Podcasts about off label

 Next month, the Food and Drug Administration committee will consider easing restrictions on some peptides. Some influencers have claimed these injectables improve muscle growth, create better immune function and slow aging, among other things. However, there is very little evidence to support the benefits of many of these drugs in humans. At the same time, prescription peptides that are already on the market, such as GLP-1s like Ozempic, have seen increasing demand for off-label use. Daniel Hartung is a professor of pharmacy at Oregon State University. He joins us to share more on the FDA processes and off-label prescriptions.  

GLP1 Analoga, Ozempic® oder Weegovy® ist vielen ein Begriff. Das sind Medikamente für Diabetes und Adipositas. Werde jedoch Off Label auch häufig verwendet um seinen Stoffwechsel und seine Risikofaktoren zu verbessern. Ist das zielführend? Athlete Check (kostenlos)Bist Du bereit für deine Performance Ziele> Finde es heraus:https://710bqyb3r5i.typeform.com/hptestPerformance Coaching Entfessel dein volles Potenzial als vielbeschäftigter Athlet. > mehr erfahren: https://www.rocket-racing.com/Homepage Golo - Longevity und Performance> mehr erfahren: https://www.doc-golo.com/ 

Send me a derm question or story through text or voicemail!Can cats safely take Apoquel or Zenrelia? In this episode, we take a deep dive into the use of JAK inhibitors in feline dermatology, exploring the science behind atopic disease, practical treatment considerations, and the realities of off-label medication use in cats.Watch The Episode: https://www.youtube.com/@thedermvet3932Follow The Derm Vet Podcast: https://www.instagram.com/thedermvetpod/Follow Me: https://www.instagram.com/thedermvet/Timestamps00:00 Intro01:31 Itch Inquiry: Atopic Dogs and the pathophysiology04:22 JAK Inhibitors and Cats05:58 Using Apoquel with a Cat 08:58 Using Zenrelia with a Cat10:53 Dosing These Medications in Cats 12:35 Lab Work Monitoring the Cats14:02 The Risk14:25 The Duration15:40 Discussion of Off Label Use with Owners16:58 Outro

Welcome back to another special live episode of the Fill Me In Podcast, recorded straight from the floor at Modern Beauty Con! In this episode, hosts Jon and Nicole sit down with 26-year aesthetics industry pioneer Leslie Fletcher, NP-BC—founder of the InjectAbility Clinic and the InjectAbility Institute.Leslie pulls back the curtain on the most disruptive, trending, and controversial topics facing aesthetic injectors today. We dive deep into the legalities and clinical techniques surrounding Platelet-Derived Growth Factor (PDGF), discussing how to transition therapeutic data into cosmetic results safely via cannula, mitigate adverse events, and navigate the "politics" of regenerative aesthetics.Leslie also shares her clinical breakthroughs with advanced neurotoxins, including her signature Microtox® technique for skin tightening and melasma improvement. Plus, we explore the crucial business systems that keep a high-volume medical spa thriving—from leveraging Medical Assistants to boost hourly revenue by thousands, to implementing a flawless "Image Review Session" protocol using 3D clinical photography.Whether you are a new injector looking to build an authentic internal brand on social media or a seasoned practice owner getting your medical protocols in order, this episode is packed with clinical gold and practice management secrets you cannot afford to miss.Connect with Leslie Fletcher:Instagram | https://www.instagram.com/lesliefletcher_np/ Instagram | https://www.instagram.com/injectabilitybeauty/ InjectAbility Clinic | https://www.injectabilityclinic.com/InjectAbility Institute | https://www.injectabilityinstitute.com/ Patreon | https://www.patreon.com/cw/injectability?utm_source=ig&utm_medium=social&utm_content=link_in_bio LinkTree | https://linktr.ee/injectability?utm_source=linktree_profile_share<sid=241d64cf-265c-4f87-9e71-3469bc1ad0b5 

In this episode of The Better Life, Dr. Pinkston sits down with Ray Solano, pharmacist and founder of PD Labs, to expose the massive barrier to entry in the traditional pharmaceutical industry and explore why highly effective treatments often get buried by "Big Pharma." If a medication can't guarantee a billion-dollar market, major pharmaceutical companies won't touch it—even if it could save or drastically improve lives. Dr. Pinkston and Ray break down how the current clinical trial system is flawed, the massive price discrepancies between commercial biologics and tailored solutions, and why looking at global case studies and cellular science is more reliable than the corporate "show me the science" narrative. Key Topics Covered in This Episode: The Billion-Dollar Drug Hurdle: Why life-changing formulas for conditions like Peyronie’s disease and localized inflammation are ignored by major drug companies. The $22,000 Contrast: Dr. Pinkston shares a shocking look at the monthly cost of commercial autoimmune biologics versus affordable, root-cause healing. The Power of Transdermal Peptides: How PD Labs successfully formulated BPC-157 as a topical application to provide instant relief for tendonitis and muscle inflammation. Demystifying Generics & Compounding: The hidden truth about bioequivalence versus therapeutic equivalence in generic medications. Alternative Therapies That Work: Insights into the neurological benefits of Leucovorin, using Ivermectin in combination oncology therapies, and the anti-aging benefits of topical Glutathione and GHK Copper for summer skincare. The Telemedicine Trend: A warning on the safety risks of modern online prescription platforms that over-medicate without standard clinical overviews. Visit PD Labs: pdlabsrx.com Call PD Labs Pharmacy: 888-909-0110 (For clinical overviews, nutritional workups, and custom compounding programs) Watch More Episodes: Find all previous shows from the last four years at drpbetterlife.com See omnystudio.com/listener for privacy information.

The number one side effect of comfort is chronic disease, and we're more comfortable than any generation in human history. In this episode, Dr. Clay Moss and I unpack the simple, foundational shifts that produced life-changing results in a 7-day in-patient metabolic rehabilitation protocol: full elimination diet, sleep hygiene, intentional movement, stress management, and community connection. No biohacking gadgets required. Just a return to the basics, your biology was built for. CLICK HERE TO BECOME GARY'S VIP!: https://bit.ly/4ai0Xwg Listen to "Off Label with Dr. Clay Moss" on all your favorite platforms! YouTube: https://bit.ly/4defyfj  Spotify: https://bit.ly/4t5CbY7  Connect with Dr. Clay Moss Website: https://bit.ly/4cGbCE7  YouTube: https://bit.ly/423HwEo  Instagram: https://bit.ly/4mZqjoZ  Facebook: https://bit.ly/4teExEk  TikTok: https://bit.ly/423KkkU  X: https://bit.ly/3R88atg  LinkedIn: https://bit.ly/4cVVAVx  Thank you to our partners A-GAME: “ULTIMATE15” FOR 15% OFF: http://bit.ly/4kek1ij  AION: “ULTIMATE10” FOR 10% OFF: https://bit.ly/4h6KHAD  AIRES: "ULTIMATE20 " FOR 20% OFF: https://bit.ly/4a3Duze  BAJA GOLD: "ULTIMATE10" FOR 10% OFF: https://bit.ly/3WSBqUa  BODYHEALTH: “ULTIMATE20” FOR 20% OFF: http://bit.ly/4e5IjsV  COLD LIFE: THE ULTIMATE HUMAN PLUNGE: https://bit.ly/4eULUKp  CYMBIOTIKA: "ULTIMATE10" FOR 10% OFF: https://bit.ly/4tjyluP  GENETIC METHYLATION TEST (UK ONLY): https://bit.ly/48QJJrk  GENETIC TEST (USA ONLY): ⁠https://bit.ly/3Yg1Uk9  GOPUFF: GET YOUR FAVORITE SNACK!: https://bit.ly/4obIFDC   H2TABS: “ULTIMATE10” FOR 10% OFF: https://bit.ly/4hMNdgg  HEALF: 10% OFF YOUR ORDER: https://bit.ly/41HJg6S  PEPTUAL: “TUH10” FOR 10% OFF: https://bit.ly/4mKxgcn  SNOOZE: LET'S GET TO SLEEP!: https://bit.ly/4pt1T6V  WHOOP: JOIN & GET 1 FREE MONTH!: https://bit.ly/3VQ0nzW  Watch  the “Ultimate Human Podcast” every Tuesday & Thursday at 9AM EST: YouTube: https://bit.ly/3RPQYX8 Podcasts: https://bit.ly/3RQftU0 Connect with Gary Brecka Instagram: https://bit.ly/3RPpnFs TikTok: https://bit.ly/4coJ8fo X: https://bit.ly/3Opc8tf Facebook: https://bit.ly/464VA1H LinkedIn: https://bit.ly/4hH7Ri2 Website: https://bit.ly/4eLDbdU Merch: https://bit.ly/4aBpOM1 Newsletter: https://bit.ly/47ejrws Ask Gary: https://bit.ly/3PEAJuG Timestamps 00:00 ​Intro of Show 04:18 Metabolic Syndrome Definition 06:00 Dr. Clay Moss's Medical Journey 16:05 Biomarkers to Start 23:14 Functional Medicine Program 28:25 Stress Management Protocols 21:35 GLP-1: Pros and Cons 37:21 Future of Peptides 41:42 When Should People Take Peptides, GLP-1? 47:54 Muscle as Our Metabolic Currency 53:14 Female Hormone Therapy Benefits 58:04 Dr. Clay Moss's Mission-Vision 1:03:38 How to Improve Sleep Hygiene 1:08:08 Connect with Dr. Moss 1:08:40 What does it mean to you to be an Ultimate Human? Disclaimer: This podcast is for informational purposes only and does not provide medical advice. It is not intended for diagnosing or treating any health condition. Always consult a licensed healthcare professional before making health or wellness decisions. Gary Brecka is the owner of Ultimate Human, LLC which operates The Ultimate Human podcast and promotes certain third-party products used by Gary Brecka in his personal health and wellness protocols and daily life and for which Ultimate Human LLC and / or Gary Brecka directly or indirectly holds an economic interest or receives compensation.  Accordingly, statements made by Gary Brecka and others (including on The Ultimate Human podcast) may be considered.  Learn more about your ad choices. Visit megaphone.fm/adchoices

