Podcasts about drug administration fda

It's Thursday, October 9th, A.D. 2025. This is The Worldview in 5 Minutes heard on 140 radio stations and at www.TheWorldview.com.  I'm Adam McManus. (Adam@TheWorldview.com) By Jonathan Clark Pakistani pastor dies after 13-year jail sentence A pastor in Pakistan died on Sunday after languishing in prison for 13 years. Pastor Zafar Bhatti founded Jesus World Mission Church ministry. Back in 2012, he was falsely accused of insulting Islam. Authorities finally overturned his conviction this month, releasing him last Wednesday. The 62-year-old pastor died days after from cardiac arrest at his home.   The British Asian Christian Association helped defend the pastor in court. The organization stated, “Though his earthly journey has ended, Zafar's faith, endurance, and ultimate vindication remain a powerful testament to hope in Christ amidst persecution.” Nigerian Anglican Church appalled that woman chosen to be new church head The Anglican Church of Nigeria declared spiritual independence from the Church of England on Tuesday. The announcement came in response to the Church of England's appointment of Sarah Mullally as the Archbishop of Canterbury. She is the first woman to hold the position. She also supports abortion and faux homosexual marriage.  Archbishop Henry Ndukuba is the Primate of the Church of Nigeria. He stated, “[Mullally's] appointment marks a tragic departure from biblical orthodoxy. . . . We remain Anglicans — but not under Canterbury. Our loyalty is to Christ and the truth of His Word, not to institutions that have abandoned it.” Police arrest man intent on blowing up church with Supreme Court Justices In the United States, police arrested a man on Sunday who had hundreds of explosive devises outside of St. Matthews Cathedral in Washington, D.C. Police made the arrest before an annual service traditionally attended by U.S. Supreme Court justices.  According to court records, the man's notebook expressed animosity toward Supreme Court justices, the Catholic Church, Jews, and immigration enforcement officials.  FBI cuts ties with God-hating Southern Poverty Law Center The Federal Bureau of Investigation announced last week it has cut ties with the Southern Poverty Law Center. The far-left nonprofit is known for listing conservative and Christian organizations as “hate groups,”  primarily because they affirm God's design for sexuality and marriage. FBI Director Kash Patel posted on X, “The Southern Poverty Law Center long ago abandoned civil rights work and turned into a partisan smear machine. Their so-called ‘hate map' has been used to defame mainstream Americans and even inspired violence. That disgraceful record makes them unfit for any FBI partnership.” Florida, Louisiana, Missouri & Texas sue FDA over mail-order Abortion Kill Pill The state of Louisiana joined a lawsuit against the Food and Drug Administration on Monday.  Florida, Missouri, and Texas are also on the case. They are challenging the FDA's 2023 policy that allows mail-order abortion drugs. Louisiana's filing states, “Every year, doctors and activists in states like California and New York mail a U.S. Food and Drug Administration (FDA)-approved abortion drug called mifepristone to thousands of Louisiana residents for the express purpose of causing abortions in Louisiana that are blatantly unlawful.” Gold hit $4,000 per ounce first time ever On Tuesday, spot gold prices hit $4,000 per ounce for the first time in history.  That's up 50% from January. Silver is up 60% this year. The demand for gold is up as investors hedge against economic uncertainty.  Financial analyst Rhona O'Connell told Reuters, “Background factors are much the same as before, in terms of geopolitical uncertainty, with the added spice of the (U.S.) government shutdown.” Prison Fellowship and Bible League to send 620,000 Bibles to prisoners And finally, Prison Fellowship International and Bible League International are partnering to distribute over half a million Bibles. The 620,000 Bibles will go to prisoners in 20 countries over the next five years. Frank Lofaro with Prison Fellowship International said, “God's Word has the power to reach prisoners in their darkest moments with the light of Jesus Christ. Through this partnership, prisoners who come to know Jesus through our evidence-based, in-prison programs are equipped to grow in their faith through a Bible that they can understand and that speaks to their circumstances.” Luke 4:18 says, “The Spirit of the LORD is upon Me, because He has anointed Me to preach the gospel to the poor; He has sent Me to heal the brokenhearted, to proclaim liberty to the captives and recovery of sight to the blind, to set at liberty those who are oppressed.” Close And that's The Worldview on this Thursday, October 9th, in the year of our Lord 2025. Follow us on X or subscribe for free by Spotify, Amazon Music, or by iTunes or email to our unique Christian newscast at www.TheWorldview.com.  I'm Adam McManus (Adam@TheWorldview.com). Seize the day for Jesus Christ.

Essential oils are concentrated plant extracts obtained through distillation and pressing. This process captures the aromatic compounds responsible for the oils' fragrance and therapeutic effects The U.S. Food and Drug Administration (FDA) designates some oils as Generally Recognized as Safe (GRAS), meaning food-grade oils are safe to ingest in tiny amounts GRAS essential oils like peppermint, lemon, ginger, cinnamon, and basil can be used to flavor foods and beverages. This reflects their culinary value when used sparingly Other essential oils, such as lavender, eucalyptus, tea tree, rosemary, chamomile, wintergreen, and camphor, are best suited for aromatic or topical use Whether in food, through scent, or applied to the skin, essential oils support wellness when used with care and intention

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: Sanofi lowers prices, oral pill for T1D prevention studied, updates from Medtronic, Tandem, and Sequel Med Tech, falsely lower A1Cs (and why that happens), Biolinq gets FDA okay for micro-needle CGM and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links:   Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX French drugmaker Sanofi says it would offer a month's supply of any of its insulin products for $35 to all patients in the U.S. with a valid prescription, regardless of insurance status. The program, originally meant for uninsured diabetes patients, would now include those with commercial insurance or Medicare, the drugmaker said. Patients will be able to purchase any combination, type, and quantity of Sanofi insulins with a valid prescription for the fixed monthly price of $35, starting January 1. Lilly and Novo also have similar programs through which they offer insulin products for $35 a month for U.S. patients regardless of whether the patients have insurance. There is no law at work here – the only legislation that has changed the price of insulin came with the Inflation Reduction Act in 2022 with the Medicare cap. Helping lower the cost here, biosimilars hitting the market and the huge profitability for GLP-1 drugs for Novo and Lilly https://www.reuters.com/business/healthcare-pharmaceuticals/sanofi-offer-all-insulin-products-35-per-month-us-2025-09-26/ XX A pill typically prescribed for rheumatoid arthritis and alopecia might help slow the progression of type 1 diabetes, a new study says. Baricitinib (bare-uh-SIT-nib) safely preserved the body's own insulin production in people newly diagnosed with type 1 diabetes.. and their diabetes started progressing once they stopped taking baricitinib, results show. They produced less insulin and had less stable blood sugar levels.   Baricitinib works by quelling signals in the body that spur on the immune system, and is already approved for treating autoimmune conditions such as rheumatoid arthritis, ulcerative colitis and alopecia, researchers said.   “Among the promising agents shown to preserve beta cell function in type 1 diabetes, baricitinib stands out because it can be taken orally, is well tolerated, including by young children, and is clearly efficacious,” Waibel said. “We are hopeful that larger phase III trials with baricitinib are going to commence soon, in people with recently diagnosed type 1 diabetes as well as in earlier stages to delay insulin dependence,” she added. “If these trials are successful, the drug could be approved for type 1 diabetes treatment within five years.”   Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal.   https://www.usnews.com/news/health-news/articles/2025-09-23/pill-effective-in-slowing-type-1-diabetes-progression XX An existing transplant drug has shown promise in slowing the progression of type 1 diabetes in newly diagnosed young people, potentially paving the way for the first therapy that modifies the disease after diagnosis. The Drug, called ATG, is currently used together with other medicines to prevent and treat the body from rejecting a kidney transplant. It can also be used to treat rejection following transplantation of other organs, such as hearts, gastrointestinal organs, or lungs. The researchers studied 117 people aged five to 25, who'd been diagnosed with type 1 diabetes within the past three to nine weeks. The participants were from 14 centers across eight European countries and were randomized to be given different doses of ATG (0.1, 0.5, 1.5, or 2.5 mg/kg) or a placebo. ATG was given as a two-day intravenous (IV) infusion. The main goal was to see how well the pancreas could still make insulin after 12 months, measured by C-peptide levels during a special meal test. C-peptide is released into the blood along with insulin by the pancreas.   The findings are promising, showing that ATG, even at a relatively low dose, can slow the loss of insulin-producing cells in young people newly diagnosed with type 1 diabetes. The lower dose also caused fewer side effects, making it a more practical option. https://newatlas.com/disease/antithymocyte-globulin-newly-diagnosed-type-1-diabetes/     XX The FDA has delayed its feedback on Lexicon Pharmaceuticals' application to bring Zynquista (sotagliflozin) to people with type 1 diabetes. The agency had planned to respond this month but will now wait until the fourth quarter after reviewing new data from ongoing studies. Zynquista, an oral drug meant to be used with insulin, has already been approved for heart failure (marketed as Inpefa). But in type 1 diabetes, it faces safety concerns: last year an FDA advisory committee voted 11–3 that its benefits don't outweigh the increased risk of diabetic ketoacidosis (DKA). The FDA later issued a complete response letter rejecting the drug. Lexicon is still pushing forward, hoping its additional submissions will strengthen Zynquista's case for type 1 diabetes approval. https://www.biospace.com/fda/after-fda-rejection-lexicons-type-1-diabetes-drug-hit-with-another-regulatory-delay     XX A common but often undiagnosed genetic condition may be causing delays in type 2 diabetes diagnoses and increasing the risk of serious complications for thousands of Black and South Asian men in the UK—and potentially millions worldwide. A new study found around one in seven Black and one in 63 South Asian men in the UK carry a genetic variant known as G6PD deficiency. Men with G6PD deficiency are, on average, diagnosed with type 2 diabetes four years later than those without the gene variant. But despite this, fewer than one in 50 have been diagnosed with the condition.   G6PD deficiency does not cause diabetes, but it makes the widely used HbA1c blood test—which diagnoses and monitors diabetes—appear artificially low. This can mislead doctors and patients, resulting in delayed diabetes diagnosis and treatment.   The study found men with G6PD deficiency are at a 37% higher risk of developing diabetes-related microvascular complications, such as eye, kidney, and nerve damage, compared to other men with diabetes.   "This study highlights important evidence that must be used to tackle these health inequalities and improve outcomes for Black communities. Preventative measures are now needed to ensure that Black people, especially men, are not underdiagnosed or diagnosed too late." https://medicalxpress.com/news/2025-09-hidden-genetic-delay-diabetes-diagnosis.html XX Novo Nordisk today announced the resubmission of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Awiqli® (insulin icodec) injection, a once-weekly basal insulin treatment for adults living with type 2 diabetes. If approved, Awiqli® would become the first once-weekly basal insulin available in the United States, providing an alternative to daily basal insulin injections for adults living with type 2 diabetes.   The resubmission is based on results from the ONWARDS type 2 diabetes phase 3a program for once-weekly Awiqli® which is comprised of five randomized, active-controlled, treat-to-target clinical trials in approximately 4,000 adults with type 2 diabetes. The clinical program evaluated Awiqli® vs. daily basal insulin and the primary endpoint in these trials was change in A1C from baseline.1-5 Awiqli® is approved in the EU, along with 12 additional countries. In addition, regulatory filings have been completed in several other countries, with further regulatory decisions expected in 2025. XX Interesting news from Sequel Med Tech – they've signed an agreement with Arecor to pair the twiist pump with AT278 an ultra-concentrated (500U/mL), ultra-rapid insulin in development. They also have a deal with Medtronic to develop insulin for new pumps. This insulin isn't yet approved, it's 5 times stronger than standard fast acting  it's hoped that a clinical study will begin next year. Arecor says its insulin could potentially be the only option capable of enabling and catalyzing the next generation of longer-wear and miniaturized automated insulin delivery systems.   https://www.drugdeliverybusiness.com/sequel-arecor-develop-rapid-insulin-twiist/ XX Tandem Diabetes Care announes its t:slim X2™ insulin pump with Control-IQ+ automated insulin delivery (AID) technology is now cleared for use with Eli Lilly and Company's Lyumjev® (insulin lispro-aabc injection) ultra-rapid acting insulin in the United States (U.S.).   – The t:slim X2 insulin pump with Control-IQ+ technology is now cleared for use with Lyumjev for people with type 1 diabetes ages 2 and above and all adults with type 2 diabetes. The companies are continuing to work toward securing Lyumjev compatibility for the Tandem Mobi pump. https://hitconsultant.net/2025/09/29/tandem-diabetes-cares-tslim-x2-pump-cleared-for-use-with-lillys-ultra-rapid-lyumjev-insulin/ XX You can now place your order for the MiniMed™ 780G system with the Instinct sensor, made by Abbott. And if you are already a MiniMed 780G user, you can place an upgrade order today. ​This is a 15 day wear sensor, with no transmitter or overtape required. It looks the same at other Abbot sensors such as the Libre but is proprietary to Medtronic. Shipments are scheduled to start in November.   ​ https://www.drugdeliverybusiness.com/medtronic-launches-minimed-780g-instinct-abbott/   XX The global type 1 diabetes (T1D) burden continues to increase rapidly driven by rising cases, ageing populations, improved diagnosis and falling death rates. ,   The study estimates that T1D will affect 9.5 million people globally in 2025 (up by 13% since 2021), and this number is predicted to rise to 14.7 million in 2040. However, due to lack of diagnosis and challenges in collecting sufficient data, the actual number of individuals living with T1D is likely much higher, researchers say.   In fact, they estimate that there are an additional 4.1 million 'missing people' who would have been alive in 2025 if they hadn't died prematurely from poor T1D care, including an estimated 669,000 who were not diagnosed. This is particularly true in India, where an estimated 159,000 people thought to have died from missed diagnoses. The study predicts that 513,000 new cases of T1D will be diagnosed worldwide in 2025, of which 43% (222,000) will be people younger than 20 years old. Finland is projected to have the highest incidence of T1D in children aged 0-14 years in 2025 at around 64 cases per 100,000. The substantial increases in T1D forecasts between 2025 and 2040 underscore the urgent need for action. As co-author Renza Scibilia from Breakthrough T1D explains, "Early diagnosis, access to insulin and diabetes supplies, and proper healthcare can bring enormous benefits, with the potential to save millions of lives in the coming decades by ensuring universal access to insulin and improving the rate of diagnosis in all countries."   The authors note some important limitations to their estimates, including that while the analysis uses the best available data, predictions are constrained by the lack of accurate data in most countries-highlighting the urgent need for increased surveillance and research. They also note that data on misdiagnosis and adult populations remain limited, and the analysis assumes constant age-specific incidence and mortality over time. Furthermore, incidence data from the COVID-19 period were excluded from part of the modelling to avoid bias. Future updates are expected to improve as new data become available and applied. https://www.news-medical.net/news/20250919/New-study-warns-of-millions-of-undiagnosed-and-missing-people-with-type-1-diabetes.aspx XX A new study has found that semaglutide — the active ingredient found in some GLP-1 medications prescribed for diabetes and to aid weight loss — may help protect the eyes from diabetic retinopathy. Researchers estimate that as much as 40% of all people with diabetes also have diabetic retinopathy — a potentially blinding eye condition caused by blood vessel damage in the eye's retina. There is currently no cure for diabetic retinopathy. The condition is often managed through injections of anti-VEGF medications into the eye, surgery, and blood sugar monitoring and control. For this lab-based study, researchers used samples of human retinal endothelial cells that were treated with different concentrations of semaglutide. The cells were then placed in a solution with both a high glucose level and high level of oxidative stress — where there is an imbalance of antioxidants and free radicals — for 24 hours.   Past studies show that oxidative stress plays a role in the formation of diabetic retinopathy.   At the study's conclusion, researchers found that the retinal cells treated with semaglutide were twice as likely to survive than cells that were untreated. Additionally, the treated cells were found to have larger stores of energy.   Scientists also found that three markers of diabetic retinopathy were decreased in the semaglutide-treated retinal cells. First, the levels of apoptosis — a form of cell death — decreased from about 50% in untreated cells to about 10% in semaglutide-treated cells. The production of the free radical mitochondrial superoxide decreased from about 90% to about 10% in the treated retinal cells.   Researchers also found the amount of advanced glycation end-products — harmful compounds that can collect in people with diabetes and are known to cause oxidative stress — also decreased substantially.   Lastly, scientists reported that the genes involved in the production of antioxidants were more active in the semaglutide-treated cells when compared to untreated cells. Researchers believe this is a sign that semaglutide may help repair damage to the retinal cells.   “Our study did not find that these drugs harmed the retinal cells in any way — instead, it suggests that GLP1-receptor agonists protect against diabetic retinopathy, particularly in the early stages,” Ioanna Anastasiou, PhD, molecular biologist and postdoctoral researcher at the National and Kapodistrian University in Greece, and lead author of this study, said in a press release.   “Excitingly, these drugs may be able to repair damage that has already been done and so improve sight. Clinical trials are now needed to confirm these protective effects in patients and explore whether GLP-1 receptor agonists can slow, or even halt, the progression of this vision-robbing condition.” https://www.medicalnewstoday.com/articles/ozempic-semaglutide-may-help-protect-against-diabetes-related-blindness-retinopathy   XX Biolinq has received De Novo Classification from the U.S. Food and Drug Administration for its lead product, Biolinq Shine, a patch on the forearm that provides real-time glucose feedback through a primary color-coded LED display, visible with or without a phone. This one is tricky – it's called a needle free CGM but it also says it uses micro needles. By the way, De Novo isn't exactly the same as what we think of for FDA approval for medical devices. It's not as rigorous but it's a streamlined route for novel, low to moderate risk devices with no existing equivalent. We'll see how this one turns out. https://www.hmenews.com/article/biolinq-s-multi-function-biosensor-receives-fda-de-novo-classification

