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Psychiatrist, internist, and addiction medicine specialist Muhamad Aly Rifai discusses his article "Psychedelic-assisted therapy: science, safety, and regulation." Muhamad explores the complex landscape of psychedelic medicine, balancing the growing public interest with the necessity of rigorous FDA oversight and safety protocols. The conversation examines the distinction between classic psychedelics like psilocybin and dissociatives like ketamine while highlighting why "set and setting" are critical for therapeutic success in treating depression and trauma. Muhamad emphasizes that these powerful agents are not simple pill swaps but require structured psychological support to translate peak experiences into lasting behavioral change. Discover why the path to effective treatment relies on transparent regulation and clinician humility rather than unsupervised experimentation. Partner with me on the KevinMD platform. With over three million monthly readers and half a million social media followers, I give you direct access to the doctors and patients who matter most. Whether you need a sponsored article, email campaign, video interview, or a spot right here on the podcast, I offer the trusted space your brand deserves to be heard. Let's work together to tell your story. PARTNER WITH KEVINMD → https://kevinmd.com/influencer SUBSCRIBE TO THE PODCAST → https://www.kevinmd.com/podcast RECOMMENDED BY KEVINMD → https://www.kevinmd.com/recommended
In this Winter News & Notes episode of The Celiac Project Podcast, Mike and Cam share powerful listener updates and real life celiac journeys. From insurance battles and refractory celiac disease to mental health, OCD, and navigating college gluten free, this episode highlights both the challenges and the progress happening in the community. They also discuss advocacy efforts around FDA labeling and helpful resources for checking whether medications are gluten free.
#200 - Miracle Cure or Internet Hype? The Truth About Castor Oil Castor oil is having a moment. Scroll social media for five minutes and you'll see it: “Cured my endometriosis.” “Detoxed my liver.” “Regrew my hairline.” “Healed… well, everything.” And when something is suddenly the solution to literally every problem… it's time to pause. Because while castor oil is absolutely powerful, not every claim floating around the internet deserves your blind trust (or all of your body parts). In this episode, I break down what castor oil actually is, what it's scientifically supported for, what I personally use it for, and what I absolutely would not recommend—especially if you're pregnant or thinking about putting it near your eyeballs. If you've been curious about castor oil packs, anti-aging benefits, hair growth hacks, stretch mark reduction, or lymphatic detox claims… this episode is your grounded, evidence-based (with a dash of anecdotal honesty) guide. What You'll Learn in This Episode What castor oil is made of (and why omega-9 fatty acids matter) FDA-approved uses vs. influencer folklore Whether castor oil actually helps with constipation Skin barrier repair, anti-aging, and collagen support Hair growth, scalp health, and rosemary oil synergy Castor oil for scars, stretch marks, arthritis, and cracked heels The truth about castor oil packs for liver detox Regular vs. Jamaican black castor oil—is there a difference? Side effects, safety, and when to absolutely avoid it Timestamps 00:00 – Castor oil: miracle cure or marketing frenzy? 01:00 – Why the FDA cracked down on exaggerated claims 02:00 – What castor oil actually is (hello, omega-9 fatty acids) 04:30 – What it's officially approved for 05:00 – Would I drink it for constipation? 06:30 – Traditional uses: skin conditions, infections, inflammation, lymphatic support 07:30 – Skin benefits that actually make sense 08:00 – Fine lines, wrinkles, and collagen support (why it may help) 09:00 – How to use it for hair growth 10:30 – Acne: helpful or hormonal disaster? (Bio-individuality matters) 12:00 – Castor oil packs for liver detox—worth it? 13:00 – Thyroid application (yes, I use it for Hashimoto's support) 14:00 – Stretch marks & scars: how to use heat to enhance absorption 16:00 – Anti-aging layering method (this is worth the price of admission) 17:00 – Lips: hyaluronic acid + castor oil combo 18:00 – Cracked heels, cuticles, and nail growth 20:00 – The fern experiment (because why not?) 21:00 – Jamaican black castor oil vs. regular: which is better? 22:00 – Side effects and when not to use it 23:00 – Pregnancy warning (seriously, a hard no) 24:00 – My honest verdict Let's Talk About What's Real Castor oil is rich in ricinoleic acid—an omega-9 fatty acid with anti-inflammatory properties. That's the magic. It's thick. It's deeply emollient. It seals moisture in like a champ. Which makes it excellent for: Dry skin Eczema-prone areas Crepey skin in perimenopause and menopause Fine lines (temporarily plumping through hydration) Cracked heels Dry cuticles Scalp nourishment And when you layer it correctly, it acts like a sealant to hold hydration in. I personally use it nightly on my face, neck, thyroid area, lips, and brows. Am I shiny before bed? Yes. Do I care? Not even a little. What I'd Be Careful With Internal use for constipation (very effective but not my first-line recommendation) Anything near your eyes (I woke up with red, burning, and irritated eyes) Vaginal dryness or sensitive internal use (research first, please) When To Never Use It Pregnancy (it induces labor) Castor Oil & Hormones As estrogen drops in perimenopause and menopause, skin becomes thinner, drier, and less elastic. This is where castor oil shines—literally and figuratively. It supports: Skin barrier repair Moisture retention Elasticity appearance That “spring back” we start to lose Is it Botox? No. Is it still amazing and affordable? Absolutely. Bottom Line Is castor oil a cure-all? Nope. Is it a potent, multi-use, low-risk tool? Yes. In a world where we're constantly sold $200 serums and complicated 12-step regimens, there's something refreshing about a humble glass bottle that's been used for centuries. If you try it: Buy organic Make sure it's in a dark glass bottle Patch test first Use cotton (preferably organic), not polyester, when covering treated areas And maybe—just maybe—pour it into something beautiful so you'll actually remember to use it. One More Thing Pretty Well was shared more than 94% of other shows in Spotify Wrapped this year. That's because of you. You share it. You text it. You send it to friends who need better information without the hype. And that means everything to me. If this episode helped you to decode the castor oil craze (or prevented you from putting it in your eyes), do me a favor and share it with a friend.
Autism, Functional Medicine, and Personalized Interventions: A Conversation with Theresa Lyons, PhD, a Yale-trained scientist and medical strategist who became an autism expert after her daughter's diagnosis and now runs AWEtism.net. Lyons describes dissatisfaction with conventional guidance that offers limited drugs for irritability and primarily ABA (Applied Behavioral Analysis), which is insurance-covered, often recommended at 40 hours/week, uses extrinsic rewards, and may help some skill-learning but has controversies and limitations for social development; she contrasts newer approaches such as RDI (Relationship Development Intervention) and PRT (Pivotal Response), which aim to build intrinsic motivation but are typically not covered by insurance. The discussion covers autism heterogeneity, changes in diagnostic categories (e.g., Asperger's folded into autism), and research including a Boston Children's Hospital study reporting 37% of children in a cohort lost their autism diagnosis over time (diagnosis based on observation). Lyons addresses debates about rising autism prevalence, noting multiple potential contributors and rejecting single-cause explanations, while citing risk-factor examples such as family autoimmune history and air pollution exposure. She outlines a functional medicine “why” approach using constipation as an example (root causes vs. symptomatic treatment), and emphasizes basic, low-risk steps such as evaluating diet, inflammation, hydration/electrolytes, and blood work for nutrients. Specific topics include gluten-free approaches (mechanisms involving gut permeability, immune burden, and CNS effects), dairy/inflammation, vitamin D deficiency and monitoring, melatonin as a well-studied short-term aid in autism (considered safe for a couple of years in studies) while still seeking underlying causes, and omega-3 fatty acids for focus and inflammation. Lyons explains leucovorin (folinic acid, prescription vitamin B9) as a targeted approach for children with folate receptor antibodies (reported in ~70% of autistic children), discusses the value and cost (~$300) of specialized testing from one U.S. lab, and notes reports of major speech and behavior improvements in responders, with dosing nuances. The episode also reviews evidence and cautions around the microbiome, including fecal microbiota transplant (FDA-approved for C. difficile; discussed as having an ~80% response rate in autism-related studies when gut issues are a key driver, but with major donor/compatibility considerations) and probiotics (some small trials and high costs). Other themes include “clean eating,” organic foods and toxin-load considerations tied to genetic detoxification vulnerabilities, discussion of acetaminophen/Tylenol in pregnancy in the context of glutathione pathways and personalized risk, and using genetics to guide interventions. Lyons warns that analysis of top autism TikTok videos found ~70% were inaccurate or overdramatized, recommending social media only for ideas, not decision-making. She also highlights parent stress, citing emerging research on increased PTSD risk among autism parents, and emphasizes support and community. Lyons advises parents to understand their child's specific health drivers and match them to appropriately specialized clinicians, noting her curated doctor listings in The Lyons Report.
It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: big updates for stem cell and islet transplants, new pen option for Zepbound, an implantable insulin pump moves forward and more! Announcing Community Commericals! Learn how to get your message on the show here. Learn more about studies and research at Thrivable here Please visit our Sponsors & Partners - they help make the show possible! Omnipod - Simplify Life All about Dexcom T1D Screening info All about VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Episode transcription with links: Welcome! I'm your host Stacey Simms and this is an In The News episode.. where we bringing you the top diabetes stories and headlines happening now. A reminder that you can find the sources and links and a transcript and more info for every story mentioned here in the show notes. Quick reminder: I'm just back from MNO DC and I'm exhausted. But it's the best kind of tired. We had an incredible time – hope you can join us in Nashville. With a reminder that we have our first Club 1921 in Nashville – that's our educational dinner series for HCPs and patient leaders. All the info is over at diabetes-connections.com events/ Okay.. our top story this week: XX An "immune system reset" eliminated Type 1, diabetes in mice in a study conducted at Stanford Medicine without immune suppressant medications. This was a combined transplant of blood stem cells and insulin-producing pancreatic islet cells from a donor whose immune profile did not match the recipient. The dual transplant approach both restored insulin production and retrained the immune system. For the full six months of the experiment, the animals did not need insulin injections or immune suppressive medications. Challenges remain using this approach to treat Type 1 diabetes. Pancreatic islets can be obtained only after death of the donor, and the blood stem cells must come from the same person as the islets. It is also unclear whether the number of islet cells typically isolated from one donor would be enough to reverse established Type 1 diabetes. But the researchers are working on solutions, which could include generating large numbers of islet cells in the laboratory from pluripotent human stem cells, or finding ways to increase the function and survival of transplanted donor islet cells. https://scitechdaily.com/stanford-scientists-cure-type-1-diabetes-in-mice-without-insulin-or-immune-suppression/ XX An electronic implant interlaced with islet cells is being looked at to treat type 1. Researchers at the University of Pennsylvania School of Medicine worked with engineers at Harvard University to combine stem-cell biology with soft electronics. They inserted an ultrathin, flexible mesh of conductive wires — thinner than a human hair — into developing pancreatic tissue. As the cells assembled into clusters, the mesh became woven through them. The electronics can record the faint electrical signals produced by the cells that control insulin release. They can also deliver small pulses of electricity back to the cells. After several days, the cells began to behave more like mature islets. Their internal signalling shifted, neighbouring cells started working in concert and insulin release became stronger and better timed. Very early on here – and the transplanted cells still need to be protected from being attacked by the immune system. https://www.thetimes.com/uk/science/article/first-cyborg-pancreas-implants-type-1-diabetes-nxkv8r0fp?gaa_at=eafs&gaa_n=AWEtsqeJYYUF9TMR-GgGUG92hPyog-ISeiqGIgdyaaIKKcpvhtoftGiUaaOtQeG0NWI%3D&gaa_ts=699c50d4&gaa_sig=w-PQ0ArosZSznYDSWEzt8aQg4WC0FF5ZFRt9NedO5sSTL2FyWzupH8eSG7RCy2S8TQnlHOeKCudANWm1MNI59w%3D%3D XX Katie Beth (hand) Eledon trial – aaron kowalski post linkedin. Last fall we told you about promising results from Eledon's drug to prevent islet transplantation rejection in type 1 diabetes. The first six patients no longer had to inject or infuse insulin.. the trials continue and this month one of the patients – Katie Beth Hand – began posting about her experiences one month in, on social media, she says she's off basal insulin already and in range 99 percent of the time. She is also encouraging people to learn more about support the islet act https://lnkd.in/e8pQ7_Y7 XX This is a bill introduced last November which would change the wording on pancreatic cell transplants. The problem is that islets are classified as drugs rather than organs, making transplantations difficult for medical teams and centers to preform due to accessibility. Insurance companies are also less likely to provide reimbursements for treatment, which can cost hundreds of thousands of dollars. The official Journal of The Transplantation Society estimates the cost at about $140,000. The bill went to the senate committee of Health, Education, Labor, and Pensions in early November. No other action has been taken since then. https://www.wtoc.com/2026/02/19/bluffton-family-advocates-islet-act-help-diabetic-son/ XX Big change for the obesity drug Zepbound – now available in the multi dose KwikPen. This is a month's worth of doses in a single pen.. and it's multi dose – you can adjust it. Cash-paying patients can get the multi-dose device, called KwikPen, on the company's direct-to-consumer website, LillyDirect. Prices start at $299 per month for the lowest dose level. Until now, you could only get zepbound in a single dose auto injector or a sing dose vial. In a release, Lilly said the Food and Drug Administration approved a label expansion for Zepbound to include the multi-dose device. The KwikPen is already used for other drugs, such as Lilly's popular diabetes medication, Mounjaro – which is the same medication as zepbound, they're both tirzepitide. https://www.cnbc.com/2026/02/23/eli-lilly-launches-zepbound-obesity-drug-pen-one-month-doses.html XX For years, researchers have observed that people who live at high elevations, tend to develop diabetes less often than those at sea level. Although the trend was well documented, the biological explanation behind it was unclear. Scientists now say they have identified the reason. Their research shows that in low oxygen environments, red blood cells begin absorbing large amounts of glucose from the bloodstream. Their work showed that when oxygen is limited, red blood cells use glucose to generate a molecule that helps release oxygen to tissues. This process becomes especially important when oxygen is in short supply. The researchers also found that the metabolic benefits of prolonged hypoxia lasted for weeks to months after mice were returned to normal oxygen levels. They then evaluated HypoxyStat, a drug recently developed in Jain's lab that mimics low oxygen exposure. HypoxyStat is taken as a pill and works by causing hemoglobin in red blood cells to bind oxygen more tightly, limiting the amount delivered to tissues. In mouse models of diabetes, the medication completely reversed high blood sugar and outperformed existing treatments. https://www.sciencedaily.com/releases/2026/02/260221060952.htm XX Watching this one closely – Portal Diabetes gets FDA breakthrough device designation for its implantable insulin pump system. This is a system that includes not just a device that's implanted into the abdomen, but also a new, temperature stable insulin. It will work with – quote – "modern" CGM technology with a fully closed loop - and aims to deliver a functional cure for type 1. While reports say Portal's system is the first in the US – there was an implantable pump developed and used by about 500 people worldwide, including about 100 in the US – by MiniMed. Medtronic bought the company and in 2007 they stopped that program. Portal Diabetes expects to begin clinical trials on its combination system around the fourth quarter of 2027. https://www.drugdeliverybusiness.com/portal-diabetes-fda-breakthrough-implantable-insulin-pump/ XX Sequel Med Tech and Senseonics (NYSE:SENS) today announced the full U.S. launch of their CGM and insulin pump integration. That's the eversense cgm and twist pump. Sequel said its full launch with Eversense 365 makes twiist available with two compatible CGMs. twiist also pairs with the Abbott FreeStyle Libre 3 Plus sensor. Eversense 365, an implantable system, rests under the skin for the duration of a year. Users can change its external, silicone-based adhesive daily with almost no skin reactions. https://www.drugdeliverybusiness.com/sequel-senseonics-full-launch-twiist-eversense/ XX Right back with a Dexcom update, and a look at which type of diet reduces insulin use overall.. right after this: -- Back to the news.. Dexcom is watching for expanded Medicare coverage of its continuous glucose monitors to people with Type 2 diabetes who don't take insulin. CEO Jake Leach told investors on Thursday that the company has been "sitting here waiting for a coverage decision" from the Centers for Medicare and Medicaid Services Dexcom started to see commercial coverage unlock for Type 2, non-insulin users toward the end of last year, Leach said. He expects broader Medicare coverage for that group would allow nearly 12 million people to access CGMs. In the meantime, the American Diabetes Association updated its guidelines last year to recommend clinicians consider using CGMs for Type 2 diabetes when patients are taking glucose-lowering medications other than insulin. Leach said that real world data the company has been generating supports that decision, and that Dexcom has launched a registry for non-insulin users. https://www.medtechdive.com/news/dexcom-seeks-expanded-medicare-coverage-of-cgms-for-type-2-diabetes/812223/ XX Medtronic's separation of MiniMed is not yet complete.. but continues to move forward. The company has submitted their next pump – MiniMed Flex – to the FDA. This is a pump smaller than the 780G but uses the same reservoirs and infusion sets. It will also work with both the Simplera Sync and Instinct sensors. Medtronic also began a U.S. pivotal study for Vivera, its third-generation algorithm for automated insulin delivery. It also remains set to submit its MiniMed Fit patch pump system to the FDA by the coming fall. https://www.drugdeliverybusiness.com/medtronic-submits-minimed-flex-fda-q3/ XX A study modelling how genes may influence a child's body mass index over time has found that BMI at age 10 and overall growth rate between ages one and 18 might be important factors, as the two are more likely linked to diabetes, high cholesterol, and heart disease in later life. Nearly 66,000 BMI measurements from around 6,300 children and adolescents aged one to 18 were analysed to understand the role of genes. "Future research is needed to help identify the most effective ages to prevent obesity or poor growth for long-term benefit." https://www.ndtv.com/health/bmi-at-age-10-growth-rate-up-to-age-18-are-important-factors-for-diabetes-heart-disease-study-11125146 XX A low-fat vegan diet—without cutting calories or carbs—may help people with type 1 diabetes significantly reduce how much insulin they need. In a new analysis published in BMC Nutrition, participants following the plant-based plan lowered their daily insulin use by 28%, while those on a portion-controlled diet saw no meaningful change. Researchers say the reduced insulin requirement likely reflects improved insulin sensitivity. The original 2024 study reported additional benefits from the vegan diet. Participants lost an average of 11 pounds and showed improvements in insulin sensitivity and glycemic control. Cholesterol levels and kidney function also improved among those following the plant-based plan. https://www.sciencedaily.com/releases/2026/02/260212234212.htm XX Interesting little tidbit from the Winter Olympic Games.. the World Anti-Doping Agency (WADA) was monitoring GLP drug use. An advisory group that makes recommendations about WADA's list of prohibited substances discussed the status of GLP-1 medications, and added semaglutide (Ozempic, Wegovy, Rybelsus) and tirzepatide (Mounjaro, Zepbound) to its monitoring program That means patterns of use of these drugs will be tracked both in and out of competition. The finding will be used to make recommendations about whether GLP-1 agonists should be added to the prohibited list, the spokesperson explained. While GLP-1 drug use is not currently prohibited, that could change before the next Summer Olympic Games in Los Angeles in 2028, he noted. https://www.medpagetoday.com/popmedicine/cultureclinic/119770 XX That's it for in the news!
Dr. Hoffman continues his conversation with Nathan Jones, CEO and founder of Xlear, Inc.
Xylitol, FTC Censorship, and the Oral–Heart Health Connection: Nathan Jones, CEO and founder of Xlear, Inc., makers of xylitol-based nasal and dental hygiene products, and a health freedom advocate, discusses Jones' ongoing legal battle with the FTC. He addresses the difficulty of making health claims for hygiene products (including toothpaste and nasal sprays), the role of “weasel words” in supplement marketing, and concerns about regulatory double standards versus pharmaceuticals. He also reviews xylitol's benefits for dental caries and respiratory/ear infections, including references to studies and public-health examples (e.g., Finland and a Belize program reducing dental caries costs), and Jones' efforts to encourage Utah to implement xylitol gum programs in schools. He contrasts fluoride's enamel-strengthening approach with xylitol's effect on the underlying bacterial cause of tooth decay, discusses Utah's fluoride policy change and claims about fluoride's limited benefit, and highlights a correlation between poor oral health and cardiovascular risk via inflammation and bacterial translocation into the bloodstream, including pathogens found in atherosclerotic plaque, and links also discussed for dementia and Parkinson's. They close with commentary on health advocacy in the “MAHA era,” the challenges of entrenched federal bureaucracy, and Jones' preference for advocacy groups that teach industry to push back rather than comply.
