Podcasts about Adverse

There are three big changes that need to be made to the H-2A foreign guestworker visa program before more farmers are forced out of business, and WAFLA CEO Enrique Gastelum says the time has come!

Did you know your childhood story can shape your health, work, and relationships? In this episode, Dr. Melissa Merrick, President and CEO of Prevent Child Abuse America, shares the science behind ACEs (Adverse Childhood Experiences) and why nearly two-thirds of adults carry them. We talk about how trauma shows up in adulthood, why high achievers often live with hypervigilance, and the protective factors that can tip the scales toward healing. Tune in to learn why your past doesn't define you and how to build a stronger, healthier future starting today. In this Episode, You Will Learn 00:00 Meet Dr. Melissa Merrick, President and CEO of Prevent Child Abuse America. 01:45 What are ACEs (Adverse Childhood Experiences) and why do they matter? 05:45 How childhood adversity increases risk for physical and mental health issues. 07:00 The #1 protective factor proven to fuel adult healing and growth. 09:45 The link between ACEs, hypervigilance, and high-achieving adults. 13:15 Why a high ACE score can shorten life expectancy by nearly 20 years. 15:00 The weight of carrying family trauma across generations. 19:30 Examples of leaders creating safer and more supportive work environments. 23:45 Daily habits that retrain your biology to handle stress better. 25:45 Dr. Merrick's go-to resources for stress and pressure relief. Resources + Links Learn more about ACEs HERE Learn more about Prevent Child Abuse America HERE Get a copy of my book - The Anxious Achiever Watch the podcast on YouTube  Find more resources on our website morraam.com Follow Follow me: on LinkedIn @morraaronsmele + Instagram @morraam Follow Dr. Merrick on LinkedIn

Farmer sentiment dipped again in August as the Purdue University-CME Group Ag Economy Barometer Index fell 10 points to 125, and a federal court decision vacates a burdensome and unfair disaggregation labor rule, part of the 2023 Adverse Effect Wage Rate Rule.

Farmer sentiment dipped again in August as the Purdue University-CME Group Ag Economy Barometer Index fell 10 points to 125, and a federal court decision vacates a burdensome and unfair disaggregation labor rule, part of the 2023 Adverse Effect Wage Rate Rule.

Enrique Gastelum, CEO at WAFLA, the Worker and Farmer Labor Association, says there are three big challenges that need addressed, and the first is the skyrocketing Adverse Effect Wage Rate.

A federal court in Louisiana has vacated the Department of Labor's 2023 Adverse Effect Wage Rate methodology rule, a major victory for Florida agriculture, and Mexico recorded 5,086 cases of flesh-eating screwworm in animals as of August 17, a 53% jump over July.

Début de la saison de la NFL hier. Tennis : en attendant la demie-finale de Félix Auger-Aliassime ce soir, on connaît maintenant les finalistes chez les dames. Caitlin Clark a confirmé ce que les amateurs de basketball craignaient. Discussion sports avec Justine St-Martin, chroniqueuse sports. Regardez aussi cette discussion en vidéo via https://www.qub.ca/videos ou en vous abonnant à QUB télé : https://www.tvaplus.ca/qub ou sur la chaîne YouTube QUB https://www.youtube.com/@qub_radio Pour de l'information concernant l'utilisation de vos données personnelles - https://omnystudio.com/policies/listener/fr

Desmopressin is a synthetic analog of vasopressin, also known as antidiuretic hormone (ADH). It works by mimicking the action of natural ADH on the kidneys, primarily increasing water reabsorption in the collecting ducts. This effect reduces urine production and helps concentrate the urine. Because of this mechanism, desmopressin is commonly used in conditions like diabetes insipidus, nocturnal enuresis (bedwetting), and sometimes for nocturia in adults. It also has a role in certain bleeding disorders, such as mild hemophilia A and von Willebrand disease, since it can increase plasma levels of factor VIII and von Willebrand factor. In this podcast, we will explore desmopressin pharmacology and much more. Desmopressin is available in several dosage forms, including oral tablets, intranasal spray, and injectable formulations. The choice depends on the indication and patient-specific factors such as age, convenience, or the need for rapid effect. Adverse effects of desmopressin are largely related to water balance. Because it reduces urine output, patients are at risk for water retention and hyponatremia, which can lead to headaches, confusion, seizures, or in severe cases, coma. Monitoring sodium levels is especially important in elderly patients and those taking other medications that can affect fluid or electrolyte balance. Clinicians also need to be mindful of drug interactions. Medications that increase the risk of hyponatremia, such as SSRIs, carbamazepine, or certain diuretics, may enhance desmopressin's adverse effects. Conversely, drugs that blunt its activity can reduce effectiveness. Careful monitoring and patient education are key parts of safe use.

In this episode of Derms and Conditions, host James Q. Del Rosso, DO, welcomes April Armstrong, MD, MPH, Professor and Chief of Dermatology at UCLA, to discuss chronic hand eczema (CHE) and the introduction of the first FDA-approved treatment developed specifically for this condition. The conversation begins with a review of CHE as a distinct clinical entity, highlighting its subtypes: irritant contact dermatitis, allergic contact dermatitis, atopic hand eczema, and the less common protein contact dermatitis. They highlight occupational exposures and daily “wet work” that increase risk, while Dr Del Rosso notes the challenge of overlapping subtypes in real-world patients. Practical considerations, such as glove selection and improving patient adherence, are also addressed. The discussion then turns to delgocitinib cream, the newly approved topical pan–JAK inhibitor for moderate-to-severe CHE. Dr Armstrong explains its mechanism of action, which targets the JAK-STAT pathway across multiple immune processes involved in different CHE subtypes. They note the significance of its approval without a boxed warning, contrasting it with other topical JAK inhibitors and providing context on evolving perspectives on JAK inhibitor safety. Clinical trial findings are discussed in detail, including meaningful improvements in itch, pain, and quality of life, along with the durability of response over time. Importantly, efficacy was observed across CHE subtypes, reflecting the drug's utility across real-world patient heterogeneity. Adverse events were minimal, with no systemic safety signals observed. Tune in to the full episode to hear Dr Armstrong and Dr Del Rosso highlight the key factors of diagnosing and treating CHE, the clinical impact of delgocitinib, and how dermatologists are now better positioned to treat this commonly encountered yet difficult to manage condition.

Enrique Gastelum, CEO at the Worker and Farmer Labor Association, says a recent court decision in Louisiana overturns the Department of Labor's Adverse Effect Wage Rate methodology rule.

Sponsored by Elanco Elise Kelly, DVM, graduated from Eastern Illinois University with a Bachelor of Sciences degree in zoology and a minor in chemistry. She earned her DVM degree from Ross University School of Veterinary Medicine, then practiced in Blue Springs, MO for 9 years before joining Elanco in 2015 as a Regional Consulting Veterinarian.  In her nine years of practice, her special interests included dermatology, small exotics, and reproductive medicine, attaining a certification in canine AI in 2012. Since joining Elanco, Kelly has had the opportunity to train intensively and speak on topics including parasitology, pain management, dermatology and immunology. She has given over 500 presentations and spoken at continuing education events including Kansas City's Frostbite and the annual Missouri Veterinary Medical Association Conference. Kelly is Fear Free Elite, compassion fatigue and Human Animal Bond certified. She supports and works with Elanco sales representatives throughout the Midwest. She is a member of the Missouri Veterinary Medical Association and is Vice Chair for the board of directors at the Kansas City Pet Project. She currently resides in Independence, Missouri with her husband, two children, Sheepadoodle puppy, cat, and four goats.  In her spare time, you might find her cheering for the Kansas City Chiefs, boating, hiking or traveling with her family. Indication Galliprant controls pain and inflammation associated with osteoarthritis in dogs. Important Safety Information For use in dogs only. Keep this and all medications out of reach of children and pets to prevent accidental ingestion or overdose. Galliprant is a non-COX inhibiting NSAID. As a class, NSAIDs may be associated with gastrointestinal, kidney and liver side effects. Evaluation for pre-existing conditions and regular monitoring are recommended.  Do not use in dogs that have a hypersensitivity to grapiprant. Concomitant use of Galliprant with other NSAIDs or corticosteroids should be avoided. Concurrent use with other anti-inflammatory drugs or protein-bound drugs has not been studied. The safe use of Galliprant has not been evaluated in dogs younger than 9 months of age and less than 8 lbs (3.6 kg), dogs used for breeding, pregnant or lactating dogs, or dogs with cardiac disease. Owners should be advised to observe for signs of potential drug toxicity. Adverse reactions may include vomiting, diarrhea, decreased appetite, watery or bloody stools, and decreases in serum albumin and total protein. Click here for full prescribing information Galliprant, Elanco, and the diagonal bar logo are trademarks of Elanco or its affiliates. ©2025 Elanco or its affiliates. PM-US-25-1504

