Episode Transcript
[00:00:02] Welcome my outside the box thinkers to the Anti Aging Unraveled podcast where I am your host, Dr. Lori Gerber. In this podcast we will explore the fascinating world of personalized anti aging medicine that considers the whole person inside and out and how all systems are interconnected to each other. In today's world of modern medicine, we often find ourselves like just another number in a system that prioritizes quick fixes over sustainable and more natural solutions. Well, let's get ready for a paradigm shift in health and beauty. We look far beyond treating symptoms and aim to get to the root cause of our health and cosmetic issues. This podcast is your go to source for all things natural, outside the box, and innovative in integrative medicine and cosmetic dermatology. So sit back, relax and get ready to dive deep into the world of functional medicine and aesthetics with me, Dr. Lori Gerber. Let's take a trip down the real skin revolution pathway together.
[00:01:05] Hi everybody. I'm so glad to have you guys back. This is Dr. Laurie and I'm here for another episode of Anti Aging Unraveled. So glad to have you guys here and I apologize for the time in between podcasts. Just getting down here to record and getting my thoughts together has been a little bit of a challenge. But I wanted to talk about something that's actually front and center right now in politics at the super bowl in my industry and medicine, and that is fda, Big Pharma and kind of how basically everything is changing and shifting. And I want to call this podcast the shift from discouraging self advocacy or self health advocacy to empowering self help advocacy. If you can say that five times fast. Because really over the last 15 years or so, maybe even 20 years, big pharma, FDA, insurance companies have really dictated our health care. They've really told us what we can use, how we can use it from a medical provider standpoint, from a patient standpoint, it's all been basically force fed to us. And now finally there's buzz chatter, people standing up about advocating for their own self help or health and what they want to use for their own healthcare. So I'm gonna lead in a little bit later with the whole super bowl ad for a pretty large mail order company and telehealth company that basically shook up the industry a little bit as well. But I've been talking about this for quite some time. Finally someone put it in front of millions of people and slapped the face of the FDA and said big Pharma and said here I'm taking the super bowl commercial for hims. For hers. And wow, has that made a lot of buzz and a lot of noise. And really they've brought to the forefront an issue that's been again been talked about in politics. Rfk. We're gonna have a whole podcast probably just on rfk. But what is happening is this paradigm shift in taking your own health into your own hands and being able to do really what you think is best based upon research and data and the help of people like myself and other companies that really can bring some of these non traditional medicines to the forefront. So I wanna really talk about quickly what the FDA's role technically is in everything really. What are their qualifications and what are they able to actually enforce? So the FDA's role in monitoring prescriptions, let's talk about that first. Is primarily to conduct surveillance and investigations, identify and mitigate risks associated with poor quality compounded drugs as they do not have the authority to verify safety and effectiveness or efficacy of a compounded drug before it's marketed, which means they cannot approve drugs like a traditional medication. That in itself is a problem when the FDA has a lot of money strings attached to it. Right. This responsibility falls on the far state boards of each state's pharmacy board. Okay. To actually enforce the compounding regulations. Key points about the fda, they have no pre market approval. So the FDA does not review compounded drugs for safety and efficacy or quality before they're dispensed. Surveillance and inspections. Again, the FDA conducts surveillance activities like reviewing complaints and adverse reactions or adverse events and can perform inspections of compounding pharmacy in that way, especially considered what we would call an outsourcing facility and identifying risks. So again, the FDA claim or aims to identify potential risks associated with poor quality compounded drugs. Get quality not ingredient. Right. And take action to mitigate them, including issuing alerts to health care professionals. The state regulation is really relegated to going to the individual pharmacies and taking care of the individual state. The individual state boards are responsible for taking care of the individual pharmacies. So let's talk about supplements. The FDA does not approve dietary supplements. They are not authorized to approve dietary supplements for safety and effectiveness. It's just not part of their role. So when something says not FDA approved, it doesn't mean that the FDA would not approve it. It means that they don't have the authority to approve it. So I want to be clear, the FDA is not a regulating body for supplements and compounded medications. So again, FDA approval or not FDA approval rather does not mean that it's not safe. It means they don't have the authority to FDA approve these things. Okay. So, for example, many dietary supplements can even be marketed without even notifying the fda, which is good and bad. Right. We have obviously checks and balances in that system, but