The FDA has proposed shutting down 503B compounding pharmacies' mass production of GLP-1 medications (semaglutide, tirzepatide, and liraglutide), which were previously used to address drug shortages and provide affordable, customizable dosing options. This regulatory shift, combined with the FDA's placement of various peptides on a Category 2 'do not compound' list since September 2023, has created significant uncertainty in the peptide and GLP-1 landscape. Patients currently using compounded GLP-1s should develop alternative access plans, as the era of easily accessible compounded versions appears to be ending. The FDA is currently investigating 12 peptides that were previously on the Category 2 list, with potential approval outcomes expected by July.
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GLP-1s + Peptides Are Changing Fast, Here’s What You Need To Know | SoloAdded:
You are tuned in to the Dr. Tina Show with Dr. Tina Moore. For more, visit drtina.com.
On this episode of the Dr. Tina Show, it is time to give you guys an all things peptides update. There has been a lot going on in the last few weeks, in the last few years actually. And I have not given a really good update to you in a long time. And I wanted to because I'm getting a ton of messages from you guys, a ton of emails and DMs like what's going on? What's happening with Compounded? A lot of people are freaked out. So, I'm going to tell it to you as I know it. I do not have any behind the-scenes insider scoop, although I know a lot of people in the space on all sides and I've been checking in and hearing what's happening and I wanted to make sure that I gave you guys to the best of my ability the most updated information. Obviously, you know, things are going to change, things are changing by the day, but per my resources, this is where we're at and I wanted to lay it all down for you.
So, let's jump in. Okay, so we're going to start with the GLP-1 situation.
What's going on there? There was a letter that came out, I think it was April 30th, and the FD it said that the FDA is proposing to shut down mass production or 503b production of semaglutide, tzepide, and luraglutide.
Luraglutide is an older generation one.
That one came off of patent so I don't know like there's generic available now.
I have no idea why that would be pulled, but I guess that's part of the package.
Um, and I'm not laying judgment at all on either side. I think modern medicine is a complete shitow. And I think that the patient is the one that pays the price and the patient is the one that suffers in all of this happening. So, you guys all know my thoughts on big pharma, but you know, here we are. I will say without big pharma, my mom would be dead. She she almost died last month. It was terrible. Go back and look at a few episodes ago. My face is like heavy heavy with grief. It was really really rough. She's alive and well. And I I'll just pause here. I talked to her today and she wanted uh God it was rough. I have PTSD from the whole thing. Um, she wanted me to thank you guys because I asked for everybody to pray for her and everybody did and I got a ton of messages on at least in my DMs on Instagram that I could see of people saying they were praying for her and it worked because she shouldn't be here after what happened like is from what she went through like she shouldn't have made it and she did. So, thank you from me from my mom. It was it was rough. So, um, anyway, here we are. And so, this letter comes out in the middle of all that. I was in the middle of all of it.
So, I just wasn't paying much attention because I was like in the throws of trying to keep my mom alive and and and get her out of the hospital and get her home and then, you know, get her reestablished in in the world. And this letter comes out and says that they're proposing to shut down 503b production.
So, what does that mean? 503barmacies are compoundingarmacies that were established, I believe, during the Obama administration. It was somewhere, oh gosh, I don't know. I was several years into clinical practice using a lot of injectables in my clinic and it was a real wrench because before this establishment we were able to have anything that we needed compounded and we were able to bring it into the clinic and use it on whomever we needed to use it on before it expired and we had to throw it away. Once the establishment of the 503b and the 503A pharmacy I'll explain what these are in a minute. Once that happened, what happened was if you wanted to get some of these substances depending on what the FDA determined um was going to be 503A or 503b, you had to then prescribe it for a patient specifically and you could only use that vial on that patient. So let's use B12 for instance.
Methylcobalamine, a particular form of B12, you could not you could no longer carry that in your clinic to be used on all your patients. you had to prescribe that vial to a patient and only use it on that patient and it might expire.
They may not use it up in time. Maybe they would have to transport it back and forth to your clinic for you to use it.
Maybe um you know, it just got messy. It was a pain in the butt for everybody.
But whatever whatever the rules are, the rules are, right? We we play the game.
So what was happening with GLP1s was they were truly on shortage. Big pharma, who makes them, could not keep up with production and demand. And so they were on the shortage list. And when they were put on the shortage list, 503b was able to step in and massroduce them in bulk.
That is what 503b was established for.
It was put in place to be able to pick up the pace if there was a drug shortage of any sort. And for the time that that drug shortage was occurring, 503barmacies could massroduce whatever it was, whatever that medication was.
And so that's what they were doing. And I won't get into my feelings about what has cropped up from that. I mean, I am so grateful that we have compounded options, but because of the readily availability of these GLP1s, you know, we saw a lot of very prudent, responsible physicians using them like myself. We were able to provide them for our patients at a very low cost comparative to the brand name. We were able to individualize and personalize dosing because they were coming in a vial form which you couldn't do at the time because the only way to get the brand name at the time was in a pen and they were predetermined doses. And so uh my micro doing strategy that I introduced to the world in 2023 a true micro doing strategy not a pseudo micro doing strategy that most people are doing which is just using the lowest standard dose of the medication and calling it a micro dose. I was truly using fractions of the standard starting dose. Um, if you want to know more about that, I won't go into it here, but I broke it all down on my Substack. So, you can head over to Substack. It's drtina.substack.com.
Come subscribe over there. That's where I can I love writing. That's where I can really dive into certain topics that I may not necessarily be talking about on the podcast. And um, that's where you're going to find a lot of my updates on GLP1's.