In his weekly clinical update, Dr. Griffin with Vincent Racaniello are dismayed about the recent attack on public health the firing of the director of the CDC as well as resignation of 3 others members of the agency's leadership, the continued Legionnaire's outbreak in Harlem, suspension of Ixchiq the Chikungunya virus attenuated infectious vaccine, the first US case of New World screwworm before Dr. Griffin deep dives into recent statistics on the measles epidemic, RSV, influenza and SARS-CoV-2 infections, the Wasterwater Scan dashboard, Johns Hopkins measles tracker, association Guillian-Barré syndrome with RSV vaccination, guidelines for using RSV vaccines, whether or not the NB.1.8.1 should be included in the fall 2025 vaccines, the American College Obstetricians and Gynecologists recommendations for the COVID, RSV and influenza vaccines, FDA approval letters for Pfizer, moderna and Novagax COVID vaccines including label changes for use in those between 5 through 64 years, where to find PEMGARDA, long COVID treatment center, where to go for answers to your long COVID questions, and contacting your federal government representative to stop the assault on science and biomedical research. Subscribe (free): Apple Podcasts, RSS, email Become a patron of TWiV! Links for this episode White House Says New C.D.C. Director Is Fired, but She Refuses to Leave (NY Times) CDC director refuses to leave after White House order (BBC) Legionnaires' Disease: In Harlem(NYC Health) New York City Health Department Provides Update on Community Cluster of Legionnaires' Disease in Central Harlem(NYC Health: Promoting and protecting the City's health) FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live) (FDA) Vimkunya (Bavarian Nordiac) U.S. and Panama for the control of the Screwworm pest (COPEG) Rare human case of flesh-eating parasite New World screwworm identified in US(CNN) USDA Announces Sweeping Plans to Protect the United States from New World Screwworm (USDA) HHS details New World screwworm response after human case(CIDRAP) Wastewater for measles (WasterWater Scan) Measles cases and outbreaks (CDC Rubeola) Tracking Measles Cases in the U.S. (Johns Hopkins) Weekly measles and rubella monitoring (Government of Canada) Measles (WHO) Get the FACTS about measles (NY State Department of Health) Measles (CDC Measles (Rubeola)) Measles vaccine (CDC Measles (Rubeola)) Presumptive evidence of measles immunity (CDC) Contraindications and precautions to measles vaccination (CDC) Measles (CDC Measles (Rubeola)) Measles vaccine recommendations from NYP (jpg) Adverse events associated with childhood vaccines: evidence bearing on causality (NLM) Measles Vaccination: Know the Facts(ISDA: Infectious Diseases Society of America) Deaths following vaccination: what does the evidence show (Vaccine) Influenza: Waste water scan for 11 pathogens (WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) Respiratory virus activity levels (CDC Respiratory Illnesses) Weekly surveillance report: clift notes (CDC FluView) Relative effectiveness of high-dose versus standard-dose influenza vaccine against hospitalizations and mortality according to frailty score (JID) FDA-CDC-DOD: 2025-2046 influenza vaccine composition (FDA) RSV: Waste water scan for 11 pathogens (WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) ENFLONSIA: novel drug approvals 2025 (FDA) RSV-Network (CDC Respiratory Syncytial virus Infection) Vaccines for Adults (CDC: Respiratory Syncytial Virus Infection (RSV)) Evaluation of Guillain-Barré Syndrome (GBS) following Respiratory Syncytial Virus (RSV) Vaccination Among Adults 65 Years and Older (FDA) Economic Analysis of Protein Subunit and mRNA RSV Vaccination in Adults aged 50-59 Years (CDC: ACIP) Evidence to Recommendations Framework (EtR): RSV Vaccination in Adults Aged 50–59 years (CDC: National Center for Immunization and Respiratory Diseases) Waste water scan for 11 pathogens (WastewaterSCan) COVID-19 deaths (CDC) Respiratory Illnesses Data Channel (CDC: Respiratory Illnesses) COVID-19 national and regional trends (CDC) COVID-19 variant tracker (CDC) SARS-CoV-2 genomes galore (Nextstrain) Antigenic and Virological Characteristics of SARS-CoV-2 Variant BA.3.2, XFG, and NB.1.8.1 (bioRxiV) Veering from CDC, ACOG recommends maternal vaccination against COVID-19 (CIDRAP) ACOG Releases Updated Maternal Immunization Guidance for COVID-19, Influenza, and RSV (American College of Obstericians and Gynecologists) COVID-19 Vaccination Considerations for Obstetric–Gynecologic Care (American College of Obstericians and Gynecologists) Pfizer and BioNTech's COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19 (Pfizer)  COMIRNATY approval letter (FDA) Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccines Targeting LP.8.1 Variant of SARS-CoV-2 (FEEDS) SPIKEVAX approval letter (FDA) Novavax's Nuvaxovid 2025-2026 Formula COVID-19 Vaccine Approved in the U.S (Novavax) NUVAXOVID approval letter (FDA) Where to get pemgarda (Pemgarda) EUA for the pre-exposure prophylaxis of COVID-19 (INVIYD) Infusion center (Prime Fusions) CDC Quarantine guidelines (CDC) NIH COVID-19 treatment guidelines (NIH) Drug interaction checker (University of Liverpool) Paxlovid (Pfizer) Infectious Disease Society guidelines for treatment and management (ID Society) Molnupiravir safety and efficacy (JMV) Convalescent plasma recommendation for immunocompromised (ID Society) What to do when sick with a respiratory virus (CDC) Managing healthcare staffing shortages (CDC) Steroids,dexamethasone at the right time (OFID) Anticoagulation guidelines (hematology.org) Daniel Griffin's evidence based medical practices for long COVID (OFID) Long COVID hotline (Columbia : Columbia University Irving Medical Center) The answers: Long COVID Reaching out to US house representative Letters read on TWiV 1248 Dr. Griffin's COVID treatment summary (pdf) Timestamps by Jolene Ramsey. Thanks! Intro music is by Ronald Jenkees Send your questions for Dr. Griffin to daniel@microbe.tv Content in this podcast should not be construed as medical advice.

You use ketamine. I use ketamine. We all use ketamine. But… how safe it is, really? A new study out of Toronto suggests 30% of patients who receive ketamine have adverse events, a rate higher than seen in the ED. What are we to make of this? I bring Dr Remle Crowe on to discuss…Citations:1.     Kwong JL, Verbeek PR, Leong YC, Turner L, Huiskamp M, Drennan IR, Francom S, Ropp S, Cheskes S: Paramedic use of ketamine for severe agitation and violence. Can J Emerg Med. doi: 10.1007/s43678-025-00963-w (Epub ahead of print).2.     Fernandez AR, Bourn SS, Crowe RP, Bronsky ES, Scheppke KA, Antevy P, Myers JB: Out-of-Hospital Ketamine: Indications for Use, Patient Outcomes, and Associated Mortality. Annals of Emergency Medicine. 2021;78(1):123–31.3.     Brown LH, Crowe RP, Pepe PE, Miller ML, Watanabe BL, Kordik SS, Wampler DA, Page DI, Fernandez AR, Bourn SS, et al.: Adverse events following emergent prehospital sedation of patients with behavioral emergencies: A retrospective cohort study. The Lancet Regional Health - Americas. 2022;May;9:100183.

On this podcast, I cover ciprofloxacin pharmacology. Ciprofloxacin is one of the most widely recognized fluoroquinolone antibiotics and has been on the market for decades. Because of its broad utility, it often comes up in practice, but it also carries significant adverse effect concerns and boxed warnings that pharmacists and prescribers need to keep in mind. From a pharmacology standpoint, ciprofloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes that are essential for bacterial DNA replication, transcription, and repair. This action gives ciprofloxacin bactericidal activity against a variety of gram-negative organisms, including E. coli, Klebsiella, Enterobacter, and Pseudomonas aeruginosa. It also has some gram-positive activity, though it is generally not the best choice for strep infections. Ciprofloxacin comes in multiple dosage forms, including oral tablets, oral suspension, and intravenous formulations, which makes it flexible across care settings. I discuss the conversion of IV and PO formulations. Pharmacokinetics are important to consider. Ciprofloxacin is primarily renally eliminated, so dose adjustments are necessary in patients with impaired kidney function. Distribution into tissues is generally good, but it has limited activity in the lungs against Streptococcus pneumoniae, which is why it is not a first-line option for community-acquired pneumonia. Adverse effects are a major concern. The fluoroquinolone class carries multiple boxed warnings. Ciprofloxacin has been associated with tendon rupture, peripheral neuropathy, CNS effects such as agitation or seizures, and exacerbation of myasthenia gravis. More recent warnings include the risk for aortic aneurysm and hypoglycemia or hyperglycemia, particularly in older adults or those with comorbidities. On top of these boxed warnings, ciprofloxacin can also prolong the QT interval and cause GI upset. Drug interactions are another big factor in practice. Ciprofloxacin is a CYP1A2 inhibitor, which can raise levels of drugs like theophylline, tizanidine, and clozapine. It also interacts with polyvalent cations such as calcium, magnesium, iron, and aluminum, which can dramatically reduce its absorption—sometimes by more than 50%. This is a common reason for treatment failure if counseling isn't provided. From a dosing perspective, ciprofloxacin is usually given 250–750 mg orally twice daily or 400 mg IV every 8–12 hours depending on the indication and severity of infection. Renal dosing adjustments are needed as kidney function declines. In summary, ciprofloxacin is a powerful antibiotic when used appropriately. It remains an option for urinary tract infections, complicated intra-abdominal infections, and some cases of hospital-acquired pneumonia, but its use must be balanced with the potential for significant adverse effects and interactions. For pharmacists, educating patients on drug interactions, counseling about boxed warnings, and ensuring correct dosing in renal impairment are some of the most valuable interventions when ciprofloxacin shows up on a medication list.

We're bringing back one of our most downloaded episodes ever – a deep dive into how adverse events should be analyzed properly. This conversation with Jan Beyersmann and Kaspar Rufibach is packed with methodological insights and practical implications for statisticians working in clinical trials. Adverse event (AE) analysis has long been approached differently from efficacy analysis, often using overly simplistic methods that can bias results. In this episode, we discuss why that's a problem – and how the SAVVY collaboration (Survival analysis for AdVerse events with Varying follow-up times) is pushing the field forward. Together with academia and multiple pharma companies, this collaboration tackled the issue of AE analysis using real randomized trial data, not just simulations. The findings show how common methods can underestimate or overestimate event probabilities and how established statistical methods can be applied more consistently to ensure fair benefit–risk assessments. If you've ever wondered whether your approach to safety analysis is leading to misleading conclusions, this episode is a must-listen.

My head hurts. Today in Bizarro America 2025, Bobby Kennedy Jr. becomes the government PHARMA pimp and Peter Hotez plays the anti-vaxxer. The complete inversion of roles is something to behold and highly demoralizing, to be honest. But what about this ‘new universal vaccine’? Sasha Latypova calls it the ‘All One & Done Kill Shot’ in a recent piece warning of serious problems with the new MAHA endorsed product. ALSO - today we will talk about preparedness in a special sponsored segment with the awesome Brett Miller, CEO of Galileyo Inc! Thank you to The Satellite Phone Store for helping America to be independent AND prepared! The Satellite Phone Store has EVERYTHING you need when the POWER goes OUT. Use the promo code JOY for 10% off your entire order TODAY! www.SAT123.com/Joy We discuss this and more today on The Shannon Joy Show. WATCH LIVE HERE: https://rumble.com/c/TheShannonJoyShow Shannon’s Top Headlines, August 20, 2025: Peter Hotez Anti Vaxxer? https://x.com/ShannonJoyRadio/status/1958505773429829886 NEW Bill - The GRACE ACT Seeks T0 Bring Religious Exemptions to Vaccination Back to All 50 States! https://childrenshealthdefense.org/community/support-the-grace-act-bring-religious-exemptions-to-vaccination-back-to-all-50-states/ Human Antennas? When 6G is released, humans will function as walking power sources: https://www.smartmeters.news/2023-01-10-6g-humans-function-walking-power-source-antennas.html# The Trump Digital Control Grid: https://solari.com/trump-administration-digital-control-grid-coming-together-at-high-speed/ Where is $500M for Pandemic Preparedness going? A sober take on HHS terminating 22 mRNA projects with BARDA https://sashalatypova.substack.com/p/sober-reading-of-hhs-press-release SJ Show Notes: Please support Shannon’s independent network with your donation HERE: https://www.paypal.com/donate/?hosted_button_id=MHSMPXEBSLVT Support Our Sponsors: The best medicine is chronic GOOD health and achieving it naturally. It’s why my family uses Native Path Collagen every day! Go to getnativepathcollagen.com/joy today to claim your EXCLUSIVE 45% off deal before it’s gone. Protect your retirement today with GOLD. Click HERE today to get started and see if you qualify for $7500 in free silver! Go to www.colonialmetalsgroup.com/joy Please consider Dom Pullano of PCM & Associates! He has been Shannon’s advisor for over a decade and would love to help you grow! Call his toll free number today: 1-800-536-1368 or visit his website at https://www.pcmpullano.com

On the latest and greatest episode of the Empowering Plans podcast series, attorneys Bryan Dunton and Cindy Merrell discuss news that matters to you: how recent headlines signal sweeping changes to adverse claims determinations and prior authorization practices.