Weingart, Christopher www.deutschlandfunk.de, Sprechstunde

Al's on with a quick commute sprint: Downing Street drags TikTok, Meta, X and mates into No.10 to talk kids' online safety — because infinite scroll isn't exactly a public service. Then a genuinely hopeful medical headline: a major trial looks at using existing targeted cancer drugs “off label”, guided by tumour genetics, with actual evidence and guardrails. After the break, it's Patch Tuesday chaos — 167 Microsoft fixes including zero-days — so yes, you're updating today. And in gaming, Animal Crossing quietly drops a 25th anniversary gift that politely reminds you the GameCube was… a while ago. More on everything at standard.co.uk — and follow Tech and Science Daily from The Standard for your weekday briefing. Hosted on Acast. See acast.com/privacy for more information.

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 crucial episode of Beauty Bytes, I sit down with Madison Dini, a powerhouse attorney at Michelman & Robinson who operates right at the intersection of science, medicine, and the law. We tackle the "Wild West" of modern aesthetics and the regulatory challenges facing practices today—from exosomes and polynucleotides to the controversial landscape of PDGF (platelet-derived growth factor).Madison breaks down the critical difference between FDA approval of a product versus the medical board's regulation of the practice of medicine, helping us understand where the lines are truly drawn . We discuss why taking legal advice from social media is dangerous, how to properly navigate off-label use, and the practical steps you need to take regarding malpractice insurance and informed consent to protect your business .

This episode dives into the ASHP Guidelines on the Evaluation of Off-Label Medication Use in the Inpatient Setting. Off-label prescribing is a common yet complex practice in hospitals, requiring careful oversight to ensure safety, efficacy, and cost-effectiveness. We'll explore the pharmacist's role in this process, the importance of institutional policies, and how Pharmacy and Therapeutics (P&T) Committees can support appropriate use. Whether you're a pharmacy leader, clinician, or health-system administrator, this conversation offers practical insights for navigating off-label use with confidence and clarity. The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.

In this episode Dr's J and Santhosh explore the history of off label prescribing of medications. Along the way they cover literature and the rise of food safety, the importance of legal phrasing, false statements versus false advertising, sulfanilamide tragedy of 1937, the creation of prescription and over the counter medications, the thalidomide scandal and the us physician who mostly prevented it, drug repurposing and some famous examples of off label uses for medication. So sit back and relax as we read the fine print on off label medications!Further Readinghttps://pmc.ncbi.nlm.nih.gov/articles/PMC8508135/#:~:text=Off%2Dlabel%20practice%20is%20a,scope%20of%20the%20marketing%20authorization.chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/files/about%20fda/published/The-Sulfanilamide-Disaster.pdfhttps://www.pharmacytimes.com/view/pharmacys-past-the-soothing-syrup-known-for-causing-death-in-thousands-of-babies-#:~:text=Mrs.,to%20kill%20the%20average%20child.https://www.medrxiv.org/content/10.1101/2022.09.08.22279709v1.fullSupport Us spiritually, emotionally or financially here! or on ACAST+travelmedicinepodcast.comBlueSky/Mastodon/X/Instagram: @doctorjcomedy @toshyfroTikotok: DrjtoksmedicineGmail: travelmedicinepodcast@gmail.comSpotify: https://open.spotify.com/show/28uQe3cYGrTLhP6X0zyEhTPatreon: https://www.patreon.com/travelmedicinepodcast Hosted on Acast. See acast.com/privacy for more information.

Heute steigen wir ein wenig tiefer ein und fragen uns, ob ein Arzneimittel außerhalb der im Beipackzettel aufgeführten Anwendungsgebiete von einem Arzt verordnet werden darf. Wenn ja, bei welchen Anwendungen oder Patientengruppen macht dies Sinn? Wann kann eine solche Verschreibung sogar notwendig sein? Wir schauen uns die Möglichkeiten und Grenzen des sog. Off-Label-Use genauer an, beleuchten rechtliche Aspekte und veranschaulichen das Thema anhand von Fallbeispielen. Mehr Infos findest Du auf unserer Website oder auf Social Media⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.westfalenapotheke.de/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠instagram.com/westfalen.apotheke⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.youtube.com/@westfalen_apotheke⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Hast du eine Frage?Schreib uns gerne eine Email oder ruf uns an!⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠welper@westfalenapotheke.de⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠02324/ 67888

Dem Thema Unlust haben wir uns schon über so viele Pfade genähert, über den heutigen allerdings noch nicht. Dieser Trend erreichte uns aus den USA, genauer gesagt über unseren lieben Kollegen Hawe (Hans-Werner Klein) vom achwas.fm-Podcast. Einem Artikel der renommierten New York Times zufolge berichten zahlreiche Frauen auf Social-Media-Plattformen von einem Wundermittel gegen ihre eingeschlafene Libido. Die Rede ist von Testosteron. Teils in sehr hohen Dosen und Off-Label konsumiert, soll es ein regelrechter Booster sein - nicht nur im Bett, sondern auch im Alltag. Vor allem Best Agerinnen berichten von deutlich mehr Energie und plötzlich aufflammender und unbändiger Lust auf ihren Partner - allerdings auch von einigen unangenehmen, teils irreversiblen Nebenwirkungen. Grund genug für Ann-Marlene und Caro, der Sache einmal genauer auf die Spur zu gehen. Was kann Testosteron bei Frauen wirklich Gutes leisten – und was nicht? Hört rein, und begleitet uns auf unserer Spurensuche!

