Podcasts about fda approved

What if the reason you’re not healing isn’t that you need another diagnosis? 0:08 It’s that your cells aren’t receiving the right signals. Because the body doesn’t run on diagnosis, it runs on 0:16 communication. And peptides are one of the most powerful, most misunderstood 0:21 tools we have for cellular signaling, immune balance, tissue repair, gut 0:27 lining support, metabolic control, brain signaling, sleep cycles, and even sexual 0:35 wellness. Today, I’m going to do what most people won’t. Define peptides in 0:41 plain English for you. break them into categories by what they’re best at and 0:47 tell you which ones are FDA approved on the list and which ones are commonly 0:53 used off label or investigational with the evidence that actually says these 1:00 work. This is going to be a powerful episode and if you’ve ever felt like you’re hearing hype without clarity, 1:07 this one’s for you. So, as usual, grab your cup of coffee or tea and settle in 1:13 as we talk about peptides that can fit into your healing journey. We’re going 1:19 to have a short word from our sponsor. You know, we got to do that. That’s how we stay on the air here. So, we will be 1:26 right back after this. Did you know sweating can literally heal your cells? 1:32I nfrared saunas don’t just relax you. They detox your body, balance hormones, 1:37 and boost mitochondrial energy. I’m obsessed with my health tech sauna. And 1:42 right now, you can save $500 with my code at healthtechalth.com/drmuthqen25. 1:54 All right, here we go, guys. I am excited to dive into peptides with you. 2:00 So understanding peptides is foundational, right? And I’ve been 2:06 studying peptides now for about nine years. Um, and I find that they are 2:13 incredible. Um, so I want to break down for you what peptides actually are, what 2:19 they do, and some of the top peptides that are available today, and how they 2:25 can be utilized. Because I think it’s really important. And I think it’s it’s there’s a lot of confusion out there about what these things actually are and 2:32 are they safe? Are they not? When do we use them? What’s the science behind them? So, we’re going to dive in and 2:38 we’re going to talk about all things peptides. So, let’s get ready here. Here we go. So, peptides are short chains of 2:45 amino acids and they typically range anywhere from 2 to 50 amino acids and 2:51 they’re linked by peptide bonds. So think of them as the superglue that holds the amino acids together. They sit 2:58 between the amino acids and they are full proteins in terms of their size and 3:04 their complex structure. And what makes peptides particularly interesting in 3:10 medicine is their role as signaling molecules. They’re essentially the 3:15 body’s text messages carrying specific instructions to cells and tissues. And 3:21 unlike our proteins which often serve as structural roles or act as enzymes, 3:28 peptides typically function as hormones, neurotransmitters and growth factors and 3:33 they bind to specific receptors on the cell’s surfaces or within the cells and 3:39 they trigger this effect. It’s like a cascade effect of a biochemical reaction 3:45 that ultimately changes the cellular behavior. So basically, it’s changing 3:50 the way the body’s cell structure acts. And this is why peptides can be so 3:56 incredibly powerful and therapeutic when you introduce the right peptide signal. 4:02 Now, you could theoretically redirect cellular processes toward healing, 4:07 towards metabolism, immune balance, tissue repair. Any of those things can 4:14 be manipulated to do a certain thing once we add the peptide. The challenge 4:19 in peptide medicine though lies in distinguishing between those peptides that have been rigorously studied, 4:26 proven safe and effective and approved by regulatory bodies like the FDA versus 4:31 those that exist in what we call the gray zone of a promising clinical data. 4:36 But they really lack human validation so far. And this distinction is critical because the presence of a plausible 4:43 mechanism does not guarantee safety or efficacy in living humans. So, this is 4:50 really important and we’re going to dive in and look at some of the research on all of these different peptides that are 4:56 available and I’m excited to say there’s some amazing peptides being studied right now that unfortunately are not 5:01 available. But I can’t wait to see them hit the market for us because it is going to be a gamecher as far as health 5:09 and longevity. So there is a quality control issue and there is a hidden 5:14 variable in peptide medicine with this and it’s one of the most underappreciated aspects of peptide 5:21 therapy particularly for non-FDA approved peptides. It’s quality control. 5:26 When we discuss pharmaceutical medicines, we take for granted that the pill contains what the label says. Not 5:32 always true depending on where it comes from. You guys, if you’ve heard my episodes before talk about how many of our medications are made in China and 5:41 have been contaminated with other things, you will realize that that is not always true. So, just because it has 5:48 the FDA stamp of approval on the medication, it still does not necessarily mean it’s safe and we still 5:54 need to do our homework on it. So, sorry for digressing on you guys, but you know, when we get a medication, we we 6:00 think that what the amount says is what is there, doesn’t have contaminants, it’s manufactured with good 6:06 manufacturing practices. You’ll see that listed as GMP on the bottle, and it’s been stored properly, it’s been 6:12 maintained stable, and with research peptides and compounded formulations, 6:17 none of this can be assumed. So, I will share a story with you. There was a gentleman that was purchasing these 6:24 peptides online from a research facility and um did not know that they were 6:30 coming from China and he was ordering a particular growth hormone peptide and 6:35 after a little while he had he had done fine for the few first few bottles. After a little while he started having 6:42 some complications. He started getting really irritable and angry and ragy and 6:47 he didn’t quite know what was going on. And so he decided to go get some testing done. He had some blood testing done and 6:53 his testosterone level was over 5,000. So for those of you who know what testosterone level should be for a guy, 7:00 they really shouldn’t be any higher than about 1,00200 would be absolute max that we’d want to see. Now he was taking 7:06 testosterone but not to that degree. And prior to adding this peptide, his 7:12 testosterone was very stable. What they ended up finding out was the peptide that he was getting, whoever was 7:18 manufacturing it added testosterone to the peptide. They felt like if if it had growth hormone, that was great, but if 7:25 it had growth hormone and tes testosterone, all the better. And he didn’t know that. And this is the 7:31 problem that we can have with peptides if you don’t source them properly. if you’re not working with somebody that 7:37 knows how to source them and can prove that they are what they say they are. Um, I’m sure there’s a whole bunch of 7:42 studies out there too of people getting these peptides and paying hundreds of thousands of dollars for them over their 7:48 lifetime and finding out they were nothing more than just sterile water. So, you really do need to be careful 7:53 with your quality control. Now, this kind of leads us right into the next topic that we’re going to talk about and that’s the manufacturing question, 8:00 right? The FDA approved peptides are manufactured in facilities subject to 8:05 the FDA inspection rules following our GMP regulations and these facilities 8:11 must validate their manufacturing process, demonstrate consistency batch to batch, test for purity and potency. 8:18 They need to test for bacterial endotoxins and sterility and they need to maintain detailed records. So, when a 8:25 pharmaceutical company submits a drug application, the FDA inspects the manufacturing facility as part of the 8:32 approval process. If you’re getting peptides from a different country, none of that is happening. And there are some 8:38 ways for us to determine if that is what you’re getting. Typically, the rule of thumb is if your peptides are coming 8:44 with a different colored top, every one of them has a different colored top. Those are typically being sourced out of 8:49 China. I wouldn’t say that’s 100% but that’s kind of the rule of thumb that people follow. So compoundingies these 8:56 are thearmacies that make our bio identical hormones. They can make medications in any dose or strength or 9:02 route. There are thousands of them in every not that not in every state but 9:08 there are thousands of them around the country right now. So these compoundingies are registered as 503A 9:15 facilities. They do traditional compounding for individual prescriptions, right? Like they can make 9:20 thyroid, they can make LDN, they can make estrogen. You can also have a 503b 9:27 facility, which is an outsourcing facility. And these companies produce larger batches of products. They’re they 9:34 have some oversight, but they’re less stringent than for FDA approved 9:40 manufacturers. And state boards of pharmacy regulate a 503A pharmacy. And 9:45 the FDA can inspect the 503b facility, but doesn’t preapprove any of their 9:52 compounding products. So, they can inspect it, but they don’t approve them. So, research chemicals and these 9:58 suppliers operate essentially with no oversight. They explicitly market products for research use only, not for 10:06 human consumption to avoid FDA regulation. If they put that on their 10:12 product, they don’t have to comply to what the FDA is saying. And there is no required manufacturing strategies or 10:19 standards, no required testing, no required sterility assurance, and no enforcement mechanisms if products are 10:26 mislabeled or contaminated. So basically, they don’t have the liability, but that doesn’t mean that 10:31 all of them are badies or bad suppliers. It just means they don’t have to comply 10:37 to the FDA rules. Now, there are many of these companies that I’ve seen and I’ve talked to that do do a lot of this. They 10:44 do test their product for sterility. They do test their product to make sure it is what it says it is. They don’t 10:51 have to, but they do. So, if you’re going to decide to use a company that 10:56 has research only, not for human consumption, at least ask for their 11:02 proof of testing so that you know that the product you’re getting is what it says it is and that it’s clean. Because 11:08 this is where we run into the problem is in purity. So in purity peptide 11:13 synthesis can produce not just the targeted peptide but also related 11:19 peptides with deletions, substitutions, truncations or truncations of amino 11:25 acids. Sorry. And this high performance liquid we call it uh chromatography can 11:30 separate these related impurities and quality and quantify the actual target 11:35 of the peptide content. So a certificate of analysis is what you want to ask these companies for. This shows the HPLC 11:44 the testing mechanism with greater than 95% or ideally 98% purity which 11:51 indicates a higher quality product. So this certificate of analysis can be fabricated may not represent the 11:57 specific batch being sold. It happens. We need to know not everybody is honest. Not everybody, you know, does what they 12:03 say and it does what’s right. But at least you at least they’re giving you something and you have some security. 12:10 and then choose a company that was referred to by someone else that has done some homework as well. In in 12:16 commercial research, there’s independent testing and they research peptides and this has been really shocking 12:23 variability that they’ve seen. Some products contain 50% or less of the 12:29 claimed peptide and some contained primarily degradation of the product or manufacturing impurities and some 12:36 contained bacterial endotoxins at levels that could cause fever and systemic 12:42 inflammation if it was truly injected. And I would also worry with some of those problems, you know, depending on 12:48 what impurity or bacterial endotoxin was there. If you’re using a product to boost your immune system and your immune 12:54 system is already compromised, these bacterial endotoxins can actually make you sicker instead of what you want it 13:02 to do, which is making you better. So, sterility is always an issue with anything that is manufactured, 13:08 especially things that we’re doing as an injection. Peptides are intended for injection. They must be sterile. They 13:16 must be kept safe. And pharmaceutical manufacturers conduct this sterility testing on every batch. 13:22 Compoundingarmacies should conduct sterility testing particularly for high-risisk compounded 13:28 sterile preparations and research chemical suppliers may or may not conduct any testing. So injecting 13:35 non-sterile material can cause local infections, abscesses at the injection 13:41 site and or if the bacteria enters the bloodstream could potentially be 13:46 life-threatening and you could have sepsis. Now, excuse me. We saw this 13:52 happen in a compounding pharmacy uh gosh, it’s probably been 10 years ago 13:57 now, I think. um they unfortunately had a strep uh contamination in their 14:03 product and they weren’t testing it. It was a large compounding pharmacy out of Florida and they were making products 14:08 that were being injected into the joints and um these people got very very sick 14:14 and some of them died and um some of them got very very injured by this uh 14:21 complication that happened. So it’s not like this doesn’t happen. It does, but it doesn’t happen often. And that’s what 14:28 we have to know about. And so, when we’re talking with you guys about storage and stability, it’s really 14:34 important to make sure you maintain your peptides well. So, many peptides are unstable at room temperature. They 14:41 require refrigeration or freezing. We tell everyone to make sure you’re refrigerating your peptides. That way, 14:48 there’s no question about it. when it stays cold um it prevents or slows down 14:54 the process of uh bacteria growing in it. So some of these peptides actually 14:59 degrade very rapidly in the solution and they must be reconstituted immediately before use and reconstitution of the 15:07 peptides really has limited stability often just days to weeks not months. So 15:13 improper storage, temperature, um changes during shipping or prolonged 15:19 storage of a reconstituted product can lead to degradation into inactivity or 15:25 potentially even a harmful breakdown of the product itself. So if you have a product that’s been sitting in your 15:30 refrigerator for a month or two months or 3 months or 6 months, just throw it away. It’s not going to be any good. 15:37 you’re not going to actually get the peptide and the uh potency that you’re looking for anyway out of it and the 15:44 potential of you introducing an endotoxin, a bacterial endotoxin is quite high at that point. So you just 15:50 really don’t want to take the risk, excuse me. So what practitioners, what 15:56 should we do and what should patients do? Well, for any peptide therapy, we 16:03 want to source our verification. know where the peptide product comes from. Is 16:08 it an FDA approved product? Is it a 503b compounding? A research chemical 16:14 supplier? Is there a certificate of analysis? Request and review this COA. 16:20 And you want it to show purity greater than 95% but ideally greater than 98%. 16:27 You want that identity be identity to be confirmed by mass spectromedy. Uh 16:33 sterility testing should be done. Bacterial endotoxin testing should be done. Batch number matching of the 16:39 product that you received should be done. Proper storage. You want to know that this has been refrigerated or 16:46 frozen as directed once it’s been mixed. Look at the expiration dates for reconstituting your peptides. Track that 16:53 reconstitution date and discarded accordingly like we just talked about. Monitor for your adverse effects. Even 17:01 with the perfect quality control, monitoring for adverse effects is essential with questionable quality and 17:08 vigilance is really critical here. I know it’s frustrating for a lot of patients when they have to get several 17:15 bottles and they only last a week or two. right here, you guys. This is why 17:21 they only last a short period of time because once they’re mixed, they start 17:26 to degrade and they won’t be good and you won’t get the benefit from it. So, 17:31 it’s really important with these research peptides specifically, practitioners should recognize that all 17:38 recommending products without quality assurance violates the fundamental medical principle of first do no harm. 17:45 If a patient is determined to use research peptides despite counseling, providing guidance on quality 17:52 verification, requesting those COAs, using pharmaceutical grade sources when available, proper testing, this all 17:59 reduces harm, but doesn’t constitute necessarily that recommendation. Now, 18:06 that being said, today it’s very difficult to find peptides by the compoundingies because of what the FDA 18:13 has done. So most of the peptides that are available to us have been labeled 18:18 not for human consumption, not because they’re not good products, but because 18:25 of what the FDA did. And this is how these companies have been able to 18:31 continue to provide peptides to the medical community. And if you know you 18:36 have a good company, then you’re, you know, you’re still taking the risk, right? But at the end of the day, the 18:42 reason they’re doing that is to protect themselves from the FDA, from liability. Um, so just kind of know that there is 18:50 some talk in the community with um Bobby Kennedy that this is going to change and 18:55 they are going to bring peptides back to the compounding pharmacies. Now, we don’t know which ones they’re going to 19:01 bring back. Uh, will it be all of them? Will it just be some of them? What’s going to happen here? Um, is it going to 19:07 go to the pharmaceutical companies like our GLP1s did? We don’t know what that’s going to look like quite yet. Um, but it 19:14 is coming and that is positive news. So, let’s talk now about FDA approved 19:21 peptide medications. So, this is the metabolic revolution, right? GLP1 19:28 and our dual increeting agonists. This is an exciting time. GLP-1s are amazing. 