Season 2 is going out with a bang! On the finale, Gillie and Wallo of Million Dollaz Worth of Game pull up to Red Hook. Gillie speaks his truth about Cam Newton, the duo talk about their love for Coach Prime, and they explain how they built a million dollar business. Tap in! Learn more about your ad choices. Visit megaphone.fm/adchoices

Examining patient demographics and major adverse cardiac events following noncardiac surgery: Applying a health equity lens

Gabriela Goldfarb, the Environmental Health Section Manager for the Oregon Health Authority, joins the Exchange.

L-Glutamine stands as one of the most powerful amino acids for optimizing gut health, muscle function, immune and brain health. It's a common solution for leaky gut, but overall can enhance the improvement of other therapies. In this episode, I'll dive into the benefits of l-glutamine, the best food sources, and effective protocols for different conditions.    ✅ Start healing with us! Learn more about our virtual clinic:https://drruscio.com/virtual-clinic/

Guests Eddy Conroy and Nick Graetz discuss their recent issue brief, “Ousted from Opportunity: Eviction's Adverse Impact on Parenting College Students,” which examines the unique challenges faced by students caring for children while enrolled in college, and the results of their analysis revealing the consequences that the threat of eviction has, impacting not only the likelihood of completing a degree but even life expectancy. Policy reforms and investments in education and housing are needed to address this issue, and housing and education advocates and institutions must partner together to achieve lasting change. Read the brief here: https://www.newamerica.org/education-policy/briefs/what-happens-student-parents-threatened-with-eviction/

Asenapine is an atypical antipsychotic that acts as an antagonist at multiple receptors, including dopamine D2 and serotonin 5-HT2A, contributing to its antipsychotic and mood-stabilizing effects. Adverse effects of asenapine include somnolence, dizziness, and extrapyramidal symptoms. Because asenapine is significantly metabolized by CYP1A2, inhibitors or inducers of these enzymes can affect its plasma concentrations. Co-administration with other CNS depressants may increase the risk of sedation and impaired cognitive or motor function. Asenapine can prolong the QT interval, so caution is advised when used with other medications that affect cardiac conduction.

Send us a textAssociation of a Count of Inpatient Morbidities with 2-Year Outcomes among Infants Born Extremely Preterm.Dorner RA, Li L, DeMauro SB, Schmidt B, Zangeneh SZ, Vaucher Y, Wyckoff MH, Hintz S, Carlo WA, Gustafson KE, Das A, Katheria A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network.J Pediatr. 2025 Mar;278:114428. doi: 10.1016/j.jpeds.2024.114428. Epub 2024 Dec 4.PMID: 39643110Support the showAs always, feel free to send us questions, comments, or suggestions to our email: nicupodcast@gmail.com. You can also contact the show through Instagram or Twitter, @nicupodcast. Or contact Ben and Daphna directly via their Twitter profiles: @drnicu and @doctordaphnamd. The papers discussed in today's episode are listed and timestamped on the webpage linked below. Enjoy!

Depending on who you talk to, labor reform is desperately needed in agriculture, with costs soaring, pricing out more and more farmers every day.

Depending on who you talk to, labor reform is desperately needed in agriculture, with costs soaring, pricing out more and more farmers every day.

Headlines on today's episode include:-Adverse weather impacting some key global ag regions-Nitrogen deficiency popping up in Indiana-Slow wheat harvest nears its end in Kansas-USDA lowers wheat production-President Trump addresses dairy trade in letter to CanadaSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Patrick McKenzie (patio11) is joined again by Ricki Heicklen to discuss the evolution of her trading education business, Arbor, one year after their first conversation. They dive deep into the pedagogy of trading, exploring how simulated markets teach concepts like adverse selection, team dynamics, and risk management through hands-on experience. Ricki shares war stories from the bootcamp trenches—infinite loop bugs that mirror Knight Capital's disaster, WiFi outages that create unexpected trading opportunities, and that the most successful trading teams often focus on internal team communication even more than trade execution or technical acumen.See the full transcript: https://www.complexsystemspodcast.com/think-like-a-trader-ricki-heicklen/–[Patrick notes: Complex Systems now produces occasional video episodes.You can access them directly on YouTube: https://www.youtube.com/@patio11podcast. My kids inform me that I'm supposed to tell you to like and subscribe.]–Links:Trading Camp : https://trading.camp/Metagame: https://www.metagame.games/#tickets Story of Knight Capital: https://www.sec.gov/files/litigation/admin/2013/34-70694.pdf–Timestamps:(00:00) Intro(00:46) Ricki's journey from trading to teaching(01:25) The birth of Arbor and first bootcamps(03:32) Developing a trader's mindset(05:53) Understanding heuristics in trading(08:21) Adverse selection in everyday life(15:40) Insights from teaching trading bootcamps(21:07) Pedagogical approach: learning by doing(32:00) Handling mistakes and learning opportunities(36:17) Unplanned bugs and real-world lessons(39:47) Learning from Knight Capital's bug(40:24) Understanding exchange-side bugs(43:10) Risk limits and strategy separation(44:41) Importance of UI in trading bots(46:53) The Madagascar button(48:20) The big red button in manufacturing(49:45) Simulated trading and information aggregation(50:29) Sibling trading game explained(53:24) Modeling and hidden information(01:01:15) Trading behavior and market updates(01:04:38) Real-world applications and lessons(01:13:58) Surprises and market opportunities(01:16:24) Pedagogical approaches in trading education(01:17:08) Market dynamics and counterparty behavior(01:17:53) Retail vs. institutional order flow(01:19:23) Simplifying trading concepts for beginners(01:21:27) Introducing market characters and their roles(01:31:31) Team dynamics and communication in trading(01:39:13) The importance of redundancy in trading systems(01:47:52) Future of trading education and online classes(01:53:47) Wrap

Childhood trauma, often referred to as ‘complex' or ‘developmental' trauma, is extremely common but is not often discussed in the context of our work as early childhood educators. And yet, children are showing up to our settings/programs every day carrying the weight of these circumstances and, according to research, a trajectory of negative health outcomes for the lifespan as a result. But Mary Hewitt shares with us that there is hope: early positive relationships and experiences with informed educators have the power to protect, buffer, and even reverse the devastating impacts of childhood trauma.   This episode is sponsored by Mangotree Kids. Mangotree Kids provides African drumming programs and inclusive toys and educational resources which promote the beauty of culture. Our main focus is enhancing the quality and diversity of products that represent Black children, ensuring they see themselves and their culture reflected in the toys they play with.   Our Jolly Djembe Club workshop introduces nursery children to the art of Djembe drumming in a fun and engaging way, and promotes wellbeing through our Rhythmic Meditation exercise. The program ends with a wonderful parents showcase. Mangotree Kids also provides a stress relief program called Beat the Stress for nursery staff.   To find out more visit: https://www.mangotreekids.com/     Read Mary's article here:  https://thevoiceofearlychildhood.com/understanding-the-impact-of-childhood-trauma-and-how-to-develop-trauma-informed-practices/   Our 2026 conference info & tickets: https://thevoiceofearlychildhood.com/early-years-conference-2026/   You might also like… -      Proactively promoting positive mental health by Matt Bawler – https://thevoiceofearlychildhood.com/proactively-promoting-positive-mental-health/ -      Self-regulation, co-regulation & mental health by Dr Mine Conkbayir – https://thevoiceofearlychildhood.com/self-regulation-co-regulation-and-mental-health/ -      ‘It's not time out, it's time in' for both of us: Co- and self-regulation by Julia Robinson & Charlotte Hannah – https://thevoiceofearlychildhood.com/its-not-time-out-its-time-in-for-both-of-us/ -      Understanding neuroscience in early childhood by Mandy Worsley – https://thevoiceofearlychildhood.com/understanding-neuroscience-in-early-childhood/   Share your voice: Do you have a topic or guest you would like to hear on the podcast? Get in touch here! – https://thevoiceofearlychildhood.com/contact/   Episode break down: 00:00 – Welcome! 03:00 – Topic warning – A difficult conversation 03:45 – What is trauma? 07:30 – How do traumas show up as behaviours? 08:40 – Trading connection for protection 10:00 – Dissociation – Shutting down & disconnecting 11:20 – Arousal response – Fight or flight mode, aggressive state & confrontation 12:45 – Examples of traumatic experiences 17:00 – Adverse childhood experiences (ACEs) research 21:00 – Effects of trauma on the body and brain 22:00 – Survival brain taking over – Stress response is maladaptive 24:00 – Mary's personal ACEs story 26:00 – Positive childhood experiences (PCEs) 31:00 – Elevated stress response – Living in high alert 36:00 – Floodlight approach 39:00 – Educators as agents of protection and buffers 42:00 – Rhythm and heartbeat – First sign of safety 43:30 – Drumming as co-regulation & eliciting a sense of safety 47:00 – Music & movement to elicit PCEs 48:30 – Rhythm of your day – A sense of safety 50:00 – Side by side rather than face to face 52:00 – Stage-like approach to regulation 55:00 – Removing the shame & therefore resistance 01:00:00 – ‘Little big moments' 01:02:00 – Feeling seen, heard & that you matter 01:04:00 – The lasting impact educators have on children 01:07:00 – Further reading 01:09:30 – Key takeaways & related podcast episodes For more episodes and articles visit The Voice of Early Childhood website: https://www.thevoiceofearlychildhood.com

This conversation provides a comprehensive overview of foundational legal principles in property and criminal law, emphasizing the importance of understanding key concepts for law school exams and the bar exam. It covers essential topics such as property rights, intellectual property, co-ownership, conveyancing, landlord-tenant relationships, and the intricacies of criminal law, including defenses and self-defense. The discussion highlights the interconnectedness of these legal fields and the analytical skills necessary for success in legal studies and practice.TakeawaysUnderstanding property law is crucial for law students.The concept of property as a 'bundle of sticks' is fundamental.Intellectual property rights encourage innovation.Co-ownership forms have distinct legal implications.Adverse possession allows non-owners to claim property.Conveyancing involves multiple legal steps in property sales.Self-defense laws vary significantly by jurisdiction.Criminal procedure safeguards individual rights during trials.The prosecution must prove guilt beyond a reasonable doubt.Legal principles are interconnected and require analytical skills.property law, criminal law, legal education, bar exam, property rights, intellectual property, co-ownership, conveyancing, landlord-tenant law, eminent domain, criminal procedure, self-defense, legal principles

김영철의 파워FM - 진짜 영국식 영어 443회 - 부작용이야~ = It's an adverse reaction.

Darshan H. Brahmbhatt, Podcast Editor of JACC: Advances, discusses a recently published original research paper on Coronary Plaque, Inflammation, Subclinical Myocardial Injury, and Major Adverse Cardiovascular Events in the REPRIEVE Substudy.

