Podcasts about drug safety

If you have ever felt uneasy about a prescription but could not quite explain why, this episode is for you. Not because the goal is to scare you, but because you deserve to understand how the system actually works — from someone who worked inside it for years. Welcome I am a Registered Nurse and Christian holistic health coach, and before I ever coached women toward natural healing, I spent years inside the pharmaceutical industry working in drug safety and pharmacovigilance. I processed the reports. I saw the conflicts of interest. And eventually, I became the patient. This episode is for the Christian woman who has been dismissed, medicated, and sent home with a prescription and zero real answers. The woman who suspects there is a better way but does not know where to start. If that is you, keep listening. What the Drug Approval Process Actually Looks Like Most people assume that by the time a drug reaches your pharmacist, it has been tested on hundreds of thousands of people over decades. The reality is more sobering. Before a drug is approved, it goes through clinical trials. For your average drug, the median total number of participants across all clinical trials before FDA approval is 1,708 people. For orphan drugs — drugs created for rare diseases — that number drops to a median of 438 participants. That is the data your doctor's prescription is based on. The Conflict of Interest Nobody Talks About Here is what most people outside the industry do not know. When a patient has an adverse event during a clinical trial, a report gets sent to the drug safety department. A physician is then required to determine whether or not the drug caused that event. But that physician works for — or is contracted by — the pharmaceutical company. The chief medical officer, the person setting the tone for how reports are assessed, has a financial stake in the outcome. Even the most ethical physician in that position faces a fundamental conflict of interest. And in some cases, if the clinical trial investigator — the doctor actually watching the patient — determines the drug caused the adverse event, the pharmaceutical company's physician can override that assessment entirely. The Human Factor Inside the System The people who work in drug safety are largely detail-oriented, hardworking, and genuinely care about patient outcomes. That matters and it is worth saying. But the system itself has real limitations. High turnover rates mean institutional knowledge walks out the door constantly. Clinical trial teams spread across the globe sometimes do not understand their own reporting obligations. Physicians reviewing dozens of nearly identical reports daily are fighting boredom and burnout. And patients taking 10, 15, or even 30 medications at once make causality nearly impossible to determine with any real certainty. The science is not as clean as the packaging suggests. After FDA Approval — The Data Gets Even Thinner Once a drug is on the market, the primary way a pharmaceutical company learns about safety issues is through voluntary reports — from you or your doctor. Most patients have never heard of a pharmacovigilance department. Most healthcare professionals do not know they can or should be reporting adverse events directly to pharmaceutical companies. That means the post-market safety data is largely dependent on a system most people do not know exists. Vioxx is the example that opened this episode. FDA approved. Widely prescribed. Pulled from the market after data showed an increased risk of heart attacks and strokes. The clinical trials passed. The stamp of approval was given. And people were still harmed. What This Means for Your Health Decisions None of this means every pharmaceutical product is dangerous or that every person working in the industry has bad intentions. That is not the point. The point is discernment. The safety profile of the drug you may be taking rests heavily on the worldview of one chief medical officer at one pharmaceutical company, filtered through a reporting system most people have never heard of, built on a data set far smaller than most people realize. That is not a conspiracy. That is just how the system is structured. Why God Must Come First My friend had Crohn's disease for roughly 15 years. One day she was healed. Her doctor's response? It must be that you never had Crohn's disease in the first place. That response reveals everything about a worldview that cannot make room for healing outside of its own framework. God is not limited by what the data set allows. He is not constrained by what the chief medical officer approves. His wisdom is complete, and He designed your body with purpose and precision. I am not here to get you off your medications. I am not here to tell you pharmaceutical companies are entirely bad. My mission is simpler and more important than that — to encourage you to go to God first. To seek His wisdom before you outsource your health to a system that was never designed to heal you. As one of my dear friends shared with me for my book, Discover God's Health Wisdom: Science and knowledge are gifts from the Almighty One, yet they are not God. When we believe the deception that academia, research, and humanity's partial understanding is more powerful than the One who created it all, then it controls us and leaves us susceptible to more deception. Time-Stamped Highlights 0:01 — The Vioxx story: what it reveals about FDA approval and drug safety 1:00 — What pharmacovigilance is and why most people have never heard of it 3:51 — The good inside the system: the people who genuinely care 4:17 — The chaotic human factor and the God complex in conventional medicine 7:08 — The conflict of interest at the heart of drug safety assessments 9:29 — The clinical trial data sets: how many people a drug is actually tested on 11:22 — Post-market reporting and why the data gets thinner after approval 13:15 — Why comorbidities and polypharmacy make causality nearly impossible to assess 16:31 — How a physician's worldview shapes the safety conclusions of an entire drug program 17:56 — The invitation: go to God first for your health Key Takeaways Drug approvals are based on smaller data sets than most people assume — medians of 1,708 participants for standard drugs and 438 for orphan drugs across all clinical trials The physician determining whether a drug caused an adverse event often works directly for the pharmaceutical company — a structural conflict of interest Post-market safety data depends largely on voluntary reporting from patients and doctors, most of whom do not know the system exists The science is real and has genuine value — but it is incomplete, human, and subject to bias like every other human system Seeking God's wisdom first does not mean rejecting medicine; it means approaching your health with discernment rather than blind trust True lasting healing is possible — and God's design for your body is more complete than any clinical trial Ready to Stop Outsourcing Your Health? If this episode stirred something in you — if you have been wondering whether there is a better path forward for your energy, your autoimmune symptoms, or your overall health — I want to invite you to book a More Energy Strategy Session with me. This is a private, one-on-one conversation where we look at what is actually going on in your body and begin building a path forward rooted in God's design for your health. Not another prescription. Not another dead end. If you are ready to stop spinning your wheels and start moving forward with clarity and confidence, the link is herholistichealing.com/services.   Sources Duijnhoven RG, Straus SM, Raine JM, de Boer A, Hoes AW, De Bruin ML. "Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis." PLOS Medicine, March 19, 2013. Full study: https://pmc.ncbi.nlm.nih.gov/articles/PMC3601954/   This content is for informational purposes only and is not meant to be medical advice.