19:35 Um, a lot of people are skeptical, a lot of people love them, a lot of people hate them. Whichever side of the fence 19:42 that you’re on, I understand. But I want to talk about the science of it today 19:48 and what it actually means for people. So, the story of GLP1 glucagon like 19:54 peptide one represents one of the most significant advances in metabolic 19:59 medicine in the past several decades. GLP-1 is an accretin hormone. It’s 20:05 gutder derived peptide that potentiates insulin secretion in response to food 20:11 intake. And the body naturally produces GLP-1 in the intestinal L cells, but it 20:17 rapidly degraded by the enzyme DPP4 giving it a halflife of only about 2 20:24 minutes. So this rapid breakdown made in therapeutically impractical until 20:31 research was developed and modified the analoges that resist the enzyme degradation. So for those people who 20:39 never feel full when they’re eating, never feel satisfied when they’re done, this is because their body is either not 20:46 producing enough GLP1 or it’s not getting the signal right. And this is a 20:51 leptin issue. This is an insulin issue. It’s a GLP-1 issue. It’s a complicated 20:56 issue. This is not anything that the person is doing wrong. It’s what is happening to their body. And so GLP1s 21:03 have really revolutionized this. So one particular GLP-1 that we have is 21:09 semiglutide. And this GLP-1 agonist is what changed everything in the world of 21:16 metabolic medicine. Semiglutide is marketed as ompic for type 2 diabetes 21:23 and it’s marketed as WGOI for chronic weight management. It is a modified 21:29 GLP-1 analog with 95 or sorry 94% amino acid sequence uh homology to human 21:37 GLP-1. So it means that it’s it’s just like our own GLP-1 that we make. This 21:42 modification includes specific amino acid substitutions and the addition of C18 21:50 a fatty acid chain which allows the peptide to bind to albumin. Now this 21:56 albumin binding dramatically extends the half-life to approximately one week 22:01 enabling one weekly dosing which is a major advantage over the earlier GLP-1 22:07 agonists that require daily or twice daily injections. The mechanism by which 22:13 semiglutide works is multiaceted. At the pancreatin level, it binds to GLP-1 22:20 receptors on the pancreatic beta cells enhancing glucose depending sorry 22:27 enhancing glucose dependent insulin secretion. This glucose dependency is 22:33 crucial. It means the peptide only stimulates insulin release when blood glucose is elevated. This dramatically 22:41 reduces the hypoglycemic risk compared to insulin or even uh sulfuras. 22:47 Simultaneously semiglutide suppresses glucagon secretion from pancreatic alpha 22:53 cells further improving glycemic control. This is really amazing because 23:00 over the years when we’ve used insulin, which is also a peptide by the way, you 23:05 had to dose it just right because if you didn’t, you would produce so much insulin that it would crash the blood 23:12 sugar and then somebody would have too low of a blood sugar. They’d be hypoglycemic and they’d have to eat more 23:18 sugar and then they’d have to modify the insulin again and the person would be going up and down, up and down, up and 23:24 down all day long. And that created a lot of problems for people and so this 23:30 helps to stabilize that so it is not such an intense change. Now in the GI 23:36 tract semiglutide delays the gastric emptying particularly pronounced during 23:41 the initial weeks of therapy. This slowing of the gastric emptying contributes to the sensation of being 23:48 full and early satiety that patients often describe. However, this effect 23:54 tends to attend to weight over time as the body adapts through the appetite 24:00 suppressing effects generally persist through central mechanisms. So, when we 24:05 talk about what is actually happening, we’re slowing that digestive process down. That’s why people aren’t so 24:11 hungry. It’s why they’re not eating so much. This is why people can develop constipation with these products because 24:17 it’s slowing the body’s digestive tract down. Now some people will call this 24:22 gastroparesis. Um gastroparesis is actually different. 24:28 It is when we lose control over what’s happening in the in the colon like the 24:34 nerves and things like that just stop working. I have never seen that with the GLP1s that we prescribe in micro doing. 24:42 um it’s been documented. It can happen, but again it a lot of it is dosing and a 24:48 lot of it is staying on top of your client and what’s happening and what’s going on and what you’re doing and making sure that they do have good 24:54 motility still. So a lot of these things can be mitigated if you have problems 24:59 with them. Now one of the most profound effects of semiglutide occur in the 25:05 central nervous system. GLP-1 receptors are widely distributed in the brain 25:10 particularly in the hypothalamus and the brain stem area where we are involved in 25:15 appetite regulation. So when when wilding and colleagues published their 25:20 landmark step one trial in the New England Journal of Medicine in 2021, 25:25 they demonstrated that participants receiving 2.4 4 milligrams of semiglutide weekly achieved an average 25:32 weight loss of 14.9% of their body weight over 68 weeks. Now, I want you 25:39 guys to really understand this. We’re talking roughly 15% body weight loss 25:45 over a year, longer than a year. 52 weeks is a year, right? This is 68 25:50 weeks. So, it took longer for them to lose. We’re not talking about giving 25:55 somebody a dose to lose 15% of their body mass in a month or two. That that 26:01 is not healthy for any of us. That is not what we’re talking about doing here. Now, they compared this to placebo and 26:08 the placebo was only 2.4%. So, that is a significant difference. 26:14 And even beyond the numbers, patients reported something very qualitatively different, a reduction in what’s now 26:21 called food noise. Everybody knows what food noise is. We’ve talked about this long before GLP1. It’s that craving. 26:28 It’s that part of your brain that just keeps thinking about I want to eat something. You know, that was actually 26:34 reduced and they didn’t expect to see that happen. Now, this refers to the constant mental preoccupation with food, 26:42 the intrusive thoughts about eating, the difficulty in feeling satisfied. Semi-glutide appears to appears to 26:49 modulate reward pathways in the misolyic system reducing hedonic eating and food 26:57 cravings. Now there are also great cardiovascular effects of semiglutide 27:02 that extend beyond weight loss. Uh the sustained six and select trials 27:07 demonstrated significant reductions in major adverse cardiovascular events uh 27:14 mace in high-risisk populations. The select trial published in 2023 showed 27:20 that semiglutide reduced cardiovascular death, non-fatal myioardial inffection 27:25 and non-fatal stroke by 20% in adults with overweight or obesity and 27:31 established cardiovascular disease but without diabetes. So this suggests that 27:37 mechanisms beyond glucose control and weight loss possibly including 27:42 anti-inflammatory effects, improvements in endothelial function and favorable 27:47 changes to lipid profiles. Now I will tell you the clients that I work with that are on GLP1, 27:53 they will tell you that their inflammation has been significantly reduced. We are also seeing really 28:00 amazing results in lipid profiles. um part of its weight loss, but there is a 28:06 component to this that is lowering the triglyceride levels because it’s related to sugar and how the body’s processing 28:11 it. And we’re seeing better profiles, less need for statins as a result of 28:17 that. If if you want to listen to my episode on statins, I have one on that. Uh they are not my favorite medication. 28:24 I think it’s overprescribed and overused um and not really affecting or 28:29 addressing the problem. So these things can really be helpful. There’s also some 28:34 uh ramblings going on with GLP-1s saying that they may be able to help with 28:40 addiction in the future because of where they’re finding it affecting the brain and how it affects the food noise and 28:47 the cravings that we have for food and the addiction for food. Could it potentially help with other addictions 28:53 down the road? We’ll have to wait and see on that one. So semiglutide’s FDA prescribing information also includes a 29:00 box uh boxed warning about thyroid sea cell tumors. So in rodent studies 29:06 semiglutide caused dose dependent and treatment duration dependent sea cell 29:12 tumors at clinically relevant exposures. So while it’s unknown whether or not 29:17 semiglutide causes uh thyroid cancer tumors in humans and the rodent thyroid biology 29:26 differs significantly from humans, the drug is contraindicated in patients with a personal or family history of 29:33 medillary thyroid carcinoma or in patients with multiple endocrine neopl neoplasia syndrome type two. it is 29:42 uh contraindicated for safety effects with that. Um I have seen endocrinologists okay GLP1s to be used 29:50 in patients who’ve had other forms of thyroid cancer just not the meillary 29:55 thyroid cancer. So there is possibility there. Now the most common side effects 30:00 are gastrointestinal. It’s nausea affects about 20 to 44% of patients 30:06 depending on the formulation with diarrhea, vomiting, constipation, abdominal pain, and also frequently 30:13 reported in clinical trials. I see this in my clinic, too, especially dose dependent. Um, and it happens early on 30:20 when you’re first starting the medication, but seems to settle out over time. The one that I would add to this 30:26 that I don’t think they have on here is an increase in acid reflux. We also see that quite often uh especially in people 30:33 who suffer with acid reflux to begin with. Now these effects are typically most 30:40 pronounced during the escalation and they like I said often improve over time 30:45 but more serious but less common adverse effects include acute pancreatitis. 30:51 The medication needs to be discontinued immediately if this is confirmed. You can see some diabetic retinopathy 30:57 complications in patients with pre-existing retinopathy and acute kidney injury. Um, this usually happens 31:05 secondarily to dehydration from the GI effects. There are some gallbladder disease um that can occur and people who 31:13 have a sensitive gallbladder will describe uh discomfort with that. I’ve 31:18 even seen some people who’ve had their gallbladder out on GLP1s at the higher doses complain of similar pain that they 31:25 used to have when their gallbladder was in. So, really important to just kind of monitor these symptoms and work closely 31:32 with somebody that understands them and can be on top of them quite quickly if this happens. Excuse me. From an 31:39 integrative medicine perspective, semiglutide really represents a powerful tool, but it’s not a standalone 31:46 solution. Remember, the medication addresses one aspect of the metabolic dysfunction, the signaling systems 31:53 controlling appetite and glucose homeostasis, but it doesn’t address the root cause that led to the metabolic 32:00 disease in the first place. Patients who rely solely on the medication without addressing the ultrarocessed food 32:07 consumption, the ccadian disruptions, the chronic stress, the sleep apnea, or 32:12 underlying hormonal imbalances often experience weight regain when the medication is discontinued. 32:20 The drug is also not a substitute for addressing the emotional and psychological drivers of eating 32:26 behavior, including the unresolved trauma that may manifest as emotional eating. I think this is really important 32:33 because we don’t address the trauma issue enough with clients and we need to 32:38 be looking at that. There is a huge trauma effect out there these days that is I don’t want to say leading to or 32:45 causing but it is definitely contributing to chronic illness and it’s not being talked about enough. So we 32:52 really need to be talking about this and addressing this trauma aspect. Now the next GLP that one that I want to talk 32:59 about is trespathide. This is a dual agonist. It takes center stage. It is my 33:05 favorite GLP one. Trisepatide is marketed as Mangjaro for type 2 diabetes 33:11 and Zepbound for chronic weight management and it represents the next 33:16 evolution in increantbased therapy. This is a dual agonist a 39 amino acid 33:23 synthetic peptide structurally based on the human glucose dependent insulin tropic peptide so GIP sequence but 33:31 modified to activate both the GIP receptors and the GLP1 receptors. So the 33:37 addition of the GI GIP agonism to the GLP1 agonism appears to create this 33:46 synergistic effect that goes beyond simply adding the two mechanisms together. So the GIP like GLP-1 is an 33:55 increant hormone secreted by what is called the K cells in response to nutrient intake. It enhances glucose 34:02 dependent insulin secretion but it also effects on atapost tissue metabolism 34:09 potentially improving the insulin sensitivity in fat cells and influencing 34:14 how the body stores and metabolizes fat. So some research suggests that GIP may 34:20 also have effects on energy expenditure though this remains an area of 34:26 investigation. So basically what we’re saying is this drug may actually help 34:32 people who are insulin resistant or insulin sensitive, not just somebody who 34:38 has problems with glucose control. So, this is super exciting because it opens 34:43 up the door for all of these people for decades that we’ve been trying to manage with insulin resistance and trying to 34:50 prevent diabetes and honestly most of the time have been unsuccessful 34:56 unless you can keep your diet at 50 grams of carbs or less a day, which is extremely difficult. Um, and take some 35:04 supplements that may or may not work and or take some metformin that may or may not help. this drug actually really 35:11opens that up and helps in that capacity. So there was a clinical trial 35:17 called the surmount clinical trial which demonstrated that trespathide produces 35:22 even more substantial weight loss than semiglutide. In the surerount one trial published by uh J tree I might have said 35:31 that wrong. I apologize if I slaughtered your name and colleagues in the New York England Journal of Medicine in 2022. 35:38 Participants receiving the highest dose of trespide, which is 15 milligrams, achieved an average weight loss of 20.9% 35:47 of their body weight over 72 weeks, compared to 3.1% with placebo. This 35:54 level of weight loss approaches what’s typically only seen in beriatric surgery. So, this is amazing because if 36:02 this medication works and we don’t have to do beriatric surgery, stomach stapling basically, um, oh my gosh, it’s 36:11 amazing. There are so many complications and risks that go with stomach stapling and the different procedures that they 36:17 do these days. People don’t absorb their nutrients properly. They have to do liquid nutrients. It’s very complicated. 36:24 It’s very challenging. Many of these people gain their weight back. Um, and 36:30 this procedure is not fun to go through. So, if we could change that and change 36:35 the lives of people who’ve really been struggling, it is amazing. And I will tell you that I have seen this work. I 36:42 have seen people lose 100 150 pounds on these medications over a year or two 36:50 period of time. It is definitely slower than beriatric surgery on some standpoints, but that is okay. You don’t 36:56 want that rapid weight loss. It’s not good for you. It’s not healthy for you. It doesn’t look well. You know, we want 37:03 to do this safely and effectively in the best way that we can possibly do that for you. Now, the adverse effect profile 37:10 is similar to semiglutide. It’s dominated by gastrointestinal effects. 37:15 Nausea, diarrhea, decreased appetite, vomiting, constipation. These were all commonly reported in the surmount 37:22 trials. And like semiglutide, tricepide carries a blackbox warning regarding the 37:27 thyroid sea cell tumors based on the rodent data and it shares the same contra indications in patients with a 37:34 family history of thyroid cancer and men too. So the mechanism behind why 37:40 tepatide often produces more substantial weight loss than GLP-1. The agonism 37:45 alone remains under investigation, but it may relate to the complimentary effects on the different aspects of 37:51 energy homeostasis or to GIP’s effects on atapost tissue and potentially on 37:58 central central nervous system pathways that GLP1 alone doesn’t fully address. 38:03 Now patients often report even more profound reductions in food noise with tricepide compared to GLP1 and uh sorry 38:12 GLP1 the agonists through this is anecdotal and hasn’t been regularly 38:17 quantified in quality studies. So I’ve done both uh personally and in my 38:22 practice. I really like trespide better than semiglutide. For me I had too many side effects with semiglutide. uh I had 38:30 less side effects with trespathide. I also plateaued on semiglutide which I 38:35 didn’t really care for. And with Tresepide, I haven’t plateaued and I’ve been able 38:42 to lose about 25 pounds in um a year and a half and I’ve been able to maintain 38:49 that. Um and I continued to use it because I do have a strong family history of cardiovascular disease. And 38:56 if this could help me so that I don’t follow my family lineage with cardiovascular disease, I am all for 39:03 trying to do that. I’ve watched too many of my family members suffer from this. I’ve lost my dad at a very young age. I 39:09 lost my grandfather at a young age to it. All of their brothers to this. And I don’t want to be that same person. So 39:16 that is why I chose to do that. And I think it’s really important for us to take a look at that and understand that. 39:24 Now, I know this has been a really long podcast and I don’t typically do podcasts this long. I have a whole host 39:31 of information on additional peptides. So, I’m going to break this up for you 39:36 guys and I’m going to do another episode and we’re going to pick up where we left off here with these peptides so that we 39:43 can actually start to dive into different peptides as well. So, check 39:48 out my next podcast show when we’re going to dive into the peptides that 39:54 talk about sexual wellness, immune function, and all the other cool things 39:59 that we can do with peptides. So until then, remember to like, share, and 40:04 subscribe. It really helps us get out to other people and share our information, 40:10 and join us for our next episode as we continue the talk about peptides. 40:15 Welcome to Let’s Talk Wellness Now, where we bring expert insights directly to you. Please note that the views and 40:21 information shared by our guests are their own and do not necessarily reflect those of Let’s Talk Wellness Now, its 40:28 management, or our partners. Each affiliate, sponsor, and partner is an 40:34 independent entity with its own perspectives. Today’s content is provided forformational and educational 40:40 purposes only and should not be considered specific advice, whether financial, medical, or legal. While we 40:48 strive to present accurate and useful information, we cannot guarantee its completeness or relevance to your unique 40:56 circumstances. We encourage you to consult with a qualified professional to address your 41:01 individual needs. Your use of information from this broadcast is entirely at your own risk. By continuing 41:08 to listen, you agree to indemnify and hold Let’s Talk Wellness Now and its 41:14 associates harmless from any claims or damages arising from the use of this 41:20 content. We may update this disclaimer at any time and changes will take effect 41:26 immediately upon posting or broadcast. Thank you for tuning in. We hope you 41:31 find this episode both insightful and thought-provoking. Listener discretion 41:36 is advised.The post Episode 256 – How Peptides Work, Benefits, and FDA-Approved vs Off-Label Use Explained first appeared on Let's Talk Wellness Now.