Gilead is acquiring Arcellx for $7.8 billion up front three years after forging a partnership with the biotech around a cell therapy for multiple myeloma. On the latest BioCentury This Week podcast, BioCentury's analysts assess what the deal does for the Foster City, Calif.-based biotech's pipeline.The analysts also discuss the case for using ctDNA as a surrogate endpoint for early cancer trials. Turning to Washington, Steve Usdin offers his takeaways from last week's PhRMA Forum, which focused on China and the Trump administration's most favored nation (MFN) drug pricing policy, and on the lessons that can be drawn from FDA's about-face on the recent vaccine application from Moderna.View full story: https://www.biocentury.com/article/658516#BiotechMA #MultipleMyeloma #ctDNA #DrugPricingPolicy #FDA00:00 - Introduction02:34 - Gilead's Arcellx Buy11:14 - ctDNA Surrogate Endpoints21:59 - PhRMA Forum Takeaways29:19 - FDA Moderna U-turnTo submit a question to BioCentury's editors, email the BioCentury This Week team at podcasts@biocentury.com.Reach us by sending a text
"Why are we paying $10,000 for a $30 drug?"My guest this week is Pramod John, a former Silicon Valley tech entrepreneur who entered the healthcare space to tackle the largest economic problem in the country: skyrocketing healthcare costs. Pramod quickly realized that healthcare's dysfunction is actually not a technology problem - it is a deeply ingrained problem with economic incentives.In this episode, we dive into the murky waters of Pharmacy Benefit Managers (PBMs) and why the traditional model is designed to drive up costs rather than lower them. We discuss the shocking statistics of drug spend (where 2% of people account for 55% of the costs), why FDA approval doesn't always mean a drug is effective (using the infamous Alzheimer's drug as an example), and the implications of recent fiduciary lawsuits like the one against J&J.Pramod explains how we can bring common sense back to healthcare by treating drugs like any other consumer purchase. By utilizing an "open market" drug management model, he argues that we can effectively replace traditional PBMs with transparent transaction processing software - saving plans 30% to 50% without relying on restrictive formularies or rebate games. Tune in this week for a clear roadmap for how to actually fix the irrational economics of our healthcare system.Thank you to our 2026 sponsors!ParetoHealth: ParetoHealth empowers midsize employers with a long-term solution to reduce volatility and lower overall health benefits costs. Visit ParetoHealth.com to learn more.Samaritan Fund: A program that connects those who need help to the support they need. We are proud to offer the Samaritan Fund Program. Visit SamaritanFundProgram.com to learn more.Vālenz Health: We're Vālenz Health, your partner in improving health literacy, reducing plan spend, and delivering high-value healthcare. Visit ValenzHealth.com to learn more.Imagine360: Imagine360 helps self-funded employers save on healthcare with smarter health plans. Cut expenses by 20-30% with custom solutions. Contact us today at Imagine360.com.Chapters:(00:00:00) Intro: Why We Talk About Cost Instead of Quality (00:02:42) From Silicon Valley & Defense Tech to McKesson (00:10:43) Why Healthcare is NOT a Technology Problem (00:15:53) Fiduciary Responsibility & The J&J Lawsuit (00:19:03) The Butter Knife vs. Pareto: The Math of Drug Spend (00:23:54) Building an "Open Market" Alternative to PBMs (00:29:40) Why Doctors Fly Blind on Drug Pricing & Formularies (00:35:42) FDA Approval vs. Real-World Efficacy (00:45:44) How to Actually Fix the Model: The Real-Time "Pause" (00:58:36) Why International Sourcing & PAPs Aren't the Fix (01:11:00) Replacing PBMs with Simple Transaction SoftwareKey Links for Social:@SelfFunded on YouTube for video versions of the podcast and much more - https://www.youtube.com/@SelfFundedListen/watch on Spotify - https://open.spotify.com/show/1TjmrMrkIj0qSmlwAIevKA?si=068a389925474f02Listen on Apple Podcasts - https://podcasts.apple.com/us/podcast/self-funded-with-spencer/id1566182286Follow Spencer on LinkedIn - https://www.linkedin.com/in/spencer-smith-self-funded/Follow Spencer on Instagram - https://www.instagram.com/selffundedwithspencer/
As global demand for meat grows, this episode of Duke University's Leading Voices in Food podcast examines cell-cultivated protein—real meat grown from animal cells—and the evolving U.S. policy landscape shaping its future. Host Norbert Wilson (Duke World Food Policy Center) speaks with postdoctoral researchers Kate Consavage Stanley (Duke/Bezos Center for Sustainable Proteins) and Katariina Koivusaari (NC State/Bezos Center) about their article in Trends in Food Science and Technology on U.S. regulatory and legislative activity. The conversation explains the joint FDA–USDA regulatory approach for cell-cultivated meat (FDA oversight through cell cultivation; USDA oversight from harvest through processing, packaging, and labeling) and FDA oversight for cell-cultivated seafood (except catfish). They discuss timelines companies report for approval (often two to three years), the lack of federal public guidance on naming and labeling so far, and how USDA label approvals are currently handled case by case (e.g., "cell-cultivated chicken" and "cell-cultivated pork"). The episode also covers state-level labeling laws and the likelihood of federal preemption if state requirements conflict with federal statutes, as well as a growing wave of state restrictions and bans—Florida and Alabama in 2024, followed by Indiana, Mississippi, Montana, Nebraska, and Texas in 2025—plus funding restrictions in South Dakota and Iowa. The guests explore implications for consumers, interstate commerce, innovation, investment, and U.S. leadership, noting ongoing lawsuits in Florida and Texas and continued legislative activity such as a proposed ban in Georgia. Interview Transcript Kate, let's begin with you. In the paper, you write about the regulatory frameworks that have been developed for cell-cultivated meat and seafood products in the US. To start, let's talk about what's unique about cell-cultivated products from a regulatory standpoint and how the US Department of Agriculture and US Food and Drug Administration have decided to handle cell-cultivated protein products. Kate - Yes, so as you mentioned in the introduction, Norbert, cell-cultivation is a new technology for use of the food supply. So, the US government had to adapt its existing legal frameworks for food safety regulation. As your listeners may already know seafood is regulated by the FDA, so it was within their scope to also regulate cell-cultivated seafood. The FDA therefore regulates all cell-cultivated seafood products with the exception of catfish. When it came to determining the regulatory approach for cell-cultivated products from livestock, poultry, and catfish, it was a bit more nuanced as the processes and components evolved fell under both USDA and FDA purview. In 2019, the FDA and USDA therefore agreed on a joint regulatory approach where the FDA regulates the early stages of the cell cultivation process, including when those cells are taken from the animal, grown in the bioreactor, and matured into specific cell types such as muscle or fat cells. At the point where those cells are ready to be harvested from the bioreactor to use in a food product, oversight transfers to USDA who oversees that harvesting process as well as food processing, packaging, and labeling. I know this joint regulatory approach may sound complicated, but it's important to note that USDA and FDA already coordinate oversight over other foods in the food supply. I'll give you an example that we all love pizza. A frozen cheese pizza is regulated by the FDA, whereas a frozen pizza with meat toppings like pepperoni is regulated by the USDA. It is therefore not unprecedented that FDA and USDA would agree to jointly regulate cell-cultivated products. And while the process is new, the products go through the same safety checks as other foods in the food supply. In the past few years, we've seen four cell-cultivated meat products go through the joint USDA-FDA regulatory process, meaning they can be sold in the US food supply. And one cell-cultivated seafood product has gone through the FDA regulatory process. Kate, thank you for sharing this. And I've used a pizza example in my class, and it is super complex this regulatory maze that we're talking about. It seems like there has been a lot of collaboration between these two agencies, and so that's important to hear. But it is also the case that it seems challenging for cell-cultivated protein companies to get through this process. Is this a fair assessment and would you elaborate? Kate - Yes, absolutely. We've heard from cell-cultivated companies that it can take two to three years to get through this process. And there certainly is a lot of back and forth between the companies and FDA and USDA. Great, thank you. Katariina, now let's turn to you. How do these regulations extend to labeling and what do we know about the federal government's approach to labeling the sale of cultivated products thus far? Katariina – So, labeling regulations are the most consumer facing part of regulations, really. And they are used to ensure that the product label has information that's truthful, that's not misleading. And that the package has sufficient information and consistent information also across products so that the consumer can make an educated decision on what product they want to purchase. And you'd think that how you label the product or just how you call the product on the label would be simple. But there are certain regulations in place that define how food items can or cannot be called. Now, when it comes to cell-cultivated products, as you and Kate mentioned, they are novel in the food supply. So, there is not a long-established term or nomenclature on how we should call these products. The federal regulators, FDA and USDA, to date have not released any public guidance either on how these products should be called on the label. The USDA did release an advanced notice of proposed rulemaking back in 2021, requesting comments from stakeholders on how these products should be labeled. And the FDA has also requested comments when it comes to labeling cell-cultivated fish and seafood. But to date, no guidance has been published yet. Kate gave an overview of the regulatory process between FDA and UFDA when it comes to labeling this product products. The USDA oversees labeling cell-cultivated meat, and the FDA oversees labeling cell-cultivated fish and seafood. The USDA has a pre-market approval process for labels, similarly to conventional meat industry. So, whenever a company wants to bring to market a new product, they first submit their label to the USDA. And the USDA reviews it and make sure that they agree with the language used in the label. The FDA does not have a similar pre-market approval process for labeling fish or seafood or cell-cultivated fish or seafood. So, currently cell-cultivated meat labels are approved on a case-by-case basis. And we can see from the products that have gone through the regulatory review so far that the USDA seem to approve the use of 'cell-cultivated' as a qualifying term, together with a meaty term such as chicken or pork. So, the products that we've seen approved to date or brought to market to date are called cell-cultivated chicken or cell-cultivated pork. This is really helpful to know what's happened at the federal level. We also know that there are several actions happening at the state level, so several states have proposed their own laws outlining how and what to label these products. Katariina, can you talk us through what this study regarding state labeling? Katariina - To date, about half of the US states have enacted or proposed their own labeling legislation on cell-cultivated products. Missouri became the first state in 2018, so well before any of these products was available on the market. And they specifically prohibited the use of word meat unless the food was from harvested production livestock or poultry. Restricting, therefore, the use of meat not only on cell-cultivated, but also on other alternative protein products such as plant-based meat analogs or fermentation derived proteins. And this is true for many state level labeling laws. That they are applicable not only to cell-cultivated meat, but also other alternative proteins aiming to mimic meat. In addition to Missouri, there are six other states that prohibit the use of meat or meat related terms, such as chicken or pork. Now, the other group of states that have restrictions on cell-cultivated meat labeling do not concentrate on prohibiting the use of word meat, but they require the use of qualifying terms or other additional language that clearly states that the product does not come from livestock or poultry. And this group of states, there are 18 states, have quite a bit of variation in what kind of qualifying terms they require to be used. And I thought I'd give a couple of examples here. For example, Indiana requires the package to include the phrase this is an imitation meat product. Iowa requires the product to be labeled with qualifying terms such as cell-cultivated, cell-cultured, fake, grown in a lab, imitation, lab grown, lab created, meat free, or meatless. What's interesting though is that the federal statutes that regulate the US food supply have actual language that prevents states from establishing laws or regulations that conflict with or are additional to the federal labeling regulations. So, this means that the state level labeling laws are actually likely to be preempted if they conflict with the federal regulations. So, we've only talked about labeling so far. Kate, I want to go back to you. More recently, we've seen a number of states propose greater restrictions on these products. Can you describe these attempts to restrict cell-cultivated meat and their immediate implications? And how have cell-cultivated companies and other stakeholders responded? Kate - In the past few years we've seen quite a few attempts by states to ban or restrict cell-cultivated meats. And these attempts fall into two buckets: bans that aim to restrict the manufacturer sale or distribution of cell-cultivated products and bans that aim to limit the use of state funding to support these products. In 2024, Florida was the first state to pass a ban on the manufacture, sale, and distribution of cell-cultivated meats. Alabama followed shortly thereafter. In 2025, five more states passed similar bans on cell-cultivated products, including Indiana, Mississippi, Montana, Nebraska, and Texas. And many other states proposed bans that ultimately didn't pass. The language on what is banned differs some between states. For instance, Texas only bans the sale of cell-cultivated products. Whereas Florida and others also ban cell-cultivated manufacturing and distribution. But the core message in all these bans is similar. Cell-cultivated meats are not welcome in those states. The time span for the bans differs too. So, Indiana and Texas have two-year bans while Florida and other states passed indefinite bans. And we've seen two states, South Dakota and Iowa pass legislation to restrict the use of state funding to support cell-cultivated products. What's frustrating about these bands and confusing for those in the alternative protein sector is that cell-cultivated technology is largely still in the early stages. Yes, as I mentioned earlier, five products have passed through the regulatory process. But these products have mainly been made available in small tasting events. And only one has actually made it to retail. Most Americans have never had a chance to actually try these products. So, it begs the question, why is there such resistance? State bans on these products mean that Americans will not have the chance to decide for themselves if they like these products, or if and how they want to incorporate them into what they eat. Another big concern is that these bans create a fragmented policy landscape that's challenging for cell-cultivated startups, especially, to navigate. And it raises a lot of concerns about cross state sales. Concerns like these are the basis for two lawsuits against cell-cultivated bans in Florida and Texas. Those lawsuits are still playing out in court, so we don't yet know how those may Kate, this is really fascinating. And as both you and Katariina described, there's a patchwork of policies and a complex landscape for these companies to navigate. It has the potential of keeping consumers from even trying the products, as you've already suggested, when they're made available. And what I'm hearing from both of you is that this is an ongoing project. So even though there's a paper that's published now, it seems like there will be opportunities to keep going back as new laws and new regulations and new lawsuits are decided. So, this is a policy space that we need to keep an eye on. That's something I want to pick up on this last question. In closing, what does this legislation mean for consumers and the future of cell-cultivated products in the US and even globally? Katariina, let's begin with you. Katariina - Yes. In addition to impeding interstate and international commerce of cell-cultivated products, these bans could negatively impact the US investment climate on these products and technologies. For example, China has included developing cell-cultivated meat in their five-year plan. Within Europe, there's some variation. Some countries are being rather supportive of these technologies and products, whereas others have tried to ban them similarly to some US states. But I think it's important to note that even with some states in the US banning these products, the US will still likely remain a significant market area for cell-cultivated products. And it still takes significant investment and infrastructure to produce the products on a large scale enough to even reach the whole country. Another really important thing to mention here is that the global demand for meat is growing. If we look at global population forecasts, global meat or protein consumption forecasts, we need these alternative proteins. Not only cell-cultivated meat, but also for example, plant-based meat alternatives to help meet the increasing demand for protein and complement conventional meat supply. Kate, what about you? Kate – I agree with everything that Katariina said. To add on to her points, I note that the US has been a leader in the cell-cultivated research development and innovation spaces to date. We are one of only a few countries that have both developed a framework for regulating these products and had products successfully pass through that process. The bans tell a different story, and they may restrict US innovation in the cell-cultivated space because companies will be limited to only the states where they can produce and sell these products. What this means for US leadership in the space remains to be seen. However, one could ask will cell-cultivated companies choose to set up shop in the US versus another country that isn't facing such legal challenges? We don't yet know the answer to that. You also mentioned consumers. We don't yet know about how these bans and the media surrounding them may influence consumer perceptions of cell-cultivated foods. Products, as you said, they've never even really had the chance to try. But these bans will certainly restrict consumer access to these products in certain states, and the varying state approaches to labeling that Katariina described are likely to confuse consumers. Going back to something you mentioned earlier, Norbert, we're excited to have this paper out in the world. But this work is certainly continuing to evolve. Just recently, a senator in Georgia proposed a new ban on cell-cultivated meat in the state, and other countries have faced similar legislative challenges against these products. So, we'll be watching and learning as these challenges continue to play out. Bios Katariina Koivusaari, Ph.D. is a postdoctoral researcher at the Bezos Center for Sustainable Protein at North Carolina State University. Her work focuses on stakeholder engagement and the regulatory and policy landscape of alternative proteins, including cell-cultivated products, fermentation-derived proteins, and plant-based proteins. She received her Ph.D. in Public Health Nutrition and M.Sc. in Food Sciences from the University of Helsinki. Prior to her current role, she worked in the biotechnology industry as a Senior Regulatory Scientist, where she focused on scientific strategy and regulatory affairs related to cell-cultured human milk ingredients. Katherine (Kate) Consavage Stanley, Ph.D., serves as a postdoctoral associate within the World Food Policy Center at the Sanford School. In this role, Kate supports Duke's research for the Bezos Center for Sustainable Protein housed at NC State. Her research seeks to detail the complexities of the consumer, market, and policy landscapes for alternative protein products. Kate holds a Ph.D. from Virginia Polytechnic Institute and State University where her research focused on how diverse U.S. food and health systems actors can support sustainable diet transitions through promoting plant-rich dietary patterns and reducing red and processed meat intake. She has also published scholarly work on digital food and nutrition literacy, sugary beverage media campaigns, and incorporating sustainability considerations into dietary guidelines, among others. Prior to starting her doctoral studies, Kate worked for the U.S. Agency for International Development (USAID) where she developed technical, communications, and advocacy-focused materials on key nutrition and maternal and child health issues. Kate holds a Master of Science in global health from Georgetown University and a Bachelor of Science in biology from Emmanuel College.
Last year, the FDA approved adaptive deep brain stimulation for the treatment of people with Parkinson's disease. This is a major step forward in neurology. It allows personalized therapy by adjusting deep brain stimulation settings in real-time based on an individual's brain signals. Our guest on this episode is Dr. Helen Bronte-Stewart, the John E. Cahill Family Professor of Neurology and Director of the Human Motor Control and Neuromodulation Lab at Stanford University. Dr. Bronte-Stewart was interviewed by Dr. Karlo Lizarraga, Associate Professor of Neurology and Director of the Motor Physiology and Neuromodulation program at the University of Rochester. Disclosures: Dr. Bronte-Stewart disclosed equity in QDG Health. Dr. Lizarraga disclosed FHC: Consulting (Course Instructor), BlueRock: Research support.
