Podcasts about fda

Agency of the United States Department of Health and Human Services

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    Free Talk Live
    FTL2025-12-27

    Free Talk Live

    Play Episode Listen Later Dec 28, 2025 146:05


    Trump's act of war against Venezuela - US exactly like pirates :: Trump's executive order telling the FDA to reschedule weed to a lower level :: Have ICE deaths gone up? :: ISPs may be forced to kick users off for piracy :: Trump actually stands up to EU for trying to encroach on Free Speech :: Keeping Bitcoin in a roth IRA :: TSA giving names and photos of everyone to ICE :: the Fed to end paper checks :: 2025-12-27 Hosts: Bonnie, Angelo, Mr.Penguin

    Vitality Radio Podcast with Jared St. Clair
    #599: The Hidden Epidemic Part 3: Estrogen Dominance Explained

    Vitality Radio Podcast with Jared St. Clair

    Play Episode Listen Later Dec 27, 2025 62:27


    On this episode, Jared and Jen break down one of the most misunderstood hormone issues affecting both women and men: estrogen dominance. This isn't always about having “too much estrogen”—it's about a ratio problem, driven largely by low or depleted progesterone. You'll learn how estrogen is metabolized through different liver pathways, why some forms of estrogen are far more disruptive than others, and how liver health, gut function, stress, blood sugar, and environmental exposures all shape hormone balance. The episode also explores how estrogen dominance shows up differently in women and men, why symptoms often persist even when labs look “normal,” and how modern lifestyle factors quietly stack the deck against hormonal health.Jared and Jen also take an honest look at hormonal birth control, endocrine disruptors, seed oils, and genetic factors that can impair estrogen clearance—without fear-mongering or oversimplification. The episode closes with a clear, practical framework for supporting estrogen metabolism, restoring progesterone balance, and addressing the root causes naturally.Products:LiverVitalityEndoCleanseBack on TractVital D3/K2Ultimate Vitality MultiActive B ComplexMagnesium BisglycinateAdditional Information:#588: The Hidden Epidemic Part 1: How Endocrine Disruptors Are Hijacking Your Health#589: The Hidden Epidemic Part 2: The Complete Endocrine Detox Strategy#595: The Estrobolome Explained: How Your Gut Shapes Your HormonesCheck out all five“Jen's Story” Episodes!Dirty Genes - Book by Dr. Ben LynchVisit 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.

    Infertile AF
    Encore Presentation: Elizabeth Carr, The First Baby Born in the U.S., Thanks to IVF

    Infertile AF

    Play Episode Listen Later Dec 26, 2025 44:47 Transcription Available


    It's an encore presentation of one of our favorite episodes! Ali's very special guest today is Elizabeth Carr, the first person born in the U.S. — in 1981 — via in vitro fertilization. "My birth was so widely publicized that my first press conference was at three days old," Elizabeth says. "I didn't get here like everybody else." Elizabeth shares what it's been like to live under media scrutiny since the moment she was born (check out the NOVA documentary about her life). She also explains why her parents did IVF in the first place, what the IVF landscape was like back then, how the actual procedure worked (so much has changed!) and the incredible work she's doing today to advocate for IVF and reproductive rights. She also shares how the pope, when she was born, called her "a child of the devil." For more, check out https://ejordancarr.com/ and her IG: @ejordan12 EPISODE 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 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.Order "Work of ART," "Beautiful Bird" and "You Are a Work of ART," now at https://www.infertileafgroup.com/booksFERTILITY RALLYIG: @fertilityrallywww.fertilityrally.comNo one should go through infertility alone. Join the Worst Club with the Best Members at fertilityrally.com. We offer 5 to 6 support groups per week, three private Facebook groups, tons of curated IRL and virtual events, and an entire community of more than 500 women available to support you, no matter where you are in your journey.Join today at link in bio on IG @fertilityrally or at www.fertilityrally.com/membershipPHERDALIG: @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.BELIIG: @belibabywww.belibaby.com Are you thinking about growing your family? Whether you're just starting to plan or are actively trying to conceive, preconception health is key. Beli has vitamins to help both women and men optimize their health before pregnancy. With essential nutrients like Folate, Iodine, and Zinc, Beli ensures your body is ready for this exciting next step. Give yourself and your future baby the best foundation for a healthy start.Visit Belibaby.com today and use code IAF15 for 15% off your first order. Support 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

    The Oncology Nursing Podcast
    Episode 395: Pharmacology 101: Monoclonal Antibodies

    The Oncology Nursing Podcast

    Play Episode Listen Later Dec 26, 2025 45:09


    "They [monoclonal antibodies] are able to cause tumor cell death by binding to and blocking to necessary growth factor signaling pathways for tumor cell survival. That's going to be dependent on the target of the antibody, but I'll give an example of epidermal growth factor, or EGFR. This is overexpressed in several different kinds of cancers where activation of this growth factor increases the amount of proliferation and migration of cancer cells. So, if we bind to it and block to it, then that would help halt these pathways and stop cancer cell growth," Carissa Ganihong, PharmD, BCOP, oncology and bone marrow transplantation clinical pharmacist at Hackensack University Medical Center in New Jersey, told Jaime Weimer, MSN, RN, AGCNS-BS, AOCNS®, manager of oncology nursing practice at ONS, during a conversation about monoclonal antibodies. Music Credit: "Fireflies and Stardust" by Kevin MacLeod Licensed under Creative Commons by Attribution 3.0  Earn 0.75 contact hours of nursing continuing professional development (NCPD) (including 45 minutes of pharmacotherapeutic content) by listening to the full recording and completing an evaluation at courses.ons.org by December 26, 2026. The planners and faculty for this episode have no relevant financial relationships with ineligible companies to disclose. ONS is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center's Commission on Accreditation. Learning outcome: Learners will report an increase in knowledge in the history of, the mechanism of action of, and the use of monoclonal antibodies in the treatment of cancer.  Episode Notes  Complete this evaluation for free NCPD. ONS Podcast™ episodes: Pharmacology 101 series Episode 391: Pharmacology 101: Antibody–Drug Conjugates Episode 383: Pharmacology 101: Bispecific Antibodies Episode 375: Pharmacology 101: VEGF Inhibitors Episode 338: High-Volume Subcutaneous Injections: The Oncology Nurse's Role Episode 283: Desensitization Strategies to Reintroduce Treatment After an Infusion-Related Reaction Episode 275: Bispecific Monoclonal Antibodies in Hematologic Cancers and Solid Tumors ONS Voice articles: An Oncology Nursing Overview of Biosimilars Make Subcutaneous Administration More Comfortable for Your Patients Oncology Nurses' Role in Translating Biomarker Testing Results Reduce Chair Time by as Much as 16 Minutes by Priming IVs With Drug Shorter Administration Times Still Require High-Acuity Care The Names of Targeted Therapies Give Clues to How They Work ONS Voice drug reference sheets: Datopotamab deruxtecan-dlnk Enfortumab vedotin Margetuximab-cmkb Mirvetuximab soravtansine-gynx Nivolumab and hyaluronidase-nvhy Nivolumab and relatlimab-rmbw Pembrolizumab and berahyaluronidase alfa-pmph Retifanlimab-dlwr ONS book: Chemotherapy and Immunotherapy Guidelines and Recommendations for Practice (second edition) ONS course: ONS Fundamentals of Chemotherapy and Immunotherapy Administration™ Clinical Journal of Oncology Nursing articles: Bolusing IV Administration Sets With Monoclonal Antibodies Reduces Cost and Chair Time: A Randomized Controlled Trial Management of Immunotherapy Infusion Reactions Nurse-Led Grading of Antineoplastic Infusion-Related Reactions: A Call to Action Safety and Adverse Event Management of VEGFR-TKIs in Patients With Metastatic Renal Cell Carcinoma Oncology Nursing Forum articles: Administration of Subcutaneous Monoclonal Antibodies in Patients With Cancer Depressive Symptoms and Quality of Life Associated With the Use of Monoclonal Antibodies in Breast Cancer Treatment ONS huddle cards: Bispecifics Checkpoint Inhibitors Monoclonal Antibodies Other ONS resources: Biomarker Database Bispecific Antibodies video Patient Education Sheets Antibodies article: A Comprehensive Review About the Use of Monoclonal Antibodies in Cancer Therapy Cureus article:  A Comprehensive Review of Monoclonal Antibodies in Modern Medicine: Tracing the Evolution of a Revolutionary Therapeutic Approach Association of Cancer Care Centers (ACCC) homepage Cancer Immunology, Immunotherapy article: Therapeutic Antibodies in Oncology: An Immunopharmacological Overview Drugs@FDA package inserts Future Oncology article: Biosimilars: What the Oncologist Should Know Hematology/Oncology Pharmacy Association homepage National Comprehensive Cancer Network homepage Network for Collaborative Oncology Development and Advancement (NCODA) subcutaneous therapy article Oncolink: Side Effects of Immunotherapy World Health Organization: New International Nonproprietary Names (INN) Monoclonal Antibody Nomenclature Scheme To discuss the information in this episode with other oncology nurses, visit the ONS Communities.  To find resources for creating an ONS Podcast club in your chapter or nursing community, visit the ONS Podcast Library. To provide feedback or otherwise reach ONS about the podcast, email pubONSVoice@ons.org. Highlights From This Episode "Prior to monoclonal antibodies, all we really had were these toxic chemotherapies or toxic radiation, so it was recognized how great it would be if we could have a treatment that was much more specific to the tumor cells and have agents that have less toxicities. These advancements in monoclonal antibody production began in the 1980s. ... Eventually, we had the first monoclonal antibody that was approved by the U.S. Food and Drug Administration (FDA) for an oncologic indication, rituximab." TS 4:14  "Nowadays, we do have treatments that are also considered tumor-agnostic. This is when a patient has a certain biomarker, then that treatment can be given and FDA approval was given, regardless what type of tumor the patient has. We typically see these kinds of tumor-agnostic therapies more so in patients who have recurrent or advanced diseases in solid tumors. One monoclonal antibody example that comes to mind is dostarlimab. That's a checkpoint inhibitor that's approved for patients who are deficient in mismatch repair mechanism." TS 23:48 "Our immune system constantly has this surveillance system and it's able to recognize foreign pathogens, abnormal cells, and even precancerous cells. And they're able to eliminate them before they become cancerous. But on the flip side, one of the regulatory mechanisms that we have so our immune system doesn't attack itself is the presence of checkpoints. When these checkpoints bind to their ligands, this can then act as an off switch so that, again, our immune system is not going to attack itself. But then the tumor cells can take advantage of this and actually use this mechanism to evade the immune system. So, when we're giving a checkpoint inhibitor, now we're removing that off switch. As a consequence, common adverse effects can include things like immune mediated adverse events. These most commonly affect the skin, gastrointestinal tract, and liver. Essentially, this can cause any '-itis' you can think of." TS 26:36 "Looking at strategies to prevent infusion reactions, one example is the use of premedication. If premedication is recommended, this typically includes any combination of antipyretics, which is typically acetaminophen. Antihistamine, which is typically an H1 antagonist like diphenhydramine. Although, there could be cases where we want to substitute this agent because maybe the patient has been tolerating therapy okay, and they're having a lot of side effects. So, we might use a second-generation antihistamine in some cases. The premedication may be given with or without some kind of steroid, whether that's methylprednisolone, hydrocortisone, or dexamethasone." TS 29:53 "We tend to think of monoclonal antibody usage to be primary oncology, but that's not really the case. The first monoclonal antibodies that were developed were not for oncologic indications, they were for transplant indication for cardiac indication. So, they're really diversely utilized across all specialties and medicines. We have monoclonal antibodies for hyperlipidemia, for neurology, for rheumatology, so the uses are so very expansive across all specialties." TS 41:01

    Badlands Media
    MAHA News [12.26] Vaccine Schedule, MAHA Wins of the Year + 2026 MAHA Resolutions

    Badlands Media

    Play Episode Listen Later Dec 26, 2025 88:30


    In this post-holiday MAHA News episode, Jordan Sather and Nate Prince reflect on the realities of modern health culture before diving into a comprehensive breakdown of Year One of the MAHA movement. The discussion moves from personal holiday habits into practical, tiered MAHA resolutions covering nutrition, exercise, mental health, and discipline, offering actionable steps at basic, intermediate, and advanced levels. The show then examines major policy wins, including vaccine schedule reforms, SNAP food changes, microbiome science, FDA and HHS actions, and challenges to Big Pharma and Big Food. The episode closes by connecting food systems, agriculture, environmental health, and personal responsibility into a unified framework for building long-term resilience heading into 2026.

    Gyno Girl Presents: Sex, Drugs & Hormones
    2025 Women's Health Year in Review: From FDA Changes to Menopause Breakthroughs

    Gyno Girl Presents: Sex, Drugs & Hormones

    Play Episode Listen Later Dec 26, 2025 44:06 Transcription Available


    What does it mean when 6,000 women a day enter menopause but there are only 4,100 certified clinicians to treat them?In this year end solo episode, I'm reflecting on 2025 in women's health. It was a year that felt heavy at the start personally for me after losing my mother, and globally with so much suffering and injustice. But even in all of that, women's health moved forward in meaningful ways. Not perfectly. Not fast enough. But enough that it deserves reflection.I'm covering the moments that shifted conversations this year from the FDA removing the black box warning on estrogen to new cervical cancer screening guidelines allowing self-collection HPV tests. From Addyi finally being approved for women under 65 to the release of comprehensive GSM guidelines that make genitourinary syndrome everyone's business, not just gynecologists'.And I'm getting personal about why I launched a concierge practice this year, what it taught me about the broken healthcare system, and why sexual health cannot be practiced in 10-minute appointments.Highlights:Why you're not too old for screening and what "safe exit criteria" really means.Menopause certification jumped from under 1,000 to over 4,100 practitioners in 2025.Menopause divorce vs. midlife clarity: Why hormonal chaos shouldn't decide your marriage.DARE to PLAY is a new, topical sildenafil launching in 2026 for female arousal disorder.Treating male partners reduces recurrent BV by 50% (New England Journal of Medicine).Hormone therapy for prevention: The nuanced conversation about bone health and cardiovascular risk.Why I launched a concierge practice and what it revealed about what women actually need.Thank you for being here for another year of Gyno Girl Presents: Sex, Drugs & Hormones. Your support, your messages, and your stories are what keep me going you are my why. If this year-in-review resonated with you, please share it with someone who needs to hear that they're not broken, not dramatic, and not asking for too much. And keep following the show in 2026 we've got incredible conversations lined up.Get in Touch with Me: WebsiteInstagramYoutubeSubstack

    Pharma and BioTech Daily
    Revolutionizing Medicine: Antibiotics, Gene Therapy, and AI

    Pharma and BioTech Daily

    Play Episode Listen Later Dec 25, 2025 4:03


    Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we are diving into a series of significant breakthroughs and updates that are shaping the industry landscape.Starting with a remarkable scientific advancement, researchers have made headway in the development of a new class of antibiotics that shows promise against drug-resistant bacteria. This comes as a beacon of hope in the ongoing battle against superbugs, a problem that has been escalating over the past few decades. The new antibiotics work by targeting bacterial cell walls in a novel way, which may bypass the resistance mechanisms that have rendered many traditional antibiotics ineffective. This innovation could potentially extend the lifespan of existing drugs and provide new treatment options for infections that are currently difficult to manage. It's crucial to monitor how these developments will proceed through clinical trials and regulatory scrutiny, as successful outcomes could revolutionize our approach to bacterial infections.Shifting focus to regulatory news, the FDA has recently approved a groundbreaking gene therapy for a rare genetic disorder affecting children. The therapy is designed to target and correct specific genetic mutations, offering hope for families affected by this debilitating condition. This approval not only marks a milestone for personalized medicine but also sets a precedent for future gene therapies targeting other rare diseases. The implications of such advancements are vast, as they open doors to tailored treatments that address the root causes of genetic disorders rather than just managing symptoms. As we continue to explore the potential of gene editing technologies like CRISPR, it's important to consider both the ethical and logistical challenges that accompany these scientific leaps.In clinical trial news, a late-stage study has shown promising results for a new cancer immunotherapy targeting non-small cell lung cancer. This therapy leverages the body's immune system to identify and destroy cancer cells more effectively than traditional treatments. The trial demonstrated significant improvements in patient survival rates and quality of life, underscoring the potential of immunotherapies to transform oncology care. These findings add to a growing body of evidence supporting immunotherapy as a cornerstone of future cancer treatment regimens. However, it is essential to continue researching how these therapies can be optimally combined with existing treatments to enhance outcomes and minimize side effects.Turning our attention to industry trends, there is an increasing emphasis on digital health solutions in drug development processes. Pharmaceutical companies are integrating artificial intelligence and machine learning technologies to streamline clinical trials and accelerate drug discovery. These digital tools enable more efficient data analysis, patient monitoring, and predictive modeling, which can significantly reduce development timelines and costs. As this trend gains momentum, it will be important to assess how these technologies can be best utilized without compromising data integrity or patient safety.Lastly, let's discuss an interesting development in sustainable biomanufacturing practices. Companies are investing in greener production methods that reduce environmental impact while maintaining high-quality standards for pharmaceuticals. This includes optimizing energy use, minimizing waste, and incorporating renewable resources into manufacturing processes. As regulatory bodies increasingly prioritize sustainability, we can expect these practices to become more widespread across the industry.These stories highlight how innovation continues to drive progress within pharmaceuticals and biotechnology, offering new possibilities for treatment and care. As always, it's eSupport the show