In this episode, Jess and Sarah welcome Dr. Neil Goldenberg to explore the unique challenges and complexities of conducting pediatric clinical trials. The scientists examine the necessity of multi-center studies, ethical considerations specific to research involving children, and the critical physiological differences between pediatric and adult populations that require distinct research approaches. Dr. Goldenberg shares valuable insights from his research experiences, including the KidsDOTT and COVAC-TP trials, while discussing the essential roles of funding and infrastructure in advancing pediatric research. Throughout the conversation, the experts emphasize the importance of collaboration and advocacy in this field. The episode concludes with an optimistic perspective on the future of pediatric clinical research and its potential to improve health outcomes for children. Watch the conversation on YouTube: https://youtu.be/yqS4b3kqHHM (00:00) Intro & Public Health Update (05:33) What's A Health/Science News Item That Caught Your Attention? (07:34) What Is A Multi-Center Study? (09:35) What Protections Are There For Human Subject Clinical Trials? (13:04) Why Is There A Need For Separate Trials For Children Vs Adults? (17:42) Examples of Dr. Goldenberg's Trials (24:50) What Does It Mean If Pediatric Trials Don't Get Funded? (29:13) Is There Anything We Can Do To Support Pediatric Clinical Trials? (31:51) What's Giving You Hope In Public Health And Science Right Now? https://www.hopkinsmedicine.org/all-childrens-hospital/ https://www.linkedin.com/in/neil-goldenberg-md-phd-59226b63 Disclaimer from Dr. Goldenberg: "The opinions I share during this conversation are my own and do not necessarily reflect the official positions or policies of my employer." ----------------------------------------------------------------------------------------------------------------------- Interested in advertising with us? Please reach out to advertising@airwavemedia.com, with “Unbiased Science” in the subject line. PLEASE NOTE: The discussion and information provided in this podcast are for general educational, scientific, and informational purposes only and are not intended as, and should not be treated as, medical or other professional advice for any particular individual or individuals. Every person and medical issue is different, and diagnosis and treatment requires consideration of specific facts often unique to the individual. As such, the information contained in this podcast should not be used as a substitute for consultation with and/or treatment by a doctor or other medical professional. If you are experiencing any medical issue or have any medical concern, you should consult with a doctor or other medical professional. Further, due to the inherent limitations of a podcast such as this as well as ongoing scientific developments, we do not guarantee the completeness or accuracy of the information or analysis provided in this podcast, although, of course we always endeavor to provide comprehensive information and analysis. In no event may Unbiased Science or any of the participants in this podcast be held liable to the listener or anyone else for any decision allegedly made or action allegedly taken or not taken allegedly in reliance on the discussion or information in this podcast or for any damages allegedly resulting from such reliance. The information provided herein do not represent the views of our employers. Learn more about your ad choices. Visit megaphone.fm/adchoices

Join Dr. Nemo Patel, Dr. Matthew Donovan, and Dr. Danny Mammo as they share real-world insights on how the next generation of retina specialists are optimizing their patient care by adopting FDA-approved therapies for appropriate patients. Together, they explore how to navigate patient selection, safety monitoring, and workflow integration—while maintaining efficiency and patient confidence. The conversation highlights how practices are evolving to meet the growing need for GA management, from staff training and patient education to effective collaboration with referring optometrists.Listen in to gain actionable strategies that you can implement in your practice today. Please see full Prescribing Information at http://bit.ly/4jXHTsb. This episode is sponsored by Apellis Pharmaceuticals, which developed its content and compensated the speakers.

SummaryIn this episode, Clayton Cuteri delves into various pressing topics, including the importance of enjoying the present moment amidst chaos, political commentary on Israel's actions during Christmas, Trump's controversial military decisions, food safety issues, and the recent ceasefire between Thailand and Cambodia. He emphasizes the need for personal empowerment and knowledge as a means to create a better world and achieve peace.BONUS: Clayton discusses some Indigo Education knowledge.Clayton's Social Media LinkTree | TikTok | Instagram | X (Twitter) | YouTube | RumbleTimecodes 00:00 - Intro01:07 - Current Events and the State of the World03:04 - Political Commentary on Israel and Christmas15:03 - Trump's Actions and the Consequences19:00 - Food Safety and Health Concerns22:46 - Ceasefire in Thailand and Cambodia24:40 - Empowerment and the Path to World PeaceIntro/Outro Music Producer: Don Kin IG: https://www.instagram.com/donkinmusic/Spotify: https://open.spotify.com/artist/44QKqKsd81oJEBKffwdFfPSuper grateful for this guy ^NEWSLETTER - SIGN UP HEREBecome a supporter of this podcast: https://www.spreaker.com/podcast/traveling-to-consciousness-with-clayton-cuteri--6765271/support.Official Traveling to Consciousness Website HEREALL Indigo Education Podcasts HEREMy Book: The Secret Teachings of Jesus HERE

In this episode, we sit down with Dr. Jean Bennett, Professor Emeritus of Ophthalmology at Penn Medicine and a true pioneer in gene therapy research. Dr. Bennett led the team that developed the first FDA-approved gene therapy to treat inherited blindness, transforming the lives of patients with retinitis pigmentosa and other retinal diseases. Her groundbreaking work spans over three decades and has opened doors for gene therapy applications far beyond ophthalmology. Dr. Bennett shares her remarkable journey from a curious child in New Haven, Connecticut—who chose seeds over candy at age four—to becoming a world-renowned scientist. She opens up about the challenges she faced as a woman in science, including being advised to leave her field entirely when seeking tenure at Penn. With candor and humor, she discusses how mentorship from previous Girl Power Gurus guest, Dr. Virginia Lee, helped her persevere, the emotional eureka moment when blind dogs first regained their sight, and what it felt like to witness blind children see for the first time. Dr. Bennett also offers invaluable advice for young women pursuing STEM careers, emphasizing the importance of finding work you love, building collaborative teams, and never giving up on your dreams despite the obstacles. This is a must-listen for anyone interested in science, medicine, or the power of determination.