In this episode of the Heart to Heart podcast, host Dr.Mike Hart welcomes author Serena Choo, who delves into her journey of writing and overcoming imposter syndrome. They discuss Serena's second book, 'The Monkey and the Way of Zen,' which contains 28 short Zen-inspired stories aimed at providing readers a relaxing and reflective experience. Choo shares insights into the origins of her work, the importance of letting go and subtracting complexities from life, and how personal transformation can be achieved without the burden of constant goal-setting. Additionally, they touch upon topics such as her career transition, the specifics of dealing with imposter syndrome, the concept of emotional intelligence, and the potential benefits of neurolinguistic programming (NLP).   Serena Choo is a transformation coach, author, and thought leader in personal growth and self-discovery. With over two decades of experience spanning corporate finance, executive coaching, and nutritional therapy, Serena has dedicated her career to helping people break free from self-doubt, imposter syndrome, and burnout. She is the author of Letting Go of Imposter Syndrome and The Monkey and the Way of Zen: A Transformation Journey in 28 Short Stories, books that blend practical wisdom with storytelling to inspire reflection, inner peace, and authentic living. Drawing from her background in executive coaching, functional medicine, and NLP, Serena's work emphasizes radical surrender, self-awareness, and creating fulfillment through subtraction rather than constant striving. Learn more about Serena at serenachoo.com Books available on Amazon: Letting Go of Imposter Syndrome and The Monkey and the Way of Zen   Links: Stanford Encyclopedia of Philosophy – Stoicism NLP Association Functional Medicine Coaching Academy Show Notes: 00:00 Welcome back to the Hart2Heart Podcast with Dr. Mike Hart 00:30 Discussing Serena's books 02:00 The inspiration behind 'the monkey and the zen' 02:00 Serena's writing journey 04:30 Finding nemo and storytelling 05:30 The essence of zen stories 06:00 Mike's reflection on reading 07:30 Goal setting and personal fulfillment 08:30 Serena's career background 10:00 Transition to coaching 17:00 Imposter syndrome explained 21:30 Techniques to overcome imposter syndrome 27:30 Changing thought patterns 31:30 The role of fortune and stoicism 33:30 Imposter syndrome and self-doubt 34:00 Personal anecdotes and overcoming challenges 38:00 Accepting compliments and authenticity 48:30 Emotional intelligence and reactions 48:50 “To me, emotional intelligence is first about understanding what's going on within yourself — not pushing away the feelings, but being aware of the programs running underneath.” 55:30 Coaching differences between genders 01:00:30 NLP and its benefits   — The Hart2Heart podcast is hosted by family physician Dr. Michael Hart, who is dedicated to  cutting through the noise and uncovering the most effective strategies for optimizing health,  longevity, and peak performance. This podcast dives deep into evidence-based approaches to  hormone balance, peptides, sleep optimization, nutrition, psychedelics, supplements, exercise  protocols, leveraging sunlight light, and de-prescribing pharmaceuticals—using medications only when absolutely necessary.   Beyond health science, we tackle the intersection of public health and politics, exposing how  Policy decisions shape our health landscape and what actionable steps people can take to reclaim control over their well-being.   Guests range from out-of-the-box thinking physicians such as Dr. Casey Means (author of "Good Energy") and Dr. Roger Sehult (Medcram lectures) to public health experts such as Dr. Jay Bhattacharya (Director of the National Institutes of Health (NIH) and Dr. Marty Mckary  (Commissioner of the Food and Drug Administration (FDA) and high-profile names such as  Zuby and Mark Sisson (Primal Blueprint and Primal Kitchen).   If you're ready to take control of your health and performance, this is the podcast for you. We cut through the jargon and deliver practical, no-BS advice that you can implement in your daily life, empowering you to make positive changes for your well-being.   Connect on social with Dr. Mike Hart: Instagram: @drmikehart Twitter: @drmikehart Facebook: @drmikehart  

In this episode of Healthy Waves by Healthy Mind By Avik™, host Avik Chakraborty sits down with David Hunter, founder of Global Phytoplankton Alliance, to uncover the untapped potential of marine phytoplankton for human health, brain function, and sustainability. David shares how a microscopic ocean plant, often invisible to the naked eye, may hold the foundation for human vitality—supporting cellular repair, energy, and even mental clarity. With nearly 20 years of experience, he discusses the surprising history of phytoplankton in nutrition, how it contributes to Earth's oxygen supply, and why it might reshape the way we think about supplements, immunity, and disease prevention. Whether you're curious about brain health, natural nutrition, or the future of sustainable wellness, this conversation offers insights you won't want to miss. About the Guest  : David Hunter is the founder of Global Phytoplankton Alliance. Nearly two decades ago, he witnessed phytoplankton transform a life when nothing else worked. Since then, he has dedicated himself to educating the world on how these microscopic organisms—responsible for much of Earth's oxygen—could be the missing link in human health, foundational nutrition, and planetary sustainability. Key Takeaways:   Medical Disclaimer  : The content in this episode and its accompanying show notes is for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition, nutrition, or supplementation—including marine phytoplankton or any nutraceuticals. Never disregard professional medical advice or delay seeking it because of something you heard in this episode. Statements discussed here (including any potential benefits of phytoplankton) have not been evaluated by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or any other regulatory authority. These products are not intended to diagnose, treat, cure, or prevent any disease. Individual results may vary. If you are pregnant, nursing, have a medical condition, or are taking prescription or over-the-counter medications, consult your healthcare professional before using any supplement. Discontinue use and consult a healthcare professional if you experience any adverse reaction. In case of a medical emergency, call your local emergency number immediately. All opinions expressed by the guest are their own and do not represent the views of the host or Healthy Mind By Avik™.   Phytoplankton is the original source of nutrition, containing essential fatty acids, vitamins, minerals, and antioxidants in their purest form. Marine phytoplankton provides 60–75% of the oxygen we breathe, making it critical for planetary and human health. Unlike synthetic supplements, phytoplankton nutrients bypass digestion and may feed directly into human cells. Stories of improved energy, mental clarity, reduced migraines, and other benefits highlight its potential role in foundational wellness. Growing phytoplankton on land in clean, filtered seawater avoids ocean depletion and provides a sustainable nutrient source. Its potential impact could disrupt the supplement industry and support a healthier, more resilient global population. Preventive health—focusing on nourishment before illness—can reduce dependency on reactionary treatments. The future of wellness may be less about "bigger solutions" and more about microscopic foundations. Connect with the Guest   Website: USAGPA.com – Global Phytoplankton Alliance Want to be a guest on Healthy Mind, Healthy Life?   DM on PM – Send me a message on PodMatch DM Me Here: https://www.podmatch.com/hostdetailpreview/avik Disclaimer   This video is for educational and informational purposes only. The views expressed are the personal opinions of the guest and do not reflect the views of the host or Healthy Mind By Avik™️. We do not intend to harm, defame, or discredit any person, organization, brand, product, country, or profession mentioned. All third-party media used remain the property of their respective owners and are used under fair use for informational purposes. By watching, you acknowledge and accept this disclaimer. About Healthy Mind By Avik™️   Healthy Mind By Avik™️ is a global platform redefining mental health as a necessity, not a luxury. Born during the pandemic, it has become a sanctuary for healing, growth, and mindful living. Hosted by Avik Chakraborty—storyteller, survivor, and wellness advocate—this channel shares powerful podcasts and soul-nurturing conversations on:• Mental Health & Emotional Well-being• Mindfulness & Spiritual Growth• Holistic Healing & Conscious Living• Trauma Recovery & Self-Empowerment With over 4,400+ episodes and 168.4K+ global listeners, join us as we unite voices, break stigma, and build a world where every story matters.

Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to announce that the company has received encouraging feedback from its recent Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the clinical development pathway of its innovative microneedle-based therapy, Skinject™ (D-MNA), for the treatment of basal cell carcinoma (BCC). The Type C meeting focused on reviewing key elements of the protocol, including study design, endpoints, and patient population definitions for upcoming clinical trials. According to Dr. Bokhari, the FDA provided clarity and alignment on several critical points. Specifically, the agency indicated that a relative bioavailability study with D-MNA, administered under certain conditions, could serve as a basis for establishing a regulatory bridge while addressing bioavailability requirements for the product. Importantly, the FDA offered constructive and supportive guidance on multiple aspects of the proposed development program, including the appropriate primary endpoint for the next clinical study. The company must define the patient population, such as tumor size limits, lesion location restrictions, and histological confirmation requirements and design a randomized, double-blind, placebo-controlled trial to demonstrate efficacy in treating BCC. This regulatory clarity is expected to further strengthen Medicus Pharma's ongoing clinical program. The company is currently conducting its Phase 2 trial across nine clinical sites in the United States. Patient randomization began in August 2024. In March 2025, Medicus Pharma announced results from an interim analysis of the Phase 2 study, showing a positively trending clinical clearance rate exceeding 60%. The interim data, based on more than half of the targeted 60 patients randomized at the time, were highly encouraging, although final results may vary once the study is fully completed. #proactiveinvestors #nasdaq #mdcx #tsxv #mdcx #pharma #Biotech #CancerTreatment #ClinicalTrials #FDAApproval #SkinCancer #HealthcareInnovation #Investing #MedicalResearch #SkinCancer #BasalCellCarcinoma #BiotechNews #CancerResearch #UAEHealth #NonInvasiveTherapy #Doxorubicin #ClinicalTrials #HealthcareInnovation

On this Healthy Waves episode, host Avik digs into how aerospace-level problem-solving meets wellness tech. Guest Mark Fox (former Space Shuttle chief engineer, hot-air balloonist, and airplane builder) explains why he shifted from aircraft to energy-based wellness devices. We unpack what pulsed electromagnetic field (PEMF) and resonance-frequency approaches claim to do, how protocols are designed, portability and cost tradeoffs vs. legacy gear, and where AI-driven biometrics might steer the next decade. Direct, no fluff—just a clear look at what this tech promises, what users report, and what still needs rigorous proof for platforms like YouTube, Facebook, Instagram, and LinkedIn. About the guest  : Mark Fox is an aerospace engineer turned wellness tech founder at Resona Health (resona.health). Drawing on systems thinking (including TRIZ creative problem-solving), he designs portable, non-invasive devices intended to support general well-being through frequency-based protocols. Key takeaways: Why the pivot: engineering skills can transfer from avionics to wellness when the goal is simpler, more accessible tools for everyday use. Frequency-based view: the talk frames the body as chemical, mechanical, and electrical—arguing wellness tools shouldn't ignore bio-electromagnetic processes. How protocols are built: “frequency pairs” change over time like chords in a song; many protocols emerged from decades of practitioner iteration. Portability and access: a pocket device aims to make sessions simpler and more affordable than clinic-only mats or large systems. Reported use cases: the guest discusses user-reported improvements in stress, HRV, sleep, pain, and more—presented as claims and ongoing studies, not medical advice. Safety framing: energy level and frequency matter; the device output described is far below MRI fields, though MRI safety analogies should not be read as equivalence in efficacy. AI + biometrics: future direction includes watches, cloud trends, and automated recommendations—raising opportunities and the need for privacy and validation. Bottom line: intriguing engineering applied to wellness; further independent, peer-reviewed evidence is essential before making health decisions. Medical Disclaimer This content is for educational and informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of your physician or other qualified health provider with any questions you may have regarding a medical condition, symptoms, or health objectives. Never disregard professional medical advice or delay seeking it because of something you heard in this episode or read in the show notes. Any products, devices, protocols, or practices discussed are presented as general wellness information only. They are not intended to diagnose, treat, cure, or prevent any disease. Statements made by guests are their personal opinions and experiences and have not been evaluated by the U.S. Food and Drug Administration (FDA) or other regulatory authorities. Results vary from person to person. If you are experiencing a medical emergency or mental health crisis, call your local emergency number immediately or contact your nearest crisis hotline. How to connect with the guest   Website: https://resona.health/ Email: info@resona.health Want to be a guest on Healthy Mind, Healthy Life? DM on PM - Send me a message on PodMatch DM Me Here: https://www.podmatch.com/hostdetailpreview/avik   Disclaimer: This video is for educational and informational purposes only. The views expressed are the personal opinions of the guest and do not reflect the views of the host or Healthy Mind By Avik™️. We do not intend to harm, defame, or discredit any person, organization, brand, product, country, or profession mentioned. All third-party media used remain the property of their respective owners and are used under fair use for informational purposes. By watching, you acknowledge and accept this disclaimer.   Healthy Mind By Avik™️ is a global platform redefining mental health as a necessity, not a luxury. Born during the pandemic, it's become a sanctuary for healing, growth, and mindful living. Hosted by Avik Chakraborty—storyteller, survivor, wellness advocate—this channel shares powerful podcasts and soul-nurturing conversations on: • Mental Health & Emotional Well-being• Mindfulness & Spiritual Growth• Holistic Healing & Conscious Living• Trauma Recovery & Self-Empowerment With over 4,400+ episodes and 168.4K+ global listeners, join us as we unite voices, break stigma, and build a world where every story matters.

The U.S. Food and Drug Administration (FDA) has now launched a safety label change warning of the dangers of Tylenol in pregnant mothers. The FDA also announced approval of leucovorin, a form of folic acid suggested as a treatment for autism symptoms. The medical community, in collusion with public health officials, has long pointed to a ‘blame-the-victim' approach, saying it was just children with unlucky genetics – a nod to eugenics musings and insulting to families looking for answers.

  In this episode of The Heart to Heart podcast, host Dr. Mike Hart interviews Alex Leaf, an independent nutritional researcher renowned for debunking nutritional misinformation on social media. The discussion covers topics such as the benefits of collagen for skin health, the potential advantages of ketogenic diets for athletes, and the truth behind various nutrition myths including the effects of soy on testosterone and semen retention. Alex also shares his insights on intermittent fasting, ideal protein intake, and the debate over seed oils. The conversation concludes with their thoughts on cardiovascular health markers and the relevance of particle size in LDL cholesterol.    Alex Leaf is an independent nutritional researcher, scientific communicator, and educator specializing in human health and performance. With a decade of experience translating complex science into actionable insights, Alex rose to prominence as a researcher and writer at Examine.com before joining Ari Whitten's Energy Blueprint. His work spans peer-reviewed publications—including contributions to the ISSN position stand on ketogenic diets—and teaching in the Master's program in Human Nutrition and Functional Medicine at the University of Western States. Follow him here: Website: alexleaf.com Instagram: @AlexJLeaf   Links: IVF and Abstinence Studies Systematic Review on Ketogenic Diets in Athletes Whey Protein vs. Beef Protein Show Notes: 00:00 – Welcome back to the Hart2Heart Podcast with Dr. Mike Hart 02:30 – Collagen and skin health 08:30 – Ketogenic diets for athletes 14:00 – Protein intake for athletes 18:00 – Intermittent fasting vs caloric restriction 25:00 – Seed oils: myths and facts 30:00 – Semen retention: debunking the myths 35:00 – Soy and hormones 38:30 – Soy consumption and hormonal effects 39:30 – Whey protein: benefits and misconceptions 42:30 – Post-workout nutrition myths 45:00 – Insulin sensitivity and carbohydrate timing 54:00 – Protein intake strategies 57:00 – Calories and diet composition 57:14 – “A calorie is a calorie, but depending on your diet's composition, you'll absorb and utilize very different amounts of calories from food.” 01:01:00 – Debating dietary approaches 01:05:00 – Cardiovascular health markers 01:12:00 – Conclusion and contact information   — The Hart2Heart podcast is hosted by family physician Dr. Michael Hart, who is dedicated to  cutting through the noise and uncovering the most effective strategies for optimizing health,  longevity, and peak performance. This podcast dives deep into evidence-based approaches to  hormone balance, peptides, sleep optimization, nutrition, psychedelics, supplements, exercise  protocols, leveraging sunlight light, and de-prescribing pharmaceuticals—using medications only when absolutely necessary.   Beyond health science, we tackle the intersection of public health and politics, exposing how  Policy decisions shape our health landscape and what actionable steps people can take to reclaim control over their well-being.   Guests range from out-of-the-box thinking physicians such as Dr. Casey Means (author of "Good Energy") and Dr. Roger Sehult (Medcram lectures) to public health experts such as Dr. Jay Bhattacharya (Director of the National Institutes of Health (NIH) and Dr. Marty Mckary  (Commissioner of the Food and Drug Administration (FDA) and high-profile names such as  Zuby and Mark Sisson (Primal Blueprint and Primal Kitchen).   If you're ready to take control of your health and performance, this is the podcast for you. We cut through the jargon and deliver practical, no-BS advice that you can implement in your daily life, empowering you to make positive changes for your well-being.   Connect on social with Dr. Mike Hart: Instagram: @drmikehart Twitter: @drmikehart Facebook: @drmikehart  

On Monday, President Donald Trump, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., and other Trump administration officials announced a pair of actions the Food and Drug Administration (FDA) will take to address the increase in autism spectrum disorder (ASD) in children. First, the FDA will update the warning labels for acetaminophen — the active ingredient in pain relievers like Tylenol — to note a potential association between the ingredient and neurological conditions — such as ASD and attention-deficit/hyperactivity disorder (ADHD) — in children (though it also emphasized that no causal link has been established). Second, the agency has initiated the approval of leucovorin calcium tablets for patients with cerebral folate deficiency (CFD). Ad-free podcasts are here!To listen to this podcast ad-free, and to enjoy our subscriber only premium content, go to ReadTangle.com to sign up!You can read today's podcast⁠ ⁠⁠here⁠⁠⁠, our “Under the Radar” story ⁠here and today's “Have a nice day” story ⁠here⁠.You can subscribe to Tangle by clicking here or drop something in our tip jar by clicking here. Take the survey: What do you think about the HHS announcement, autism, and Tylenol? Let us know.Disagree? That's okay. My opinion is just one of many. Write in and let us know why, and we'll consider publishing your feedback.Our Executive Editor and Founder is Isaac Saul. Our Executive Producer is Jon Lall.This podcast was written by Ari Weitzman and edited and engineered by Dewey Thomas. Music for the podcast was produced by Diet 75.Our newsletter is edited by Managing Editor Ari Weitzman, Senior Editor Will Kaback, Lindsey Knuth, Kendall White, Bailey Saul, and Audrey Moorehead. Hosted on Acast. See acast.com/privacy for more information.