    Breaking Beauty Podcast
    The Gift of Real Talk: Is Vitamin C Overrated? "Anec-data" and the Truth About $400 Luxury Serums With Dermatologist Dr. Aegean Chan

    Breaking Beauty Podcast

    Play Episode Listen Later Dec 24, 2025 46:20


    This week we welcome double board-certified dermatologist AND dermatopathologist, Dr. Aegean Chan to bridge the gap between medical dermatology and your daily skincare routine. Tapping her clinical expertise in medical dermatology, skin cancer and acne, we unwrap Dr. Chan's professional insights on the skin barrier, sun protection, and why she believes we should be wary of "anec-data" especially when it comes to a $400 serum.In this week's episode, we discuss: How truly complex the skin barrier is (as she sees it under a microscope), and why it's the foundation of great skinHoliday break ready! Which sunscreen Dr. Chan personally buys in bulkTruth bombs about Vitamin C! Why Dr. Chan doesn't think this hero ingredient is right for everyoneWhy she *doesn't* think shopping for skincare based on a pH level is a necessary strategyWhat Dr. Chan makes of transdermal patches for skincare – are they the future of youthful skin?Plus: Should we rethink trending, in-office procedures like radiofrequency combined with microneedling per recent FDA guidelines? For any products or links mentioned in this episode, check out our website: https://breakingbeautypodcast.com/episode-recaps/ Get social with us and let us know what you think of the episode! Find us on Instagram, Tiktok,X, Threads. Join our private Facebook group. Or give us a call and leave us a voicemail at 1-844-227-0302. Sign up for our Substack here. Subscribe to our YouTube Channel to watch our episodes! Related episodes like this: Derm Hot Takes! The Real Deal on Those Viral Hypochlorous Acid Skin Sprays, the Most Legit At-Home Skincare Devices and the Unsexy Vitamin C Serum You Need To Know About NowAre You Applying Your Sunscreen the Right Way? Plus Myth-Busting Those Rage-Bait SPF Headlines, Tanning on Trial and More With Board-Certified Dermatologist Dr. Michelle HenryDr. Muneeb Shah aka @DermDoctor On Starter Skincare Routines For Aging Skin, The New Accutane-Alternative For Acne and Should You Mix Your Rx Retinol With Drugstore Moisturizer?? PROMO CODES: When you support our sponsors, you support the creation of Breaking Beauty Podcast! SeedGet ahead of the New Year with a routine that helps you now by going to Seed.com/BEAUTY and use code BEAUTY to get 20% off your first month of Seed's DS-01® Daily Synbiotic.Curology Enjoy our limited-time holiday offer — a personalized prescription FREE with your subscription, all you pay is $5.45 shipping and handling! To claim this offer, go to curology.com/beauty to take Curology's skin quiz! In just a few minutes, you'll share your skin concerns and upload a few photos for a licensed dermatology provider, who will create a custom treatment plan tailored to your unique goals. Restrictions apply. See website for full details and important safety information. *Disclaimer: Unless otherwise stated, all products reviewed are gratis media samples submitted for editorial consideration.* Hosts: Carlene Higgins and Jill Dunn Theme song, used with permission: Cherry Bomb by Saya
 Produced by Dear Media Studio See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

    AMERICA OUT LOUD PODCAST NETWORK
    Aluminum in vaccines: Understanding adjuvants through a pharmacist's lens

    AMERICA OUT LOUD PODCAST NETWORK

    Play Episode Listen Later Dec 24, 2025 57:57 Transcription Available


    The Nurses Report on America Out Loud with Melissa Schreibfeder, BSN, RN, BC-FMP – A pharmacist-led discussion examines aluminum adjuvants in childhood vaccines, comparing injected versus ingested exposure, FDA safety limits, and emerging neurological research. The conversation emphasizes transparency, informed consent, and the importance of continued investigation so parents can make informed, individualized decisions for...

    Vitality Radio Podcast with Jared St. Clair
    #598: VR Vintage: Your Parasite Cleansing User's Guide

    Vitality Radio Podcast with Jared St. Clair

    Play Episode Listen Later Dec 24, 2025 74:43


    This episode originally aired as #432 on 5/22/24 and we are bringing it to you again! Parasite cleansing has become a hot topic in the natural health world, but it can feel a little overwhelming. Are you confused about where to start or how to do a cleanse yourself? On this episode of Vitality Radio, Jared demystifies the process by sharing his experience along with his wife's, and a thorough breakdown of the entire process, the products, and what to expect. You'll learn a couple of ways to approach parasite cleansing and which one might be right for you or your family, including kids.  If you never thought about parasites being a problem in America, think again! For a deeper understanding of why parasites are indeed a bigger problem than is understood by most, be sure to listen to Jared's interviews with Dr. Todd Watts and Dr. Jay Davidson - the founders of CellCore.Products:CellCore Para KitVitality Nutrition Parasite CleanseVital 5 Precision Probiotic Vital SporesMagnesium BisglycinateCellCore Bowel MoverLife Seasons Regulari-TRedmond RelyteTrace Minerals Endure Drops***Inquire for capsule-free protocol Additional Information:For information on coaching options and personalized support, please email jessica@vitalitynutrition.comVitality Wellness Community Detox & Support GroupVitality Radio Podcast Listener Community#359: Comprehensive Detoxification of Parasites, Lyme, and Other Toxins With Dr. Todd Watts of CellCore Biosciences#431: Are Parasites Part of Your Health Concerns? With Dr. Jay Davidson#385: Rebalancing and Healing the Body Through Functional Medicine Detoxification With Dr. Stephen Cabral#258: Your Magnesium User's Guide***Be sure to check out all of the Emotional Vitality Episodes, including Jen's Story mentioned in this showVisit the podcast website here: VitalityRadio.comYou can follow @vitalityradio and @vitalitynutritionbountiful 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!Please also join us on the Dearly Discarded Podcast with Jared St. Clair.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.

    CBS Evening News
    CBS Evening News, 12/23/25

    CBS Evening News

    Play Episode Listen Later Dec 24, 2025 23:11


    Why the weather could make holiday travel for some a challenge. The FDA approves a new option in the world of weight loss drugs. And, all aboard! A Christmas train bringing joy to the rails from stop to stop. 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

    DTC POD: A Podcast for eCommerce and DTC Brands
    #367 - The Insider's Guide to Supplements: What Every Founder Needs to Know About Compliance, Claims, and Scale

    DTC POD: A Podcast for eCommerce and DTC Brands

    Play Episode Listen Later Dec 24, 2025 53:37


    Graham Rigby is the President and CEO of the American Herbal Products Association (AHPA), the leading trade association for the herbal products industry. With 20 years of experience across startups and industry leadership—including serving as Chief Innovation Officer at Care/of—Graham has helped shape how modern supplement brands navigate regulation, formulation, and go-to-market strategy.In this episode of DTC Pod, Graham shares what it actually takes to launch and scale a supplement brand without getting burned by regulators. He breaks down exactly where the line is between claims that sell and claims that get you in trouble, why so many founders get blindsided by FDA and FTC enforcement, and how to work with contract manufacturers when you're just starting out. Graham also gets into the real opportunity in supplements right now—why clinical trials cost 90% less than they did two decades ago, how AI is changing the formulation game, and why a $70 billion market growing at 6.5% still has plenty of room for new entrants. Plus, his take on the brands that are doing it right, from AG1 to Ritual, and what founders can learn from their playbooks.Episode brought to you by StordInteract with other DTC experts and access our monthly fireside chats with industry leaders on DTC Pod Slack.On this episode of DTC Pod, we cover:1. The evolution and growth of the herbal supplement industry2. Key regulatory milestones: DSHEA, GMPs, and FDA compliance for supplements3. What founders must do to stay compliant when launching a supplement brand4. The distinction between pharmaceuticals, dietary supplements, and nutraceuticals5. Marketing, claims, and the importance of substantiation6. Emerging opportunities with clinical trials and claim innovation7. DTC, Amazon, TikTok, and brick-and-mortar distribution channels for wellness brands8. The practicalities and risks of supplement retail (and when to scale beyond DTC)9. Practitioner and non-traditional channels for supplement sales10. How Ingredient AI, Infinite Garden, and other platforms are applying AI to supplements11. Content creators, credentialed doctors, and the new face of trusted health advice12. The role of diagnostics, wearables, and personalization in driving supplement trends13. Growth outlook: Why the supplement market is just getting startedTimestamps00:00 Intro to DTC POD and Graham Rigby02:25 20 years of supplements: Startup vs. regulatory side03:00 The exponential growth of the herbal products market04:44 Regulatory basics: DSHEA, FDA oversight, and GMPs explained07:14 How AHPA helps brands navigate compliance and education08:03 Launching a supplement brand: Key compliance steps and best practices10:00 FDA's post-market regulatory process and founder responsibilities13:04 Supplements vs. pharmaceuticals: Safety, claims, and approvals17:32 Telling stories and using clinical research for marketing claims20:00 What marketers can and cannot say: Health vs. disease claims22:04 Substantiating claims and the importance of compliance for growth24:31 Label vs. online claims: How rules apply to different channels27:02 DTC vs. Amazon, TikTok, and expanding to retail and practitioner channels30:19 The risks and rewards of brick-and-mortar expansion35:14 AI and technology's role in supplement industry efficiency and safety40:47 The rise of content creators and doctors shaping supplement education46:34 Diagnostics, wearables, and the future of personalized wellness51:13 Supplement industry outlook and advice for emerging brands52:25 How to connect with Graham and AHPA, and upcoming founder programsShow notes powered by CastmagicPast guests & brands on DTC Pod include Gilt, PopSugar, Glossier, MadeIN, Prose, Bala, P.volve, Ritual, Bite, Oura, Levels, General Mills, Mid Day Squares, Prose, Arrae, Olipop, Ghia, Rosaluna, Form, Uncle Studios & many more.  Additional episodes you might like:• #175 Ariel Vaisbort - How OLIPOP Runs Influencer, Community, & Affiliate Growth• #184 Jake Karls, Midday Squares - Turning Your Brand Into The Influencer With Content• #205 Kasey Stewart: Suckerz- - Powering Your Launch With 300 Million Organic Views• #219 JT Barnett: The TikTok Masterclass For Brands• #223 Lauren Kleinman: The PR & Affiliate Marketing Playbook• ​​​​#243 Kian Golzari - Source & Develop Products Like The World's Best Brands-----Have any questions about the show or topics you'd like us to explore further?Shoot us a DM; we'd love to hear from you.Want the weekly TL;DR of tips delivered to your mailbox?Check out our newsletter here.Projects the DTC Pod team is working on:DTCetc - all our favorite brands on the internetOlivea - the extra virgin olive oil & hydroxytyrosol supplementCastmagic - AI Workspace for ContentFollow us for content, clips, giveaways, & updates!DTCPod InstagramDTCPod TwitterDTCPod TikTokGraham Rigby - President & CEO of American Herbal Products Association (AHPA)Blaine Bolus - Co-Founder of CastmagicRamon Berrios - Co-Founder of Castmagic

    Nurses Out Loud
    Aluminum in vaccines: Understanding adjuvants through a pharmacist's lens

    Nurses Out Loud

    Play Episode Listen Later Dec 24, 2025 57:57 Transcription Available


    The Nurses Report on America Out Loud with Melissa Schreibfeder, BSN, RN, BC-FMP – A pharmacist-led discussion examines aluminum adjuvants in childhood vaccines, comparing injected versus ingested exposure, FDA safety limits, and emerging neurological research. The conversation emphasizes transparency, informed consent, and the importance of continued investigation so parents can make informed, individualized decisions for...

    Parkinson's Warrior Podcast
    Stem Cells, Patches, and "Miracle Cures": What's Real and What's a Rip-Off?

    Parkinson's Warrior Podcast

    Play Episode Listen Later Dec 24, 2025 22:22


    In this episode (watch on YouTube) we will unpack the growing number of scam and unproven "treatments" being marketed to people living with Parkinson's disease. From stem cell "miracles" to wearable patches, exotic overseas clinics, and expensive supplement stacks — we break down what's real, what's risky, and how to spot the red flags before you waste your money (or your hope).

    Movement Logic: Strong Opinions, Loosely Held
    119: Testosterone in Menopause: What We Know, What We Don't

    Movement Logic: Strong Opinions, Loosely Held

    Play Episode Listen Later Dec 24, 2025 25:45


    Testosterone is everywhere in menopause conversations right now, often framed as a solution for everything from low energy and brain fog to bone health and longevity. In this episode, Dr. Sarah Court breaks down what actually matters when it comes to testosterone for menopausal women, separating social media hype from clinical evidence. The real questions are not whether women have testosterone or whether levels change with age, but whether testosterone should be prescribed, for whom, and what the data truly supports.Using current consensus guidelines, this episode explains why testosterone has one narrow, evidence-based indication, hypoactive sexual desire disorder, and why claims about mood, energy, cognition, bone health, and longevity are not supported by high-quality research. Dr. Court also walks through how testosterone is prescribed in the real world, why the lack of FDA-approved products for women creates problems, and what the safety data does and does not tell us about long-term risks. If you have heard confident claims about testosterone as a menopause cure-all, this episode provides the context you need to evaluate those messages with clarity and skepticism.FOLLOW @MovementLogicTutorials on InstagramMovement Logic: Free Barbell Mini CourseInstagram: Professor Susan DavisInstagram: Dr. Kelly CaspersonGlobal Consensus Position Statement on the Use of Testosterone Therapy for Women — Davis et al., 2019, Journal of Clinical Endocrinology & MetabolismISSWSH Clinical Practice Guideline on Systemic Testosterone for Women — Parish et al., 2021Testosterone Therapy for Women, Systematic Review & Meta-analysis(Lancet Review) — Islam et al., 2019Androgen Therapy in Women, A Reappraisal — Davis & Wahlin-Jacobsen, 2015Kelly Casperson blog post — Testosterone Can Help With Libido, Energy, Focus, & More During MenopauseYou Are Not Broken Podcast — Kelly Casperson, MDYouTube Short: Testosterone and Bone HealthYouTube Short: Testosterone, Motivation & Vitality

    Dental Implant Talk: Stories of REAL Patients
    Are You Too Old for Dental Implants? (My Experience at 68)

    Dental Implant Talk: Stories of REAL Patients

    Play Episode Listen Later Dec 24, 2025 30:39


    HOW MUCH DO DENTAL IMPLANTS COST!? Download the FREE Guide to Dental Implants Here: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://bit.ly/3MK6x31Want to know if you may be eligible for Permanent Teeth in 24 Hours? Take the 60-Sec Quiz Here: ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://bit.ly/49oywwX▬▬▬▬▬▬▬▬ Contents of this video ▬▬▬▬▬▬▬▬▬▬Disclaimer: Nuvia Dental Implant Centers are locally owned and operated by licensed dental practitioners. These locally owned and operated practices are part of a professional network of dental implant centers operated by prosthodontists, oral surgeons, and restorative dentists. Each Nuvia Dental Implant Center has a business affiliation with Nuvia MSO, LLC, a Dental Support Organization that provides non-clinical support to each center.*Nuvia Dental Implant Centers are able to provide patients with a bridge made with an FDA approved permanent material, zirconia, in 24-hours. No temporary denture. Not all those who come in for a consultation are medically cleared to receive permanent zirconia teeth in 24-hours. Follow up appointments are required to confirm implant integration and make adjustments if necessary. Results may vary in individual cases. Patients represented in videos are actual NUVIA patient(s) and may have been compensated for their time in telling their story.*While soft foods immediately after surgery are generally approved by our clinical team, the local surgeon may give individual instruction on dental implant aftercare according to the specific circumstances applicable to each case.To hear patient's speech after prosthetic placement please search Nuvia Dental Implant Center on YouTube and watch patient stories. *Individual results may vary based on a number of factors.Copyright 2024. Nuvia Dental Implant Centers. All rights reserved.