Dr. Michelle explains off-label medications for tinnitus and what the evidence really shows. Antidepressants may reduce distress without lowering the sound for many people. Get the key pros, cons, side effects, and when these meds make sense.Get started with Treble Health:Schedule a complimentary telehealth consultation: treble.health/free-telehealth-consultation Take the tinnitus quiz: https://treble.health/tinnitus-quiz-1Download the Ultimate Tinnitus Guide: 2024 Edition: https://treble.health/tinnitus-guide-2024

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the reasons US Food and Drug Administration Commissioner Martin Makary could have helped negotiate the Most Favored Nation drug pricing deal with Astra Zeneca (:30) and the deal's potential impact on the 340B program (16:35). They also consider the Justice Department's alternative interpretation of off-label promotion regulations and the effect on the scientific exchange of information about drugs (19:16). More On These Topics From The Pink Sheet US FDA Commissioner's Involvement In AstraZeneca Pricing Deal Raises Ethical, Legal Questions: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/us-fda-commissioners-involvement-in-astrazeneca-pricing-deal-raises-ethical-legal-questions-IJV4LMTDA5E65KCOFQUQM76GCA/ EMD Serono IVF Candidate Among First US FDA Priority Voucher Recipients As Part Of MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/emd-serono-ivf-candidate-among-first-us-fda-priority-voucher-recipients-as-part-of-mfn-deal-LKHA6VRTKRE6DJERGNCWCGMBF4/ Manufacturer Most Favored Nation Deals: How They Could Be Protected From 340B: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/manufacturer-most-favored-nation-deals-how-they-could-be-protected-from-340b-FALSG7GHM5GQBFN3I5SPERJIYU/ Off-Label Promotion: DOJ May Take New Look At Scientific Information Exchange: https://insights.citeline.com/pink-sheet/legalandip/litigation/off-label-promotion-doj-may-take-new-look-at-scientific-information-exchange-R62PQJFQTRBCVGCZE57GWM3Q3Q/

 Neste episódio de encerramento da viagem, Paulo Schor compartilha reflexões entre história, inovação e vida pessoal. De Berlim às universidades e startups, passando por encontros culturais e familiares, ele fala sobre pertencimento, maturidade, tempo de qualidade e o valor de manter conexões. 

In this episode of The Common Sense MD, Dr. Tom Rogers dives into the revolutionary practice of microdosing GLP-1 medications, a class of drugs originally developed for diabetes but now widely recognized for their impressive benefits in weight loss, metabolic health, and beyond. Dr. Rogers shares his own experience with microdosing tirzepatide—even though he isn't diabetic or obese—and discusses why these medications are game-changers not just for diabetes and obesity, but for a wide array of health issues.He breaks down how GLP-1 and GIP incretin hormones work, the evolution of these medications, and what makes microdosing effective and accessible for more people. Dr. Rogers also covers the many potential off-label benefits: from cardiovascular and neuroprotective effects, to improved liver function, help with conditions like PCOS and migraines, addiction support, and more. He addresses the cost and accessibility of these drugs, especially through compounding pharmacies, and emphasizes safety, monitoring, and individualized care.Whether you're a patient interested in the latest in metabolic medicine or just curious about GLP-1s, this episode offers a clear, practical, and insightful look at how these medications can fit into a broader strategy for health, longevity, and well-being.What did you think of this episode of the podcast? Let us know by leaving a review!Connect with Performance Medicine!Check out our new online vitamin store:⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://performancemedicine.net/shop/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Sign up for our weekly newsletter: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://performancemedicine.net/doctors-note-sign-up/⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Facebook: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠@PMedicine⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Instagram: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠@PerformancemedicineTN⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠YouTube: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Performance Medicine

In this compelling episode, I sit down with integrative medicine pioneer Dr. Jeffrey Dach, MD, to explore his holistic, science-backed approach to fighting cancer. Drawing from his powerful book The Cancer Toolkit, Dr. Dach explains the core mechanisms behind cancer development and progression, and the multifaceted toolkit he uses to address it, from off-label pharmaceuticals and checkpoint inhibitors, to nutritional protocols, repurposed drugs, and targeted supplements. We also break down the three key cellular pathways that go awry in cancer, how to support the body's natural defenses, and why addressing the root cause—not just the tumor—is essential for long-term remission and recovery.  Topics We Cover: Dr. Dach's integrative and functional approach to cancer treatment Key drivers of cancer: inflammation, angiogenesis, metabolic dysfunction The most promising off-label drugs (e.g., metformin, mebendazole, statins) Why the Warburg effect matters—and how to target it Supplements with strong anti-cancer evidence Checkpoint inhibitors and immune activation Building a multi-modal protocol for better outcomes Patient empowerment and the future of cancer care  COMING SOON: Don't miss Part 2 of this interview, where we dive into Dr. Dach's newest book Bioidentical Hormones 101, and his trailblazing protocols for restoring hormonal health safely and naturally. Whether you're a practitioner, patient, or someone interested in cancer prevention, this episode delivers a deep dive into truly transformative insights. Connect with Dr Jeffrey: Website: Jeffreydachmd.com The Cancer Toolkit: Jeffreydachmd.com/books BIO: Special Guest - Dr. Jeffrey Dach Jeffrey Dach (pronounced DASH) was originally board certified in Diagnostic and Interventional Radiology and worked in the hospital setting for 25 years. After eye trouble, Dr. Dach retired from radiology and started a clinic specializing in bioidentical hormones and natural thyroid and continued this for the last 24 years. He is the author of Bioidentical Hormones 101, Natural Thyroid Toolkit, Heart Book and Cracking Cancer Toolkit.

Listen every weekday for a local newscast featuring town, county, state and regional headlines. It's the daily dose of news you need on Wyoming, Idaho and the Mountain West — all in four minutes or less. 

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?

In this episode of ASCP Esty Talk, Ella and Maggie dive into the wilder side of off-label skin care—the hacks your clients swear by (and you secretly hope they don't try). From using Monistat as makeup primer to dabbing toothpaste on zits and slathering on milk of magnesia to control shine, we unpack the surprising science, hidden risks, and when to gently intervene. Whether these creative shortcuts are rooted in desperation, TikTok trends, or passed-down “wisdom,” we're separating the myths from the mildly effective. Spoiler alert: Not all hacks belong in your routine, but some may spark a safer, pro-grade alternative. Read the Skin Deep article here ASCP Esty Talk with hosts Ella Cressman and Maggie Staszcuk   Produced by Associated Skin Care Professionals (ASCP) for licensed estheticians, ASCP Esty Talk is a weekly podcast, hosted by licensed estheticians, Ella Cressman, ASCP Skin Deep Magazine contributor, and Maggie Staszcuk, ASCP Program Director. We see your passion, innovation, and hard work and are here to support you by providing a platform for networking, advocacy, camaraderie, and education. We aim to inspire you to ask the right questions, find your motivation, and give you the courage to have the professional skin care career you desire.  About Ella Cressman:  Ella Cressman is a licensed esthetician, certified organic formulator, business owner, ingredient junkie, and esthetic cheerleader! As an educator, she enjoys empowering other estheticians and industry professionals to understand skin care from an ingredient standpoint rather than a product-specific view.  In addition to running a skin care practice, Cressman founded a comprehensive consulting group, the HHP Collective, and has consulted for several successful skin care brands.    Connect with Ella Cressman:  Website: www.hhpcollective.com  LinkedIn: linkedin.com/in/ella-cressman-62aa46a    About Maggie Staszcuk:  Maggie Staszcuk serves as the Program Director for ASCP and is the cohost of ASCP Esty Talk podcast. With over 18 years' experience in the esthetics industry, her diverse background includes roles in spa management, spa and med-spa services, and esthetics education. Since becoming a licensed esthetician in 2006, she carries a range of certifications in basic and advanced esthetics. Maggie is dedicated to equipping estheticians with the knowledge and resources they need to thrive in their careers.   Connect with Maggie Staszcuk:  P: 800.789.0411 EXT 1636  E: MStaszcuk@ascpskincare.com    About our Sponsors:   The popular and revolutionary LAMPROBE utilizes radio and high-frequency technology to treat a wide variety of Minor Skin Irregularities™ (MSI)—non-invasively—with instantaneous results. Common conditions treated by the LAMPROBE include: vascular MSI, such as cherry angiomas; dilated capillaries; sebaceous MSI, including cholesterol deposits and milia; and hyperkerantinized MSI, such as keratoses and skin tags.   The LAMPROBE uniquely assists modern, capable, and skilled skin care practitioners to do their work more effectively and with greater client and professional satisfaction. Setting standards in quality, education, and training, the LAMPROBE has become an essential tool enabling skin care practitioners around the world to offer new revenue-enhancing and highly in-demand services.   Website: www.lamprobe.com   Email: info@lamskin.com   Phone: 877-760-2722   Instagram: www.instagram.com/lamprobe   Facebook: www.facebook.com/theLAMPROBE   Skin Script Skin Care provides outstanding products and education, so estheticians prosper and succeed. Skin Script's three pillars are: amazing professional products, excellent customer service that is friendly and fast, and quality education at an approachable price. Skin Script delivers the promise of healthy, vitalized, youthful-looking skin by providing superior, innovative ingredients and formulations that are gentle yet effective. Skin Script Skin Care has been empowering estheticians since 2007 and welcomes you to unite with them in your professional journey.    YouTube: https://www.youtube.com/c/skinscriptrx   Facebook: https://www.facebook.com/skinscriptrx/   Instagram: https://www.instagram.com/skinscriptrx/?hl=en   Massage Envy is a national franchisor and does not independently own or operate any of the Massage Envy franchised locations nationwide. The Massage Envy franchise network, through its franchise locations, is the leading provider of massage services. Founded in 2002, Massage Envy now has approximately 1,100 franchise locations in 49 states that have together delivered more than 200 million massages and skin care services. Website: www.massageenvy.com/careers/career-areas/esthetician  Facebook: @MassageEnvyCareers LinkedIn: @MassageEnvy   About Associated Skin Care Professionals (ASCP):    Associated Skin Care Professionals (ASCP) is the nation's largest association for skin care professionals and your ONLY all-inclusive source for professional liability insurance, education, community, and career support. For estheticians at every stage of the journey, ASCP is your essential partner. Get in touch with us today if you have any questions or would like to join and become an ASCP member.  Connect with ASCP:  Website: www.ascpskincare.com  Email: getconnected@ascpskincare.com  Phone: 800-789-0411  Facebook: facebook.com/ASCPskincare  Instagram: @ascpskincare   