Ein Standpunkt von Uwe Froschauer.In letzter Zeit tut sich Einiges im Bereich Impfung. Die von den Regierungen vorangetriebene Impfagenda verliert immer mehr an Fahrt. Die Menschen haben aus dem Coronabetrug gelernt. Nachfolgend möchte ich Ihnen neue Erkenntnisse, Meinungen und Bewegungen zu den Themen Impfung und Corona näherbringen.„Die Corona-Impfung hat Millionen Leben gerettet“,so das Narrativ vieler Politiker, unterstützt von ihren medialen, behördlichen und wissenschaftlichen Handlangern. Interessant ist, dass einige Verantwortliche des Coronabetrugs sich immer noch trauen, trotz erdrückender Gegenbeweise, dieses Ammenmärchen aufrechtzuerhalten. Ein großer Teil der Weltgeschichte besteht aus Märchen, die uns als Realität verkauft wurden und nach wie vor wird. Nicht nur die Kinder werden mit Märchen verzaubert, auch die Erwachsenen sind zunehmend Zielgruppe hanebüchener Narrative.Eine neue, im Fachjournal Research in Social and Administrative Pharmacy veröffentlichte Studie zeigt, dass die Covid-19-Impfung eher das Gegenteil bewirkt hat. In vielen Regionen stiegen die Todeszahlen nach Einführung der Impfungen signifikant an. Das heißt, statt dem in diversen Impfkampagnen versprochenen Rückgang der Todeszahlen, folgte nach der Impfung ein massiver Anstieg der gemeldeten Todesfälle. Regionen mit hoher Impfquote hatten eine hohe Übersterblichkeit zu verzeichnen und umgekehrt. Das „Coronajahr“ 2020 war in Deutschland ein moderates Sterbejahr, die Jahre danach hatten eine zunehmende Übersterblichkeit vorzuweisen.Das politische Märchen, stimuliert mit dem Mantra von den „Millionen geretteten Leben“, war reine Propaganda mit dem Ziel der Rechtfertigung des erhöhten politischen Drucks und drastischer Maßnahmen wie Lockdowns – im Nachhinein Freiheitsberaubung – und der Nötigung zur Impfung – in meinen Augen fahrlässige Körperverletzung bis hin zur fahrlässigen Tötung, sowie der gezielten Ausgrenzung, Diffamierung, Diskreditierung und Etikettierung Andersdenkender – ein klarer Verstoß gegen Artikel 1 Grundgesetz: Die Würde des Menschen ist unantastbar.Die Impfung schützte weder vor erneuter Infektion, sie schützte ebenso wenig andere davor, vom Geimpften angesteckt zu werden, und auch der Schutz vor einem schweren Verlauf der Infektion war nicht gegeben. Junge, gesunde Menschen waren durch das Virus kaum gefährdet, jedoch umso mehr durch Impfnebenwirkungen wie Myokarditis (Herzmuskelentzündung) oder Perikarditis (Herzbeutelentzündung), die teilweise tödlich verliefen.„Intensive Untersuchung“ zu Todesfällen bei Kindern nach COVID-ImpfungDie US-amerikanische Food and Drug Administration (FDA) führt eine „intensive Untersuchung” zu den Todesfällen junger, gesunder Kinder nach einer COVID-19-Impfung durch, bestätigte der Leiter der Behörde, Dr. Marty Makary, letzte Woche in einem CNN-Interview.„Wir werden in den nächsten Wochen einen Bericht veröffentlichen”,sagte der Leiter der FDA in diesem Interview.„Wir sprechen mit den primären Quellen, den Familienmitgliedern, die ein Kind verloren haben ... wir überprüfen die Autopsieberichte, wir lassen Ärzte die Untersuchung durchführen”,...https://apolut.net/nachrichten-jenseits-des-mainstreams-rund-um-die-themen-impfungen-und-corona-von-uwe-froschauer/ Hosted on Acast. See acast.com/privacy for more information.

The latest episode of the DDW Highlights Podcast is now available to listen to below. DDW's Bruno Quinney narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. In this week's news, AstraZeneca has halted its £200 million research investment in the UK. Elsewhere, the US Food and Drug Administration (FDA) has fast-tracked a gene therapy, CAR-T therapy could be an effective cancer treatment, and the National Institute for Health and Care Excellence (NICE) has updated its thresholds for ultra-rare disease drugs. You can listen below, or find The Drug Discovery World Podcast on Spotify, Google Play and Apple Podcasts. 

In this episode of The Heart to Heart podcast, host Dr. Mike Hart welcomes back Rav, an author and host of the Illusion of Consensus podcast. The conversation delves into Rav's evolving interests, from his initial focus on COVID-19 and myocarditis to his current pursuit of a more holistic and spiritually grounded life. Rav discusses his journey through rigorous psychotherapy, aided by psychedelics, to uncover subconscious patterns and improve his overall well-being. The discussion also touches on the utility of AI tools like ChatGPT as supplementary therapy, the impact of social media on Gen Z's social behaviors, and the rising influence of independent journalism. The episode sheds light on finding balance in a hyper-productive world, integrating different therapeutic pathways, and the significance of peaceful presence in one's life. Rav Arora is an independent journalist, cultural critic, and podcast host exploring the intersections of health, spirituality, and human performance. Rising to prominence through his widely read Substack, The Meta Mystic, and as co-host of The Illusion of Consensus podcast, Rav has become a leading voice challenging mainstream narratives in science, psychology, and culture. Follow him here: Substack: The Meta MysticPodcast: The Illusion of ConsensusTwitter/X: @Ravarora1 Links: Psilocybin & Religious Leaders Study Internal Family Systems (IFS) Pain Reprocessing Therapy (PRT) Show Notes: (00:00)Welcome back to the Hart2Heart Podcast with Dr. Mike Hart (01:00) Shifting gears: From COVID to holistic living (02:30) The role of psychedelics in therapy (04:00) Balancing productivity and relaxation (10:00) ChatGPT as a therapeutic tool (18:30) Exploring psychedelic therapy (28:00) The power of peaceful presence (39:00) Psilocybin study on religious leaders (40:30) Challenges in recruiting for the study (41:00) Gen Z and alcohol consumption (42:30) Impact of social media on social skills (43:00) Dating apps and their consequences (50:48) “Social media has provided this illusion and comfort.” (53:30) Independent journalism's rise (01:00:30) The future of media and podcasting   — The Hart2Heart podcast is hosted by family physician Dr. Michael Hart, who is dedicated to  cutting through the noise and uncovering the most effective strategies for optimizing health,  longevity, and peak performance. This podcast dives deep into evidence-based approaches to  hormone balance, peptides, sleep optimization, nutrition, psychedelics, supplements, exercise  protocols, leveraging sunlight light, and de-prescribing pharmaceuticals—using medications only when absolutely necessary.   Beyond health science, we tackle the intersection of public health and politics, exposing how  policy decisions shape our health landscape and what actionable steps people can take to reclaim control over their well-being.   Guests range from out-of-the-box thinking physicians such as Dr. Casey Means (author of "Good Energy") and Dr. Roger Sehult (Medcram lectures) to public health experts such as Dr. Jay Bhattacharya (Director of the National Institutes of Health (NIH) and Dr. Marty Mckary  (Commissioner of the Food and Drug Administration (FDA) and high-profile names such as  Zuby and Mark Sisson (Primal Blueprint and Primal Kitchen).   If you're ready to take control of your health and performance, this is the podcast for you. We cut through the jargon and deliver practical, no-BS advice that you can implement in your daily life, empowering you to make positive changes for your well-being.   Connect on social with Dr. Mike Hart: Instagram: @drmikehart Twitter: @drmikehart Facebook: @drmikehart  

The U.S. Food and Drug Administration (FDA) launched an investigation after shrimp bound for Walmart tested positive for a man-made radioactive substance.Advertising Inquiries: https://redcircle.com/brandsPrivacy & Opt-Out: https://redcircle.com/privacy

Question: When should relevant documentation submitted to a regulatory review body be submitted for the Office for review? Answer: Where relevant documentation is submitted to a regulatory review body, such as the U.S. Food & Drug Administration (FDA), and is material to any pending patent application or reexamination proceeding, such documentation should be submitted for […] The post MPEP Q & A 336: Circumstances when relevant documentation should be submitted to regulatory review body. appeared first on Patent Education Series.

In this solo podcast episode, Dr Mike Hart provides actionable, evidence-backed strategies to improve overall circadian rhythm and consequently enhance sleep quality. He discusses the importance of a regulated sleep-wake cycle and its impact on hormone release, metabolism, immune function, and general well-being. Various methods to maintain a healthy circadian rhythm are explored, including the benefits of morning sunlight exposure, the role of blue light blocking in the evening, and the timing of meals and exercise. He also touches on the effects of caffeine and alcohol on sleep, the ideal sleep environment, and additional supportive practices like social interaction, light physical activity, and evening routines that promote relaxation.   Links: Dual Orexin Receptor Antagonists (DORAs) Forgiveness & Better Sleep (PubMed) Omega-3 (Fish Oil / EPA)   Show Notes: (0:00) Welcome back to the Hart2Heart Podcast with Dr. Mike Hart (01:30) Natural sleep improvement tips (02:33)  "Cortisol isn't bad—it's about timing. You want it high in the morning and low at night for better sleep." (04:30) Behavioral modifications and supplements (08:30) Introduction to prescription sleep medications (10:00) Dual orexin receptor antagonists (DORAs) (14:30) Z-Drugs: Benefits and risks (18:00) Benzodiazepines: Usage and caution (20:30) Doxepin and H1 inverse agonists (22:30) Gabapentinoids for sleep and pain (26:30) Alpha adrenergic agents (31:30) Sedating antidepressants (37:30) Sodium oxybate for narcolepsy — The Hart2Heart podcast is hosted by family physician Dr. Michael Hart, who is dedicated to  cutting through the noise and uncovering the most effective strategies for optimizing health,  longevity, and peak performance. This podcast dives deep into evidence-based approaches to  hormone balance, peptides, sleep optimization, nutrition, psychedelics, supplements, exercise  protocols, leveraging sunlight light, and de-prescribing pharmaceuticals—using medications only when absolutely necessary.   Beyond health science, we tackle the intersection of public health and politics, exposing how  policy decisions shape our health landscape and what actionable steps people can take to reclaim control over their well-being.   Guests range from out-of-the-box thinking physicians such as Dr. Casey Means (author of "Good Energy") and Dr. Roger Sehult (Medcram lectures) to public health experts such as Dr. Jay Bhattacharya (Director of the National Institutes of Health (NIH) and Dr. Marty Mckary  (Commissioner of the Food and Drug Administration (FDA) and high-profile names such as  Zuby and Mark Sisson (Primal Blueprint and Primal Kitchen).   If you're ready to take control of your health and performance, this is the podcast for you. We cut through the jargon and deliver practical, no-BS advice that you can implement in your daily life, empowering you to make positive changes for your well-being.   Connect on social with Dr. Mike Hart: Instagram: @drmikehart Twitter: @drmikehart Facebook: @drmikehart  

Multitasking feels productive but it's actually draining your energy. I share what happened when I spent a full day doing one thing at a time, how it impacted my stress and focus, and why single-tasking can help you feel calmer and more energized in perimenopause. Hey Hormone Hotties:If you want to learn more about how you can work with me or what services I offer including those below- https://linktr.ee/TheHappyHormonesCoach Interested in being a guest expert (even if you are not in business but a woman who has a story to share) fill out the application and book an appointment. Affiliated Partner for awesome products in wellness and more including the "Body balancing" slenderize for a discount using my code HAPPY24 Join me in Happy Hormones Circle. This and my email list is where I will be focusing my time and content Disclaimer: The content shared in ‘The Happy Hormones Coach' podcast (including affiliate and non affiliate products) is for informational purposes only and is not intended as medical advice, diagnosis, or treatment. Please consult with a qualified healthcare provider before making any changes to your diet, exercise, or health routine. The opinions expressed in this podcast are those of the host and guests and do not necessarily reflect the views of any healthcare organizations. The statements made regarding any of the products that I mention have not been evaluated by the Food and Drug Administration (FDA). Individual results may vary.

 One day, I closed my planner, walked away from my list, and let my energy lead the way. In this episode, I share why ignoring my to-do list lowered my stress, improved my focus, and reminded me that rest is a productive choice  especially in perimenopause. Hey Hormone Hotties:If you want to learn more about how you can work with me or what services I offer including those below- https://linktr.ee/TheHappyHormonesCoach Interested in being a guest expert (even if you are not in business but a woman who has a story to share) fill out the application and book an appointment. Affiliated Partner for awesome products in wellness and more including the "Body balancing" slenderize for a discount using my code HAPPY24 Join me in Happy Hormones Circle. This and my email list is where I will be focusing my time and content Disclaimer: The content shared in ‘The Happy Hormones Coach' podcast (including affiliate and non affiliate products) is for informational purposes only and is not intended as medical advice, diagnosis, or treatment. Please consult with a qualified healthcare provider before making any changes to your diet, exercise, or health routine. The opinions expressed in this podcast are those of the host and guests and do not necessarily reflect the views of any healthcare organizations. The statements made regarding any of the products that I mention have not been evaluated by the Food and Drug Administration (FDA). Individual results may vary.

In this episode of the Heart to Heart podcast, Dr. Mike Hart hosts Dr. Chester Sokolowski, a peptide expert and the founder of Thrive Telehealth Clinic, which specializes in hormone replacement therapy (HRT) and peptide treatments for both men and women. Dr. Sokolowski discusses his background, career, and various business ventures focused on human performance and optimization. The conversation delves deep into the benefits and applications of testosterone replacement therapy (TRT), peptides, and other health-related topics. Key points include the implications of TRT, managing estrogen levels, the benefits of combining peptides for muscle growth and recovery, and the groundbreaking potential of GLP-1 agonists like Ozempic and Retatrutide for weight loss and metabolic health. Dr. Sokolowski also touches on the benefits of glutathione, the latest research on peptides such as BPC-157 and TB-500, and the ethical considerations of using these therapies in professional sports. Dr. Chester Sokolowski is a performance optimization expert, telehealth clinician, and leading voice in hormone and peptide therapy. He earned his doctoral training at Florida State University and has dedicated his career to human performance, healthspan, and longevity. Known online as “Dr. Soko”, he shares cutting-edge insights on testosterone therapy, peptides, recovery, and performance through social media and educational content. His work empowers people to look, feel, and perform at their absolute best. Follow him on Instagram: @dr.soko, LinkedIn: Dr. Chester Sokolowski and YouTube: Dr. Soko Links: TRT (Testosterone Replacement Therapy) Ozempic (Semaglutide) DIM (Diindolylmethane) Oxidative stress & disease   Show Notes: (00:00) Introduction to the Heart to Heart Podcast (02:30) Dr. soko's dissertation on binge drinking and muscle growth (06:00) Cold therapy and hypertrophy (08:00) TRT and arimidex discussion (13:35) “Estrogen is not the enemy; it's actually protective for your heart, your brain, your joints.” (14:30) HCG and fertility (20:00) Peptides and GLP-1 drugs (34:30) Minimizing side effects and dosage strategies (35:30) Understanding GLP-1 mechanisms (36:00) Red aide: the unique GLP-1 (39:00) Visceral fat and GLP-1 effectiveness (41:00) GLP-1s and impulse control (46:30) Glutathione: the ultimate antioxidant (50:30) Peptides for skin and hair health (51:00) Growth hormone peptides: which is best? (55:00) BPC-157 and tb-500: healing peptides (01:00:30) TRT, peptides, and sports (01:03:00) Conclusion and contact information   — The Hart2Heart podcast is hosted by family physician Dr. Michael Hart, who is dedicated to  cutting through the noise and uncovering the most effective strategies for optimizing health,  longevity, and peak performance. This podcast dives deep into evidence-based approaches to  hormone balance, peptides, sleep optimization, nutrition, psychedelics, supplements, exercise  protocols, leveraging sunlight light, and de-prescribing pharmaceuticals—using medications only when absolutely necessary.   Beyond health science, we tackle the intersection of public health and politics, exposing how  policy decisions shape our health landscape and what actionable steps people can take to reclaim control over their well-being.   Guests range from out-of-the-box thinking physicians such as Dr. Casey Means (author of "Good Energy") and Dr. Roger Sehult (Medcram lectures) to public health experts such as Dr. Jay Bhattacharya (Director of the National Institutes of Health (NIH) and Dr. Marty Mckary  (Commissioner of the Food and Drug Administration (FDA) and high-profile names such as  Zuby and Mark Sisson (Primal Blueprint and Primal Kitchen).   If you're ready to take control of your health and performance, this is the podcast for you. We cut through the jargon and deliver practical, no-BS advice that you can implement in your daily life, empowering you to make positive changes for your well-being.   Connect on social with Dr. Mike Hart: Instagram: @drmikehart Twitter: @drmikehart Facebook: @drmikehart  

 Your grocery cart tells a story about your priorities, your season of life, and your health goals. I'm taking you inside my own cart, guilty pleasures and all, to show you how to shop for hormone health without giving up balance, joy, or flavor. Hey Hormone Hotties:If you want to learn more about how you can work with me or what services I offer including those below- https://linktr.ee/TheHappyHormonesCoach Interested in being a guest expert (even if you are not in business but a woman who has a story to share) fill out the application and book an appointment. Affiliated Partner for awesome products in wellness and more including the "Body balancing" slenderize for a discount using my code HAPPY24 Join me in Happy Hormones Circle. This and my email list is where I will be focusing my time and content Disclaimer: The content shared in ‘The Happy Hormones Coach' podcast (including affiliate and non affiliate products) is for informational purposes only and is not intended as medical advice, diagnosis, or treatment. Please consult with a qualified healthcare provider before making any changes to your diet, exercise, or health routine. The opinions expressed in this podcast are those of the host and guests and do not necessarily reflect the views of any healthcare organizations. The statements made regarding any of the products that I mention have not been evaluated by the Food and Drug Administration (FDA). Individual results may vary.