Within the last few days, there has been breaking news regarding the war on gonorrhea. Nuzolvence (zoliflodacin) was FDA approved on December 13, 2025, and Blujepa (gepotidacin) was FDA approved on December 11, 2025.These new oral treatments are particularly important given the global rise in gonococcal drug resistance and the convenience they offer over injectable options, potentially improving patient adherence and public health outcomes. Listen in for details. 1. FDA News Release. FDA Approves Two Oral Therapies to Treat Gonorrhea. fda.gov2. Innoviva Specialty Therapeutics. U.S. FDA Approves NUZOLVENCE® (zoliflodacin), a First-in-Class, Single-Dose Oral Antibiotic, for the Treatment of Uncomplicated Urogenital Gonorrhea in Adults and Adolescents. innovivaspecialtytherapeutics.com3. CNN. New gonorrhea treatments approved by FDA for first time in decades. 4. The New York Times. F.D.A. Approves Two New Drugs to Treat Gonorrhea. 5. STAT. FDA approves zoliflodacin, a gonorrhea pill marketed as Nuzolvence. 6. Fierce Pharma. FDA endorses another gonorrhea treatment, blessing Innoviva's Nuzolvence.

In this episode, Ben exposes a hidden ingredient the FDA quietly approved that's now damaging your gut, metabolism, hormones, and mitochondria: industrial seed oils. These oils are found in more than 80 percent of the U.S. food supply and create toxic compounds linked to inflammation, insulin resistance, obesity, fatty liver, cravings, and even altered gene expression. Ben breaks down:• The 8 seed oils to avoid and why they're so harmful• How companies hide them under over 50 different names• The shocking 680-day half-life of these fats in your body• How they trigger metabolic slowdown, hormone disruption, and gut permeability• Healthier fats to use instead for energy, fat loss, and cellular healing• How to avoid seed oils at restaurants using Ben's free allergy card• Why seed oils may be worse for insulin resistance than sugar• Clean product swaps and detox strategies to repair your metabolism faster You'll also learn how to clean out your pantry, support your mitochondria, and rebuild your cell membranes using simple daily practices. This is one of the most important episodes for anyone dealing with stubborn weight, cravings, low energy, gut issues, or metabolic dysfunction. FREE GUIDE: 5 Vegetables You Must Avoid To Lose Weight & Belly Fat-  https://bit.ly/4oPJEIN 

The topic of low-dose atropine, not FDA-approved, has become one of the most important conversations in pediatric eye care this year, especially as clinicians turn to the STAR Study for clarity on atropine's role in modern myopia control. The STAR Study is the largest and most ethnically diverse atropine study to date, evaluating 0.01% and 0.03% atropine versus placebo in more than 800 children across three countries.

See all the Healthcasts at https://www.biobalancehealth.com/healthcast-blog You will learn: What holds up new treatments for diseases and conditions How long the FDA sits on a known safe medical medication before it is released to the public. Why safe and effective drugs are NOT approved by the FDA Why doctors are forced to use medications off label How you can help During my 44 years of medical practice, I have encountered conditions for which there is no approved medication or surgical treatment available as recognized by the American College of OBGYN or the FDA. This situation can present challenges both for physicians managing these patients and for individuals seeking relief from their symptoms. This issue is not often addressed on Dr Oz, in the news, or at medical conferences. For many conditions, physicians wait for the development of approved medications or treatments, and in the meantime may inform patients that there is currently no treatment or cure available. Some doctors may attribute a patient's concerns to aging, stating that it is a universal experience. While this may be accurate, such explanations may not provide comfort to patients seeking solutions to their symptoms. This lack of helpful guidance can discourage individuals from seeking medical care when they feel their concerns are not acknowledged. This seems to result from insurance companies prioritizing cost savings by minimizing patient care.  Every year insurance companies decrease what they pay doctors for their services, while their expenses go up, and the Government requires more and more work behind the scenes like HIPPA, OSHA, and Clia requirements that costs more to deliver the same service.  If you have a problem with the time your doctor spends with you then blame the insurance companies whose profits rise every year…Soon doctors will do what I do and only take cash.  The practice of medicine is not working in a free market. While insurance limits the prescriptions of medication to those meds that are FDA Approved, the FDA and medical specialty colleges often delay approval of new, low-risk treatments for up to 20 years after their effectiveness is demonstrated. This lengthy process should be reconsidered to treat people who are ill and suffering, now. There is plenty of research in the medical journals that explain the safety of new and effective treatments that can save peoples' lives that are not FDA approved yet. The FDA is not interested in expediting the release of medication/ devices quickly to those people who need help now. They drag out the testing of a medicine that has been effective for years and may or may not approve it. On the flip side they have approved many drugs that later are found to have severe side effects, and they just change the warnings on the medication inserts. They don't take them off the market except in severe cases. Drugs that have worked treating patients successfully are being used but are not FDA approved. These “grandfathered drugs” don't need to go through the testing that new drugs go through because they work with few well-known risks. I use many if these medications because they are inexpensive for my patients and are often more effective than new meds for the same problem. One of the drugs that the FDA has not had to approve is Armour Thyroid, a natural thyroid replacement. My experience with treatments not approved by the FDA Armour Thyroid: Armour Thyroid (AT) has been prescribed by doctors to replace thyroid hormones for about 100 years. It is natural, made from Pig thyroid. It only comes from “medical Pigs” that are raised for medical purposes.  We use medical pigs for skin grafts, and other parts of the pig to treat human diseases like heart valve replacements.  Armour Thyroid is composed of the four thyroid hormones that humans make: T4, T3, T2, T1. The synthetic thyroid replacement, Synthroid/levothyroxine is only T4.  The active form of thyroid is T3, and it requires an enzyme to convert T4 into T3. If a person can't convert T4 into active T3 then nothing improves except the blood levels of T4, and TSH. The majority of women cannot convert T4 into T3. Therefore, if they take Synthroid or levothyroxine and their doctor only checks their TSH level and not the level of free T3 and free T4 to see if the Thyroid is working, then women are told that they are healed, yet they know they are not because none of their low thyroid symptoms are resolved. When this happens, doctors tell female patients that it is all in their heads and dismiss us when we tell them we are not cured with this synthetic T4 medication. Yet Synthroid is a chemical, and AT is natural from medical pigs, so the FDA is trying to Bann the only drug that has successfully treated millions of women. PS. Synthroid was not tested on women like many other drugs that were passed through the FDA before 2014! If you think this is a small problem, think again. Thyroid hormones are vital to human life, and the thyroid gland requires Iodine in the diet. The Midwest US has no Iodine in the soil or water. Therefore, this area is overburdened with hypothyroidism. I have been on AT for 50 years without complication and I have prescribed it thousands of times ever since I went into private practice.  AT works to relieve the symptoms of hypothyroidism for women and men, and it works better for women that the “new” drug Synthroid/levothyroxine, which is FDA approved. You ask how could the FDA approve a drug that doesn't successfully treat women? It is because Synthroid was not tested on women!  Until 2014 the FDA did not test women in the required drug trials.  AT works for us (women), Levothyroxine does not. Now the FDA wants to ban AT. It is not approved because it was around for decades before they started testing medications like they do now, and the history of successful treatment should stand on its own merit! Example 2: Bio-Identical Hormones BIH:  BIHs had not been approved by the FDA until recently and there was no announcement that they are now approved for women who have hormone deficiency symptoms or postmenopausal symptoms. Most doctors and women who have been afraid of the only hormones that can help them, bioidentical hormones, haven't yet been told that NOW, FINALLY the medical colleges and the FDA finally have quietly approved BI hormones.  There are no pure estradiol and pure testosterone pellets that are made by a drug company for women. My patients get their estradiol and testosterone pellets from a compounding pharmacy.  I have been prescribing BIH since 1985 without FDA approval because the oral estrogen formulations that were available at pharmacies caused weight gain and put women at high risk for blood clots. Non-oral BI hormones have fewer risks than FDA approved estrogens.  I waited more than 45 years for the FDA to approve BI hormones for treatment of women.  All those women in the last 45 years who were taking FDA approved estradiol and those who couldn't tolerate them have been harmed by FDA goals of never approving compounded or bio-identical hormones.  The delay has harmed 50% of American women. Example #3 Devices for Weight Loss I was involved in the discovery and testing of a unique device that stimulated acupuncture points with a TENS-unit-type patch connected to your cell phone for easy adjustment of your hunger or “fullness”. The FDA requires testing to approve any new device so the group of investors I was part of had to invest thousands of dollars for a device we already knew worked. The FDA told the investigators of all new devices who they should test, who they can't have in the study, and how long the testing should take. I found their parameters for the study of this device to be unrealistic. The women in our test group could not be taking hormones of any kind (birth control, ERT, HRT), and could not be on antidepressants, could not have diabetes or insulin resistance or be on any drug that assisted in weight loss. These women subjects had to be a certain BMI (level of obesity) and had to be tested repeatedly with weight and body composition measurements None of my patients who needed weight loss could participate.  Most GYN patients are on some medication or supplement, so the FDA made this study of our device so narrow that REAL WOMEN weren't tested! Sadly, we lost many women in the control group from the study because they were NOT losing weight while the ones on the device were obviously dropping pounds, so we had trouble maintaining test subjects. The testing phase of this simple device took 7 years! Our device works and no one will ever know about it or be able to use this non-medicinal weight loss device because when the FDA rejects your device you will be breaking the law if you produce and sell it directly to the public. It has no side effects or dangers..it just controls the amount you eat with stimulation of an acupuncture point. There are many ways to change this situation, and it takes years and billions of dollars to change the whole system of bringing treatments to patients quickly.  I'm afraid I won't see a revolution of the way we bring medicines and devices to market during my lifetime. Currently there is a 17-year delay between proving a drug or device works for a particular illness or condition and when it becomes available to doctors and patients. So what do we do in the meantime?  I seek treatments for patients who are unresponsive to traditional medicine by reading journals like Life Extension, that inform doctors and patients alike about new effective solutions for common medical complaints and diseases that the FDA has ignored or stymied with endless drug trials.  Life Extension Magazine highlights studies on new medications for diseases without an FDA approved solution and publicizes diagnostic tests often overlooked by mainstream publications because they are not yet FDA approved. The medical journals I read (New England Journal of Medicine, JAMA, Menopause, Metabolism and Endocrinology, Journal of Age management, to name a few) offer treatments for orphan diseases or even common problems that haven't been blessed by the FDA. It takes an average of 17 years from the culmination of research on a new drug, test or device until it is approved for use by the public! At the end of this Blog, I will give you a link to make your voice heard by signing a petition to shorten the approval of new treatments and medications from the average of 17 years to 3 years! My patients don't have time to wait for relief, and that may be the case for you as well. If you want to do something to help, please click this link and let the FDA know how you feel. Please sign a Petition to enact an amendment to the FOOD, DRUG and COSMETIC ACT, by going to: https://age-reversal.net/fda/