Not necessarily keeping up as a journalist, but I want to put my thoughts down there. So, follow me over there. Anyway, we could individualize dose which we couldn't do with a pen and that was very exciting. However, we had med spas dispensing it. We had tele medicine companies pop up. Billiondoll industry has popped up, you know, virtually overnight. Some of these tele medicine companies are not doing their due diligence. They're not being responsible. I mean, people could access them anywhere anyhow. And I'm not even talking about the gray market uh research only peptides. I'm talking truly getting prescribed very easily in some cases just answering a questionnaire online, not even talking to a doctor and people were getting prescriptions for GLP1s. I think that's ridiculous. That's this this stuff can be very dangerous if you're not carefully monitoring things and it can get away from you. I've heard many stories. I've heard of people who were using their thinking they were using a different peptide and ending up using massive doses of GLP1s and getting really sick from them. Um, my doctor friends and nurse friends who work in the ER have told me that the vast majority the vast majority of GLP-1 issues that they're seeing in the ER are coming from people using compounded because at the end of the day, people are not very good at math. And even the doctors that I've worked with, um, I've spent I've spent a lot of years training doctors in injection therapy. I was doing regenerative injection therapy, but even getting doctors to understand milligrams per ml, like just the strength of what the vial says and then how much to pull up, and I'm talking like pretty benign substances.
We're talking over here with GLP-1s, like you pull up a little too much and it's a lot too much depending on the patient. You would not believe the amount of DMs I have gotten on Instagram and just text messages from friends and colleagues in the space who have just completely effed up the math. And so I get how people could mess things up with the compounded. I do. I understand that.
That is the job of the physician who can hopefully do math and figuring out h you know cuz these if they come from a compounded pharmacy they're already constituted meaning they're already liquid form and so figuring out the math on how to pull up the appropriate amount for that patient is the responsibility and duty of the physician and there are physicians getting it wrong. There was one case I heard about where a physician had a patient on 10 times the dose because they couldn't do math. So, it's shocking how many doctors can't do math that I have encountered. And I it's just if if you if you don't know what you're doing with it, you can get in trouble real fast is my point. So, a whole industry has cropped up that I think borderlines on dangerous and at the very least just not good medicine, not prudent medicine. And so a whole army of people are out there dispensing GLP-1s and patients are the ones on the receiving end kind of paying the price, not really knowing what they're doing. I get messages from people all the time asking me really detailed questions about their GLP1s and I can't answer them because I can't do internet medicine because it's not legal and it's not ethical and it's not prudent. But I'm shocked when I just punt back and say that's a great question for your doctor and they'll say I asked my doctor and this is like really basic stuff. So if you don't know what you're doing, don't be prescribing it. But because of how readily available they were because of the 503b mass production of them, because they were on the shortage list, they were everywhere and very accessible. Now there's 503AIE, and what those are more, think of the compoundingies where you're actually getting your medication from. Uh more of the mom and pop ones, you know, the ones that I'm used to using. I there was a variety of ones that I used in Portland when I was practicing there and you know these were sometimes bigger productions, sometimes smaller productions. Not all of them actually very few of them offered injectables but the these are the 503A. And so what does this mean? It means that couple years ago Nova Nordisk and Eli Liy came out and said that the shortage was over. That they had met production needs through their facilities. You know, the question is like how true is that? Because there's probably millions of prescriptions going out through compoundingies. Can they actually meet the need? And so they took their medications off the shortage list. When that happened, 503barmacies were supposed to cease and desist. They were supposed to stop producing them.
Well, some still continued and then there was a whole bunch of lawsuits.
There was like years of lawsuits.
There's been a ton of different lawsuits and I can't keep up with all of them and I haven't shared out about them because it was like total chaos. my friend Dave Knap uh on the pen is his handle. You can find him on Tik Tok and Instagram and YouTube and he's great. I've been on his podcast. He's been on mine. Uh he's an advocate for GLP1 and and an independent journalist and so he keeps up with all of that. So if you want that information, he's a great resource to follow. But I have just been sitting back because it seemed like it was like dayto-day a different story and like hour to hour it seemed like there, you know, it was going back and forth like ping pong. And so I was just sort of waiting to see how it all shook out. And I knew the FDA was going to get involved. And I have been telling my friends and colleagues like just you guys really should be looking for different resources for your GLP-1 patients because I think that the the time of the easily accessible compounded version is coming to an end. And everyone's like, "Oh, Tina, you're fearongering." I'm like, "No, for real.
Like you might want to look into other options because this it's not looking great." You know, I mean, I was just waiting for the FDA to come in and do this. And lo and behold, as of April 30th, the FDA sends out this letter.
What has happened since then is the three main big 503barmacies that were still mass- prodducing GLP-1 compounded, two of them have shut down their GLP-1 production. So that one is left. What does this mean for you if you're getting your medication through a compounded pharmacy or a compounded resource? It means that the burden now falls on the 503AIES and as I just said a lot of those are smaller mom and pop places. They don't actually do many of them don't actually do injectables in their facility. They were relying on the 503b facilities to produce the sterile clean compounded version and then they were buying those and dispensing them out of theiries. I believe that's how it was happening. And so I'm not a compounding pharmacist, but I believe that's how that access was happening. If you were a compounding pharmacy and you wanted to dispense injectables, you had to have like a whole facility to do injectables. It was a whole big process. And I will say just from my end as a physician and knowing many compounding pharmacists, um the witch hunt on them has been severe the entirety of my career. Like I have been watching them get witch hunted. really ramped up when the GLP1 thing was going on. And suddenly I was getting I've talked about this on the pod before. I was getting emails from all of my medical establishments that I subscribed to and it just seemed like daily suddenly there was just this smear campaign against all compounded medications. And that's a totally a topic for another day.
Man, I had no idea that doctors weren't using compoundingies. Like that is what I have been using for the entirety of my lensure. And then before that, I was working with my mentor for a decade and that's what he used for the for the bulk. I mean, if we can get something from a traditional pharmacy, of course, you know, if it's inexpensive, it's if it's accessible, of course, we're going to use a traditional pharmacy like your Walgreens or your CVS or whatever. But many medications, we might want to change the delivery format or we might want to change the dosage and make it more personalized and individualized. I mean, there's a lot of reasons why you would want to go to a compounding pharmacy. And that's the originalies, you guys. I mean, the originalies, they were making the medications back there in theiries and then dispensing them. You might want something different for a pediatric dose. You might want something different for a geriatric dose. A lot of PET medications come through compoundingies because you can change the delivery format to make sure that we can get it in the pet. We might do something topical, a troy, a sublingual, um, an injectable. You know, there's a lot of variation here and utility for a compounding pharmacy to exist, but that's neither here nor there. This is what's happening. And so, has it happened yet? No. But the FDA has proposed it. And the two big production facilities have shut down production. So, there's one left. And now we are probably going to see a huge, massive backlog. And I'm guessing a very different expense when it comes to what's going through the 503As because a lot of thesearmacies don't have the space or the setup to make injectables.