May 22nd is the National Day of Prayer and Remembrance for Mariners and Seafarers. Bishop Brendan Cahill discusses the ministry of the church to seafarers through the work of Stella Maris. The day is intended to remember the men and women seafarers. Many seafarers are Catholic Christians and largely a migrant population in the world. Because of the nature of their work, they are not always a visible community presence. In over 50 ports, there are more than 100 Stella Maris chaplains, maritime deacons, and lay ecclesial ministers who minister to seafarers. They welcome, network, and reach out to seafarers, fishermen and women, their families, and all who work or travel on the seas. Through the celebration of the Eucharist and the Word of God, the chaplaincy team helps seafarers discover the loving presence of God in an often-challenging world. Their continued presence is a clear indication of their dedication to this vital pastoral ministry and love for the people of the sea. https://www.usccb.org/committees/pastoral-care-migrants-refugees-travelers/stella-maris-who-we-are On Wednesday, May 10, a panel of advisors to the U.S. Food and Drug Administration (FDA) voted unanimously to make the birth-control drug, Opill, available to consumers over-the-counter in the United States. The FDA is reportedly poised to make a final decision this summer. In response to the FDA panel's recommendation, Bishop Robert E. Barron of Winona-Rochester, and chairman of the U.S. Conference of Catholic Bishops' (USCCB) Committee on Laity, Marriage, Family Life and Youth, urged the government agency to reject this advice as “not good medicine” and continue their efforts to protect women's health. Read the full statement. https://www.usccb.org/news/2023/fda-acknowledges-harm-oral-contraceptives-while-its-own-panel-advisors-push-make-drug After literally hundreds of public prayers for peace in Ukraine and 443 days after Russia launched an all-out war on the Eastern European country, Pope Francis welcomed Ukrainian President Volodymyr Zelenskyy to the Vatican. This was their first face-to-face meeting since the war began. Read the Catholic News Service Rome story. https://www.usccb.org/news/2023/pope-ukrainian-leader-talk-about-humanitarian-situation-provoked-war

 Sometimes the healthiest choice is breaking your own “perfect” routine. In this episode, I share what happened when I swapped my strict morning plan for what my body actually needed and why that flexibility can be a game-changer for your hormones, stress, and energy in perimenopause. Hey Hormone Hotties:If you want to learn more about how you can work with me or what services I offer including those below- https://linktr.ee/TheHappyHormonesCoach Interested in being a guest expert (even if you are not in business but a woman who has a story to share) fill out the application and book an appointment. Affiliated Partner for awesome products in wellness and more including the "Body balancing" slenderize for a discount using my code HAPPY24 Join me in Happy Hormones Circle. This and my email list is where I will be focusing my time and content Disclaimer: The content shared in ‘The Happy Hormones Coach' podcast (including affiliate and non affiliate products) is for informational purposes only and is not intended as medical advice, diagnosis, or treatment. Please consult with a qualified healthcare provider before making any changes to your diet, exercise, or health routine. The opinions expressed in this podcast are those of the host and guests and do not necessarily reflect the views of any healthcare organizations. The statements made regarding any of the products that I mention have not been evaluated by the Food and Drug Administration (FDA). Individual results may vary.

What does “great” Medical Affairs look like in 2025? We talk evidence, access, patient voice, and how to work with Commercial without crossing the promotional line. Abdul Hameed Al-Khateeb, Country Medical Director, shares practical lessons on measurement, real-world evidence, and where AI actually helps.Email to your listSubject line options (pick one):Inside Medical Affairs: From Evidence to AccessThe Missing Link Between Science and PatientsWhat Great Medical Affairs Looks Like (and How to Measure It)

 If your energy swings between “I can conquer the world” and “I need a nap now,” you're not alone — and you're not broken. In this episode of The Happy Hormones Coach Podcast, I share why energy highs and lows are so common in perimenopause and how cortisol, blood sugar, and hormone shifts work together to keep you on the roller coaster. We'll dive deep into the cravings–cortisol connection, why quick fixes like sugar or coffee make things worse, and the simple daily shifts that can help you create steady, all-day energy. You'll learn how to support your hormones, balance your blood sugar, and smooth out those frustrating energy crashes so you can feel focused, steady, and in control again. Hey Hormone Hotties:If you want to learn more about how you can work with me or what services I offer including those below- https://linktr.ee/TheHappyHormonesCoach Interested in being a guest expert (even if you are not in business but a woman who has a story to share) fill out the application and book an appointment. Affiliated Partner for awesome products in wellness and more including the "Body balancing" slenderize for a discount using my code HAPPY24 Join me in Happy Hormones Circle. This and my email list is where I will be focusing my time and content Disclaimer: The content shared in ‘The Happy Hormones Coach' podcast (including affiliate and non affiliate products) is for informational purposes only and is not intended as medical advice, diagnosis, or treatment. Please consult with a qualified healthcare provider before making any changes to your diet, exercise, or health routine. The opinions expressed in this podcast are those of the host and guests and do not necessarily reflect the views of any healthcare organizations. The statements made regarding any of the products that I mention have not been evaluated by the Food and Drug Administration (FDA). Individual results may vary.

In this solo podcast episode, Dr Mike Hart provides actionable, evidence-backed strategies to improve overall circadian rhythm and consequently enhance sleep quality. He discusses the importance of a regulated sleep-wake cycle and its impact on hormone release, metabolism, immune function, and general well-being. Various methods to maintain a healthy circadian rhythm are explored, including the benefits of morning sunlight exposure, the role of blue light blocking in the evening, and the timing of meals and exercise. He also touches on the effects of caffeine and alcohol on sleep, the ideal sleep environment, and additional supportive practices like social interaction, light physical activity, and evening routines that promote relaxation.   Links: Luminette 3 Glasses Light Therapy Box (10,000 lux standard) The Paleo Solution (Book)   Show Notes: (0:00) Welcome back to the Hart2Heart Podcast with Dr. Mike Hart (02:00) Morning sunlight: The key to a healthy circadian rhythm (07:00) Evening strategies for better sleep (09:00) Exercise and movement: Timing and types (14:30) Meal timing and its impact on sleep (19:00) The role of melatonin and caffeine (20:41) “Caffeine within six hours of bed can cost you a full hour of sleep.” (25:00) Alcohol and other sleep disruptors (30:00) Optimizing your sleep environment (33:00) Pre-sleep relaxation techniques — The Hart2Heart podcast is hosted by family physician Dr. Michael Hart, who is dedicated to  cutting through the noise and uncovering the most effective strategies for optimizing health,  longevity, and peak performance. This podcast dives deep into evidence-based approaches to  hormone balance, peptides, sleep optimization, nutrition, psychedelics, supplements, exercise  protocols, leveraging sunlight light, and de-prescribing pharmaceuticals—using medications only when absolutely necessary.   Beyond health science, we tackle the intersection of public health and politics, exposing how  policy decisions shape our health landscape and what actionable steps people can take to reclaim control over their well-being.   Guests range from out-of-the-box thinking physicians such as Dr. Casey Means (author of "Good Energy") and Dr. Roger Sehult (Medcram lectures) to public health experts such as Dr. Jay Bhattacharya (Director of the National Institutes of Health (NIH) and Dr. Marty Mckary  (Commissioner of the Food and Drug Administration (FDA) and high-profile names such as  Zuby and Mark Sisson (Primal Blueprint and Primal Kitchen).   If you're ready to take control of your health and performance, this is the podcast for you. We cut through the jargon and deliver practical, no-BS advice that you can implement in your daily life, empowering you to make positive changes for your well-being.   Connect on social with Dr. Mike Hart: Instagram: @drmikehart Twitter: @drmikehart Facebook: @drmikehart  

 You're eating healthy, moving your body, and following all the “rules” — so why is the scale still creeping up? In this episode of The Happy Hormones Coach Podcast, I break down the real reasons women in perimenopause gain weight despite doing everything “right.” We'll talk about how hormone shifts, lowered progesterone, fluctuating estrogen, and insulin resistance can change how your body stores fat. I'll share why old advice like “eat less, move more” can backfire, and what to do instead to work with your body, not against it. You'll walk away with a smarter, hormone-friendly plan that supports weight loss, energy, and overall health in this season of life. Hey Hormone Hotties:If you want to learn more about how you can work with me or what services I offer including those below- https://linktr.ee/TheHappyHormonesCoach Interested in being a guest expert (even if you are not in business but a woman who has a story to share) fill out the application and book an appointment. Affiliated Partner for awesome products in wellness and more including the "Body balancing" slenderize for a discount using my code HAPPY24 Join me in Happy Hormones Circle. This and my email list is where I will be focusing my time and content Disclaimer: The content shared in ‘The Happy Hormones Coach' podcast (including affiliate and non affiliate products) is for informational purposes only and is not intended as medical advice, diagnosis, or treatment. Please consult with a qualified healthcare provider before making any changes to your diet, exercise, or health routine. The opinions expressed in this podcast are those of the host and guests and do not necessarily reflect the views of any healthcare organizations. The statements made regarding any of the products that I mention have not been evaluated by the Food and Drug Administration (FDA). Individual results may vary.

 Think bloating is just about what you eat? Think again. In this episode of The Happy Hormones Coach Podcast, I share why bloating in perimenopause often has more to do with hormone shifts, stress, sluggish digestion, and water retention than it does with gluten or dairy. You'll learn the hidden triggers that keep you feeling puffy — even when your diet is “perfect” — and why over-restricting foods can actually make bloating worse. I'll walk you through practical, hormone-friendly strategies to support digestion, reduce water retention, and calm your nervous system so you can feel lighter and more comfortable without cutting out all your favorite foods. Hey Hormone Hotties:If you want to learn more about how you can work with me or what services I offer including those below- https://linktr.ee/TheHappyHormonesCoach Interested in being a guest expert (even if you are not in business but a woman who has a story to share) fill out the application and book an appointment. Affiliated Partner for awesome products in wellness and more including the "Body balancing" slenderize for a discount using my code HAPPY24 Join me in Happy Hormones Circle. This and my email list is where I will be focusing my time and content Disclaimer: The content shared in ‘The Happy Hormones Coach' podcast (including affiliate and non affiliate products) is for informational purposes only and is not intended as medical advice, diagnosis, or treatment. Please consult with a qualified healthcare provider before making any changes to your diet, exercise, or health routine. The opinions expressed in this podcast are those of the host and guests and do not necessarily reflect the views of any healthcare organizations. The statements made regarding any of the products that I mention have not been evaluated by the Food and Drug Administration (FDA). Individual results may vary.

Brain-computer interfaces, or BCIs, aim to enable people to control various adaptive devices directly with their thoughts. There are many BCI devices currently in various stages of development, with the potential to help people with ALS and similar conditions across many different activities of daily life. One particular area in which BCI devices may be able to support people with advanced ALS symptoms is communication. Many people with ALS rely on devices such as smartphones, tablets, and laptops to write or speak. All tools like these, collectively known as augmentative and alternative communication or AAC devices, need some kind of input to work. This could mean using a keyboard, a touchscreen, or, for people with advanced paralysis, an eye-gaze device. As ALS progresses, however, even eye gaze devices may become difficult for some people to use. BCIs—by allowing people to control AAC devices with their minds—could be a potential solution to this problem. Today, on Endpoints, we’re joined by two experts to discuss BCI technology and, in particular, its potential to help people with ALS continue to communicate. The views expressed in this podcast are those of the speakers and do not represent official endorsements by any organization. Kate Nilsen currently serves as an advisor to Synchron, a company developing a brain-computer interface (BCI) device. This device is investigational and is currently in clinical trials approved by the U.S. Food and Drug Administration (FDA). For those interested in staying informed about Synchron’s ongoing work and updates, please join the Synchron community: https://link.edgepilot.com/s/4239f747/ca21cbCpKkOSLI5ZXNqTdQ?u=https://www.synchronbci.com/StayConnected.htmlSupport the show: https://www.als.net/donate/See omnystudio.com/listener for privacy information.

In this edition of the Heart to Heart podcast, Dr. Mike Hart sits down with Todd Shapiro, CEO of Red Light Holland, a prominent figure in the psychedelic space. They discuss various aspects of psychedelic therapy, particularly focusing on psilocybin and its potential benefits for mental health, anxiety, and personal well-being. Todd shares his personal journey from working various jobs to becoming a key player in the psychedelic industry. They delve into recent developments in psychedelic research, the challenges of legalization, and the importance of proper protocols and responsible use. The conversation also highlights the role of microdosing and macro dosing, the differences between medicinal mushrooms and other psychedelics like MDMA and ayahuasca, and the future of psychedelic therapy.  Guest Bio and Links Todd Shapiro is the CEO of Red Light Holland, a publicly traded leader in legal psilocybin truffles and psychedelic research. A former top Canadian radio host turned mental health advocate, Todd champions safe, science-backed access to psychedelics, working with world-class researchers to advance policy reform and personal sovereignty. Follow him on X (Twitter) @ToddMShapiro Red Light Holland: http://redlight.co Third Wave: https://thethirdwave.co/microdosing-psilocybin-mushrooms-stamets-stack/?utm_source=chatgpt.com schedule35.co: https://schedule35.co/blog/paul-stamets-microdosing-protocol/?utm_source=chatgpt.com Show Notes: (00:00) Introduction to the Heart to Heart Podcast (01:30) Todd Shapiro's journey into psychedelics (03:30) Microdosing and its impact (13:30) Challenges and legalities of psychedelics (19:30) Advocacy and future of psychedelics (32:00) Concerns about unregulated psilocybin use (34:00) Regulated psilocybin sales in the Netherlands (37:00) Psilocybin administration methods (46:36) “The most clear anecdotal model of consistency… has got to be psilocybin. “ (49:30) Corporate influence on psychedelics (57:30) Global leadership in psychedelic research (59:30) Closing remarks and future prospects   --- The Hart2Heart podcast is hosted by family physician Dr. Michael Hart, who is dedicated to  cutting through the noise and uncovering the most effective strategies for optimizing health,  longevity, and peak performance. This podcast dives deep into evidence-based approaches to  hormone balance, peptides, sleep optimization, nutrition, psychedelics, supplements, exercise  protocols, leveraging sunlight light, and de-prescribing pharmaceuticals—using medications only when absolutely necessary.   Beyond health science, we tackle the intersection of public health and politics, exposing how  policy decisions shape our health landscape and what actionable steps people can take to reclaim control over their well-being.   Guests range from out-of-the-box thinking physicians such as Dr. Casey Means (author of "Good Energy") and Dr. Roger Sehult (Medcram lectures) to public health experts such as Dr. Jay Bhattacharya (Director of the National Institutes of Health (NIH) and Dr. Marty Mckary  (Commissioner of the Food and Drug Administration (FDA) and high-profile names such as  Zuby and Mark Sisson (Primal Blueprint and Primal Kitchen).   If you're ready to take control of your health and performance, this is the podcast for you. We cut through the jargon and deliver practical, no-BS advice that you can implement in your daily life, empowering you to make positive changes for your well-being.   Connect on social with Dr. Mike Hart:   Instagram: https://www.instagram.com/drmikehart/  Twitter: https://twitter.com/drmikehart   Facebook: https://www.facebook.com/MikeHartEPS/   

Olestra (also known by its brand name Olean) is a fat substitute food additive that adds no metabolizable calories to products. It has been used in the preparation of otherwise high-fat foods, thereby lowering or eliminating their fat content. The Food and Drug Administration (FDA) approved olestra for use in the US as a replacement for fats and oils in prepackaged ready-to-eat snacks in 1996,[2] concluding that such use "meets the safety standard for food additives, reasonable certainty of no harm".[3]: 46399  In the early 2000s, olestra lost popularity due to supposed side effects and is largely phased out, but products containing the ingredient are available in some countries.