See all the Healthcasts at https://www.biobalancehealth.com/healthcast-blog If you ever doubted your doctor because she wrote a script that you later “Googled” and found was not FDA approved, I hope you trusted your doctor enough to realize that she wouldn't recommend any medication that would hurt you…. What is an unapproved use of a drug, also called “off-label”? Unapproved use of an approved drug is often called “off-label” use. This term can mean that the drug is: Used for a disease or medical condition that it is not approved to treat, such as when a chemotherapy is approved to treat one type of cancer, but healthcare providers use it to treat a different type of cancer. The drugs that are not approved by the FDA, yet are commonly used, have been used for decades before the 1964 law that required new drugs to go through extensive and very expensive testing before their release to the public. The operative word is NEW DRUGS AFTER 1964. Today I will talk about the safety of non-FDA approved drugs because they are: Older cheaper drugs used for many diseases and conditions before 1964 and are still used Drugs that are approved for one use, or one condition, but not for other conditions that it is effective and safe for. Drugs made by compounding pharmacies for diseases that the FDA has not approved a drug for, but there is research backing the drug and years of safe use. First, before we discuss the non-FDA approved drugs, I will discuss the safety/risks of FDA approved drugs, and why FDA approval doesn't mean a drug will do no harm or even that it is effective for the use it is approved for. A little background will help you understand the problem and the reason an FDA approval does not necessarily mean a drug is safe.  Since 1964, a law was passed that established testing prior to a drug being approved by the FDA became mandatory.   Since that time several drugs that survive FDA approval and are released but are later removed or banned after their FDA release when the public finds side effects that the FDA didn't discover in their trials. One such drug is Fen-Phen, Fenfluramine/Phentermine. This drug was released during my time practicing medicine and was withdrawn after one study claimed it caused heart valve disease…In the end the “one post approval study” that claimed that heart valves were affected by this drug that caused its bann was found to be false. The withdrawal of the drug followed one study by a single cardiologist from Kansas City had reviewed all of the cardiac valve echo tests and falsified the results to make Fen-Phen appear dangerous to heart valves, when in reality it wasn't.  She lost her license, but the FDA never put Fen-Phen back on the market!  The FDA hates to be wrong twice, so they never allowed this drug back on the market after its removal. Other mistakes made by the FDA include not allowing women in the studies to approve a drug before 2014 which ignores or misses all of the side effects or lack of effectiveness for a drug when taken by women.  Despite all the expensive testing before the release of a drug by the FDA, many drugs not tested on women were later often found to have severe side effects only on women. A few examples follow: You might have heard of the FDA approved drug Ambien that causes many women to experience “night eating”, sleepwalking, and night terrors, while their male counterparts were not affected, so because they only tested men the drug was approved. In retrospect it should have been tested on women as well, and then either not passed through the FDA or should have had a black box warning for women. It takes years get action from the FDA, notifying doctors of these side effects. Women were not included in testing for any drugs except female hormones until 11 years ago, but no other drugs.   Before 2014 all (non-hormonal) drugs that passed the FDA were not tested on women so the effect on women was unknown until it was tested on the public. The FDA left women out of drug-trials because it viewed women as “mini men”, or they didn't consider us important enough to test new drugs on…OR worse, they believed we were too complicated to easily test us because of pregnancy, menopause and other hormonal swings that normal healthy women have.  In any case, we are now suffering their decisions, when a medication works one way for men and another way for women! Finally, we are tested when drugs are being evaluated for approval by the FDA. Professional women have achieved a level of authority in medicine and pharmacology (2025) and are weighing in on the inequity. Women in the medical profession and the public are pulling back the curtain on the side effects of FDA approved drugs that are experienced by women only! Slowly, study by study investigators are now publishing the side effects and problems for women with FDA approved drugs….yet these findings are not included in the warnings on most of these drugs, even now over 15 year after they became obvious to the doctors who treat women! Drugs that either don't work for women, or that have severe side effects include that were approved before 2014. All statin drugs for high cholesterol (Crestor, rosuvastatin, atorvastatin, etc.) cause women to have muscle breakdown and muscle pain. Synthroid (levothyroxine), doesn't cure the symptoms of hypothyroidism in 80% of women, but just makes the TSH lower, so it appears as if it is working! This leads doctors to tell women that their symptoms are all in their heads!! Wrong.  It is the wrong medicine. Women have enzymes that differ from men that make it difficult for them to convert the inactive form (T4) into the active form (T3), so we can't convert Synthroid (all T4) into the active form. Synthroid, the FDA approved drug for hypothyroidism, shouldn't be given to most women. Women should be given the non-FDA approved drug Armour Thyroid or NP thyroid that have both T3 and T4 in them! Ambien Prednisone and other oral steroids We have reviewed the lack of testing on women before 2014, now we will discuss safe drugs that have been used for decades even before 1964 when the FDA required testing for FDA approval? Older, yet effective and inexpensive drugs have been tested by the public, some for almost 100 years that have saved thousands of lives, yet they are not given the FDA stamp of approval!  In fact, the FDA tries to put these drugs out of circulation, replacing them with very expensive drugs that are new! Or they just shut them down, because they are not FDA approved.  Young doctors are told not to use them by their medical schoolteachers who rarely have experienced these medications in private practice…. These doctors in training don't know the history of older safer, cheaper drugs, or even why the FDA tells them avoid them. They comply not knowing why, so you are left with no drug that works for you, or you pay 3-10 times the amount for a newer FDA version of the older drug which may even have more side effects. Some of these older very effective and cheap drugs are Penicillin, Nitroglycerine for chest pain, Morphine (pain), Phenobarbital (seizures), Codeine, Armour Thyroid, hormone injections including estradiol injections and testosterone, Thorazine for psychiatric use, (Pitocin) oxytocin for labor, lactation support and Autism Colchicine:Used to treat and prevent gout. Progesterone in oil (IM) Estradiol in oil (IM) B12 for injection Testosterone Cypionate for injection Compounded Estradiol in any form Compounded Testosterone for women These drugs have been used for so long that any safety risks or side effects have been found through the use of these drugs in the population. Yet the FDA won't grandfather them in and approve them based on their history! What do doctors do when the drug the FDA has approved a drug that doesn't work for a group of their patients (gender, race, blood type, etc.)?  What happens when a doctor can't find a drug that is FDA approved needed to treat a condition she is faced with? Why do we as citizens, allow the government to have power over doctors who are already controlled by their state licensing boards as to what medications they?  Lastly Why do taxpayers allow a government agency that they fund with tax dollars control their health by banning, or not approving drugs, or banning one drug so an outrageously expensive drug is put in its place? Compounded Medications/ Compounding Pharmacies: These drugs are made by mixing ingredients to meet individual patient needs and are not subject to premarket review for safety, effectiveness, or quality. However, they ARE subject to the success or failure for which they were prescribed. If a doctor prescribes a compounded drug that doesn't work, she is apt to be confronted by her patient who is not getting the expected results.  Compounding pharmacies usually don't get paid by insurance, so patients are more invested in getting a drug that works and that is one of the big reasons that Compounded medicines are at least as good or better than big pharma or generic drugs. I absolutely could not successfully treat the thousands of women and men that I have without compounding pharmacies.  They compound hormones/drugs that are safe and effective, mostly hormones that can't be patented because they occur in nature and won't ever be made by big pharma. More than that, big producers of drugs can't produce in mass quantities many doses of a certain hormone like compounding pharmacies do.  Compounding pharmacies provide what people need and they continue to do so because patients prefer their dosing and quality.  FDA approved Generic Drugs can be legally 25 % lower dose than what they say they are.  That would be a big problem if my compounded pellets had that kind of variability. People might need pellets every 2months or every 5 months instead of every 4 months..it would be like guessing what you need ahead of time…..I believe dedicated compounding pharmacists are more accurate than any generic on the market. Compounding pharmacies: Unsung Heros Compounding pharmacies serve the public when big pharma fails and hasn't developed a safety net for production if they have a problem and the FDA shuts them down. That situation leaves patients who take their medications, without an alternative. Compounding pharmacies step into the breech when big pharma has a problem with a particular drug and stop making a drug (e.g. Lidocaine, B12 injectable, IV Fluids, to name a few shortages and no production that have occurred in the recent past). What if patients couldn't get the meds they need, and if there were no compounding pharmacies—Chaos and suffering and dying patients would closely follow! The FDA is Fickle and is not on your side! For years the FDA did not approve of Bioidentical estrogen and testosterone in any form, and just a few months ago all of a sudden, long after they scared women from taking the hormones they needed to improve their length of life and quality of life, they decided bioidentical hormones are better than the FDA approved hormones!!!  That is a little too late.  Some of us will never forget the stress lack of approval of compounded hormones caused for doctors and patients alike.  Other doctors criticized us and now most of them aren't even in practice anymore.  Maybe the FDA read my blog!!! Compounded hormones have been approved by the masses of women who have taken them under my signature! Compounded BI hormones are medications with a long track record and should not have to be tested with the bloated expense required of testing for the FDA. For Gynecological Disorders that don't have an FDA approved hormone drug because testosterone and estradiol have been used for so long that they don't need testing. If there was a significant problem with them their history of use of over 5-7 decades has proven the efficacy and safety of the female hormones for treatment and hormone replacement. For Psychiatric Disorders: Some patients need compounded ketamine products for conditions like severe depression, despite lacking FDA approval for these uses and potential risks, yet it has been used for this purpose for decades and was used for childbirth for almost a century, until epidurals and saddle blocks took their place. Testosterone for women still is not recognized as a female hormone even though women produce over twice as much Testosterone as Estradiol when they are in their fertile years.   Replacement of T with bioidentical T pellets offers a treatment for dozens of symptoms women face after age 40, and it prevents the diseases of aging: osteoporosis, heart disease, sarcopenia, frailty, diabetes and more that have not been addressed by mainstream medicine and the FDA. Over a decade ago, the FDA turned down the approval of testosterone patch after over 3 years of positive research studies, the FDA said they didn't approve T for women is because the side effect of T for women, facial hair, was dangerous for women.…I cry B—–S—-!  That is really men not wanting to share testosterone replacement with women. I say leave us alone and let women and their doctors determine what they need.  It is proven that only 5% of all professionals in any profession are not trustworthy, so give doctors their due and trust that we are looking for answers to our patients' problems that you don't even know about! The FDA is paid for by us…everyone in this country. I say hands off! Speed up the approval process or forget it for older drugs and BI hormones! ~

In this episode of Peer2Peer by Rayner, host Dr Ben LaHood (Australia) is joined by Mr Allon Barsam (UK) and Dr Deb Ristvedt (USA) to discuss the exciting news that RayOne EMV Toric has received FDA approval. Together, they explore: The clinical pathway and IDE study behind FDA approval. How RayOne EMV Toric's global success shaped its journey to the US market. Surgical pearls and insights from experienced international users. Why this milestone represents a new era for astigmatism correction in cataract surgery. With RayOne EMV and EMV Toric lenses implanted worldwide in 75+ countries, this episode highlights how proven performance and surgeon trust have paved the way for US approval.

It's Tuesday, October 7, A.D. 2025. This is The Worldview in 5 Minutes heard on 140 radio stations and at www.TheWorldview.com.  I'm Adam McManus. (Adam@TheWorldview.com) By Kevin Swanson Nigerian military opened fire on Christians Christian persecution at the hands of Muslim terrorists in Nigeria was tough enough. Now, Truth Nigeria reports that the Nigerian military has opened fire on Christians in the Benue State — this time killing three young men. Ten others sustained life-threatening gunshot wounds and are receiving medical treatment in Jato-Aka. The local chief said, “We no longer need the military in our land. … They have joined Fulani to kill us and take over our land. They have turned their guns against us. … The betrayal is unbearable. Enough is enough. President Tinubu and Governor Alia should hear this message and take immediate action.” Newsweek urges State Dept to declare Nigeria “Country of Particular Concern” Newsweek.com has joined the voices of comedian Bill Maher and others, pointing to the egregious level of Christian killings in Nigeria. The Nigerian government has “categorically” denied that terrorists are waging a systematic genocide against Christians in the country. Newsweek noted that the Trump State Department has thus far failed at making Nigeria a “Country of Particular Concern.” Europe's swirling politics France just lost its third prime minister in about a year. Sébastien Lecornu was the latest, and he just resigned yesterday after only 27 days in office. This marks the most instability for the French government in 70 years. France's nationalist, anti-immigration party increased from obtaining 4% of parliamentarian seats in 2008 to 37% in 2024. Germany lost its government earlier this year.  Germany's anti-immigration party is supported by 24% of the country, up from virtually nothing ten years ago.  And Portugal faces instability, still run by a minority government, having completed its third election in three years in May.  Portugal's nationalist party increased from half percent in 2019 to 23% in the 2025 elections. Also, the Netherlands, Sweden, Finland, and Italy have experienced wide swings in governance — shifting to a nationalist position over the last 5-10 years. Daniel 2:21 reminds us that it is God who “changes times and seasons; He removes kings and sets up kings; He gives wisdom to the wise and knowledge to those who have understanding.” Cuba sends 5,000 troops to aid Ukraine despite grinding poverty Reuters reports that Cuba is supporting the Ukrainian War now with up to 5,000 troops. The communist country's economy is lagging badly — suffering a four-year decline in its Gross Domestic Product, with another decline forecasted for this year, reports InDepthNews.com. Inflation is running at 28%. The nation has suffered at least five energy blackouts this year so far.  And 89% of the populace suffers from “extreme poverty” according to a recent survey. Seven out of ten Cubans have stopped eating breakfast, lunch, or dinner due to lack of money or food shortages. Only 15% have been able to eat three meals a day without interruption. That compares with the next poorest countries in Central America. Just 16% of Guatemalans  and 27% of folks in Honduras have to deal with these levels of extreme poverty. Supremes consider Trump's tariffs, Hawaii's gun restrictions, &  trans sports As the US Supreme Court reconvenes, the docket holds a slew of cases. They include the legitimacy of the Trump Tariffs, the president's removal of high level administrative bureaucrats, Colorado's ban on counselors helping minors out of homosexual sin, Hawaii's gun restrictions, and bans issued by red states on boys pretending to be girls playing in girls' sports in public schools.  Trump's FDA approve a new Abortion Kill Pill The Trump Administration's Food and Drug Administration approved another abortion kill pill to accommodate the killing of children in their mother's wombs. Last week, the FDA approved Evita Solutions' generic abortion drug for the US market. This is hardly in line with the administration's pledge to “review all the evidence—including real-world outcomes—on the safety of the drug” issued just last month. Ostensibly, the big concern is the health of the mother. The FDA reports 36 deaths attributed to the abortion kill pill thus far, but 7.5 million murdered babies. 63% of the annual abortions committed in the country today are attributed to the abortion kill pill.  Isaiah 29:15-16 speaks to this. The prophet wrote, “Woe to you who hide deep from the Lord your counsel, whose deeds are in the dark, and who say, “Who sees us? Who knows us?” You turn things upside down! Shall the potter be regarded as the clay, that the thing made should say of its maker,  “He did not make me”; or the thing formed say of him who formed it, “He has no understanding”? Mt. Everest hiker died, 200 others stranded in shock blizzard And finally, one hiker has died and 200 others are still stranded in a shock blizzard on Mount Everest over the weekend. The blizzard took about 1,000 hikers by surprise.  Thus far this year, five people have died on Everest. Last year's total was eight, and 18 others died on the treacherous slopes in 2023. About 800 people attempt to summit the tallest mountain in the world each year. Close And that's The Worldview on this Tuesday, October 7th, in the year of our Lord 2025. Follow us on X or subscribe for free by Spotify, Amazon Music, or by iTunes or email to our unique Christian newscast at www.TheWorldview.com.  I'm Adam McManus (Adam@TheWorldview.com). Seize the day for Jesus Christ.