THE LANCET 2003;362:772-776Background: Angiotensin converting enzyme inhibitors (ACEi) reduce mortality and morbidity in patients with systolic heart failure (see CONSENSUS and SOLVD trials). However, registry data showed that up to 20% of patients with systolic heart failure were not taking ACEi. One of the frequent causes for intolerance to ACEi is cough. Angiotensin converting enzyme inhibitors work by blocking the conversion of angiotensin I to angiotensin II, a key step in the renin–angiotensin–aldosterone system (RAAS). Angiotensin II receptor blockers were tolerated in patients with systolic heart failure who were intolerant to ACEi. However, data on long term effectives as an alternative to ACEi were lacking.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber.The Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM)-Alternative trial sough to assess if the angiotensin-receptor blocker (ARB) candesartan, could improve outcomes in patients with systolic heart failure who are intolerant to ACEi.Patients: Eligible patients had left ventricular ejection fraction of 40% or less and NYHA class II, III or IV symptoms of at least 4 weeks duration. Patients had also to be intolerant to ACEi.Exclusion criteria were not provided in the main manuscript.Baseline characteristics: Patients were recruited from 618 centers in 26 countries. The trial randomized 2,028 patients – 1,013 randomized to receive candesartan and 1,015 to receive placebo.The average age of patients was 67 years and 68% were men. The average left ventricular ejection fraction was 30%. Cardiomyopathy was ischemic in 68% of the patients. The NYHA class was II in 48% of the patients, III in 49% and IV in 4%.Approximately 50% had hypertension, 27% had diabetes, 61% had prior myocardial infarction, 9% had stroke, 25% had atrial fibrillation and 14% were current smokers.At the time of enrollment, 85% were taking a diuretic, 46% were taking digoxin, 55% were taking beta-blockers and 24% were taking spironolactone.The most common reasons for ACEi intolerance were cough in 72% of the patients, hypotension in 13%, renal dysfunction in 12% and angioedema or anaphylaxis in 4%.Procedures: The trial was double-blinded. Patients were assigned in a 1:1 ratio to receive candesartan starting at 4 or 8mg once daily or placebo. The treatment was doubled every two weeks to a target dose of 32mg once daily.After randomization, follow up occurred at 2, 4, and 6 weeks, 6 months and every 4 months thereafter.Endpoints: The primary outcome was a composite of cardiovascular death or heart failure hospitalizations. All deaths were classified as cardiovascular unless there was a clear non-cardiac cause.Analysis was performed based on the intention-to-treat principle. The estimated sample size to have 80% power at 5% alpha was 2,000 patients. The sample size calculation assumed 18% relative risk reduction in the primary outcome with candesartan assuming a 15% annual event rate in the placebo arm.Results: The median follow up time was 34 months. The mean candesartan daily dose was 23mg at 6 months.Candesartan reduced the primary endpoint of cardiovascular death or heart failure hospitalizations (33.0% vs 40.0%, adjusted HR: 0.70, 95% CI: 0.60 – 0.81; p< 0.001). Candesartan reduced the individual components of the primary outcome - (21.6% vs 24.8%; p= 0.02) for cardiovascular death and (20.4% vs 28.2%; p< 0.001) for heart failure hospitalizations. All-cause death was also lower with candesartan (26.2% vs 29.2%, adjusted HR: 0.83, 95% CI: 0.70–0.99; p= 0.033). The number of patients who had any hospitalization as well as the total number of hospitalizations were numerically but not statistically significantly lower with candesartan (60.2% with candesartan vs 63.3%; p= 0.16) and (1,718 vs 1,835; p= 0.06).Candesartan was associated with more hypotension (3.7% vs 0.9%), more increase in creatinine (6.1% vs 2.7%) and more hyperkalemia (1.9% vs 0.3%). Angioedema occurred in three patients in the candesartan group and none in the placebo group. Cough occurred in two patients taking candesartan and four taking placebo.Authors reported no significant subgroup interactions, however, a corresponding graph was not provided.Conclusion: In patients with systolic heart failure who are intolerant to ACEi, candesartan reduced the primary composite outcome of cardiovascular death or heart failure hospitalizations with a number needed to treat of approximately of 14 patients over 34 months of follow up. Candesartan also reduced all-cause death with a number needed to treat of approximately 33 patients. Adverse events including hypotension, increase in creatinine and hyperkalemia were more common with candesartan.The reduction in the primary endpoint with candesartan was significant and offers an alternative for patients who are unable to tolerate ACEi. Of note, 72% of the patients enrolled in the trial were intolerant to ACEi due to cough. This trial did not include a head-to-head comparison between ARBs and ACEi, and therefore does not address which agent should be preferred as first-line therapy. Only 24% of participants were receiving spironolactone. The combination of ARBs with spironolactone, may increase the risk of adverse events, particularly hyperkalemia and kidney injury.Cardiology Trial's Substack is a reader-supported publication. To receive new posts and support our work, consider becoming a free or paid subscriber. Get full access to Cardiology Trial's Substack at cardiologytrials.substack.com/subscribe