Send us a textFeeling stressed? You might be “managing” it in ways that actually make things worse.In this episode of The Happy Hormones Coach Podcast, I break down the most common stress relief habits that secretly sabotage your hormones — like nightly wine, constant sugar fixes, overtraining, and numbing out with screens. You'll learn how chronic stress impacts your cortisol, sleep, digestion, and weight in perimenopause, and why quick fixes keep you stuck in the cycle. I'll walk you through my simple 5-Minute Reset Method so you can calm your nervous system, lower stress, and start supporting your hormones — without adding more to your plate. Hey Hormone Hotties:If you want to learn more about how you can work with me or what services I offer including those below- https://linktr.ee/TheHappyHormonesCoach Interested in being a guest expert (even if you are not in business but a woman who has a story to share) fill out the application and book an appointment. Affiliated Partner for awesome products in wellness and more including the "Body balancing" slenderize for a discount using my code HAPPY24 Join me in Happy Hormones Circle. This and my email list is where I will be focusing my time and content Disclaimer: The content shared in ‘The Happy Hormones Coach' podcast (including affiliate and non affiliate products) is for informational purposes only and is not intended as medical advice, diagnosis, or treatment. Please consult with a qualified healthcare provider before making any changes to your diet, exercise, or health routine. The opinions expressed in this podcast are those of the host and guests and do not necessarily reflect the views of any healthcare organizations. The statements made regarding any of the products that I mention have not been evaluated by the Food and Drug Administration (FDA). Individual results may vary.

The Commissioner of the Food and Drug Administration (FDA), Dr. Marty Makary, shares what the FDA is doing to combat Americans' health concerns, including new approaches to medicine. He explains the changes made to SNAP, the Supplemental Nutrition Assistance Program, and how the federal government plans to regulate it beyond relying on grocery store management. Dr. Makary discusses President Trump's pursuit to lower drug prices for Americans and the impending pushback from pharmaceutical companies. Later, he shares an update about the Presidential Physical Fitness Test. Learn more about your ad choices. Visit podcastchoices.com/adchoices

In the past two months, several major U.S. food companies have voluntarily committed to removing artificial food dyes from their products, following a plan from the Food and Drug Administration (FDA) to work with the industry to phase out petroleum-based synthetic dyes. In June, Heinz and General Mills committed to removing synthetic dyes from all their products by the end of 2027, while Nestlé committed to their removal by the end of 2026. Tangle LIVE tickets are available!We're excited to announce that our third installment of Tangle Live will be held on October 24, 2025, at the Irvine Barclay Theatre in Irvine, California. If you're in the area (or want to make the trip), we'd love to have you join Isaac and the team for a night of spirited discussion, live Q&A, and opportunities to meet the team in person. You can read more about the event and purchase tickets here.Ad-free podcasts are here!To listen to this podcast ad-free, and to enjoy our subscriber only premium content, go to ReadTangle.com to sign up!You can read today's podcast⁠ ⁠⁠here⁠⁠⁠, our “Under the Radar” story ⁠here and today's “Have a nice day” story ⁠here⁠.Take the survey: What do you think about removing artificial dyes from food? Let us know!Disagree? That's okay. My opinion is just one of many. Write in and let us know why, and we'll consider publishing your feedback.You can subscribe to Tangle by clicking here or drop something in our tip jar by clicking here. Our Executive Editor and Founder is Isaac Saul. Our Executive Producer is Jon Lall.This podcast was written by: Isaac Saul and edited and engineered by Jon Lall. Music for the podcast was produced by Diet 75.Our newsletter is edited by Managing Editor Ari Weitzman, Senior Editor Will Kaback, Lindsey Knuth, Kendall White, Bailey Saul, and Audrey Moorehead. Hosted on Acast. See acast.com/privacy for more information.

In this week's episode of the BroadEYE Podcast, hosts Dr. Shawn Maloney and Dr. Carlos Quezada-Ruiz sit down with Dr. Wiley Chambers, recently retired Deputy Director of the Division of Ophthalmology at the U.S. Food and Drug Administration (FDA). With over 36 years at the FDA, Dr. Chambers offers a rare insider's perspective on regulatory science, ophthalmic drug development, and the evolution of clinical trial oversight. This episode explores: How ophthalmology regulation has changed over the decades Common pitfalls in pre-IND meetings and what smart innovators do differently Lessons learned from reviewing countless drug and biologic applications The future of FDA guidance in areas like rare disease, gene therapy, and digital endpoints Dr. Chambers also shares personal reflections on mentorship, scientific integrity, and his transition out of federal service after a distinguished career. About Our Guest Dr. Wiley Chambers served as a lead ophthalmic reviewer at the U.S. FDA from 1987 until his retirement in 2023. As Deputy Director of the Division of Ophthal

In this exclusive interview, I spoke with Dr. Marty Makary, commissioner of the U.S. Food and Drug Administration (FDA), about his first 100 days in office and how he is transforming the agency.In this wide-ranging interview, we dive into his work to change food guidelines and drug approval processes, reduce supply chain vulnerabilities, and tackle conflicts of interest. We also address criticism of some of the FDA's recent decisions surrounding vaccines.Views expressed in this video are opinions of the host and the guest, and do not necessarily reflect the views of The Epoch Times.

This week, something extraordinary happened: menopause took center stage at the highest levels of US government in an unprecedented way. The US Food and Drug Administration (FDA) convened leading experts from across the country to discuss what millions of women have been waiting to hear: their experiences matter, their suffering is real, and there may be evidence-based solutions that have been withheld. This historic hearing offers tremendous hope for women navigating menopause.Are you ready to awaken your sensuality and feel more empowered in your body? Access the FREE Pleasure Upgrade Bundle at https://www.pleasureinthepause.com/gift.I am your host, Gabriella Espinosa, and in this special episode, I dive into the profound implications of this gathering. The FDA panel, the first of its kind in over two decades, aimed to fundamentally reimagine how we approach women's health during menopause, going beyond mere symptom management. This signifies a cultural awakening, recognizing that dismissing this universal experience has real consequences for women's health, careers, relationships, and quality of life.In this episode, we discuss:The End of Silence: Menopause, once a shamed and dismissed topic, has finally entered serious public discourse, moving beyond quiet endurance to high-level recognition.A Personal Story Driving Change: The head of the FDA shared his personal story about his mother who suffered greatly due to outdated fears around hormone therapy, emphasizing that bone fractures in older women can be fatal.Dismantling Dogma: Experts revealed that vaginal estrogen is categorically safe for all women, with no systemic absorption, directly challenging the black box warning.The Cost of Fear: Data revealed that tens of thousands of women died over the past two decades simply by avoiding estrogen, highlighting the tragic triumph of fear over facts.Brain and Bone Health: Researchers presented alarming data on how estrogen decline impacts brain function and bone density, emphasizing that hormone therapy can be a critical prevention tool, not just a treatment for the elderly.This hearing signals a critical shift: women's health matters, our experiences are valid, and we deserve care based on current science, not outdated assumptions. Whether or not you choose hormone therapy, there is now hope that you can make informed decisions based on facts.Your voice matters in this conversation!The FDA is opening a public comment period on this topic. Please go to the FDA YouTube channel, listen to the full hearing, and leave your public comment. This is our opportunity to ensure today's expert testimony translates into policy changes that will help millions of women.Help us spread more pleasure in the world!Please subscribe, rate, and review this episode, and share it with someone you love. Your voice is crucial in creating ripples of pleasure and connection throughout our communities.Until we meet again, remember, your pleasure matters.FDA HearingFDA InstagramCONNECT WITH GABRReclaim your sensuality and step into a powerful new chapter. The Midlife Pleasure Collective is a monthly membership designed to help midlife women reconnect with their bodies, embrace their desires, and cultivate deeper pleasure. Join the founding members for just $20/month - spots are limited, so apply now at pleasure-in-the-pause.com/collective. Full episodes on YouTube.