Date: August 12, 2025 Article: FDA Approved and Ineffective by Jeanne Lenzer and Shannon Brownlee. June 5, 2025. The Lever. Guest Skeptic: Jeanne Lenzer is a long-time medical investigative journalist and returning SGEM guest. Her previous work, including the book The Danger Within Us, explored how conflicts of interest and weak evidence can endanger patient care. In […] The post SGEM Xtra: Tell Me Lies, Sweet Little Lies – FDA Approved & Ineffective first appeared on The Skeptics Guide to Emergency Medicine.

Microsoft reportedly plans to begin using Anthropic's latest Claude models to power some of the Copilot features in its Office 365 apps. In a report published Tuesday, The Information said the tech giant would announce the change "in the coming weeks." Microsoft currently relies on OpenAI's tech to power the majority of AI features found inside of Word, Excel, Outlook and PowerPoint. Also, the FDA approved the biotech company eGenesis to begin human trials of pig-to-human kidney transplants. eGenesis provides pigs with CRISPR-modified genes. These genetic changes reduce the chances of organ rejection in human recipients. Learn more about your ad choices. Visit podcastchoices.com/adchoices

Nutritionist Leyla Muedin discusses recent advancements in the detection and prevention of Alzheimer's disease. Topics include the new FDA-approved Lumipulse blood test, the role of a ketogenic diet in improving mitochondrial health, and the significance of lifestyle changes such as social and cognitive activities. The episode also highlights promising research from the University of California Irvine on using natural compounds like nicotinamide and EGCG to rejuvenate aging brain cells and address the buildup of Alzheimer's-associated proteins. Leyla also provides insights into the difference between Alzheimer's and general dementia and emphasizes the importance of accurate diagnosis and appropriate treatments.

Steve Marchese, the CEO of LightStim, the largest LED Medical Device Manufacturer in the US, shares insights, truths, and myths regarding the benefits of true "light stimulation". Steve Marchese joins Dr. Haley to discuss how what people call "red light therapy" is more than just one color. It also includes blue and infrared, which are crucial for seeing full benefits. Listen to the full podcast to learn more about these alternative therapies.RESOURCES:https://drhaley.com/truth-about-red-light-therapy/https://lightstim.com/https://www.facebook.com/lightstimhttps://www.instagram.com/lightstimhttps://www.linkedin.com/company/lightstim/https://www.youtube.com/LightStimTIMESTAMPS:00:00 Intro Snip00:33 Coupon Announcement for use at Lightstim.com02:38 Introduce Steve Marchese CEO of Lightstim04:02 Why "light therapy" should be called "light stimulation"04:33 What is light therapy and light stimulation used for?07:52 Do you treat just the injury with light stimulation or the whole body when there is an injury?11:22 How can you tell if you are buying a quality light therapy device and if it does what it is supposed to do?13:48 What is the difference between FDA Registered and FDA Cleared or FDA Approved?15:25 How can we use multiple wavelengths at the same time without cancelling out the wavelengths?18:00 How close should you be to the LED light source for efficacy?20:10 What happens when you use an acrylic layer for the patient to lay on?21:58 What is the FDA's test for efficacy?26:00 What did the FTC warn the health and wellness industry about red light therapy?27:22 What did a law firm do recently regarding an FDA "EXEMPTION" in January of 2021?28:25 What did the "FDA Exemption" actually require?30:00 What were the 2 additional requirements to qualify for the exemption?33:16 What is the difference between red laser treatment and red led treatments?35:20 What makes red light the right color and wavelength?37:17 What do the infared radiators in the sauna tent do?40:40 Does insurance pay for light stimulation?41:10 How does light stimulation affect blood pressure?43:04 Where can we go to try one of the red light stimulation beds?44:24 Us there a difference in the output between battery and corded handheld units?46:31 Where are the LightStim products manufactured?49:15 Where should people go for more information?50:15 What are some of the myths of red light therapy?52:25 What are the general principles between using red, blue, and amber?56:40 How to use an aloe vera leaf for anti-aging57:25 How to use a lightstim unit to improve the performance of skin products

RESOURCES & LINKS  Watch a message from Barbara HERE  Check out the Osteoboost Official Website HERE  Visit the Bone Health & Osteoporosis Foundation Website HERE  EPISODE UPDATE This is a replay of our March episode with Laura Yecies, CEO of Osteoboost. Since our original conversation aired, I have started using the Osteoboost vibration belt—30 minutes daily—as part of my bone health routine.  In this conversation, Laura and I discuss Osteoboost, an FDA-approved device using NASA-inspired vibration therapy to combat bone loss. Laura explains how the technology works, its impressive clinical results (85% reduction in spinal bone loss), and who benefits most.  KEY TAKEAWAYS  Early intervention in bone health is crucial; hip fractures pose significant risks  Osteoboost uses precision vibration technology inspired by NASA research  The device works best when combined with nutrition and exercise  Particularly effective for postmenopausal women with osteopenia  FDA-approved and backed by clinical studies showing microarchitectural improvements  Telehealth options are available for prescriptions  Future studies planned for osteoporosis applications  Note: For informational purposes only. Consult your healthcare provider before starting any new health regimen.  Take a listen—and don't forget to follow the show so you never miss an episode.    If you're enjoying Age Better, I'd be so grateful if you left a quick review wherever you listen.     And if there's a topic or question you'd love for me to cover in a future episode, send a note to agebetterpodcast@gmail.com -- I love hearing from you!   Learn more about your ad choices. Visit megaphone.fm/adchoices

There's a big difference between FDA approval, registration, and compliance—and most whitening reps don't get it. This week's episode breaks down the facts behind the label and why “approval” might actually be a red flag. 00:00 – Intro: “Are my gels FDA-approved?” Trend or truth? 01:01 – Cosmetic vs dental gels: what you can (and can't) use 02:10 – The red flag of “FDA approved” claims 03:20 – Medical-grade gels vs cosmetic scope (the real difference) 04:15 – Rach's “Ask Them” theory – get receipts or walk away 05:08 – What FDA & Health Canada actually regulate 06:04 – Facility standards, compliance & why your gel is still safe 07:05 – What to actually ask your supplier instead of “FDA approval” 07:55 – Why overselling “FDA approved” makes you look sketchy 08:30 – Final mic-drop: Stop the false trends Thank you to our sponsor Fern Whitening Supplies.

BUFFALO, NY – August 15, 2025 – A new #research paper was #published in Volume 16 of Oncotarget on August 13, 2025, titled “Clinical and analytical validation of MI Cancer Seek®, a companion diagnostic whole exome and whole transcriptome sequencing-based comprehensive molecular profiling assay.” In this study, first authors Valeriy Domenyuk and Kasey Benson, along with corresponding author David Spetzler from Caris Life Sciences in Irving, Texas, introduce MI Cancer Seek, an FDA-approved test designed to deliver comprehensive tumor profiling. MI Cancer Seek demonstrated strong concordance with other FDA-approved companion diagnostics and serves as a powerful tool to guide treatment decisions in both adult and pediatric cancer patients. Cancer remains one of the most complex and diverse diseases to treat. With many targeted therapies currently FDA-approved, selecting the right one for a specific patient requires detailed genetic insights. MI Cancer Seek addresses this need by analyzing both DNA and RNA from a single tumor sample. The tool identifies key biomarkers linked to FDA-approved treatments for several major cancers, including breast, lung, colon, melanoma, and endometrial cancers. One of the most significant strengths of MI Cancer Seek is its ability to deliver accurate and reliable results from minimal tissue input (50 ng). Even when analyzing formalin-fixed paraffin-embedded samples, which are widely used but often degraded, the test maintained high levels of accuracy. It successfully detected important genetic alterations such as PIK3CA, EGFR, BRAF, and KRAS/NRAS mutations and measured tumor mutational burden (TMB) and microsatellite instability (MSI), both of which are key indicators for immunotherapy response. In clinical comparisons, the test achieved over 97% agreement with other FDA-approved diagnostic tools, confirming its reliability in detecting critical biomarkers. Notably, it showed near-perfect accuracy in identifying MSI status in colorectal and endometrial cancers. The researchers also demonstrated that the test maintains precision across different lab conditions and varying DNA input levels, confirming its robustness for routine clinical use. Beyond its role as a companion diagnostic, MI Cancer Seek incorporates additional features developed under its predecessor, MI Tumor Seek Hybrid. These include detection of homologous recombination deficiency, structural variants, and cancer-related viruses. It also includes advanced tools such as the Genomic Probability Score for identifying the tissue of origin in cancers of unknown primary, as well as a gene signature to guide first-line chemotherapy in colorectal cancer. “One limitation to be considered is the low PPA for ERBB2 CNA detection.” By offering deeper genetic insights from a single, small sample, MI Cancer Seek has the potential to streamline diagnostics, reduce testing costs, and connect patients to effective therapies more quickly. As precision medicine continues to expand, this assay stands out as a comprehensive and efficient solution for meeting the evolving needs of modern oncology. DOI - https://doi.org/10.18632/oncotarget.28761 Correspondence to - David Spetzler - dspetzler@carisls.com Video short - https://www.youtube.com/watch?v=D4hd2FxCYY8 Subscribe for free publication alerts from Oncotarget - https://www.oncotarget.com/subscribe/ To learn more about Oncotarget, please visit https://www.oncotarget.com and connect with us: Facebook - https://www.facebook.com/Oncotarget/ X - https://twitter.com/oncotarget Instagram - https://www.instagram.com/oncotargetjrnl/ YouTube - https://www.youtube.com/@OncotargetJournal LinkedIn - https://www.linkedin.com/company/oncotarget Pinterest - https://www.pinterest.com/oncotarget/ Reddit - https://www.reddit.com/user/Oncotarget/ Spotify - https://open.spotify.com/show/0gRwT6BqYWJzxzmjPJwtVh MEDIA@IMPACTJOURNALS.COM

Dr. Aliaksandr Ramaniuk and Nicole Piriak discuss the importance of smoking cessation, the dangers of vaping, and various replacement therapies. 

Story at-a-glance Results of a two-year investigation found that the U.S. Food and Drug Administration (FDA) approved nearly 75% of new drugs between 2013 and 2022 without meeting its own basic standards Some cancer and Alzheimer's drugs were fast-tracked using surrogate markers like tumor shrinkage or protein levels, not real improvements in survival, memory, or function Dangerous side effects — including brain inflammation, hemorrhage, and blindness — were linked to drugs approved on minimal or flawed data, with thousands of deaths occurring each year The reporters created a searchable database on FDA drug approvals made between 2013 and 2022 — use it to check if any of your prescriptions meet the four scientific standards Always ask if a drug shows real-world benefits, look up its approval history, wait on new drugs, review your prescriptions, and work with a doctor who questions the system

In this episode, we explore groundbreaking head-to-head research comparing topiramate and naltrexone for alcohol use disorder, revealing surprising equivalence in effectiveness. Could the off-label option actually be as good as our FDA-approved standard for treating problematic drinking? Faculty: David Gorelick, M.D. Host: Richard Seeber, M.D. Learn more about our membership here Earn 0.5 CME: Quick Take Vol. 69 Can Topiramate Replace FDA-Approved Medications for Alcohol Use Disorder?

Dr. Sterling Elliott, clinical pharmacist at Northwestern Medicine and assistant professor of orthopedics at Feinberg School of Medicine, joins Lisa Dent to discuss ivermectin. Dr. Elliot explains, is prescribed to treat parasitic infections. He shares when its prescribed, and whether or not ivermectin is FDA approved.

Send us a textWhy do so many digital pathology tools stall before they ever reach patients? In this USCAP 2025 special sponsored by Muse Microscopy, I talk with Esther Abels, founder of SolarisRTC, regulatory strategist, and the force behind the first FDA-cleared whole slide imaging system.We break down what startups and established companies must do from day one to succeedbin getting their devices through the FDA. Hint: regulatory strategy isn't a final step—it's your starting line.

This blog was created using Notebook LM.This podcast describes the FDA approval of Suzetrigine, a novel non-opioid medication intended for moderate to severe pain. It explains that Suzetrigine operates by inhibiting voltage-gated sodium channel 1.8, which are crucial for transmitting pain signals. 

