be suitable to be a drug. Most starting points, whether that's something you found in nature or in a molecular screen, most of those things are not going to be drugs. They require modification because they either get eliminated from your body too quickly, they break down because they're not stable, they're not potent enough against the target because all these receptors you want to bind to are you're competing with whatever's already in the body. You need something that might be even better at binding. You have to make modifications to improve these, to give them what we call more drug-like properties. That might mean extending how long they stay in your blood, helping them get to the tissues they need to get to. Peptides have to be injected. We now have an orally available GLP-1 that I think is getting approved. We had to develop a special technology to allow that to actually get through the intestinal cells because peptides by themselves are generally not cell-permeable. They can't just diffuse into your tissues. All of these steps you go through when you have to optimize something, whether that's a small molecule, a peptide, or biologic, result in changes. As long as those changes follow certain parameters that are set by the patent law space, you can then patent them. I haven't seen a huge amount of super-concerning safety signals in the data. A lot of people bring that up, that it seems like it's mostly beneficial and positive data, which seems to be the case. I have not read this entire body of literature, but some of the other things I brought up would be things that would raise a red flag. If you see the research only coming from a couple of research groups in one specific area, and you don't see this being widely recapitulated that there isn't a scientific consensus on it, that would be a concern. Some of the studies, you don't see these dose-responsive relationships in animal models or you don't see that the same dose gives you a similar result in different types of animal models, and the lack of molecular mechanism, and these very generalized biological growth pathways and things that you're inducing. All of those to me would be red flags if I were considering whether I should start working on this.

Speaker 1:
[33:40] What's the threshold of evidence at animal study level with regards to a new compound? If we're talking about a compound and determining if it's safe, are we just talking about short studies that are looking at toxicity, or do you have to run the studies long enough to look at actual hard outcomes? Do those mice develop disease? Are they living longer or shorter lives?

Speaker 2:
[34:05] The area that you're referring to is what we call IND enabling studies. And those are, so I'm going to pick specifically the small molecule space because it's easier to explain. And it's also the area that I have more familiarity with. But the IND enabling studies are a specific repertoire of tests that you have to do in order to check all these boxes to be allowed to apply for permission to go into humans. Those studies largely fall into two categories, a safety pharmacology and safety toxicology. And from a non-scientific standpoint, what you look at is, if I give animals, and it's not just mice, you often have to do a rodent and a non-rodent, and you have to follow specific laboratory practices. We actually have a whole group where I work that this is what they do. This is their specialty, coordinating these studies to write an IND. You give sort of what the therapeutic dose would be, chronically, for a long period of time, and you look for any adverse events. Or you give, and that's the safety pharmacology. You also do safety toxicology, where you're giving more and more and more of it, or very high doses for a shorter period of time, and seeing sort of how far you can push the system before something bad happens.

Speaker 1:
[35:12] Okay, so it's kind of a combination of the two. The other bit of pushback that I think someone may have here, and I think you've covered it, is, and I've heard this from a few people, is this idea that the FDA is actually protecting big pharma by not approving these cheaper natural peptides. But based on our conversation today, it seems to me that the FDA is not approving them because the research is not there.

Speaker 2:
[35:37] I don't think they're going to the FDA to ask for approval. They would have to have gone through all of the preclinical development, filed an IND, registered human clinical trials, etc. If they were even at the point to apply for approval, and something that a lot of people don't know, with clinical trials, you actually have to register them through clinicaltrials.gov. So if there's something that you're interested in and you want to know if there are clinical trials, you can look it up. It's publicly available and you can see if the trial is registered, it's recruiting, where it is.

Speaker 1:
[36:06] What would you say to someone who is of the position that these peptides have been used now for decades really? I believe the bodybuilding industry, fitness industry, which is often the case, is often using these compounds first, perhaps a higher appetite for risk. And then I think the general public see those people and say, hey, they look healthy, so these must be good for you. So it ends up trickling out and influencing everyone. But if they had the view that, hey, these have been used for decades, guys, we would know if these were dangerous by now.

Speaker 2:
[36:43] How would we know? Who's tracking it? Yeah.

Speaker 1:
[36:47] I mean, it seems like an obvious answer, right?

Speaker 2:
[36:50] Who's tracking it? The other thing that people don't usually understand. So there's lots of anecdotal data on tons of things. I've had tons of people come to my videos and say, well, I use this, this and this, and I feel amazing. You know, I was hitting menopause and I started this and now I feel 30. And I'm like, I'm happy for you. I'm glad that you've had a positive result from this. I'm glad that you feel it's helping you. That's your choice. I just don't want people to think that they're getting something they're not. You know what I mean? If you have a good experience and you want to experiment on yourself and you're willing to take that level of risk, that's totally fine. I personally am not willing to take that level of risk. And yes, if people are using them for years and years and years and we don't see anything bad happening, that's great. But there are always confounding variables. So when you do randomized human clinical studies, you need to know that all of the demographics are similar between the people that you're testing and that they get randomized into a treatment and a control group. You're mentioning like the fitness industry, right? So you're taking a group of people who might be using these, but those are probably already people who exercise a lot. They're not overweight. They probably don't have, you know, type two diabetes or whatever other chronic health conditions because they're using, you know, they're building their physique as part of their brand. So it's already a specific demographic. So you can't really use that type of anecdotal data to extrapolate recommendations for like a general population.