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

“To navigate proof, we must reach into a thicket of errors and biases. We must confront monsters and embrace uncertainty, balancing — and rebalancing —our beliefs. We must seek out every useful fragment of data, gather every relevant tool, searching wider and climbing further. Finding the good foundations among the bad. Dodging dogma and falsehoods. Questioning. Measuring. Triangulating. Convincing. Then perhaps, just perhaps, we'll reach the truth in time.”—Adam KucharskiMy conversation with Professor Kucharski on what constitutes certainty and proof in science (and other domains), with emphasis on many of the learnings from Covid. Given the politicization of science and A.I.'s deepfakes and power for blurring of truth, it's hard to think of a topic more important right now.Audio file (Ground Truths can also be downloaded on Apple Podcasts and Spotify)Eric Topol (00:06):Hello, it's Eric Topol from Ground Truths and I am really delighted to welcome Adam Kucharski, who is the author of a new book, Proof: The Art and Science of Certainty. He's a distinguished mathematician, by the way, the first mathematician we've had on Ground Truths and a person who I had the real privilege of getting to know a bit through the Covid pandemic. So welcome, Adam.Adam Kucharski (00:28):Thanks for having me.Eric Topol (00:30):Yeah, I mean, I think just to let everybody know, you're a Professor at London School of Hygiene and Tropical Medicine and also noteworthy you won the Adams Prize, which is one of the most impressive recognitions in the field of mathematics. This is the book, it's a winner, Proof and there's so much to talk about. So Adam, maybe what I'd start off is the quote in the book that captivates in the beginning, “life is full of situations that can reveal remarkably large gaps in our understanding of what is true and why it's true. This is a book about those gaps.” So what was the motivation when you undertook this very big endeavor?Adam Kucharski (01:17):I think a lot of it comes to the work I do at my day job where we have to deal with a lot of evidence under pressure, particularly if you work in outbreaks or emerging health concerns. And often it really pushes the limits, our methodology and how we converge on what's true subject to potential revision in the future. I think particularly having a background in math's, I think you kind of grow up with this idea that you can get to these concrete, almost immovable truths and then even just looking through the history, realizing that often isn't the case, that there's these kind of very human dynamics that play out around them. And it's something I think that everyone in science can reflect on that sometimes what convinces us doesn't convince other people, and particularly when you have that kind of urgency of time pressure, working out how to navigate that.Eric Topol (02:05):Yeah. Well, I mean I think these times of course have really gotten us to appreciate, particularly during Covid, the importance of understanding uncertainty. And I think one of the ways that we can dispel what people assume they know is the famous Monty Hall, which you get into a bit in the book. So I think everybody here is familiar with that show, Let's Make a Deal and maybe you can just take us through what happens with one of the doors are unveiled and how that changes the mathematics.Adam Kucharski (02:50):Yeah, sure. So I think it is a problem that's been around for a while and it's based on this game show. So you've got three doors that are closed. Behind two of the doors there is a goat and behind one of the doors is a luxury car. So obviously, you want to win the car. The host asks you to pick a door, so you point to one, maybe door number two, then the host who knows what's behind the doors opens another door to reveal a goat and then ask you, do you want to change your mind? Do you want to switch doors? And a lot of the, I think intuition people have, and certainly when I first came across this problem many years ago is well, you've got two doors left, right? You've picked one, there's another one, it's 50-50. And even some quite well-respected mathematicians.Adam Kucharski (03:27):People like Paul Erdős who was really published more papers than almost anyone else, that was their initial gut reaction. But if you work through all of the combinations, if you pick this door and then the host does this, and you switch or not switch and work through all of those options. You actually double your chances if you switch versus sticking with the door. So something that's counterintuitive, but I think one of the things that really struck me and even over the years trying to explain it is convincing myself of the answer, which was when I first came across it as a teenager, I did quite quickly is very different to convincing someone else. And even actually Paul Erdős, one of his colleagues showed him what I call proof by exhaustion. So go through every combination and that didn't really convince him. So then he started to simulate and said, well, let's do a computer simulation of the game a hundred thousand times. And again, switching was this optimal strategy, but Erdős wasn't really convinced because I accept that this is the case, but I'm not really satisfied with it. And I think that encapsulates for a lot of people, their experience of proof and evidence. It's a fact and you have to take it as given, but there's actually quite a big bridge often to really understanding why it's true and feeling convinced by it.Eric Topol (04:41):Yeah, I think it's a fabulous example because I think everyone would naturally assume it's 50-50 and it isn't. And I think that gets us to the topic at hand. What I love, there's many things I love about this book. One is that you don't just get into science and medicine, but you cut across all the domains, law, mathematics, AI. So it's a very comprehensive sweep of everything about proof and truth, and it couldn't come at a better time as we'll get into. Maybe just starting off with math, the term I love mathematical monsters. Can you tell us a little bit more about that?Adam Kucharski (05:25):Yeah, this was a fascinating situation that emerged in the late 19th century where a lot of math's, certainly in Europe had been derived from geometry because a lot of the ancient Greek influence on how we shaped things and then Newton and his work on rates of change and calculus, it was really the natural world that provided a lot of inspiration, these kind of tangible objects, tangible movements. And as mathematicians started to build out the theory around rates of change and how we tackle these kinds of situations, they sometimes took that intuition a bit too seriously. And there was some theorems that they said were intuitively obvious, some of these French mathematicians. And so, one for example is this idea of you how things change smoothly over time and how you do those calculations. But what happened was some mathematicians came along and showed that when you have things that can be infinitely small, that intuition didn't necessarily hold in the same way.Adam Kucharski (06:26):And they came up with these examples that broke a lot of these theorems and a lot of the establishments at the time called these things monsters. They called them these aberrations against common sense and this idea that if Newton had known about them, he never would've done all of his discovery because they're just nuisances and we just need to get rid of them. And there's this real tension at the core of mathematics in the late 1800s where some people just wanted to disregard this and say, look, it works for most of the time, that's good enough. And then others really weren't happy with this quite vague logic. They wanted to put it on much sturdier ground. And what was remarkable actually is if you trace this then into the 20th century, a lot of these monsters and these particularly in some cases functions which could almost move constantly, this constant motion rather than our intuitive concept of movement as something that's smooth, if you drop an apple, it accelerates at a very smooth rate, would become foundational in our understanding of things like probability, Einstein's work on atomic theory. A lot of these concepts where geometry breaks down would be really important in relativity. So actually, these things that we thought were monsters actually were all around us all the time, and science couldn't advance without them. So I think it's just this remarkable example of this tension within a field that supposedly concrete and the things that were going to be shunned actually turn out to be quite important.Eric Topol (07:53):It's great how you convey how nature isn't so neat and tidy and things like Brownian motion, understanding that, I mean, just so many things that I think fit into that general category. In the legal, we won't get into too much because that's not so much the audience of Ground Truths, but the classic things about innocent and until proven guilty and proof beyond reasonable doubt, I mean these are obviously really important parts of that overall sense of proof and truth. We're going to get into one thing I'm fascinated about related to that subsequently and then in science. So before we get into the different types of proof, obviously the pandemic is still fresh in our minds and we're an endemic with Covid now, and there are so many things we got wrong along the way of uncertainty and didn't convey that science isn't always evolving search for what is the truth. There's plenty no shortage of uncertainty at any moment. So can you recap some of the, you did so much work during the pandemic and obviously some of it's in the book. What were some of the major things that you took out of proof and truth from the pandemic?Adam Kucharski (09:14):I think it was almost this story of two hearts because on the one hand, science was the thing that got us where we are today. The reason that so much normality could resume and so much risk was reduced was development of vaccines and the understanding of treatments and the understanding of variants as they came to their characteristics. So it was kind of this amazing opportunity to see this happen faster than it ever happened in history. And I think ever in science, it certainly shifted a lot of my thinking about what's possible and even how we should think about these kinds of problems. But also on the other hand, I think where people might have been more familiar with seeing science progress a bit more slowly and reach consensus around some of these health issues, having that emerge very rapidly can present challenges even we found with some of the work we did on Alpha and then the Delta variants, and it was the early quantification of these.Adam Kucharski (10:08):So really the big question is, is this thing more transmissible? Because at the time countries were thinking about control measures, thinking about relaxing things, and you've got this just enormous social economic health decision-making based around essentially is it a lot more spreadable or is it not? And you only had these fragments of evidence. So I think for me, that was really an illustration of the sharp end. And I think what we ended up doing with some of those was rather than arguing over a precise number, something like Delta, instead we kind of looked at, well, what's the range that matters? So in the sense of arguing over whether it's 40% or 50% or 30% more transmissible is perhaps less important than being, it's substantially more transmissible and it's going to start going up. Is it going to go up extremely fast or just very fast?Adam Kucharski (10:59):That's still a very useful conclusion. I think what often created some of the more challenges, I think the things that on reflection people looking back pick up on are where there was probably overstated certainty. We saw that around some of the airborne spread, for example, stated as a fact by in some cases some organizations, I think in some situations as well, governments had a constraint and presented it as scientific. So the UK, for example, would say testing isn't useful. And what was happening at the time was there wasn't enough tests. So it was more a case of they can't test at that volume. But I think blowing between what the science was saying and what the decision-making, and I think also one thing we found in the UK was we made a lot of the epidemiological evidence available. I think that was really, I think something that was important.Adam Kucharski (11:51):I found it a lot easier to communicate if talking to the media to be able to say, look, this is the paper that's out, this is what it means, this is the evidence. I always found it quite uncomfortable having to communicate things where you knew there were reports behind the scenes, but you couldn't actually articulate. But I think what that did is it created this impression that particularly epidemiology was driving the decision-making a lot more than it perhaps was in reality because so much of that was being made public and a lot more of the evidence around education or economics was being done behind the scenes. I think that created this kind of asymmetry in public perception about how that was feeding in. And so, I think there was always that, and it happens, it is really hard as well as a scientist when you've got journalists asking you how to run the country to work out those steps of am I describing the evidence behind what we're seeing? Am I describing the evidence about different interventions or am I proposing to some extent my value system on what we do? And I think all of that in very intense times can be very easy to get blurred together in public communication. I think we saw a few examples of that where things were being the follow the science on policy type angle where actually once you get into what you're prioritizing within a society, quite rightly, you've got other things beyond just the epidemiology driving that.Eric Topol (13:09):Yeah, I mean that term that you just use follow the science is such an important term because it tells us about the dynamic aspect. It isn't just a snapshot, it's constantly being revised. But during the pandemic we had things like the six-foot rule that was never supported by data, but yet still today, if I walk around my hospital and there's still the footprints of the six-foot rule and not paying attention to the fact that this was airborne and took years before some of these things were accepted. The flatten the curve stuff with lockdowns, which I never was supportive of that, but perhaps at the worst point, the idea that hospitals would get overrun was an issue, but it got carried away with school shutdowns for prolonged periods and in some parts of the world, especially very stringent lockdowns. But anyway, we learned a lot.Eric Topol (14:10):But perhaps one of the greatest lessons is that people's expectations about science is that it's absolute and somehow you have this truth that's not there. I mean, it's getting revised. It's kind of on the job training, it's on this case on the pandemic revision. But very interesting. And that gets us to, I think the next topic, which I think is a fundamental part of the book distributed throughout the book, which is the different types of proof in biomedicine and of course across all these domains. And so, you take us through things like randomized trials, p-values, 95 percent confidence intervals, counterfactuals, causation and correlation, peer review, the works, which is great because a lot of people have misconceptions of these things. So for example, randomized trials, which is the temple of the randomized trials, they're not as great as a lot of people think, yes, they can help us establish cause and effect, but they're skewed because of the people who come into the trial. So they may not at all be a representative sample. What are your thoughts about over deference to randomized trials?Adam Kucharski (15:31):Yeah, I think that the story of how we rank evidence in medicines a fascinating one. I mean even just how long it took for people to think about these elements of randomization. Fundamentally, what we're trying to do when we have evidence here in medicine or science is prevent ourselves from confusing randomness for a signal. I mean, that's fundamentally, we don't want to mistake something, we think it's going on and it's not. And the challenge, particularly with any intervention is you only get to see one version of reality. You can't give someone a drug, follow them, rewind history, not give them the drug and then follow them again. So one of the things that essentially randomization allows us to do is, if you have two groups, one that's been randomized, one that hasn't on average, the difference in outcomes between those groups is going to be down to the treatment effect.Adam Kucharski (16:20):So it doesn't necessarily mean in reality that'd be the case, but on average that's the expectation that you'd have. And it's kind of interesting actually that the first modern randomized control trial (RCT) in medicine in 1947, this is for TB and streptomycin. The randomization element actually, it wasn't so much statistical as behavioral, that if you have people coming to hospital, you could to some extent just say, we'll just alternate. We're not going to randomize. We're just going to first patient we'll say is a control, second patient a treatment. But what they found in a lot of previous studies was doctors have bias. Maybe that patient looks a little bit ill or that one maybe is on borderline for eligibility. And often you got these quite striking imbalances when you allowed it for human judgment. So it was really about shielding against those behavioral elements. But I think there's a few situations, it's a really powerful tool for a lot of these questions, but as you mentioned, one is this issue of you have the population you study on and then perhaps in reality how that translates elsewhere.Adam Kucharski (17:17):And we see, I mean things like flu vaccines are a good example, which are very dependent on immunity and evolution and what goes on in different populations. Sometimes you've had a result on a vaccine in one place and then the effectiveness doesn't translate in the same way to somewhere else. I think the other really important thing to bear in mind is, as I said, it's the averaging that you're getting an average effect between two different groups. And I think we see certainly a lot of development around things like personalized medicine where actually you're much more interested in the outcome for the individual. And so, what a trial can give you evidence is on average across a group, this is the effect that I can expect this intervention to have. But we've now seen more of the emergence things like N=1 studies where you can actually over the same individual, particularly for chronic conditions, look at those kind of interventions.Adam Kucharski (18:05):And also there's just these extreme examples where you're ethically not going to run a trial, there's never been a trial of whether it's a good idea to have intensive care units in hospitals or there's a lot of these kind of historical treatments which are just so overwhelmingly effective that we're not going to run trial. So almost this hierarchy over time, you can see it getting shifted because actually you do have these situations where other forms of evidence can get you either closer to what you need or just more feasibly an answer where it's just not ethical or practical to do an RCT.Eric Topol (18:37):And that brings us to the natural experiments I just wrote about recently, the one with shingles, which there's two big natural experiments to suggest that shingles vaccine might reduce the risk of Alzheimer's, an added benefit beyond the shingles that was not anticipated. Your thoughts about natural experiments, because here you're getting a much different type of population assessment, again, not at the individual level, but not necessarily restricted by some potentially skewed enrollment criteria.Adam Kucharski (19:14):I think this is as emerged as a really valuable tool. It's kind of interesting, in the book you're talking to economists like Josh Angrist, that a lot of these ideas emerge in epidemiology, but I think were really then taken up by economists, particularly as they wanted to add more credibility to a lot of these policy questions. And ultimately, it comes down to this issue that for a lot of problems, we can't necessarily intervene and randomize, but there might be a situation that's done it to some extent for us, so the classic example is the Vietnam draft where it was kind of random birthdays with drawn out of lottery. And so, there's been a lot of studies subsequently about the effect of serving in the military on different subsequent lifetime outcomes because broadly those people have been randomized. It was for a different reason. But you've got that element of randomization driving that.Adam Kucharski (20:02):And so again, with some of the recent shingles data and other studies, you might have a situation for example, where there's been an intervention that's somewhat arbitrary in terms of time. It's a cutoff on a birth date, for example. And under certain assumptions you could think, well, actually there's no real reason for the person on this day and this day to be fundamentally different. I mean, perhaps there might be effects of cohorts if it's school years or this sort of thing. But generally, this isn't the same as having people who are very, very different ages and very different characteristics. It's just nature, or in this case, just a policy intervention for a different reason has given you that randomization, which allows you or pseudo randomization, which allows you to then look at something about the effect of an intervention that you wouldn't as reliably if you were just digging into the data of yes, no who's received a vaccine.Eric Topol (20:52):Yeah, no, I think it's really valuable. And now I think increasingly given priority, if you can find these natural experiments and they're not always so abundant to use to extrapolate from, but when they are, they're phenomenal. The causation correlation is so big. The issue there, I mean Judea Pearl's, the Book of Why, and you give so many great examples throughout the book in Proof. I wonder if you could comment that on that a bit more because this is where associations are confused somehow or other with a direct effect. And we unfortunately make these jumps all too frequently. Perhaps it's the most common problem that's occurring in the way we interpret medical research data.Adam Kucharski (21:52):Yeah, I think it's an issue that I think a lot of people get drilled into in their training just because a correlation between things doesn't mean that that thing causes this thing. But it really struck me as I talked to people, researching the book, in practice in research, there's actually a bit more to it in how it's played out. So first of all, if there's a correlation between things, it doesn't tell you much generally that's useful for intervention. If two things are correlated, it doesn't mean that changing that thing's going to have an effect on that thing. There might be something that's influencing both of them. If you have more ice cream sales, it will lead to more heat stroke cases. It doesn't mean that changing ice cream sales is going to have that effect, but it does allow you to make predictions potentially because if you can identify consistent patterns, you can say, okay, if this thing going up, I'm going to make a prediction that this thing's going up.Adam Kucharski (22:37):So one thing I found quite striking, actually talking to research in different fields is how many fields choose to focus on prediction because it kind of avoids having to deal with this cause and effect problem. And even in fields like psychology, it was kind of interesting that there's a lot of focus on predicting things like relationship outcomes, but actually for people, you don't want a prediction about your relationship. You want to know, well, how can I do something about it? You don't just want someone to sell you your relationship's going to go downhill. So there's almost part of the challenge is people just got stuck on prediction because it's an easier field of work, whereas actually some of those problems will involve intervention. I think the other thing that really stood out for me is in epidemiology and a lot of other fields, rightly, people are very cautious to not get that mixed up.Adam Kucharski (23:24):They don't want to mix up correlations or associations with causation, but you've kind of got this weird situation where a lot of papers go out of their way to not use causal language and say it's an association, it's just an association. It's just an association. You can't say anything about causality. And then the end of the paper, they'll say, well, we should think about introducing more of this thing or restricting this thing. So really the whole paper and its purpose is framed around a causal intervention, but it's extremely careful throughout the paper to not frame it as a causal claim. So I think we almost by skirting that too much, we actually avoid the problems that people sometimes care about. And I think a lot of the nice work that's been going on in causal inference is trying to get people to confront this more head on rather than say, okay, you can just stay in this prediction world and that's fine. And then just later maybe make a policy suggestion off the back of it.Eric Topol (24:20):Yeah, I think this is cause and effect is a very alluring concept to support proof as you so nicely go through in the book. But of course, one of the things that we use to help us is the biological mechanism. So here you have, let's say for example, you're trying to get a new drug approved by the Food and Drug Administration (FDA), and the request is, well, we want two trials, randomized trials, independent. We want to have p-values that are significant, and we want to know the biological mechanism ideally with the dose response of the drug. But there are many drugs as you review that have no biological mechanism established. And even when the tobacco problems were mounting, the actual mechanism of how tobacco use caused cancer wasn't known. So how important is the biological mechanism, especially now that we're well into the AI world where explainability is demanded. And so, we don't know the mechanism, but we also don't know the mechanism and lots of things in medicine too, like anesthetics and even things as simple as aspirin, how it works and many others. So how do we deal with this quest for the biological mechanism?Adam Kucharski (25:42):I think that's a really good point. It shows almost a lot of the transition I think we're going through currently. I think particularly for things like smoking cancer where it's very hard to run a trial. You can't make people randomly take up smoking. Having those additional pieces of evidence, whether it's an analogy with a similar carcinogen, whether it's a biological mechanism, can help almost give you more supports for that argument that there's a cause and effect going on. But I think what I found quite striking, and I realized actually that it's something that had kind of bothered me a bit and I'd be interested to hear whether it bothers you, but with the emergence of AI, it's almost a bit of the loss of scientific satisfaction. I think you grow up with learning about how the world works and why this is doing what it's doing.Adam Kucharski (26:26):And I talked for example of some of the people involved with AlphaFold and some of the subsequent work in installing those predictions about structures. And they'd almost made peace with it, which I found interesting because I think they started off being a bit uncomfortable with like, yeah, you've got these remarkable AI models making these predictions, but we don't understand still biologically what's happening here. But I think they're just settled in saying, well, biology is really complex on some of these problems, and if we can have a tool that can give us this extremely valuable information, maybe that's okay. And it was just interesting that they'd really kind of gone through that kind process, which I think a lot of people are still grappling with and that almost that discomfort of using AI and what's going to convince you that that's a useful reliable prediction whether it's something like predicting protein folding or getting in a self-driving car. What's the evidence you need to convince you that's reliable?Eric Topol (27:26):Yeah, no, I'm so glad you brought that up because when Demis Hassabis and John Jumper won the Nobel Prize, the point I made was maybe there should be an asterisk with AI because they don't know how it works. I mean, they had all the rich data from the protein data bank, and they got the transformer model to do it for 200 million protein structure prediction, but they still to this day don't fully understand how the model really was working. So it reinforces what you're just saying. And of course, it cuts across so many types of AI. It's just that we tend to hold different standards in medicine not realizing that there's lots of lack of explainability for routine medical treatments today. Now one of the things that I found fascinating in your book, because there's different levels of proof, different types of proof, but solid logical systems.Eric Topol (28:26):And on page 60 of the book, especially pertinent to the US right now, there is a bit about Kurt Gödel and what he did there was he basically, there was a question about dictatorship in the US could it ever occur? And Gödel says, “oh, yes, I can prove it.” And he's using the constitution itself to prove it, which I found fascinating because of course we're seeing that emerge right now. Can you give us a little bit more about this, because this is fascinating about the Fifth Amendment, and I mean I never thought that the Constitution would allow for a dictatorship to emerge.Adam Kucharski (29:23):And this was a fascinating story, Kurt Gödel who is one of the greatest logical minds of the 20th century and did a lot of work, particularly in the early 20th century around system of rules, particularly things like mathematics and whether they can ever be really fully satisfying. So particularly in mathematics, he showed that there were this problem that is very hard to have a set of rules for something like arithmetic that was both complete and covered every situation, but also had no contradictions. And I think a lot of countries, if you go back, things like Napoleonic code and these attempts to almost write down every possible legal situation that could be imaginable, always just ascended into either they needed amendments or they had contradictions. I think Gödel's work really summed it up, and there's a story, this is in the late forties when he had his citizenship interview and Einstein and Oskar Morgenstern went along as witnesses for him.Adam Kucharski (30:17):And it's always told as kind of a lighthearted story as this logical mind, this academic just saying something silly in front of the judge. And actually, to my own admission, I've in the past given talks and mentioned it in this slightly kind of lighthearted way, but for the book I got talking to a few people who'd taken it more seriously. I realized actually he's this extremely logically focused mind at the time, and maybe there should have been something more to it. And people who have kind of dug more into possibilities was saying, well, what could he have spotted that bothered him? And a lot of his work that he did about consistency in mass was around particularly self-referential statements. So if I say this sentence is false, it's self-referential and if it is false, then it's true, but if it's true, then it's false and you get this kind of weird self-referential contradictions.Adam Kucharski (31:13):And so, one of the theories about Gödel was that in the Constitution, it wasn't that there was a kind of rule for someone can become a dictator, but rather people can use the mechanisms within the Constitution to make it easier to make further amendments. And he kind of downward cycle of amendment that he had seen happening in Europe and the run up to the war, and again, because this is never fully documented exactly what he thought, but it's one of the theories that it wouldn't just be outright that it would just be this cycle process of weakening and weakening and weakening and making it easier to add. And actually, when I wrote that, it was all the earlier bits of the book that I drafted, I did sort of debate whether including it I thought, is this actually just a bit in the weeds of American history? And here we are. Yeah, it's remarkable.Eric Topol (32:00):Yeah, yeah. No, I mean I found, it struck me when I was reading this because here back in 1947, there was somebody predicting that this could happen based on some, if you want to call it loopholes if you will, or the ability to change things, even though you would've thought otherwise that there wasn't any possible capability for that to happen. Now, one of the things I thought was a bit contradictory is two parts here. One is from Angus Deaton, he wrote, “Gold standard thinking is magical thinking.” And then the other is what you basically are concluding in many respects. “To navigate proof, we must reach into a thicket of errors and biases. We must confront monsters and embrace uncertainty, balancing — and rebalancing —our beliefs. We must seek out every useful fragment of data, gather every relevant tool, searching wider and climbing further. Finding the good foundations among the bad. Dodging dogma and falsehoods. Questioning. Measuring. Triangulating. Convincing. Then perhaps, just perhaps, we'll reach the truth in time.” So here you have on the one hand your search for the truth, proof, which I think that little paragraph says it all. In many respects, it sums up somewhat to the work that you review here and on the other you have this Nobel laureate saying, you don't have to go to extremes here. The enemy of good is perfect, perhaps. I mean, how do you reconcile this sense that you shouldn't go so far? Don't search for absolute perfection of proof.Adam Kucharski (33:58):Yeah, I think that encapsulates a lot of what the book is about, is that search for certainty and how far do you have to go. I think one of the things, there's a lot of interesting discussion, some fascinating papers around at what point do you use these studies? What are their flaws? But I think one of the things that does stand out is across fields, across science, medicine, even if you going to cover law, AI, having these kind of cookie cutter, this is the definitive way of doing it. And if you just follow this simple rule, if you do your p-value, you'll get there and you'll be fine. And I think that's where a lot of the danger is. And I think that's what we've seen over time. Certain science people chasing certain targets and all the behaviors that come around that or in certain situations disregarding valuable evidence because you've got this kind of gold standard and nothing else will do.Adam Kucharski (34:56):And I think particularly in a crisis, it's very dangerous to have that because you might have a low level of evidence that demands a certain action and you almost bias yourself towards inaction if you have these kind of very simple thresholds. So I think for me, across all of these stories and across the whole book, I mean William Gosset who did a lot of pioneering work on statistical experiments at Guinness in the early 20th century, he had this nice question he sort of framed is, how much do we lose? And if we're thinking about the problems, there's always more studies we can do, there's always more confidence we can have, but whether it's a patient we want to treat or crisis we need to deal with, we need to work out actually getting that level of proof that's really appropriate for where we are currently.Eric Topol (35:49):I think exceptionally important that there's this kind of spectrum or continuum in following science and search for truth and that distinction, I think really nails it. Now, one of the things that's unique in the book is you don't just go through all the different types of how you would get to proof, but you also talk about how the evidence is acted on. And for example, you quote, “they spent a lot of time misinforming themselves.” This is the whole idea of taking data and torturing it or using it, dredging it however way you want to support either conspiracy theories or alternative facts. Basically, manipulating sometimes even emasculating what evidence and data we have. And one of the sentences, or I guess this is from Sir Francis Bacon, “truth is a daughter of time”, but the added part is not authority. So here we have our president here that repeats things that are wrong, fabricated or wrong, and he keeps repeating to the point that people believe it's true. But on the other hand, you could say truth is a daughter of time because you like to not accept any truth immediately. You like to see it get replicated and further supported, backed up. So in that one sentence, truth is a daughter of time not authority, there's the whole ball of wax here. Can you take us through that? Because I just think that people don't understand that truth being tested over time, but also manipulated by its repetition. This is a part of the big problem that we live in right now.Adam Kucharski (37:51):And I think it's something that writing the book and actually just reflecting on it subsequently has made me think about a lot in just how people approach these kinds of problems. I think that there's an idea that conspiracy theorists are just lazy and have maybe just fallen for a random thing, but talking to people, you really think about these things a lot more in the field. And actually, the more I've ended up engaging with people who believe things that are just outright unevidenced around vaccines, around health issues, they often have this mountain of papers and data to hand and a lot of it, often they will be peer reviewed papers. It won't necessarily be supporting the point that they think it's supports.Adam Kucharski (38:35):But it's not something that you can just say everything you're saying is false, that there's actually often a lot of things that have been put together and it's just that leap to that conclusion. I think you also see a lot of scientific language borrowed. So I gave a talker early this year and it got posted on YouTube. It had conspiracy theories it, and there was a lot of conspiracy theory supporters who piled in the comments and one of the points they made is skepticism is good. It's the kind of law society, take no one's word for it, you need this. We are the ones that are kind of doing science and people who just assume that science is settled are in the wrong. And again, you also mentioned that repetition. There's this phenomenon, it's the illusory truth problem that if you repeatedly tell someone someone's something's false, it'll increase their belief in it even if it's something quite outrageous.Adam Kucharski (39:27):And that mimics that scientific repetition because people kind of say, okay, well if I've heard it again and again, it's almost like if you tweak these as mini experiments, I'm just accumulating evidence that this thing is true. So it made me think a lot about how you've got essentially a lot of mimicry of the scientific method, amount of data and how you present it and this kind of skepticism being good, but I think a lot of it comes down to as well as just looking at theological flaws, but also ability to be wrong in not actually seeking out things that confirm. I think all of us, it's something that I've certainly tried to do a lot working on emergencies, and one of the scientific advisory groups that I worked on almost it became a catchphrase whenever someone presented something, they finished by saying, tell me why I'm wrong.Adam Kucharski (40:14):And if you've got a variant that's more transmissible, I don't want to be right about that really. And it is something that is quite hard to do and I found it is particularly for something that's quite high pressure, trying to get a policymaker or someone to write even just non-publicly by themselves, write down what you think's going to happen or write down what would convince you that you are wrong about something. I think particularly on contentious issues where someone's got perhaps a lot of public persona wrapped up in something that's really hard to do, but I think it's those kind of elements that distinguish between getting sucked into a conspiracy theory and really seeking out evidence that supports it and trying to just get your theory stronger and stronger and actually seeking out things that might overturn your belief about the world. And it's often those things that we don't want overturned. I think those are the views that we all have politically or in other ways, and that's often where the problems lie.Eric Topol (41:11):Yeah, I think this is perhaps one of, if not the most essential part here is that to try to deal with the different views. We have biases as you emphasized throughout, but if you can use these different types of proof to have a sound discussion, conversation, refutation whereby you don't summarily dismiss another view which may be skewed and maybe spurious or just absolutely wrong, maybe fabricated whatever, but did you can engage and say, here's why these are my proof points, or this is why there's some extent of certainty you can have regarding this view of the data. I think this is so fundamental because unfortunately as we saw during the pandemic, the strident minority, which were the anti-science, anti-vaxxers, they were summarily dismissed as being kooks and adopting conspiracy theories without the right engagement and the right debates. And I think this might've helped along the way, no less the fact that a lot of scientists didn't really want to engage in the first place and adopt this methodical proof that you've advocated in the book so many different ways to support a hypothesis or an assertion. Now, we've covered a lot here, Adam. Have I missed some central parts of the book and the effort because it's really quite extraordinary. I know it's your third book, but it's certainly a standout and it certainly it's a standout not just for your books, but books on this topic.Adam Kucharski (43:13):Thanks. And it's much appreciated. It was not an easy book to write. I think at times, I kind of wondered if I should have taken on the topic and I think a core thing, your last point speaks to that. I think a core thing is that gap often between what convinces us and what convinces someone else. I think it's often very tempting as a scientist to say the evidence is clear or the science has proved this. But even on something like the vaccines, you do get the loud minority who perhaps think they're putting microchips in people and outlandish views, but you actually get a lot more people who might just have some skepticism of pharmaceutical companies or they might have, my wife was pregnant actually at the time during Covid and we waited up because there wasn't much data on pregnancy and the vaccine. And I think it's just finding what is convincing. Is it having more studies from other countries? Is it understanding more about the biology? Is it understanding how you evaluate some of those safety signals? And I think that's just really important to not just think what convinces us and it's going to be obvious to other people, but actually think where are they coming from? Because ultimately having proof isn't that good unless it leads to the action that can make lives better.Eric Topol (44:24):Yeah. Well, look, you've inculcated my mind with this book, Adam, called Proof. Anytime I think of the word proof, I'm going to be thinking about you. So thank you. Thanks for taking the time to have a conversation about your book, your work, and I know we're going to count on you for the astute mathematics and analysis of outbreaks in the future, which we will see unfortunately. We are seeing now, in fact already in this country with measles and whatnot. So thank you and we'll continue to follow your great work.**************************************Thanks for listening, watching or reading this Ground Truths podcast/post.If you found this interesting please share it!That makes the work involved in putting these together especially worthwhile.I'm also appreciative for your subscribing to Ground Truths. All content —its newsletters, analyses, and podcasts—is free, open-access. I'm fortunate to get help from my producer Jessica Nguyen and Sinjun Balabanoff for audio/video tech support to pull these podcasts together for Scripps Research.Paid subscriptions are voluntary and all proceeds from them go to support Scripps Research. They do allow for posting comments and questions, which I do my best to respond to. Please don't hesitate to post comments and give me feedback. Many thanks to those who have contributed—they have greatly helped fund our summer internship programs for the past two years.A bit of an update on SUPER AGERSMy book has been selected as a Next Big Idea Club winner for Season 26 by Adam Grant, Malcolm Gladwell, Susan Cain, and Daniel Pink. This club has spotlighted the most groundbreaking nonfiction books for over a decade. As a winning title, my book will be shipped to thousands of thoughtful readers like you, featured alongside a reading guide, a "Book Bite," Next Big Idea Podcast episode as well as a live virtual Q&A with me in the club's vibrant online community. If you're interested in joining the club, here's a promo code SEASON26 for 20% off at the website. SUPER AGERS reached #3 for all books on Amazon this week. This was in part related to the segment on the book on the TODAY SHOW which you can see here. Also at Amazon there is a remarkable sale on the hardcover book for $10.l0 at the moment for up to 4 copies. Not sure how long it will last or what prompted it.The journalist Paul von Zielbauer has a Substack “Aging With Strength” and did an extensive interview with me on the biology of aging and how we can prevent the major age-related diseases. Here's the link. Get full access to Ground Truths at erictopol.substack.com/subscribe