Dr. Allison Zibelli and Dr. Rebecca Shatsky discuss advances in breast cancer research that were presented at the 2025 ASCO Annual Meeting, including a potential new standard of care for HER2+ breast cancer, the future of ER+ breast cancer management, and innovations in triple negative breast cancer therapy. Transcript Dr. Allison Zibelli: Hello and welcome to the ASCO Daily News Podcast. I'm Dr. Allison Zibelli, your guest host of the podcast today. I'm an associate professor of medicine and a breast medical oncologist at the Sidney Kimmel Comprehensive Cancer Center at Jefferson Health. There was a substantial amount of exciting breast cancer data presented at the 2025 ASCO Annual Meeting, and I'm delighted to be joined by Dr. Rebecca Shatsky today to discuss some of these key advancements. Dr. Shatsky is an associate professor of medicine at UC San Diego and the head of breast medical oncology at the UC San Diego Health Moores Cancer Center, where she also serves as the director of the Breast Cancer Clinical Trials Program and the Inflammatory and Triple-Negative Breast Cancer Program.  Our full disclosures are available in the transcript of this episode. Dr. Shatsky, it's great to have you on the podcast today. Dr. Rebecca Shatsky: Thanks, Dr. Zibelli. It's wonderful to be here. Dr. Allison Zibelli: So, we're starting with DESTINY-Breast09, which was trastuzumab deruxtecan and pertuzumab versus our more standard regimen of taxane, trastuzumab pertuzumab for first-line treatment of metastatic HER2-positive breast cancer. Could you tell us a little bit about the study? Dr. Rebecca Shatsky: Yeah, absolutely. So, this was a long-awaited study. When T-DXd, or trastuzumab deruxtecan, really hit the market, a lot of these DESTINY-Breast trials were started around the same time. Now, this was a global, randomized, phase 3 study presented by Dr. Sara Tolaney from the Dana-Farber Cancer Institute of Harvard in Boston. It was assessing essentially T-DXd in the first-line setting for metastatic HER2-positive breast cancer in addition to pertuzumab. And that was randomized against our standard-of-care regimen, which was established over a decade ago by the CLEOPATRA trial, and we've all been using that internationally for at least the past 10 years. So, this was a large trial, and it was one-to-one-to-one of patients getting T-DXd plus pertuzumab, T-DXd alone, or THP, which mostly is used as docetaxel and trastuzumab and pertuzumab every three weeks for six cycles. And this was in over 1,000 patients; it was 1,159 patients with metastatic HER2-positive breast cancer. This was a very interesting trial. It was looking at the use of trastuzumab deruxtecan, but patients were started on this treatment for their first-line metastatic HER2-positive breast cancer with no end date to their T-DXd. So, it was, you know, you were started on T-DXd every 3 weeks until progression. Now, CLEOPATRA is a little bit different than that, though, as we know. So, CLEOPATRA has a taxane plus trastuzumab and pertuzumab. But generally, patients drop the taxane after about six to seven cycles because, as we know, you can't be really on a taxane indefinitely. You get pretty substantial neuropathy as well as cytopenias, other things that end up happening. And so, in general, that regimen has sort of a limited time course for its chemotherapy portion, and the patients maintained after the taxane is dropped on their trastuzumab and their pertuzumab, plus or minus endocrine therapy if the investigator so desires. And the primary endpoint of the trial was progression-free survival by blinded, independent central review (BICR) in the intent-to-treat population. And then it had its other endpoints as overall survival, investigator-assessed progression-free survival, objective response rates, and duration of response, and of course, safety. As far as the results of this trial, so, I think that most of us key opinion leaders in breast oncology were expecting that this was going to be a positive trial. And it surely was. I mean, this is a really, really active drug, especially in HER2-positive disease, of course. So, the DESTINY-Breast03 data really established that, that this is a very effective treatment in HER2-positive metastatic breast cancer. And this trial really, again, showed that. So, there were 383 patients that ended up on the trastuzumab plus deruxtecan plus pertuzumab arm, and 387 got THP, the CLEOPATRA regimen. What was really interesting also to note of this before I go on to the results was that 52% of patients on this trial had de novo metastatic disease. And that's pretty unusual for any kind of metastatic breast cancer trial. It kind of shows you, though, just how aggressive this disease is, that a lot of patients, they present with de novo metastatic disease. It's also reflecting the global nature of this trial where maybe the screening efforts are a little bit less than maybe in the United States, and more patients are presenting as later stage because to have a metastatic breast cancer trial in the United States with 52% de novo metastatic disease doesn't usually happen. But regardless, the disease characteristics were pretty well matched between the two groups. 54% of the patients were triple positive, or you could say hormone-positive because whether they were PR positive or ER positive and PR negative doesn't really matter in this disease. And so, the interim data cutoff was February of this year, of 2025. So, the follow-up so far has been about 29 months, so the data is still really immature, only 38% mature for progression-free survival interim analysis. But what we saw is that T-DXd plus pertuzumab, it really improved progression-free survival. It had a hazard ratio that was pretty phenomenal at 0.56 with a confidence interval that was pretty narrow of 0.44 to 0.71. So, very highly statistically significant data here. The progression-free survival was consistent across all subgroups. Overall survival, very much immature at this time, but of course, the trend is towards an overall survival benefit for the T-DXd group. The median durable response with T-DXd plus pertuzumab exceeded 3 years. Now, importantly, though, I want to stress this, is grade 3 or above treatment-emergent adverse events occurred in both subgroups pretty equally. But there were 2 deaths in the T-DXd group due to interstitial lung disease. And there was a 12.1% adjudicated drug-induced interstitial lung disease/pneumonitis event rate in the T-DXd group and only 1%, and it was grade 1-2, in the THP group. So, that's really the caveat of this therapy, is we know that a percentage of patients are going to get interstitial lung disease, and that some may have very serious adverse events from it. So, that's always something I keep in the back of my mind when I treat patients with T-DXd. And so, overall, the conclusions of the trial were pretty much a slam dunk. T-DXd plus pertuzumab, it had a highly statistically significant and clinically meaningful improvement in progression-free survival versus the CLEOPATRA regimen. And that was across all subgroups for first-line metastatic HER2-positive breast cancer here. And so, yeah, the data was pretty impressive. Just to go into the overall response rate, because that's always super important as well, you had 85.1% of patients having a confirmed overall RECIST response rate in the T-DXd plus pertuzumab group and a 78.6 in the CLEOPATRA group. The complete CR rate, complete response was 15.1% in the T-DXd group and 8.5 in the CLEOPATRA regimen. And it was really an effective regimen in this group, of course. Dr. Allison Zibelli: So, the investigators say at the end of their abstract that this is the new standard of care. Would you agree with that statement? Dr. Rebecca Shatsky: Yeah, that was a bold statement to make because I would say in the United States, not necessarily at the moment because the quality of life here, you have to think really hard about. Because one thing that's really important about the DESTINY-Breast09 data is that this was very much an international trial, and in many of the countries where patients enrolled on this, they were not able to access T-DXd off trial. And so, for them, this means T-DXd now or potentially never. And so, that is a really big difference whereas internationally, that may mean standard of care. However, in the US, patients have no issues accessing T-DXd in the second- or third-line settings. And right now, it's the standard of care in the second line in the United States, with all patients basically getting this second-line therapy except for some unique patients where they may be doing a PATINA trial regimen, which we saw at San Antonio Breast Cancer in 2024 of the triple-positive patients getting hormonal therapy plus palbociclib, which had a really great durable response. That was super impressive as well. Or there is the patient that the investigator can pick KADCYLA because the patient really wants to preserve their hair or maybe it's more indolent disease. But the quality of life on T-DXd indefinitely in the first-line setting is a big deal because, again, that CLEOPATRA regimen allows patients to drop their chemotherapy component about five to six months in. And with this, you're on a drug that feels very chemo-heavy indefinitely. And so, I think there's a lot more to investigate as far as what we're going to do with this data in the United States because it's a lot to commit a patient in the first-line metastatic setting. These de novo metastatic patients, some of them may be cured, honestly, on the HER2-targeting regimen. That's something we see these days. Dr. Allison Zibelli: So, very interesting trial. I'm sure we'll be talking about this for a long time.  So, let's move on to SERENA-6, which was, I thought, a very interesting trial. This trial took patients with ER positive, advanced breast cancer after six months on an AI (aromatase inhibitor) and a CDK4/6 inhibitor. They did ctDNA every two to three months, and when they saw an ESR1 mutation emerge, they changed half of the patients to camizestrant plus CDK4/6 and kept the other half on the AI plus CDK4/6. Can you talk about that trial a little bit, please? Dr. Rebecca Shatsky: Yeah, so this was a big trial at ASCO25. This was presented as a Plenary Session. So, this was camizestrant plus a CDK4/6 inhibitor, and it could have been any of the three, so palbo, ribo, or abemaciclib in the first-line metastatic hormone-positive population, and patients were on an AI with that. They were, interestingly, tested by ctDNA at baseline to see if they had an ESR1 mutation. So, that was an interesting feature of this trial. But patients had to have already been on their CDK4/6 inhibitor plus AI for at least 6 months to enroll. And then, as you mentioned, they got ctDNA testing every 2 to 3 months. This was also a phase 3, double-blind, international trial. And I do want to highlight again, international here, because that's important when we're considering some of this data in the U.S. because it influences some of the results. So, this was presented by Dr. Nick Turner of the Royal Marsden in the UK. So, just a little bit of background for our listeners on ESR1 mutations and why they're important. This is the most common, basically, acquired resistance mutation to patients being treated with aromatase inhibitors. We know that treatment with aromatase inhibitors can induce this. It makes a conformational change in the estrogen receptor that makes the estrogen receptor constitutively active, which allows the cell to signal despite the influence of the aromatase inhibitor to decrease the estrogen production so that the ligand binding doesn't matter as much as far as the cell signaling and transcription is concerned. And camizestrant, you know, as an oral SERD, just to explain that a little bit too; these are estrogen receptor degraders. The first-in-class of a selective estrogen receptor degrader to make it to market was fulvestrant. And that's really been our standard-of-care estrogen degrader for the past 25 years, almost 25 years. And so, a lot of us are just looking for some of these oral SERDs to replace that. But regardless, they do tend to work in the ESR1-mutated population. And we know that patients on aromatase inhibitors, the estimates of patients developing an ESR1 mutation, depending on which study you look at, somewhere between 30% to 50% overall, patients will develop this mutation with hormone-positive metastatic breast cancer. There is a small percentage of patients that have these at baseline without even treatment of an aromatase inhibitor. The estimates of that are somewhere between 0.5 and up to 5%, depending on the trial you look at and the population. But regardless, there is a chance someone on their CDK4/6 inhibitor plus AI at 6 months' time course could have had an ESR1 mutation at that time. But anyway, so they got this ctDNA every 2 to 3 months, and once they were found to develop an ESR1 mutation, the patients were then switched to the oral SERD. AstraZeneca's version of the oral SERD is camizestrant, 75 mg daily. And then their type of CDK4/6 inhibitor was maintained, so they didn't switch the brand of their CDK4/6 inhibitor, importantly. And that was looked at then for progression-free survival, but these were patients with measurable disease by RECIST version 1.1. And the data cut off here was November of 2024. This was a big trial, you know, and I think that that's influential here because this was 3,256 patients, and that's a lot of patients. So, they were all eligible. And then 315 patients ended up being randomized to switch to camizestrant upon presence of that ESR1 mutation. So, that was 157 patients. And then the other half, so they were randomized 1:1, they continued on their AI without switching to an oral SERD. That was 158 patients. They were matched pretty well. And so, their baseline characteristics, you know, the two subgroups was good. But this was highly statistically significant data. I'm not going to diminish that in any way. Your hazard ratio was 0.44. Highly statistically significant confidence intervals. And you had a median progression-free survival in those that switched to camizestrant of 16 months, and then the non-switchers was 9.2 months. So, the progression-free survival benefit there was also consistent across the subgroups. And so, you had at 12 months, the PFS rate was 60.7% for the non-treatment group and 33.4% in the treatment group. What's interesting, though, is we don't have overall survival data. This is really immature, only 12% mature as far as overall survival. And again, because this was an international trial and patients in other countries right now do not have the access to oral SERDs that the United States does, the crossover rate, they were not allowed to crossover, and so, a very few patients, when we look at progression-free survival 2 and ultimately overall survival, were able to access an oral SERD in the off-trial here and in the non-treatment group. And so, that's really important as far as we look at these results. Adverse events were pretty minimal. These are very safe drugs, camizestrant and all the other oral SERDs. They have some mild toxicities. Camizestrant is known for something weird, which is called photopsia, which is some flashing lights in the periphery of the eye, but it doesn't seem to have any serious clinical significance that we know of. It has a little bit of bradycardia, but it's otherwise really well tolerated. You know, I hate to say that because that's very subjective, right? I'm not the one taking the drug. But it doesn't have any serious adverse events that would cause discontinuation. And that's really what we saw in the trial. The discontinuation rates were really low. But overall, I mean, this was a positive trial. SERENA-6 showed that switching to camizestrant at the first sign of an ESR1 mutation on CDK4/6 inhibitor plus AI improved progression-free survival. That's all we can really say from it right now. Dr. Allison Zibelli: So, let's move on to ASCENT-04, which was a bit more straightforward. Sacituzumab govitecan plus pembrolizumab versus chemotherapy plus pembrolizumab in PD-L1-positive, triple-negative breast cancer. Could you talk about that study? Dr. Rebecca Shatsky: Yeah, so this was also presented by the lovely Sara Tolaney from Dana-Farber. And this study made me really excited. And maybe that's because I'm a triple-negative breast cancer person. I mean, not to say that I don't treat hundreds of patients with hormone- positive, but our unmet needs in triple negative are huge because this is a disease where you have got to throw your best available therapy at it as soon as you can to improve survival because survival is so poor in this disease. The average survival with metastatic triple-negative breast cancer in the United States is still 13-18 months, and that's terrible. And so, for full disclosure, I did have this trial open at my site. I was one of the site PIs. I'm not the global PI of the study, obviously. So, what this study was was for patients who had had at least a progression-free survival of 6 months after their curative intent therapy or de novo metastatic disease. They were PD-L1 positive as assessed by the Dako 22C3 assay of greater than or equal to a CPS score of 10. So, that's what the KEYNOTE-355 trial was based on as well. So, standard definition of PD-L1 positive in breast cancer here. And basically, these patients were randomized 1:1 to either their sacituzumab govitecan plus pembrolizumab, day 1 they got both therapies, and then day 8 just the saci, as is standard for sacituzumab. And then the other group got the KEYNOTE-355 regimen. So, that is pembrolizumab with – your options are carbogem there, paclitaxel or nab-paclitaxel. And it's up to investigator's decision which upon those they decided. They followed these patients for disease progression or unacceptable toxicity. It was really an impressive trial in my opinion because we know already that this didn't just improve progression-free survival, because survival is so poor in this disease, of course, we know that it improved overall survival. It's trending towards that very much, and I think that's going to be shown immediately. And then the objective response rates were better, which is key in this disease because in the first-line setting, you've got a lot of people who, especially your relapsed TNBC that don't respond to anything. And you lose a ton of patients even in the first-line setting in this disease. And so, this was 222 patients to chemotherapy and pembro and 221 to sacituzumab plus pembro. Median follow-up has only been 14 months, so it's still super early here. Hazard ratio so far of progression-free survival is 0.65, highly statistically significant, narrow confidence intervals. And so, the median duration of response here for the saci group was 16.5 months versus 9.2 months. So, you're getting a 7-month progression-free survival benefit here, which in triple negative is pretty fantastic. I mean, this reminds me of when we saw the ASCENT data originally come out for sacituzumab, and we were all just so happy that we had this tool now that doubled progression-free and overall survival and made such a difference in this really horrible disease where patients do poorly. So, OS is technically immature here, but it's really trending very heavily towards improvement in overall survival. Importantly, the treatment-related adverse events in this, I mean, we know sacituzumab causes neutropenia, people who are experienced with this drug know how to manage it at this point. There wasn't any really unexpected treatment-related adverse events. You get some people with sacituzumab who have diarrhea. It's usually pretty manageable with some Imodium. So, it was cytopenias predominantly in this disease in this population that were highlighted as far as adverse events. But I'm going to be honest, like I was surprised that this wasn't the plenary over the SERENA-6 data because this, in my mind, there we have a practice-changing trial. I will immediately be trying to use this in my PD-L1 population because, to be honest, as a triple-negative breast cancer clinical specialist, when I get a patient with metastatic triple-negative breast cancer who's PD-L1 positive, I think, "Oh, thank God," because we know that part of the disease just does better in general. But now I have something that really could give them a durable response for much longer than I ever thought possible when I started really heavily treating this disease. And so, this was immediately practice-changing for me. Dr. Allison Zibelli: I think that it's pretty clear that this is at least an option, if not the option, for this group of patients. Dr. Rebecca Shatsky: Yeah, the duration of responses here was – it's just really important because, I mean, I do think this will make people live longer. Dr. Allison Zibelli: So, moving on to the final study that we're going to discuss today, neoCARHP (LBA500), which was neoadjuvant taxane plus trastuzumab, pertuzumab, plus or minus carbo(platin) in HER2-positive early breast cancer. I think this is a study a lot of us have been waiting for. What was the design and the results of this trial? Dr. Rebecca Shatsky: I was really excited about this as well because I'm one of those people that was waiting for this. This is a Chinese trial, so that is something to take note of. It wasn't an international trial, but it was a de-escalation trial which had become really popular in HER2-positive therapy because we know that we're overtreating HER2-positive breast cancer in a lot of patients. A lot of patients we're throwing the kitchen sink at it when maybe that is not necessary, and we can really de-escalate and try to personalize therapy a little bit better because these patients tend to do well. So, the standard of care, of course, in HER2-positive curative intent breast cancer with tumors that are greater than 2 cm is to give them the TCHP regimen, which is docetaxel, carboplatin, trastuzumab, and pertuzumab. And that was sort of established by several trials in the NeoSphere trial, and now it's been repeated in a lot of different studies as well. And so, that's really the standard of care that most people in the United States use for HER2-positive curative intent breast cancer. This was a trial to de-escalate the carboplatin, which I was super excited about because many of us who treat this disease a lot think carbo is the least important part of the therapy you're giving there. We don't really know that it's necessary. We've just been doing it for a long time, and we know that it adds a significant amount of toxicity. It causes thrombocytopenia, it causes severe nausea, really bad cytopenias that can be difficult in the last few cycles of this to manage. So, this trial was created. It randomized patients one to one with stage 2 and 3 HER2-positive breast cancer to either get THP, a taxane, pertuzumab, trastuzumab, similar to the what we do in first-line metastatic HER2-positive versus the whole TCHP with a carboplatin AUC of 6, which is what's pretty standard. And it was a non-inferiority trial, so important there. It wasn't to establish superiority of this regimen, which none of us, I think, were looking for it to. And it was a modified intent-to-treat population. And so, all patients got at least one cycle of this to be assessed as a standard for an intent-to-treat trial. And so, they assumed a pCR rate of about 62.8% for both groups. And, of course, it included both HER2-positive triple positives and ER negatives, which are, you know, a bit different diseases, to be honest, but we all kind of categorize them and treat them the same. And so, this trial was powered appropriately to detect a non-inferiority difference. And so, we had about 380 patients treated on both arms, and there was an absolute difference of only 1.8% of those treated with carbo versus those without. Which was fantastic because you really realized that de-escalation here may be something we can really do. And so, the patients who got, of course, the taxane regimen had fewer adverse events. They had way fewer grade 3 and 4 adverse events than the THP group. No treatment-associated deaths occur, which is pretty standard for- this is a pretty safe regimen, but it causes a lot of hospitalizations due to diarrhea, due to cytopenias, and neutropenic fever, of course. And so, I thought that this was something that I could potentially enact, you know, and be practice-changing. It's hard to say that when it's a trial that was only done in China, so it's not necessarily the United States population always. But I think for patients moving forward, especially those with, say, a 2.5 cm tumor, you know, node negative, those, I'd feel pretty comfortable not giving them the carboplatin here. Notes that I want to make about this population is that the majority were stage 2 and not stage 3. They weren't necessarily your inflammatory HER2-positive breast cancer patients. And that the taxane that was utilized in the trial is a little different than what we use in the United States. The patients were allowed to get nab-paclitaxel, which we don't have FDA approval for in the first-line curative intent setting for HER2-positive breast cancer in the United States. So, a lot of them got abraxane, and then they also got paclitaxel. We tend to use docetaxel every 3 weeks in the United States. So, just to point out that difference. We don't really know if that's important or not, but it's just a little bit different to the population we standardly treat. Dr. Allison Zibelli: So, are there patients that you would still give TCHP to? Dr. Rebecca Shatsky: Yeah, great question. I've been asked that a lot in the past like week since ASCO. I'd say in my inflammatory breast cancer patients, that's a group I do tend to sometimes throw the kitchen sink at. Now, I don't actually use AC in those because I know that that was the concern, but I think the TRAIN-2 trial really showed us you don't need to use Adriamycin in HER2-positive disease unless it's like refractory. So, I don't know that I would throw this on my stage 3C or inflammatory breast cancer patients yet because the majority of this were not stage 3. So, in your really highly lymph node positive patients, I'm a little bit hesitant to de-escalate them from the start. This is more of a like, if there's serious toxicity concerns, dropping carbo is absolutely fine here. Dr. Allison Zibelli: All right, great.  Thank you, Dr. Shatsky, for sharing your valuable insights with us on the ASCO Daily News Podcast today. Dr. Rebecca Shatsky: Thanks so much, Dr. Zibelli and ASCO Daily News. I really want to thank you for inviting me to talk about this today. It was really fun, and I hope you find my opinions on some of this valuable. And so, I just want to thank everybody and my listeners as well. Dr. Allison Zibelli: And thank you to our listeners for joining us today. You'll find the links to all the abstracts discussed today in the transcript of this episode. Finally, if you like this podcast and you learn things from it, please take a moment to rate, review, and describe because it helps other people find us wherever you get your podcasts. Thank you again. Disclaimer: The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement. More on today's speakers Dr. Allison Zibelli Dr. Rebecca Shatsky @Dr_RShatsky Follow ASCO on social media:  @ASCO on Twitter  @ASCO on Bluesky  ASCO on Facebook  ASCO on LinkedIn   Disclosures: Dr. Allison Zibelli: No relationships to disclose Dr. Rebecca Shatsky: Consulting or Advisory Role: Stemline, Astra Zeneca, Endeavor BioMedicines, Lilly, Novartis, TEMPUS, Guardant Health, Daiichi Sankyo/Astra Zeneca, Pfizer Research Funding (Inst.): OBI Pharma, Astra Zeneca, Greenwich LifeSciences, Briacell, Gilead, OnKure, QuantumLeap Health, Stemline Therapeutics, Regor Therapeutics, Greenwich LifeSciences, Alterome Therapeutics  