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're continuing our conversation on off-label communication. In this part, we're examining the downside or negative aspects of this practice. We cover potential concerns and scenarios to avoid. Specifically, the following questions are addressed:Mike, maybe you can kick things off with a very quick overview of what we previously covered in the first part of the conversation.Now getting into that downside I mentioned in my opening, what are the disadvantages of off-label communication? In other words, what's potentially wrong with allowing manufacturers to advertise uncleared or unapproved product claims?Why are some (including some within the industry) opposed to giving manufacturers permission to advertise off-label claims?Do you have any examples you can share?Is it possible to find an appropriate balance between what claims should be vetted through the FDA and those that don't need to be?What happens when a company makes unsupported, deceptive, or completely false claims about a product?In your professional opinion, should we allow a company to advertise unapproved claims that haven't gone through a formal review process? Is it a good thing or a bad thing?What else is important?What are the most important takeaways?Listen to this discussion after you've heard Part 1 and see what you think of off-label communication and the guidance. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit https://www.mpomag.com.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we're speaking about off-label communication. More specifically, we're reviewing a recent guidance from the FDA that offers insights on how off-label communication can be performed in accordance to the regulation. We get a definition of the topic as well as examples of successful off-label communication efforts. During the discussion, the following questions are addressed:Can you first please provide an explanation of what “off-label” is in terms of the FDA?Before getting into the details of this “new” guidance, what is the difference between Off-Label Use vs. Off-Label Communication?What's new in this “final” guidance?What is meant by firm-initiated communication containing scientific information on unapproved uses?If you communicate with an organization about unapproved (or off-label) uses, what will happen?If you send such a communication, are you acknowledging the off-label use and then need to submit it to FDA for a label expansion?Does FDA need to know about the communication?What else is important?What are the most important takeaways?Listen to this discussion and see if you can benefit from off-label communication. Then check out part 2 of this discussion. If you'd like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com, and we'll see if we want to address your ideas/inquiries/suggestions in a future episode.Send us a textFor more medtech news and information, visit https://www.mpomag.com.

Episode #206 In this Fasting Q&A episode, hosted by Coach Lisa Chance, Dr. Jason Fung answers questions from the TFM Community: Are there common strategies that help to avoid the common pitfalls of Ramadan, like late night eating, overeating, or accidentally doing OMAD for too long and slowing down the metabolic rate? [01:07] Concerns about off-label use of GLP-1s. Some medical professionals seem to be prescribing GLP-1 medications for anti-aging/longevity purposes in people who aren't overweight or diabetic. What do you think about the trend of “microdosing” GLP-1s as a preventative health measure? [02:36] Are there further short and long-term side effects of GLP-1s coming to light? [06:36] Are there ethical concerns around supply issues with GLP-1s due to increased demand from off-label use? [ 10:12] Are there bioethical concerns about GLP-1s that doctors should be discussing with patients? [12:03] Can you address how people with Type 1 diabetes can develop insulin resistance similar to those with Type 2, sometimes referred to as ‘double diabetes'? [16:21] How concerning is an elevated Lp(a) and how can you lower it? [20:47] Do you know of research or trials with fasting to reduce prostate size?  [26:28] Can someone who is considering kidney donation fast/fat fast? [29:08] I'm seeing many reputable sources saying that the claims against seed oils aren't actually based in the science. I'm curious whether Dr. Fung's opinion has evolved on this? [30:51]   Links A Conversation with Dr. Tro Kalayjian  https://youtu.be/2Vuhip2UlTs?si=fxHBpgNkcI65SOrV Cholesterol Ration Calculator - Omni Calculator https://www.omnicalculator.com/health/cholesterol-ratio    Please note that you need to be a member of the TFM Community to submit questions to the Q&A webinars with Dr. Fung but you can submit questions to our regular Q&A episodes here: https://bit.ly/TFMPodcastQs   Transcripts of all episodes are available on the Podcast page at www.thefastingmethod.com   Sign Up to the How to Fat Fast Masterclass with Dr. Nadia Pateguana here: https://www.thefastingmethod.com/masterclasses-and-live-workshops-2025/#FFMC Discount Code - PODCAST10   Explore the TFM Community with a 7-Day FREE TRIAL https://www.thefastingmethod.com/community/   Book a complimentary 15-minute coaching intake assessment with one of the TFM coaches https://www.thefastingmethod.com/coaching/   Connect With Us Instagram: https://www.instagram.com/fastingmethod/ Facebook Page: https://www.facebook.com/TheFastingMethod Join our FREE Facebook Group: https://bit.ly/TFMNetwork   Summary Timestamps 00:00 Intro 01:07 Fasting Strategies for Ramadan 02:36 GLP-1s for Off-Label Use 06:36 Side Effects of GLP-1s 10:12 Ethical Concerns with GLP-1 Supply Issues 12:03 Bioethical Concerns GLP-1s 16:21 Type 1 Diabetes and IR 20:47 Lp(a) 29:08 Kidney Donation and Fasting 30:51 Seed Oils     Disclaimer This podcast is for educational purposes only and is not a substitute for professional care by a doctor or other qualified medical professional. You should always speak with your physician or other healthcare professional before doing any fasting, changing your diet, taking or adjusting any medication or supplements, or adopting any treatment for a health problem. The use of any other products or services purchased by you as a result of this podcast does not create a healthcare provider-patient relationship between you and any of the experts affiliated with this podcast. Information and statements regarding dietary supplements have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease.