Dagens ämnen: 0:00 Intro 5:05 Rapporter, Bonesupport och blankningar 13:57 Novo Nordisk 21:17 Fastigehetsbolag 26:17 AI 35:53 Index 42:58 FDA 44:13 Veckans Fill or Kill www.instagram.com/fillorkillpodden Tack RoboMarkets! http://gorobo.pro/2aue @RoboMarketsSE Tack @avanzabank! www.avanza.se
"Why are we paying $10,000 for a $30 drug?"My guest this week is Pramod John, a former Silicon Valley tech entrepreneur who entered the healthcare space to tackle the largest economic problem in the country: skyrocketing healthcare costs. Pramod quickly realized that healthcare's dysfunction is actually not a technology problem - it is a deeply ingrained problem with economic incentives.In this episode, we dive into the murky waters of Pharmacy Benefit Managers (PBMs) and why the traditional model is designed to drive up costs rather than lower them. We discuss the shocking statistics of drug spend (where 2% of people account for 55% of the costs), why FDA approval doesn't always mean a drug is effective (using the infamous Alzheimer's drug as an example), and the implications of recent fiduciary lawsuits like the one against J&J.Pramod explains how we can bring common sense back to healthcare by treating drugs like any other consumer purchase. By utilizing an "open market" drug management model, he argues that we can effectively replace traditional PBMs with transparent transaction processing software - saving plans 30% to 50% without relying on restrictive formularies or rebate games. Tune in this week for a clear roadmap for how to actually fix the irrational economics of our healthcare system.Thank you to our 2026 sponsors!ParetoHealth: ParetoHealth empowers midsize employers with a long-term solution to reduce volatility and lower overall health benefits costs. Visit ParetoHealth.com to learn more.Samaritan Fund: A program that connects those who need help to the support they need. We are proud to offer the Samaritan Fund Program. Visit SamaritanFundProgram.com to learn more.Vālenz Health: We're Vālenz Health, your partner in improving health literacy, reducing plan spend, and delivering high-value healthcare. Visit ValenzHealth.com to learn more.Imagine360: Imagine360 helps self-funded employers save on healthcare with smarter health plans. Cut expenses by 20-30% with custom solutions. Contact us today at Imagine360.com.Chapters:(00:00:00) Intro: Why We Talk About Cost Instead of Quality (00:02:42) From Silicon Valley & Defense Tech to McKesson (00:10:43) Why Healthcare is NOT a Technology Problem (00:15:53) Fiduciary Responsibility & The J&J Lawsuit (00:19:03) The Butter Knife vs. Pareto: The Math of Drug Spend (00:23:54) Building an "Open Market" Alternative to PBMs (00:29:40) Why Doctors Fly Blind on Drug Pricing & Formularies (00:35:42) FDA Approval vs. Real-World Efficacy (00:45:44) How to Actually Fix the Model: The Real-Time "Pause" (00:58:36) Why International Sourcing & PAPs Aren't the Fix (01:11:00) Replacing PBMs with Simple Transaction SoftwareKey Links for Social:@SelfFunded on YouTube for video versions of the podcast and much more - https://www.youtube.com/@SelfFundedListen/watch on Spotify - https://open.spotify.com/show/1TjmrMrkIj0qSmlwAIevKA?si=068a389925474f02Listen on Apple Podcasts - https://podcasts.apple.com/us/podcast/self-funded-with-spencer/id1566182286Follow Spencer on LinkedIn - https://www.linkedin.com/in/spencer-smith-self-funded/Follow Spencer on Instagram - https://www.instagram.com/selffundedwithspencer/
Today, Ali talks to Barbara Ginty, host of the Future Rich podcast, for a special crossover episode to share her deeply personal fertility journey — and to talk honestly about the emotional and financial realities of IVF. Barbara froze her eggs in her 30s, not knowing exactly when or how she might use them. Seven years later, she returned to those frozen eggs and went through IVF — and now, as this episode airs, she's on the brink of welcoming her first baby. Barbara shares what it was like to trust a decision she made years earlier, the uncertainty of the process, and the surreal feeling of finally reaching this moment. Barbara also turns the mic on Ali, who opens up about her secondary infertility and IVF journey, including the complicated emotions that can come with trying to grow your family after already having a child. For more, check out www.futurerichpodcast.comEPISODE SPONSORS: THE WORK OF ART BOOK SERIESAli's Children's Book Series about IVF, IUI and Family Building Through Assisted Reproductive Technology https://www.infertileafgroup.com/booksThe 3-book bundle is now just $49 (normally $79)!The latest book in the Work of ART series, “You Are a Work of ART," is for every kiddo born through ART -- and the people who love them.PHERDALIG: @pherdal_sciencePherDal is the world's first and only FDA-cleared, sterile, at-home insemination kit designed to help people build their families in the comfort of home. Created by parents who've been there, PherDal is safe, simple, and affordable—putting more options in your hands as you grow your family. Explore at PherDal.com.Go to PherDal.com today and use code INFERTILEAF for $10 off.Our Sponsors:* Check out BetterHelp: https://www.betterhelp.comSupport this podcast at — https://redcircle.com/infertile-af-infertility-and-modern-family-building-through-art/donationsAdvertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy
About this episode: A recent analysis of FDA documents has found that the agency has historically regulated mifepristone—a medication commonly used to terminate pregnancy—based on available scientific evidence and without ideological bias. In this episode: Caleb Alexander, an author of the study, discusses these findings and their implications for a possible new review of the medication by FDA. Guests: Dr. G. Caleb Alexander, MS, is a practicing internist and drug safety expert at the Johns Hopkins Bloomberg School of Public Health. Host: Lindsay Smith Rogers, MA, is the producer of the Public Health On Call podcast, an editor for Expert Insights, and the director of content strategy for the Johns Hopkins Bloomberg School of Public Health. Show links and related content: The US Food and Drug Administration's Regulation of Mifepristone—JAMA Study: FDA Regulation of Abortion Drug Mifepristone from 2011 to 2023 Shaped by Evidence and Caution—Johns Hopkins Bloomberg School of Public Health F.D.A. Decisions on Abortion Pill Were Based on Science, New Analysis Finds—New York Times What Is Mifepristone, aka "The Abortion Pill"?—Johns Hopkins Bloomberg School of Public Health What's at Stake for Access to Medication Abortion and the FDA in the Supreme Court Case FDA v. the Alliance for Hippocratic Medicine?—KFF Transcript information: Looking for episode transcripts? Open our podcast on the Apple Podcasts app (desktop or mobile) or the Spotify mobile app to access an auto-generated transcript of any episode. Closed captioning is also available for every episode on our YouTube channel. Contact us: Have a question about something you heard? Looking for a transcript? Want to suggest a topic or guest? Contact us via email or visit our website. Follow us: @PublicHealthPod on Bluesky @PublicHealthPod on Instagram @JohnsHopkinsSPH on Facebook @PublicHealthOnCall on YouTube Here's our RSS feed Note: These podcasts are a conversation between the participants, and do not represent the position of Johns Hopkins University.
How are these abusive teen rehab centers still open? Why are parents still sending their kids there? Can't they be shut down? Maia Szalavitz is an award-winning author and journalist who covers addiction and neuroscience. Her book, Help at Any Cost: How the Troubled-Teen Industry Cons Parents and Hurts Kids, is the first comprehensive look at systemic abuse in “tough love” programs and helped spur Congressional hearings & GAO investigations. In this episode, you'll hear how the abusive teen rehab centers featured in Netflix's The Program & Wayward (think Straight Inc., The Seed, Synanon & wilderness camps) began with tough love doctrine, why you can legally treat kids worse than prisoners, why parents aren't suing & why regulations just don't stick. We also weave in the perspective of struggling parents who feel that the anti-troubled teen industry is hurting their healing efforts. If you like this episode, you'll also like episode 248: SURVIVING THE TROUBLED TEEN INDUSTRY: SEPARATING IDENTITY FROM EXPERIENCE [REMASTERED] Guest:https://x.com/maiasz https://maiasz.com/ Resources:Boy who was raised as a dog https://a.co/d/0bA3dxmi Pace Center for Girls Pensacola https://www.pacecenter.org/locations/florida/escambia-santa-rosa/ Gulf Coast Kids House https://www.gulfcoastkidshouse.org/ Greenhouse Counseling https://www.ghcpensacola.com/ Host: https://www.meredithforreal.com/ https://www.instagram.com/meredithforreal/ meredith@meredithforreal.comhttps://www.youtube.com/meredithforreal https://www.facebook.com/meredithforrealthecuriousintrovert Sponsors: https://www.jordanharbinger.com/starterpacks/ https://www.historicpensacola.org/about-us/ 02:00 — The cult origins: Synanon begins04:00 — “I must have needed that” psychology05:00 — The rattlesnake assassination attempt07:00 — The Seed and brainwashing teens08:00 — Straight Incorporated goes national10:00 — Why parents don't believe abuse reports12:00 — Utah wilderness programs rise13:00 — The death of Aaron Bacon14:00 — Moral panic & religious fear15:00 — Good parents, fatal decisions16:00 — Why regulation keeps failing17:00 — Regulatory capture in Utah20:00 — Unannounced inspections change everything22:00 — Why traumatized kids need gentleness27:00 — Warehouses of neglect28:00 — Should therapy have an FDA?29:00 — Renaming punishment as treatment32:00 — Exhausted parents & marketing fear34:00 — How small power corrupts42:00 — Why lawsuits rarely succeed44:00 — Private right of action explained45:00 — Does awareness help or hurt?46:00 — Educational consultants & kickbacks54:00 — Local resources for struggling families55:00 — Undoing drugs & keeping people aliveRequest to join my private Facebook Group, MFR Curious Insiders https://www.facebook.com/share/g/1BAt3bpwJC/
This episode's Community Champion Sponsor is Ossur. To learn more about their ‘Responsible for Tomorrow' Sustainability Campaign, and how you can get involved: CLICK HEREEpisode Overview: Stress is the missing vital sign that determines whether treatments succeed or fail.Our next guest, Dr. Andrew Holman, is tackling this challenge as CEO of Inmedix. With 25 years of clinical experience as a practicing rheumatologist, Andrew possesses a unique perspective bridging medicine and diagnostics innovation.Watching billions wasted annually on autoimmune treatments that fail, he developed the CloudHRV platform to measure stress biology with medical-grade precision in just five minutes.Driven by a passion to end the trial-and-error cycle plaguing chronic disease care, Andrew shares how Inmedix tripled remission rates in rheumatoid arthritis patients from 25% to 79%.Join us to discover how stress biology is transforming precision medicine and unlocking new outcomes for the 15 million Americans living with autoimmune diseases. Let's go!Episode Highlights:FOUNDER WISDOM: Surround yourself with smarter people who tell you straight where your strengths and weaknesses are.ORIGIN STORY: A $10 million patent sale at age 46 came from championing fibromyalgia patients when they were dismissed by medicine.CLINICAL BREAKTHROUGH: The FDA-cleared CloudHRV platform tripled remission rates from 25% to 79% by measuring stress biology.FUTURE OF MEDICINE: Autonomic nervous system science may be to this century what antibiotics were to the last.PASSIONATE PIONEER MOMENT: "I try to be a learn-it-all instead of a know-it-all."About our Guest:Dr. Andrew Holman is the CEO of Inmedix. He is a practicing rheumatologist with 25 years of clinical experience who discovered the missing link in healthcare: stress—the unmeasured vital sign that determines whether treatments work or fail.As a physician watching 75% of autoimmune treatments fail while $10 billion is wasted annually on ineffective drugs, he developed Inmedix's FDA-cleared CloudHRV platform to measure stress biology with medical-grade precision in just 5 minutes. His clinical trials tripled remission rates in rheumatology from 25% to 79%, transforming medicine from trial-and-error to precision care in a $3.1 billion market.Dr. Holman brings proven commercial execution alongside clinical expertise: he leads a team with decades of experience scaling diagnostics companies through IPOs and acquisitions at Myriad Genetics, Crescendo Bioscience, and Exagen.Links Supporting This Episode: Inmedix Website: CLICK HEREDr. Andrew Holman LinkedIn page: CLICK HEREMike Biselli LinkedIn page: CLICK HERE
This episode features Ivanny Franklin, Managing Partner at MedSight Capital, who brings a wealth of experience from her background in molecular biology and her decade-long tenure at NAMSA. The conversation centers on the shifting paradigms of medical device investment, specifically how the industry is moving away from service-based models toward a focus on clinical outcomes.Etienne and Ivanny explore the critical intersection of global regulatory bodies—such as the NMPA in China and the FDA in the US—and the necessity of a cohesive clinical evidence strategy. Ivanny emphasizes that for startups, understanding market-specific data requirements is not just a regulatory hurdle but a fundamental component of commercialization and investor conviction.The discussion also dives into the "patient empowerment" movement, fueled by the convergence of wearables, AI, and at-home monitoring. Ivanny shares her bullish outlook on technologies that give patients control over their data, while acknowledging the tension this creates for physicians and the ongoing need for rigorous regulatory oversight to ensure safety and effectiveness.Key Timestamps[03:15] Global Regulatory Strategy: Insights into the NMPA (formerly CFDA) and why China requires in-country clinical evidence.[07:42] Leveraging Data: How to run a single clinical trial to satisfy multiple global regulatory bodies.[10:18] The At-Home Monitoring Shift: The rise of wearables and OTC testing in the wake of COVID-19.[13:45] The "Data Gap": Addressing the friction between patient-gathered data and physician adoption.[18:22] Investment Non-Negotiables: Why revenue-generating companies and clear regulatory classifications are key for MedSight Capital.[23:10] Diligence and Deception: The importance of honesty regarding reimbursement codes and 510(k) vs. PMA paths.[27:45] SPV vs. Hedge Fund Models: A breakdown of how Special Purpose Vehicles allow family offices to be nimble in MedTech.Quotes"FDA and NMPA, for example, are quite strict in clinical evidence coming from in-country... as a startup, you really need to understand can we run a single trial with multiple global sites to achieve clearance cohesively." - Ivanny Franklin"I'm an advocate for [at-home monitoring]. I do think that's the future. However, there is concern around what types of information should patients be receiving and how are they going to act on that information?" - Ivanny FranklinTakeawaysRegulatory is the Roadmap: An investment is often "de-risked" based on the clarity of the regulatory path. If a founder cannot distinguish between a 510(k) and a PMA, it is a major red flag for investors.Harmonize Your Trials: To achieve "economies of scale" in clinical evidence, work with consultants to design trials that meet the stringent requirements of both the FDA and international bodies like the NMPA early on.
David Klein, a longtime healthcare innovator and Founder and CEO of Click Therapeutics, is a pioneer in the field of prescription digital therapeutics, PDT, which are defined as software as medicine. Click has received FDA authorization for an app to treat depression and migraine and had a successful piviotal trial for an app treating negative symptoms of schizophrenia. These digital therapeutics are designed to fill significant gaps in current care and there are opportunities to combine software with drugs and biometric data from wearables to determine personalized treatment plans. David explains, "Click's approach towards digital therapeutics is, I would say, probably the most rigorous from a clinical evidence perspective in the industry. So we really take a drug-like clinical approach to these programs where we discover and then validate these programs in multiple randomized control trials, all culminating usually in a pivotal trial. And on top of that, you'll often see in some other areas of the world or even in this country, to some degree, folks might say randomized control trial, but they're really using standard of care as the control or wait list control, and so on and so forth. We actually test our interventions against sham active control, so against other apps that control for time on task, expectation of benefit, and so on and so forth." "Just a few months ago, we announced with Behringer Ingelheim, our partner in schizophrenia, that we hit our primary endpoint in our pivotal trial for our app that's designed to be a treatment of negative symptoms of schizophrenia. So, the holy grail, in serious mental illness altogether, but certainly in schizophrenia, is trying to mitigate negative symptoms of schizophrenia. This is such a huge patient issue and frankly an economic issue that none of the drugs have been successful at actually hitting it. So that's a unique one because we showed that an app can actually effectively and safely treat a disease that even a drug can't." #ClickTherapeutics #DigitalTherapeutics #DigitalHealth #FDA #MedicalDevices #SoftwareAsMedicine #HealthTech #Innovation #Migraine #Depression #Schizophrenia #PrescriptionApps #PDT #PrescriptionDigitalTherapeutics #ClinicalTrials #HealthcareInnovation clicktherapeutics.com Listen to the podcast here
David Klein, a longtime healthcare innovator and Founder and CEO of Click Therapeutics, is a pioneer in the field of prescription digital therapeutics, PDT, which are defined as software as medicine. Click has received FDA authorization for an app to treat depression and migraine and had a successful piviotal trial for an app treating negative symptoms of schizophrenia. These digital therapeutics are designed to fill significant gaps in current care and there are opportunities to combine software with drugs and biometric data from wearables to determine personalized treatment plans. David explains, "Click's approach towards digital therapeutics is, I would say, probably the most rigorous from a clinical evidence perspective in the industry. So we really take a drug-like clinical approach to these programs where we discover and then validate these programs in multiple randomized control trials, all culminating usually in a pivotal trial. And on top of that, you'll often see in some other areas of the world or even in this country, to some degree, folks might say randomized control trial, but they're really using standard of care as the control or wait list control, and so on and so forth. We actually test our interventions against sham active control, so against other apps that control for time on task, expectation of benefit, and so on and so forth." "Just a few months ago, we announced with Behringer Ingelheim, our partner in schizophrenia, that we hit our primary endpoint in our pivotal trial for our app that's designed to be a treatment of negative symptoms of schizophrenia. So, the holy grail, in serious mental illness altogether, but certainly in schizophrenia, is trying to mitigate negative symptoms of schizophrenia. This is such a huge patient issue and frankly an economic issue that none of the drugs have been successful at actually hitting it. So that's a unique one because we showed that an app can actually effectively and safely treat a disease that even a drug can't." #ClickTherapeutics #DigitalTherapeutics #DigitalHealth #FDA #MedicalDevices #SoftwareAsMedicine #HealthTech #Innovation #Migraine #Depression #Schizophrenia #PrescriptionApps #PDT #PrescriptionDigitalTherapeutics #ClinicalTrials #HealthcareInnovation clicktherapeutics.com Download the transcript here
Love the episode? Send us a text!In this powerful episode of Breast Cancer Conversations, Laura Carfang speaks with Kathy Giusti, a two-time cancer survivor who has lived with multiple myeloma for 30 years and later faced a breast cancer diagnosis as well.Diagnosed at 37 after what she thought was a routine visit, Kathy was told she had a fatal blood cancer and would live “three years at best.” Instead of accepting that prognosis, she helped change the trajectory of cancer research by founding the Multiple Myeloma Research Foundation (MMRF)—a model that brought scientists, clinicians, biotech, and the FDA together to accelerate treatments.This conversation explores survivorship, advocacy, and what patients and caregivers can do when the science is moving fast—but the system isn't.In This Episode, We DiscussGetting a shocking diagnosis after a “routine” appointmentWhy multiple myeloma was once considered a “silent killer”How Kathy helped build a research engine that accelerated drug developmentThe difference between fast-moving science and slow-moving systemsHow Kathy's identical twin impacted her breast cancer risk and screeningDCIS decisions and why “there's no right or wrong—only what's best for you”Why “looking healthy” can cause people to underestimate what you're carryingHow to set boundaries when you're in treatment or survivorshipWhy you shouldn't rely on only one or two caregivers—and how to “invite people in”Kathy's book: Fatal to Fearless: 12 Steps to Beating Cancer in a Broken Medical SystemResources & LinksFollow Kathy: @kathy.giustiBook: Fatal to Fearless: 12 Steps to Beating Cancer in a Broken Medical SystemSurvivingBreastCancer.org: Free programs, support groups, and communityDownload the SBC App: Search SurvivingBreastCancer.org in the App Store or Google Play Support the showLatest News: Become a Breast Cancer Conversations+ Member! Sign Up Now. Join our Mailing List - New content drops every Monday! Discover FREE programs, support groups, and resources! Enjoying our content? Please consider supporting our work.
EPISODE SUMMARY In this episode, Arundhati Parmar interviews Shalin Shah, CEO of Marius Pharmaceuticals, about Testosterone Replacement Therapy (TRT) and the long-standing regulatory classification that places testosterone as a Schedule III controlled substance. Shah explains that testosterone was scheduled in 1990 following Olympic doping scandals — despite opposition at the time from the FDA, DEA, and the American Medical Association. More than 30 years later, he argues that the regulatory framework no longer reflects current clinical evidence and may be doing more harm than good. The conversation explores: The scientific evidence surrounding cardiovascular and prostate safety The differences between injectable and oral testosterone therapies The stigma and logistical barriers created by controlled substance status How GLP-1 drugs intersect with hormone health and muscle preservation The possibility of expanding testosterone therapy access to women Whether the current regulatory environment may revisit testosterone scheduling At its core, this episode examines whether testosterone is being regulated based on outdated controversy rather than modern clinical science — and what that means for patients navigating care today. Episode Resources Connect with Arundhati Parmar aparmar@medcitynews.com https://twitter.com/aparmarbb?lang=en https://medcitynews.com/ KEYWORDS Testosterone Replacement Therapy TRT regulation Schedule III classification Controlled substances Hormone therapy stigma Men's health Women's hormone therapy TRAVERSE study Cardiovascular risk Prostate cancer risk Oral testosterone Injectable testosterone Hematocrit levels GLP-1 muscle loss Hypogonadism FDA regulation Healthcare policy Hormone optimization EPISODE HIGHLIGHTS 00:00–01:40 - Why testosterone became a Schedule III controlled substance in 1990 01:40–02:30 - Political backlash after Olympic doping scandals 02:30–03:56 - Testosterone as the only controlled hormone 03:56–04:58 - The physiologic role of testosterone across multiple organ systems 04:58–06:19 - Cardiovascular and prostate cancer risk: What the TRAVERSE study showed 06:19–07:04 - Physiologic vs. supraphysiologic dosing 07:04–08:49 - How controlled status creates stigma and access barriers 08:49–10:10 - Provider tracking, pharmacy hurdles, and patient friction 10:10–11:48 - Would deregulation increase abuse or doping? 11:48–13:20 - GLP-1 drugs, rapid weight loss, and muscle preservation 13:20–15:08 - Testosterone in women: The overlooked half of the population 15:08–16:22 - Injectable vs oral TRT: Mimicking natural diurnal rhythms 16:22–17:40 - Hematocrit elevation differences between injections and oral therapy 17:40–19:07 - Side effect profiles and hormone signaling differences 19:07–20:32 - Go-to-market strategy: Cash pay vs insurance coverage 20:32–21:24 - Stigma among payers and barriers to reimbursement 21:24–22:43 - Expanding label indications and idiopathic hypogonadism 22:43–22:22 - Could the current administration reconsider testosterone scheduling?