In his weekly clinical update, Dr. Griffin and Vincent Racaniello discuss in shock how RFK is breaking his promise of not altering vaccine policies by appointing new members of the ACIP, next ACIP meeting on guidelines for the COVID and RSV vaccines, circulation of “human insect viruses” including West Nile virus, and an outbreak of mpox on a cruise ship, and the ongoing measles outbreak before Dr. Griffin reviews recent statistics on RSV, influenza and SARS-CoV-2 infections the Wasterwater Scan dashboard, how to reduce the use of antibiotics for RSV and influenza infections in children, approval of the moderna RSV mRNA vaccine, whether or not the NB.1.8.1 should be included in the fall 2025 vaccines, immunization recommendations for COVID-19 vaccines, where to find PEMGARDA, provides information for Columbia University Irving Medical Center's long COVID treatment center, where to go for answers to your long COVID questions, contacting your federal government representative to stop the assault on science and biomedical research, and a shout out for the special episode of TWiV with David Tuller on long COVID and ME/CFS. Subscribe (free): Apple Podcasts, RSS, email Become a patron of TWiV! Links for this episode RFK Jr. is sabotaging the vaccine program. Here's how to stop him (Washington Post) Innovaciones Alumbra (Alumbra Innovaciones) John T Walton (Wikiepedia) Walmart (Wikipedia) Sam Walton (Wikipedia) Condé Nast (Wikipedia) Christy Walton (Wikipedia) Vaccine Integrity Project ( CIDRAP) CIDRAP launches Vaccine Integrity Project (Twin Cities: University of Minnesota) Next ACIP meeting (CDC: ACIP) June meeting: MEETING OF THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP)(CDC: ACIP agenda) West Nile Virus and Other Nationally Notifiable Arboviral Diseases — United States, 2023 (CDC: MMWR) Clade II Mpox Infections Among Cruise Ship Passengers and Crew Members — United States, 2024 (CDC: MMWR) H5 bird flu: current situation (CDC: Avian Influenza) Wastewater for measles (WasterWater Scan) Measles cases and outbreaks (CDC Rubeola) Weekly measles and rubella monitoring (Government of Canada) Measles (WHO) Get the FACTS about measles (NY State Department of Health) Measles (CDC Measles (Rubeola)) Measles vaccine (CDC Measles (Rubeola)) Presumptive evidence of measles immunity (CDC) Contraindications and precautions to measles vaccination (CDC) Measles (CDC Measles (Rubeola) Measles vaccine recommendations from NYP (jpg) Adverse events associated with childhood vaccines: evidence bearing on causality (NLM) Measles Vaccination: Know the Facts (ISDA: Infectious Diseases Society of America) Deaths following vaccination: what does the evidence show (Vaccine) Influenza: Waste water scan for 11 pathogens (WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) Weekly surveillance report: clift notes (CDC FluView) Respiratory virus activity levels (CDC Respiratory Illnesses) Weekly surveillance report: clift notes (CDC FluView) Pediatric antibiotic use associated with respiratory syncytial virus and influenza in the United States, 2008-2018 (JID) FDA-CDC-DOD: 2025-2046 influenza vaccine composition (FDA) RSV: Waste water scan for 11 pathogens (WastewaterSCan) US respiratory virus activity (CDC Respiratory Illnesses) RSV-Network (CDC Respiratory Syncytial virus Infection) Novel Drug Approvals for 2025 (FDA) Effectiveness and impact of nirsevimab in Chile during the first season of a national immunisation strategy against RSV (NIRSE-CL) (LANCET: Infectious Diseases) Safety, Tolerability, and Immunogenicity ofmRNA-1345 in Adults at Increased Risk for RSV Disease Aged 18 to 59 Years (CID) Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease (moderna) Waste water scan for 11 pathogens (WastewaterSCan) COVID-19 deaths (CDC) COVID-19 national and regional trends (CDC) Spatiotemporal Association of Coronavirus Disease 2019 Cases and Deaths With Exposure to Wildfire Particulate Matter in 2020 (OFID) COVID-19 variant tracker (CDC) SARS-CoV-2 genomes galore (Nextstrain) Next ACIP meeting (CDC: ACIP) Antigenic and Virological Characteristics of SARS-CoV-2 Variant BA.3.2, XFG, and NB.1.8.1 (biRxiV) Where to get pemgarda (Pemgarda) EUA for the pre-exposure prophylaxis of COVID-19 (INVIYD) Infusion center (Prime Fusions) CDC Quarantine guidelines (CDC) NIH COVID-19 treatment guidelines (NIH) Implementation of an online drug-drug interaction screener for the STRIVE ensitrelvir trial for COVID-19 (OFID) Drug interaction checker (University of Liverpool) Infectious Disease Society guidelines for treatment and management (ID Society) Molnupiravir safety and efficacy (JMV) Convalescent plasma recommendation for immunocompromised (ID Society) What to do when sick with a respiratory virus (CDC) Managing healthcare staffing shortages (CDC) Steroids,dexamethasone at the right time (OFID) Anticoagulation guidelines (hematology.org) Daniel Griffin's evidence based medical practices for long COVID (OFID) Long COVID hotline (Columbia : Columbia University Irving Medical Center) The answers: Long COVID Long COVID and ME/CFS with David Tuller (microbeTV) Reaching out to US house representative Letters read on TWiV 1228 Dr. Griffin's COVID treatment summary (pdf) Timestamps by Jolene Ramsey. Thanks! Intro music is by Ronald Jenkees Send your questions for Dr. Griffin to daniel@microbe.tv Content in this podcast should not be construed as medical advice.