probably not enough. But there's again, a lot of money tied up with FDA and pharma studies and things like that. They stand to lose a lot of money if certain supplements and certain compounded drugs come out on the market. Companies are required to submit a premarket safety notification to the FDA at least 75 days prior to marketing, especially if it contains new dietary ingredients. Dietary supplement companies must ensure their products are safe before marketing and comply with labeling and quality requirements, such as good manufacturing practices. And the FDA inspects facilities for compliance and monitors adverse events. Right. So we're not talking about going and seeing if it's effective. It's if there's an adverse event. So let's just say there's a sterility complaint or there's an issue with a certain manufacturer, they could take action to protect the public in that manner. Food labels. This is really big in the news recently with finally banning red food dyes in the United States. The FDA does not approve individual food labels before food products can be marketed, period. The FDA regulations require specific labeling elements, nutrition information, to appear on most foods, diet and dietary supplements. Any statements on food products must be, quote, unquote, truthful and not misleading. Again, that's left to interpretation and must comply with any regulatory requirements for the type of statement as applicable. So leaves tons of room for interpretation there. Right? So there's really. That's one of the reasons we have such a problem in this country with our foods is because of the lack of regulation of our food and the lack of really labeling enforcement. Manufacturers must provide the serving size of the food and that's relatively recent and specified information about the nutrient content on the nutrient facts label. Supplements similarly are required to have the supplement facts label for all dietary supplements as well. FDA does not approve structure and function claims on dietary supplements or other foods. So anything that has to do with how something works, how it affects the human body, like for example, calcium building strong bones, they do not approve any of that. So again, there's the good and bad of that, right? There's the construct that says, well, that could lead to false claims. But there's also why does the FDA get involved in certain compounds when there's never been any reports of safety and efficacy issues if they're not involved in approving the structure and function and functionality of a drug that's compounded or supplement based dietary supplement. Companies that make structure, function claims on labels or an other labeling must submit a notification to the fda. So they do have to submit that they're making a claim, but they don't approve the structure and functions of those claims. We are very strong about, and this is pretty consistent across the board in the industry not to intend to diagnose, treat or cure or prevent a disease. We're not making claims that are over the top and excessive. But there are a lot of claims out there, like I said, that are positive claims that would probably be backed by data and some that aren't. The FDA does not require conventional food manufacturers, interestingly enough, to notify the FDA about their structure or function claims or that they need to carry a disclaimer saying that this is not FDA approved or anything like that. So interestingly enough, the same guidelines are not applied to food as they are to drugs or to supplements and medications. When I say medications, I mean non pharmaceutical manufactured. So supplements are compounded. So let's talk a little bit about this super bowl ad. They call the super bowl ad the sick of the system. That is the name it was aired in the third quarter. If you guys watched the super bowl, the most watched super bowl ever with 127.7 million viewers. And it was really a montage of junk food abdominal fat statistics about the health risks of obesity. Big Pharma's high prices really was a pretty big slap in the face. The ad then promotes hims and hers weight loss products including compounded GLP1s which as you guys know, I'm a big proponent of compounded GLP1s which is the compounded versions of your semaglutide and tirzepatide as an alternative to Ozempic and Wegovy. And you know, again, they're putting it out there. They're not only slapping the healthcare, the traditional healthcare industry in the face, Big Pharma as well as the fda. And now it's caught the attention of pharma industry lawmakers, medical experts, patient advocacy groups for deceptive air quotes, deceptive advertising, and perpetuating a stigma on obesity. Okay, so we'll break that down a little bit. You know, talking about losing weight, I don't know, is perpetuating a stigma on obesity, Especially when you take a look at the health benefits to weight loss and the life extension benefits to weight loss. But in deceptive advertising, I would say it's truthful advertising and puts the ideas out front and center that are primary issues in our healthcare community right now. So compounded semaglutide injections. I'm gonna use semaglutide as a generic term. I will switch over to tirzepatide when I need to. But they have the same active ingredient as all these buzzy brands, Right? So the ingredient that's in them is actually exactly the same. Pharma cannot produce an identical molecule in nature. So they do have to change a couple peptides in that structure to produce it. Okay, I just want you all to know this compound is natural. It's existed