Why did Walmart fall on strong earnings? And how are Omnicom's big cost cuts boosting its stock? Plus, will a major FDA reversal change Moderna's fortunes? Host Jack Pitcher discusses the biggest stock moves of the week and the news that drove them.Sign up for the WSJ's free Markets A.M. newsletter. Learn more about your ad choices. Visit megaphone.fm/adchoices
Why did Walmart fall on strong earnings? And how are Omnicom's big cost cuts boosting its stock? Plus, will a major FDA reversal change Moderna's fortunes? Host Jack Pitcher discusses the biggest stock moves of the week and the news that drove them.Sign up for the WSJ's free Markets A.M. newsletter. Learn more about your ad choices. Visit megaphone.fm/adchoices
On this episode, Jared starts a new series - Mighty Minerals! He kicks the series off by exploring lithium from a completely different perspective—not just as a psychiatric medication, but as a naturally occurring trace mineral that may play a role in mood balance, stress resilience, sleep rhythm, and cognitive support. You'll learn the difference between high-dose pharmaceutical lithium and low-dose nutritional lithium, why dosage and intent matter, and how integrative practitioners are using micro-doses as part of a broader wellness strategy. Jared also breaks down how lithium interacts with circadian rhythm, neurotransmitter signaling, and brain stability, plus how nutrients like magnesium, omega-3s, B vitamins, inositol, and adaptogenic herbs may complement it. This episode is educational and empowering, designed to help you think critically about mental wellness, trace minerals, and personal responsibility for your health.Products:KAL Lithium OrotateSolaray Lithium AspartateVisit the podcast website here: VitalityRadio.comYou can follow @vitalitynutritionbountiful and @vitalityradio on Instagram, or Vitality Radio and Vitality Nutrition on Facebook. Join us also in the Vitality Radio Podcast Listener Community on Facebook. Shop the products that Jared mentions at vitalitynutrition.com. Let us know your thoughts about this episode using the hashtag #vitalityradio and please rate and review us on Apple Podcasts. Thank you!Just a reminder that this podcast is for educational purposes only. The FDA has not evaluated the podcast. The information is not intended to diagnose, treat, cure, or prevent any disease. The advice given is not intended to replace the advice of your medical professional.
This episode covers: • Microplastics Are Destroying Male Fertility and Metabolism New research is putting microplastics in a category most men still are not taking seriously: direct reproductive and hormone risk. A 2024 study detected microplastics in every human testicle examined, with polyethylene and PVC among the most common polymers. PVC is especially relevant because it's often tied to chemical additives that can disrupt endocrine signaling. The broader body of evidence points to micro- and nanoplastics crossing barriers like the blood–testis barrier, driving inflammation and oxidative stress in the testes, and showing associations with impaired sperm quality and hormone disruption. The longevity move here is reducing overall load: better water filtration, less plastic food contact, no heating food in plastic, fewer packaged foods, and taking indoor dust and air quality seriously, especially for men thinking about fertility now or hormone resilience over decades. • Sources: – Study (PubMed): https://pubmed.ncbi.nlm.nih.gov/38745431/ – Coverage: https://people.com/microplastics-in-every-human-testicle-infertility-8651215 • Fear of Aging Is Linked to Faster Biological Aging A new study ties aging anxiety to measurable acceleration in biological aging using DNA methylation clocks. People who reported more worry and negative beliefs about aging showed faster epigenetic aging signals, and the molecular differences clustered around stress and inflammatory pathways. In plain terms, chronic threat-mode thinking around aging maps onto biology that looks older on the clocks. For a longevity audience, this is a practical reminder that mental inputs affect physiological outputs. If your day-to-day mindset is constant pressure and decline narratives, that can show up downstream in stress biology and inflammatory tone. A smarter play is building a longevity framework around function, strength, purpose, and community, alongside the usual pillars like sleep, training, and metabolic health. • Source: https://medicalxpress.com/news/2026-02-older-links-health-faster-epigenetic.html • Additional source: https://www.nyu.edu/about/news-publications/news/2026/february/aging-anxiety.html • Retatrutide, the Triple-Agonist Weight-Loss Drug Pushing Bariatric-Level Results Retatrutide is a triple agonist that targets GLP-1, GIP, and glucagon receptors, and the weight-loss numbers being reported are massive. In a 68-week study in people with obesity and knee osteoarthritis, the highest dose group averaged about 28.7% body-weight loss, along with meaningful improvements in knee pain and function. This is the next phase of incretin medicine: multi-agonist drugs that can move body weight by a quarter or more. For biohackers, the performance and longevity angle is implementation: preserving lean mass through resistance training, hitting protein targets, monitoring micronutrients, and building a maintenance plan that doesn't collapse the moment the drug stops. The upside is cardiometabolic risk reduction at scale. The key is running it with structure. • Sources: – Eli Lilly release: https://investor.lilly.com/news-releases/news-release-details/lillys-triple-agonist-retatrutide-delivered-weight-loss-average – Coverage: https://nypost.com/2026/02/18/health/people-dropped-out-of-retatrutide-trial-for-losing-too-much-weight/ – Background: https://news.harvard.edu/gazette/story/2026/02/whats-next-for-glp-1s/ • AI Can Predict 130 Diseases From a Single Night of Sleep Stanford's SleepFM project shows how much long-horizon health information is encoded in sleep. Researchers trained a foundation model on roughly 585,000 hours of clinical polysomnography data from about 65,000 people. From a single night of sleep study signals, the model could estimate risk for 130 conditions, including dementia, heart attack, heart failure, chronic kidney disease, stroke, atrial fibrillation, and all-cause mortality, and it generalized across cohorts better than simple demographic baselines. The big implication is that sleep architecture and micro-patterns (stage distribution, fragmentation, breathing stability, micro-arousals) function like a dense biomarker stream for systemic aging and disease risk. Expect better sensors and more validated risk dashboards over time. Right now, this is another reason to treat sleep as a core diagnostic pillar, not just a recovery habit. • Sources: – Stanford Medicine: https://med.stanford.edu/news/all-news/2026/01/ai-sleep-disease.html – Paper (Nature Medicine): https://www.nature.com/articles/s41591-025-04133-4 • Living at High Altitude May Protect Against Diabetes by Turning Red Blood Cells Into Glucose Sinks For years, population data has suggested lower diabetes rates at higher elevations. New mechanistic work is pointing to a surprising driver: red blood cells changing how they handle glucose under low oxygen conditions. In hypoxia, red blood cells can behave like glucose sinks, pulling more sugar out of circulation and improving glucose tolerance, which may help explain the protective association seen at altitude. The downstream potential is a new class of altitude-mimetic approaches that target erythrocyte metabolism as a glucose lever, separate from appetite suppression or classic diabetes pathways. For biohackers, it expands the metabolic toolkit and reinforces that oxygen environment and blood physiology matter more than we've given them credit for. • Source: https://medicalxpress.com/news/2026-02-red-blood-cells-sugar-high.html • Dietary Supplement Regulatory Uniformity Act and the Future of Supplement Access A proposed bill is aiming to stop states from layering extra rules on dietary supplements beyond federal law, creating one national standard instead of a patchwork of state-by-state restrictions. Industry groups are supporting it as a way to reduce confusion and compliance chaos, especially as some states explore age limits or special labeling requirements for certain supplement categories. The strategic implication for biohackers is that regulation shapes access. Uniformity can stabilize availability, but it also raises the stakes of federal decisions on controversial ingredients. This is one of those policy stories that quietly determines what stays on shelves, what disappears, and how much innovation survives in the supplement space. • Sources: – NutritionInsight: https://www.nutritioninsight.com/news/npa-crn-supplements-us-fda-legislation.html – Congressional release: https://langworthy.house.gov/media/press-releases/congressman-langworthy-introduces-dietary-supplement-regulatory-uniformity-act – NutraIngredients: https://www.nutraingredients.com/Article/2026/02/05/new-bill-aims-to-end-state-supplement-regulations/ All source links are provided for direct access to the original reporting and research. New episodes every Tuesday, Thursday, Friday, and Sunday. Keywords: microplastics male fertility, microplastics testosterone decline, blood–testis barrier toxins, endocrine disruption plastics, sperm count microplastics, epigenetic age acceleration, fear of aging methylation, biological aging mindset, stress inflammation aging, retatrutide triple agonist, GLP-1 GIP glucagon weight loss, incretin drugs obesity treatment, muscle preservation on GLP-1, SleepFM AI model, sleep disease prediction, polysomnography risk scoring, dementia risk sleep data, altitude diabetes protection, hypoxia glucose metabolism, red blood cells glucose uptake, altitude mimetic therapy, Dietary Supplement Regulatory Uniformity Act, supplement regulation federal preemption, FDA supplement policy, biohacking news longevity, metabolic health optimization Thank you to our sponsors! - HeartMath | Go to https://www.heartmath.com/dave to save 15% off. - BrainTap | Go to http://braintap.com/dave to get $100 off the BrainTap Power Bundle. Resources: • Get My 2026 Biohacking Trends Report: https://daveasprey.com/2026-biohacking-trends-report/ • Dave Asprey's Latest News | Go to https://daveasprey.com/ to join Inside Track today. • Danger Coffee: https://dangercoffee.com/discount/dave15 • My Daily Supplements: SuppGrade Labs (15% Off) • Favorite Blue Light Blocking Glasses: TrueDark (15% Off) • Dave Asprey's BEYOND Conference: https://beyondconference.com • Dave Asprey's New Book – Heavily Meditated: https://daveasprey.com/heavily-meditated • Join My Substack (Live Access To Podcast Recordings): https://substack.daveasprey.com/ • Upgrade Labs: https://upgradelabs.com Timestamps: 0:00 – Intro 0:19 – Story 1: Microplastics in Testicles 1:44 – Story 2: Fear of Aging Accelerates Aging 3:30 – Story 3: Retatrutide Weight Loss Drug 4:42 – Story 4: Sleep Predicts Disease Risk 6:34 – Story 5: High Altitude & Diabetes 7:57 – Story 6: Supplement Regulation Bill 9:16 – Weekly Summary 10:51 – Outro See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
With national debt up $2.6 trillion in one year and trade deficits exploding despite tariffs, the dollar faces collapse while oil and gold signal inflation's return.- This episode is sponsored by Grammarly. Download Grammarly for free at https://grammarly.com- This episode is also sponsored by Pebl. Go to https://hipebl.ai to get a free estimate.Peter Schiff analyzes mounting evidence that the U.S. dollar is heading for a major decline, driven by exploding deficits and failed trade policies. With the national debt surging $2.6 trillion in just over a year under Trump, and trade deficits widening despite tariffs, Schiff argues that the same deficit spending Republicans blamed for Biden's inflation is now accelerating under the current administration. Oil prices have surged 21% in two months, hitting six-month highs above $66, while gold holds support above $5,000 as central banks continue dumping dollars. The December trade deficit data reveals Trump's tariffs are backfiring spectacularly - imports rising while exports fall, proving Americans pay 90% of tariff costs according to New York Fed studies. Housing markets show severe stress with pending home sales hitting record lows, signaling price corrections ahead. Schiff credits Trump for reducing FDA drug approval requirements from two studies to one, but argues this modest deregulation doesn't address the fundamental problem of government interference in healthcare markets that didn't exist before 1962.Chapters:01:33 Gold & Silver Snapshot: Buy the Dip Below $5,00002:14 Oil Breakout: Why Gas Prices Are Headed Higher05:42 Dollar Weakness #1: Exploding Deficits and the Debt Rollover Bomb09:52 Tariffs, Taxes, and the Myth of 1880s Prosperity15:54 DOGE, Elon Musk, and Why Government Can't Be Efficient20:14 World Ditches the Dollar: Central Banks Buy Gold21:32 Trade Deficit Reality Check: December Numbers Blow Out27:28 Tariffs Backfire: New York Fed Study Says Americans Pay36:20 Twin Deficits → Inflation & Rates: The Macro Chain Reaction39:22 Housing Bubble Math: Rates Up Means Prices Must Fall42:04 Giving Credit Where Due: Trump's FDA Change to One Efficacy Study45:05 Before 1962/1938: How Drug Approval Worked in a Freer Market53:28 Wrap-Up: Newsletter, Gold/Silver, EuroPac Funds & Upcoming Live ShowFollow @peterschiffX: https://twitter.com/peterschiffInstagram: https://instagram.com/peterschiffTikTok: https://tiktok.com/@peterschiffofficialFacebook: https://facebook.com/peterschiffSign up for Peter's most valuable insights at https://schiffsovereign.comSchiff Gold News: https://www.schiffgold.com/newsFree Reports & Market Updates: https://www.europac.comBook Store: https://schiffradio.com/books#Gold #Tariffs #InflationOur Sponsors:* Check out GhostBed: https://ghostbed.com/PETER* Check out TruDiagnostic and use my code GOLD20 for a great deal: https://www.trudiagnostic.comPrivacy & Opt-Out: https://redcircle.com/privacy
Watch every episode ad-free & uncensored on Patreon: https://patreon.com/dannyjones Travis Kitchens was a psychedelic research subject for Johns Hopkins University who eventually uncovered a secret plan to revive religion with drugs. Travis is currently a freelance journalist who writes extensively on the history and philosophy of psychedelic research. He lives in Kentucky. SPONSORS https://rag-bone.com - Use code DANNY & get 20% off sitewide. https://takeultra.com - Use code DANNY for 15% off. https://shopify.com/dannyjones - Sign up for your one-dollar-per-month trial & start selling today. https://amentara.com/go/dj - Use code DJ22 for 22% off. https://whiterabbitenergy.com/?ref=DJP - Use code DJP for 20% off EPISODE LINKS https://vegetabletelevision.substack.com https://www.psymposia.com/magazine/a-channel-for-magic-ralph-hoods-mysticism-scale-and-the-occult-roots-of-the-johns-hopkins-psychedelic-research-program https://www.csmonitor.com/Technology/2019/0418/Why-Wendell-Berry-is-still-not-going-to-buy-a-computer FOLLOW DANNY JONES https://www.instagram.com/dannyjones https://twitter.com/jonesdanny OUTLINE 00:00 - Psymposia is sabotaging MDMA research 05:41 - serpent handling cults 09:41 - FDA reason for rejecting MDMA therapy 16:28 - Psychedelics are being weaponized 21:16 - Andrew Callaghan & Nick Shirley 24:30 - The modern journalism landscape 27:50 - The ChatGPT information model 32:17 - Human lifespans are going DOWN 34:59 - Jordan Peterson & John Vervaeke 38:52 - Epstein's interest in the CIA Stargate program 41:22 - Epstein's interview with Steve Bannon 46:29 - The most likely Epstein theory 49:17 - Art forgery & weaponized art 56:37 - Epstein files are confirming the worst conspiracies 01:01:00 - Jeffrey Epstein's brother is worse than him 01:04:01 - Epstein's art exhibit for Roman Polanski 01:05:28 - Noam Chomsky's Epstein connection 01:12:20 - Dark details of Jolly West 01:15:21 - Charles Manson & MKUltra 01:21:42 - Reagan's war on drugs 01:23:03 - Most likely Manson murder theory 01:28:13 - Candace Owen's new Charlie Kirk theory 01:35:13 - Rise of Nick Feuntes 01:39:07 - Trump's plan to sabotage the mid-terms 01:42:33 - Scientology headquarters 01:49:15 - Why Scientologists don't speak out 01:56:53 - Where L. Ron Hubbard escaped to 01:58:03 - How remote viewing works 02:00:49 - Psychedelics & telepathy 02:03:54 - Coming down from DMT 02:07:02 - The need for psychedelic churches 02:09:40 - New plant stronger than DMT 02:10:31 - Changa plant 02:14:00 - Psychedelic drugs of the future 02:14:36 - Ammon Hillman's debate with Luke Gorton 02:18:28 - The apple of knowledge from Adam & Eve 02:21:16 - Why deadly shark attacks are on the rise 02:31:17 - John Lilly's psychedelic NASA research 02:37:55 - Harmony Korine & IDF fundraising 02:44:09 - Florida's donations to Israel 02:49:23 - Museum of Tarot's conspiracy theories 02:55:17 - Bob Lazar 02:57:40 - Danny's theory on UFOs & aliens 02:58:57 - Alex Jones' predictions 03:04:29 - Probability of life beyond earth 03:07:19 - Is there a "creator"? 03:13:11 - Technology vs. evolution 03:15:07 - Graham Hancock & Flint Dibble 03:17:28 - Ancient Egyptian Vases 03:19:13 - Who the ancient Egyptians were 03:20:26 - Tobacco is worse than LSD 03:25:58 - Paganism in Conan the Barbarian 03:27:45 - Oliver Stone's interview with Putin 03:31:57 - The dark tale of Gary Stewart 03:33:40 - The Immortality Con & the psychedelic renaissance 03:41:25 - Why people must be cautious 03:43:05 - The message of psychedelics Learn more about your ad choices. Visit podcastchoices.com/adchoices
When we talk about hormones and women's sexual health, the focus is almost always on estrogen. But testosterone also plays a key role in desire, arousal, and overall sexual well-being. Despite being labeled a “male hormone,” women produce (and need) it too. In this episode, we separate myth from fact about testosterone in women and why it remains one of the most overlooked topics in sexual medicine. I am joined once again by Dr. Maria Sophocles, a board-certified OB/GYN and Menopause Society Certified Practitioner. She is the CMO of EMBR Labs, a Boston-based wellness device company. Maria is also author of the new book, The Bedroom Gap, which is all about sex at midlife. Some of the specific topics we explore in this episode include: What testosterone does in women's bodies and sex lives How levels change across the lifespan When testosterone may help menopausal symptoms Potential risks and side effects Why there's still no FDA-approved testosterone treatment for women To learn more about Maria’s work, you can check out her website. Got a sex question? Send me a podcast voicemail to have it answered on a future episode at speakpipe.com/sexandpsychology. *** Thank you to our sponsors! Soaking Wet from VB Health is the world’s first probiotic specifically designed for vaginal and vulva health and wellness. It’s a doctor formulated blend of prebiotics, probiotics, and vitamins specifically designed to restore balance and increase lubrication. Visit vb.health and use code JUSTIN for 10% off. The Kinsey Institute is where the world turns to understand sex and relationships. You can help continue its expert-led research by donating to the Kinsey Institute Research Fund. Learn more and make a donation here: https://give.myiu.org/centers-institutes/I380010749.html *** Want to learn more about Sex and Psychology? Click here for previous articles or follow the blog on Facebook, Twitter, or Bluesky to receive updates. You can also follow Dr. Lehmiller on YouTube and Instagram. Listen and stream all episodes on Apple, Spotify, or Amazon. Subscribe to automatically receive new episodes and please rate and review the podcast! Credits: Precision Podcasting (Podcast editing) and Shutterstock/Florian (Music). Image created with Canva; photos used with permission of guest.
Big news from ONE TRAY®! On this Beyond Clean Vendor Spotlight™ episode, we're joined by Tim Tzimas, newly appointed President & CEO of ONE TRAY®/IST, along with Barbara Ann Harmer, Vice President of Clinical Services, to share two major ONE TRAY® announcements. Listen in to learn more about Tim's story and what inspired him to take the helm of ONE TRAY/IST. Also learn about ONE TRAY®'s secondary FDA clearance: 365-day event-related shelf life/storage period with a 15-minute minimum dry time. What does that mean for your SPD? Tune in to find out! To learn more and to virtually meet Tim, visit onetray.com/newceo, and for more information on ONE TRAY®'s second FDA clearance, visit onetray.com/ifucomparison. Don't forget to stay connected on LinkedIn and Facebook for updates! ------ Condoc 754 Rev 00. Follow one of the following IFUs for use: K052567* and K250029**. *Reference 510k summary- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K052567 **Reference 510k summary- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250029
February 13, 2026: AI in Drug DiscoveryIt costs $2.5 billion and up to 10 years of effort to successfully bring a new drug to market.That's an extremely high hurdle to succeed!It's no wonder why the high costs of FDA trials & the elevated rates of failure often result in small-cap drug developers declaring bankruptcy. Biotechnology is one of the stock market's riskiest sectors to invest in.But what if there was a way to change that?What if we could use technology to alleviate some of the biotech industry's deepest and most systemic risks?AI doesn't necessarily produce better drugs. Though it might be able to reduce drug development costs and timelines significantly.And if it did, that would be a game-changer for the entire industry.On today's show, my special guest Manisha Samy and I will discuss how AI-native infrastructure could vastly improve the return profiles of early-stage biotech companies.Our stock of focus will be Recursion Pharmaceuticals (Nasdaq: RXRX) who's creatively using AI to guide several programs in its development pipeline.