Products often tell you exactly how they're intended to be used. But why leave it at that? As a culture, we have long had a knack for finding ingenious, off-label uses for things. In this episode, we take a close look at a few examples of products that are ostensibly meant for one thing, but are better known for something else entirely. We explore Q-tips, which we are explicitly told not to put into our ears; the Hitachi Magic Wand, the iconic sex toy marketed as a body massager; the musical washboard; and the children's electrolyte solution Pedialyte that many adults swear by as a hangover cure. You'll hear from Hallie Lieberman, author of Buzz: A Stimulating History of the Sex Toy; Jacqui Barnett of the Columbus Washboard Company; Christopher Wilson, curator and chair of the Division of Home and Community Life at the Smithsonian; musician and educator Súle Greg Wilson; zydeco musicians C.J. Chenier and Steve Nash; Shaughnessy Bishop-Stall, author of Hungover: The Morning After and One Man's Quest for the Cure; as well as writers Roberto Ferdman, Dan Brooks, and Kaitlyn Tiffany. Decoder Ring is produced by Willa Paskin, Max Freedman, Katie Shepherd, and Evan Chung, Decoder Ring's supervising producer. We had additional production from Sofie Kodner. Merritt Jacob is Senior Technical Director. Special thanks to Kate Sloan, Dr. Carol Queen, Bryony Cole, Amber Singer, Molly Born, Laura Selikson, and Nell McShane Wulfhart. If you have any cultural mysteries you want us to decode, please email us at DecoderRing@slate.com, or leave a message on our hotline at 347-460-7281. Sources for This Episode Bishop-Stall, Shaughnessy. Hungover: The Morning After and One Man's Quest for the Cure, Penguin, 2018. Brooks, Dan. “Letter of Recommendation: Pedialyte,” New York Times Magazine, Jan. 26, 2017. Comella, Lynn. Vibrator Nation: How Feminist Sex-Toy Stores Changed the Business of Pleasure, Duke University Press, 2017. Dodson, Betty. “Having Sex with Machines: The Return of the Electric Vibrator,” Dodson and Ross, June 9, 2010. Feran, Tim. “Pedialyte Is Not Just For Kids,” Columbus Dispatch, July 19, 2015. Ferdman, Roberto A. “The strange life of Q-tips, the most bizarre thing people buy,” Washington Post, Jan. 20, 2016. Kushner, David. “Inside Orgasmatron,” Village Voice, March 26, 1999. Lieberman, Hallie. Buzz: A Stimulating History of the Sex Toy, Pegasus Books, 2017. Lieberman, Hallie. “Selling Sex Toys: Marketing and the Meaning of Vibrators in Early Twentieth-Century America,” Enterprise & Society, June 2016. Russel, Ruth. “Hangover Remedies? I'll Drink to That!,” Idaho Statesman, Jan. 1, 1978. Sloan, Kate. Making Magic, 2024. Tiffany, Kaitlyn. “How Pedialyte got Pedialit,” Vox, Sep. 10, 2018. Williams, Dell. “The Roots of the Garden,” Journal of Sex Research, August 1990. Wulfhart, Nell McShane. “The Best Hangover Cure,” Slate, Aug. 29, 2013. Want more Decoder Ring? Subscribe to Slate Plus to unlock exclusive bonus episodes. Plus, you'll access ad-free listening across all your favorite Slate podcasts. Subscribe now on Apple Podcasts by clicking “Try Free” at the top of the Decoder Ring show page. Or, visit slate.com/decoderplus to get access wherever you listen. Learn more about your ad choices. Visit megaphone.fm/adchoices

Products often tell you exactly how they're intended to be used. But why leave it at that? As a culture, we have long had a knack for finding ingenious, off-label uses for things. In this episode, we take a close look at a few examples of products that are ostensibly meant for one thing, but are better known for something else entirely. We explore Q-tips, which we are explicitly told not to put into our ears; the Hitachi Magic Wand, the iconic sex toy marketed as a body massager; the musical washboard; and the children's electrolyte solution Pedialyte that many adults swear by as a hangover cure. You'll hear from Hallie Lieberman, author of Buzz: A Stimulating History of the Sex Toy; Jacqui Barnett of the Columbus Washboard Company; Christopher Wilson, curator and chair of the Division of Home and Community Life at the Smithsonian; musician and educator Súle Greg Wilson; zydeco musicians C.J. Chenier and Steve Nash; Shaughnessy Bishop-Stall, author of Hungover: The Morning After and One Man's Quest for the Cure; as well as writers Roberto Ferdman, Dan Brooks, and Kaitlyn Tiffany. Decoder Ring is produced by Willa Paskin, Max Freedman, Katie Shepherd, and Evan Chung, Decoder Ring's supervising producer. We had additional production from Sofie Kodner. Merritt Jacob is Senior Technical Director. Special thanks to Kate Sloan, Dr. Carol Queen, Bryony Cole, Amber Singer, Molly Born, Laura Selikson, and Nell McShane Wulfhart. If you have any cultural mysteries you want us to decode, please email us at DecoderRing@slate.com, or leave a message on our hotline at 347-460-7281. Sources for This Episode Bishop-Stall, Shaughnessy. Hungover: The Morning After and One Man's Quest for the Cure, Penguin, 2018. Brooks, Dan. “Letter of Recommendation: Pedialyte,” New York Times Magazine, Jan. 26, 2017. Comella, Lynn. Vibrator Nation: How Feminist Sex-Toy Stores Changed the Business of Pleasure, Duke University Press, 2017. Dodson, Betty. “Having Sex with Machines: The Return of the Electric Vibrator,” Dodson and Ross, June 9, 2010. Feran, Tim. “Pedialyte Is Not Just For Kids,” Columbus Dispatch, July 19, 2015. Ferdman, Roberto A. “The strange life of Q-tips, the most bizarre thing people buy,” Washington Post, Jan. 20, 2016. Kushner, David. “Inside Orgasmatron,” Village Voice, March 26, 1999. Lieberman, Hallie. Buzz: A Stimulating History of the Sex Toy, Pegasus Books, 2017. Lieberman, Hallie. “Selling Sex Toys: Marketing and the Meaning of Vibrators in Early Twentieth-Century America,” Enterprise & Society, June 2016. Russel, Ruth. “Hangover Remedies? I'll Drink to That!,” Idaho Statesman, Jan. 1, 1978. Sloan, Kate. Making Magic, 2024. Tiffany, Kaitlyn. “How Pedialyte got Pedialit,” Vox, Sep. 10, 2018. Williams, Dell. “The Roots of the Garden,” Journal of Sex Research, August 1990. Wulfhart, Nell McShane. “The Best Hangover Cure,” Slate, Aug. 29, 2013. Want more Decoder Ring? Subscribe to Slate Plus to unlock exclusive bonus episodes. Plus, you'll access ad-free listening across all your favorite Slate podcasts. Subscribe now on Apple Podcasts by clicking “Try Free” at the top of the Decoder Ring show page. Or, visit slate.com/decoderplus to get access wherever you listen. Learn more about your ad choices. Visit megaphone.fm/adchoices