for a lot of years and actually way precedes pharma manufacturing it as a drug. And we were using it in compounding much, much earlier, years earlier, to be honest. And even in overseas, they've been using it probably decades longer than we have. Okay, so again, they have to change the drug. The one that's compounded is natural. It is the exact identical molecule. So I want to put that out there because really they're not the same, although they have the identical functionality, but they have a minute change in the structure that does not affect the function. But it allows Big Pharma to make these drugs. So they are not required because it's compounded to go for the Food and Drug Administration's rigorous approval process. And they're not FDA approved. Again, not FDA approved does not mean not safe. It means they are unable to approve it. They don't carry the standard FDA required labeling side effects box warnings. However, they are still subject to the state Board of Pharmacies oversight and must comply with USP compounding standards. So several years ago, the FDA did get involved with sterility compounding and created a sterility compounding protocol, which is USP compounding standards. And that is basically how everybody is to abide by. And that's called their 503A and 503B sections of the federal Food and Drug and Cosmetic act, according to the alliance for Pharmacy Compounding. So they do have compliance and regulation. It's just not necessarily all under FDA regulation. In June of 2023, the FDA issued a warning, and I'll put that in some air quotes as well, that unapproved versions of GLP1 drugs can be risky for patients, as unapproved versions do not undergo the FDA's review for safety, effectiveness and quality before they are marketed. They put in place a safety and sterility and compounding alliance to allow for sterility and safety. And this compound is exactly the same as what is in nature. And barring those two couple amino acid changes in the structure, they're the same as what big pharma makes. So why do we think they put out this warning? Politics, money, business, right? Capitalist society, selling drugs. You're taking business away from big pharma. So this has now become a huge controversy. This is the one of many peptides on the market that have been now quote unquote banned by the FDA because they can't ban them, but they can basically say that the raw ingredients are dangerous, not allow them to be purchased, even though there has not been any data to suggest that this is true. So that is basically what's happening is it's a money grab. They're trying to save face and save pharma from losing millions and millions of dollars by people buying these drugs cheaper and saying that they quote unquote, are a safety risk when a drug is in shortage. So when, let's just say tirzepatide or semaglutide was in shortage, that we are allowed and we compounders to make a version of that drug to meet certain requirements of the Food and Drug Administration is what was released in January. The FDA said that patients should not use a compounded GLP1 drug if approved drug like Wegovy is available. Okay, so if the thousand dollar compound is available or $1,500 compound is available, go get that from your pharma. Don't get the one that's a third of the price. That's just as safe, if not safer because it is the exact same molecule in a sterile compounding facility that is 503A and 503B accredited, which means that it is to the highest standards that we have available. But no, go pay the extra money to pharma so we can keep the lobbyists going and keep pharma happy and everything else. So Novo Nordisk for its part, hit back almost immediately with this commercial placing an ad in the New York Times and USA Today on the Monday after the Super Bowl. Because this commercial was pre released called check before you inject. A company spokesperson said the ad was a direct response to the Hims and hers super bowl commercial. And the ad features a vial that reads compounded semaglutide with a syringe. Some compounded semaglutide vials have been found to contain dangerous impurities, banned substances or incorrect doses. Bottom line, if the label doesn't say Wegovy or Ozembic, it's not FDA approved and you have no idea what's Inside is what the ad says. Well, first of all, every single batch of these credited facilities are tested for impurities, for added ingredients to make sure the purity standards are to the highest standards possible and that is regulated. They have certificates on every single product of authentication that says what is in each and every compounded drug. If you are a credit accredited compounding facility, I'm not saying go get it from some mom and pop who's making it in their basement, but these accredited facilities are accredited for sterility and they're accredited for the ingredients that they're putting into their product. So they are checked and they are third party checked as well. With this check before you inject ad. Novo Nordisk is warning customers about the significant dangers of reaching for illegitimate compounded semaglutide drugs which have been shown to contain impurities and ingredients dangerous to patients. Okay. The recent explosion in irresponsible and misleading advertising about GLP1 drugs like the hims and hers super bowl commercials put patients safety at risk. And we can no longer stay silent, says the company. Well, they stayed silent for a really long time selling their drugs and making it really hard for compounders to make drugs on the silent. You can suppress things and