TW: there is a story about sexual assault of minors around the time stamp 14:10-21. Our Feminist Buzzkill Lizz is solo this week, serving you a pod full of horror — but with that super sweet pro-abortion cherry on top! She brings you up to speed on the latest WTAF reports of the government rounding up pregnant migrant teens and shipping them to a Texas prison known for not providing adequate healthcare. Yes, you read that right. Add in increased cases of pregnancy criminalization and the Right's continued crusade against abortion pills out of Kentucky and Louisiana, and we're ready to just nope right the fuck off this planet. GUEST ROLL CALL: Becca Rea-Tucker, The Sweet Feminist, is here to chat about her new book, The Abortion Companion handbook and allllll things abortion! Pro-abortion cakes AND supporting abortion seekers? WHAT MORE COULD YOU ASK FOR?! Times are heavy, but knowledge is power, y'all. We gotchu. OPERATION SAVE ABORTION: You can still join the 10,000+ womb warriors fighting the patriarchy by clicking HERE to for past Operation Save Abortion trainings, your toolkit, marching orders, and more. HOSTS: Lizz Winstead IG: @LizzWinstead Bluesky: @LizzWinstead.bsky.social Moji Alawode-El IG: @Mojilocks Bluesky: @Mojilocks.bsky.social SPECIAL GUESTS: Becca Rea-Tucker IG: @TheSweetFeminist Bluesky: @TheSweetFeminist.bsky.social GUEST LINKS: BUY: Becca's handbook, “The Abortion Companion” The Abortion Companion Book Swap The Sweet Feminist Website Becca's Linktree BUY: Becca's Baking Book SIGN UP: Becca's Substack AVOW Texas Expose Fake Clinics NEWS DUMP: KY Couple Arrested, Charged With Reckless Homicide After Reporting Miscarriage Abortion Pills Would Be Classified as Controlled Substances Under New Bill Republican US Senators File Amicus Brief to Eliminate the Mailing of Chemical Abortion Drugs, Including Mifepristone Judge Rejects Anti-Abortion Center's Lawsuit Against Top Massachusetts Officials Trump Administration Is Sending Pregnant Migrant Girls to South Texas Shelter Flagged as Medically Inadequate AAF Breakdown on Pregnant Incarceration AAF RESOURCE: Hypocrites Unmasked EPISODE LINKS: BUY: Michael Shannon / Jason Narducy & Friends Lifes Poster TICKETS: Michael Shannon & Jason Narducy Tour ADOPT-A-CLINIC: Emma Goldman Clinic in Iowa City, IA Operation Save Abortion Expose Fake Clinics BUY AAF MERCH! EMAIL your abobo questions to The Feminist Buzzkills AAF's Abortion-Themed Rage Playlist FOLLOW US: Listen to us ~ FBK Podcast Instagram ~ @AbortionFront Bluesky ~ @AbortionFront TikTok ~ @AbortionFront Facebook ~ @AbortionFront YouTube ~ @AbortionAccessFront TALK TO THE CHARLEY BOT FOR ABOBO OPTIONS & RESOURCES HERE! PATREON HERE! Support our work, get exclusive merch and more! DONATE TO AAF HERE! ACTIVIST CALENDAR HERE! VOLUNTEER WITH US HERE! ADOPT-A-CLINIC HERE! GET ABOBO PILLS FROM PLAN C PILLS HERE! When BS is poppin', we pop off! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.
Episode 213: HIV PrEP Review H. Nicole Magaña, medical student, reviews the history of PrEP and outlines the currently FDA-approved medications used for HIV prevention. Dr. Arreaza provides additional perspective on long-acting injectable options, including how quickly they begin to protect patients after initiation. Written by Nicole Magana, MSIV, American University of the Caribbean. Comments and edits by Hector Arreaza, MD. You are listening to Rio Bravo qWeek Podcast, your weekly dose of knowledge brought to you by the Rio Bravo Family Medicine Residency Program from Bakersfield, California, a UCLA-affiliated program sponsored by Clinica Sierra Vista, Let Us Be Your Healthcare Home. This podcast was created for educational purposes only. Visit your primary care provider for additional medical advice. Pre-exposure prophylaxis for HIV. Previous episodes related to HIV: -Episode 67, HIV history (September 2021) -Episode 68, HIV transmissibility (October 2021) -Episode 70 (October 2021), HIV prevention (including HIV Prep with oral medications) -Episode 98 (June 2022), we introduced Apretude, the first injectable for HIV PrEP. Apretude was approved in December 2021. What is Pre-Exposure prophylaxis (PrEP)? Pre-exposure prophylaxis, or PrEP, is the use of antiretroviral medications taken by individuals who are HIV-negative to prevent HIV acquisition. There are 30,000 new HIV infections annually in the US. How effective is it? When taken as prescribed, PrEP is highly effective at reducing the risk of HIV transmission through sexual exposure and injection drug use. Patients who are adherent to PrEP can lower their risk of contracting HIV by 99%. The effectiveness of oral PrEP is highly adherence dependent. In trials with 70% adherence, the relative risk of HIV acquisition was 0.27, compared to 0.51 with 40-70% adherence and no significant benefit with adherence ≤40%. How does PrEP work? PrEP works by maintaining therapeutic drug levels in the bloodstream and in target tissues. If HIV exposure occurs, viral replication is inhibited, preventing the establishment of infection. Brief History of PrEP. The concept of PrEP originated from early animal studies demonstrating that antiretroviral medications could prevent retroviral transmission when administered before exposure. In 2010, the iPrEx trial showed that daily oral tenofovir disoproxil fumarate (known as Truvada) with emtricitabine significantly reduced HIV acquisition among men who have sex with men and transgender women. This was the first large clinical trial to demonstrate the effectiveness of PrEP. In 2012, the FDA approved oral Truvada, which is TDF/FTC (tenofovir disoproxil and emtricitabine) for HIV prevention. Since then, additional studies have expanded indications and introduced new formulations, including long-acting injectable options. Who Should Be Offered PrEP? PrEP should be considered for any HIV-negative individual at increased risk of HIV acquisition, including Men who have sex with men, transgender individuals, heterosexual men and women with an HIV-positive partner, individuals with recent bacterial sexually transmitted infections, people who inject drugs, individuals engaging in condomless sex with partners of unknown HIV status. Remember that PrEP should be offered in a nonjudgmental, patient-centered manner, make it a safe space to talk openly about prevention of HIV. Available HIV PrEP Options. Daily Oral PrEP: There are 2 formulations of Tenofovir. There is Tenofovir disoproxil fumarate (TDF)/ Truvada and Tenofovir alafenamide (TAF)/ Descovy. Each is available in a tablet combined with Emtricitabine a nucleoside reverse transcriptase inhibitor. Truvada: It is approved for all populations at risk through sexual exposure or injection drug use. Something to look out for before starting this medication is for pre-existing CKD. Do not give to patients who have an estimated glomerular filtration rate of less than 60 mL/min. (6) Descovy: This option is approved for men who have sex with men and transgender women but is not approved for individuals at risk through receptive vaginal sex. It has less impact on renal function and bone mineral density compared to Truvada. It can be used in moderately reduced kidney function (GFR between 30-60 mL/min). Truvada and Descovy are taken orally once a day. After patients start taking these medications, when are they considered to be protected? Nicole: With daily oral PrEP, guidelines differ with WHO and International Aids Society-USA stating it takes about 7 days, while CDC states 21 days to allow for adequate concentration in tissues (1). Adherence is critical for efficacy. Injectable HIV PrEP. In 2021, the FDA approved the first Injectable PrEP option Long-acting cabotegravir (CAB-LA)- known on the market as Apretude. Cabotegravir is an integrase strand transfer inhibitor administered as an intramuscular injection.Dosing consists of an initial injection, a second injection one month later, and then maintenance injections every two months (1). Another option is Lenacapavir (Yeztugo). The Yeztugo as a pre-exposure prophylaxis (PrEP) for HIV in Oct 2024. Yeztugo is the first and only FDA-approved HIV prevention treatment that requires just two injections per year, offering a long-acting option for people who weigh at least 35kg. It is given as 2 injections every 6 months. First dose is given with 2 tablets on Day 1 and Day 2, then every 6 months 2 injections on the same day. Clinical trials, including HPTN 083 and HPTN 084, demonstrated that injectable cabotegravir is superior to daily oral PrEP in preventing HIV infection. This advantage is largely due to improved adherence rather than differences in intrinsic drug potency. There have been no head-to-head comparisons between Yeztugo and Apretude, but they are both very effective. Apretude starts protecting 7 days after the first dose, and Yeztugo starts protecting 2 hours after Day 2 (if patient takes the oral loading dose) or 3-4 weeks if no oral load is taken. Injectable PrEP is particularly beneficial for patients who struggle with daily pill adherence, have trouble swallowing pills, prefer a discreet option, have difficulty storing their medication or have renal or bone disease that limits the use of tenofovir-based regimens like Truvada and Descovy (6). In one unpublished report by Medline, patients who received Apretude had an increase in bone mineral density compared to those who received Truvada (1). Tests prior to starting PrEP. Before initiating PrEP, patients must be confirmed to be HIV-negative. Baseline evaluation includes HIV testing with a fourth-generation antigen/antibody assay, HIV RNA testing if acute infection is suspected, renal function testing for oral PrEP, Hepatitis B screening, sexually transmitted infection screening, and pregnancy testing when appropriate. PrEP should not be started in individuals with known or suspected acute HIV infection. Monitoring for patients on HIV PrEP. Monitoring typically includes HIV testing every 2 to 3 months, STI screening every 3 to 6 months, renal function monitoring for those on oral PrEP (tenofovir- based), ongoing adherence and risk-reduction counseling. And for injectable PrEP, adherence to the injection schedule is essential, as delayed dosing may increase the risk of resistance if HIV infection occurs. HIV PrEP is not a prevention for other STIs. Screening for STIs and counseling about prevention is essential. Breakthrough HIV infections on PrEP are rare and most often associated with poor adherence or delayed diagnosis. Truvada is more studied in all populations and is considered safe during pregnancy and breastfeeding. There is less data regarding the injectable option in patients who are pregnant, may become pregnant, or whose primary risk factor is injection drug use (1). Injectable PrEP provides an important alternative for patients with chronic kidney disease and bone disease (1). Key Takeaway Pre-exposure prophylaxis is a safe, effective, and evidence-based strategy for HIV prevention. With both daily oral and long-acting injectable options available, PrEP can be individualized to meet patient needs. Normalizing PrEP discussions in clinical practice is essential to reducing new HIV infections and advancing public health goals. Even without trying, every night you go to bed a little wiser. Thanks for listening to Rio Bravo qWeek Podcast. We want to hear from you, send us an email at RioBravoqWeek@clinicasierravista.org, or visit our website riobravofmrp.org/qweek. See you next week! References: Antiretroviral Drugs for Treatment and Prevention of HIV in Adults: 2024 Recommendations of the International Antiviral Society–USA Panel. The Journal of the American Medical Association. 2025. Gandhi RT, Landovitz RJ, Sax PE, et al. Long-Acting Lenacapavir Acts as an Effective Preexposure Prophylaxis in a Rectal SHIV Challenge Macaque Model. The Journal of Clinical Investigation. 2023. Bekerman E, Yant SR, VanderVeen L, et al. Pharmacokinetics and Safety of Once-Yearly Lenacapavir: A Phase 1, Open-Label Study. Lancet. 2025. Jogiraju V, Pawar P, Yager J, et al.
Have you been following the increasingly louder discussions on GRAS? Those are the additives in our food supply that are "Generally Recognized As Safe" - but are they? Would you be shocked to know that even the FDA doesn't know just how many GRAS additives there even are in the United States? They *think* it's somewhere between 4,000-10,000 ingredients that are currently in our supermarket foods - but they're not really sure. If that doesn't cause you some concern, we're not sure what will! How you can you be assured that it's "safe" if they don't even know how many there are? We're talking all things GRAS today with the BrainStim gang - so take a listen and see what actionable steps you can take to protect yourself and your family from ultra-processed foods. www.invisionchiropractic.com
Though uncertainty still surrounds the Trump administration’s pharmaceutical import tariffs, the trade rhetoric set off a clear response across the industry in 2025. Drugmakers accelerated U.S. manufacturing plans, pushing production higher as companies looked to insulate their supply chains. Now, with many of those moves already underway, that breakneck pace is expected to level off through 2026 and 2027, according to a recent outlook from Atradius. In this week’s episode of "The Top Line," Fierce Pharma’s Fraiser Kansteiner speaks with Brady McKinney, an underwriter for Atradius' pharmaceuticals sector focusing on the Americas, about the credit insurer's recent industry report. McKinney explains how tariff concerns drove last year’s manufacturing surge and why Atradius expects a period of stabilization ahead. He also discusses how companies are weighing the risk of future trade flare-ups and what that could mean for production, investment and credit conditions across the sector. To learn more about the topics in this episode: Global pharma manufacturing output surged in '25 in 'front-loading' response to US tariff threats: report FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program In quick reversal, Trump calls off tariff threat related to Greenland pursuit 3 biopharma CEOs explain why they are 'authentically optimistic' for 2026 See omnystudio.com/listener for privacy information.
In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we explore FDA's plausible mechanism pathway for ultra-rare genetic disorders with Holly Fernandez Lynch, Associate Professor of Medical Ethics at the University of Pennsylvania's Perelman School of Medicine. She discusses how this pathway enables personalized gene therapies for N-of-one or N-of-few diseases while raising important questions about regulatory process, evidence standards, and equitable access. Professor Fernandez Lynch also examines the remarkable case of baby KJ, who received a gene editor to treat his urea cycle disorder, and considers both the transformative potential and the procedural concerns surrounding FDA's approach.
Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss a series of US Food and Drug Administration proposals for user fee program changes that would advance President Trump's priorities and the concerns they raise (:31). They also consider the impact of the agency's decision to review Moderna's mRNA flu vaccine application shortly after refusing to file it and using accelerated approval for one of the proposed indications (8:37), as well as ideas for sponsors wondering if their development advice is still good (25:24). More On These Topics From The Pink Sheet US FDA Proposing White House-Aligned Policies For User Fee Agreements: https://insights.citeline.com/pink-sheet/pathways-and-standards/user-fees/us-fda-proposing-white-house-aligned-policies-for-user-fee-agreements-D5JWRDGLCFBT7CYT3FGK3JAZNI/ After Moderna Flu Vaccine, Is US FDA's Accelerated Approval A Pathway Or A Pressure Valve?: https://insights.citeline.com/pink-sheet/pathways-and-standards/review-pathways/after-moderna-flu-vaccine-is-us-fdas-accelerated-approval-a-pathway-or-a-pressure-valve-EWMFKFWO3BB3JA6CQHC4E3JWPA/ Moderna Flu Vaccine Debate Could Resolve With Postmarket Study, FDA's Makary Suggests: https://insights.citeline.com/pink-sheet/vaccines/moderna-flu-vaccine-debate-could-resolve-with-postmarket-study-makary-suggests-Y3R657N2JZABRGFOSKADM33YA4/ Horse Trading? Oz, Bourla Exchange MFN Codification, Vaccine Collaboration Requests: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/horse-trading-oz-bourla-exchange-mfn-codification-vaccine-collaboration-requests-X6UDDVOSMRBSTO5WC224IN6PTE/
The Trump administration appears to be gearing up for a substantial response to Iran, Washington State allegedly spends millions on gender surgeries for inmates, and whiplash hits Moderna as the FDA reverses its decision to not review the company's new flu vaccine. Get the facts first with Morning Wire.- - -Ep. 2640- - -Wake up with new Morning Wire merch: https://bit.ly/4lIubt3- - -Today's Sponsors:Hello Fresh - Go to https://HelloFresh.com/morningwire10fm to Get 10 free meals + a FREE Zwilling Knife (a $144.99 value) on your third box. Offer valid while supplies last.Vanta - Get started at https://Vanta.com/MORNINGWIRE- - -Privacy Policy: https://www.dailywire.com/privacymorning wire,morning wire podcast,the morning wire podcast,Georgia Howe,John Bickley,daily wire podcast,podcast,news podcast Learn more about your ad choices. Visit podcastchoices.com/adchoices
Grok, make Forrest Gump meet himself. For simple, online access to personalized and affordable care for Hair Loss, ED, Weight Loss, and more, visit https://Hims.com/SUPERMEGA Featured products include compounded drug products, which the FDA does not approve or verify for safety, effectiveness, or quality. Prescription required. See website for full details, restrictions, and important safety information. Individual results may vary. Based on studies of topical and oral minoxidil and finasteride. Sign up for your $1 per month trial and start selling today at https://Shopify.com/super Download Cash App Today: https://capl.onelink.me/vFut/1y1gs9ys #CashAppPod. Cash App is a financial services platform, not a bank. Banking services provided by Cash App's bank partner(s). Prepaid debit cards issued by Sutton Bank, Member FDIC. See terms and conditions at https://cash.app/legal/us/en-us/card-agreement. Direct deposit and promotions provided by Cash App, a Block, Inc. brand. Visit http://cash.app/legal/podcast for full disclosures. Follow Matt: @matthwatson Follow Ryan: @elirymagee Follow the show: @supermegashow Learn more about your ad choices. Visit podcastchoices.com/adchoices
In episode 2009, Jack and guest co-host Pallavi Gunalan are joined by comedian, actor, and host of Podcast But Outside, Andrew Michaan, to discuss… RFK Jr. And Kid Rock Team Up For Workout Video/Cringe Comedy Masterclass, We Need to Talk About Piven Experience, The Epstein Files Just Derailed Jimmy Fallon’s Pasta Sauce Plans and more! RFK Jr. And Kid Rock Team Up For Workout Video/Cringe Comedy Masterclass ‘What the [bleep] did I just watch?’ RFK Jr. posts workout video with Kid Rock urging Americans to ‘get active’ Conservatives trying to put Tim Heidecker out of a job. Another Controversial Stance From RFK Jr: Working Out in Jeans Inside Kid Rock's Massive White House Replica with Golden Urinal Kid Rock RFK Rock Out Work Out Has Dropped And We’ll Never Be The Same The Epstein Files have smashed Jimmy Fallon’s spaghetti sauce dreams Jimmy Fallon Kills Planned Pasta Sauce Line With Pal Tommy Mottola as Epstein Friendship Is Revealed This is the trademark for the sauce venture that Jimmy Fallon and Tommy Mottola were launching Soon Yi Previn Shades Fallon in Epstein Files Email Jimmy Debuts New P'Jimmies Summer Line | The Tonight Show Starring Jimmy Fallon Awkward Moment Between Paris Hilton And Jimmy Fallon Highlights The Absurdity Of NFTs Celebrity Promoters Sued Over Bored Ape NFT Endorsements Xochitl Welcomes Jimmy Fallon as an Investor and Brand Partner Helen Mirren and Pierce Brosnan Try Jimmy's Celebrity Tomato Salsa, Talk The Thursday Murder Club Eli Manning, Derek Jeter, Jimmy Fallon join TGL New York Golf Club investor group A short-seller has challenged Jimmy Fallon to a $1 million bet over an air-taxi company he's promoted LISTEN: Robbed You (with Mariah the Scientist) by Summer WalkerSee omnystudio.com/listener for privacy information.