Dr. David Clarke shares his 40-year journey as a medical consultant specializing in neuroplastic conditions—real physical symptoms generated by the brain in response to stress, trauma, or emotional challenges. He explains how these conditions affect 20% of adults and 40% of doctor visits, yet remain frequently misdiagnosed despite being highly treatable.• Neuroplastic symptoms are physical manifestations created by the brain in response to stress or trauma• These conditions affect strong individuals carrying burdens they've normalized, not "weak" or "neurotic" people• Adverse childhood experiences (ACEs) can create lasting impacts through stressful personality traits, triggers, and unrecognized emotions• Brain circuits physically change with chronic stress and can change back with appropriate treatment• The brain creates all sensations—even with physical injuries, pain signals originate in the brain• Long Covid and similar conditions may involve neuroplastic mechanisms that maintain symptoms after initial triggers• Recovery includes reframing self-perception from weakness to strength, setting boundaries, and processing emotions• Transformation extends beyond symptom relief to improved relationships and becoming "who you were meant to be"Visit Symptomatic Me to take a 12-item questionnaire assessing for neuroplastic symptoms, and check out "The Story Behind the Symptoms" podcast where Dr. Clarke interviews patients about their recovery journeys.Symptomatic.MeMessage the podcast! - questions will be answered on my youtube channel :) For more information about Long Covid Breathing courses & workshops, please check out LongCovidBreathing.com (music credit - Brock Hewitt, Rule of Life) Support the show~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~The Long Covid Podcast is self-produced & self funded. If you enjoy what you hear and are able to, please Buy me a coffee or purchase a mug to help cover costsTranscripts available on individual episodes herePodcast, website & blog: www.LongCovidPodcast.comFacebook @LongCovidPodcastInstagram Twitter @LongCovidPodFacebook Creativity GroupSubscribe to mailing listPlease get in touch with feedback, suggestions or how you're doing - I love to hear from you, via socials or LongCovidPodcast@gmail.com**Disclaimer - you should not rely on any medical information contained in this Podcast and related materials in making medical, health-related or other decisions. Please consult a doctor or other health professional**

Dr Erin Louise Bellamy founded Integrative Ketogenic Research and Therapies which uses principles of Metabolic Psychiatry to provide remote, highly personalized 1:1 Metabolic Therapy for both psychiatric conditions and overall metabolic health. Dr. Erin Bellamy has a PhD in Psychology, specializing in Ketogenic Diets & Depression from the University of East London. She also has an MSc in Psychiatric Research from the Institute of Psychiatry at King's College London. She is a Chartered Psychologist, an Associate Fellow of the British Psychological Society and an accredited member of the Society of Metabolic Health Practitioners. In this episode, Drs. Brian and Erin talk about… (00:00) Intro (01:36) How Dr. Erin became interested in Metabolic Psychiatry (05:38) Ketogenic diets and psychiatric conditions (15:39) Fasting and mental clarity (18:12) The areas in which clinical psychology is deficient in helping patients (23:46) Adverse childhood events, PTSD, and metabolic health (28:24) Binge eating, stress, and support groups (40:00) Food addiction and ketosis (43:59) Schizophrenia, autism, and ketosis (01:00:46) Outro/plugs For more information, please see the links below. Thank you for listening! Links: Please consider supporting us on Patreon: https://www.lowcarbmd.com/ Resources Mentioned in this Episode: Dr. Erin Bellamy on the Life's Best Medicine Podcast: https://lifesbestmedicine.com/podcast/episode-248-dr-erin-bellamy/ Dr. Erin Bellamy: Instagram: https://www.instagram.com/erinlouisebellamy/ X: https://x.com/erinlbellamy Integrative Ketogenic Research & Therapies: https://www.ikrt.org Dr. Brian Lenzkes:  Website: https://arizonametabolichealth.com/ Twitter: https://twitter.com/BrianLenzkes?ref_src=twsrc^google|twcamp^serp|twgr^author Dr. Tro Kalayjian:  Website: https://www.doctortro.com/ Twitter: https://twitter.com/DoctorTro Instagram: https://www.instagram.com/doctortro/ Toward Health App Join a growing community of individuals who are improving their metabolic health; together.  Get started at your own pace with a self-guided curriculum developed by Dr. Tro and his care team, community chat, weekly meetings, courses, challenges, message boards and more.  Apple: https://apps.apple.com/us/app/doctor-tro/id1588693888  Google: https://play.google.com/store/apps/details?id=uk.co.disciplemedia.doctortro&hl=en_US&gl=US Learn more: https://doctortro.com/community/ 

Credits: 0.25 AMA PRA Category 1 Credit™   CME/CE Information and Claim Credit: https://www.pri-med.com/online-education/podcast/frankly-speaking-cme-436 Overview: Many patients with chronic obstructive pulmonary disease (COPD) are improperly treated with inhaled corticosteroids (ICS), increasing their risk of harm. This episode explores the latest evidence on long-term ICS risks and provides practical guidance to help you align COPD care with current guidelines—improving outcomes while minimizing adverse effects like pneumonia, cataracts, type 2 diabetes mellitus, and osteoporosis. Episode resource links: Pace WD, Callen E, Gaona-Villarreal G, Shaikh A, Yawn BP. Adverse outcomes associated with inhaled corticosteroid use in individuals with chronic obstructive pulmonary disease. Ann Fam Med. 2025;23(2):127-135. doi:10.1370/afm.240030 Pocket Guide to COPD Diagnosis, Management, and Prevention: A Guide for Healthcare Professionals. 2025 Edition. Global Initiative for Chronic Obstructive Lung Disease. https://goldcopd.org/2025-gold-report/ Guest: Jillian Joseph, PA-C   Music Credit: Matthew Bugos Thoughts? Suggestions? Email us at FranklySpeaking@pri-med.com   

Credits: 0.25 AMA PRA Category 1 Credit™   CME/CE Information and Claim Credit: https://www.pri-med.com/online-education/podcast/frankly-speaking-cme-436 Overview: Many patients with chronic obstructive pulmonary disease (COPD) are improperly treated with inhaled corticosteroids (ICS), increasing their risk of harm. This episode explores the latest evidence on long-term ICS risks and provides practical guidance to help you align COPD care with current guidelines—improving outcomes while minimizing adverse effects like pneumonia, cataracts, type 2 diabetes mellitus, and osteoporosis. Episode resource links: Pace WD, Callen E, Gaona-Villarreal G, Shaikh A, Yawn BP. Adverse outcomes associated with inhaled corticosteroid use in individuals with chronic obstructive pulmonary disease. Ann Fam Med. 2025;23(2):127-135. doi:10.1370/afm.240030 Pocket Guide to COPD Diagnosis, Management, and Prevention: A Guide for Healthcare Professionals. 2025 Edition. Global Initiative for Chronic Obstructive Lung Disease. https://goldcopd.org/2025-gold-report/ Guest: Jillian Joseph, PA-C   Music Credit: Matthew Bugos Thoughts? Suggestions? Email us at FranklySpeaking@pri-med.com   

In this episode of the Global Medical Device Podcast, Etienne Nichols and regulatory expert Mike Drues take a critical look at the FDA's Manufacturer and User Facility Device Experience (MAUDE) database. While intended to serve as a vital tool for post-market surveillance, the MAUDE database is fraught with issues—from late reporting and missing data to unclear mission alignment. Mike challenges MedTech professionals to rethink how we engage with the system, exposing how widespread underreporting and data hygiene problems not only weaken safety efforts but also increase legal risk. This eye-opening discussion reveals where the breakdowns are occurring, who's responsible, and what industry and regulators can do to fix it.Key Timestamps[02:30] What is the MAUDE database, and why does it matter?[06:10] The critical difference between reportable and non-reportable adverse events[11:20] Limitations of MAUDE: Why FDA warns against using it for rate comparisons[17:45] Underreporting, late submissions, and missing data: The disturbing stats[25:00] High-profile companies dominating late reporting violations[32:10] Legal consequences: What expert witnesses look for in MAUDE data[38:50] Is it poor systems or lack of regulatory understanding causing failures?[46:00] Recommendations for manufacturers: What responsible reporting looks like[53:20] How FDA could modernize the MAUDE database to better serve patients[1:01:30] Carrots or sticks: Creating incentives vs. penalties for compliance[1:09:00] Final thoughts: The true mission of MAUDE and how to fulfill itStandout Quotes"A report in the MAUDE database is just a historical record. It doesn't say why it happened or who's at fault—just that it happened."— Mike DruesThis quote underscores the limited utility of MAUDE reports and why interpretation requires caution."If you're not a medical device professional without your tools, then you're not really a medical device professional."— Etienne NicholsA poignant reminder that compliance and quality are human-led, not software-enabled by default.Top TakeawaysLate Reporting is Widespread and RiskyNearly 30% of MAUDE reports are filed late, with 10% submitted more than six months past due. This creates legal exposure and potential patient harm.MAUDE Is Misused—Despite FDA WarningsManufacturers commonly use MAUDE for competitive analysis or trend detection, even though the FDA explicitly warns against it.Three Companies Account for Over Half of Late ReportsLarge, well-resourced companies like Medtronic and Becton Dickinson are responsible for a disproportionate share of noncompliance.Electronic Tools Help, but Culture Matters MoreSoftware can support MDR timelines, but organizations still need internal processes and urgency to act responsibly.FDA and Industry Both Need to EvolveSuggestions include AI-driven cross-referencing, tiered reporting urgency, and incentive-based compliance recognition.ReferencesFDA MAUDE Database21 CFR 803.16 – MDR Reporting RequirementsEtienne Nichols on LinkedInMedTech 101: What Is MAUDE and Why Should You Care?Think of the MAUDE database as a public logbook of adverse events involving medical

Since Mircea has just gotten to Aspen for the summer, we thought it would be a great time to talk about adjusting to adverse playing conditions in pickleball. Today we talk altitude, wind, indoor, sun, cold, and hot, and how to adjust to them! Learn more about your ad choices. Visit megaphone.fm/adchoices

Dustin, Tony, and Kyle are on to talk about 10/22's, 777 grain 45-70 rounds, Akdas Alcor conversion kits, AR10's, bush plinking, and How to Stay Motivated as Gun Owners in the Current Adverse Climate. The post Episode 608 – How to Stay Motivated as Gun Owners in the Current Adverse Climate appeared first on Slam Fire Radio.

The Legal Team discusses some of the nuances around disclosing material adverse facts.

reference: Sri Aurobindo and the Mother, Looking from Within, Chapter 4, Ordeals and Difficulties, pp.90-91This episode is also available as a blog post at https://sriaurobindostudies.wordpress.com/2025/05/26/overcoming-the-obstruction-of-universal-adverse-forces/Video presentations, interviews and podcast episodes are allavailable on the YouTube Channel https://www.youtube.com/@santoshkrinsky871More information about Sri Aurobindo can be found at www.aurobindo.net  The US editions and links to e-book editions of SriAurobindo's writings can be found at Lotus Press www.lotuspress.com

Irbesartan is an angiotensin II receptor blocker (ARB) used primarily for the management of hypertension and diabetic nephropathy in type 2 diabetes. It selectively inhibits the binding of angiotensin II to the AT1 receptor found in vascular smooth muscle and the adrenal gland. This blockade results in vasodilation, reduced aldosterone secretion, decreased sodium and water retention, and ultimately lower blood pressure. Irbesartan is administered orally, with a typical starting dose of 150 mg once daily, which may be increased to 300 mg depending on the patient's clinical response and tolerability. Adverse effects of irbesartan are generally mild but can include hyperkalemia and dizziness. Hypotension may occur, especially in volume-depleted individuals or those on diuretics. Routine monitoring of renal function and serum potassium is recommended, especially in patients with underlying kidney disease or those taking potassium-sparing agents or supplements. Irbesartan is contraindicated in pregnancy due to the risk of fetal toxicity and should be discontinued as soon as pregnancy is detected.