Lane Highbarger, Ph.D. worked for 26 years in the food additive regulatory and compliance field with the U.S. Food and Drug Administration (FDA), serving as lead microbiologist in FDA's Office of Food Additive Safety (OFAS). He is also an expert in food additive regulations and served as the regulatory review scientist for regulatory submissions at OFAS. Dr. Highbarger holds a Ph.D. in Biochemistry and a B.S. degree in Microbiology, both from the University of Maryland. In this episode of Food Safety Matters, we speak with Dr. Highbarger [23:58] about: His previous work at FDA's Office of Food Additive Safety and how his area of work is important to food safety His thoughts on what effect the Trump administration's FDA workforce cuts will have on the agency's ability to ensure safe food for consumers What the future of chemical safety work looks like at FDA now, in light of the changes and FDA's newly established risk management "pillars" His thoughts on FDA's approach to fast-tracking approval of new food dyes and chemicals so that other chemicals considered "harmful" can be phased out What role he sees science playing in the new administration's approach to food safety policy. News and Resources California Bill Would Remove Ultra-Processed Foods from School Lunches [2:12] ECDC: Europe Saw Record-High Levels of STEC and Listeria Infections in 2023 [9:21] Research Reveals Drop in AMR Bacteria Levels During Poultry Processing [18:35] STOP Foodborne Illness Opens Nominations for '40 Under 40' Program [22:16]   We Want to Hear from You! Please send us your questions and suggestions to podcast@food-safety.com

On Saturday night, the U.S. military attacked several Iranian nuclear facilities in an attempt to eliminate their potential. Following the announcement, President Trump addressed the nation, boasting the U.S. "obliterated" Iran's nuclear capabilities. Some Americans fear this may drag the United States into an open-ended war. However, the Trump administration rejects those claims. Chairman of the House Intelligence Committee, Rep. Rick Crawford (AR-01) joins the Rundown to discuss what inspired the President to act in a swift, secretive manner while enabling the U.S. military to strike the Iranian nuclear facilities. He shares his hope that the strike will embolden the Iranian people to rise against their repressive regime.  President Donald Trump is taking a closer look at infant formula, a topic that the Food and Drug Administration (FDA) hasn't thoroughly examined in decades. The last comprehensive review of infant formula was conducted in 1998, over two decades ago. Currently, a new FDA panel is seeking answers regarding childhood diseases, such as obesity and diabetes. Former FDA Commissioner Dr. David Kessler, the author of "Diet, Drugs, and Dopamine: The New Science of Achieving a Healthy Weight," joins to discuss strategies for improving health, the popularity of Ozempic-like drugs, and whether or not food companies are trying to get us addicted to junk food. Plus, commentary from senior policy analyst at the Competitive Enterprise Institute, Ben Lieberman. Photo Credit: AP Learn more about your ad choices. Visit podcastchoices.com/adchoices

On Saturday night, the U.S. military attacked several Iranian nuclear facilities in an attempt to eliminate their potential. Following the announcement, President Trump addressed the nation, boasting the U.S. "obliterated" Iran's nuclear capabilities. Some Americans fear this may drag the United States into an open-ended war. However, the Trump administration rejects those claims. Chairman of the House Intelligence Committee, Rep. Rick Crawford (AR-01) joins the Rundown to discuss what inspired the President to act in a swift, secretive manner while enabling the U.S. military to strike the Iranian nuclear facilities. He shares his hope that the strike will embolden the Iranian people to rise against their repressive regime.  President Donald Trump is taking a closer look at infant formula, a topic that the Food and Drug Administration (FDA) hasn't thoroughly examined in decades. The last comprehensive review of infant formula was conducted in 1998, over two decades ago. Currently, a new FDA panel is seeking answers regarding childhood diseases, such as obesity and diabetes. Former FDA Commissioner Dr. David Kessler, the author of "Diet, Drugs, and Dopamine: The New Science of Achieving a Healthy Weight," joins to discuss strategies for improving health, the popularity of Ozempic-like drugs, and whether or not food companies are trying to get us addicted to junk food. Plus, commentary from senior policy analyst at the Competitive Enterprise Institute, Ben Lieberman. Photo Credit: AP Learn more about your ad choices. Visit podcastchoices.com/adchoices

Join host, Karli Burridge, as she speaks with the Obesity Action Coalition's President, Joe Nadglowski, about why getting involved in advocacy matters and how you can join too!Websites:Convention website (register): https://www.ywmconvention.com/Obesity Action Coalition (join): https://www.obesityaction.org/Social toolkit: https://www.ywmconvention.com/toolkit/Instagram (follow): https://www.instagram.com/obesityaction/Facebook (follow): https://www.facebook.com/ObesityActionCoalition/LinkedIn (follow): https://www.linkedin.com/company/obesity-action-coalition/Bio: Joseph Nadglowski is President and CEO of the Obesity Action Coalition. A frequent speaker and author on the importance of obesity awareness, Mr. Nadglowski has more than 25 years of experience working in patient advocacy, public policy and education and is a graduate of the University of Florida. As a patient advocate who has publicly shared his own personal experience with obesity as well as those of OAC's members on many boards, taskforces, workgroups and public testimony, Mr. Nadglowski was recipient of the 2012 Society for the Study of the Alimentary Tract (SSAT) Public Service Award. As part of his advocacy work, he has dedicated a significant part of his work toward the recognition of weight bias, its impact on those with obesity and our nation's efforts to combat it. He has been a guest of First Lady Michelle Obama at the White House to discuss childhood obesity and has testified before the Food and Drug Administration (FDA) on the importance of increasing treatment options for individuals affected by obesitySupport the showThe Gaining Health Podcast will release a new episode monthly, every second or third Wednesday of the month. Episodes including interviews with obesity experts as well as scientific updates and new guidelines for the management of obesity.If you're a clinician or organization looking to start or optimize an obesity management program, and you want additional support and resources, check out the Gaining Health website! We offer a Roadmap to starting an obesity program or practice, pre-recorded Master Classes, digital resources including patient education materials and office forms, and much more! Check out our resources on our Gaining Health Shop! If you are loving this podcast, please consider supporting us on Patreon

Dr. David Kessler is a renowned pediatrician, lawyer, public health advocate, and former Commissioner of the U.S. Food and Drug Administration (FDA). A graduate of Amherst College, the University of Chicago Law School, and Harvard Medical School, Dr. Kessler has spent his career at the intersection of science, policy, and consumer protection. He served as Dean of the Yale School of Medicine and the University of California, San Francisco Medical School, and most recently held the role of Chief Science Officer for the White House COVID-19 Response Team. Dr. Kessler is the acclaimed author of several influential books including the New York Times bestseller The End of Overeating, Fast Carbs, Slow Carbs, and his latest work, Diet, Drugs & Dopamine: The New Science on Achieving a Healthy Weight. His writing and research have been pivotal in shifting the public health conversation from willpower to biological understanding—especially regarding food addiction, the manipulation of hyper-palatable foods, and the role of dopamine in modern eating behaviors. A true trailblazer in the field, Dr. Kessler has dedicated decades to unraveling the powerful science behind why we eat the way we do—and how we can reclaim our health in a world of ultra-processed foods. Dr. Kessler shares his personal journey with weight regain and the "aha moment" that led him to call it what it is—addiction. He explores the role of GLP-1 medications, the dark side of food addiction, and how we must move beyond willpower to tackle this epidemic with compassion, science, and actionable tools.

Story at-a-glance The U.S. Food and Drug Administration (FDA) allows U.S. food companies to use nearly 1,000 chemicals banned in Europe, many of which are linked to DNA damage, hormone disruption, or cancer Thanks to a legal loophole called “Generally Recognized as Safe” or GRAS, manufacturers are allowed to self-declare additives as safe without FDA approval, review, or even disclosure on the label Hidden additives are often disguised as “natural flavors” or “spices,” masking substances you'd never knowingly eat but are consuming regularly Ultraprocessed foods make up 73% of the U.S. food supply, designed with chemicals that increase cravings, damage gut health, and disrupt brain signaling Even after hospitalizations and deaths linked to hidden ingredients, the FDA rarely takes meaningful action — leaving your health in the hands of corporations

Dr. Eugene Lipov is one of the world's leading experts on the treatment of symptoms related to post-traumatic stress.Truly, a pioneer in stellate ganglion treatment for symptoms of PTSD, he knows first-hand that trauma can be all-consuming. Growing up with a veteran father stricken with PTSD, and a mother with debilitating depression who eventually took her own life, he truly understands the impact that trauma can have on the lives of many. He's made it his mission to help others relieve their traumatic suffering from PTSD and restore hope to their spirit.In 2006, Dr. Lipov pioneered the use of Stellate Ganglion Block (SGB) for the treatment for post-traumatic stress disorder (PTSD) — a procedure that was initially approved by the U.S. Food and Drug Administration (FDA) in the 1950s for the treatment of certain types of pain and circulation disorders. It is performed with an injection of medication into a collection of nerves at the bottom of the front side of your neck. It is most commonly known as a pain-relieving treatment, used to relieve hot flashes for menopause and cancer patients and treating shingles — and, now, to alleviate symptoms related to post-traumatic stress disorder (PTSD). SHOWNOTES:

The Rich Zeoli Show- Hour 4: 6:05pm- While appearing on Fox News with Maria Bartiromo, FBI Director Kash Patel and FBI Deputy Director Dan Bongino explained they have reviewed all evidence and concluded that Jeffrey Epstein's 2019 death was, as originally reported, a suicide. During the interview, Bongino also revealed that there is no evidence suggesting a larger conspiracy surrounding the assassination attempt against Donald Trump in Butler, PA. 6:15pm- Senate Minority Leader Chuck Schumer is now blaming DOGE for everything—including a Mexican naval ship crashing into the Brooklyn Bridge. 6:20pm- Rich receives ANOTHER invitation to the White House! Hillary Clinton is BACK—and she hates the nuclear family! AND Commissioner Marty Makary announces that the U.S. Food and Drug Administration (FDA) is removing ingestible fluoride from prescription drugs for children. 6:40pm- In a statement on Sunday, former President Joe Biden's office announced that he has been diagnosed with an aggressive form of prostate cancer with metastasis to the bone. In response to the news, President Donald Trump posted to Truth Social: “Melania and I are saddened to hear about Joe Biden's recent medical diagnosis. We extend our warmest and best wishes to Jill and the family, and we wish Joe a fast and successful recovery.” 6:45pm- While appearing on MSNBC's Morning Joe, Dr. Ezekiel Emanuel—an oncologist and bioethicist at the University of Pennsylvania—said that “there is no disagreement” within the medical community, Joe Biden had cancer while he was president of the United States even if he was only diagnosed last Friday. 6:50pm- Jake Tapper's new book, “Original Sin: President Biden's Decline, Its Cover-up, and His Disastrous Choice to Run Again,” which is critical of the Biden Administration for covering up the president's physical and cognitive decline is due to be released later this week—but many Democrats and mainstream media members, including David Axelrod and Brian Steltzer, are saying the conversation regarding the “cover-up” should be paused given Biden's cancer diagnosis.