They were relying on supply through the 503bs. And so that's going to create a big mess. It's going to create a big bottleneck and a big mess. I think if you are on a compounded GLP-1, you might want to start talking to your doctor about what is the plan. What are you going to do? How are you going to access a different route?
Fortunately, big pharma has stepped in and they have different options out there and there's different ways to access these options out there. So, I'm going to go through a couple of them.
the week that I was deplatformed from Instagram, meaning I woke up and my Instagram account was gone and I tried to create a second one really quick so I could at least get through to you guys and that one was taken down within 36 hours. Um, and I apparently was banned from Instagram.
That same week, ironically, Eli Lily released Zepbound in a vial, which was interesting because my micro my true micro doing strategy relied on a vial form of a GLP-1 medication and you could up until that time you could only get that compounded.
So, I don't know. Isn't it ironic, as Alonas Moriceette would say, that the week that the vials were released, my account disappeared. I got it back. I got it back and was told that uh they definitely don't like me, the you know, the powers that be in the big pharma space. So, who knows how that went down.
I I got no warning. I got no um dings on my account. I I wasn't in any kind of trouble. And next thing I know, my account's gone. And I was like, "Huh, that's weird." And I was really careful on Instagram in particular. I've been really careful all along because I really don't think you guys should be playing with this stuff by yourself. And I think you should be working with somebody who knows what they're doing.
I'm sorry if there's not a lot of doctors who know what they're doing.
That is nothing I can change. Except I tried to educate people through my course. But even those doctors, some of them that have gone through the program, I see them online and they're touting like a pseudo micro doing too. They're telling you that the standard starting dose is a micro dose, which is not true at all. I was talking about a fraction of that and again go read my substack if you want to know my thoughts but we now have vile forms of GLP1s. So Novon Nordisk is in supposed to be at the beginning of this year was supposed to be releasing WGOi in a vial which is saglutide and then like I said in September of 2024 u Eli Liy released sebound which is Tzepide in a vial form.
So those are the way goi is not out yet but if you're on tzepetide you can access it via a vial and then they've also introduced to the United States the click pen which can allow you to individualize the dose a bit better meaning the other pens were like you got the dose you got and with the click pen you can actually change it a bit and those are all available through different formats so you can go Lily direct your doctor can prescribe through Lily direct is one way we've been doing it. You also can go through Trump RX, which is essentially just piggybacking off the Good RX platform. So, you don't have to, this is not about whether you hate or love Trump. Um, but that is one outlet to get your medication. I think that the pricing on that is much better than it had been. Trump did work with these companies, these big pharma companies to bring the cost down. And I think that that's admirable at the very least to try to make these more accessible to people. The Good RX option is out there as well. You can go through Good RX and I I even believe they have a questionnaire where they end up prescribing it. I don't know how that works exactly, but I've had a couple patients look into it. You can basically go to good RX and you can find the GLP-1 link and then you can go through a series of questions and I I believe that they might even be acting as the dispensing format which is you know again I have my thoughts on that and then uh Amazon is now in the game and I'm thinking at the end of the day Amazon's probably going to beat everybody on price. Who knows? I know a lot of the tele medicine companies I'm seeing are shifting from offering a compounded to having negotiated with Eli Liy and they're offering the Zbound vials. So there's options out there and I think that that still allows us to do a more personalized individualized dose regardless of what dose you're on and I think that's probably going to be your best bet as far as the most affordable bet. I think those are your options, which is not terribly great when in many cases we were able to get a vial of Turzetide for, you know, a couple hundred bucks. Now it's more like 450.
And if you don't, the way that it works is if you don't re-up that vial every 45 days, they jack the price up pretty significantly. So, I have several people in my circle who have three or four or five vials that are backing up in their refrigerator because they're accepting that monthly delivery or that every 45 days, I believe. So, go to Lily Direct and look it up. Go to Good RX and look it up. Go check out what your options are. Talk to your physician, but come up with a plan. I don't have all the details worked out on every single one of them because it's even many of my physician friends are a little bit confused right now, but we still have the ability to have something that's much more affordable than it was. It's not $1,000 a month anymore. It's not $1,200 a month. It's $400 and something dollars a month if you stay on that every 45 days at least at the very maximum. And then there's a couple different outlets to do it. So, I'll leave it at that. Okay. I think compounded GLP ones have seen their day.
I think if we try to hope for the best and hope that the 503As will be able to keep up with demand. I think that's a pipe dream and I don't think it's going to happen. I think cost is going to be a problem. Obviously, production is going to be a problem. People are going to be waiting potentially months and months and months and so we'll see. Whenever I talk to my compounding pharmacy friends, they are kind of vague and I think they're waiting to see how this shakes out too. Everybody's sort of waiting with baited breath to see how this shakes out. But I'm just going to call a spade a spade and say make a different plan. Have a plan B because we don't want people running out. And truly, I don't know if you guys follow um Dr. Phil. Dr. Phil is my pharmacist. Phil is my pharmacist is his is his handle on Instagram. Great account. And he said it so well the other day on a real. He said, "The time has come where the wealthy will be able to afford to be skinny and the notw wealthy will not."
And that's really unfortunate. Like that's not how medicine's supposed to be because I don't know a lot of people who can afford, you know, $450, $500 a month to get their medication. I know people who will do it, but that's a lot of money, especially in the economy the way it is right now, especially the way things are going, especially with gas prices. So, I don't mean to be a Debbie Downer, but I think this is where we're at, and it's it's lame. So, anyway, that's where we're at on GLP1s. If you are going to rely on the 503As, good luck. I don't think that's going to be a viable option and I'll leave it alone. Okay. So, where are we with the other peptides? Because I know everybody got really excited. RFK was on Joe Rogan several months ago and he said, "We're going to try to bring back several of the peptides." What is he talking about?