push things under the rug, but when things are aired out and you're losing millions and millions and millions of dollars at this point, you're going to fight back and you're going to sling some mud. And that is basically what has been happening with the FDA and non traditional medicine for the last for all existence to be honest, but at least the last 15 years that I've been practicing. So if we really think about this, you know, and we think about the new political regime, I don't really care what your political affiliation is. But if you care about health and you care about health care and not what I like to call money care, then really you should be slightly intrigued. You might not be on board with everything, but slightly intrigued with what's going on with the RFK and the new steps that are being taken to change the way the FDA is managed or, and, or mismanaged and how quickly or lack of facilitation of things coming through the pipeline with the fda, especially when it's not produced by a large pharmaceutical company and really discouraging natural medications and diet. I mean I will do a whole other podcast on this, but we can talk about how corn became the bottom of the food pyramid to basically support our crop farmers, not because it was the healthiest option for people, but because they were the strongest lobbyists and we needed to help our economy. We can also talk about sugar. Sugar is really the new tobacco. I mean, there was tons of data in the early 70s about sugar being the bad guy and not fat and cholesterol. But it got swept under the rug by the administrators that were involved with pharma, had some vested interest in pharma. Maybe we can stretch that to statin therapy. But if we think about the connection between who went from the FDA to pharma, it's very interesting and I'll talk a little bit about that shortly. But there's so many players that have been part of the FDA approval process or an administration very high up that have left the FDA and ironically enough, gone to pharma right after to make the rest of their money. Because now they've gotten things approved, they've pushed everything the way that they wanted it to go, and now you can push out a drug. Same thing with Synthroid. Back when Synthroid first came out. We can talk about the iodine kind of controversy and how that went down. But the FDA has dictated the direction our country has gone in a negative way for at least the last 15 years that I've been practicing. And if you look back, probably the last 60. Okay. Because when we talk about corn, when we talk about sugar, we could talk about HIV and AIDS therapies. There are a lot of controversy over the FDA's choices, monetarily speaking. We can fast forward to Covid and COVID vaccine. Why were these choices made and what was the bottom line? So what did PIMS and hers say back to them? We take safety, quality and transparency steps for every customer on our platform. That includes making certificates of analysis, which is that report card on USP benchmarks available to every GLP1 customer so they know exact ingredients from FDA regulated suppliers that are in the medications they receive. Any good provider will do this for you. Any good compounder will do this for you. But the political environment might be in him's and hers favors like I was just talking about. And the ad actually might hit the right tone with the Trump administration and RFK Jr. Who again has championed this Make America Healthy Again platform and been very critical of the pharma industry. So this to me is just a microcosm of what's going on in our industry. And it's actually quite, it's tumultuous, but it's also quite exciting because I do think we'll finally have some backing to actually bring some of these things really to the mainstream and more affordable because really they're cheaper, but they're still not affordable for, I would say, the general population. So Hims and Hers, I want to say what the CEO, Chief Commercial Officer told the Wall Street Journal. The goal of the ad was not only to talk to customers, but to raise the issue among regulators, legislators, and those who can drive change. And that's what we're trying to do. The alliance of Pharmacy Compounders put a statement out in support of the Hims and Hers ad, of course, noting that unlike FDA approved drugs, which must comply with strict labeling requirements under the federal Food and Drug and Cosmetic act, compounded medications have different rules for marketing and advertising. We just went through that. They do not have the same rules. Compounded drug advertisements fall under the FTC jurisdiction, not the FDA's typical prescription drug advertising rules. The organization kindly put out there for us. So they're not providing specific drug or medication, therefore they're not required to provide information on side effects or risks. Again, it was that more like that social commentary. And they focus on drug pricing and it might push the envelope in terms of, like, the role of compounding drugs in our healthcare system, which is really a debate worth having, right? Because there is a place for these drugs and they should not be swept under the rug or forced out of existence by lawyers, FDA and Big Pharma. The ad was perfectly consistent with laws and regulations that allow companies to promote health care services without promoting a drug or needing to make certain disclosures about those drugs. So I want to just kind of summarize this podcast a little bit by talking about what the FDA has done, gosh, probably the last 25 years, really. I