Products often tell you exactly how they're intended to be used. But why leave it at that? As a culture, we have long had a knack for finding ingenious, off-label uses for things. In this episode, we take a close look at a few examples of products that are ostensibly meant for one thing, but are better known for something else entirely. We explore Q-tips, which we are explicitly told not to put into our ears; the Hitachi Magic Wand, the iconic sex toy marketed as a body massager; the musical washboard; and the children's electrolyte solution Pedialyte that many adults swear by as a hangover cure. You'll hear from Hallie Lieberman, author of Buzz: A Stimulating History of the Sex Toy; Jacqui Barnett of the Columbus Washboard Company; Christopher Wilson, curator and chair of the Division of Home and Community Life at the Smithsonian; musician and educator Súle Greg Wilson; zydeco musicians C.J. Chenier and Steve Nash; Shaughnessy Bishop-Stall, author of Hungover: The Morning After and One Man's Quest for the Cure; as well as writers Roberto Ferdman, Dan Brooks, and Kaitlyn Tiffany. Decoder Ring is produced by Willa Paskin, Max Freedman, Katie Shepherd, and Evan Chung, Decoder Ring's supervising producer. We had additional production from Sofie Kodner. Merritt Jacob is Senior Technical Director. Special thanks to Kate Sloan, Dr. Carol Queen, Bryony Cole, Amber Singer, Molly Born, Laura Selikson, and Nell McShane Wulfhart. If you have any cultural mysteries you want us to decode, please email us at DecoderRing@slate.com, or leave a message on our hotline at 347-460-7281. Sources for This Episode Bishop-Stall, Shaughnessy. Hungover: The Morning After and One Man's Quest for the Cure, Penguin, 2018. Brooks, Dan. “Letter of Recommendation: Pedialyte,” New York Times Magazine, Jan. 26, 2017. Comella, Lynn. Vibrator Nation: How Feminist Sex-Toy Stores Changed the Business of Pleasure, Duke University Press, 2017. Dodson, Betty. “Having Sex with Machines: The Return of the Electric Vibrator,” Dodson and Ross, June 9, 2010. Feran, Tim. “Pedialyte Is Not Just For Kids,” Columbus Dispatch, July 19, 2015. Ferdman, Roberto A. “The strange life of Q-tips, the most bizarre thing people buy,” Washington Post, Jan. 20, 2016. Kushner, David. “Inside Orgasmatron,” Village Voice, March 26, 1999. Lieberman, Hallie. Buzz: A Stimulating History of the Sex Toy, Pegasus Books, 2017. Lieberman, Hallie. “Selling Sex Toys: Marketing and the Meaning of Vibrators in Early Twentieth-Century America,” Enterprise & Society, June 2016. Russel, Ruth. “Hangover Remedies? I'll Drink to That!,” Idaho Statesman, Jan. 1, 1978. Sloan, Kate. Making Magic, 2024. Tiffany, Kaitlyn. “How Pedialyte got Pedialit,” Vox, Sep. 10, 2018. Williams, Dell. “The Roots of the Garden,” Journal of Sex Research, August 1990. Wulfhart, Nell McShane. “The Best Hangover Cure,” Slate, Aug. 29, 2013. Want more Decoder Ring? Subscribe to Slate Plus to unlock exclusive bonus episodes. Plus, you'll access ad-free listening across all your favorite Slate podcasts. Subscribe now on Apple Podcasts by clicking “Try Free” at the top of the Decoder Ring show page. Or, visit slate.com/decoderplus to get access wherever you listen. Learn more about your ad choices. Visit megaphone.fm/adchoices

Products often tell you exactly how they're intended to be used. But why leave it at that? As a culture, we have long had a knack for finding ingenious, off-label uses for things. In this episode, we take a close look at a few examples of products that are ostensibly meant for one thing, but are better known for something else entirely. We explore Q-tips, which we are explicitly told not to put into our ears; the Hitachi Magic Wand, the iconic sex toy marketed as a body massager; the musical washboard; and the children's electrolyte solution Pedialyte that many adults swear by as a hangover cure. You'll hear from Hallie Lieberman, author of Buzz: A Stimulating History of the Sex Toy; Jacqui Barnett of the Columbus Washboard Company; Christopher Wilson, curator and chair of the Division of Home and Community Life at the Smithsonian; musician and educator Súle Greg Wilson; zydeco musicians C.J. Chenier and Steve Nash; Shaughnessy Bishop-Stall, author of Hungover: The Morning After and One Man's Quest for the Cure; as well as writers Roberto Ferdman, Dan Brooks, and Kaitlyn Tiffany. Decoder Ring is produced by Willa Paskin, Max Freedman, Katie Shepherd, and Evan Chung, Decoder Ring's supervising producer. We had additional production from Sofie Kodner. Merritt Jacob is Senior Technical Director. Special thanks to Kate Sloan, Dr. Carol Queen, Bryony Cole, Amber Singer, Molly Born, Laura Selikson, and Nell McShane Wulfhart. If you have any cultural mysteries you want us to decode, please email us at DecoderRing@slate.com, or leave a message on our hotline at 347-460-7281. Sources for This Episode Bishop-Stall, Shaughnessy. Hungover: The Morning After and One Man's Quest for the Cure, Penguin, 2018. Brooks, Dan. “Letter of Recommendation: Pedialyte,” New York Times Magazine, Jan. 26, 2017. Comella, Lynn. Vibrator Nation: How Feminist Sex-Toy Stores Changed the Business of Pleasure, Duke University Press, 2017. Dodson, Betty. “Having Sex with Machines: The Return of the Electric Vibrator,” Dodson and Ross, June 9, 2010. Feran, Tim. “Pedialyte Is Not Just For Kids,” Columbus Dispatch, July 19, 2015. Ferdman, Roberto A. “The strange life of Q-tips, the most bizarre thing people buy,” Washington Post, Jan. 20, 2016. Kushner, David. “Inside Orgasmatron,” Village Voice, March 26, 1999. Lieberman, Hallie. Buzz: A Stimulating History of the Sex Toy, Pegasus Books, 2017. Lieberman, Hallie. “Selling Sex Toys: Marketing and the Meaning of Vibrators in Early Twentieth-Century America,” Enterprise & Society, June 2016. Russel, Ruth. “Hangover Remedies? I'll Drink to That!,” Idaho Statesman, Jan. 1, 1978. Sloan, Kate. Making Magic, 2024. Tiffany, Kaitlyn. “How Pedialyte got Pedialit,” Vox, Sep. 10, 2018. Williams, Dell. “The Roots of the Garden,” Journal of Sex Research, August 1990. Wulfhart, Nell McShane. “The Best Hangover Cure,” Slate, Aug. 29, 2013. Want more Decoder Ring? Subscribe to Slate Plus to unlock exclusive bonus episodes. Plus, you'll access ad-free listening across all your favorite Slate podcasts. Subscribe now on Apple Podcasts by clicking “Try Free” at the top of the Decoder Ring show page. Or, visit slate.com/decoderplus to get access wherever you listen. Learn more about your ad choices. Visit megaphone.fm/adchoices

Dr Kelly Victory, Chief of Disaster & Emergency Medicine twc.health/GRUBER, use promo code: GRUBER How safe are drugs like Ivermectin and Mebendazole for off label uses?

Join AFS Life Sciences Partner Stephanie Trunk and Darshan Kulkarni, Life Sciences regulatory and compliance attorney, as they explore the major shifts occurring in the pharmaceutical industry under the Trump Administration. Highlights of the conversation include: Evolving regulations for off-label pharmaceutical promotion. Enhancing a firm's global footprint by building trust with sovereign governments. Examining new compliance challenges stemming from AI technology. Navigating US Food and Drug Administration guidance as an unreliable indicator of enforcement priorities. Increasing scrutiny of the role of medical affairs. Finding balance between patient access and regulatory compliance.

Editor's Summary by Kirsten Bibbins-Domingo, PhD, MD, MAS, Editor in Chief, and Preeti Malani, MD, MSJ, Deputy Editor of JAMA, the Journal of the American Medical Association, for articles published from February 1-7, 2025.

 Because of Physical issues and Psychology issues.1.) Low libido.When having a menopausal problem,- the females have a lack of sex hormones or a dry vagina. In these cases, they have pain when they have sex… Or if the body is too fat. 2.) Difficulty being aroused. When women are:stressed out, tired, depressed, too many problems,bad lover,   or have anxiety. -the majority of women don't like under these circumstances to have sex with men.3.) Aversion to sex and/or of men.If a girl is growing up in a family that abuse sex then the girl will have a bad consciousness if it will enjoy sex.On average every 10th girl is sexually abused through their family… In both cases, the sexually abused woman needs a therapy to get rid of all these aversions of sex and traumas. Otherwise, intimacy or a deep connection to her boyfriend or spouse will be a problem.4.) Asexuality. Women who have no or less sex drive… That is possible.5.) Inability to reach orgasm.Up to 10-20% of women never achieve an orgasm.  In all cases exist some remedies… First, check a female doctor. A.) For a low testosterone level, menopause and aging take daily:1.) Maca powder from a high altitude mountain (Andean) (otherwise it will not work!!!).  Maca powder can be very powerful to overcome menopause. Or try Ashwagandha (can't be used during pregnancy). 2.) Ginseng3.) Fo-Ti (He Shou Wu, Chinese Cornbind)4.) Gingko Biloba5.) Goji Berries (Wolf Berries)6.) Astragalar7.) Lingzhi Mushrooms8.) Gotu Kola9.) Jiao Gu Lan The first 5 herbs are increasing your testosterone and other sexual hormones… At least they make your body strong. The last 4 herbs are for busting your immune system and heart…B.) Zesta (a botanical oil to apply to the genitals) to enhance the climax of women.C.) INTONE ™ and Intensity™  are approved electrical stimulating devices that can help to get an orgasm and help to treat the urinary leakage in women. D.) Vaginal estrogen – Available as a cream, a tablet or a vaginal ring, and considered the best treatment for genital arousal problems and pain from vulvovaginal atrophy that occurs in many postmenopausal women.E.) Off-Label use of Vaginal DHEA 1 percent suppository – An adrenal precursor that women with vaginal atrophy/thinning/decreased sensation can use as an alternative to vaginal estrogen.F.) Osphena – The first, non-estrogen oral therapy for moderate to severe painful sexual activity due to vulvovaginal atrophy.G.) Flibanserin (Addyi®) – This drug was recently approved by the FDA to restore female sexual desire in women before menopause. It must be taken orally every day, and it may have side effects, such as severe low blood pressure and fainting.My Video: Why can't women sleep with men? https://youtu.be/zeT3eA_f_T0My Audio: https://divinesuccess.net/wp-content/uploads/2021/Podcast.B/Why-can't-women-sleep-with-men.mp3

Join Lee Henrikson and Dr Jill as they talk about drugs that are being used for multiple issues other than FDA designated use. Understand the FDA process and studies they reference.