What are Adverse Religious Experiences (AREs) and spiritual abuse? Aren't they the same thing as religious trauma? Join Andrew and Laura on this week's episode to discuss AREs, spiritual abuse, dynamics of power and control, how this relates to fundamentalism and how all of this…isn't religious trauma? You heard us correctly!  Andrew and Laura discuss all of this AND how these things can result in religious trauma on this episode of Sunday School Dropouts!This podcast is brought to you by the Center for Trauma Resolution and Recovery: an online trauma coaching company whose practitioners are trauma informed and trauma trained to work with individuals, couples and families who have experienced high control religion, cults, and religious trauma. For more information on the support that CTRR provides, for resources–including courses, workshops, and more–head to traumaresolutionandrecovery.com or follow us on Instagram: @traumaresolutionandrecovery The views and opinions expressed by Sunday School Dropouts are those of the hosts and not necessarily reflect the official policy or position of the Center for Trauma Resolution and Recovery. Any of the content provided by our guests, sponsors, authors, or bloggers are their own ideas and opinions.The Sunday School Dropouts podcast is not anti-religion but it is anti -harm, -power and control, -oppression and, -abuse and will speak to the harmful practices and messaging of fundamentalist groups. Follow Andrew on Instagram and TikTok @deconstruct_everything Follow Laura on Instagram and TikTok @drlauraeanderson or on her website: www.drlauraeanderson.com Hosts: Laura Anderson and Andrew KerbsMusic by Benjamin Faye Music @heytherebenji Editing and Production by Kevin Crowe

Today's guest is Marie Flanagan, Director of Product Management in Digital Projects and Solutions at IQVIA, who joins us to explore the overlooked intersection of AI and safety workflows in life sciences. As the industry experiences an explosion in the volume and diversity of data—from social media and call centers to audio and video files—Marie outlines the mounting challenges for pharmacovigilance and the opportunities AI is unlocking for healthcare and life sciences leaders. Marie discusses how advancements in voice-to-text transcription and automation are helping safety teams manage massive datasets, pinpoint potential risks, and reallocate human resources toward high-value activities like signaling and benefit-risk management. She also shares insights into where human expertise remains essential, particularly in interpreting complex clinical contexts that AI alone cannot fully capture. Want to share your AI adoption story with executive peers? Click emerj.com/expert2 for more information and to be a potential future guest on Emerj's flagship ‘AI in Business' podcast!

Marco Sammon joins Ben and Dan to unpack his latest paper, ‘Index Rebalancing and Stock Market Composition', beginning with how Marco's work (co-written by John Shim) compares to the Nobel Prize-winner Bill Sharpe's paper, ‘Arithmetic of Active Management.' We investigate the missing links in Sharpe's logic before defining “the market” and ascertaining the main objectives of index funds. Then, we dive deeper into the mechanics of Marco's paper, index and market tracking errors, why delayed rebalancing is more beneficial than instant rebalancing, and the role of technology in the modern tracking error obsession. We also assess the passive-active spectrum of index funds in portfolio management and learn how investors should choose their optimal excess return. To end, Marco shares practical applications for improving performance benchmarked against traditional indexes, and The Aftershow is all about bridging the gap between PWL Capital and you, our listeners. Key Points From This Episode:   (0:00:00) Key takeaways from Marco Sammon's latest paper and how it compares to Bill Sharpe's ‘Arithmetic of Active Management.' (0:08:10) Marco describes what's missing from the ‘Arithmetic of Active Management' logic. (0:09:11) Defining ‘the market', the main objective of an index fund, and how index funds track the market. (0:15:57) The mechanics of Marco's paper, ‘Index Rebalancing and Stock Market Composition.' (0:18:38) Factor exposure, index and market tracking errors, and how often index funds trade. (0:26:28) Rebalancing less frequently; why delayed does better than instant rebalancing. (0:31:59) The tech run-up and lazy rebalancing, and the modern tracking error obsession.  (0:36:51) Assessing the passive-active spectrum of index funds in portfolio management. (0:41:02) Exploring how investors should decide on their optimal excess return.  (0:45:14) How the rising index fund ownership of stocks impacts the implicit cost of indexing (0:46:58) Practical ways to improve performance benchmarked against traditional indexes. (0:52:30) The Aftershow: Canadian finances, more airtime for Cameron, and PWL – OneDigital.    Links From Today's Episode: Meet with PWL Capital — https://calendly.com/d/3vm-t2j-h3p Rational Reminder on iTunes — https://itunes.apple.com/ca/podcast/the-rational-reminder-podcast/id1426530582. Rational Reminder Website — https://rationalreminder.ca/  Rational Reminder on Instagram — https://www.instagram.com/rationalreminder/ Rational Reminder on X — https://x.com/RationalRemindRational Reminder on TikTok — www.tiktok.com/@rationalreminder Rational Reminder on YouTube — https://www.youtube.com/channel/ Rational Reminder Email — info@rationalreminder.caBenjamin Felix — https://pwlcapital.com/our-team/ Benjamin on X — https://x.com/benjaminwfelix Benjamin on LinkedIn — https://www.linkedin.com/in/benjaminwfelix/ Dan Bortolotti on LinkedIn — https://www.linkedin.com/in/dan-bortolotti-8a482310/ Episode 322: Prof. Marco Sammon: How are Passive Investors Affecting the Stock Market? — https://rationalreminder.ca/podcast/322 Episode 200: Prof. Eugene Fama — https://rationalreminder.ca/podcast/200  Episode 268: Itzhak Ben-David: ETFs, Investor Behavior, and Hedge Fund Fees — https://rationalreminder.ca/podcast/268  Episode 112: Michael Kitces: Retirement Research and the Business of Financial Advice — https://rationalreminder.ca/podcast/112  Marco Sammon — https://marcosammon.com/  Marco Sammon on LinkedIn — https://www.linkedin.com/in/marco-sammon-b3b81456/  Marco Sammon on X — https://x.com/mcsammon19  Marco Sammon | Harvard Business School — https://www.hbs.edu/faculty/Pages/profile.aspx?facId=1326895  Marco Sammon Email — mcsammon@gmail.com  John Shim on LinkedIn — https://www.linkedin.com/in/john-shim-2931271b/  Vanguard — https://global.vanguard.com/  Sheridan Titman on LinkedIn — https://www.linkedin.com/in/sheridan-titman-226b0811/  Alex Chinko — https://alexchinco.com/  Erik Stafford | Harvard Business School — https://www.hbs.edu/faculty/Pages/profile.aspx?facId=6625  Itzhak (Zahi) Ben-David on LinkedIn — https://www.linkedin.com/in/ibendavi/  Bill Ackman on X — https://x.com/billackman   ‘Millennium Loses $900 Million on Strategy Roiled by Market Chaos' — https://www.bloomberg.com/news/articles/2025-03-08/millennium-loses-900-million-on-strategy-roiled-by-market-chaos   Bogleheads — https://www.bogleheads.org/   The Money Scope Podcast Episode 8: Canadian Investment Accounts — https://moneyscope.ca/2024/03/01/episode-8-canadian-investment-accounts/  The Wealthy Barber Podcast — https://thewealthybarber.com/podcast/   Financial Advisor Success Podcast — https://www.kitces.com/blog/category/21-financial-advisor-success-podcast/  Financial Advisor Success Podcast Episode 433: When You 10X Your Advisory Firm To Over $20M Of Revenue…And Want To 10X Again, With Cameron Passmore — https://www.kitces.com/blog/cameron-passmore-pwl-capital-10x-revenue-growth-advisory-firm/   OneDigital — https://www.onedigital.com/  The Longview Podcast: Ben Felix   Papers From Today's Episode:    ‘The Arithmetic of Active Management' — https://www.jstor.org/stable/4479386    ‘Index Rebalancing and Stock Market Composition: Do Index Funds Incur Adverse Selection Costs?' — https://papers.ssrn.com/sol3/papers.cfm?abstract_id=5080459     ‘Luck versus Skill in the Cross-Section of Mutual Fund Returns' — https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1356021    ‘The Passive-Ownership Share Is Double What You Think It Is' — https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4188052    ‘Long-Term Returns on the Original S&P 500 Companies' — https://www.researchgate.net/publication/247884354_Long-Term_Returns_on_the_Original_SP_500_Companies     ‘The Price of Immediacy' — https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1001762   ‘Competition for Attention in the ETF Space' — https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3765063    ‘Passive in Name Only: Delegated Management and “Index” Investing' — https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3244991      Jeremy Stein — “Unanchored” Strategy

Watch every episode ad-free & uncensored on Patreon: https://patreon.com/dannyjones Rick Strassman is best known for pioneering DMT research in humans and proposing that DMT could be a biological gateway to mystical or alternate realities. Currently, Dr. Strassman serves as a Clinical Associate Professor of Psychiatry at the University of New Mexico School of Medicine. His new book, "My Altered States: A Doctor's Extraordinary Account of Trauma, Psychedelics, and Spiritual Growth," is available now. SPONSORS http://morning.ver.so/danny - Use code DANNY for 15% off your first order. https://hims.com/danny - Start your FREE online visit today. https://whiterabbitenergy.com/?ref=DJP - Use code DJP for 20% off EPISODE LINKS https://x.com/rick_strassman https://www.rickstrassman.com FOLLOW DANNY JONES https://www.instagram.com/dannyjones https://twitter.com/jonesdanny OUTLINE 00:00 - Adverse effects of DMT 06:54 - Is DMT the source of human consciousness? 10:25 - Extended state DMT experiments 20:19 - DMT reveals a universal religion 29:08 - Psychedelic religion of mystical consciousness 35:10 - What Danny saw during DMT experiment 37:54 - Terrifying experience on 5-MeO DMT 41:39 - Melatonin & the pineal gland 52:43 - When DMT stops working 57:38 - DMT & NDE's 01:02:45 - Telepathic experiences on psychedelics 01:12:53 - Prophets of the bible 01:18:34 - The first anti-christ 01:31:42 - Drugs in antiquity 01:37:24 - CIA-funded LSD clinics w/ Charles Manson 01:40:13 - Rick's friendship with Joe Rogan 01:45:42 - Did ergot & psychedelics create religion? 01:53:12 - Government research on psychedelic soldiers 02:03:01 - Amphetamines & adderall 02:14:00 - Next species of humans will have telepathy 02:19:39 - John Mack's alien research vs. psychedelics 02:26:53 - Remembering previous lives 02:29:20 - Translating the book of Genesis 02:34:06 - DARPA research on buddhism Learn more about your ad choices. Visit podcastchoices.com/adchoices