Melissa Lavasani & Jay Kopelman join our podcast to discuss how psychedelic policy is actually moving in Washington, DC. Lavasani leads Psychedelic Medicine Coalition, a DC-based advocacy organization focused on educating federal officials and advancing legislation around psychedelic medicine. Kopelman is CEO of Mission Within Foundation, which provides scholarships for veterans and first responders seeking psychedelic-assisted therapy retreats, often outside the United States. The conversation centers on veterans, the VA, and why that system may be the first realistic federal pathway for psychedelic care. Early Themes Lavasani describes PMC's work on Capitol Hill, including hosting events that bring lawmakers, staffers, and advocates into the same room. Her focus is steady engagement. In DC, progress often happens through repeated conversations, not headlines. Kopelman shares his background as a Marine and how his own psychedelic-assisted therapy experience led him to Mission Within. The foundation has funded more than 250 scholarships for veterans and first responders seeking treatment for PTSD, mild traumatic brain injury, depression, and addiction. They connect this work to pending veteran-focused legislation and explain why the VA matters. As a closed health system, the VA can pilot programs, gather data, and refine protocols without the pressures of private healthcare markets. Core Insights A recent Capitol Hill gathering, For Veteran Society, brought together members of Congress and leaders from the psychedelic caucus. Lavasani describes candid feedback from lawmakers. The message was clear: coordinate messaging, avoid fragmentation, and move while bipartisan interest remains. Veteran healthcare is not framed as the final goal. It is a starting point. If psychedelic therapies can demonstrate safety and effectiveness within the VA, broader adoption becomes more plausible. Kopelman raises operational realities that must be addressed: Standardized safety protocols across providers Integration support, not medication alone Clear training pathways for clinicians Real-world data beyond tightly screened clinical trials They also address recent negative headlines involving ibogaine treatment abroad. Kopelman emphasizes the need for shared learning across providers, especially when adverse events occur. Lavasani argues that inconsistency within the ecosystem can slow federal confidence. Later Discussion and Takeaways The discussion widens to federal momentum around addiction and mental health. Lavasani notes that new funding initiatives signal growing openness to innovative treatment models, even if psychedelics are not named explicitly in every announcement. Both guests stress that policy moves slowly by design. Meetings, follow-ups, and relationship building often matter more than public statements. For clinicians, researchers, operators, and advocates, the takeaways are direct: Veterans are likely the first federal pathway Public education remains essential Safety standards must be shared and transparent Integration and workforce development need attention now If psychedelic medicine enters federal systems, infrastructure will determine success. Frequently Asked Questions What do Melissa Lavasani & Jay Kopelman say about VA psychedelic policy? They argue that veteran-focused legislation offers a realistic first federal pathway for psychedelic-assisted care. Is ibogaine currently available through the VA? No. They discuss ibogaine in the context of private retreats and future possibilities, not an existing VA program. Why do Melissa Lavasani & Jay Kopelman emphasize coordination? Lawmakers respond more positively when advocates present aligned messaging and clear priorities. What safety issues are discussed by Melissa Lavasani & Jay Kopelman? They highlight the need for standardized screening, monitoring, integration support, and transparent review of adverse events. Closing Melissa Lavasani & Jay Kopelman provide a grounded look at how psychedelic policy develops inside federal systems. Their message is practical: veterans may be the first lane, but long-term success depends on coordination, safety standards, and sustained engagement. Closing This episode captures a real-time view of how federal policy could shape the next phase of the psychedelic resurgence, especially through veteran-facing legislation and VA infrastructure. Melissa Lavasani & Jay Kopelman argue that coordination, public education, and shared safety standards will shape whether access expands with credibility and care. Transcript Joe Moore: [00:00:00] Hello everybody. Welcome back to Psychedelics Today. Today we have two guests, um, got Melissa Sani from Psychedelic Medicine Coalition. We got Jake Pelman from Mission Within Foundation. We're gonna talk about I bga I became policy on a recent, uh, set of meetings in Washington, DC and, uh, all sorts of other things I'm sure. Joe Moore: But thank you both for joining me. Melissa Lavasani: Thanks for having us. Jay Kopelman: Yeah, it's a pleasure. Thanks. Joe Moore: Yeah. Um, Melissa, I wanna have you, uh, jump in. First. Can you tell us a little bit about, uh, your work and what you do at PMC? Melissa Lavasani: Yeah, so Psychedelic Medicine Coalition is, um, the only DC based Washington DC based advocacy organization dedicated to the advancing the issue of psychedelics, um, and making sure the federal government has the education they need, um, and understands the issue inside out so that they can generate good policy around, around psychedelic medicines. Melissa Lavasani: [00:01:00] Uh, we. Host Hill events. We host other convenings. Our big event every year is the Federal Summit on psychedelic medicine. Um, that's going to be May 14th this year. Um, where we talk about kinda the pressing issues that need to be talked about, uh, with government officials in the room, um, so that we can incrementally move this forward. Melissa Lavasani: Um, our presence here in Washington DC is, is really critical for this issue's success because, um, when we're talking about psychedelic medicines, um, from the federal government pers perspective, you know, they are, they are the ones that are going to initiate the policies that create a healthcare system that can properly facilitate these medicines and make sure, um, patient safety is a priority. Melissa Lavasani: And there's guardrails on this. And, um, you know, there, it's, it's really important that we have. A home base for this issue in Washington DC just [00:02:00] because, uh, this is very complicated as a lot of your viewers probably understand, and, you know, this can get lost in the mix of all the other issues that, um, lawmakers in DC are focused on right now. Melissa Lavasani: And we need to keep that consistent presence here so that this continues to be a priority for members of Congress. Joe Moore: Mm. I love this. And Jay, can you tell us a bit about yourself and mission within Foundation? Jay Kopelman: Yeah, sure. Joe, thanks. Uh, I, I am the CEO of Mission within Foundation. Prior to this, most of my adult life was spent in the military as a Marine. Jay Kopelman: And I came to this. Role after having, uh, a psychedelic assisted therapy experience myself at the mission within down in Mexico, which is where pretty much we all go. Um, we are here to help [00:03:00] provide, uh, access for veterans and first responders to be able to attend psychedelic assisted therapy retreats to treat issues like mild TBI, post-traumatic stress disorder, uh, depression, sometimes addiction at, at a very low level. Jay Kopelman: Um, and, and so we've, we've been doing this for a little more than a year now and have provided 250 plus scholarships to veterans and first responders to be able to access. These retreats and these, these lifesaving medicines. Um, we're also partnered, uh, you may or may not know with Melissa at Psychedelic Medicine Coalition to help advance education and policy, specifically the innovative, uh, therapy Centers of Excellence Act [00:04:00] that Melissa has worked for a number of years on now to bring to both Houses of Congress. Joe Moore: Thank you for that. Um, so let's chat a little bit about what this event was that just, uh, went down, uh, what, what was it two weeks ago at this point? Melissa Lavasani: Yeah. Yeah. It's called For Veteran Society and it's all, um, there's a lot of dialogue on Capitol Hill about veterans healthcare and psychedelics, but where I've been frustrated is that, you know, it was just a lot of. Melissa Lavasani: Talk about what the problems are and not a lot of talk about like how we actually propel things forward. Um, so it, at that event, I thought it was really important and we had three members of Congress there, um, Morgan Latrell, who has been a champion from day one and his time in Congress, um, having gone through the experience himself, um, [00:05:00] at Mission within, um, and then the two chairs of the psychedelic caucus, uh, Lou Correa and Jack Bergman. Melissa Lavasani: And we really got down to the nitty gritty of like w like why this has taken so long and you know, what is actually happening right now? What are the possibilities and what the roadblocks are. And it was, I thought it was a great conversation. Um, we had an interesting kind of dynamic with Latres is like a very passionate about this issue in particular. Melissa Lavasani: Um, I think it was, I think it was really. A great event. And, you know, two days later, Jack Bergman introduced his new bill for the va. Um, so it was kind of like the precursor to that bill getting introduced. And we're just excited for more and more conversations about how the government can gently guide this issue to success. Joe Moore: Hmm. Yeah. [00:06:00] That's fantastic. Um, yeah, I was a little bummed I couldn't make it, but next time, I hope. But I've heard a lot of good things and, um, it's, it sounded like there was some really important messages in, in terms of like feedback from legislators. Yeah. Yeah. Could you speak to that? Melissa Lavasani: Yeah, I mean, I think when, uh, representative Latrell was speaking, he really impressed on us a couple things. Melissa Lavasani: Um, first is that, you know, they really kind of need the advocates to. Coordinate, collaborate and come up with like a, a strategic plan, you know, without public education. Um, talking to members of Congress about this issue is, is really difficult. You know, like PMC is just one organization. We're very little mission within, very little, um, you know, we're all like, kind of new in navigating, um, this not so new issue, but new to Washington DC [00:07:00] issue. Melissa Lavasani: Um, without that public education as a baseline, uh, it's, it's, you have to spend a lot of time educating members of Congress. You know, that's like one of our things is, you know, we have to, we don't wanna tell Congress what direction to go to. We wanna provide them the information so they understand it very intimately and know how to navigate through things. Melissa Lavasani: Um, and secondly. Um, he got pretty frank with us and said, you know, we've got one cha one chance at this issue. And it's like, that's, that's kind of been like my talking point since I started. PMC is like, you have a very limited window, um, when these kind of issues pop up and they're new and they're fresh and you have a lot of the veteran community coming out and talking about it. Melissa Lavasani: And there's a lot of energy there. But now is the time to really move forward, um, with some real legislation that can be impactful. Um, but, you know, we've gotta [00:08:00] be careful. We, we forget, I think sometimes those of us who are in the ecosystem forget that our level of knowledge about these medicines and a lot of us have firsthand experience, um, with these drugs and, and our own healing journeys is, um, we forget that there is a public out there that doesn't have the level of knowledge that we all have. Melissa Lavasani: And, um. We gotta make sure that we're sticking to the right elements of, of, of what needs to happen. We need to be sure that our talking points are on track and we're not getting sideways about anything and going down roads that we don't need to talk about. It's why, um, you know, PMC is very focused on, um, moving forward veteran legislation right now. Melissa Lavasani: Not because we're a veteran organization, but because we're, we see this long-term policy track here. Um, we know where we want to get [00:09:00] to, um. Um, and watching other healthcare issues kind of come up and then go through the VA healthcare system, I think it's a really unique opportunity, um, to utilize the VA as this closed system, the biggest healthcare system in the country to evaluate, uh, how psychedelics operate within systems like that. Melissa Lavasani: And, you know, before they get into, um, other healthcare systems. What do we need to fix? What do we need to pay attention to? What's something that we're paying too much attention to that doesn't necessarily need that much attention? So it's, um, it's a real opportunity to look at psychedelic medicines within a healthcare system and obviously continue to gather the data. Melissa Lavasani: Um, Bergman's Bill emerging, uh, expanding veteran access to emerging treatments. Um, not only mandates the research, it gives the VA authority for this, uh, for running trials and, and creating programs around psychedelic medicines. But also, [00:10:00] one of the great things about it, I think, is it provides an on-ramp for veterans that don't necessarily qualify for clinical trials. Melissa Lavasani: You know, I think that's one of the biggest criticisms of clinical trials is like you're cre you're creating a vacuum for people and people don't live in a vacuum. So we don't necessarily know what psychedelics are gonna look like in real life. Um, but with this expanding veteran access bill that Bergman introduced, it provides the VA an opportunity to provide this access under. Melissa Lavasani: Um, in a, in a safe container with medical supervision while collecting data, um, while ensuring that the veteran that is going through this process has the support systems that it needs. So, um, you know, I think that there's a really unique opportunity here, and like Latrell said, like, we've got one shot at this. Melissa Lavasani: We have people's attention in Congress. Um, now's the time to start acting, and let's be really considerate and thoughtful about what we're doing with it. Joe Moore: Thanks for that, Melissa and Jay, how, [00:11:00] anything to add there on kind of your takeaways from the this, uh, last visit in dc? Jay Kopelman: Yeah, I, I think that Melissa highlighted it really well and there, there were a couple other things that I, I think, you know, you could kind of tie it all together with some other issues that we face in this country, uh, and that. Jay Kopelman: Uh, representative Correa brought up as well, but one of the things I wanted to go back and say is that veterans have kind of led this movement already, right? So, so it's a, it's a good jumping off point, right? That it's something people from both sides of the aisle, from any community in America can get behind. Jay Kopelman: You know, if you think about it, uh, in World War ii, you know, we had a million people serving our population was like, not even 200 million, but now [00:12:00] we have a population of 330 million, and at any given time there might be a million people in uniform, including the Reserve and the National Guard. So it's, it, it's an easy thing to get behind this small part of the population that is willing to sign that contract. Jay Kopelman: Where you are saying, yeah, I'm going to defend my country, possibly at the risk of my l my own life. So that's the first thing. The other thing is that the VA being a closed health system, and they don't have shareholders to answer to, they can take some risks, they can be innovative and be forward thinking in the ways that some other healthcare systems can't. Jay Kopelman: And so they have a perfect opportunity to show that they truly care for their veterans, which don't, I'm not saying they don't, but this would be an [00:13:00] opportunity to show that carrot at a whole different level. Uh, it would allow them to innovate and be a leader in something as, uh, as our friend Jim Hancock will say, you know. Jay Kopelman: When he went to the Naval Academy, they had the world's best shipbuilding program. Why doesn't the VA have the world's best care program for things like TBI and PTSD, which affects, you know, 40 something percent of all veterans, right? So, so there's, there's an opportunity here for the VA to lead from the front. Jay Kopelman: Um, the, these medicines provide, you know, reasonably lasting care where it's kind of a one and done. Whereas with the current systems, the, you know, and, and [00:14:00] again, not to denigrate the VA in any way, they're doing the best job they can with the tools in their toolbox, right? But maybe it's time for a trip to Home Depot. Jay Kopelman: Let's get some new tools. And have some new ways of fixing what's broken, which is really the way of doing things. It's not, veterans aren't broken, we are who we are. Um, but it's a, it's a way to fix what isn't working. So I, I think that, you know, given there's tremendous veteran homelessness still, you know, addiction issues, all these things that do translate to the population at large are things that can be worked on in this one system, the va that can then be shown to have efficacy, have good data, have [00:15:00] good outcomes, and, and take it to the population at large. Joe Moore: Mm-hmm. Brilliant. Thanks for that. And so there was another thing I wanted to pivot to, which is some of the recent press. So we've, um, seen a little bit of press around some, um, in one instance, some bad behavior in Mexico that a FI put out Americans thrive again, put out. And then another case there was a, a recent fatality. Joe Moore: And I think, um, both are tragic. Like we shouldn't be having to deal with this at this point. Um, but there's a lot of things that got us here. Um, it's not necessarily the operator's fault entirely, um, or even at all, honestly, like some medical interventions just carry a lot of risk. Like think, think about like, uh, how risky bypass surgery was in the nineties, right? Joe Moore: Like people were dying a lot from medical interventions and um, you know, this is a major intervention, uh, ibogaine [00:16:00] and also a lot of promise. To help people quite a bit. Um, but as of right now, there's, there's risk. And part of that risk, in my opinion, comes from the inability of organizations to necessarily collaborate. Joe Moore: Like there's no kind of convening body, sitting in the middle, allowing, um, for, and facilitating really good data sharing and learnings. Um, and I don't, I don't necessarily see an organization stepping up and being the, um, the convener for that kind of work. I've heard rumors that something's gonna happen there, and I'm, I'm hopeful I'll always wanna share my opinion on that. Joe Moore: But yeah. I don't know. Jay, from your perspective, is there anything you want to kind of speak to about, uh, these two recent incidents that Americans for Iboga kind of publicized recently? Jay Kopelman: Yeah, so I, I'll echo your sentiment, of course, that these are tragic incidents. Um, and I, [00:17:00] I think that at least in the case of the death at Ambio, AMBIO has done a very good job of talking about it, right? Jay Kopelman: They've been very honest with the information that they have. And like you said, there are risks inherent to these medicines, and it's like anything else in medicine, there are going to be risks. You know, when I went through, uh, when I, when I went through chemo, you know, there were, there are risks. You know, you don't feel well, you get sick. Jay Kopelman: Um, and, and it. There are processes in place to counter that when it happens. And there are processes and, and procedures and safety protocols in place when caring for somebody going through an ibogaine [00:18:00] journey. Uh, when I did it, we had EKG echocardiogram. You're on a heart monitor the entire time they push magnesium via iv. Jay Kopelman: You have to provide a urinalysis sample to make sure that there is nothing in your system that is going to potentially harm you. During the ibogaine, they have, uh, a cardiologist who is monitoring the heart monitors throughout the ibogaine experience. So the, the safety protocols are there. I think it's, I think it's just a matter of. Jay Kopelman: Standardizing them across all, all providers, right? Like, that would be a good thing if people would talk to one another. Um, as, as in any system, right? You've gotta have [00:19:00] some collaboration. You've gotta have standardization, you know, so, you know, they're not called standard operating procedures for nothing. Jay Kopelman: That means that in a, you know, in a given environment, everybody does things the same way. It's true in Navy and Marine Corps, air Force, army Aviation, they have standard operating procedures for every single aircraft. So if you fly, let's say the F 35 now, right? Because it's flown by the Navy, the Marine Corps, and the Air Force. Jay Kopelman: The, the emergency procedures in that airplane are standardized across all three services, so you should have the same, or, you know, with within a couple of different words, the same procedures and processes [00:20:00] across all the providers, right? Like maybe in one document you're gonna change, happy to glad and small dog to puppy, but it's still pretty much the, the same thing. Jay Kopelman: And as a service that provides scholarships to people to go access these medicines and go to these retreats, you know, my criteria is that the, this provider has to be safe. Number one, safety's paramount. It's always gotta be very safe. It should, it has to be effective. And you know, once you have those two things in place, then I have a comfort level saying, okay, yeah, we'll work with this provider. Jay Kopelman: But until those standardized processes are in place, you'll probably see these one-off things. I mean, some providers have been doing this longer than others and have [00:21:00] really figured out, you know, they've, they've cracked the code and, you know, sharing that across the spectrum would be good. Um, but just when these things happen, having a clearing house, right, where everybody can come together and talk about it, you know, like once the facts are known because. Jay Kopelman: To my knowledge, we still don't know all the facts. Like as, you know, as horrible as this is, you still have to talk about like an, has an autopsy been performed? What was found in the patient's system? You know, there, there are things there that we don't know. So we need to, we need to know that before we can start saying, okay, well this is how we can fix that, because we just don't know. Jay Kopelman: And, you know, to their credit, you know, Amio has always been safe to, to the, to the best of my knowledge. You know, I, [00:22:00] I haven't been to Ambio myself, but people that I have worked with have been there. They have observed, they have seen the process. They believe it's safe, and I trust their opinion because they've seen it elsewhere as well. Jay Kopelman: So yeah, having, having that one place where we can all come together when this happens, it, it's almost like it should be mandatory. In the military when there's a training accident, we, you know, we would have to have what's called a safety standout. And you don't do that again for a little while until you figure out, okay, how are we going to mitigate that happening again? Jay Kopelman: Believe me, you can go overboard and we don't want to do that. Like, we don't wanna just stop all care, but maybe stop detox for a week and then come back to it. [00:23:00] Joe Moore: Yeah. A dream would be, let's get like the, I don't know, 10, 20 most popular, uh, or well-known operators together somewhere and just do like a three day debrief. Joe Moore: Hey, everybody, like, here's what we see. Let's work on this together. You know how normal medicine works. And this is, it's hard because this is not necessarily, um, something people feel safe about in America talking about 'cause it's illicit here. Um, I don't understand necessarily how the operations, uh, relate to each other in Mexico, but