FDA has changed its mind about off label marketing. Today, we're diving into how drug and device companies can effectively engage with payers and providers, exploring recent updates and guidelines. Let's start with the basics: FDA Regulations and the First Amendment. The FDA's ability to impose restrictions on speakers and content is limited by the First Amendment, which protects commercial speech. While the FDA can regulate marketing to prevent false or misleading claims, it must balance this with constitutional protections.Next, we discuss the CFL Guidance—focused on medical device and product communications consistent with FDA-required labeling. This guidance helps evaluate whether communications about approved products align with FDA labeling, including considerations for patient populations, usage directions, and potential harm. Despite its existence for six years, companies still face challenges due to high penalties for non-compliance and a lack of concrete steps for implementation.We'll also cover the FDAMA 114 Guidance, which clarifies how manufacturers can share healthcare economic information with payers about both approved and unapproved products. This guidance aims to ensure that communications are truthful, non-misleading, and based on competent and reliable scientific evidence.Additionally, the PIE Act (Prescription Drug and Medical Device Pre-Approval Information Exchange Act) facilitates communication about investigational drugs, allowing for early planning and budgeting by providing data on clinical trial phases and anticipated approval timelines.Finally, we'll touch on the SIUU Guidance, which focuses on communications from firms to healthcare providers about unapproved uses of approved products. This guidance is designed to ensure that such communications are truthful and separate from promotional content, despite the complexities and scrutiny involved.The key takeaways for medical affairs teams are to develop strategies that ensure compliance with these diverse guidelines, addressing both regulatory and legal aspects of communication. For robust support, contact the Kulkarni Law Firm, where we provide expert guidance to navigate these complex issues and ensure compliance.Support the show

Join host Duane Schulthess on the Vital Health Podcast as he explores the groundbreaking Prime Rose Project, an initiative redefining the use of off-label drugs in oncology. Featuring insights from Dr. Hans Gelderblom, Chair of Medical Oncology at Leiden University Medical Center, and Sahar Barjesteh van Waalwijk van Doorn-Khosrovani, a member of the Dutch National Payers Evaluation Committee, this episode delves into the challenges and opportunities of drug rediscovery protocols. Learn how this innovative approach balances accessibility, affordability, and evidence-based treatments, transforming the landscape of personalized medicine across Europe.See omnystudio.com/listener for privacy information.

Eli Lilly's changed its opinion on Off-Label uses! Eli Lilly, a company that makes a diabetes drug, is now urging people not to use it for weight loss, a common off-label use, despite not raising concerns about off-label uses in the past. Off-label use, where a drug is used for something other than its original purpose, is a normal part of healthcare, and the FDA acknowledges this practice. However, Lilly's sudden stance seems driven by a shortage of the drug, which they want to prioritize for diabetes patients. This shift appears more about supply management than safety. It's crucial that companies and regulatory bodies maintain consistent messaging to avoid confusion and ensure patient care remains a priority. Let's continue advocating for what's best for patients.Support the show

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. A study has found that Novo Nordisk's semaglutide may reduce the risk of Alzheimer's disease by 40% to 70%. Roche has entered a potential $1 billion gene therapy deal with Dyno Therapeutics, focusing on neurological diseases. Off-label prescribing of GLP-1 receptor agonists for type 1 diabetes has increased, despite lack of FDA approval. Viking Therapeutics plans to accelerate the development of an obesity drug with two Q4 catalysts. Trilink Biotechnologies has expanded its mRNA synthesis services offerings for screening studies. The USP aims to double its volunteer applicant pool, while a CDC panel recommends pneumococcal vaccines for adults aged 50-64. Updates on companies like Catalent, Sangamo, and Moderna are also included in today's news. Additionally, the FDA has approved Pfizer's Abrysvo as the first RSV vaccine for younger adults.

A new medication is knocking on the door for FDA approval in PTSD, and it isn't MDMA. We cover that, and 8 other off label medications.CME: Take the CME Post-Test for this EpisodePublished On: 09/23/2024Duration: 27 minutes, 18 secondsChris Aiken and Kellie Newsome, PMHNP have disclosed no relevant financial or other interests in any commercial companies pertaining to this educational activity.

This week we speak with noted interventional cardiologist Dr. Shyam Sathanandam of LeBonheur Children's Hospital in Memphis, TN about novel, 'off-label' uses of the Amplatzer Piccolo device in children. In what sorts of lesions does Dr. Sathanandam believe this device offers distinct advantages for vascular closure? What is the feature of this device that allows it to work for small defect closure so effectively and safely? Are there any new changes coming to this device or the delivery system for PDA closure in the premature infant? These are amongst the questions and topics reviewed with our guest this week!https://doi.org/10.1080/14796678.2024.2355057

Pink Sheet reporter and editors discuss former Surgeon General Jerome Adams' views on how the FDA can better ensure clinical trial diversity (:27), questions about approving a new drug that would be used with a standard of care regimen that is off-label (15:00), and the agency beginning to schedule fully in-person advisory committee meetings (24:03). More On These Topics From The Pink Sheet ‘You Shall Not Pass:' Former Surgeon General On Why US Government Should Push Trial Diversity: https://pink.citeline.com/PS155063/You-Shall-Not-Pass-Former-Surgeon-General-On-Why-US-Government-Should-Push-Trial-Diversity Gaps Found In Most Pharma Trial Diversity Policies: https://pink.citeline.com/PS155086/Gaps-Found-In-Most-Pharma-Trial-Diversity-Policies Zevra's Arimoclomol Use With Standard Of Care Complicates US FDA Adcomm Efficacy Assessment: https://pink.citeline.com/PS155091/Zevras-Arimoclomol-Use-With-Standard-Of-Care-Complicates-US-FDA-Adcomm-Efficacy-Assessment Back To White Oak: US FDA Adcomms Go Fully In-Person, Starting With Antimicrobials Panel: https://pink.citeline.com/PS155100/Back-To-White-Oak-US-FDA-Adcomms-Go-Fully-InPerson-Starting-With-Antimicrobials-Panel