So, in September of 2023, we all woke up to the reality that the FDA had pulled all of these different peptides that we had been able to compound and have access to for our patients for gosh 10 years.
Maybe not at that point. I you know, I I think that they really came on the scene.
2016, 2017 is when it started getting louder and my in the regenerative medicine space. That was the first space that was the first group of doctors to really grab on to peptides and use them because they have regenerative properties, right? And so a few of my friends were using them. I did not become like I wasn't doing a ton of primary care anymore, like generalized care. I had very specifically narrowed my practice down to regenerative injection therapies and HRT along with that. And so I was using the peptides that were involved with that specific need, right? So the BPC-157, the TB500, anything that would help me get patients either ready for regenerative injection therapies or to recover from injury or muscularkeeletal medicine, that's what I was doing. All right? So if it was outside of that, if we were talking like body composition or longevity in general or extending tieumirs or whatever else, I was not playing with those. Those were not in my wheelhouse. I wasn't trying to boost mitochondrial function. I wasn't I was no longer I used to do a ton of that and then I have resumed uh in the past few years to doing more of that. But at the time that peptides came out, my practice had been narrowed very strictly to regenerative injection therapy patients only and whatever they needed within that. And if it was more complicated than a simple HRT prescription or a simple peptide prescription, I referred them to colleagues nearby who would do that generalized naturopathic care because sometimes their joint pain was coming from their gut or their joint pain was coming from, you know, whatever it may be. And then I even got to the point where I quit dispensing the HRT and I referred that out to a few trusted colleagues. They would work with them knowing that they would send them back to me when they were in healing mode, when they were ready to be treated. So the whole peptide rush um came in in my space of the regenerative medicine scene, but I wasn't doubling down on it. I was actually working my way out of practice.
I was at that time looking to shut down my big clinic. I was trying to simplify down. I w, you know, I was I was working my way out. I had already made a plan to ultimately get out of clinical practice.
And you know, while I'm still seeing patients on the side and I still have a few private clients on the side, the whole big boom that happened, it happened during COVID and I was in Oregon. I was in Portland and there was no way I was going to play that game in Oregon. It was insane. They were playing full out pandemic and it was illogical to a fault. And so I very quickly the small I had worked my way from 2018 to 2020 down to very few patients very few select group of patients and I worked my way out of that if you will. I got myself out of my clinic. I shut down the clinic space. I got myself you know the whole brickandmortar thing that whole big thing. And so I wasn't playing the whole thing and I I just shut it down.
And fortunately, I had already discharged a lot of patients and I was really comfortable walking away. Like I I was I was good with that and best decision of my life. Honestly, if any of you are clinicians and you are wanting to get out of practice, I have zero regrets. I get asked about it all the time. Zero regrets and would never encourage anyone to go into medicine the way that it is happening right now.
Although I'm grateful for the wonderful people who took care of my mom while she was in the hospital and the wonderful afterare that she's received. Um, I just I think that the system is really busted and it got a lot more busted during COVID. So, I'll leave that at that. So, the peptides, there were, you know, over a dozen that were able to be compounded and they disappeared in September of 2023, just overnight. Like, boom. What happened to them? They went on to what's called a category 2 list. The way I understand it, and there's it's hard to even find information that's real clear on this, but the way that I understand it is that because they were put on category 2, they were basically put on a um a do not compound list, so to speak. And what the problem was was they were no longer allowed to get supply is how I understand it. That they were no longer allowed to get access to supply. So, they couldn't get stock in. That was kind of what that was. It's it's kind of a vague zone, if you will. And because they couldn't get stock, they couldn't dispense it. And that seemed to be the problem. Some compoundingies still had backstock, and so they were allowed to continue to dispense what they had. And so this is where the confusion comes in, and I don't have all the answers yet, so we're going to wait to see how this shakes out. But where a lot of you are confused is you're hearing me say and other people say that these are on the do not compound list and they have been since September of 2023, but you're still getting compounded prescriptions of them. And so you're confused. You're like, "Wait a minute. I heard these were illegal or I heard we weren't supposed to be able to get them in injectable form from a compounding pharmacy and yet I have the prescriptions sitting in my refrigerator." I hear this all the time from people. I have my doctor prescribed them to me. this pharmacy is still dispensing them. And I'm like, yeah, it's vague. And are they supposed to?
Are they not supposed to? I don't know.
I'm not trying to get anyone in trouble, but there are still compoundingies where you can still get access to some of these peptides. That's the word on the street. And then over here is the gray market research lab peptides. These are to be used only in rats. You're not supposed to be able to or you're not supposed to put them in your body as a human.
Um, it's gotten so messy out there and so noisy, you guys. So, I'm gonna break this down as well as I can. All peptides are coming from China is how I understand it. And supposedly, even the companies who say that they are manufacturing them in the United States are still getting raw supplies to some degree from China. So, where does that leave us? When you get a compounded medication, it has to go through a whole arsenal of checks and balances and and making sure that things are, you know, not necessarily FDA approved, but that they're coming from hopefully a clean source. And so, your best bet of getting something that isn't full of endotoxins and who knows what else, heavy metals. I mean, there's there's been just so much speculation out there. And then there's been labs who are running tests on these vials that are coming in from research labs and finding all kinds of discrepancies. Your best, cleanest route is going to be through a compounding pharmacy, but it's on the do not compound list. So like what are you going to do, right? So like I said, it sounds like there's stillarmacies out there that you can access through.