Most people assume that if a drug sits on the shelf at Costco or Walgreens, it must be pretty safe. But what if some of the most common over-the-counter (OTC) medications are among the riskiest drugs in America? On this vintage episode of Vitality Radio, Jared exposes the hidden dangers behind everyday pain relievers, sleep aids, and heartburn drugs—medicines that cause thousands of deaths every year when misused or taken long-term. You'll learn how a drug becomes “OTC,” what happens when pharmaceutical companies push for that switch, and why the FDA's approval process might not tell the whole story. Jared dives into the startling realities of PPIs like Prilosec, NSAIDs like ibuprofen, and acetaminophen (Tylenol)—uncovering their risks to the liver, kidneys, bones, and brain. He also discusses how marketing convinces consumers these drugs are harmless. Finally, Jared offers a resource for safe, natural alternatives for reflux, pain, inflammation, sleep, and immune support—options that nourish the body instead of depleting it. This episode will change the way you look at “harmless” OTC drugs and help you take real control of your health.Additional Information:#341: Your Digestive Health Supplement User's Guide. From IBS to Acid Reflux - Learn How to Balance Your Gut Health With Natural Products. #522: Q&A Show #5 - Jared Answers Your Questions About Energy and Sleep!#471: Boosting Your Immune System Ahead of Winter #553: Boswellia & Curcumin: Nature's Dream Team for Pain & Inflammation with Dr. Lexi LochVisit the podcast website here: VitalityRadio.comYou can follow @vitalitynutritionbountiful and @vitalityradio on Instagram, or Vitality Radio and Vitality Nutrition on Facebook. Join us also in the Vitality Radio Podcast Listener Community on Facebook. Shop the products that Jared mentions at vitalitynutrition.com. Let us know your thoughts about this episode using the hashtag #vitalityradio and please rate and review us on Apple Podcasts. Thank you!Just a reminder that this podcast is for educational purposes only. The FDA has not evaluated the podcast. The information is not intended to diagnose, treat, cure, or prevent any disease. The advice given is not intended to replace the advice of your medical professional.