Part 3 of a 3 part series We are thrilled to welcome RN and community member Mandy Baker as she dives into her personal experience taking a GLP-1 off-label brand drug. Mandy is a busy wife, mom of six, and grandma of five. She is a registered nurse and has spent the majority of her life caring for her family and serving in her church and community.  Please check out our part 1 (ep. 223) and part 2 (ep. 226) on this topic. In this episode we discuss: A personal journey with off-label GLP-1 class drugs.  How Mandy felt while taking these drugs. Making lifestyle changes alongside taking the drug. Side-effects of taking the drug. Other ways to educate yourself on this topic and eliminate addictive foods. This is such a thought provoking episode, don't forget to head on over to YouTube to watch it in video. We'd love to know your thoughts on this topic because it really does impact everyone.  **Please note that the information provided in this podcast is not intended to be a substitute for professional medical advice, diagnosis or treatment that can be provided by your own Medical Doctor.   Helpful links and resources: https://www.brightlineeating.com/ Podcasts we mention: Episode 226: Part 2 with Jeff Dachis Episode 223: Part 1 in this series --------------------------------------------------------- Thanks to our amazing Sponsor, Vivarays Are you looking for a way to improve your sleep and boost your energy during the day? Meet Vivarays' Circadian Light Harmonizing Glasses! Unlike regular blue light blockers, these glasses are engineered with a deep understanding of light and its impact on your body. Designed by leading sleep experts, Vivarays helps keep your circadian rhythm in sync with nature, improving your hormonal balance, sleep quality, energy levels and productivity. Head over to https://vivarays.com/livingwell to check out their amazing glasses and use promo code ARTOFLIVINGWELL during checkout to save 10%. --------------------------------------------------------- Invigorating Outdoor Community Yoga with Anne Gustin Tuesday, July 23rd in Edina, 7 PM Sign-up here --------------------------------------------------------- Need more protein in your day? Check out these amazing, high quality products from Kion, especially their essential amino acids, which we both use daily.   Use code 'ARTOFLIVING' for a discount off your purchase. ----------------------------------------------------------- Ask us a question/make a recommentation We'd love to hear from you! Click here to share your feedback and suggestions. ----------------------------------------------------------- Sign-up for your 15 minute Health Transformation Audit - Click here. ----------------------------------------------------------- Revitalize your body and prepare for summer with our self-guided liver detox, designed to leave you feeling refreshed, energized, and ready to embrace the season ahead! We now have a program where you can do it on your own schedule but still receive all the wonderful support and recipes of the full program.  Register here! ----------------------------------------------------------- Let us help you get to the root cause of your unwanted symptoms. Schedule a 15 minute consultation to discuss at-home functional medicine lab testing here. ----------------------------------------------------------- How can you support our podcast? Apple users, please subscribe and review our show on Apple Podcasts,we make sure to read them all. Android users, please be sure to subscribe to our show on Google Podcasts so that you don't miss any of the action. Tell a friend about The Art of Living Well Podcast® and our community programs. Share your favorite episode on social media and don't forget to tag us @theartofliving_well. Subscribe to our Youtube channel Shop our Favorite Products: https://www.theartoflivingwell.us/products Connect with us on social media: IG: @theartofliving_well FB: theartoflivingwell Get on our list so you don't miss out on announcements, programs and events. You can download our guests' favorite reads here. Learn more about your hosts: Marnie Dachis Marmet Stephanie May Potter

Off-label use of dental devices during direct laryngoscopy by AORNJournal

We shed light on the complexities surrounding off-label promotion and reimbursement in the pharmaceutical industry.We discuss the following:What does off-label mean from a reimbursement standpoint? Lessons from the US v. Eli Lilly 2009 case How do recent court decisions impact off-label promotion? United States v. Caronia and US v. Facteau How are weight loss drugs, initially approved for treating diabetes, reimbursed within Medicare and Medicaid? How are compounded drugs reimbursed? Could a company be held accountable for off-label use of a drug due to compounded products? Are weight loss drugs exempted from reimbursement? Support the Show.

Dr. Helveston's new book tells the history of the Clostridium botulinum, a bacterium that was discovered and researched as a poison and how it came to be Botox, with multiple medical applications and a household word in the beauty industry. As an ophthalmologist, Dr. Helveston worked with Alan Scott who is credited with developing and manufacturing Botox although, as you'll hear in the episode, his rewards were more advancing science and having fun rather than making money. It's a fascinating tale of a remarkable person and his dedication to a useful toxin.Eugene Helveson's website:https://eugenehelveston.com/Thoughts? Comments? Potshots? Contact the show at:https://booksshowstunes.discreetguide.com/contact/Sponsored by Discreet Guide Training:https://training.discreetguide.com/Follow or like us on podomatic.com (it raises our visibility :)https://www.podomatic.com/podcasts/books-shows-tunes-mad-actsSupport us on Patreon:https://www.patreon.com/discreetguideJennifer on Post.News:@JenCrittendenJennifer on XTwitter:@DiscreetGuideJennifer on LinkedIn:https://www.linkedin.com/in/jenniferkcrittenden/

Dr. Joe Sirven and Dr. Natohya Mallory share insights on the weight loss drug Ozempic. Then, Jacksonville Today reporter Will Brown explores the life of civil rights patriarch Lloyd Pearson. Finally, we hear about two efforts to revitalize North Springfield and Downtown.

Following a number of challenges to administrative enforcement on First Amendment grounds, the Food and Drug Administration (FDA) released new draft guidance document addressing truthful and non-misleading communications for product uses not approved or cleared by the FDA. Notably, the document updates standard for using scientific or medical journal reprints and creates a new category for firm-generated presentations. These changes suggest a potential expansion of the safe harbor for manufacturers' communication of scientific information. In this episode of Connected With Latham, Ben Haas, Global Vice Chair of Latham's Healthcare & Life Sciences Practice Group, speaks with counsel Monica Groat and associate Nate Beaton. They discuss the implications of the FDA's draft guidance document, including the “scientifically sound and clinically relevant” criteria for reprints, the scope of the “firm-generated presentation” definition, and the parts of the document that may be challenged by industry.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

A terminal cancer diagnosis can be paralyzing. However, when Jane McLelland was diagnosed with a Stage IV cancer in 1999, she didn't freeze. Using her medical knowledge and researching heavily, Jane put together a cancer-starving formula using natural therapies, exercise, diet, and a unique cocktail of drugs that acted synergistically to kill even the toughest of cancers. In fact, Jane became one of the pioneers in discovering the use of off-label drugs for cancer, mapping the landscape of cancer metabolism in a new way for patients to understand. In today's episode, Jane shares how off-label & repurposed drugs can effectively starve cancer. Jane is truly incredible, and continues to serve as an inspiration and source of encouragement for anyone facing a terminal cancer diagnosis.What you'll learn from this episode: How off-label drugs are now being recognized as an effective cancer treatmentSpecific drug combinations that Jane used to treat her Stage IV cancer diagnosisHow Jane created her famous "metro-map" of drugs to block different cancer pathwaysCancer fuel sourcesSpecific drug combinations that Jane used to block her own cancer& So much more!Resources:Book: How To Starve CancerWebsite | InstagramWarburg Effect (National Library of Medicine, PubMed)Glossary of terms Jane references and moreLINK:  Metro Map ProtocolInternational Doctors familiar with Jane's Metro Map ProtocolTo learn more about WellnStrong: Subscribe to my newsletter! WellnStrong Blog WellnStrong Instagram WellnStrong Pinterest

Is there such a thing as a quick fix? Neil deGrasse Tyson, Chuck Nice, and Gary O'Reilly learn about the science behind a wave of new weight loss drugs, the ethics of Ozempic use, and off-label prescriptions with exercise scientist, Dr. Nick Tiller.For more information on the new book: https://startalkmedia.com/books/NOTE: StarTalk+ Patrons can listen to this entire episode commercial-free here: https://startalkmedia.com/show/miracle-drugs-quick-fixes-with-dr-nick-tiller/Thanks to our Patrons Christian Attwood, Tyler Loveland, Ruhan Periyacheri, Jeff Parker, Ed Thorton, and Dakota Ponder for supporting us this week.Photo Credit: HualinXMN, CC BY-SA 4.0, via Wikimedia Commons

First up, Jillian explores the practice of prescribing drugs for off label use -- a different purpose than what the drug is FDA approved for. Why is it done? What are the risks and benefits? And some things you need to know before you engage in off label drug use. Then, Jillian resumes her role as a world renowned fitness expert and certified nutritionist to dig in to what it means to be over trained. What are the consequences and how can you fix them? Plus, listener questions on everything from the safety of Stevia and how to use a BMR calculator accurately, to top tips to heal sore muscles.For 25% off The Fitness App by Jillian Michaels, go to www.thefitnessapp.com/podcastdealFollow us on Instagram @JillianMichaels and @MartiniCindyJillian Michaels Community: https://www.facebook.com/groups/1880466198675549Email your questions to JillianPodcast@gmail.comSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.