Whether your doctor knows what they are or not, I'm not I don't know. the research labs, those are just coming in from China and there's not a great checks and balances system on that. And so there's some reputable companies supposedly that are research labs that are dispensing really clean product and some of them saying that they're manufacturing in the United States. But again, I still think they're getting raw substance from China. Um, and I'm in no way, shape, or form promoting that you go gray market and use research labs because again, we don't know what's in there. I don't I am a libertarian to the core and I am married to a libertarian and he's he's more hardcore than I am and he believes that we should be able to access whatever medication we need without a prescription, no questions asked. As a physician, I don't agree with that because I have seen so many people mess themselves up so badly with that. I will use antibiotics as an example. It's really easy to go to Mexico and come back with a stock of antibiotics. I have watched people destroy their guts and destroy their health by just mamsy pamsy grabbing whatever they have that they brought back from Mexico. Or the other example is when people use medications that oh my husband had this from when he was sick and he had some leftover. Um yes in some cases that can be really wonderful and maybe even potentially life-saving but the blanket use of medications by people who don't know what they're doing like I'm not a fan of that. So libertarian or not I don't care what you guys do. I am not promoting that you reach for gray market peptides. I do understand that's the only way to get some of these anymore. So I'm I'm just not giving I mean beyond that I don't have an opinion. As a physician I would want to be overseeing that experience for that patient. I would want to be helping them walk through that because I don't know about you but I'm a sensitive Sally and I have had some pretty gnarly experiences with peptides that I didn't love. compounded clean from a pharmacy.
Didn't respond well to them. And if I didn't know what was going on and I didn't know what I knew, I would have been scared. People message me and say, "I'm taking this. I'm having these terrible side effects. What's going on?"
I ask them what the stren what the dose is. And everybody answers me the same.
Oh, I'm taking five units or I'm taking 10 units. And I'm like, "No, honey. What is the milligrams per ml? What's the strength on the vial? Tell me that and then I'll figure out your units for you and I'll tell you what you're taking." I mean, people don't know what dose they're taking of anything. They're just pulling up units. And there's a whole industry that I've talked about before that it blows my mind why the FDA is not cracking down on this. And it is this sort of pseudo medical peptide companies who look medical from their websites. They look medical from when you talk to people. They might even have a nurse practitioner talk to you.
They're sending you gray market peptides. And the medical oversight is not great. Some of these are geared towards women. Some of these are geared towards mamas. I definitely think that the middle-aged cohort of women, the US Gen Xers, are being prayed upon. And it's so freaking gross, you guys. Like, I would be the happiest girl in the world if I could see the FDA go after and shut down those companies because they are predatory. And we also have a whole group of, you know, the Fitzpo girls who are making their affiliate cut when they are pumping you full of peptides. It's crazy. I see these women on there. They're like, "You should just use this for body composition. Comment the word and I'll send you my guide."
And I get the guide and I look at it and I am in disbelief. There's a ton of people using my content to sell this nonsense. Um, there are people using my content from other people's podcasts to sell this.
It's this. It's crazy. It It's so crazy to me. And how I'm even involved in this is bizarre because I haven't gotten a check from anybody. I have specifically I gosh, my husband was talking to me the other day and he was like, "How much have you turned down? Like add it up."
And I'm like, "Oh gosh, probably at least half a million dollars at least from companies." Every company who has, let's put it this way, virtually every company who has a tele medicine platform and is pumping out GLP1s and HRT has contacted me and asked me to come work with them in some capacity. And I'm not doing it. Like I was selling you education back then. I'm selling you education. Now I'm not selling you peptides. I'm not telling you to go to any of these other companies because I don't love what they're doing. And even the ones that are really prudent, I still don't think it's the same as having a doctor oversee your care. It's just not the same. Like I even the patients that I talk to, not my patients, but the folks that are patients of these clinics who tell me they're happy with the outcomes, rarely that's the case actually, but the ones who say they're really happy with the outcomes, they're when I start asking them questions and probing, they're still not getting a comprehensive integrative approach. They're just kind of getting this cookie cutter prescription approach. And I just don't think that's if if you're in any way, shape, or form sensitive or you've got any kind of, you know, immune dysregulation or you've got a history of histamine issues or what have you. Like, they're not testing your gut. They're not looking at other factors. They're not It's And I know there's not a lot of doctors out there who are good with peptides either. So, I know you guys are in a bind and you're just doing the best you can, but this is where we're at and it's gotten messy. So RFK, I'm sorry a long rant. RFK said on Joe Rogan's podcast that he was going to bring these peptides back. It's not as simple as that. And so what happened more recently, beginning of April, I believe, there are 12 of them, I think, that are up for investigation. So they're going to they basically said, "We're going to take the this group of peptides that were on the category 2, the do not compound list, and we are going to put them through the rigomearal of the FDA and see if they pass. and if they pass, we'll make them available again.
It's been very strange, though, because two things have happened. When RFK first said what he said, the entire peptide community blew up and the whole internet was like, "We're going to get peptides back." Like, it was this sure statement.
And it's just not sure. I mean, he can't just He's not the only person who can he can't wave a wand and make that happen.
Um, number two, when these came off category 2, a bunch of doctors said, "Well, that means that they are on category 1, which means we can prescribe them in compoundingies can dispense them again." And that's not what happened. They didn't go to category 1. They're they're in this limbo zone. They're just in the void, if you will. It's like the upside down, right? It's in Stranger Things. They're they're just in this void where you're taking your chances as a physician if you're prescribing these.
I'm just telling you, I follow a lot of lawyers who are actually starting to get hip to all of this and they're starting to put out content around it. If you are a prescribing doctor and you are prescribing these, you could be held liable.
I'm not even going to talk about the compoundingies who are dispensing them.
I I mean, we we have to have our medications, right? And so I I there are a lot of people who've benefited greatly from these and I'm not trying to pick a side. I'm not saying I mean I I don't I don't want the whole thing shut down on either side.
But the way that they have taken off, the way that people are just mamsy pamsy injecting themselves with things they don't know or understand. the way that the predatory influencer scene is is so gross because this is so there's so much money on the table to be had and they're getting affiliate kickbacks and some of these people have huge audiences.