In this enlightening episode, we sit down with Laura Yecies to discuss Osteoboost, the first and only FDA-cleared, drug-free prescription medical device designed to treat osteopenia in postmenopausal women. Dr. Yecies shares insights into the clinical research behind Osteoboost, its development inspired by NASA-funded studies, and the importance of proactive bone health management. Key Topics Covered: The Innovation Behind Osteoboost: Understanding how precision vibration therapy targets the spine and hips to reduce bone density and strength loss. (Osteoboost) Clinical Efficacy: Discussing the results from a double-blind, placebo-controlled clinical trial showing up to an 85% reduction in spine bone density loss and an 83% reduction in bone strength loss among consistent users. (MedicalEconomics) Importance of Early Intervention: Exploring why addressing bone health before the onset of osteoporosis is crucial, especially for postmenopausal women. User Experience: Highlighting the ease of incorporating Osteoboost into daily routines, with just 30 minutes of use per day during activities like walking or cooking. (MedicalEconomics) Broader Implications: Considering how Osteoboost fits into the larger conversation about aging, mobility, and long-term health. Resources & Links: Learn more about Osteoboost: Osteoboost Clinical Trial Details: Osteoboost Clinical Trial Results FDA Clearance Information: FDA Grants Clearance to Bone Health Technologies' Wearable Device for Osteopenia Guest Bio: Laura Yecies is the CEO of Osteoboost Health, Inc., the company behind the first and only FDA-cleared, non-drug wearable for low bone density. She has over 30 years of leadership experience in the technology and medical sectors. Prior to Osteoboost, she was CEO of NeuroSync, Catch (acq. by Apple), and SugarSync. Laura is also an active advisor and executive coach for early-stage digital health and therapeutics companies, focusing on supporting women founders. She holds an MBA from Harvard, MSFS from Georgetown, and AB from Dartmouth.

Eating crickets and meat grown in a lab with cancer-like cells - WHO APPROVED THAT?! Scott Tips, president of the National Health Federation (NHF) and internationally recognized health freedom attorney, joins host, Jamie Belz, to help us understand the deeper mechanisms of Codex Alimentarius, the World Trade Organization (WTO), and the global regulatory web that threatens access to nutrient-dense food, natural health remedies, and therapeutic supplements.   As the only health-freedom organization with official INGO (International Non-Governmental Organization) status at Codex, NHF is uniquely positioned to stand up for the public's right to safe, informed, and autonomous healthcare choices on the global stage.   Over the last 70 years, NHF has defended medical choice and challenged the federal government's overreach into nutrition, supplementation, and holistic healing.   Some quick topics/snippets from this episode: Codex creates international food law—affecting everything from vitamin dosage limits to whether or not your meat contains drug residues. Most people don't even know Codex exists. And yet, decisions made there determine what shows up in your grocery cart, your supplement bottle, and your child's plate. The U.S. can now force genetically modified foods into countries that don't want them — not through diplomacy, but through international tribunals using Codex standards as their weapon. Ractopamine is a drug with zero therapeutic value. It makes animals fatter, faster — but it's banned in the EU, China, and Russia. In the U.S., you're probably eating it. When you hear ‘scientific consensus,' be cautious. The phrase is used to bulldoze public concern. You can be banned for calling out corruption at Codex. At CODEX, NHF is the only one defending your right to natural health freedom. The EU, Russia, even Iran — they've stood up for consumer safety at Codex more than the U.S. delegates have. The scary thing isn't just what the FDA is doing. It's how many people still trust them, blindly — even when their actions have harmed more people than every U.S. war combined. We need advocacy from the ground up. Most parents feeding their kids toxic food don't even know it — because the truth has been buried. “Frankenmeat”, insect protein, and natural flavoring cover-ups, all of which bypass transparent labeling laws while being quietly introduced into the food supply. They're trying to outlaw homeopathy—while promoting lab-grown meat and insect protein as sustainable alternatives. We don't want to be right. We want to get it right.   “Unless we put medical freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship… To restrict the art of healing to one class of men and deny equal privileges to others will constitute the Bastille of medical science. All such laws are un-American and despotic.” - Dr. Benjamin Rush, Declaration of Independence signator and Surgeon General of the Continental Army   "If people let the government decide what foods they eat and what medicines they take, their bodies will soon be in as sorry a state as the souls of those who live under tyranny.” - Thomas Jefferson   TAKE ACTION:  Join the National Health Federation for only $45/year to support international advocacy at Codex and receive the quarterly NHF magazine. This low-cost membership helps fund independent watchdog efforts that no other organization is legally authorized to perform at the global level. ⁠JOIN HERE⁠   Other mentions: ⁠⁠Ep 034: Fight For Your Right To Health Freedom⁠⁠ ⁠The HighWire report exposing Peter Marks and vaccine data suppression⁠    Health freedom is necessary. As government and corporate interests grow more entangled, grassroots advocacy is no longer optional. It's essential. Join the NHF and become part of the movement to reclaim sovereignty over what we eat, how we heal, and what we're allowed to know.    

May 20, 2025 ~ A new FDA-approved blood test, the Shield test, is available for colon cancer screening for people 45 and older. Guardian VP of Clinical Development, Dr. Sam Asgarian, talks with Lloyd, Jamie, and Chris about this alternative test to traditional methods and simplifying the screening process.

How Gene Editing Could Transform Global Pork HealthJoin us for an exclusive conversation with PIC as we explore the historic FDA approval of the first gene-edited PRRS-resistant pig. Discover what this milestone means for the future of pork production, how gene editing differs from traditionalGMOs, and why this matters for both producers and consumers. We also dive into the potential $1.2 billion impact on global herd health and what's next as PIC plans for a responsible international rollout.

In this episode, Dr. Rohrich is joined by Dr. Steven Faigan to discuss Letybo, the newest FDA-approved neuromodulator from Korea.

*In this Episode, Dr. Lisa Faast discusses the FDA-approved product Ycanth, the only approved cantharidin treatment for molluscum contagiosum.** **Show Notes:** 1. **Introduction to the Podcast and Lisa Faast** [0:00] 2. **Overview of Cantharidin and Its Uses** [1:47] 3. **Development and Features of Ycanth** [3:16] 4. **Benefits and Availability of Ycanth** [6:22] 5. **Ordering and Billing Process for Ycanth** [9:14] 6. **Conclusion and Additional Resources** [11:01]   Websites Mentioned: https://www.drlisafaast.com/ ----- #### **Becoming a Badass Pharmacy Owner Podcast is a Proud to be Apart of the Pharmacy Podcast Network**

Send us a message with this link, we would love to hear from you. Standard message rates may apply.The meteoric rise in demand for weight loss drugs has created widespread shortages, leading to the emergence of compounding pharmacies as an alternative source for these medications.• Compounding pharmacies create custom medications by combining, mixing, or altering ingredients to meet specific needs• Unlike FDA-approved medications, compounded drugs don't undergo the same rigorous safety and effectiveness reviews• Dosing errors with compounded weight loss medications have led to serious adverse events requiring hospitalization• Confusion between units, milliliters, and milligrams contributes to potentially dangerous dosing mistakes• Some compounding pharmacies add unproven ingredients like vitamins, L-carnitine, and NAD to their formulations• The long half-life of these medications (about one week) means overdose symptoms can persist for extended periods• Pharmaceutical companies have responded with direct-to-consumer models offering FDA-approved versions at reduced prices• Eli Lilly now offers Zepbound in vial form for approximately $499/month versus $1000+ for pen versions• Novo Nordisk's NovaCare pharmacy provides direct-to-patient delivery of Wegovy single-dose pens at similar price pointsPlease talk to your healthcare provider about what option might be right for you, as these medications require careful consideration and proper dosing is essential for safety.Support the showProduction and Content: Edward Delesky, MD & Nicole Aruffo, RNArtwork: Olivia Pawlowski

RESOURCES & LINKS  - Osteoboost Official Website  - Video: Laura Yecies Discussing Osteoboost  - Bone Health & Osteoporosis Foundation Website  - Email questions to agebetterpodcast@gmail.com   AGE BETTER host Barbara Hannah Grufferman and Laura Yecies, CEO of Osteoboost, discuss Osteoboost, an FDA-approved device using NASA-inspired vibration therapy to combat bone loss. Laura explains how the technology works, its impressive clinical results (85% reduction in spinal bone loss), and who benefits most.     KEY TAKEAWAYS  - Early intervention in bone health is crucial; hip fractures pose significant risks  - Osteoboost uses precision vibration technology inspired by NASA research  - The device works best when combined with nutrition and exercise  - Particularly effective for postmenopausal women with osteopenia  - FDA-approved and backed by clinical studies showing microarchitectural improvements  - Telehealth options are available for prescriptions  - Future studies planned for osteoporosis applications  *Note: For informational purposes only. Consult your healthcare provider before starting any new health regimen.*  Learn more about your ad choices. Visit megaphone.fm/adchoices

Shawn Ryan Show: Read the notes at at podcastnotes.org. Don't forget to subscribe for free to our newsletter, the top 10 ideas of the week, every Monday --------- Paul Saladino, MD, is a double board-certified physician and a prominent advocate for an animal-based diet, known for his controversial views on nutrition and health. He graduated from the University of Arizona College of Medicine and completed his residency at the University of Washington. Saladino is the author of *The Carnivore Code* and *The Carnivore Code Cookbook*, where he argues that many chronic illnesses are linked to poor dietary choices and can be prevented or reversed through proper nutrition. His professional philosophy emphasizes questioning mainstream medical narratives, focusing instead on optimal health through dietary changes. In addition to his writing, Saladino hosts the *Fundamental Health* podcast, where he engages with various experts to discuss health optimization. He co-founded Lineage Provisions, which produces high-quality air-dried meat snacks, and Heart & Soil, offering desiccated organ supplements aimed at enhancing nutrient intake. Recently, he has been involved in projects like a collaboration with Raw Farm USA to create a raw kefir smoothie at Erewhon Market, further promoting his vision of ancestral nutrition and wellness through innovative products. Shawn Ryan Show Sponsors: https://ShawnLikesGold.com | 855-936-GOLD #goldcopartner https://amac.us/srs https://meetfabric.com/shawn https://americanfinancing.net/srs | 866-781-8900 | NMLS 182334, www.nmlsconsumeraccess.org https://hillsdale.edu/srs https://patriotmobile.com/srs | 972-PATRIOT This episode is sponsored by BetterHelp. Give online therapy a try at betterhelp.com/srs and get on your way to being your best self. https://helixsleep.com/srs https://rocketmoney.com/srs https://prizepicks.onelink.me/LME0/SRS https://blackbuffalo.com Paul Saladino Links: Website - https://www.ABNRF.org Instagram - https://www.instagram.com/paulsaladinomd/?hl=en X - https://x.com/paulsaladinomd TikTok - https://www.tiktok.com/@paulsaladinomd2 YouTube - https://www.youtube.com/c/PaulSaladinoMD Heart & Soil - https://heartandsoil.co/ Lineage Provisions - https://lineageprovisions.com/ShawnRyan Learn more about your ad choices. Visit podcastchoices.com/adchoices

Paul Saladino, MD, is a double board-certified physician and a prominent advocate for an animal-based diet, known for his controversial views on nutrition and health. He graduated from the University of Arizona College of Medicine and completed his residency at the University of Washington. Saladino is the author of *The Carnivore Code* and *The Carnivore Code Cookbook*, where he argues that many chronic illnesses are linked to poor dietary choices and can be prevented or reversed through proper nutrition. His professional philosophy emphasizes questioning mainstream medical narratives, focusing instead on optimal health through dietary changes. In addition to his writing, Saladino hosts the *Fundamental Health* podcast, where he engages with various experts to discuss health optimization. He co-founded Lineage Provisions, which produces high-quality air-dried meat snacks, and Heart & Soil, offering desiccated organ supplements aimed at enhancing nutrient intake. Recently, he has been involved in projects like a collaboration with Raw Farm USA to create a raw kefir smoothie at Erewhon Market, further promoting his vision of ancestral nutrition and wellness through innovative products. Shawn Ryan Show Sponsors: https://ShawnLikesGold.com | 855-936-GOLD #goldcopartner https://amac.us/srs https://meetfabric.com/shawn https://americanfinancing.net/srs | 866-781-8900 | NMLS 182334, www.nmlsconsumeraccess.org https://hillsdale.edu/srs https://patriotmobile.com/srs | 972-PATRIOT This episode is sponsored by BetterHelp. Give online therapy a try at betterhelp.com/srs and get on your way to being your best self. https://helixsleep.com/srs https://rocketmoney.com/srs https://prizepicks.onelink.me/LME0/SRS https://blackbuffalo.com Paul Saladino Links: Website - https://www.ABNRF.org Instagram - https://www.instagram.com/paulsaladinomd/?hl=en X - https://x.com/paulsaladinomd TikTok - https://www.tiktok.com/@paulsaladinomd2 YouTube - https://www.youtube.com/c/PaulSaladinoMD Heart & Soil - https://heartandsoil.co/ Lineage Provisions - https://lineageprovisions.com/ShawnRyan Learn more about your ad choices. Visit podcastchoices.com/adchoices

Extra Extra, Read all about it! Actually, it's a podcast, Listen all about it!  New Pain Med! New Pain Med! New Non-Opioid Pain Med! Suzetrigine (Journavx) is now FDA Approved for Moderate to Severe Acute Pain in Adults, but what fun facts come along with it????? We turn to the Simpsons, Brugada, and enjoy some club seats while succinctly reviewing everything there is to know about this new non-opioid pain medication on the Pain Pod! Come one, come all, to the Pain Pod!!! Pain Guy • www.painguy.us  

Helo & Airline Crash Pt.2, New Pain Drug FDA Approved, Confirmation Highlights & Fake StoriesJoin Matt, Amy and Olivia tonight at 7pm A-BLOCK: Helo and Airline Crash Pt.2B-BLOCK: New Pain Drug FDA ApprovedC-Block: Best Moments From ConfirmationD-Block: Fake StoriesF-Block: Overtime Random StoriesWatch the Live Show on the following channels: linktapgo.com/thedumshowBecome a supporter of this podcast: https://www.spreaker.com/podcast/the-dum-show--6012883/support.