Speaker 1:
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Speaker 2:
[41:17] That's exactly what it is. At least if I want to consider taking a GLP-1, which I'm not considering it, I don't think there's any reason I would need it. But if I were considering it, I would say, oh, well, I know that it can cause some muscle loss or bone density decrease. There are known risks because we've established them in the development process. That's part of what we do. We understand what risks are. We also establish a therapeutic index. What amount of this is safe and what amount of it will cause some dangerous effects? What margin do I have to play in here? For these things, we don't know what the dose is, how often it should be, we don't know the pathways we're effecting. There's so many unknowns that it really is just an unknown risk. If people want to take that risk, I'm not judging, you'd want to take a risk for yourself, that's totally fine, it's your choice.

Speaker 1:
[42:09] What would you do if you had a debilitating shoulder injury? Let's say you'd been doing six months of rehab, surgery wasn't an option, physio was throwing everything at it, super compliant, doing everything you'd been told, not getting better, you were struggling with doing things around the home, struggling with whatever recreational sport you enjoyed, and then someone on the internet sends you BPC 157, a link to that and says this helped me so much. How would you then in that situation approach this?

Speaker 2:
[42:42] If I didn't do what I do for a living, I might consider taking it. I completely understand why people do that. In my own personal life, what I would do is probably go to whoever the leader is in that particular kind of injury, see what they recommend and try that. If they recommend those peptides to me, I would want to see the data, and I don't think they would recommend it because they wouldn't have randomized human clinical trial data and there's no FDA approval. So yeah, I would rely on the people who are the experts. I know we're in this age where nobody likes expertise anymore and we all think for whatever reason that it's not good, but I don't know. It takes so long to build expertise, even in one specific area, that to me, someone who has an expertise of like 40, like the person who did my knee surgery a couple of years ago, he works at Hospital for Special Surgery. They have incredible surgeons and he treats NFL players. So whatever he wanted to do to my knee, knowing that I'm just like a normal mom who's got a job, I trust his judgment because look who he takes care of. He knows what he's doing.

Speaker 1:
[43:45] I think the difficulty is that, particularly on social media, it's become harder and harder for people, particularly without a background in science, to determine who are the true experts.

Speaker 2:
[43:59] Absolutely. You also have a lot of people. There's a variety of things that you see on social media, which is part of the reason I put myself there. It's also part of the reason I ended up adding my name and stuff to my account. I didn't have it there originally because I have a lot of friends who are women science communicators, and I see some of the messages and threats they get, and it can be really scary. But I think credibility is really important, and knowing exactly what someone's expertise is and isn't. And you see people who are calling themselves experts on something who don't have any educational or professional experience in it. That's like one bucket. You have people who are saying they're doctors, who aren't doctors, which is pretty much illegal. But then you have people who are actually experts, except they're kind of talking about things that I would say are outside their lane. So I saw a plastic surgeon who kept posting about sunscreens and all these risks about sunscreens, which I had seen debunked by someone who's a cosmetic chemist, who literally is definitely an expert in that. I was like, you should check out their stuff. So it's a hard thing because you want to educate and you want to provide information, but I do think it's really important that we stay in our lanes, which is why when you asked me, what about the regulatory things and what about this and what about that? I know some about those things, but that is not my expertise. So for some of the stuff, I don't mind saying I don't know. Yeah.

Speaker 1:
[45:19] I think that we can all be more discerning and not just accept the information we see on social media, at face value and something that I've found helpful is using AI to basically vet certain claims that are on social media, but doing it in a way where you're prompting it and saying that you want this reviewed through an evidence-based lens. You want to understand human clinical control data, the risks, the benefits, everything, in order to make the most objective, evidence-based, rational decision. I think that is a tool that can help people mine through this misinformation on social media.

Speaker 2:
[46:00] Absolutely. I've definitely done that. I'm a huge fan of using AI. I will say that I like Chat GPT. I made my own little account and I always use that one because they learn over time. So it knows what my job is. It knows what resources I consider acceptable and not acceptable, and that I always want references. So I'll ask it questions and it will now give me exactly the kind of answers I want. But it's really important what you ask. If you put in a biased skewed prompt, you're going to get a different answer. You have to ask in a specific way.

Speaker 1:
[46:35] OK, great. Thank you so much for joining me today, and thank you for jumping on social media and putting yourself out there. I think you're doing a great service in bringing clarity to this important topic of peptides and drug development. Was there anything that you really wanted to communicate today that we haven't got to, or anything that you kind of wanted to sign off with here?

Speaker 2:
[46:58] I think one of the things that's important to understand is that when it comes to making drugs, every step of that process is like incredibly challenging and incredibly complicated. And there's probably no one out there who's an expert on every single step of that process, even if you've done it for like 30 years. So all scientific understanding and developing medicines, all of this, it always takes a community. It takes people doing the basic research who have the understanding of the biology, and it takes people who understand how to do each step of the process to get that into patients and improve lives. It's not one person. None of this is being done by one person. It's always a multi-disciplinary collaborative group that's gonna be hundreds of people. So the idea of having one expert who you can consult to get answers on all these things is just not feasible.

Speaker 1:
[47:48] Thank you very much. It's been a pleasure.

Speaker 2:
[47:52] Thank you.

Speaker 1:
[47:53] There you have it friends. I hope you enjoyed this episode. If you did and want to stay up to date with future episodes, be sure to hit that subscribe button on YouTube and follow on Apple or Spotify. Finally, thank you for showing up and the effort that you're making to take control of your health. I look forward to hanging out with you again in the next episode.