mean, we can talk about longer than that. But what they've done the last 20, 20 years, for me, what drugs were put out on the market and pulled back, what people went from the FDA over to big Pharma. And really why this peptide ban, which is really a ban of the top peptides that we've used in compounding. Just so you know, GLP1S is one of those peptides and why they banned them. And in their words, it was that there was safety concerns with these medications and they cannot produce any reports of adverse reactions or adverse effects. They didn't ban the drug. They banned basically the purchase of those raw ingredients to make the drug. And I put the ban in air quotes because really it's not a true ban, because really they don't have the jurisdiction to completely ban these medications. They can say that they're not safe for human consumption because they are afraid of Safety issues. Again, no one can produce these safety complaints. There's no data, there's no articles, there's no case reports. So it's a money ploy. Hey, compounding pharmacies. Stop making GLP1s. Maybe we'll give you back the rest of those peptides that we banned. We banned about 20 something of your top selling products last year. Stop making GLP1s. Let us reap the benefits. Maybe we'll give you your compounded peptides back. And that's what I wanna talk about. I wanna talk a little bit about the interconnectedness of trail here. So in the F. The FDA approved over 20,000 of prescription drugs for market according to available data. A significant number of these FDA drugs were later withdrawn from the market due to safety concerns. So these are drugs that have actually been approved by the FDA and then pulled. Why? Because either they rushed them out for money, they swept under the rug the data that they didn't want people to see. There's lots of reasons. We could talk about the COVID vaccine being one of those. One report stated that over 1/3 of new drugs approved by the FDA between 2001 and 2010 were later withdrawn or given the infamous black box warning for safety concerns. A specific count of the exact number of withdrawn drugs is not readily available, strangely enough, and I did continue to look, but it's considered to be substantial. Hospitals, health insurances and pharma collectively hold the first, second, fourth and fifth positions on the list of highest grossing industries in the us. Commercial banking sits at third, in case you're wondering. So what holds that third spot is banking. Suffice it to say, medicine is big business. It's important to keep the Benjamins in mind because they help explain the revolving door on the regulation. I mean, let's be completely honest. And regulation determines options, what you can and what you can't do to improve your health. This is why I'm calling this podcast basically Empowering Self Health Advocacy. Because I really feel like this shift is coming. The unelected officials go right from regulating Big Pharma to owning them. Really? Which might help explain why the makers of the drugs are in bed with the ones approving them. Because honestly, they are. So I found this to be really fascinating. I went through a series of people that have gone from either the FDA to pharma or pharma to the FDA. Most of them are FDA to pharma. For example, Dr. Mark McClelland, sworn in as the commissioner of the Food and Drug Administration November 14th of 2002 joined the board of directors of JJ on October 14th of 2013. Dr. Steven Hahn was the 24th commissioner of the FDA December 17th, 2019 to 2021. In June 14th of 2021 he joined the flagship pioneering which launched Moderna, another very large pharmaceutical company. If you remember them from the COVID vaccine, you see what's happening right there. Just maybe just some. What do the conspiracy theorists say? Conflicts of interest when it comes to decision making of the people regulating the drugs that get approved and then in turn what happens to their direct competitors? They disappear. They can't get something onto the market. So maybe in 2022 US spending on pharmaceuticals topped $633 billion. So you can speculate that some incentive could exist to keep that bankroll going and get rid of the competition that is the compounding pharmacies. Cheap and effective therapeutics like the compounders supplements. How about exercise, food, eating healthy, not promoting the bottom of the carbohydrate food train. Spinach, green leafies, they stand in the way of hundreds of billions of dollars in profit. So I think that that's pretty evident in a lot of the smear campaigns that came out on vitamins and supplements. So we can talk about vitamin D, we can talk about zinc. We all remember ivermectin during the pandemic. Everyone talking about it's a horse dewormer. It can't, it's horrible. Why would you use that? Well it's not just a horse dewormer. If you look at the studies and actually the how it works. So vitamin D is dangerous. It could be taken at too high of a dose and then when it's taken too high it can give you kidney stones. I've been doing this 15 years giving up to 10,000 IUs of vitamin D to people and have never seen a vitamin D overdose. If anything immune systems get exponentially better. Studies were designed for these drugs to be underpowered, under, under dosed, given too late in the course of illness, especially with COVID and designed for the clear endpoint in mind. These inexpensive things don't work. Use our shiny drugs, please. It's the same playback tactics that is are now being employed with the peptides. I mean really we can look at the same. It's the same