The FBI arrests alleged child predators. The Food and Drug Administration (FDA) hires a new top vaccine official to replace Dr. Peter Marks. And the Department of Government Efficiency's (DOGE) effort has hit a new milestone, as well as a new legal snag. Let's go through a full update on today's episode of Facts Matter.Episode Resources:

Vaccination is one of the best ways to prevent diseases. Over the past 50 years, essential vaccines saved at least 154 million lives (1). During the same period, vaccination has reduced infant deaths by 40%. Together with governments, vaccine manufacturers, scientists and medical experts, WHO's vaccine safety program is constantly helping monitor the safety of vaccines. This helps ensure that vaccines are safe for you and your family. ​In the United States, a number of safeguards are required by law to help ensure that the vaccines we receive are safe. Because vaccines are given to millions of healthy people—including children—to prevent serious diseases, they're held to very high safety standards. Every authorized or approved vaccine goes through safety testing, including: Testing and evaluation of the vaccine before it's licensed by the Food and Drug Administration (FDA) and recommended for use by the Centers for Disease Control and Prevention (CDC) Monitoring the vaccine's safety after it is recommended for infants, children, or adults ​ Before a vaccine is ever recommended for use, it's tested in labs. This process can take several years. FDA uses the information from these tests to decide whether to test the vaccine with people. During a clinical trial, a vaccine is tested on people who volunteer to get vaccinated. Clinical trials usually start with 20 to 100 volunteers, but eventually include thousands of volunteers. These tests can take several years and answer important questions like: Is the vaccine safe? What dose (amount) works best? How does the immune system react to it? Throughout the process, FDA works closely with the company producing the vaccine to evaluate the vaccine's safety and effectiveness. All safety concerns must be addressed before FDA licenses or authorizes a vaccine. ​Once a vaccine is approved or authorized, it continues to be tested. The company that makes the vaccine tests batches to make sure the vaccine is: Potent (It works like it's supposed to) Pure (Certain ingredients used during production have been removed) Sterile (It doesn't have any outside germs) FDA reviews the results of these tests and inspects the factories where the vaccine is made. This helps make sure the vaccines meet standards for both quality and safety. ​Once a vaccine is recommended for use, FDA, CDC, and other federal agencies continue to monitor its safety. ​The United States has one of the most advanced systems in the world for tracking vaccine safety. Each of the systems below supplies a different type of data for researchers to analyze. Together, they help provide a full picture of vaccine safety. Vaccine Adverse Events Reporting System (VAERS): VAERS is an early warning system managed by CDC and FDA that is designed to find possible vaccine safety issues. Patients, health care professionals, vaccine companies, and others can use VAERS to report side effects that happen after a patient received a vaccine. Some side effects might be related to vaccination while others might be a coincidence (happen by chance). VAERS helps track unusual or unexpected patterns of reporting that could mean there's a possible vaccine safety issue that needs further evaluation. The Vaccine Safety Datalink (VSD): VSD is a collaboration between CDC and several health care organizations across the nation. VSD uses databases of medical records to track vaccine safety and do research in large populations. By using medical records instead of self-reports, VSD can quickly study and compare data to find out if reported side effects are linked to a vaccine. Post-licensure Rapid Immunization Safety Monitoring System (PRISM), links to an external website, opens in a new tab: PRISM is part of the Sentinel Initiative, which is FDA's national system for monitoring medical products after they're licensed for use. PRISM focuses on vaccine safety—it uses a database of health insurance claims to identify and evaluate possible safety issues for licensed vaccines. Clinical Immunization Safety Assessment Project (CISA): CISA is a collaboration between CDC and a national network of vaccine safety experts from medical research centers. CISA does clinical vaccine safety research and—at the request of providers—evaluates complex cases of possible vaccine side effects in specific patients. Biologics Effectiveness and Safety (BEST) System: A system that uses multiple data sources and rapid queries to detect or evaluate adverse events or study specific safety questions. Additional research and testing: The Department of Defense (DoD), the U.S. Department of Veterans Affairs (VA), and the Indian Health Service (IHS) have systems to monitor vaccine safety and do vaccine safety research. The National Institutes of Health (NIH) and the Office of Infectious Disease and HIV/AIDS Policy (OIDP) also support ongoing research on vaccines and vaccine safety. During emergencies, such as the COVID-19 pandemic, additional safety activities are utilized to help evaluate the data in quickly and with special populations. For example, a new smartphone tool called V-safe uses text messaging and surveys to check in with COVID-19 vaccine recipients after vaccination.  (CREDITS)   

Piper hosts Plaidcast LIVE! from The Madeira School in McLean, VA with guests Phoebe Lang, Dr. Lisa Metcalf, DVM/MS and Dr. Kimberly Brokaw, DVM. Brought to you by Taylor, Harris Insurance Services.Host: Piper Klemm, publisher of The Plaid HorseGuest: Phoebe Lang was born and raised in the Washington, DC area and ignited her passion for horses at Madeira's summer riding program when she was seven years old. Upon graduating from Madeira in 1985, Phoebe attending Kenyon College and then moved to San Francisco, raised her three children, and started riding again in her 30's. Phoebe has devoted the past 25 years to pursuing elite-level show jumping throughout the US, Canada, and Europe, reaching the FEI 3* level. She built her farm and training business, Zeitgeist Equestrian and Equstech, in Petaluma, CA, and has worked on developing several equine therapeutic devices. While Phebe has retired from riding competitively, she still owns and cares for six horses and has been spending time launching the breeding career of one of her former grand prix stallions. Guest: Dr. Lisa Metcalf, DVM/MS grew up on a horse farm in northern VA, and her lifelong passion for horses shaped a distinguished academic and professional journey. After attending Madeira and then earning her BA in Biology from Wesleyan University, Dr. Metcalf went on to obtain her DVM from The Virginia-Maryland Regional College of Veterinary Medicine and her MS in Endocrinology from UC Davis. Dr. Metcalf is a decorated and board-certified theriogenologist; a specialist in the practice of animal reproduction. Beyond her clinical work, she has held influential roles with organizations such as the Oregon Veterinary Racing Commission, the American Association of Equine Practitioners, and the Portland Mounted Patrol Unit. An internationally sought-after speaker and widely published author, Dr. Metcalf brings deep expertise, passion, and perspective to the world of veterinary reproductive medicine. Guest: Dr. Kimberly Brokaw DVM's passion for horses and animal science, fostered by the Madeira school, led her to pursue her BS in animal science at the University of Maryland. She then earned her Doctorate from Virginia-Maryland College of Veterinary Medicine. Following her 15 years of service at the Walkersville Veterinary Clinic of Maryland, she currently brings her expertise to two impactful roles: as a Veterinary Medical Officer for the Food and Drug Administration (FDA) and as a passionate team member at Gentle Giants Draft Horse Rescue in Mount Airy, MD, a nonprofit organization devoted to rescuing and rehabilitating draft horses.Title Sponsor: Taylor, Harris Insurance ServicesSubscribe To: The Plaid Horse MagazineSponsors: Foxhall Equine and Great American Insurance Group Join us at an upcoming Plaidcast LIVE!

It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: A new Austrailian study aims to prevent type 1, the new twiist pump will integrate with Eversnse CGM as well as Libre, diabetes deaths are down in the US, Dexcom U is looking for college athletes, and more! Find out more about Moms' Night Out  Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom   Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com  Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX A world-first human trial of a drug designed to treat the underlying cause of type 1 diabetes has begun in Australia. University of Queensland researcher Ranjeny Thomas said the experimental drug — dubbed ASITI-201 — was designed to retrain the immune system so it no longer attacks the insulin-producing pancreatic cells, known as beta cells. The drug, given as an injection under the skin, combines fragments of a protein found in the beta cells of people with type 1 diabetes and vitamin D to calm the immune response. She said if effective, the drug would initially be given to patients with type 1 diabetes as soon as possible after diagnosis to preserve remaining pancreatic cells and reduce the amount of insulin needed. But eventually, if screening programs can be developed to pick up people at risk of developing type 1 diabetes, it may be possible to "prevent the progression of the disease altogether". The first in-human trial of 36 participants will test the safety of the drug, but blood tests will also determine the impact of the therapy on a patient's immune system and glucose tolerance. https://www.abc.net.au/news/2025-04-29/type-1-diabetes-drug-trial-auto-immune-disease-science/105223022 XX   Diabetes deaths in the U.S. have fallen to some of the lowest rates in years, according to new preliminary figures published by the Centers for Disease Control and Prevention, reversing a surge in mortality that was seen during the COVID-19 pandemic.   There were 26.4 deaths per 100,000 people from diabetes, according to early death certificate data for the third quarter of 2024 published this month by the CDC's National Center for Health Statistics.   Death rates from diabetes peaked in 2021, according to CDC figures, at 31.1 deaths per 100,000 people for that year. Diabetes was the eighth leading cause of death in 2021. The CDC says the link between COVID-19 and diabetes may be to blame for that increase.   "Data show an increase in mortality rates for all people during the COVID-19 pandemic, and research shows that people with underlying conditions, including diabetes, are more likely to become very sick from COVID-19 and have a higher risk of hospitalization and death," Christopher Holliday, head of the CDC's Division of Diabetes Translation, told CBS News in a statement.   Holliday added that research shows the pandemic may also have made it harder for Americans to properly manage the disease, ranging from interruptions to physical activity to disruptions to routine medical care diagnosing and treating the disease.   https://www.cbsnews.com/news/diabetes-deaths-lowest-levels-years-early-cdc-figures/ XX Big news for the Eversense CGM – they have their first pump partner. Sequel Med Tech says the twist pump will integrate with Senseonics Eversense 365 continuous glucose monitor (CGM). This collaboration would make twiist the first AID system compatible with Eversense 365, the world's first and only one-year CGM. Sequel and Senseonics say they have already started their work to integrate the latest-generation, 365-day implantable sensor with twiist. They expect to make the integrated offering available in the third quarter of this year. This marks the second CGM integration for Sequel, which partnered with Abbott and its FreeStyle Libre platform earlier this year. This week we also got a peek at the packaging and delivery of the twist as the first people posted about wearing it. We'll follow up and learn more about this newest insulin pump in the us. Senseonics, meanwhile, brought the first year-long CGM to market last year, launching Eversense 365 with its global distribution partner, Ascensia Diabetes Care, in October 2024. The system also received clearance as an integrated CGM (iCGM) system, meaning it can work with compatible medical devices. Those include insulin pumps as part of automated insulin delivery systems. https://www.drugdeliverybusiness.com/sequel-senseonics-integrate-cgm-insulin-pump/ XX Medtronic has announced the U.S. Food and Drug Administration (FDA) approval for the Simplera Sync sensor for use with the MiniMed 780G system. With this approval, the MiniMed 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection technology with both the Guardian 4 sensor and Simplera Sync sensor.   The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard or overtape and features a simple, two-step insertion process. It is the company's newest addition to its CGM portfolio, which expands options and provides greater flexibility for users.   The MiniMed 780G system's adaptive algorithm automatically anticipates, adjusts, and corrects glucose levels every 5 minutes, 24/7 – working around the clock so users can focus on what matters. It's the only system featuring Meal Detection technology, which detects rising sugar levels and delivers more insulin as needed to help users keep glucose levels in range more often – even when users occasionally forget to dose insulin for snacks or meals or underestimate their carbs.   The system uses a “treat to target” approach and flexible glucose targets as low as 100 mg/dL, which, combined with its adaptive algorithm allows it to more closely mirror the glucose levels of someone not living with diabetes.   Real-world data of the system shows global users consistently achieve time in range above international targets of 70% when using optimal settings (active insulin time of two hours and 100 mg/dL target glucose). It is also the only system that works with the world's only infusion set that lasts up to 7 days so that users only have to change their infusion set once per week and can experience 96% fewer injections compared to multiple daily injections.   “We're committed to driving innovation that makes life easier for those living with diabetes so they can forget about their diabetes as much as possible throughout the day,” said Que Dallara, EVP and president of Medtronic Diabetes. “Our MiniMed 780G system delivers advanced diabetes technology for so many around the world, and we're excited to continue evolving this experience with expanded CGM options —including our Simplera Sync sensor, which we look forward to bringing to people living with diabetes in the U.S.”   A limited launch of the Simplera Sync sensor will begin in the U.S. in the fall of 2025. Today, the MiniMed 780G system can be used with the Guardian 4 sensor.   Like this:https://med-techinsights.com/2025/04/29/simplera-sync-sensor-for-minimed-780g-now-fda-approved/ XX Front office changes at Insulet.. The former head of Johnson & Johnson's worldwide medtech business, Ashley McEvoy will take over as president and CEO from Jim Hollingshead, who has led Insulet since 2022. In its announcement of the leadership change, Insulet said that Hollingshead and the company mutually agreed to part ways, effective immediately. McEvoy served as worldwide medtech chairman at J&J from 2018 until her departure in late 2023, the culmination of nearly 30 years at the company and several executive roles—including president of its Ethicon division and group chairman of vision and diabetes care. Since then, she has also served as a board member at Procter & Gamble. https://www.fiercebiotech.com/medtech/insulet-taps-former-jj-medtech-head-ashley-mcevoy-be-ceo XX New free mobile game launched this week to make type 1 diabetes onboarding faster easier and less overwhelming. It's called Level One.. created by Level Ex (Powered by Relevate Health), the studio behind award-winning medical games for medical professionals. Level Ex CEO Sam Glassenberg created the game after a – quote  - brutal onboarding experience when his daughter was diagnosed five years ago He says  It took a year to understand how to manage this disease. So we fixed it. We built a game that can train your brain to do it in a matter of hours." The game is launching in partnership with leading diabetes organizations Beyond Type 1 and Breakthrough T1D Play, who are integrating Level One into their outreach and educational campaigns to support newly diagnosed families worldwide. Download Level One on the App Store: https://apps.apple.com/us/app/level-one-a-diabetes-game/id6739605694 Learn more: https://playlevelone.com   https://www.prnewswire.com/news-releases/level-ex-launches-level-one-a-free-mobile-game-to-redefine-type-1-diabetes-onboarding-302440929.html XX   Collagen is widely recognized for its role in maintaining healthy skin, but its importance extends far beyond that. As the most abundant protein in the human body, collagen provides essential structure and support to nearly all tissues and organs.   Now, researchers at Carnegie Mellon's Feinberg Lab have made a major breakthrough using their novel Freeform Reversible Embedding of Suspended Hydrogels (FRESH) 3D bioprinting technique. This method enables the precise printing of soft, living cells and tissues. Leveraging this technology, the team successfully created the first-ever microphysiologic system, also known as a tissue model, constructed entirely from collagen. This advancement opens new possibilities for studying disease and engineering tissue therapies, including potential treatments for conditions like Type 1 diabetes.   Traditionally, small-scale models of human tissue, referred to as microfluidics, organ-on-chip devices, or microphysiologic systems, have been fabricated using synthetic materials such as silicone rubber or plastics. These materials were necessary due to limitations in earlier manufacturing techniques. However, because they are not biologically native, they fail to fully replicate natural tissue environments, restricting their effectiveness in biomedical research and therapeutic development.   “Now, we can build microfluidic systems in the Petri dish entirely out of collagen, cells, and other proteins, with unprecedented structural resolution and fidelity,” explained Adam Feinberg, a professor of biomedical engineering and materials science & engineering at Carnegie Mellon University. “Most importantly, these models are fully biologic, which means cells function better.”   Building Complex Tissues with FRESH Bioprinting In new research published in Science Advances, the group demonstrates the use of this FRESH bioprinting advancement, building more complex vascularized tissues out of fully biologic materials, to create a pancreatic-like tissue that could potentially be used in the future to treat Type 1 diabetes. This advancement in FRESH bioprinting builds on the team's earlier work published in Science, by improving the resolution and quality to create fluidic channels that are like blood vessels down to about 100-micron diameter.   “There were several key technical developments to the FRESH printing technology that enabled this work,” described Daniel Shiwarski, assistant professor of bioengineering at the University of Pittsburgh and prior postdoctoral fellow in the Feinberg lab. “By implementing a single-step bioprinting fabrication process, we manufactured collagen-based perfusable CHIPS in a wide range of designs that exceed the resolution and printed fidelity of any other known bioprinting approach to date. Further, when combined with multi-material 3D bioprinting of ECM proteins, growth factors, and cell-laden bioinks and integration into a custom bioreactor platform, we were able to create a centimeter-scale pancreatic-like tissue construct capable of producing glucose-stimulated insulin release exceeding current organoid based approaches.” https://scitechdaily.com/scientists-bioprint-living-tissues-that-could-revolutionize-diabetes-treatment/ XX Another study showing the blood sugar benefit of walking after a meal. Skeletal muscle plays a central role in glucose uptake. Exercise stimulates glucose transport into muscle cells through insulin-independent pathways, notably through the action of glucose transporter type 4 (GLUT-4), which is responsible for transporting glucose from blood to skeletal muscles.4 This means that even without a robust insulin response, physical activity can facilitate glucose clearance from the bloodstream. These effects also occur without requiring high-intensity exercise, making postprandial walking accessible to a broad range of individuals, including those with limited exercise tolerance. multiple studies show that starting activity within 30 minutes after a meal is optimal. https://www.news-medical.net/health/Walking-After-Meals-Small-Habit-Big-Metabolic-Gains.aspx XX Dexcom brings back Dexcom U for a 4th years. This is a name, image and license program for college athletes with diabetes and includes a nationwide open call for passionate and inspiring college athletes to join its roster. Now through May 23, athletes, coaches, friends and family members can nominate candidates through an online submission. Those selected, along with the eight returning athletes from last year, will be invited to attend the Dexcom U Signing Day Camp this summer, hosted by Dexcom Warrior and Baltimore Ravens tight end Mark Andrews. https://www.hmenews.com/article/dexcom-u-returns-for-fourth-season