    Pharma and BioTech Daily
    2025's Breakthroughs: Oral Wegovy, J&J Verdict, and AI in Drug Discovery

    Pharma and BioTech Daily

    Play Episode Listen Later Dec 24, 2025 6:29


    Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we delve into the significant events of 2025, a year marked by pivotal scientific breakthroughs, regulatory changes, and industry trends that have reshaped drug development and patient care.One of the standout advancements was Novo Nordisk gaining FDA approval for an oral version of Wegovy, a glucagon-like peptide-1 (GLP-1) receptor agonist for obesity management. This marks a notable shift in treatment accessibility, as it provides an easier alternative to injectables for those managing weight and cardiovascular risks. This development could significantly enhance patient adherence and broaden access to this critical therapy.However, not all news was positive. Pfizer faced a challenging situation when a patient death occurred in the extension of their Hympavzi hemophilia study. Such incidents highlight the intrinsic risks of clinical trials, especially within gene therapy realms where safety monitoring is paramount. These events remind us of the delicate balance between innovation and patient safety in advanced biologic therapies.In legal news, Johnson & Johnson was ordered by a Baltimore jury to pay $1.56 billion in a talc-related cancer case. This ruling underscores heightened scrutiny on product safety and consumer protection within the pharmaceutical industry, potentially influencing future litigation and regulatory measures.Clinical trial outcomes also presented mixed results. Neurocrine Biosciences' Ingrezza did not meet efficacy endpoints in its phase 3 trial for cerebral palsy-related dyskinesia. Although it is approved for other movement disorders, this setback reflects the complexities involved in expanding drug indications. Such challenges highlight ongoing hurdles in translating preclinical successes into clinical realities.Despite geopolitical tensions, particularly between China and the U.S., Chinese biotech firms thrived, maintaining robust deal activity. China's continued growth as an innovation hub is driven by strategic investments and collaborations that bolster global drug development efforts, underscoring its increasing influence in life sciences.Regulatory landscapes also shifted with proposals from the Center for Medicare & Medicaid Innovation to align U.S. drug prices with international rates under Medicare Parts B and D. These proposed models could significantly impact pricing strategies and market dynamics within the U.S., requiring pharmaceutical companies to adapt while ensuring equitable access to medications.Ethical challenges surfaced as six individuals were charged with insider trading involving biotech stocks. Such incidents highlight the necessity for stringent ethical standards and regulatory oversight to maintain investor confidence and market integrity.Meanwhile, AstraZeneca's extended partnership with Niowave for actinium-225 supply reflects an interest in radiopharmaceuticals as targeted cancer therapies. This collaboration highlights the potential of radiopharmaceuticals in oncology, opening promising avenues for precision medicine approaches.As 2025 closes, it's clear that this year has been one of both triumphs and trials for the pharmaceutical and biotech industries. Scientific innovations like Novo Nordisk's oral GLP-1 receptor agonist offer new hope for patients, yet challenges such as clinical trial setbacks and legal battles indicate ongoing hurdles in drug development and commercialization. These developments will likely influence industry strategies and regulatory policies as we advance into 2026.The sustained momentum of China's biotech industry amid global trade tensions remains notable. This trend reflects China's strategic investments in biotech capabilities and its growing role in global markets despite geopolitical frictions.In clinical research, Hope BioscienceSupport the show

    WBEN Extras
    WBEN's Tom Puckett on the FDA's approval of the Wegovy pill

    WBEN Extras

    Play Episode Listen Later Dec 24, 2025 1:07


    WBEN's Tom Puckett on the FDA's approval of the Wegovy pill full 67 Wed, 24 Dec 2025 08:52:00 +0000 OKOYfHqTMtzYsi5M8m9rC1OBh8MZmTct news & politics,news WBEN Extras news & politics,news WBEN's Tom Puckett on the FDA's approval of the Wegovy pill Archive of various reports and news events 2024 © 2021 Audacy, Inc. News & Politics News False https://player.amperwavepodcastin

    WBEN Extras
    Pharmacist Steve Giroux on FDA approval of the Wegovy pill

    WBEN Extras

    Play Episode Listen Later Dec 24, 2025 5:18


    Pharmacist Steve Giroux on FDA approval of the Wegovy pill full 318 Wed, 24 Dec 2025 09:45:00 +0000 MXSahP2UGClnVQe0mcVdz86DrWs0trjT news & politics,news WBEN Extras news & politics,news Pharmacist Steve Giroux on FDA approval of the Wegovy pill Archive of various reports and news events 2024 © 2021 Audacy, Inc. News & Politics News False https://player.amperwavepodcasting

    WBEN Extras
    Dr. Ashley Bernotas of Kaleida Health Weight Management Center on FDA approval of Wegovy pill

    WBEN Extras

    Play Episode Listen Later Dec 24, 2025 4:11


    Dr. Ashley Bernotas of Kaleida Health Weight Management Center on FDA approval of Wegovy pill full 251 Wed, 24 Dec 2025 09:45:00 +0000 ylB3qvtkWp3O32YPG2FAsScKqLddUd1y news & politics,news WBEN Extras news & politics,news Dr. Ashley Bernotas of Kaleida Health Weight Management Center on FDA approval of Wegovy pill Archive of various reports and news events 2024 © 2021 Audacy, Inc. News & Politics News False

    Dr. Joseph Mercola - Take Control of Your Health
    Personalized Vitamin D Levels Cut Repeat Heart Attack Risk by Half

    Dr. Joseph Mercola - Take Control of Your Health

    Play Episode Listen Later Dec 23, 2025 7:28


    A new Intermountain Health study presented at the American Heart Association's 2025 Scientific Sessions found that adults with heart disease who optimized their vitamin D levels cut their risk of another heart attack by 52% Most participants began the trial with low vitamin D levels, showing that deficiency is common in people with cardiovascular disease and silently increases the risk of recurring heart problems More than half of the patients needed over 5,000 IU of vitamin D3 daily — six times the FDA's recommended intake — to reach protective blood levels between 40 and 80 ng/mL Vitamin D acts as a hormone that helps lower inflammation, maintain proper calcium balance, improve blood vessel function, and reduce oxidative stress — all key to preventing heart damage Regular testing, personalized dosing, sunlight exposure, and daily exercise are simple, measurable ways to restore vitamin D, strengthen your heart, and reduce your risk of another cardiac event

    The Ultimate Human with Gary Brecka
    229. Dr. Marty Makary: Vaccines, Chronic Disease, Drug Prices & Hormone Therapy

    The Ultimate Human with Gary Brecka

    Play Episode Listen Later Dec 23, 2025 79:40


    The people running our federal health agencies have finally pulled back the curtain, and what they're revealing changes everything we thought we knew about how decisions get made at the highest levels of government. In this groundbreaking conversation, FDA Commissioner Dr. Marty Makary discusses the sweeping reforms transforming America's approach to food safety, drug approvals, and medical transparency under the Make America Healthy Again initiative. What would you change first if you had the power to reform our entire healthcare system?  CLICK HERE TO BECOME GARYS VIP!: ⁠https://bit.ly/4ai0Xwg⁠ Get Dr. Marty Makary's book, “Blind Spots“ here: ⁠https://bit.ly/3MIcg9x⁠ Connect with Dr. Marty Makary Website: ⁠https://bit.ly/48JPxCD⁠  YouTube: ⁠https://bit.ly/4j2IBUx⁠  Instagram: ⁠https://bit.ly/4qaIicv⁠  TikTok: ⁠https://bit.ly/48UlOFK⁠  Facebook: ⁠https://bit.ly/4pJ9QG4⁠  X.com: ⁠https://bit.ly/4pIWGcd⁠  Thank you to our partners H2TABS: “ULTIMATE10” FOR 10% OFF: ⁠https://bit.ly/4hMNdgg⁠ BODYHEALTH: “ULTIMATE20” FOR 20% OFF: ⁠http://bit.ly/4e5IjsV⁠ BAJA GOLD: "ULTIMATE10" FOR 10% OFF: ⁠https://bit.ly/3WSBqUa⁠ COLD LIFE: THE ULTIMATE HUMAN PLUNGE: ⁠https://bit.ly/4eULUKp⁠ WHOOP: JOIN AND GET 1 FREE MONTH!: ⁠https://bit.ly/3VQ0nzW⁠ AION: “ULTIMATE10” FOR 10% OFF: ⁠https://bit.ly/4h6KHAD⁠ A-GAME: “ULTIMATE15” FOR 15% OFF: ⁠http://bit.ly/4kek1ij⁠ PEPTUAL: “TUH10” FOR 10% OFF: ⁠https://bit.ly/4mKxgcn⁠ CARAWAY: “ULTIMATE” FOR 10% OFF: ⁠https://bit.ly/3Q1VmkC⁠ HEALF: 10% OFF YOUR ORDER: ⁠https://bit.ly/41HJg6S⁠ RHO NUTRITION: “ULTIMATE15” FOR 15% OFF: ⁠https://bit.ly/44fFza0⁠ GOPUFF: GET YOUR FAVORITE SNACK!: ⁠https://bit.ly/4obIFDC⁠ GENETIC METHYLATION TEST (UK ONLY): ⁠https://bit.ly/48QJJrk⁠ GENETIC TEST (USA ONLY): ⁠⁠https://bit.ly/3Yg1Uk9⁠ Watch  the “Ultimate Human Podcast” every Tuesday & Thursday at 9AM EST: YouTube: ⁠https://bit.ly/3RPQYX8⁠ Podcasts: ⁠https://bit.ly/3RQftU0⁠ Connect with Gary Brecka Instagram: ⁠https://bit.ly/3RPpnFs⁠ TikTok: ⁠https://bit.ly/4coJ8fo⁠ X: ⁠https://bit.ly/3Opc8tf⁠ Facebook: ⁠https://bit.ly/464VA1H⁠ LinkedIn: ⁠https://bit.ly/4hH7Ri2⁠ Website: ⁠https://bit.ly/4eLDbdU⁠ Merch: ⁠https://bit.ly/4aBpOM1⁠ Newsletter: ⁠https://bit.ly/47ejrws⁠ Ask Gary: ⁠https://bit.ly/3PEAJuG⁠ Timestamps 00:00 Intro of Show 03:29 Leading the Food and Drug Administration 07:22 Setting the FDA's Mission and Agenda 12:12 Time to Change the Medical Educational System 17:01 Going through the FDA's Agenda 22:48 Rewriting the Food Dietary Guidelines 27:13 Unveiling the Scientific Data 30:01 The Truth behind Hormone Therapy 37:32 Dr. Marty's Vision for the FDA 39:19 Are Children Over-Vaccinated? 43:21 FDA's Movement on Vaccination 45:48 FDA Belongs to the American People, Not the Big Pharma 46:41 FDA on Peptides, Stem Cells, and Other Unconventional Therapies 48:14 Scientific Data on Gut Microbiome (Addressing Cancer, Diabetes) 1:14:31 FDA's Challenges against Political Bureaucracy  1:17:01 What does it mean to you to be an Ultimate Human? The Ultimate Human with Gary Brecka Podcast is for general informational purposes only and does not constitute the practice of medicine, nursing or other professional health care services, including the giving of medical advice, and no doctor/patient relationship is formed. The use of information on this podcast or materials linked from this podcast is at the user's own risk. The Content of this podcast is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Users should not disregard or delay in obtaining medical advice for any medical condition they may have and should seek the assistance of their health care professionals for any such conditions. Learn more about your ad choices. Visit megaphone.fm/adchoices

    Jay Fonseca
    PODCAST LAS NOTICIAS CON CALLE DE 23 DE DICIEMBRE 2025

    Jay Fonseca

    Play Episode Listen Later Dec 23, 2025 20:52


    PODCAST LAS NOTICIAS CON CALLE DE 23 DE DICIEMBRE 2025 - Trump hace nueva flota de barcos que se llamarán Trump - FTNovo Nordisk logra FDA apruebe medicamento para rebajar con pastilla diaria siendo la primera en lograrlo - FTCerca de epidemia de influenza A - El Vocero Otra vez irregularidad de subasta en cámaras de escuelas, vuelven a ordenar subasta - Metro Nuevas leyes sobre el cuerpo de la mujer y embarazo, leyes contradictorias unas con otras - El Nuevo Día Más hospitales al borde de la quiebra en 2026 - El Nuevo Día FEMA exige que todo proyecto vuelva a evaluarse si hay cambios de 100 mli dólares retrasando reconstrucción de PR - El Vocero Seguirá gratis el Tren Urbano - Primera Hora Gobierno le da los 40 millones a Bayamón para terminar la PR 5, no va la PR 10 - Primera HoraSube la presión para quedarse con CNN, Warner Bros. Discovery - QzSecretaria de Vivienda dice que hay que agilizar títulos de propiedad, pero pelea con la Junta por expresiones de que no hay plan del gobierno de PR para resolver el problema de Vivienda - El Vocero La Junta saldrá a favorecer a LUMA en contrato advirtiendo que tiene impacto fiscal el pleito legal del gobierno - El Vocero Trump detiene demanda contra la Junta de PR para ver lo que resuelve el Supremo sobre su autoridad de botar gente de la rama ejecutiva - El Vocero Salud dice que nuevas leyes no alteran la decisión de mujeres embarazadas - El Vocero Aguadilla pide que le den ciudadanía a PR, mientras senador federal exige que se tenga que escoger entre ciudadanía de USA u otras, pero no podrían tener las dos - El Vocero Proponen modelo para convertir estadio hasta de 50 mil personas - El Vocero Rivera Schatz empuja proyecto de Juan Oscar Morales para las escoltas - El Nuevo Día JGo descarta conflictos de interés en casos de sus portavoces contratistas - El Nuevo Día Van al Tribunal Supremo para evitar que baje de precio medicamentos como Eliquis - Axios Trump mata las fincas solares que estaban sin construirse, le quita los fondos - NYTLarry Ellison plantea dar de su propio dinero hasta 40 billones para comprar Paramount - WSJ   Para una salud completa, MCS Personal Directo te ofrece cubiertasaccesibles para que cuides de tu salud y la de los tuyos con el MCS Alivia, unprograma de medicina integral y alternativa que beneficia a pacientes con múltiplescondiciones crónicas, a través de terapias y servicios de acupuntura, masajeterapéutico, reflexología, entre otras modalidades, que pueden complementar tutratamiento médico tradicional.¡Únete HOY a la familia de MCS!¡Salud que completa tu vida! Llama al 787.945.1259 y oriéntate.Endoso pagado

    CNBC's
    Stocks & Commodities Hit Record Highs.. And Novo's Weight Loss Pill Pop 12/23/25

    CNBC's "Fast Money"

    Play Episode Listen Later Dec 23, 2025 43:53


    The S&P 500 closing at a fresh record high, as commodities come along for the ride. If the metal moves in Gold, Silver, and Copper can keep rocking into the new year, and how this morning's strong GDP report will impact the Fed's next rate decision. Plus Shares of Novo Nordisk on the move as the pharma company's weight loss pill gets approved by the FDA. How the decision can tip the scales for Novo, and what one analyst sees in store for the weight loss drug space.Fast Money Disclaimer Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

    Science Salon
    The Future of Brain Implants: Restoring Speech, Regaining Mobility, Treating Pain

    Science Salon

    Play Episode Listen Later Dec 23, 2025 60:21


    Brain-computer interfaces are moving out of the lab and into real medical use. In this episode of The Michael Shermer Show, Michael Shermer talks with Dr. Matt Angle, founder and CEO of Paradromics, a neurotechnology company developing one of the most advanced high-data-rate brain implants in the world, similar to Neuralink. These devices record activity from individual neurons, making it possible to restore speech in people with paralysis, reconnect the brain to external devices, and potentially treat chronic pain and neurological disorders with far greater precision than existing approaches. Angle explains why progress in neuroscience has been limited not by biology, but by data—how much information we can actually read from the brain, and how fast. He describes how patients who can no longer speak may soon communicate fluently using only brain signals, why invasive implants can sometimes be safer than long-term drug treatments, and what it takes to bring a brain implant through FDA approval and into the clinic. The conversation also touches on the larger questions raised by this technology, including autonomy, consciousness, and what happens when the boundary between brain and machine begins to blur. Matt Angle is the Founder and CEO of Paradromics, a neurotechnology leader developing the world's most advanced and clinically viable brain-computer interface (BCI) platform—bridging human thought and digital capability. Paradromics' BCI platform records brain activity with unmatched precision, capturing data at the level of individual neurons. This advanced technology enables the decoding of vast amounts of brain data, opening the door to next-generation treatments for paralysis, chronic pain, addiction, mental health conditions, and more. With the power of AI, this platform has the potential to radically shift how healthcare providers approach some of the most challenging medical conditions. Angle earned his PhD in Neuroscience from the University of Heidelberg, followed by postdoctoral research at Stanford University. Paradromics engineered its first clinical product, the Connexus® BCI, received two FDA Breakthrough Device Designations, and performed the first-in-human neural recording in May 2025. The company is now preparing to launch a clinical trial in early 2026, pending regulatory approval.