story, different book, right? The peptides. The disinformation campaign deployed about these peptides saying that they're not safe. I pulled actually a really great picture and I might write a blog for this too guys but it's a great photo of from Camels and It basically what I'm trying to say, and I like to say that the disinformation campaigns that happened in our country, we had a tobacco campaign, I think there's a huge sugar campaign, disinformation and carb campaign. And they have an ad where it says more doctors smoke Camels than any other cigarette, which I think is probably one of the most amusing advertisements out there. Again, just saying like, hey, tobacco is okay, doctors use it, right? Well, we had the data for decades that tobacco was not okay. Just like we have the data that sugar is not okay as a preservative and as in our foods, just like we have the data that corn and carbohydrates should not be the bottom of our food chain or should not have been the bottom of our food chain. Same thing with Peptides, right? So now we're getting into this peptides world and we're all looking for things that prevent illness. We want to prevent ending up in the hospital with diabetes, with heart disease. We want to prevent the insurance companies from shelling out all this money on these chronic diseases. Why? They wouldn't support it because it is going to save them millions and millions of dollars or billions of dollars eventually. Again, is that lobbying interest and money? So those of us in this space, we're really not. We're looking for the safest and most effective product. We're not really worried about where it comes from. Obviously we want it to be clean and safely produced so you don't have to take your blinders off before learning or realizing that Big pharma, big medicine, big fda, they have an angle. They all have an angle. They profit when you take their drugs. If you get a side effect, well, guess what, there's another drug to counter that. And they all quite possibly come from the same sister companies. And then fast forward, it all keeps you tied to health insurance and healthcare. And there's also lobbying interest between the two of those as well. So, you know, to heal yourself, you're your own best advocate. So try to look at the data through the lens of the propaganda and profit instead of seeing really just what they're trying to put in front of you. I think honestly, the WHI study, the Women's Health Initiative, while it may not have been all money driven, that data was super skewed as well. And if you look back at the study and the statistical significance and the patient size and population that they used and the drug they used and how bad that was for you, what they were trying to do is shift people away from Hormone therapy. The question is really, what was the other angle? Do we want to go more towards birth control? Are we trying to squash the compounding pharmacies? Because they were basically making compounded hormones way back that early. And I do believe that there was an angle with that as well. So what is peptides? I want to give you a little blurb on peptides that end there. Until 2020, peptides were just a string of amino acids. They were like the building blocks of life numbering 50amino acids or less. And once you hit 51, it changed basically to what we would classify as a protein. And in 2020, this is interesting, the FDA changed the definition of a peptide to a string of amino acids totaling less 40 or less. Okay, so they took away what, ten amino acids. Right. Science still uses the old fashioned definition, but pharma does not. And this allows for certain regulatory changes to be enforced on those 40 to 50amino acid peptide crews that weren't available previously. So now when they start calling it a peptide, they can get to at a lower number. They can start to basically pull them off the market more peptides than they were able to previously. Generally speaking, there's a hands off approach for the smaller molecules. And if we can shrink the total number of those, it's a big win for medicine. So how do they work? Peptides work as a signaling molecule. That's what they do. And the signaling molecule changes things. It's like a light switch. They flip things on, they flip things off, but if the light bulb is burnt out, the cell is gonna stay dark. Okay. So we think of drugs and medications. We think of as basically entering the room with contractors and rewiring a whole house with these peptides. We're really trying to turn the light switch on and off to try to basically reset certain pathways. They can't rewire. They can only enhance what your body is able to do already. So the safety and efficacy of these drugs is a lot better because we're not basically rewiring that house. We're not changing things. We're stimulating certain aspects of what your body can already do. In the world of functional medicine, we've historically used peptides to enhance, like immune system, regeneration, healing, cognition, things like that. And the question really is, are peptides natural? Are peptides synthetic? Can they be patented? Where are they made? And I think the key to this is all peptides have to be made. I mean, we were not like harvesting them from humans. So yes, they're made, they're synthesized, but they're synthesized to be identical to what's in our body. And this is what I alluded to earlier. For example, BPC157, or body protective complex is like one of the be all and end alls of peptides. We love it. And it naturally occurs in the gastric tissue, but it is made and synthesized