They're sending them to companies like LEMD. LMD is is an interesting one because it's ran like an MLM from what I understand and there's no place for that in medicine in my opinion. That's just my opinion. Um I have no shade on MLMs by the way. Like I have no shade on that. I just don't think when it comes to actual prescriptions that that is an ethical thing. Like how a Fitzpow influencer can send you to LMD, get an affiliate kickback. They call it marketing dollars. It's it's it's an it's it's it's it's a kickback. That's fee spplitting. That's illegal in in medicine, by the way. But they call it something else so that they can get not get in trouble. Um but if I were to send you to like an imaging facility cuz I loved the owner and they gave me a kickback, that's illegal. So, I don't see how this is any different. I don't see how, you know, Susan with her 100,000 followers can tell you she's micro doing for inflammation and then send you her free guide and her free guide has her LEMD link and then she's getting a kickback off that and then that's legal somehow. Like that that's bizarre and gross. Uh I don't think that's ethical. And then from there, you're getting it's kind of an MLM structure where she can sign affiliates up underneath her. It's it's weird. I'm also not against affiliate marketing. I affiliate market. Like, I love the fact that I don't have to stock something in my store and you can still get it. I get a bonus off it and you get a big discount. Like, I don't see anything wrong with that model, but when it comes to actual prescription medications that people are injecting into themselves, I have a problem with that. That's just me. I'm sure my comment section will blow up and you guys will have opinions.
There are some genius people in the strength and conditioning community, um, in the peptide community who are smarter and more well-versed in these peptides than any doctor that I know. And they are sending you to gray market. But I see a lot of these folks running things really responsibly. Like that's the part where I don't want to see all this get shut down if I'm being honest with you because I love that there's people out there with big brains and good intentions and they're really helping people through and they're helping walk them through and they're acting as a consultant and uh there's no regulation on that. There's no licensing so you know who knows what you're getting and I could see how doctors would be threatened by that or say that that shouldn't be done but I'm telling you I know some of these guys and they are smarter than any of the doctors I know.
So, I think when you have people in an expert space, but for you guys as the consumer, you don't know what you're getting, right? You don't know what you're getting into. And so, you have to do your homework. You can't just hire somebody off of Instagram and pay. I I saw a woman today.
This is mindblowing. She's offering $100, $99 consultations for 30 minutes to talk to her about peptides. and she literally just started peptides herself and she's so excited about them she wants to counsel you guys. So you can pay her $99 for 30 minutes of her time.
That's more than most doctors I know charge and I charge a lot more than that. But I it's it's blowing my mind, right? And so you guys just got to know what you're getting into. I'm I'm not trying to take sides. I'm not trying to judge anybody.
I'm just trying to let you know this is all that's happening and it's crazy. I want people to be able to have access to what they need. I want there to be access to good, clean, quality peptides so that the people who know how to use them can continue to use them. There's a whole group of MDs online trashing on peptides right now, but they're all making the same argument and they don't know anything about them.
And yes, there is the argument that there's not a ton of data. There's not peer-reviewed double blind placebo control data. I just want to like punt the ball back and be like, where were you? Where was this opinion in 2021, guys? Like, where was that? The end of 2020 and the beginning of 2021 and then on through mandates.
Like, where was that? Because those studies were pretty shady that when they warp uh warp speeded everything, right?
But everyone just lined up for that. But anyway, we've been using these clinically, safely, effectively for a long time. And I just it kills me that the concept of evidence-based medicine is only reliant upon studies because that's not what evidence-based medicine that's not the definition. The definition is a three-pronged approach.
It is equally it's like a three-pronged stool, you guys. And it is equally as important as the physician's experience and then the patients desires and lived experience and with with the treatment like that matters too. And so if everything has to go through an FDA approval process, we're not going to get anywhere. The I wake up every single morning and open Medscape, which is the big medical MD alopathic, you know, journal, if you will. I open it up every single day and there's some new groundbreaking study. Did you know that blah blah blah and they've proven it and I kid you not, every single day I look at it and I'm like, we've been doing that in practice for 20 years. We've been doing that in naturopathic medicine for 30 years. And in fact, 10 years ago when I was trying to talk about it on Instagram, you guys were calling me a quack. It's so bizarre. So my point is is that this [ __ ] takes time and if you've got people who are experts in using it, I'm a big fan of making sure they have access to it so that they can talk to their patients about it. Of course, we always want to do a proper informed consent. And it's up to the two adults in the room as to what they're going to do.
We can use things off label as well. So pharmaceuticals that have been put through FDA approval, we can use them for other reasons than the FDA has has approved them for. So there's just holes in the argument. I know you guys are going to come for me in the comments.
This is just how I feel. We've been doing a lot of these things for a long time, very safely, very effectively now.
There's this whole argument about do these peptides cause cancer? And you see people who know nothing about peptides on these big platforms. I just saw a gal the other day and she's like, I would never suggest that peptide because it could cause cancer. And I'm like, you don't know anything about any of this, but I'll add, what's the concern there?
It's a concern I brought up several years ago on this podcast, and I have said it a few times over. Some of these peptides are regenerative specifically, and what they do is they upregulate veg F. I know about VegF because a huge part of my practice was plateletri plasma.
And one of the biggest growth factors that we rely on in PRP treatments is the VEGF. What is VEGF? It's a vascular endothelial growth factor. That's the VEGF. It means that it helps when that growth factor is around, it helps create angioenesis. It helps create vascule to an area. And so if I pull your blood and I spin out the platelets and I concentrate them down and I reinject them back into an injured area, ideally those growth factors would call the body up to bring more vasculature, which means more blood flow, which means more productive healing, right? Well, guess how cancer metastasizes from its original tumor source?
It uses VEGF.
And so there has been an argument for a long time in the PRP scene, and it's something I've actually brought up.
There was a lot of doctors back several years ago injecting PRP into women's breasts under the guise that it would make their breasts larger. Um, I was not keen on that because I was like, "Hey guys, if there's a breast tumor in there and you're injecting PRP that's highly concentrated in VEGF, what what's potentially happening there?" And they would argue with me and say, "Well, we haven't had any cases of cancer." And I'm like, "Well, that's great, but the potential's there, right? So, where does this leave us?" Um I think it's really important to note that is it positive or is it correlative cancer being present the patient will have high ve levels in their blood tests. That's one of the ways you can kind of monitor what's going on in cancer is by running and and looking at VEGF levels. If it's increasing there's probably active metastases trying to happen or happening, right? So that complicates things because is the VEGF in the area because of the cancer?