    Why Isn't Everyone Doing This? with Emily Fletcher
    102. Why Isn't Everyone Tripping With Their Family? | Lauren Taus

    Why Isn't Everyone Doing This? with Emily Fletcher

    Play Episode Listen Later Dec 23, 2025 91:25


    What if healing didn't have to be solitary?What if family — messy, imperfect, deeply conditioned family — could actually be part of the medicine? In this episode of Why Isn't Everyone Doing This?, I sit down with Lauren Tauss, psychedelic facilitator, teacher, and one of the clearest communicators I know in this space. Lauren has a rare ability to bring humor, rigor, compassion, and responsibility into conversations that are often either sensationalized or sanitized. We talk about why “life itself is psychedelic,” how healing is inherently relational, and what becomes possible when we stop treating transformation as something that happens in isolation. Lauren shares her own deeply personal journey — from anorexia and control to surrender, embodiment, and trust — and how psychedelic-assisted therapy helped rewire her relationship with her body, her family, and life itself. This conversation isn't about glorifying substances or breaking taboos for shock value. It's about maturity. Integration. And learning how to say hello to yourself — instead of checking out. If you've ever been curious, cautious, skeptical, or quietly fascinated by psychedelic healing… this episode will meet you with intelligence and heart. In this episode, we explore: • Why Lauren says “life is the biggest psychedelic” • The difference between using medicine to say hello vs. goodbye • How relational healing changes family systems • Why shame, addiction, and “drug” culture need a language upgrade • The connection between meditation, surrender, and psychedelic work • Healing body image, control, and fear at the root• What integration actually means (and why it matters more than the experience) Key Moments: 00:00:00 — Why isn't everyone tripping with their family? 00:03:35 — “Life is the ceremony”: redefining what psychedelic really means 00:06:26 — Hello vs. goodbye: the two reasons people partner with substances 00:07:47 — Compassion over judgment in addiction and numbing 00:09:15 — Lauren's first ayahuasca experience and healing anorexia 00:12:27 — “It's time to retire your extra-small life” 00:14:41 — Body as gift: remembering the blessing of being alive 00:15:49 — Why meditation is surrender school (and prepares you for life) Where This Work Continues If this conversation stirred something in you, especially around integration, relationship, or embodiment, you may feel drawn to Level 3. Level 3 is where we focus on building the inner stability, nervous system resilience, and daily practices that allow deep experiences (psychedelic or otherwise) to actually change how you live. Learn more about Level 3 here:

    CNN News Briefing
    TX Plane Crash, Wegovy Pill, Kansas City Chiefs moving and more

    CNN News Briefing

    Play Episode Listen Later Dec 23, 2025 6:31


    A strike on another suspected drug trafficking boat in the Pacific is again escalating tensions between US and Venezuela. Five people are dead after a plane crash off the coast of Texas. The FDA has approved a pill version of Wegovy. President Donald Trump made his first public comments on the latest release of the Epstein files. Plus, the Kansas City Chiefs are leaving Kansas City, Missouri. Learn more about your ad choices. Visit podcastchoices.com/adchoices

    Squawk on the Street
    FDA Approves Novo Nordisk's Wegovy Pill, ServiceNow CEO on $7.75B Deal, Q3 GDP Jumps 12/23/25

    Squawk on the Street

    Play Episode Listen Later Dec 23, 2025 44:45


    Carl Quintanilla and Jim Cramer led off show with the weight loss drug wars: Shares of Novo Nordisk shares surged after the FDA approved the company's Wegovy pill — making it the first oral GLP-1 cleared by regulators for treatment of obesity. ServiceNow CEO Bill McDermott joined the program to discuss his company's deal to acquire cybersecurity startup Armis for $7.75 billion in cash. Hear what McDermott had to say about this year's slump in shares of ServiceNow and other software stocks. Also in focus: Q3 GDP shows 4.3% growth, the AI trade, countdown to Christmas and new data on holiday spending, Tesla gets a big price target boost on Wall Street, the stock that's getting a lift from President Trump's battleship announcement. Squawk on the Street Disclaimer Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

    Squawk on the Street
    SOTS 2nd Hour: Novo Nordisk Oral Weight-Loss Pill, Global Market Outlook, “Aggressive Housing Reform” 12/23/25

    Squawk on the Street

    Play Episode Listen Later Dec 23, 2025 43:08


    The FDA approving the first GLP-1 pill for obesity from Wegovy maker Novo Nordisk. CNBC speaking with the CEO about expanding access and how the pill will increase the company's competitive edge. Then, former U.K. Treasury Minister Jim O'Neill. His outlook for global markets. And President Trump saying “aggressive housing reform” is coming next year. UBS helps look at possible policy changes and the impact to stocks in the sector. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

    TODAY
    TODAY News December 23: Winter Weather Impacts Holiday Travel | U.S. Targets Another Venezuelan Vessel | FDA Approves New Weight Loss Pill

    TODAY

    Play Episode Listen Later Dec 23, 2025 28:50


    The latest on severe weather across the country and the impact it's having on the holiday travel rush. Also, the U.S. military announces it has conducted another strike on an alleged drug-smuggling boat. Plus, a homeowner slams into a suspected burglar's car in dramatic video. And, the FDA approves a pill version of the weight-loss injectable drug Wegovy. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

    Nightly Business Report
    A Tale of Two Economies, GLP-1 Gains & Zero-Gravity Data Centers 12/23/25

    Nightly Business Report

    Play Episode Listen Later Dec 23, 2025 44:08


    Third quarter growth was much stronger than expected, but low consumer confidence paints a mixed picture. Novo Nordisk shares climb after the FDA approves the first GLP-1 obesity pill. Plus, could space be the place for data centers? Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

    The Morning Rundown
    Epstein files released overnight; Trump unveils new Navy battleships

    The Morning Rundown

    Play Episode Listen Later Dec 23, 2025 9:06


    The Justice Department released its largest batch of Epstein files to date overnight. This collection includes tens of new documents, emails, photos and videos that are now publicly available. Plus, President Donald Trump is rolling out plans for the “Golden Fleet,” a new generation of massive American battleships he said will be the most powerful ever built. And a major shift in the weight-loss drug boom. The FDA has approved the first GLP-1 pill for obesity, with no injections required. These stories and more highlight your Unbiased Updates for Tuesday, December 23, 2025.

    The Options Insider Radio Network
    The Hot Options Report: 12-23-2025

    The Options Insider Radio Network

    Play Episode Listen Later Dec 23, 2025 9:44


    Welcome to today's episode of The Hot Options Report—your essential guide to options trading and stock market analysis as we head into the holiday break. Host Mark Longo breaks down the day's market volatility, concentrating on the top options trades and key stock movements driving the tape before the holiday. In this episode, we dive into the massive trading volumes and unusual activity seen across the leaderboard, including a historic day for Novo Nordisk (NVO) and the continued dominance of Tesla (TSLA) and Nvidia (NVDA). On This Episode, We Discuss: The NVO "Pill" Pop: Novo Nordisk shares surged following the landmark FDA approval of the oral version of Wegovy. We analyze the explosion in call volume and what this fundamental shift means for the GLP-1 "Weight Loss War" heading into 2026. Tesla (TSLA) Sentiment: Tesla remains the undisputed king of the tape as it pushes toward key psychological levels. We break down the massive open interest and the "Santa Rally" positioning ahead of the highly anticipated January delivery report. Nvidia (NVDA) & The China Pivot: With reports circulating about a green light for specific AI chip shipments to China, Nvidia is seeing a massive influx of aggressive call buying. Is the "AI Trade" finding a second wind for the new year? Broad Market Check: Is the market gift-wrapped for a year-end surge? We look at the sentiment reflected in the major index options chains amidst thin holiday liquidity and record highs for the S&P 500. Unusual Activity Spotlight: We track the "Hot Trades" of the day, including surprising volume in names like MicroStrategy (MSTR) and Robinhood (HOOD). Year-End Positioning: A look at why traders are rolling positions and selling premium to capture holiday decay. Tune in for detailed insights into each options trade, the macro drivers behind today's tape, and the vital implications for active traders. Get more options data, charts, and analysis at: TheHotOptionsReport.com

    Food Safety Matters
    Ep. 208: Reviewing 2025—A Year of Change for Food Safety Policy

    Food Safety Matters

    Play Episode Listen Later Dec 23, 2025 91:46


    In this episode of Food Safety Matters, we discuss the top food safety stories of 2025 and their implications. We cover: The Trump Administration's impact on federal agencies overseeing food safety [7:52]: FDA, CDC Ordered to Temporarily Pause All External Communications, Obtain Trump Admin Approval RFK Jr. Confirmed as HHS Secretary; Widespread Firings Coming to FDA, CDC USDA Inspector General Phyllis Fong Dismissed by Trump Administration Brooke Rollins Confirmed as Secretary of Agriculture, Cites 'Aggressive Plan' to Eliminate USDA Jobs FDA Leader Jim Jones Resigns After 89 'Indiscriminate' Firings in Human Foods Program Attorney Kyle Diamantas Expected to Replace Jim Jones as FDA Deputy Commissioner of Human Foods FDA Spending Freeze Leaves Staffers Feeling 'Dangerously Unprepared' for Next Foodborne Illness Outbreak Federal Workforce Data Reveal Impact of Trump Admin RIFs on USDA Food Safety Expertise More Than 15,000 USDA Employees Take Trump Administration's Resignation Offer  FDA Suspends Milk Quality Testing Amid Health and Human Services Cuts Entire Departments of CDC Outbreak Experts Fired, Rehired During Shutdown RIFs FDA Reportedly Reinstating Some Fired Food Safety Scientists, Inspection Support Staff Government Shutdown Affects Food Safety: HHS Furloughs Employees, FDA Pauses CORE Investigation Table Ep. 196. Dr. Lane Highbarger: How the FDA Workforce Cuts May Impact Food Safety Dozens of Prominent Food Safety Stakeholders Call for Reinstatement of NACMCF and NACMPI USDA Withdraws Proposed Regulatory Framework for Salmonella in Poultry After Years of Development USDA Indefinitely Delays Enforcement of Salmonella as Adulterant in Raw Breaded, Stuffed Chicken  CDC Slashes FoodNet Surveillance From Eight Foodborne Pathogens to Two Public Health Professionals, Groups Demand Resignation of HHS Secretary RFK Jr.  Trump-Appointed CDC Director Dr. Susan Monarez Fired After Clashes With Secretary Kennedy RFK Jr.'s Second in Command Named CDC Acting Director Following Sudden Firing Federal Layoffs to Hit HHS Amid Government Shutdown, May Affect Food Safety Staffers FDA Delays FSMA 204 Traceability Rule Compliance Date by 30 Months States and the "Make America Healthy Again" (MAHA) movement declare war on "toxic" food chemicals and ultra-processed foods (UPFs) [27:52]: FDA Announces Plan to Phase Out Synthetic, Petroleum-Based Food Dyes From U.S. Food Supply Bonus Episode: Diamantas and Choiniere: FDA Focuses on Produce Safety, MAHA, Culture, and More MAHA Report Sets Stage for Overhaul of Food Chemicals, Environmental Contaminants, and Childhood Nutrition What the Final MAHA Report Could Mean for Food Safety FDA Announces 'Proactive' Post-Market Chemical Review Program to Keep Food Supply Safe FDA Adds Six Artificial Food Dyes to List of Chemicals Under Post-Market Review FDA to Issue Proposed Rule Tightening GRAS Oversight FDA's Developing Rule to Tighten GRAS Oversight Moves to White House FDA, USDA Issue Joint RFI to Address the Risks of Ultra-Processed Foods  California Enacts Law Defining Ultra-Processed Foods, Will Ban UPFs in Schools  Food Industry Stakeholders Share Input on FDA, USDA's Intent to Define UPFs MAHA Pushback Kills 'Big Food'-Aligned Legislative Effort to Stop State Food Laws Industry Giants Support New Coalition Aimed at Stopping MAHA-Aligned State Food Additive Bans More Than 80 Groups Urge Congress Not to Block State Food Additives Bans Ep. 187. Rainer and Coneski: Evolving Legislation Around Food Packaging Chemicals and Additives—Implications for Industry Ep. 199. George Misko: The Future of Food Regulation Under MAHA Ep. 162. Brian Sylvester: How the California Food Safety Act is Shaping U.S. Food Additives Regulation Ep. 207. Brian Sylvester: Preparing for 'MAHA'-Driven Policy Changes on Food Dyes, UPFs, GRAS FDA's focus on infant formula safety and the infant botulism outbreak linked to ByHeart formula [57:44]: FDA Publishes Long-Term Strategy to Increase Resiliency of U.S. Infant Formula Market FDA Launches 'Operation Stork Speed' to Improve Infant Formula Safety, Including Contaminant Testing Infants Nationwide Hospitalized With Botulism After Consuming ByHeart Formula ByHeart Outbreak Grows: 31 Infants in 15 States Hospitalized for Botulism From Tainted Formula Infant Botulism Spike Exceeds 100 Cases, Extent of ByHeart's Involvement Unclear A History of Food Safety Failures at ByHeart, the Formula Company Behind Infant Botulism Outbreak  ByHeart Finds Widespread Contamination in Infant Formula as Botulism Outbreak Grows; FDA Publishes Inspection Reports Coalition Urges RFK Jr. to Fix Infant Formula Oversight Problems that Allowed Infant Botulism Outbreak FDA Urges Industry to Improve Recall Efficiency After Delay in Removing ByHeart Formula from Stores Emerging science on Listeria monocytogenes and biofilms [1:08:26]: Study Shows Water Hoses as Reservoirs for Biofilms in Food Processing Facilities Study Demonstrates Listeria's Ability to Colonize, Survive in Preexisting Multispecies Biofilms First-of-its-Kind Study Shows How Listeria Strains Evolve Into Strong Biofilm Formers Study Explores Sanitizer Limitations Against Listeria Biofilms in Leafy Greens Production Listeria From Multispecies Biofilms More Prone to Growth in RTE Foods, Study Shows Study Shows Combining Antimicrobial Blue Light and Chemical Sanitizers Can Enhance Listeria Inactivation FAO/WHO Developing Risk Assessment Models for Listeria in Four Food Commodity Groups The ongoing Highly Pathogenic Avian Influenza H5N1 (HPAI H5N1) outbreak in U.S. dairy cattle and poultry flocks and continued monitoring to ensure food safety [1:14:09]: California Declares State of Emergency Over HPAI H5N1 Outbreak in Dairy Cows  USDA Begins Five-Part National Milk Testing Strategy for HPAI H5N1  USDA Extends H5N1 Testing in Dairy Cattle; EU Releases Guidance on Avian Flu Prevention CDC: Avoid Consuming Raw Milk, as Risk of Bird Flu Infection is Low but Possible FDA-Backed Study Shows Aging Raw Milk Cheese Does Not Inactivate Avian Flu, but Low pH Helps Study Shows Avian Flu Does Not Pose Food Safety Risk in Various Pasteurized Dairy Products  USDA to Invest in Farm Biosecurity, Chicken Vaccinations to Combat Avian Influenza Study Shows Acidification is Inexpensive, Easy Way to Inactivate Bird Flu in Raw Waste Milk FDA Now Requires Raw Pet Food Manufacturers to Consider HPAI in Food Safety Plans  House Cat Dies After Eating Raw Pet Food Contaminated With HPAI H5N1 FDA-Backed Study Shows Aging Raw Milk Cheese Does Not Inactivate Avian Flu, but Low pH Helps H5N1 and the Growing Risk to Food Safety—Why Raw Milk Requires Special Attention FDA Begins Testing Assignment for HPAI H5N1 in Aged Raw Cow Milk Cheese  FAO Encourages All Countries to Monitor for HPAI H5N1 Spread to Cattle  Dutch Field Studies Show Promise for Two Experimental Avian Flu H5N1 Vaccines  Federal Workforce Data Reveal Impact of Trump Admin RIFs on USDA Food Safety Expertise Growing artificial intelligence (AI) applications for food safety [1:17:57]: FAO Report Highlights Needs for Responsible AI Adoption in Food Safety Fields FDA Announces Completion of First AI-Assisted Scientific Review Pilot and Agency-Wide AI Rollout Timeline Using AI, Researchers Offer Promising Real-Time Mycotoxin Detection Method for Foods Big Data, AI, and the Coming Philosophical Challenges with Food Safety Welcome to the Machine: AI and Potential Implications for the Food Industry Ep. 193. Christian Ararat: A Global Perspective on Auditing, Certifications, AI, and Beyond  Ep. 205. Black and Gabor: Digital Transformation and Emerging International Standards for Food Safety We Want to Hear from You! Please send us your questions and suggestions to podcast@food-safety.com