For bird enthusiasts, hearing about the negative impacts of habitat loss on bobwhite quail isn't anything new. In fact, this issue have been largely blamed for North America's shrinking bobwhite population. However, parasites may have a larger effect on wild quail than previously thought, especially in Texas and Oklahoma. “Something happened,” said Dr. Ron Kendall, the founder of Texas Tech's Wildlife Toxicology Lab. “We saw innumerable quail in the summer of 2010. Conditions were perfect. But by that fall, the quail were gone.” That year, biologists, wildlife managers, researchers, and hunters rallied together and launched "Operation Idiopathic Decline." The operation brought together multiple universities. Scientists explored the potential causes of the quail population crash. “We looked at pesticides, environmental contaminants, viruses, bacteria, and parasites,” said Dr. Kendall. “Lo and behold, we saw these parasitic worms called helminths in the birds.” 

Stock market update for January 21, 2025. Check out our Instagram account @TheRundownDaily

BUFFALO, NY - December 30, 2024 – A new #editorial was #published in Oncotarget's Volume 15 on December 24, 2024, titled “Pitfalls and perils from FDA-approved germ-line cancer predisposition tests." Authored by Dr. Wafik S. El-Deiry, Editor-in-Chief of Oncotarget, and Dr. Eli Y. Adashi from Brown University, the article highlights concerns about the risks of a newly approved genetic test for cancer risk. This test, called the “Invitae Common Hereditary Cancers Panel," was approved in 2023 and examines 48 genes linked to inherited cancers, including breast, ovarian, and Lynch syndrome-related cancers. Although the test increases access to genetic information, the authors warn that using it without professional guidance may lead to confusion, stress, and potential harm. One concern is that people can order this test online without consulting healthcare professionals or genetic counselors. Without expert help, users might struggle to understand their results especially if they indicate risks that are unclear or difficult to act on. This can cause unnecessary anxiety and confusion. “The DTC option of germ-line testing for cancer susceptibility should be discouraged given the risks of anxiety, lack of adequate interpretation for variants not strongly associated with cancer, potential for minors to be tested outside the healthcare system and potential for loss of follow-up if test results are not shared with health care professionals or never make it into the medical record.” The editorial also points out ethical and medical issues when minors use these tests. If a child's test is done without medical oversight, results might not be added to their health records, making follow-up care harder to manage and potentially risking their long-term health. Cost is another issue. These tests are often not covered by insurance, which can place a financial burden on families who might need additional testing or medical advice. The researchers emphasize that genetic testing for cancer risk should always include healthcare providers and genetic counseling. This ensures users fully understand their results and receive proper guidance. The authors also call on the US Food and Drug Administration (FDA) to provide clear rules for using these tests, particularly for minors. In conclusion, while genetic testing holds great potential for improving cancer prevention and care, its benefits must not come at the cost of safety and public health. Responsible use of these tests will require collaboration between regulators, healthcare professionals, and testing companies to address the risks and ensure these tools are used effectively. DOI - https://doi.org/10.18632/oncotarget.28677 Correspondence to - Wafik S. El-Deiry - wafik@brown.edu Video short - https://www.youtube.com/watch?v=DjKpiBNDWHo Subscribe for free publication alerts from Oncotarget - https://www.oncotarget.com/subscribe/ About Oncotarget Oncotarget (a primarily oncology-focused, peer-reviewed, open access journal) aims to maximize research impact through insightful peer-review; eliminate borders between specialties by linking different fields of oncology, cancer research and biomedical sciences; and foster application of basic and clinical science. Oncotarget is indexed and archived by PubMed/Medline, PubMed Central, Scopus, EMBASE, META (Chan Zuckerberg Initiative) (2018-2022), and Dimensions (Digital Science). To learn more about Oncotarget, please visit https://www.oncotarget.com and connect with us: Facebook - https://www.facebook.com/Oncotarget/ X - https://twitter.com/oncotarget Instagram - https://www.instagram.com/oncotargetjrnl/ YouTube - https://www.youtube.com/@OncotargetJournal LinkedIn - https://www.linkedin.com/company/oncotarget Pinterest - https://www.pinterest.com/oncotarget/ Reddit - https://www.reddit.com/user/Oncotarget/ Spotify - https://open.spotify.com/show/0gRwT6BqYWJzxzmjPJwtVh MEDIA@IMPACTJOURNALS.COM

Dominique Jean Larrey lived quite a life. He was born in 1766, and at the age of 13, had to walk from his home in a French village to study in the city of Toulouse. That journey was 70 miles, and yes, he walked it. That would be important much later in his life, when he found himself walking through the bitter cold in Russia as the Chief Surgeon of Napoleon's army. During that time, Napoleon's troops had to contend with the reality of Russian cold and temperatures that got as low as -37 degrees Celsius, which is about -35 Fahrenheit.Larrey attributed his ability to withstand the cold to his walking. But many of the soldiers around him wound up with frostbite, and to treat them, Larrey suggested slowly rewarming the affected area and rubbing it with snow. Frostbite treatment has been on quite the journey since then, and it was just earlier this year that the FDA approved the first drug to treat frostbite in the US, which is exciting news for the doctors who see cases of frostbite and for patients who are often left with the horrific reality of amputation. Send us your science stories/factoids/news for a chance to be featured on an upcoming Tiny Show and Tell Us bonus episode and to be entered to win a Tiny Matters coffee mug! And, while you're at it, subscribe to our newsletter at bit.ly/tinymattersnewsletter.Links to the Tiny Show & Tell story are here and here. All Tiny Matters transcripts and references are available here.

Hey how are you doing today? Do you feel good? Are you feeling good about yourself? If not, have I got the product for you - a lil substance you can inject to spawn a hotter version of yourself who will ruin your life. Are you interested?  We're talking THE SUBSTANCE (2024), a very weird and disgusting and delightful film we can not recommend highly enough. Don't cheat yourself out of watching this without spoilers! And ladies, remember - you're more than just one b00b Follow us on Bluesky: https://bsky.app/profile/noshowmonster.bsky.social Follow us on Instagram: https://www.instagram.com/noshowmonster/ Email us at noshowmonster@gmail.com Follow Kelly Attaway Bluesky: https://bsky.app/profile/kellyattaway.bsky.social Instagram: https://www.instagram.com/spooky_kellyyy/ Follow Chelsea Hollander lol SIKE you can't she's not online because she values her mental health and wellbeing  Hosted by Kelly Attaway and Chelsea Hollander Produced by Kelly Attaway Art by Ryan Tate Theme by Unicorn Heads    

The U.S. Food and Drug Administration has approved cannabis-derived medications for several indications. In this episode, family practitioner Randy Easterling, MD, highlights the current regulatory status of FDA-approved cannabis-derived medications and their approved uses.     ⭐⭐⭐⭐⭐

Kate Willis is an esteemed leader in Healthcare and MedTech, known for her strategic prowess and innovative approaches. Currently, she serves as the Vice President of Commercialization at Neurovalens, responsible for leading all global and US commercial functions, including the US launch. Her career highlights include serving as the Director of Government Affairs and Advocacy, where she has been a powerful force in shaping industry standards and policies.Kate's robust track record of leadership extends through premier companies such as Nevro, Medtronic, Nuvasive, and Zimmer Biomet, where her initiatives have not only spurred organizational growth but have also earned her multiple accolades. These honors include prestigious recognitions such as multiple President's Club awards, Sales Rep of the Year, and Rookie of the Year. Beyond her healthcare expertise, Kate is a recognized figure in the arts as a producer and investor, with successful ventures in Broadway, West End, and film productions. Her unique flair for bridging the realms of business and entertainment underlines her diverse capabilities and visionary outlook. SHOWNOTES:

Guests: Ross O'Neill Ph.D (Founding CEO) & Hubert Lim Ph.D (Chief Scientific Officer) of Neuromod Dave is joined by Ross & Hubert to discuss: - The backstory of how Ross & Hubert met and ultimately partnered together on Lenire - Hubert's research and papers he wrote about paired stimulation & Pavlovian conditioning, which included data that identified tongue stimulation combined with sound as a promising direction to pursue - An overview of what exactly tinnitus is and why Lenire presents such a novel approach to treating tinnitus - Other types of synchronous-stimuli approaches that have emerged in other healthcare verticals (i.e. mirror therapy for phantom limb pain) - The challenging process of gaining FDA approval and the clinical trials that were conducted throughout the process - Being featured as the cover story on Nature Communications - The initial roll-out of Lenire, the current state of the provider network, and the real-world data that's being collected and published

I dive deep into the illusion of safety behind FDA approvals and doctor recommendations. I unpack the shocking reality that the FDA, the very agency tasked with protecting public health, is often funded by the same conglomerates it's supposed to regulate. From fast-tracked pharmaceuticals to harmful food additives like aspartame and glyphosate, I reveal how corporate interests and profit often overshadow genuine concern for our well-being. Exploring conflicts of interest embedded within the system, like the opioid crisis, I challenge the notion that “doctor-recommended” always means safe. I urge you to become your own health advocate, question the system, and reconnect with nature to truly reclaim your health. This episode is a must-listen for anyone ready to break free from blind trust in labels and take control of their wellness journey. Resources:  Puori Supplements discount code: HEALINGTHESOURCE for 20% off your order sitewide (don't miss out PW1 grass-fed protein powder and CP1 collagen!!) Follow the host, Claudia Gilani, here, and check out HealingTheSource.org

As of 2019, there are urine-free FDA-approved bioidentical hormones that skirt the standardization concerns of compounded preparations. Are they any safer?

Recently, the FDA approved a genetic test for opioid use disorder despite clear opposition from scientists and the FDA advisory panel that had reviewed the evidence. The case demonstrates the space where Pharma's incentive may drive innovation that may not help–or worse, cause harm. Abdul reflects on how genetic essentialism and the wrong incentives can reinforce each other. Than he speaks with Dr. Elizabeth Joniak-Grant, a sociologist and patient advocate who voted against the genetic test. This show would not be possible without the generous support of our sponsors. America Dissected invites you to check them out. This episode was brought to you by: Marguerite Casey Foundation invites you to sign up for their new Summer School program at caseygrants.org/summerschool. Henson Shaving invites you to find the razor that will last you a lifetime. Go to https://hensonshaving.com and enter AD at checkout to get 100 free blades with your purchase. (Note: you must add both the 100-blade pack and the razor for the discount to apply.) Blueland invites you to celebrate Plastic Free July with up to 25% off your Blueland order. Go to Blueland.com/america now for your special limited time offer.

Last month the FDA approved a new treatment for sickle cell disease, the first medical therapy to use CRISPR gene editing technology. It works by identifying the gene or genes causing the disorder, modifying those genes and then returning them to the patient's body.There are now two gene therapies offered by pharmaceutical companies for sickle cell disease: Casgevy from Vertex Pharmaceuticals and CRISPR Therapeutics, and Lyfgenia from BlueBird Bio. But prices for these one-time treatments are steep: Casgevy costs $2.2 million per patient and Lyfgenia $3.1 million.Both promise a full cure, which would be life-changing for patients with this debilitating condition. Over 100,000 Americans, mostly of African descent, have sickle cell disease.This milestone raises more questions: What will be the next disease that CRISPR can help cure? And is it possible to reduce the costs of gene therapy treatments?Ira talks with Dr. Fyodor Urnov, professor of molecular and cell biology and scientific director of technology and translation at the Innovative Genomics Institute, based at the University of California, Berkeley, about the future of CRISPR-based cures.Transcripts for this segment will be available the week after the show airs on sciencefriday.com. To stay updated on all things science, sign up for Science Friday's newsletters.

The death rate for young adult Americans, the people who are supposed to be in peak physical health, has surged abruptly over the past few years. In fact, the surge matches almost exactly with the rollout of Covid vaccines — and vaccine mandates — in early 2021. So when will public officials finally allow people to ask whether the obvious cause is the actual one? Charlie speaks to Dr. Pierre Kory about his op-ed on this surge in deaths, as well as a recent FDA admission that doctors are free to prescribe Ivermectin. Plus, Alan Dershowitz responds to the imminent fourth indictment of Donald Trump, which may be the most outlandish one yet.Support the show: http://www.charliekirk.com/supportSee omnystudio.com/listener for privacy information.