Yes, probably. That's probably what's going on.
Would adding VEGF to a body make cancer grow that's already there.
Maybe would adding veg F to an area specifically where the tumor is localized, would that make that metastasize? I mean, those are all reaches, right? Those are big reaches and we haven't seen that happen. We haven't seen I' I've done a lot of PRP and I've never had anybody come back and say, "Oh my gosh, I now have cancer."
But here's the big butt part.
I never run these peptides indefinitely.
And what's happening is a lot of people who can get their hands on the oral form of these peptides. A lot of doctors that I know are selling them through their supplement stores and they're never ever warning people that a talk to your doctor, right? I always tell you guys that. Talk to your doctor. Talk to your doctor. Discuss this with your doctor.
B, and I know maybe your doctor doesn't know diddly squad about peptides, so I'm sorry, but I you should still talk to somebody who does, right? And then B, we never I never run anything indefinitely.
And if I do even make a recommendation, there's one product in particular that I love that does have BPC57 in it. It's an oral product. It's it's uh advertised for gut health. I use it for a variety of reasons, but anytime I ever discuss it, it's because it's phenomenal and we want to make sure and I tell you guys like this is how I use it. I use it for, you know, 10 to 30 days max myself. I am not telling anybody how to take it and I'm definitely not telling them to run it forever. But a lot of these doctors have jumped on the bandwagon and don't know what they're doing. So, they're just running peptides indefinitely.
There's a lot of people I know who are taking like the glow stack and the close stack indefinitely. They're not running cycles. We cycle these things and that's why you need someone who knows what they're doing. Whether they're you know a bro science guy who's really really good with them and have been doing it for years or whether they are a doctor who knows what they're doing. We need people understanding the basic concepts and mechanisms of actions of these peptides so that we can at least tell the patient like hey do you have active cancer before I suggest that you take this peptide that may potentially induce increases in ve which is how they help regenerate and maybe we should talk about if you are going to use them and agree to it that we have a plan so that we can monitor this right we're running blood tests we're We're checking on our people and that is what prudent medicine is. And so this is I know I'm rambling but this is where my problem is with the whole scene is it's there's no nuance and medicine is nuanced. It's not cut and dry and it's not throw this peptide at everybody and see if it sticks. I never once said everybody should be on a JLP1. I said talk to your doctor. Talk to your prescriber. Talk to somebody who knows what they're doing. talk to your health care expert on the subject so that they can monitor you because I don't even think GLP1 should be forever.
I have a whole argument against high doses of GLP1s that people have to be on indefinitely. It seems I'm not saying it doesn't work wonderfully for obesity and I'm not saying it hasn't changed lives and it isn't one of the most monumental medications I've ever seen ever in the history of medicine truly. Um, but we have to really be careful that we don't have people just cranking doses of any peptide indefinitely without monitoring, without talking about the potential consequences of that, without considering receptor sensitivity, without considering do they have active cancer, do they know the risks?
What are we doing here? Right? And I don't think any of that's really happening with this whole peptide craze.
I just think a lot of people out there are buying [ __ ] from the internet and injecting themselves with it or there's a lot of tele medicine companies indefinitely dispensing things and they do check in once in a while but some of them are a lot more diligent than others and it's the wild west. So I've done other entire podcasts on this. I don't want to keep beating this horse but it's really we're in a crazy place and I'm not stoked on how it's going down at all. I just think it's wild. And when people bring it up to me, I just want to eye roll because I'm like, what the f is happening? This is nuts. So, I am excited that this group of a dozen peptides is being evaluated. Supposedly, we should know by July what the outcome is going to be. So, that's not very far off. That maybe we'll start to get some answers. I know that if those peptides go through approval and are allowed to be uh prescribed again through compoundingies, I know two things are going to happen. one, the MDs who hate the peptides are going to blow their fuses and say, "How could this happen?"
Which is exactly how I felt in 2021 when I was like, "How are you releasing this on the world?" Um, the intervention that they released upon the world and the mandate the world inject into them. So, I get it. I hear you and I understand your frustrations, doctors who hate peptides. And number two, big pharma will find a way to patent these. They will. They will find a way. they will find a way to tweak them enough that they become a pharmaceutical. And so I think that's what we're looking at too, which again, I'm being Debbie Downer here, but I think a we're going to see the end of compounded GLP-1s in the near future. And B, I think we will see potentially approval of some of these peptides and then we're going to shortly see big pharma find a way to profit off of them and make them their own and make put them under patent. So how can they they tweak it? So in the case of semaglutide that is a naturally occurring peptide in our bodies they tweaked it so that it has a longer halflife in your body. It's instead of being minutes like your body produces it and it's in and out in a few minutes it now becomes a week. It's in and out within you know 5 to seven days if you will.
They tweaked it so that in a very simplistic way so that that would happen and then they can patent it. If it's a naturally occurring substance, especially if it's made up of amino acids, they cannot patent it. And that's how these other peptides are. So, I don't know. I don't have an answer for you. When I talk to the people who should have the answers, they're just like, we're just waiting to see what's going on here, too. We're all kind of waiting to see what's going to come down in July. See how that goes. I'm excited for that. I think that we're going to see some of those return and people can now get them in a safe, affordable way.
I also think that the FDA is not done and they're probably going to start cracking down on the research labs, which again, as a libertarian, I I appreciate that people can access medications when they need them or peptides or supplements. Like, I'm not a big fan of a lot of restrictions. I'm very much in the political party of leave me the f alone, don't tell me what to do. But I still think that you need to find somebody to work with who can help you navigate even if it's new to them. Even if I can't tell you how many times patients came into me and said, "I want to try this. Here is what I've read. Here's a study I found. Here's a novel use of this medication off label and I want to try it for my specific condition because I've tried everything else and I'm not getting anywhere." And I said, "Sure, let's do it. And we will learn through this process together and I will be careful and I will monitor you and we will make sure that you're safe.
I understand the mechanism of action of the medication. I understand physiology.