    TD Ameritrade Network
    Tuesday's Final Takeaways: Gold/Silver High, Weight Loss Pill Approved, Bitcoin Pulls Back

    TD Ameritrade Network

    Play Episode Listen Later Dec 23, 2025 4:19


    Marley Kayden and Jenny Horne discuss their takeaways for today. They discuss economic data, as well as gold and silver hitting new highs. They also note that the FDA approved a Wegovy weight loss pill. They then highlight that Bitcoin pulled back.======== Schwab Network ========Empowering every investor and trader, every market day. Subscribe to the Market Minute newsletter - https://schwabnetwork.com/subscribeDownload the iOS app - https://apps.apple.com/us/app/schwab-network/id1460719185Download the Amazon Fire Tv App - https://www.amazon.com/TD-Ameritrade-Network/dp/B07KRD76C7Watch on Sling - https://watch.sling.com/1/asset/191928615bd8d47686f94682aefaa007/watchWatch on Vizio - https://www.vizio.com/en/watchfreeplus-exploreWatch on DistroTV - https://www.distro.tv/live/schwab-network/Follow us on X – https://twitter.com/schwabnetworkFollow us on Facebook – https://www.facebook.com/schwabnetworkFollow us on LinkedIn - https://www.linkedin.com/company/schwab-network/ About Schwab Network - https://schwabnetwork.com/about

    WALL STREET COLADA
    Santa Rally, Wegovy Oral y el Despegue de la 'Golden Fleet

    WALL STREET COLADA

    Play Episode Listen Later Dec 23, 2025 2:02


    En este cierre de año, Wall Street busca impulso mientras los mercados se preparan para una semana corta por las festividades. Aquí están los temas clave del día:

    Lung Cancer Considered
    Lung Cancer Considered: A New Shot at Progress: Amivantamab Goes SubQ

    Lung Cancer Considered

    Play Episode Listen Later Dec 23, 2025 35:43


    The FDA has approved subcutaneous amivantamab. Join host Dr. Narjust Florez and guests, Dr. Natasha Leighl and Dr. Federico Cappuzzo, as they explore the science and convenience factor, as well as what this shift means for patients, clinicians, and oncology practice.

    The Todd Herman Show
    Jenner Furst, Director of the Latest Angel Studios Documentary Joins the Show Ep-2498

    The Todd Herman Show

    Play Episode Listen Later Dec 22, 2025 49:07 Transcription Available


    Angel Studios https://Angel.com/HermanJoin the Angel Guild today where you can stream Thank You, Dr. Fauci and be part of the conversation demanding truth and accountability.  Renue Healthcare https://Renue.Healthcare/ToddYour journey to a better life starts at Renue Healthcare. Visit https://Renue.Healthcare/Todd Bulwark Capital https://KnowYourRiskPodcast.comBe confident in your portfolio with Bulwark! Schedule your free Know Your Risk Portfolio review. Go to KnowYourRiskPodcast.com today. Alan's Soaps https://www.AlansArtisanSoaps.comUse coupon code TODD to save an additional 10% off the bundle price.Bonefrog https://BonefrogCoffee.com/ToddThe new GOLDEN AGE is here! Use code TODD at checkout to receive 10% off your first purchase and 15% on subscriptions.LISTEN and SUBSCRIBE at:The Todd Herman Show - Podcast - Apple PodcastsThe Todd Herman Show | Podcast on SpotifyWATCH and SUBSCRIBE at: Todd Herman - The Todd Herman Show - YouTubeJenner Furst, director of the latest Angel Studios documentary "Thank You Dr. Fauci" joins the show.Episode Links:Thank You Dr. Fauci | Now Streaming | AngelBREAKING/URGENT: mRNA COVID VACCINES KILLED AT LEAST 10 KIDS, THE FDA REPORTS; An FDA review found the shots to blame for the deaths, FDA's new vaccine chief - Dr. Vinay Prasad - told staffers in an email. The agency will tighten standards on new vaccine approval, Prasad wrote.Fauci's Ebola stuntURGENT: mRNA Covid jabs should NEVER have been approved for children or young adults Pfizer, Moderna, the Biden Administration, and everyone in public health who pushed these for kids and teens have blood on their handsUnmask The Truth | Official Clip | Thank You, Dr. Fauci

    Psychedelics Today
    Tricia Eastman: Seeding Consciousness, Ancestral Wisdom, and Psychedelic Initiation