I think that's something to like the public should dig into. Joe Moore: Like, what, what is this? And I, I'll start digging into that. Um, I, I asked a question recently of somebody like, is there some sort of like back channel signal everybody's using and there's no clear Yes. You know? Um, I think it would be good. That's just a [00:24:00] start, you know, that's like, okay, we can actually kind of say hi and watch out for this to each other. Jay Kopelman: It's not like we don't all know one another, right? Joe Moore: Yes. Jay Kopelman: Like at least three operators we're represented. At the Aspen Ibogaine meeting. So like that could be, and I think there was a panel kind of loosely related to this during Aspen Ibogaine meeting, but Joe Moore: mm-hmm. Jay Kopelman: It, you know, have a breakout where the operators can go sit down and kind of compare notes. Joe Moore: Right. Yeah. Melissa, do you have any, uh, comments on this thread here? And I, I put you on mute if you didn't see that. Um, Melissa Lavasani: all right, I'm off mute. Um, yeah, I think that Jay's hits the nail on the head with the collaboration thing. Um, I think that it's just a [00:25:00] problem across the entire ecosystem, and I think that's just a product of us being relatively new and upcoming field. Melissa Lavasani: Um, uh, it's a product of, you know. Our fundraising community is really small, so organizations feel like they are competing for the same dollars, even though their, their goals are all the same, they have different functions. Um, I think with time, I mean, let's be honest, like if we don't start collaborating and, and the federal government's moving forward, the federal government's gonna coordinate for us. Melissa Lavasani: And not, that might not necessarily be a bad thing, but, you know, we understand this issue to a whole other level that the federal government doesn't, and they're not required to understand it deeply. They just need to know how to really move forward with it the proper way. Um, but I think that it. It's really essential [00:26:00] that we all have this come together moment here so we can avoid things. Melissa Lavasani: Uh, I mean, no one's gonna die from bad advocacy. So like I've, I have a bit of an easier job. Um, but it can a, a absolutely stall efforts, um, to move things forward in Washington DC when, um, one group is saying one thing, another group is saying another thing, like, we're not quite at a point yet where we can have multiple lines of conversation and multiple things moving forward. Melissa Lavasani: Um, you know, for PMC, it's like, just let's get the first thing across the finish line. And we think that is, um, veteran healthcare. And, um, I know there's plenty of other groups out there that, that want the same thing. So, you know, I always, the reason why I put on the Federal Summit last year was I kind of hit my breaking point with a lack of collaboration and I wanted to just bring everyone in the same room and say like, all right, here are the things that we need to talk about. Melissa Lavasani: And I think the goal for this year is, um. To bring people in the same room and say, we talked about [00:27:00] we scratched the surface last year and this is where we need to really put our efforts into. And this is where the opportunities are. Um, I think that is going to, that's going to show the federal government if we can organize ourselves, that they need to take this issue really seriously. Melissa Lavasani: Um, I don't think we've done a great job at that thus far, but I think there's still plenty of time for us to get it together. Um, and I'm hoping with these two, uh, VA bills that are in the house right now and Senate is, is putting together their version of these two bills, um, so that they can move in tandem with each other. Melissa Lavasani: I think that, you know, there's an opportunity here for. Us to show the federal government as an ecosystem, Hey, we, we are so much further ahead and you know, this is what we've organized and here's how we can help you, um, that would make them buy into this issue a bit more and potentially move things forward faster. Melissa Lavasani: Uh, at this point in time, it's, I think that, [00:28:00] you know, psychedelics aren't necessarily the taboo thing that they, they used to be, but there's certainly places that need attention. Um, there's certainly conversations that need to be had, and like I said, like PMC is just one organization that can do this. Um, we can certainly organize and drive forward collaboration, but I, like we alone, cannot cover all this ground and we need the subject matter experts to collaborate with us so we can, you know, once we get in the door, we wanna bring the experts in to talk to these officials about it. Melissa Lavasani: So I. I, I really want listeners to really think about us as a convener of sorts when it comes to federal policy. Um, and you know, I think when, like for example, in the early eighties, a lot of people have made comparisons to the issue of psychedelics to the issue of AIDS research and how you have in a subject matter that's like extremely taboo and a patient population that the government [00:29:00] quite honestly didn't really care about in the early eighties. Melissa Lavasani: But what they did as an ecosystem is really organized themselves, get very clear on what they wanted the federal government to do. And within a matter of a couple years, uh, AIDS research funding was a thing that was happening. And what that, what that did was that ripple effect turned that into basically finding new therapies for something that we thought was a death, death sentence before. Melissa Lavasani: So I think. We just need to look at things in the past that have been really successful, um, and, and try to take the lessons from all of these issues and, and move forward with psychedelics. Joe Moore: Love that. And yes, we always need to be figuring out efficient approaches and where it has been successful in the past is often, um, an opportunity to mimic and, and potentially improve on that. Melissa Lavasani: Yeah. Jay Kopelman: One, one thing I think it's important to add to this part of the conversation is that, [00:30:00] you know, Melissa pointed out there are a number of organizations that are essentially doing the same thing. Jay Kopelman: Um, you know, I like to think we do things a little bit differently at Mission within Foundation in that we don't target any one specific type of service member. We, we work with all veterans. We work with first responders, but. What that leads to is that there are, as far as I've seen, nothing but good intentioned people in this space. Jay Kopelman: You know, people who really care about their patient population, they care about healing, they are trying to do a good job, and more importantly, they're trying to do good. Right? It, it, I think they all see the benefit down the road that this has, [00:31:00] pardon me, not just for veterans, but for society as a whole. Jay Kopelman: And, and ultimately that's where I would like to see this go. You know, I, I would love to see the VA take this. Take up this mantle and, and run with it and provide great data, great outcomes. You know, we are doing some data collection ourselves at Mission within foundation, albeit anecdotal based on surveys given before and after retreats. Jay Kopelman: But we're also working with, uh, Greg Fonzo down at UT Austin on a brain study he's doing that will have 40 patients in it when it's all said and done. And I think we have two more guys to put through that. Uh, and then we'll hit the 40. So there, there's a lot of good here that's being done by some really, really good people who've been doing this for a long time [00:32:00] and want to want nothing more than to, to see this. Jay Kopelman: Come to, come full circle so that we can take care of many, many, many people. Um, you know, like I say, I, I wanna work myself out of a job here. I, I just, I would love to see this happen and then I, you know, I don't have to send guys to Mexico to do this. They can go to their local VA and get the care that they need. Jay Kopelman: Um, but one thing that I don't think we've touched on yet, or regarding that is that the VA isn't designed for that. So it's gonna be a pretty big lift to get the right types of providers into the va with the knowledge, right, with the institutional knowledge of how this should be done, what is safe, what is effective, um, and then it, it's not just providing these medicines to [00:33:00] people and sending them home. Jay Kopelman: You don't just do that, you've gotta have the right therapists on the backend who can provide the integration coaching to the folks who are receiving these medicines. And I'm not just talking, I bga, even with MDMA and psilocybin, you should have a proper period of integration. It helps you to understand how this is going to affect you, what it, what the experience really meant, you know, because it's very difficult sometimes to just interpret it on your own. Jay Kopelman: And so what the experience was and what it meant to you. And, and so it will take some time to spin all that up. But once it's, once it's in place, you know, the sky's the limit. I think. Joe Moore: Kinda curious Jay, about what's, what's going on with Ibogaine at the federal level. Is there anything at VA right now? [00:34:00] Jay Kopelman: At the va? No, not with ibogaine. And, you know, uh, we, we send people specifically for IBOGAINE and five MEO, right? And, and so that, that doesn't preclude my interest in seeing this legislation passed, right? Jay Kopelman: Because it, it will start with something like MDMA or psilocybin, but ultimately it could grow to iboga, right? It the think about the cost savings at, at the va, even with psilocybin, right? Where you could potentially treat somebody with a very inexpensive dose of psilocybin or, or iboga one time, and then you, you don't have to treat them again. Jay Kopelman: Now, if I were, uh, you know, a VA therapist who's not trained in psychedelic trauma therapy. I might be worried [00:35:00] about job security, but it's like with anything, right? Like ultimately it will open pathways for new people to get that training or the existing people to get that training and, and stay on and do that work. Jay Kopelman: Um, which only adds another arrow to their quiver as far as I'm concerned, because this is coming and we're gonna need the people. It's just like ai, right? Like ai, yeah. Some people are gonna lose some jobs initially, and that's unfortunate. But productivity ultimately across all industries will increase and new jobs will be created as a result of that. Jay Kopelman: I mean, I was watching Squawk Box one morning. They were talking about the AI revolution and how there's gonna be a need for 500,000 electricians to. Build these systems that are going to work with the AI [00:36:00] supercomputers and, and so, Joe Moore: mm-hmm. Jay Kopelman: Where, where an opportunity may be lost. I think several more can be gained going forward. Melissa Lavasani: And just to add on what Jay just said there, there's nothing specific going on with Ibogaine at, at the va, but I think this administration is, is taking a real look at addiction in particular. Uh, they just launched, uh, a new initiative, uh, that's really centered on addiction treatments called the Great American Recovery. Melissa Lavasani: And, um, they're dedicating a hundred million dollars towards treating addiction as like a chronic treatable disease and not necessarily a law enforcement issue. So, um, in that initiative there will be federal grant programs for prevention and treatment and recovery. And, um, while this isn't just for psychedelic medicines, uh, I think it's a really great opportunity for the discussion of psychedelics to get elevated to the White House. Melissa Lavasani: Um, [00:37:00] there's also, previous to this announcement last week from the White House, there's been a hundred million dollars that was dedicated at, um, at ARPA h, which is. The advanced research projects, uh, agency for healthcare, um, and that is kind of an agency that's really focused on forward looking, um, treatments and technologies, uh, for, um, a, a whole slew of. Melissa Lavasani: Of issues, but this a hundred million dollars is dedicated to mental health and addiction. So there's a lot of opportunity there as well. So we, while I think, you know, some people are talking about, oh, we need a executive order on Iboga, it's like, well, you know, the, the president is thinking, um, about, you know, what issues can land with his, uh, voting block. Melissa Lavasani: And I think it's, I don't think we necessarily need a specific executive order on Iboga to call this a success. It's like, let's look at what, [00:38:00] um, what's just been announced from the White House. They're, they're all in on. Thinking creatively and finding, uh, new solutions for this. And this is kind of, this aligns with, um, HHS secretaries, uh, Robert F. Melissa Lavasani: Kennedy Junior's goals when he took on this, this role of Health Secretary. Um, addiction has been a discussion that, you know, he has personal, um, a personal tie to from his own experience. And, um, I think when this administration started, there was so much like fervor around the, the dialogue of like, everyone's talking about psychedelics. Melissa Lavasani: It was Secretary Kennedy, it was, uh, secretary Collins at the va. It was FDA Commissioner Marty Macari. And I think that there's like a lot of undue frustration within folks 'cause um, you don't necessarily snap your fingers and change happens in Washington dc This is not the city for that. And it's intentionally designed to move slow so that we can avoid really big mistakes. Melissa Lavasani: Um. [00:39:00] I think we're a year into this administration and these two announcements are, are pretty huge considering, um, you know, the, we, there are known people within domestic policy council that don't, aren't necessarily supportive of psychedelic medicine. So there's a really amazing progress here, and frustrating as it might be to, um, just be waiting for this administration to make some major move. Melissa Lavasani: I think they are making major moves like for Washington, DC These, these are major moves and we just gotta figure out how we can, um, take these initiatives and apply them to the issue of psychedelic medicines. Joe Moore: Thanks, Melissa. Um, yeah, it is, it is interesting like the amount of fervor there was at the beginning. You know, we had, uh. Kind of one of my old lawyers, Matt Zorn, jumped in with the administration. Right. And, um, you know, it was, uh, really cool to [00:40:00] see and hopeful how much energy was going on. It's been a little quiet, kind of feels like a black box a little bit, but I, you know, there was, Melissa Lavasani: that's on me. Melissa Lavasani: Maybe I, we need to be more out in public about like, what's actually happening, because I feel like, like day in and day out, it's just been, you gotta just mm-hmm. Like have that constant beat with the government. Mm-hmm. And, um, it's, it's, it's not the photo ops on the hill, it's the conversations that you have. Melissa Lavasani: It's the dinner parties you go to, it's the fundraisers you attend, you know? Mm-hmm. That's why I, I kind of have to like toot my own horn with PCs. Like, we need to be present here at, at not only on the Hill, not only at the White House, but kind of in the ecosystem of Washington DC itself. There's, it's, there are like power players here. Melissa Lavasani: There are people that are connected that can get things done, like. I mean, the other last week we had a big snow storm. I walked over to my friend's house, um, to have like a little fire sesh with them and our kids, and his next door neighbor came over. He was a member of Congress. I talked about the VA bills, like [00:41:00] we're reaching out to his office now, um, to get them, um, up to speed and hopefully get their co-sponsorship for, uh, the two VA bills. Melissa Lavasani: So, I mean, it, the little conversations you have here are just as important as the big ones with the photo ops. So, um, it, it's, it's really like, you know, building up that momentum and, and finding that time where you can really strike and make something happen. Joe Moore: Mm-hmm. Yeah. Jay, anything to add there? Jay Kopelman: Yeah, I was just gonna say that, you know, I, I, I think the fervor is still there, right? Jay Kopelman: But real life happens. Melissa Lavasani: Yes, Jay Kopelman: yes. And gets in the way, right? So, Melissa Lavasani: yeah, Jay Kopelman: I, I can't imagine how many issues. Secretary Kennedy has every day much less the president. Like there's so many things that they are dealing with on a daily basis, right? It, we, we just have to work to be the squeaky wheel in, in the right way, right. Jay Kopelman: [00:42:00] With the, with the right information at the right time. Like just inundating one of these organizations with noise, it's then it be with Informa, it just becomes noise, right? It it, it doesn't help. So when we have things to say that are meaningful and impactful, we do, and Melissa does an amazing job of that. Jay Kopelman: But, you know, it, it takes time. You know, it's, you know, we're not, this is, this is like turning an aircraft carrier, not a ski boat. Melissa Lavasani: Yeah, Joe Moore: yeah, absolutely. Um, and. It's, it's understandably frustrating, I think for the public and the psychedelic public in particular because we see all this hope, you know, we continue to get frustrated at politics. It's nothing new, right? Um, and we, we wanna see more people get well immediately. [00:43:00] And I, I kind of, Jay from the veteran perspective, I do love the kind of loud voices like, you're making me go to Mexico for this. Joe Moore: I did that and you're making me leave the country for the thing that's gonna fix me. Like, no way. And barely a recognition that this is a valid treatment. You know, like, you know, that is complicated given how medicine is structured here domestically. But it's also, let's face the facts, like the drug war kind of prevented us from being able to do this research in the first place. Joe Moore: You know? Thanks Nixon. And like, how do we actually kind of correct course and say like, we need to spend appropriately on science here so we can heal our own people, including veterans and everybody really. It's a, it's a dire situation out there. Jay Kopelman: Yeah. It, it really is. Um, you know, we were talking briefly about addicts, right? Jay Kopelman: And you know, it's not sexy. People think of addicts as people who are weak-minded, [00:44:00] right? They don't have any self-control. Um, but, but look at, look at the opioid crisis, right? That Brian Hubbard was fighting against in Kentucky for all those years. That that was something that was given to the patient by a doctor that they then became dependent on, and a lot of people died from that. Jay Kopelman: And, and so you, you know, it's, I I don't think it's fair to just put all addicts in a box. Just like it's not fair to put all veterans in a box. Just like it's not fair for doctors, put all their patients in a box. We're individuals. We, we have individual needs. Our, our health is very individual. Like, I, I don't think I should be put in the same box as every other 66-year-old that my doctor sees. Jay Kopelman: It's not fair. [00:45:00] You know, if you, if you took my high school classmates and put us all in a photo, we're all gonna have different needs, right? Like, some look like they're 76, not 66. Some look like they're 56. Not like they're, we, we do things differently. We live our lives differently. And the same is true of addicts. Jay Kopelman: They come to addiction from different places. Not everybody decides they want to just try heroin at a party, and all of a sudden they're addicted. It happens in, in different ways, you know, and the whole fentanyl thing has been so daggum nefarious, right? You know, pushing fentanyl into marijuana. Jay Kopelman: Somebody's smoking a joint and all of a sudden they're addicted to fentanyl or they die. Melissa Lavasani: I think we're having a, Jay Kopelman: it's, it's just not fair to, to say everybody in this pot is the same, or everybody in this one is the same. We have [00:46:00] to look at it differently. Joe Moore: Yeah. I like to zoom one level out and kind of talk about, um, just how hurt we are as a country, as a world really, but as a country specifically, and how many people are out of work for so many. Joe Moore: Difficult reasons and away from their families for so many kind of tragic reasons. And if we can get people back to their families and back to work, a lot of these things start to self-correct, but we have to like have those interventions where we can heal folks and, and get them back. Um, yeah. And you know, everything from trauma, uh, in childhood, you know, adulthood, combat, whatever it is. Joe Moore: Like these things can put people on the sidelines. And Jay, to your point, like you get knee surgery and all of a sudden you're, you know, two years later you're on the hunt for Fentanyl daily. You know, that's tough. It's really tough. Carl Hart does a good job talking about this kind of addiction pipeline and [00:47:00] a few others do as well. Joe Moore: But it's just, you know, kind of putting it in a moral failure bucket. It's not great. I was chatting with somebody about, um, veterans, it's like you come back and you're like, what's gonna make me feel okay right now? And it's not always alcohol. Um, like this is the first thing that made me feel okay, because there's not great treatments and there's, there's a lot of improvements in this kind of like bringing people back from the field that needs to happen. Joe Moore: In my opinion. I, it seems to be shared by a lot of people, but yeah, there's, it's, it's, IGA is gonna be great. It's gonna be really important. I really can't wait for it to be at scale appropriately, but there's a lot of other things we need to fix too, um, so that we can just, you know, not have so many people we need to, you know, spend so much money healing. Joe Moore: Mm-hmm. Jay Kopelman: Yeah. You ahead with that. We don't need the president to sign an executive order to automatically legalize Ibogaine. Right. But it would be nice if he would reschedule it so that [00:48:00] then then researchers could do this research on a larger scale. You know, we could, we could now get some real data that would show the efficacy. Jay Kopelman: And it could be done in a safe environment, you know? And, and so that would be, do Joe Moore: you have any kind of figures, like, like, I've been talking about this for a while, Jay. Like, does it drop the cost a lot of doing research when we deschedule things? Jay Kopelman: I, I would imagine so, because it'll drop the cost of accessing the medicines that are being researched. Jay Kopelman: Right? You, you would have buy-in from more organizations. You know, you might even have a pharma company that comes into this, you know, look at j and j with the ketamine, right? They have, they have a nasal spray version of ketamine that's doing very well. I mean, it's probably their, their biggest revenue [00:49:00] provider for them right now. Jay Kopelman: And, and so. You know, you, it would certainly help and I think, I think it would lower costs of research to have something rescheduled rather than being schedule one. You know it, people are afraid to take chances when you're talking about Schedule one Melissa Lavasani: labs or they just don't have the money to research things that are on Schedule one. Melissa Lavasani: 'cause there's so much in an incredible amount of red tape that you have to go through and, and your facility has to be a certain way and how you contain those, uh, medicines. Oh, researching has to be in a specific container and it's just very cumbersome to research schedule one drugs. So absolutely the cost would go down. Melissa Lavasani: Um, but Joe Moore: yeah, absolutely. Less safes. Melissa Lavasani: Yeah. Joe Moore: Yes. Less uh, Melissa Lavasani: right. Joe Moore: Locked. Yeah. Um, it'll be really interesting when that happens. I'm gonna hold out faith. That we can see some [00:50:00] movement here. Um, because yeah, like why make healing more expensive than it needs to be? I think like that's potentially a protectionist