in a lab to have the same amino acid chain that is natural to your own BPC157. But it's great for healing the gut, it's great for tissue repair, ligamentous injury, tendons, joints. So we used a ton of it. And there's a lot of peptides that are similarly synthesized to this. So what the FDA has done and what they will be doing is taking these peptides, pulling them off, saying they're not safe, giving them to big pharma. Pharma changes a couple amino acids in there so that they can change the peptides slightly, do these studies and put it out there as a pharmaceutical drug. Why? Because they work. They work. They have a great safety profile and they're efficacious and they work. Why are GLP1s the number one prescribed drug right now in the nation? Because it works. Right. So that is the problem, is they can't make the natural compound, compounding pharmacies can. So they will continue to try to reap the profits and the benefits of these compounded peptides that work, and to the detriment of our society, of our pocketbook, of our health, because it makes it more inaccessible to be honest and to be truthful, what happens when we change those amino acids. We don't know the downstream effects of always changing a couple. Even though they do the studies and try to make sure that there's no downstream effect of that. We really don't know that answer for until you're on it for a prolonged period of time. And that's usually data generations. Okay, okay, Just to give you an example, like Ozempic from Novo Nordisk, they swapped out two amino acids for two different ones actually at positions 8 and 34. And they put a spacer in there at 26amino acid. 26, and voila, you get a new compound which is called ozempic. Again, it's semaglutide with three amino acid changes essentially. And now you're charging a whole lot more money for it. And it's not natural anymore. It's synthesized to be non bioidentical. So, you know, here's what's strange. After widespread and uneventful use of these peptides, I mean, a really long time, all Of a sudden, the FDA comes in and decides they're going to regulate a whole heck of a lot of them all in one day. BPC157, CJC1295, thymosin beta 4, epamorelin, epitalon, thymus and alpha 1 were suddenly, quote, unquote, reclassified. Like I said, they're not banned by the fda. And we weren't blindsided by this because they were making money, people loved them and they were working. So it's only a matter of time before the FDA sees this and realizes that this is lucrative, that these drugs work and decides wherever their mutual interests in pharma lie to pull them and give them to pharma. So we joke. One dark, late, stormy evening, the regulators moved these compounds to what the FDA calls Category 2 list. Its reclassification implies that there was a, quote, unquote, a significant safety concern to these compounds in both 503A and 503B, which basically means injectable and non injectable, or in office, sorry, in office use and shipped directly to the patient and have since been effectively prob. We have since been effectively prohibited from compounding them. So why all of a sudden, I think the why all of a sudden is glp1s. Glp1s took away a lot of money. Glp1s created a lot of controversy and disdain for compounding pharmacies because now Big Pharma is losing money and they have competition and they want to reap the benefit of that basically loss. In order to do that, the FDA backed Big Pharma and said, okay, we're gonna basically tie their hands behind their back, take the top, and there's more than this. This is just the tip of the iceberg. Tape the top selling peptides and basically reclassify them and make them impossible to produce. And of course, now there's, there's also lawsuits and things like that kind of coming out between for the GLP1s. But in my opinion, these drugs all were taken off the market without any credible safety issues. There's safety problems that have been reported and I've looked and I've researched and there's no public mention of any adverse effects or dangerous spikes or mysterious cases of something leading back to peptide use. So take this for what it's worth, but we could go back to Vioxx, which was pulled off the market, and we can do a whole other podcast on this, but it all goes back to money. So on that note, I want to be clear, I really don't want to just have a public commentary here, but I think we saw this at Covid. We saw this with thyroid medications. We saw this with statins. We've seen this with food. We've seen this with tobacco. We've seen this with sugar. We've seen this so many times that really, the writing's on the wall and it needs to change. So I'm hoping that we will be able to do that, at least to some degree, with advocating for our own health and having an administration that maybe does prioritize health and wellness and not being on prescription medications and what I would say the prevention of dying. We're not in the prevention of illness. We're in the promoting wellness industry. So preventative medicine and starting early and teaching people how to eat clean and get rid of the gluten and the preservatives and get rid of red dyes and things that are in our foods is really what's keeping us sick. Right? They're keeping us sick. We need to promote the well. So on that note, guys, I am going to sign off today, but I thank you so much for being a part of my Anti Aging Unraveled podcast today. And I hope to have a guest in the next couple weeks as well. So stay tuned for a few guests on the program and I will talk to you all soon. Enjoy.
[00:39:04] Sa.