    Psychedelics Today

    Play Episode Listen Later Dec 22, 2025 73:19


    In this live episode, Tricia Eastman joins to discuss Seeding Consciousness: Plant Medicine, Ancestral Wisdom, Psychedelic Initiation. She explains why many Indigenous initiatory systems begin with consultation and careful assessment of the person, often using divination and lineage-based diagnostic methods before anyone enters ceremony. Eastman contrasts that with modern frameworks that can move fast, rely on short trainings, or treat the medicine as a stand-alone intervention. Early Themes: Ritual, Preparation, and the Loss of Container Eastman describes her background, including ancestral roots in Mexico and her later work at Crossroads Ibogaine in Mexico, where she supported early ibogaine work with veterans. She frames her broader work as cultural bridging that seeks respect rather than fetishization, and assimilation into modern context rather than appropriation. Early discussion focuses on: Why initiatory traditions emphasize purification, preparation, and long timelines Why consultation matters before any high-intensity medicine work How decades of training shaped traditional initiation roles Why people can get harmed when they treat medicine as plug and play Core Insights: Alchemy, Shadow, and Doing the Work A major throughline is Eastman's critique of the belief that a psychedelic alone will erase trauma. She argues that shadow work remains part of the human condition, and that healing is less about a one-time fix and more about building capacity for relationship with the unconscious. Using alchemical language, she describes "nigredo" as fuel for the creative process, not as something to eliminate forever. Key insights include: Psychedelics are tools, not saviors You cannot outsource responsibility to a pill, a modality, or a facilitator Progress requires practice, discipline, and honest engagement with what arises "Healing" often shows up as obstacles encountered while trying to live and create Later Discussion and Takeaways: Iboga, Ethics, and Biocultural Stewardship Joe and Tricia move into a practical and ethically complex discussion about iboga supply chains, demand pressure, and the risks of amplifying interest without matching it with harm reduction and reciprocity. Eastman emphasizes medical screening, responsible messaging, and supporting Indigenous-led stewardship efforts. She also warns that harm can come from both under-trained modern facilitators and irresponsible people claiming traditional legitimacy. Concrete takeaways include: Treat iboga and ibogaine as high-responsibility work that demands safety protocols Avoid casual marketing that encourages risky self-administration Support Indigenous-led biocultural stewardship and reciprocity efforts Give lineage carriers a meaningful seat at the table in modern policy and clinical conversations Frequently Asked Questions Who is Tricia Eastman? Tricia Eastman is an author, facilitator, and founder of Ancestral Heart. Her work focuses on cultural bridging, initiation frameworks, and Indigenous-led stewardship. What is Seeding Consciousness about? The book examines plant medicine through initiatory traditions, emphasizing consultation, ritual, preparation, and integration rather than reductionistic models. Why does Tricia Eastman critique modern psychedelic models? She argues that many models remove the ritual container and long-form preparation that reduce risk and support deeper integration. Is iboga or ibogaine safe? With the right oversite, yes. Eastman stresses that safety depends on cardiac screening, careful protocols, and experienced oversight. She warns against informal or self-guided use. How can people support reciprocity and stewardship? She encourages donating or supporting Indigenous-led biocultural stewardship initiatives like Ancestral Heart and aligning public messaging with harm reduction. Closing Thoughts This episode makes a clear case that Tricia Eastman Seeding Consciousness is not only a book about psychedelics, but a critique of how the field is developing. Eastman argues that a successful future depends on mature containers, serious safety culture, and respectful partnership with lineage carriers, especially as interest in iboga and ibogaine accelerates. Links https://www.ancestralheart.com https://www.innertraditions.com/author/tricia-eastman Transcript Joe Moore Hello, everybody. Welcome back. Joe Moore with you again from Psychedelics Today, joined today by Tricia Eastman. Tricia, you just wrote a book called Seeding Consciousness. We're going to get into that a bunch today, but how are you today? [00:00:16.07] - Tricia Eastman I'm so good. It's exciting to be live. A lot of the podcasts I do are offline, and so it's like we're being witnessed and feels like just can feel the energy behind It's great. [00:00:31.11] - Joe Moore It's fun. It's a totally different energy than maybe this will come out in four months. This is real, and there's people all over the world watching in real-time. And we'll get some comments. So folks, if you're listening, please leave us some comments. And we'd love to chat a little bit later about those. [00:00:49.23] - Tricia Eastman I'm going to join the chat so that I can see... Wait, I just want to make sure I'm able to see the comments, too. Do I hit join the chat? [00:01:01.17] - Joe Moore Sometimes you can, sometimes you can't. I can throw comments on the screen so we can see them together. [00:01:07.02] - Tricia Eastman Cool. [00:01:08.03] - Joe Moore Yeah. So it'll be fun. Give us comments, people. Please, please, please, please. Yeah, you're all good. So Tricia, I want to chat about your book. Tell us high level about your book, and then we're going to start digging into you. [00:01:22.10] - Tricia Eastman So Seeding Consciousness is the title, and I know it's a long subtitled Plant Medicine, Ancestral Wisdom, Psychedelic Initiation. And I felt like it was absolutely necessary for the times that we are in right now. When I was in Gabon in 2018, in one of my many initiations, as as an initiative, the Fung lineage of Buiti, which I've been practicing in for 11 years now, I was given the instructions. I was given the integration homework to write this book. And I would say I don't see that as this divine thing, like you were given the assignment. I think I was given the assignment because it's hard as F to write a book. I mean, it really tests you on so many levels. I mean, even just thinking about putting yourself out there from a legal perspective, and then also, does it make any sense? Will anyone buy it? And on Honestly, it's not me. It's really what I was given to write, but it's based on my experience working with several thousand people over the years. And really, the essence of it is that in our society, we've taken this reductionistic approach in psychedelics, where we've really taken out the ritual. [00:02:54.05] - Tricia Eastman Even now with the FDA trial for MDMA for PTSD. There's even conversations with a lot of companies that are moving forward, psychedelics, through the FDA process, through that pathway, that are talking about taking the therapy out. And the reality is that in these ancient initiatic traditions, they were very long, drawn out experiences with massive purification rituals, massive amounts of different types of practice in order to prepare oneself to meet the medicine. Different plants were taken, like vomatifs and different types of purification rituals were performed. And then you would go into this profound initiatic experience because the people that were working with you that were in, we call it the Nema, who gives initiations, had decades of training and experience doing these types of initiatic experiences. So if you compare that to the modern day framework, we have people that go online and get a certificate and start serving people medicine or do it in a context where maybe there isn't even an established container or facilitator whatsoever. And so really, the idea is, how can we take the essence of this ancient wisdom wisdom, like when you look at initiation, the first step is consultation, which is really going deep into the history of the individual using different types of techniques that are Indigenous technologies, such as different forms of divination, such as cowrie shell readings. [00:04:52.18] - Tricia Eastman And there's different types of specific divinations that are done in different branches of And before one individual would even go into any initiation, you need to understand the person and where they're coming from. So it's really about that breakdown of all of that, and how can we integrate elements of that into a more modern framework. [00:05:24.23] - Joe Moore Brilliant. All right. Well, thank you for that. And let's chat about you. You've got a really interesting past, very dynamic, could even call it multicultural. And you've got a lot of experience that informed this book. So how did this stuff come forward for you? [00:05:50.02] - Tricia Eastman I mean, I've never been the person to seek anything. My family on my mother's side is from Mexico, from Oaxaca, Trique, Mixtec, and Michica. And we had a long lineage of practice going back to my, at least I know from my great, great grandmother, practicing a blend of mestiza, shamanism, combining centerea and Catholicism together. So it's more of like a syncratic mestiza, mestiza being mixed tradition. And so I found it really interesting because later on, when my grandfather came to the United States, he ended up joining the military. And in being in the US, he didn't really have a place. He's very devout spiritual man, but he didn't have a place to practice this blended spiritual tradition. So the mystical aspect of it went behind. And as I started reconnecting to my ancestral lineage, this came forth that I was really starting to understand the mystical aspect of my ancestry. And interestingly, at the same time, was asked to work at Crossroads Abigain in Mexico. And it's so interesting to see that Mexico has been this melting pot and has been the place where Abigain has chosen to plant its roots, so to say, and has treated thousands of veterans. [00:07:36.28] - Tricia Eastman I got to be part of the group of facilitators back over 10 years ago. We treated the first Navy Seals with Abogaine, and that's really spurred a major interest in Abogaine. Now it's in every headline. I also got 10 I got initiated into the Fung lineage of Buiti and have really studied the traditional knowledge. I created a nonprofit back in 2019 called Ancestral Heart, which is really focused on Indigenous-led stewardship. Really, the book helps as a culmination of the decade of real-world experience of combining My husband, Dr. Joseph Barzulia. He's a psychologist. He's also a pretty well-known published researcher in Abigain and 5MEO-DMT, but also deeply spiritual and deeply in respect for the Indigenous traditions that have carried these medicines before us. So we've really been walking this complex path of world bridging between how we establish these relationships and how we bring some of these ancient knowledge systems back into the forefront, but not in a way of fetishizing them, but in a way of deeply respecting them and what we can learn, but from our own assimilation and context versus appropriation. So really, I think the body of my work is around that cultural bridging. [00:09:31.07] - Joe Moore That's brilliant. And yeah, there's some really fun stuff I learned in the book so far that I want to get into later. But next question is, who is your intended audience here? Because this is an interesting book that could hit a few categories, but I'm curious to hear from you. [00:09:49.02] - Tricia Eastman It's so funny because when I wrote the book, I wasn't thinking, oh, what's my marketing plan? What's my pitch? Who's my intended audience? Because it was my homework, and I knew I needed to write the book, and maybe that was problematic in the sense that I had to go to publishers and have a proposal. And then I had to create a formula in hindsight. And I would say the demographic of the book mirrors the demographic of where people are in the psychedelic space, which It's skewed slightly more male, although very female. I think sex isn't necessarily important when we're thinking about the level of trauma and the level of spiritual healing and this huge deficit that we have in mental health, which is really around our disconnection from our true selves, from our heart, from our souls, from this idea of of what Indigenous knowledge systems call us the sacred. It's really more of an attitude of care and presence. I'm sure we could give it a different name so that individuals don't necessarily have any guard up because we have so much negative conditioning related to the American history of religion, which a lot of people have rejected, and some have gone back to. [00:11:37.06] - Tricia Eastman But I think we need to separate it outside of that. I would say the demographic is really this group of I would say anywhere from 30 to 55 male females that are really in this space where maybe they're doing some of the wellness stuff. They're starting to figure some things out, but it's just not getting them there. And when something happens in life, for example, COVID-19 would be a really great example. It knocks them off course, and they just don't have the tools to find that connection. And I would say it even spans across people that do a lot of spiritual practice and maybe are interested in what psychedelics can do in addition to those practices. Because when we look at my view on psychedelics, is they fit within a whole spectrum of wellness and self-care and any lineage of spiritual practice, whether it's yoga or Sufism or Daoist tradition. But they aren't necessarily the thing that... I think there's an over focus on the actual substance itself and putting it on a pedestal that I think is problematic in our society because it goes back to our religious context in the West is primarily exoteric, meaning that we're seeking something outside of ourselves to fulfill ourselves. [00:13:30.29] - Tricia Eastman And so I think that when we look at psychedelic medicines as this exoteric thing versus when we look at initiatory traditions are about inward and direct experience. And all of these spiritual practices and all of these modalities are really designed to pull you back into yourself, into having a direct relationship with yourself and direct experience. And I feel like the minute that you are able to forge that connection, which takes practice and takes discipline, then you don't need to necessarily look at all these other tools outside of yourself. It's like one of my favorite analogies is the staff on the Titanic were moving the furniture around as it was sinking, thinking that they might save the boat from sinking by moving the furniture around. I think that's how we've been with a lot of ego-driven modalities that aren't actually going into the full unconscious, which is where we need to go to have these direct experiences. Sorry for the long answer, but it is for everybody, and it's not just about psychedelics. Anyone can take something from this doing any spiritual work. But we talk a lot about the Indigenous philosophy and how that ties in alongside with spiritual practice and more of this inner way of connecting with oneself and doing the work. [00:15:21.22] - Tricia Eastman And I think also really not sugar coating it in the sense that the psychedelics aren't going to save us. They're not going to cure PTSD. Nothing you take will. It's you that does the work. And if you don't do the work, you're not going to have an 87 % success rate with opioid use disorder or whatever it is, 60 something % for treatment-resistant depression or whatever. It's like you have to do the work. And so we can't keep putting the power in the modality reality or the pill. [00:16:03.18] - Joe Moore Yeah, that makes sense. So you did an interesting thing here with this book, and it was really highlighting aspects of the alchemical process. And people don't necessarily have exposure. They hear the words alchemy. I get my shoulders go up when I hear alchemizing, like transmutation. But it's a thing. And how do we then start communicating this from Jung? I found out an interesting thing recently as an ongoing student. Carl Jung didn't necessarily have access to all that many manuscripts. There's so many alchemical manuscripts available now compared to what he had. And as a result, our understanding of alchemy has really evolved. Western alchemy, European alchemy, everybody. Perhaps Kmetic, too. I don't know. You could speak to that more. I don't keep track of what's revealed in Egypt. So it's really interesting to present that in a forward way? How has it been received so far? Or were you nervous to present this in this way? [00:17:25.10] - Tricia Eastman I mean, honestly, I think the most important The important thing is that in working with several thousand people over the years, people think that taking the psychedelic and the trauma is going to go away. It's always there. I mean, we We archetypically will have the shadow as long as we need the shadow to learn. And so even if we go into a journey and we transcend it, it's still there. So I would say that the The feedback has been really incredible. I mean, the people that are reading... I mean, I think because I'm weaving so many different, complex and deep concepts into one book, it might be a little harder to market. And I think the biggest bummer was that I was really trying to be respectful to my elders and not say anything in the title about Iboga and Abigain, even though I talk a lot about it in the book, and it's such a hot topic, it's really starting to take off. But the people that have read it really consider it. They really do the work. They do the practices in the book, and I'm just getting really profound feedback. So that's exciting to me because really, ultimately, alchemy... [00:18:55.22] - Tricia Eastman Yeah, you're right. It gets used Used a lot in marketing lingo and sitting in the depth of the tar pit. For me, when I was in Gabon, I remember times where I really had to look at things that were so dark in my family history that I didn't even realize were mine until later connected to my lineage. And the dark darkness connected to that and just feeling that and then knowing really the truth of our being is that we aren't those things. We're in this process of changing and being, and so nothing is is fixed, but there is a alchemical essence in just learning to be with it. And so not always can we just be with something. And and have it change, but there are many times that we can actually just be with those parts of ourselves and be accepting, where it's not like you have to have this intellectualized process It's just like, first you have the negrado, then you tune into the albeda, and you receive the insights, and you journal about it, and da, da, da, da, da Action, Mars aspect of it, the rubeda of the process. It's not like that at all. [00:20:44.15] - Tricia Eastman It's really that the wisdom that comes from it because you're essentially digesting black goo, which is metaphoric to the oil that we use to power all of society that's pulled deep out of the Earth, and it becomes gold. It becomes... And really, the way I like to think of it is like, in life, we are here to create, and we are not here to heal ourselves. So if you go to psychedelic medicine and you want to heal yourself, you're going to be in for... You're just going to be stuck and burnt out because that's not what we're here to do as human beings, and you'll never run out of things to heal. But if you You think of the negrado in alchemy as gasoline in your car. Every time you go back in, it's like refilling your gas tank. And whatever you go back in for as you're moving in the journey, it's almost like that bit of negrado is like a lump of coal that's burning in the gas tank. And that gets you to the next point to which there's another thing related to the creative process. So it's like As you're going in that process, you're going to hit these speed bumps and these obstacles in the way. [00:22:07.29] - Tricia Eastman And those obstacles in the way, that's the healing. So if you just get in the car in the human vehicle and you drive and you continue to pull out the shadow material and face it, you're going to keep having the steam, but not just focus on it, having that intention, having that connection to moving forward in life. And I hate to use those words because they sound so growth and expansion oriented, which life isn't always. It's evolutionary and deevolutionary. It's always in spirals. But ultimately, you're in a creative process would be the best way to orient it. So I think when we look at alchemy from that standpoint, then it's productive. Effective. Otherwise, it sounds like some brand of truffle salt or something. [00:23:09.12] - Joe Moore Yeah, I think it's a... If people want to dig in, amazing. It's just a way to describe processes, and it's super informative if you want to go there, but it's not necessary for folks to do the work. And I like how you framed it quite a bit. So let's see. There is one bit, Tricia, that my ears really went up on this one point about a story about Actually, let me do a tangent for you real quick, and then we're going to come back to this story. So are you familiar with the tribe, the Dogon, in Africa? Of course. Yeah. So they're a group that looks as though they were involved in Jewish and/or Egyptian traditions, and then ended up on the far side of like, what, Western Africa, far away, and had their own evolution away from Egypt and the Middle East. Fascinating. Fascinating stories, fascinating astronomy, and much more. I don't know too much about the religion. I love their masks. But this drew an analogy for me, as you were describing that the Buiti often have stories about having lineage to pre-dynastic Egyptian culture. I guess we'll call it that for now, the Kometic culture. [00:24:44.23] - Joe Moore I had not heard that before. Shame on me because I haven't really read any books about Buiti as a religion or organization, or anything to this point. But I found that really interesting to know that now, at least I'm aware of two groups claiming lineage to that ancient world of magic. Can you speak about that at all for us? Yeah. [00:25:09.24] - Tricia Eastman So first off, there really aren't any books talking about that. Some of the things I've learned from elders that I've spoke with and asked in different lineages in Masoco and in Fong Buiti, there's a few things. One, We lived in many different eras. Even if you go into ancient texts of different religions, creation stories, and biblical stories, they talk about these great floods that wiped out the planet. One of the things that Atum talks about, who is one of my Buiti fathers who passed a couple years ago, is Is the understanding that before we were in these different areas, you had Mu or Lumaria, you had Atlantis, and then you had our current timeline. And the way that consciousness was within those timelines was very different and the way the Earth was. You had a whole another continent called Atlantis that many people, even Plato, talks about a very specific location of. And what happened, I believe during that time period, Africa, at least the Saharan band of the desert was much more lush, and it was a cultural melting pot. So if you think about, for example, the Pygmy tribes, which are in Equatorial Africa, they are the ones that introduced Iboga to the Buiti. [00:27:08.08] - Tricia Eastman If you look at the history of ancient Egypt, what I'm told is that the Pygmies lived in Pharaonic Egypt, all the way up until Pharaonic Egypt. And there was a village. And if you look on the map in Egypt, you see a town called Bawiti, B-A-W-I-T-I. And that is the village where they lived. And I have an interesting hypothesis that the God Bess, if you look at what he's wearing, it's the exact same to a T as what the Pygmies wear. And the inspiration for which a lot of the Buiti, because they use the same symbology, because each part of the outfit, whether it's the Mocingi, which is like this animal skin, or the different feathers, they use the parrot feather as a symbology of speech and communication, all of these things are codes within the ceremony that were passed along. And so when you look at Bess, he's wearing almost the exact same outfit that the Pygmies are wearing and very similar to if you see pictures of the ceremonies of Misoko or Gonde Misoko, which I would say is one of the branches of several branches, but that are closer to the original way of Buiti of the jungle, so closer to the way the Pygmies practice. [00:28:59.16] - Tricia Eastman So If you look at Bess, just to back my hypothesis. So you look at Neteru. Neteru were the... They called them the gods of Egypt, and they were all giant. And many say the word nature actually means nature, but they really represented the divine qualities of nature. There's best. Look at him. And a lot of the historians said he's the God of Harmeline and children and happiness. I think he's more than the God of Harmeline, and I think that the Pygmies worked with many different plants and medicines, and really the ultimate aspect of it was freedom. If you think about liberation, like the libation, number one, that's drunkiness. Number two, liberation, you of freeing the joyous child from within, our true nature of who we are. You look at every temple in Egypt, and you look at these giant statues, and then you have this tiny little pygmy God, and there's no other gods that are like Bess. He's one of a kind. He's in his own category. You've You've got giant Hathor, you've got giant Thoth, you've got giant Osiris, Isis, and