move. Joe Moore: Like, I'm not, I'm not here yet, but, um, look at AbbVie's, uh, acquisition of the Gilgamesh ip. Mm-hmm. Like that's a really interesting move. I think it was $1.2 billion. Mm-hmm. So they're gonna wanna protect that investment. Um, and it's likely going to be an approved medication. Like, I don't, I don't see a world in which it's not an approved medication. Joe Moore: Um, you know, I don't know a timeline, I would say Jay Kopelman: yeah. Joe Moore: Less than six years, just given how much cash they've got. But who knows, like, I haven't followed it too closely. So, and that's an I bga derivative to be clear, everybody, um mm-hmm. If you're not, um, in, in the loop on that, which is hopeful, you know? Joe Moore: Mm-hmm. But I don't know what the efficacy is gonna be with that compared to Ibogaine and then we have to talk about the kind of proprietary molecule stuff. Um, there's like a whole bunch of things that are gonna go on here, and this is one of the reasons why I'm excited about. Federal involvement [00:51:00] because we might actually be able to have some sort of centralized manufacturer, um, or at least the VA could license three or four generic manufacturers per for instance, and that way prices aren't gonna be, you know, eight grand a dose or whatever. Joe Moore: You know, it's, Jay Kopelman: well, I think it's a very exciting time in the space. You know, I, I think that there's the opportunity for innovation. There is the opportunity for collaboration. There's the opportunity for, you know, long-term healing at a very low cost. You know, that we, we have the highest healthcare cost per capita in the world right here in the us. Jay Kopelman: And, and yet we are not the number one health system in the world. So to me, that doesn't add up. So we need to figure out a way to start. Bringing costs down for a lot of people and [00:52:00] at the same time increasing, increasing outcomes. Joe Moore: Absolutely. Yeah. There's a lot of possible outcome improvements here and, and you know, everything from relapse rates, like we hear often about people leaving a clinic and they go and overdose when they get home. Tragically, too common. I think there's everything from, you know, I'm Jay, I'm involved in an organization called the Psychedelics and Pain Association. Joe Moore: We look at chronic pain very seriously, and IGA is something we are really interested in. And if. We could have better, you know, research, there better outcome measures there. Um, you know, perhaps we can have less people on opioids to begin with from chronic pain conditions. Um, Jay Kopelman: yeah, I, I might be due for another Ibogaine journey then, because I deal with chronic pain from Jiujitsu, but, Joe Moore: oh gosh, let's Jay Kopelman: talk Joe Moore: later. Jay Kopelman: That's self inflicted. Some people would say take a month off, but Melissa Lavasani: yeah, Jay Kopelman: I'm [00:53:00] not, I'm not that smart. Joe Moore: Yeah. Um, but you know, this, uh, yeah, this whole thing is gonna be really interesting to see how it plays out. I'm endlessly hopeful pull because I'm still here. Right. I, I've been at this for almost 10 years now, very publicly, and I think we are seeing a lot of movement. Joe Moore: It's not always what we actually wanna see, but it is movement nonetheless. You know, how many people are writing on this now than there were before? Right. You know, we, we have people in New York Times writing somewhat regularly about psychedelics and. Even international media is covering it. What do we have legalization in Australia somewhat recently for psilocybin and MDMA, Czech Republic. Joe Moore: I think Germany made some moves recently. Mm-hmm. Um, really interesting to see how this is gonna just keep shifting. Um Jay Kopelman: mm-hmm. Joe Moore: And I think there's no way that we're not gonna have prescription psychedelics in three years in the United States. It pro probably more like a [00:54:00] year and a half. I don't know. Do you, are you all taking odds? Melissa Lavasani: Yeah. I mean, I think Jay Kopelman: I, I gotta check Cal sheet, see what they're saying. Melissa Lavasani: I think it's safe to say, I mean, this could even come potentially the end of this year, I think, but definitely by the end of 2027, there's gonna be at least one psychedelic that's FDA approved. Joe Moore: Yeah. Yeah. Melissa Lavasani: If you're not counting Ketamine. Joe Moore: Right. Jay Kopelman: I, I mean, I mean it mm-hmm. It, it doesn't make sense that it. Shouldn't be or wouldn't be. Right. The, we've seen the benefits. Mm-hmm. We know what they are. It's at a very low cost, but you have to keep in mind that these things, they need to be done with the right set setting and container. Right. And, and gotta be able to provide that environment. Jay Kopelman: So, but I would, I would love, like I said, I'd love to work myself out of a job here and see this happen, not just for our veterans, [00:55:00] but for everybody. Joe Moore: Mm-hmm. Um, so Melissa, is there a way people can get involved or follow PMC or how can they support your work at PMC? Melissa Lavasani: Yeah, I mean, follow us in social media. Melissa Lavasani: Um, our two biggest platforms are LinkedIn and Instagram. Um, I'm bringing my newsletter back because I'm realizing, um, you know, there is a big gap in, in kind of like the knowledge of Washington DC just in general. What's happening here, and I think, you know, part of PC's value is that we're, we are plugged into conversations that are being had, um, here in the city. Melissa Lavasani: And, you know, we do get a little insight. Um, and I think that that would really quiet a lot of, you know, the, a lot of noise that, um, exists in the, our ecosystem. If, if people just had some clarity on like, what's actually happening or happening here and what are the opportunities and, [00:56:00] um, where do we need more reinforcement? Melissa Lavasani: Um, and, and also, you know, as we're putting together public education campaign, you know. My, like, if I could get everything I wanted like that, that campaign would be this like multi-stakeholder collaborative effort, right? Where we're covering all the ground that we need to cover. We're talking to the patient groups, we're talking to traditional mental health organizations, we're talking to the medical community, we're talking to the general population. Melissa Lavasani: I think that's like another area that we, we just seem to be, um, lacking some effort in. And, you know, ultimately the veteran story's always super compelling. It pulls on your heartstrings. These are our heroes, um, of our country. Like that, that is, that is meaningful. But a lot of the veteran population is small and we need the, like a, the just.[00:57:00] Melissa Lavasani: Basic American living in middle America, um, understanding what psychedelics are so that in, in, in presenting to them the stories that they can relate to, um, because that's how you activate the public and you activate the public and you get them to see what's happening in these clinical trials, what the data's been saying, what the opportunities are with psychedelics, and then they start calling their members of Congress and saying, Hey, there is this. Melissa Lavasani: Bill sitting in Congress and why haven't you signed onto it? And that political pressure, uh, when used the right way can be really powerful. So, um, I think, you know, now we're at this really amazing moment where we have a good amount of congressional offices that are familiar enough with psychedelics that they're willing to move on it. Melissa Lavasani: Um, there's another larger group, uh, that is familiar with psychedelics and will assist and co-sponsor legislation, but there's still so many offices that we haven't been able to get to just 'cause like we don't have all the time in the world and all the manpower in the world to [00:58:00] do it. But, you know, that is one avenue is like the advocates can speak to the, the lawmakers, the experts speak to the lawmakers, and we not, we want the public engaged in this, you know, ultimately, like that's. Melissa Lavasani: Like the best form of harm reduction is having an informed public. So we are not, they're not seeing these media headlines of like, oh, this miracle cure that, um, saved my family. It's like, yes, that can happen psychedelics. I mean, person speaking personally, psychedelics did save my family. But what you miss out of that story is the incredible amount of work I put into myself and put into my mental health to this day to maintain, um, like myself, my, my own agency and like be the parent that I wanna be and be the spouse that I wanna be. Melissa Lavasani: So, um, we, we need to continue to share these stories and we need to continue to collaborate to get this message out because we're all, we're all in the same boat right now. We all want the same things. We want patients to have safe and [00:59:00] affordable access to psychedelic assisted care. Um, and, uh. We're just in the beginning here, so, um, sign up for our newsletter and we can sign up on our website and then follow us on social media. Melissa Lavasani: And, um, I anticipate more and more events, um, happening with PMC and hopefully we can scale up some of these events to be much more public facing, um, as this issue grows. So, um, I'm really excited about the future and I'm, I've been enjoying this partnership with Mission Within. Jay is such a professional and, and it really shows up when he needs to show up and, um, I look forward to more of that in the future. Joe Moore: Fantastic. And Jay, how can people follow along and support mission within Foundation? Jay Kopelman: Yeah, again, social media is gonna be a good way to do that. So we, we are also pretty heavily engaged on LinkedIn and on Instagram. Um, I do [01:00:00] share, uh, a bit of my own stuff as well. On social media. So we have social media pages for Mission within Foundation, and we have a LinkedIn page for mission within foundation. Jay Kopelman: I have my own profiles on both of those as well where people can follow along. Um, one of the other things you know that would probably help get more attention for this is if the general public was more aware of the numbers of professional athletes who are also now pursuing. I began specifically to help treat their traumatic brain injuries and the chronic traumatic encephalopathy that they've, uh, suffered as a result of their time in professional sports or even college sports. Jay Kopelman: And, you know. I people worship these athletes, and I [01:01:00] think that if more of them, like Robert Gall, were more outspoken about these treatments and the healing properties that they've provided them, that it would get even more attention. Um, I think though what Melissa said, you know, I don't wanna parrot anything she just said because she said it perfectly Right. Jay Kopelman: And I'd just be speaking to hear myself talk. Um, but being collaborative the way that we are with PMC and with Melissa is I think, the way to move the needle on this overall. And like she said, if she could get more groups involved in, in these discussions, it would, it would do wonders for us. Joe Moore: Well, thank you both so much for your hard work out there. I always appreciate it when people are showing up and doing this important, [01:02:00] sometimes boring and tedious, but nevertheless sometimes, sometimes exciting work. And um, so yeah, just thank you both and thank you both for showing up here to psychedelics today to join us and I hope we can continue to support you all in the future. Jay Kopelman: Thank you, Joe. Thank you, Joe. It's a pleasure being with you today and with Melissa, of course, always Melissa Lavasani: appreciate the time and space. Joe Moore: Thanks.
Howie Kurtz on Former Prince Andrew being arrested on allegations of sharing UK trade secrets with Jeffrey Epstein, the partial government shutdown impacting FEMA's disaster recovery efforts, and the FDA's decision to review Moderna's application for an mRNA-based flu vaccine. Learn more about your ad choices. Visit podcastchoices.com/adchoices
The EV-303 trial that led to the FDA approval of perioperative enfortumab vedotin + pembrolizumab in cisplatin-ineligible bladder cancer patients in now published in NEJM. We discuss the results and ponder potential future changes to treating bladder cancer in the future. Urinary diversion surgeries: https://jamanetwork.com/journals/jamaoncology/fullarticle/2842595
Welcome to Episode 295 of Autism Parenting Secrets.This week, we shine a light on one of the most misunderstood and often controversial therapies in the autism world: medical cannabis.My guest is Dr. David Berger, known to many simply as Dr. David.He's a board-certified pediatrician with over 25 years of clinical experience.He's the founder of Wholistic Pediatrics & Family Care in Tampa, Florida, where he helps children and adults address root causes behind challenges like autism, ADHD, and immune dysfunction.He's also the founder of Wholistic ReLeaf, Florida's first pediatric medical cannabis clinic, where he's guided countless families in using cannabis-based therapies safely, responsibly, and with clear medical oversight.Dr. David brings both compassion and clarity to this conversation, helping parents understand how cannabis can support calm, focus, and balance when used appropriately as part of a broader, integrative approach.We dive into the science, the misconceptions, and the real-world application of using cannabis as medicine, along with what every parent should understand before considering this option.The secret this week is… Cannabis Is Medicine - If You Know How To Use ItYou'll Discover:How A Personal Family Experience With CBD Sparked Dr. Berger's Clinical Use Of Cannabis (2:12)What Every Parent Should Understand About The Endocannabinoid System And Why It Matters (9:00)How Different Cannabinoids (CBD, CBG, CBN, THC) Serve Very Different Therapeutic Purposes (11:42)The Research Showing Endocannabinoid Deficiency In Children With Autism (14:39)Why Many Children Respond Quickly And How To Introduce Cannabis Safely And Responsibly (18:58)About Our Guest:Dr. David Berger is a board-certified pediatrician with over 25 years of clinical experience and a national reputation for his integrative approach to family and pediatric care. He is the founder of Wholistic Pediatrics & Family Care and Wholistic ReLeaf, Florida's first pediatric medical cannabis clinic. His practice specializes in autism, ADHD, allergies, immune dysfunction, and chronic complex conditions, combining nutritional, lifestyle, and biomedical therapies to address root causes. A leading voice in the responsible use of medical cannabis for children, Dr. Berger is one of only a few pediatricians in Florida qualified to certify patients under the age of 18. He has also advised the FDA on vaccine safety and launched DrDavidMD, a media and education platform focused on health, education, and medical choice.wholisticfamilycare.comdrdavidmd.comReferences In This Episode:Dr. David's YouTube ChannelP2I HealthAdditional Resources:To learn more about personalized 1:1 support go to www.elevatehowyounavigate.comTake The Quiz: What's YOUR Top Autism Parenting Blindspot?If you enjoyed this episode, share it with your friends.
The Food and Drug Administration agreed to begin a review of biotech company Moderna's application to make a new seasonal flu shot available. The decision comes after the FDA initially refused to review the company's application. It's a back and forth that reveals increased turmoil within the agency. WSJ's Liz Essley Whyte takes us inside the FDA's unexpected reversals and explores what's next for the mRNA flu vaccine. Jessica Mendoza hosts. Further Listening: - The FDA Commissioner on Vaccines and Public Trust - Breakfast Battle: The Cereal Industry vs MAHA Sign up for WSJ's free What's News newsletter. Learn more about your ad choices. Visit megaphone.fm/adchoices
On the DSR Daily for Wednesday, we cover politicized sewage spill in Maryland,Kristi Noem's clash with the Coast Guard, the FDA agreeing to review a new mRNA vaccine, and more. Learn more about your ad choices. Visit megaphone.fm/adchoices
Your gray hair, thinning lashes, brain fog, and that low energy feeling after 30 might all trace back to one thing: falling NAD and stressed mitochondria. This episode breaks down what actually happens inside your cells as NAD declines, and what you can do about it using specific compounds from mushrooms, olive oil, and even chocolate. -Watch this episode on YouTube for the full video experience: https://www.youtube.com/@DaveAspreyBPR -Subscribe and save $15 on Wonderfeel by going to: https://getwonderfeel.com/product/wonderfeel-youngr-nmn/?utm_source=Dave&utm_medium=podcast&utm_campaign=episode2Host Dave Asprey sits down with Baran Dilaver, CEO and co-founder of Wonderfeel Biosciences, to unpack the real science behind NAD, mitochondrial energy, and long-term longevity. Baran is an entrepreneur and inventor who previously led multiple start-ups as CEO and COO, collaborated with leading scientists and medical experts, and developed award-winning products. A UC Berkeley economics graduate and former scholarship athlete, he now focuses on translating cutting-edge bioscience into practical tools that enhance people's lives. They break down how NAD powers mitochondria, why your body strategically allocates cellular energy away from peak cognitive performance as you age, and how stress accelerates that decline. You'll hear the differences between niacinamide, NR, and NMN, the FDA confusion around NMN, and why raising NAD is about cellular repair, resilience, and metabolic function, not just “more energy.” The conversation goes deep on hydroxytyrosol, the powerful olive oil polyphenol that acts as a CD38 inhibitor, and ergothioneine, a mushroom-derived antioxidant with its own receptor in the human body that can accumulate in damaged tissues. Baran shares the origin story that pushed him to research ergothioneine, along with anecdotal observations from long-term users reporting improvements in sleep, focus, energy, thicker hair, reduced gray hair, and even eyelash regrowth. You'll also hear Dave's practical take on ketosis, fasting, supplements, and metabolism, why he prefers NAD precursors over IV NAD for most people, how methyl donors affect NAD IV tolerance, and why Wonderfeelbuilt a creatine chocolate bar sweetened with allulose to stay keto-friendly and diabetic-friendly. This is biohacking grounded in mechanism, from mitochondria and neuroplasticity to anti-aging strategy and smarter supplementation. You'll Learn: • What NAD does in the body and why oral NAD itself is not effective • How niacinamide, NR, and NMN compare as NAD precursors • Why mitochondria control energy allocation, cognition, and resilience • How hydroxytyrosol may support NAD longevity through CD38 inhibition • What ergothioneine is, why it comes from mushrooms, and why the body has a receptor for it • What long-term users commonly report: better sleep, clearer thinking, stronger energy, and cosmetic shifts • Why Dave prefers supplements over NAD IVs in most cases • How allulose differs from other sweeteners and why it matters for metabolism • Why creatine supports brain energy and how heat changes absorption strategy Thank you to our sponsors! • MASA Chips | Go to https://www.masachips.com/DAVEASPREY and use code DAVEASPREY for 25% off your first order • Branch Basics | Get 15% off at https://branchbasics.com/DAVE15 with code DAVE15 • Timeline | Go to timeline.com/Dave for 20% off• OneSkin | Try OneSkin at https://www.oneskin.co/DAVE and use code DAVE for 15% off Dave Asprey is a four-time New York Times bestselling author, founder of Bulletproof Coffee, and the father of biohacking. With over 1,000 interviews and 1 million monthly listeners, The Human Upgrade brings you the knowledge to take control of your biology, extend your longevity, and optimize every system in your body and mind. Each episode delivers cutting-edge insights in health, performance, neuroscience, supplements, nutrition, biohacking, emotional intelligence, and conscious living. New episodes are released every Tuesday, Thursday, Friday, and Sunday (BONUS). Dave asks the questions no one else will and gives you real tools to become stronger, smarter, and more resilient. Keywords: NAD supplementation, NMN benefits, NR vs NMN, nicotinamide mononucleotide, mitochondrial function, CD38 inhibition, hydroxytyrosol olive oil, ergothioneine mushrooms, mushroom antioxidant benefits, Alzheimer's prevention strategies, brain fog after 30, mitochondrial energy production, anti aging supplements, longevity compounds, fertility mitochondrial health, NAD IV vs oral NMN, creatine for brain health, allulose sweetener benefits, keto friendly chocolate, GLP 1 natural support, biohacking longevity, neuroplasticity support, metabolism optimization, fasting and NAD levels, ketosis and mitochondria, supplement regulation FDA, functional medicine longevity, Dave Asprey biohacking, Wonderfeel NMN Resources: • Wonderfeel Website: https://getwonderfeel.com/product/wonderfeel-youngr-nmn/?utm_source=Dave&utm_medium=podcast&utm_campaign=episode2• Get My 2026 Biohacking Trends Report: https://daveasprey.com/2026-biohacking-trends-report/ • Dave Asprey's Latest News | Go to https://daveasprey.com/ to join Inside Track today. • Danger Coffee: https://dangercoffee.com/discount/dave15 • My Daily Supplements: SuppGrade Labs (15% Off) • Favorite Blue Light Blocking Glasses: TrueDark (15% Off) • Dave Asprey's BEYOND Conference: https://beyondconference.com • Dave Asprey's New Book – Heavily Meditated: https://daveasprey.com/heavily-meditated • Join My Substack (Live Access To Podcast Recordings): https://substack.daveasprey.com/ • Upgrade Labs: https://upgradelabs.com Timestamps: 00:00 - Introduction 01:13 - What Is Wonderfeel 05:31 - NAD and NMN Explained 09:41 - FDA Status of NMN 13:50 - Supplements vs Pharmaceuticals 16:48 - How NAD Powers Mitochondria 25:46 - NAD Benefits and Effects 30:57 - Hydroxytyrosol 35:03 - Ergothioneine 41:55 - Alzheimer's and Brain Health 44:10 - Vitamin D and K2 46:15 - Sustainable Packaging 49:26 - Creatine Bars 51:43 - Allulose Deep Dive 59:28 - Inflammation Research 01:02:15 - Supplement Regulation See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
From FCC Chair Brendan Carr—who keeps trying to silence the political opinions of late night TV comedians, to DHS pressuring social media companies to expose anti-ICE accounts, and to the willingness of serial killer RFK, Jr and his MAHA cohort to stack up dead children so they can keep their antivax con going—it's clear the shamelessness of MAGA knows no bounds. But even if the coalition that delivered Trump's victory in ‘24 has been shattered, the Dems have to skip the seven-point policy plans and focus on the economy and Trump's corruption. And Dem candidates need to do their own tweeting. Plus, the potential legal peril for Kristi and Corey, Virginia went big and bold against Republicans on redistricting, and an homage to Jesse Jackson.Rick Wilson joins Tim Miller.show notes Will Sommer on Bannon's legal trouble with his memecoin Jonathan on the FDA's anti-vaccine agenda Rick on how the pro-democracy coalition is winning Colbert's banned interview with James Talarico Abby Phillip's book on Jesse Jackson, "A Dream Deferred" Tickets are now on sale for our LIVE shows in Dallas on March 18 and in Austin on March 19. Plus, we have a handful of seats still available for our second show in Minneapolis on February 18. TheBulwark.com/Events. Get $35 off your first box of wild-caught, sustainable seafood—delivered right to your door. Go to: https://www.wildalaskan.com/BULWARK.
Gwyneth sits down with Mike Blue—CEO of HistoSonics—to explore histotripsy, a breakthrough noninvasive ultrasound technology designed to destroy tumors without surgery, chemotherapy, or radiation. He shares the 25-year journey behind the technology, the patients already benefiting from the FDA-cleared treatment for liver tumors, and how this approach could challenge decades of invasive cancer care—signaling a profound shift toward safer, more precise treatment. To learn more about listener data and our privacy practices visit: https://www.audacyinc.com/privacy-policy Learn more about your ad choices. Visit https://podcastchoices.com/adchoices
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