I understand pathophysiology. I understand biochemistry. I understand lab diagnosis. And I will make sure that we do our very best to do good prudent medicine. And this is up to the risk tolerance of the physician and the risk tolerance of the patient. And if that is in agreement, then we can proceed.
Right? That is how good medicine works in my opinion. So you guys are kind of on your own. I'm just trying to bring you the information as I can. Make a plan B for your compounded GLP1s and I'm not really sure what's going to happen in the gray market. I'm not I'm not in the gray market. I know some folks who are. They say it's going to be fine.
Probably what they mean is at the end of the day, people will always find a way to access what they need. That's called the black market. It's happened before.
It'll happen again. Um you can go out of country and access things. You know, it's is there's always ways. And so I don't think we'll see the end of access.
I just think it's going to get a little more complicated potentially. Who knows what the FDA is up to. Um I'm a big fan of an ethical FDA and an FDA that's doing due diligence.
And so I'm going to sit back and support what's happening right now and see how it shakes out. If you're on a compounded GLP1, like I said, there's resources out there and you can access I'll tell you the truth. I have several patients and friends and colleagues who have switched to the brand name Zepbound and they're getting way better results. They were uncompounded. They hit a wall. It wasn't working it or it wasn't the same. They'd get it from a different pharmacy. It would be different. I've had many people tell me that. Many of my followers have messaged me and said, "I don't know what happened. I was on a terzepatite. it was great and this was going down and uh the weight was coming down and then I switchedarmacies or they switched resources and it's not the same anymore.
And so I do like the idea of standardization and you guys are going to call me a big pharma shill and I don't care because I'm I got deplatformed I think by them. I don't think I got any checks. Last time I checked there was no income from any of that. I have gotten nothing but hell from big pharma over the past what six years at this point, right? I pissed them off back during co and I pissed them off again when I started talking about com or uh micro doing JLP1. So here we are. But I have found people getting better results with Zbound. It's standardized. It's clean. And so I'm not telling you not to source what you need where you need.
be careful and stop taking your peptide advice and injecting random [ __ ] into you because some fits influencer gave you a free guide. Like that's crazy to me. So anyway, I hope this was helpful.
Um I hope we get good news in July. I hope RFK pulls through. I hope the FDA is not corrupt and that they do the right thing. And I hope that if uh peptide doesn't meet the scrutiny that they desire, then they don't accept it.
Like I I want everything to be fair and clean. I want the patient protected. I want you guys protected. I want to see reason and logic come out through this.
And I want to actually I'll leave this and I'll close. I saw a guy the other day on Instagram and he said, "If you're not in the 1% of health and fitness, you shouldn't even be taking peptides because they're not going to do a damn thing." Now, I think it's a little bit extreme, but he's not that far off. If you are not already getting your foundations dialed, don't pick them up.
They're not going to do anything. You're wasting your money and you're potentially injecting yourself. Again, these these labs that there's these individual labs that test peptides.
groups of people in the United States are buying peptides from China and importing them into the United States in bulk so that they can get a discount and then they send them through these labs to get the certificate of analysis and to see if it's clean. And these labs are now reporting that several of these batches that come through which are ending up in these research labs are full of contaminants, full of heavy metals, full of endotoxins, right? And so you're taking your risk there. You're taking your chances there. And why would you do that if you haven't done all the things first? You need to get your [ __ ] together first, right? You need to get your metabolic health in order. You need to be going to the gym several times a week. Like, ask my husband. He was using peptides. And I was like, "Dude, you're not hitting the gym. Stop it. This is ridiculous. It's not doing anything.
You're just wasting our money. Stop. You stay active. You stay fit. You eat well.
You get your sleep dialed in. you get your HRT dialed in first and foremost before you touch a peptide and then you can consider the peptides even for GLP-1s. Now, in some cases, people need a leg up and they need the GLP-1 first to get the ball rolling. And a lot of people report after they start using the GLP1s that they start moving and they start feeling better because the inflammation comes down and the pain comes down. I get it. If that's the case, so be it. I understand. But for all the other ones, like it's not going to do a whole lot. If I use BPC157 in someone and they're in really good shape and they're muscular and they're fit and they're active and they're healthy and they're eating well and they're in good healing mode, it works awesome. If I give it to somebody who's a complete hot mess of health, it's like eh me. So, I don't think you have to be in the 1% of optimal health and fitness to get receive the benefits of peptides, but you certainly need to be in the top 10.
So, get your [ __ ] together first and then consider your peptides. They're not your bailout. They're not going to pull you out of the tail spin. They're not that potent. So, get dialed in. I have resources for you guys. I'll leave some in the show notes. I have a metabolic revamp toolkit, which is a really simple, easy, affordable toolkit. It's an ebook. It's full of guides and cheat sheets. It'll get you started. Um, I've got a strength vault if you need to get started in strength training. But that's when we start playing with peptides after we've been doing that for a period of time. That's when they really start working well for folks in my clinical experience and in my personal experience. So, all right, I will leave you with that. I will see you guys next week. Thank you for listening. I hope this was helpful. Get your plan B set up for your compounded GLP1s. Bye.
Thanks for listening to the Dr. Tina Show. This is a Wellness Loud production produced by Drake Peterson. Theme song is by John the Guilt. You can watch the full video version of this podcast inside the Spotify app or on YouTube. As always, you can email the podcast at podcasttina.com.
That's D R T Y N A. And if you like this episode, please rate, review, and subscribe on your favorite podcast app.
You can also find all of my offerings on my website at drtina.com.
For more shows by my team, go to wellnessloud.com. See you next time, and thanks for listening. This podcast is for generalformational purposes only. It does not constitute the practices of medicine, nursing, or other professional health care services, including the giving of medical advice. I am a doctor, but I am not your doctor. No doctor patient relationship is formed. The use of this information and the materials linked to this podcast is at the user's own risk. The content on this podcast is intended not to be a substitute for professional medical advice, diagnosis or treatment. Users should not disregard or delay in obtaining medical advice from any medical condition they have and they should seek the assistance of their health care professionals for any such conditions.
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