then you've got little tiny Bess. And so I think it backs this hypothesis. [00:30:48.27] - Tricia Eastman And my understanding from practitioners of Dogon tradition is that they also believe that their ancestors came from Egypt, and they definitely have a lot of similarity in the teachings that I've seen and been exposed to just from here. I mean, you can... There's some more modern groups, and who's to know, really, the validity of all of it. But there are some, even on YouTube, where you can see there's some more modern Dogon temples that are talking in English or English translation about the teachings, and they definitely line up with Kamehdi teachings. And so my hypothesis around that is that the Dogon are probably most likely pygmy descendants as, And the pygmy were basically run out of Bawiti because there was jealousy with the priest, because there was competition, because all of the offerings that were being made in the temple, there was a lot of power, connected to each of the temples. And there was competitiveness even amongst the different temples, lining the Nile and all of that, of who was getting the most offerings and who was getting the most visits. And so the Pygmies essentially were run out, and they migrated, some of them migrated south to Gabon and Equatorial Africa. [00:32:43.07] - Tricia Eastman And then If you think about the physical changes that happened during these planetary catastrophes, which we know that there had been more than one based on many historical books. So that whole area went through a desertification process, and the Equatorial rainforest remained. So it's highly likely even that Iboga, at one point, grew in that region as well. [00:33:18.00] - Joe Moore Have you ever seen evidence of artwork depicting Iboga there in Egypt? [00:33:24.17] - Tricia Eastman There are several different death temples. I'm trying to remember the name of the exact one that I went to, but on the columns, it looked like Iboga trees that were carved into the columns. And I think what's interesting about this... So Seychet is the divine scribe, the scribe of Egyptian wisdom. And she was basically, essentially the sidekick of Thoth. Thoth was who brought a lot of the ancient wisdom and people like Pythagoras and many of the ancient philosophers in Roman times went and studied in a lot of these Thoth lineage mystery schools. When you look at the the river of the Nile on the east side, east is the energy liturgy of initiation. It's always like if you go into a sweat lodge or if you see an ancient temple, usually the doorway is facing the east. West is where the sun sets, and so that's the death. And what's interesting about that is that it was on the west side in the death temple that you would see these aboga plants. But also Seixat was the one who was the main goddess depicted in the hieroglyphs, and there was other hieroglyphs. I mean, if you look at the hieroglyphs of Seixat, it looks like she has a cannabis leaf above her head, and a lot of people have hypothesized that, that it's cannabis. [00:35:16.03] - Tricia Eastman Of course, historians argue about that. And then she's also carrying a little vessel that looks like it has some mushrooms in it. And obviously, she has blue Lotus. Why would she be carrying around blue Lotus and mushrooms? I don't know. It sounds like some initiation. [00:35:36.19] - Joe Moore Yeah, I love that. Well, thanks so much for going there with me. This photo of Seixet. There's some good animations, but everybody just go look at the temple carvings picturing this goddess. It's stunning. And obviously, cannabis. I think it's hard to argue not. I've seen all these like, mushroom, quote, unquote, mushroom things everywhere. I'm like, Yeah, maybe. But this is like, Yes, that's clear. [00:36:06.27] - Tricia Eastman And if you look at what she's wearing, it's the exact same outfit as Bess, which is classic Basically, how the medicine woman or medicine man or what you would call shaman, the outfit that the healers would wear, the shamans or the oracles, those of the auracular arts, different forms of divination would wear. So if you really follow that and you see, Oh, what's Isis wearing? What's Hathor wearing? What's Thoth wearing? You can tell she's very specifically the healer. And it's interesting because they call her the divine scribe. So she's actually downloading, my guess is she's taking plants and downloading from the primordial. [00:37:02.00] - Joe Moore Well, okay. Thanks for bringing that up. That was a lovely part of your book, was your... There's a big initiation sequence, and then you got to go to this place where you could learn many things. Could you speak to that a little bit? And I hope that's an okay one to bring up. [00:37:22.22] - Tricia Eastman Are you talking about the time that I was in initiation and I went to the different ashrams, the different realms in, like Yogananda calls them astral schools that you go and you just download? It seemed like astral schools, but it seemed like it was a Bwiti initiation, where you were in silence for three days, and then Yeah, that one. So there were several different... I mean, I've done seven official initiations, and then I've had many other initiatic experiences. And I would say this one was incredible. Incredibly profound because what it showed me first was that all of the masters of the planet, it was showing me everyone from Kurt Cobain to Bob Marley to Einstein, all the people that had some special connection to an intelligence that was otherworldly, that they were essentially going to the same place, like they were visiting the same place, and they would go. And so the first thing I noticed was that I recognized a lot of people, and current, I'm not going I don't want to say names of people, but I recognize people that are alive today that I would say are profound thinkers that were going to these places as well. [00:38:57.05] - Tricia Eastman And interestingly, then I was taken into one of the classrooms, and in the classroom, this one, specifically, it showed me that you could download any knowledge instantaneously That essentially, having a connection to that school allowed you to download music or understand very complex ideas ideas of mathematics or physics or science that would take people like lifetimes to understand. So it was essentially showing this. And a lot of people might discredit that, that that might be a specific... That we as humans can do that. Well, I'm not saying that it's not that. I don't I don't want to say that it's anything. But what I can say is that I have definitely noticed the level of access that I have within my consciousness. And also what I notice with the masters of Bwiti, specifically in terms of the level of intelligence that they're accessing and that it's different. It's got a different quality to it. And so it was a really profound teaching. And one of the things, too, that I've learned is I use it to help me learn specific things. I don't know if I can give a positive testimonial, but I am learning French. [00:40:55.00] - Tricia Eastman And I noticed when I was in Aspen at the Abigain meeting, and I was with Mubeiboual, who speaks French, I started saying things French that I didn't even realize that I knew to say. I've had these weird moments where I'm actually using this tool And I'm also using it. I have a Gabonese harp. I don't know if you can see it up on the shelf over there. But I also went and asked for some help with downloading some assistance in the harp, then we'll see how that goes. [00:41:38.17] - Joe Moore Yeah. So that's brilliant. I'm thinking of other precedent for that outside of this context, and I can think of a handful. So I love that, like savant syndrome. And then there's a classic text called Ars Notoria that helps accelerate learning, allegedly. And then there's a number of other really interesting things that can help us gain these bits of wisdom and knowledge. And it does feel a little bit like the Dogon. The story I get is the receiving messages from the dog star, and therefore have all sorts of advanced information that they shouldn't we call it. Yeah. Yeah, which is fascinating. We have that worldwide. I think there's plenty of really interesting stuff here. So what I appreciated, Tricia, about how you're structuring your book, or you did structure your book, is that it it seems at the same time, a memoir, on another hand, workbook, like here are some exercises. On the other hand, like here's some things you might try in session. I really appreciated that. It was like people try to get really complicated when we talk about things like IFS. I'm like, well, you don't necessarily have to. You could. Or is this just a human thing, a human way to look at working with our parts? [00:43:20.15] - Joe Moore I don't know. Do you have any thoughts about the way you were approaching this parts work in your book versus how complicated some people make it feel? [00:43:30.00] - Tricia Eastman Yeah. I find that this is just my personal opinion, and no way to discredit Richard Schwartz's work. But parts work has existed in shamanism since forever. When we really look at even in ancient Egypt, Issus, she put Osiris act together. That was the metaphorical story of soul retrieval, which is really the spiritual journey of us reclaiming these pieces of ourselves that we've been disconnected from a society level or individually. And within the context of parts work, it's very organic and it feels other worldly. It's not like there's ever a force where I'm in the process with someone. And a lot of times I would even go into the process with people because they weren't accustomed to how to work with Iboga or game, and so they would be stuck. And then the minute I was like, you know, Iboga, in the tradition, it's really about... It's like the game Marco Polo. It's call and response. And so you're really an active participant, and you're supposed to engage with the spirits. And so the minute that things would show up, it'd be more about like, oh, what do you see? What's coming up here? Asking questions about it, being curious. [00:45:17.07] - Tricia Eastman If you could engage with it, sometimes there's processes where you can't really engage with things at all. So everything that I'm talking about is It was organically shown up as an active engagement process that it wasn't like we were going in. There have been some where you can guide a little bit, but you never push. It might be something like, go to your house, and it being completely unattached. And if they can't go there, then obviously the psyche doesn't want to go there, but it's really an exercise to help them to connect to their soul. And then in contrast, IFS is like, let's work on these different parts and identify these different parts of ourselves. But then let's give them fixed titles, and let's continually in a non-altered state of consciousness, not when we're meditating, not when we're actively in a state where we have the plasticity to change the pathway in the unconscious mind, but we're working in the egoic mind, and we're talking to these parts of ourselves. That could be helpful in the day-to-day struggles. Let's say you have someone who has a lot of rumination or a very active mind to have something to do with that. [00:46:57.01] - Tricia Eastman But that's not going to be the end-all, be-all solution to their problem. It's only moving the deck chairs around on the Titanic because you're still working in the framework where, I'm sorry, the Titanic is still sinking, and it may or may not be enough. It may or may not produce a reliable outcome that could be connected with some level of true relief and true connection within oneself. And so I think that people just... I feel like they almost get a little too... And maybe it's because we're so isolated and lonely, it's like, Oh, now I've got parts. I'm not by myself. I've got my fire I've got my firefighter, and I've got my guardian, and all these things. And I definitely think that IFS is a really great initiator into the idea of engaging with parts of ourselves and how to talk to them. But I don't think it's... And I think doing a session here and there, for some people, can be incredibly helpful, but to all of a sudden incorporate it in like a dogma is toxic. It's dangerous. And that's what we have to be really careful of. [00:48:23.25] - Joe Moore So thank you for that. There's a complicated discussion happening at the Aspen meeting. I think I was only sitting maybe 30 feet away from you. Sorry, I didn't say hi. But the folks from Blessings of the Forest were there, and I got a chance to chat with a number of them and learn more about nuclear protocols, biopiracy, literal piracy, and smuggling, and the works. I'm curious. This is a really complicated question, and I'm sorry for a complicated question this far in. But it's like, as we talk about this stuff publicly and give it increased profile, we are de facto giving more juice and energy to black markets to pirate. We're adding fuel to this engine that we don't necessarily want to see. Cameroon has nothing left, pretty much. From what I'm told, people from Cameroon are coming in, stealing it from Cabona, bringing it back, and then shipping it out. And there's It's like a whole worldwide market for this stuff. I witnessed it. This stuff. Yeah, right? This is real. So the people, the Buiti, and certain Gabanese farmers, are now being pirated. And international demand does not care necessarily about Nagoya compliance. United States didn't sign Nagoya protocol for this biopiracy protection, but we're not the only violator of these ethics, right? [00:50:00.22] - Joe Moore It's everywhere. So how do we balance thinking about talking about IBOCA publicly, given that there's no clean way to get this stuff in the United States that is probably not pirated materials? And as far as I know, there's only one, quote unquote, Nagoya compliant place. I've heard stories that I haven't shared publicly yet, that there's other groups that are compliant, too. But it's a really interesting conversation, and I'm curious of your perspectives there. [00:50:34.04] - Tricia Eastman I mean, this is a very long, drawn-out question, so forgive me if I give you a long, drawn-out answer. [00:50:41.01] - Joe Moore Go for it. [00:50:41.26] - Tricia Eastman It's all good. So in reality, I do believe... You know the first Ebo, Abogaine, that was done in the country was experiments on eight Black prisoners at a hospital under the MK program. [00:51:01.16] - Joe Moore Pre-lutz off, we were doing Abogaine tests on people. [00:51:06.00] - Tricia Eastman Yeah, so pre-Lutz off. I have a hypothesis, although a lot of people would already know me. [00:51:12.07] - Joe Moore No, I didn't know that. Thank you for sharing that with me. [00:51:14.13] - Tricia Eastman That's great. I'll send you some stuff on that. But the Aboga wanted to be here. The Abogaine wanted to be here. I think it's a complex question because on one side of the coin, you have the spirit of plants, which are wild and crazy sometimes. And then you have the initiatory traditions, which create a scaffolding to essentially put the lightning in a bottle, so to say, so that it's less damaging. [00:51:51.13] - Joe Moore It's almost like a temple structure around it. [00:51:53.16] - Tricia Eastman I like that. Yeah. Put a temple structure around it because it's like, yeah, you can work with new nuclear energy, but you have to wear gloves, you have to do all these different safety precautions. I would say that that's why these traditions go hand in hand with the medicine. So some people might say that the agenda of Iboga and even Abogaine might be a different agenda than the Buiti. And ultimately, whether we are Indigenous or not, the Earth belongs to everyone. It's capitalism and the patriarchy that created all these borders and all these separations between people. And in reality, we still have to acknowledge what the essence of Buiti is, which is really the cause and effect relationship that we have with everything that we do. And so some people might use the term karma. And that is if you're in Abogaine clinic and you're putting a bunch of videos out online, and that's spurring a trend on TikTok, which we already know is a big thing where people are selling illegal market, iBoga, is Is any of that your responsibility? Yes. And if I was to sit down with a kogi kagaba, which are the mamus from Colombia, or if I were to sit down with a who said, Hey, let's do a divination, and let's ask some deep questions about this. [00:53:54.01] - Tricia Eastman It would look at things on a bigger perspective than just like, Oh, this person is completely responsible for this. But when we're talking about a medicine that is so intense, and when I was younger, when I first met the medicine, I first was introduced in 2013 was when I first found out about Abigain and Iboga. And in 2014, I lived with someone who lived with a 14th generation Misoko, maybe it was 10th generation Misoco in Costa Rica. And then he decided to just start serving people medicine. And he left this person paralyzed, one person that he treated for the rest of his life. And Aubrey Marcus, it was his business partner for On It, and he's publicly talked about this, about the story behind this. If you go into his older podcasts and blog posts and stuff, he talks about the situation. And the reality is that this medicine requires a massive amount of responsibility. It has crazy interactions, such as grapefruit juice, for example, and all kinds of other things. And so it's not just the responsibility towards the buiti, it's also the responsibility of, does me talking about this without really talking about the safety and the risks, encourage other people. [00:55:49.10] - Tricia Eastman One of the big problems, back in the day, I went to my first guita conference, Global Abogaine Therapy Alliance in 2016. And And then, ISEARs was debating because there was all these people buying Abogaine online and self-detoxing and literally either dying or ending up in the hospital. And they're like, should we release protocols and just give people instructions on how to do this themselves? And I was like, no, absolutely not. We need to really look at the fact that this is an initiatory tradition, that it's been practiced for thousands of that the minimum level at which a person is administering in Gabon is 10 years of training. The way that we've made up for those mistakes, or sorry, not mistakes, lack of training is that we've used medical oversight. Most of the medical oversight that we've received has been a result of mistakes that were made in the space. The first patient that MAPS treated, they killed them because they gave them way over the amount of what milligrams per kilogram of Abigain that you should give somebody. Every single mistake that was made, which a lot of them related to loss of life, became the global Abogane Therapy Safety Guidelines. [00:57:28.19] - Tricia Eastman And so we've already learned from our mistakes here. And so I think it's really important that we understand that there's that aspect, which is really the blood on our hands of if we're not responsible, if we're encouraging people to do this, and we're talking about it in a casual way on Instagram. Like, yeah, microdosing. Well, did you know there was a guy prosecuted this last year, personal trainer, who killed someone And from microdosing in Colorado, the event happened in 2020, but he just got sentenced early 2025. These are examples that we need to look at as a collective that we need. So that's one side of it. And then the other side of it is the reciprocity piece. And the reciprocity piece related to that is, again, the cause and effect. Is A Abogaine clinic talking about doing Abogaine and doing video testimonials, spurring the efforts that are actively being made in Gabon to protect the cultural lineage and to protect the medicine. The reality is every Abogaine clinic is booked out for... I heard the next year, I don't know if that's fact or fiction, but someone told me for a year, because because of all the stuff with all the celebrities that are now talking about it. [00:59:05.20] - Tricia Eastman And then on top of that, you have all these policy, all these different advocacy groups that are talking about it. Essentially, it's not going to be seven... It's going to be, I would say, seven to 10 years before something gets through the FDA. We haven't even done a phase one safety trial for any of the Abigain that's being commercialized. And even if there's some magic that happens within the Trump administration in the next two years that changes the rules to fast track it, it's not going to cut it down probably more than a year. So then you're looking at maybe six years minimum. That whole time, all that strain is being put on Gabon. And so if you're not supporting Gabon, what's happening is it's losing a battle because the movement is gaining momentum, and Gabon cannot keep up with that momentum. It's a tiny country the size of Colorado. So my belief is that anyone who's benefiting from all the hype around Iboga and Abogayne or personally benefited with healing within themselves should be giving back, either to Ancestral Heart, to Blessings of the Forest, to any group that is doing authentic Indigenous-led biocultural stewardship work. [01:00:45.21] - Joe Moore Thanks for that. It's important that we get into some detail here. I wish we had more time to go further on it. [01:00:54.17] - Tricia Eastman I'll do a quick joke. I know. I have a lot. [01:00:57.17] - Joe Moore Yes. Now do Mike Tyson. Kidding. Yeah. So what did we maybe miss that you want to make sure people hear about your book, any biocultural stuff that you want to get out there? You can go for a few more minutes, too, if you have a few things you want to say. [01:01:20.03] - Tricia Eastman I mean, really, thank you so much for this opportunity. Thank you for caring and being so passionate about the context related to Buiti, which I think is so important. I would just say that I've been working with this medicine for... I've known about it for 13 years, and I've been working with it for 11 years, and this is my life. I've devoted my life to this work, me and my husband, both. And there isn't anything greater of a blessing that it has brought in our life, but it also is it's a very saturnian energy, so it brings chaos. It brings the deepest challenges and forces you to face things that you need to face. But also on the other side of the coin, everything that I've devoted and given back in service to this work has exponentially brought blessing in my life. So again, I see the issue with people doing these shortened processes, whether it's in an Abigain clinic where you just don't have the ritualistic sacred aspects of an initiatic context and really the rituals that really help integrate and ground the medicine. But you still have this opportunity to continue to receive the blessings. [01:03:09.23] - Tricia Eastman And I really feel in our current psychedelic movement, we essentially have a Bugatti. These medicines are the most finely-tuned sports car that can do every... Even more than that, more like a spaceship. We have this incredible tool, but we're driving it in first gear. We don't even really know how to operate it. It's like, well, I guess you could say flight of the Navigator, but that was a self-driving thing, and I guess, psychedelics are self-driving. But I feel that we are discounting ourselves so greatly by not looking into our past of how these medicines were used. I really think the biggest piece around that is consulting the genuine lineage carriers like Buiti elders, like Mubu Bwal, who's the head of Maganga Manan Zembe, And giving them a seat at the head of the table, really, because there's so much I know in my tradition, about what we do to bring cardiac safety. And why is it that people aren't dying as much in Gabon as they're dying in Abigan clinics. [01:04:37.28] - Joe Moore Shots fired. All right. I like it. Thank you. Thank you for everything you've done here today, I think harm reduction is incredibly important. Let's stop people dying out there. Let's do some harm reduction language. I actually was able to sweet talk my way into getting a really cool EKG recently, which I thought really great about. If you can speak clinician, you can go a long way sometimes. [01:05:11.20] - Tricia Eastman Yeah. Oh, no, go ahead. Sorry. [01:05:15.17] - Joe Moore No, that's all. That's all. So harm reduction is important. How do we keep people safe? How do we keep healing people? And thank you for all your hard work. [01:05:27.22] - Tricia Eastman Thank you. I really appreciate it. We're all figuring it out. No one's perfect. So I'm not trying to fire any shots at anybody. I'm just like, Guys, please listen. We need to get in right relationship with the medicine. And we need to include these stakeholders. And on the other side of the coin, I just want to add that there's a lot of irresponsible, claimed traditional practitioners that are running retreat centers in Mexico and Costa Rica and other places that are also causing a lot of harm, too. So the medical monitoring is definitely, if you're going to do anything, Because these people don't have the training, the worst thing you could do is not have someone going in blind that doesn't have training and not have had an EKG and all that stuff. But we've got a long way to go, and I'm excited to help support in a productive way, all coming together. And that's what me and Joseph have been devoted to. [01:06:45.02] - Joe Moore Brilliant. Tricia Eastman, thank you so much. Everybody should go check out your book Seeding Consciousness out now. The audiobook's lovely, too. Thank you so much for being here. And until next time. [01:07:00.14] - Tricia Eastman Thank you.    

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    electroCore (NASDAQ: ECOR): Non-Invasive Nerve Stimulation Products to Rebalance Autonomic Nervous System

    Planet MicroCap Podcast | MicroCap Investing Strategies

    Play Episode Listen Later Dec 22, 2025 37:13


    Welcome to the Planet MicroCap Podcast's Due Diligence series. I'm your host, Robert Kraft. My guest today is Dan Goldberger, CEO of electroCore (NASDAQ: ECOR). electroCore is a commercial-stage neuromodulation company developing a suite of non-invasive vagus nerve stimulation devices—delivering a two-minute therapy session designed to rebalance the autonomic nervous system. Built around its nVNS platform, the company operates across three channels: prescription medical devices for headache and migraine, the fast-growing Truvaga direct-to-consumer wellness brand, and a specialized military and government division built around its ruggedized tac-stim product.   Founded in 2006 as a non-invasive alternative to implanted vagus nerve stimulators, electroCore has evolved into a multi-indication business with seven FDA authorizations for headache, serving major customers like the U.S. Department of Veterans Affairs and the UK's National Health Service. I invited Dan to the show to discuss all of this, as well as: How nVNS platform works and the science behind vagus nerve modulation electroCore's evolution from implanted alternatives to multi-channel neuromodulation The prescription business model across the VA, NHS, and managed care Truvaga's growth in the wellness market and why awareness is the primary competitor The tac-stim military program and its role as a meaningful revenue stream Strategic priorities heading into 2026—profitability, capital allocation, and commercial execution Challenges around insurance coverage and overcoming the “chicken and egg” problem The path toward becoming a $150–200 million business and the long-term vision for the platform For more information about electroCore, please visit: https://www.electrocore.com/ This podcast was recorded and is being made available by SNN, Inc. (together with its affiliates and its and their employees, “SNN”) solely for informational purposes. SNN is not providing or undertaking to provide any financial, economic, legal, accounting, tax, or other advice in or by virtue of this podcast. The information, statements, comments, views, and opinions provided in this podcast are general in nature, and such information, statements, comments, views, and opinions, and the viewing of/listening to this podcast are not intended to be and should not be construed as the provision of investment advice by SNN. The information, statements, comments, views, and opinions expressed in this podcast do not constitute and should not be construed as an offer to buy or sell any securities or to make or consider any investment or other course of action. The information, statements, comments, views, and opinions expressed in this podcast (including by guest speakers who are not officers, employees, or agents of SNN) are not necessarily those of SNN and may not be current. Reference to any specific third-party entity, product, service, materials, or content does not constitute an endorsement or recommendation by the SNN. SNN assumes no responsibility or liability for the accuracy or completeness of the content contained in third party materials or on third party sites referenced in this podcast or the compliance with applicable laws of such materials and/or links referenced herein. The views expressed by guest speakers are their own and their appearance on this podcast does not imply an endorsement of them or any entity they represent. SNN does not make any representation or warranty as to the accuracy or completeness of any of the information, statements, comments, views, or opinions contained in this podcast, which may include forward-looking statements where actual results may differ materially. SNN does not undertake any obligation whatsoever to provide any form of update, amendment, change, or correction to any of the information, statements, comments, views or opinions set forth in this podcast. SNN EXPRESSLY DISCLAIMS ANY AND ALL LIABILITY OR RESPONSIBILITY FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL OR OTHER DAMAGES ARISING OUT OF ANY INDIVIDUAL'S USE OF, REFERENCE TO, RELIANCE ON, OR INABILITY TO USE, THIS PODCAST OR THE INFORMATION PRESENTED IN THIS PODCAST. By accessing this podcast, the listener acknowledges that the entire contents and design of this podcast, are the property of SNN, or used by SNN with permission, and are protected under U.S. and international copyright and trademark laws. Except as otherwise provided herein, users of this podcast may save and use information contained in the podcast only for personal or other non-commercial educational purposes. No other use, including without limitation, reproduction, retransmission, or editing of this podcast may be made without the prior written consent of SNN.

    Taking Control Of Your Diabetes - The Podcast!
    SGLT Inhibitors & What's Next for Type 1 Diabetes: FDA's Sotagliflozin Denial – with Stacey Simms

    Taking Control Of Your Diabetes - The Podcast!

    Play Episode Listen Later Dec 22, 2025 48:11


    Why did the FDA deny sotagliflozin —even with strong data showing heart, kidney, and glucose benefits? In this episode, Dr. Steve Edelman sits down with special guest Stacey Simms to break down the full story behind SGLT inhibitors and their complicated path in type 1 diabetes.Together, they walk through how SGLT inhibitors transformed type 2 diabetes care, why many clinicians believe people with type 1 should have access, and how the risk of DKA shaped the FDA's decision. Dr. Edelman also shares insights on who might benefit, how to reduce risk, and why continuous ketone monitoring could be a game-changer for future approvals.They also touch on the growing discussion around GLP-1 medications in type 1 diabetes, new study results, and what emerging evidence could mean for future treatment options.In this episode: • Sotagliflozin & SGLT Inhibitors in T1D: Why these medications matter and what the latest data shows.• The FDA Denial: Understanding the DKA concerns and why approval remains challenging.• Real-World Experience: How clinicians are using SGLT inhibitors safely today in select patients.• Continuous Ketone Monitoring: Why dual-analyte sensors could unlock safer use in T1D.• GLP-1s in Type 1 Diabetes: What recent research reveals about potential benefits.• Who Might Benefit Most: Kidney protection, heart health, and metabolic improvements.• Looking Ahead: How ongoing studies and patient advocacy could shape future guidelinesLearn more about Diabetes Connections with Stacey Simms: https://diabetes-connections.comVisit TCOYD's Website for more diabetes edutainment for people living with diabetes: tcoyd.org**Tune in for two new episodes each month! Like what you hear and want to help us grow? Please rate and review this podcast so we can reach more people living with diabetes!**Follow our social media channels to empower yourself with the essential areas of diabetes knowledge led by two endocrinologists living with type 1 diabetes: Facebook  |  Instagram  |  YouTube ★ Support this podcast ★

    Data in Biotech
    From screening to IND: How Veloxity accelerates critical drug decisions

    Data in Biotech

    Play Episode Listen Later Dec 22, 2025 25:34


    In this episode of Data in Biotech, Ross Katz sits down with Callie Celichowski and Isa Kupke from Veloxity Labs to discuss how their CRO leverages speed, precision, and innovation to support drug development. Learn how they use mass spectrometry, cloud-based infrastructure, and hands-on client partnerships to drive rapid, high-quality bioanalytical insights that support everything from preclinical studies to FDA submissions. What you'll learn in this episode: >> Why "speed with purpose" is essential for bioanalytical CROs supporting biotech and pharma clients >> The benefits and challenges of working with peptides and GLP-1 receptor agonists >> How the SCIEX 8600 enhances detection of low-concentration analytes Meet our guests Isa Kupke is Scientist II at Veloxity Labs, where she specializes in mass spectrometry and method development for preclinical and regulated bioanalytical programs. She also co-founded Blyde Botanics, bridging plant-based science and product development. Callie Celichowski is Senior Director of Business Development at Veloxity Labs, with over two decades in the pharmaceutical and CRO space. She's recognized for building strategic client partnerships and driving rapid, data-driven decision-making. About the host Ross Katz is Principal and Data Science Lead at CorrDyn. Ross specializes in building intelligent data systems that empower biotech and healthcare organizations to extract insights and drive innovation. Connect with Our Guest: Sponsor: CorrDyn, a data consultancyConnect with Isa Kupke on LinkedIn Connect with Callie Celichowski on LinkedIn  Connect with Us: Follow the podcast for more insightful discussions on the latest in biotech and data science.Subscribe and leave a review if you enjoyed this episode!Connect with Ross Katz on LinkedIn Sponsored by… This episode is brought to you by CorrDyn, the leader in data-driven solutions for biotech and healthcare. Discover how CorrDyn is helping organizations turn data into breakthroughs at CorrDyn.

    Global Medical Device Podcast powered by Greenlight Guru

    The FDA's new Quality Management System Regulation (QMSR), which replaces the 21 CFR Part 820 Quality System Regulation (QSR) and incorporates ISO 13485:2016 by reference, represents a significant harmonization effort in the medical device industry. While viewed by some as a mere streamlining, the change is mandatory, with an effective and fully enforceable date of February 2, 2026. The episode addresses industry complacency and details critical steps manufacturers must take immediately.The episode debunks the myth that familiar quality documents like the DHF, DMR, and DHR are being eliminated. While the specific terms are removed from the regulation's language, their substance is retained and mapped to new, ISO-aligned conceptual requirements: the Device Master Record (DMR) becomes the Medical Device File (MDF), the Design History File (DHF) becomes the Design and Development File (DDP), and the Device History Record (DHR) is captured in the Batch or Lot Record. The host emphasizes that internal documents can retain the old terminology, provided a clear regulatory mapping is established.Crucially, compliance requires more than just an ISO 13485 certificate. Two major philosophical shifts must be addressed: the explicit requirement for integrating lifecycle risk management as the DNA of the entire QMS, and the loss of the audit privilege, which makes internal audit reports, supplier audit reports, and management review records inspectable regulatory evidence. Furthermore, manufacturers must comply with retained, US-specific requirements under the QMSR's prevalence rule, especially concerning mandatory record content (§ 820.35) and specific labeling and packaging controls (§ 820.45).Key Timestamps[0:50] QMSR: The biggest shakeup to US quality requirements since 1996.[2:00] Effective Date: February 2, 2026—the clock is ticking.[2:42] The Goal: Harmonization with ISO 13485:2016 to reduce redundancy for global manufacturers.[3:50] Myth 1 Busted: The FDA is eliminating the DHF, DMR, and DHR (Documentation Dissolution).[5:10] Terminology Shift: DMR > Medical Device File (MDF, ISO 13485 Clause 4.2.3).[6:30] Terminology Shift: DHF > Design and Development File (DDP, ISO 13485 Clause 7.3.10).[7:40] Terminology Shift: DHR > Batch or Lot Record (ISO 13485 Clause 7.5.1).[8:40] The Practical Takeaway: Internal naming is fine, but regulatory mapping is mandatory.[10:30] Critical Shift 1: Risk Management is the DNA of the QMS—Explicitly required across all clauses.[13:00] Critical Shift 2: Loss of the Audit Privilege—Internal audit and management review records are now inspectable.[17:00] Critical Shift 3: Retained FDA Specifications (Prevalence Rule).

    You Are Not Broken
    Episode 350: Six Years In — The Big Winter Blowout, Hormones, Health, and Being in the Arena

    You Are Not Broken

    Play Episode Listen Later Dec 21, 2025 47:18


    I just wrapped 6 years of podcasting!!! Episode 350 marks a major milestone for You Are Not Broken: six years, 350 episodes, and a whole lot of growth—personally, professionally, and culturally. In this end-of-year “big winter blowout,” Dr. Kelly Casperson reflects on what 2025 brought, what changed (for better and worse), and why continuing to speak up for women's health still matters more than ever. From world events that shaped the year to personal health wins (yes, including her first colonoscopy), Dr. Casperson shares an honest recap of the moments that mattered. She celebrates big professional milestones—like opening the Casperson Clinic, publishing her second book, winning a podcast award, and helping remove outdated FDA boxed warnings on hormone therapy—while also naming the frustrations, resistance, and misconceptions that persist. This episode also looks ahead: new courses, retreats, sexual health innovations (including a vibrator!), and the continued expansion of education around hormones, sex, and aging. Anchoring it all is a reminder from Theodore Roosevelt's Man in the Arena: progress belongs to those willing to show up, be imperfect, and keep going. Six years and 350 episodes of You Are Not Broken A candid end-of-year reflection on 2025 and the state of the world “Baby's first colonoscopy” and why health screenings matter Travel highlights, including Sydney and the Opera House Publishing a second book and opening the Casperson Clinic Major personal health improvements through strength training and lifestyle changes The book "you are not broken" winning an award and hosting a second annual retreat in Sedona Three separate FDA engagements—and successfully removing outdated boxed warnings on hormone therapy The biggest misconception about FDA changes and how fast (and messy) change can be A frank moment of accountability (and humor) around language and advocacy Updates from the Casperson Clinic, waitlists, and the subscription-based care model Addyi approval for postmenopausal women The future of online education, including upcoming “Summer School” hormone courses Takeaways from male-dominated FDA panels and what they miss What's next: retreats, documentaries, new courses, and new products The top five most-listened-to You Are Not Broken episodes of 2025 Should I Take Hormones? (Ep. 328) How (and Why) to Prescribe Hormones (Ep. 318) GLP-1s with Dr. Salas-Whalen (Ep. 329) Getting Better at Sex – Part One (Ep. 333) Perimenopause Is Real (Ep. 324) New online courses covering testosterone for women, female sex education, GSM, perimenopause, and hormones for longevity A retreat in Whistler (August 2026 — limited spots remaining) The M Factor 2.0: Before the Pause (premieres expected early 2026) A sex education course with Commune launching in 2026 And yes—building a vibrator Dr. Casperson closes with Theodore Roosevelt's Man in the Arena, a reminder that meaningful change doesn't come from critics on the sidelines—it comes from those willing to step into the work, get messy, make mistakes, and keep advocating anyway. If you've been part of this community for one episode or all 350, thank you for being here. This work continues because it matters—and because you do. Listen to the You Are Not Broken podcast on ⁠⁠⁠Pinnacle's network to earn FREE CME credit⁠⁠⁠ ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠My Website⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Interested in my sexual health and hormone clinic? ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Waitlist is open⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ Thanks to our sponsor ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Midi Women's Health⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠. Designed by midlife experts, delivered by experienced clinicians, covered by insurance.Midi is the first virtual care clinic made exclusively for women 40+. Evidence-based treatments. Personalized midlife care.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠https://www.joinmidi.com⁠ Learn more about your ad choices. Visit podcastchoices.com/adchoices

    SuperMegaCast
    God's Bush | supermegashow - 093

    SuperMegaCast

    Play Episode Listen Later Dec 19, 2025 71:15


    What if it was a beautiful ginger bush. For simple, online access to personalized and affordable care for Hair Loss, ED, Weight Loss, and more, visit Hims.com/SUPERMEGA Individual results may vary. Based on studies of topical and oral minoxidil and finasteride. 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.  Follow Matt: @matthwatson Follow Ryan: @elirymagee Follow the show: @supermegashow Learn more about your ad choices. Visit podcastchoices.com/adchoices

    Straight White American Jesus
    Weekly Roundup: Cruelty as Policy, From Healthcare to Trans Panic

    Straight White American Jesus

    Play Episode Listen Later Dec 19, 2025 53:33


    Dan Miller unpacks how Republican policy and ideology are converging around harm rather than governance. He begins with healthcare, breaking down how congressional action allowed Affordable Care Act subsidies to lapse and what that means for millions of Americans who rely on them. Rather than offering alternatives, the GOP continues to frame healthcare through an ideological lens that treats public support as illegitimate, even when the human cost is clear. From there, Dan traces the familiar shift from policy failure to moral panic, focusing on the escalating attacks on trans youth. He examines the House passage of Marjorie Taylor Greene's Protect Children's Innocence Act, the Trump administration's push to ban gender affirming care for minors, and recent FDA actions targeting breast binders. Dan connects these moves to a broader right wing strategy that defines itself through opposition to marginalized groups, warning that restrictions justified in the name of protecting children and morality often pave the way for wider government overreach. He closes by looking at Pete Hegseth's influence inside the military and the dangers of folding Christian nationalism into institutions meant to serve a pluralistic society. Subscribe for $5.99 a month to get bonus content most Mondays, bonus episodes every month, ad-free listening, access to the entire 1000+ episode archive, Discord access, and more: https://axismundi.supercast.com/ Linktree: https://linktr.ee/StraightWhiteJC Order Brad's book: https://bookshop.org/a/95982/9781506482163 Subscribe to Teología Sin Vergüenza Subscribe to American Exceptionalism Learn more about your ad choices. Visit megaphone.fm/adchoices

    The Rubin Report
    The Real Reason GOP Will Lose Midterms That No One Wants to Admit | Nancy Mace

    The Rubin Report

    Play Episode Listen Later Dec 18, 2025 15:17


    Dave Rubin of "The Rubin Report" talks to Rep. Nancy Mace about why she thinks the GOP will suffer massive losses in the midterm elections; Washington dysfunction and why Congress struggles to pass legislation; why only a tiny fraction of House bills become law; how Senate gridlock is blocking President Trump's agenda; why Republicans risk losing the House without a tougher, Pelosi-style strategy; South Carolina's rapid growth and conservative values; and much more. Check out the NEW RUBIN REPORT MERCH here: https://daverubin.store/ ---------- Today's Sponsors: Juvent - Stop joint pain and stiffness with the Juvent Micro-Impact Platform. In the US, the Juvent device is considered investigational for the treatment of osteoporosis or improvement/maintenance of bone mineral density. Our claims have not been reviewed or cleared by the FDA to treat any disease or condition. The JUVENT® Micro-Impact Platform® is registered as a Class I medical device for exercise and rehabilitation." Go to http://Juvent.com/RUBIN and use the code RUBIN to save $300 on your own Juvent.