Marketing Prioritizes Inferior Drugs; Underreporting of Harm in Trials; Key Differences in Independent Trials; Why Pharma Avoids Lifestyle Comparisons; Final Recommendations for System Reform; Empowering Individuals Through Lifestyle and Skepticism; Resources and Ways to Stay Informed #PharmaTruth #EvidenceBased #MedicalEthics #HealthTalks

We are more stressed, depressed, and mentally unhealthy than ever. Are prescription drugs the solution? Today we sit down with Dr. Josef Witt-Doerring who lifts the veil on the reality of the FDA approval process and explains how and why holistic healing is far more effective for most people. We also discuss:◼️ The terrifying long-term effects of antidepressants◼️ Lila's childhood diagnosis◼️ The myths around "chemical-imbalance"◼️ Why Dr Josef disagrees with Dr Andrew Huberman◼️ How modern cannabis (weed) is far more destructive than people like to think ◼️ How gluten might be causing you depressionFollow Dr Josef:YouTube: https://youtube.com/@taperclinic His Website: https://taperclinic.com/NEW: Check out our Merch store! https://shop.lilaroseshow.com/Join our new Patreon community! https://patreon.com/lilaroseshow - We'll have BTS footage, ad-free episodes, and early access to our upcoming guests.A big thanks to our partner, EWTN, the world's leading Catholic network! Discover news, entertainment and more at https://www.ewtn.com/ Check out our Sponsors:-EveryLife Women: https://www.everylife.com/lila Buy diapers and women's health products from an amazing company and use code LILA10 to get 10% off!-Hallow: https://www.hallow.com/lila Enter into prayer more deeply this season with the Hallow App, get 3 months free by using this link to sign up! -Patriot Mobile: Get 1 month of free service at https://patriotmobile.com/lila or call 972-PATRIOT w/ code LILA-Good Ranchers: •https://www.goodranchers.com/discount/LILA Purchase your American Meat Delivered subscription today and get a free add-on of beef, chicken, or salmon! Use code LILA for $40 off!00:00:00 - Intro00:01:02 - Realizing prescriptions were hurting people00:03:24 - The secret about how psychiatric drugs are approved:00:04:45 - How are clinical studies done?00:07:34 - How do these drugs work?00:11:33 - When the cure is the problem00:14:31 - When Dr Josef started questioning the system:00:21:35 - Lila's childhood diagnosis00:25:25 - Gluten might be your problem!00:28:21 - Please be aware of THIS:00:29:02 - How to understand pharmaceuticals and SSRIs00:31:19 - The WHY Behind Mental Unhealth00:37:37 - Do prescriptions work?00:40:51 - How to live a happier life?00:42:56 - How to go from STABLE to THRIVING?00:43:53 - Why doesn't the ‘quick fix' work?00:44:57 - Has the modern world gotten more stressful?00:47:34 - How to get off drugs00:50:03 - Cannabis, bipolar, and schizophrenia00:57:08 - Whole generations are being hurt00:59:46 - Brett Cooper's brother01:05:40 - How to get better and healthier?01:09:28 - What about financial difficulties?01:12:14 - What are essential foods?01:15:25 - How does light affect our sleeping? 01:18:58 - Is depression about lack of meaning?01:23:07 - Dr Josef interviews Lila:01:25:58 - Biggest pushback Dr Josef gets01:28:00 - Advice for the next generation

Send a text message to the show!For all its ease and speed, disproportionality analysis can be distorted by many biases, making it easy to misuse and misinterpret. Michele Fusaroli from Uppsala Monitoring Centre and Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb explain why we shouldn't abuse this powerful but fragile tool.Tune in to find out:Why we should never treat disproportionality signals as verdictsHow poorly performed analyses affect scientists, regulators and patientsHow to avoid the most common sources of bias Want to know more?Michele and Eugene's paper in Drug Safety is a concrete guide to charting and sidestepping the pitfalls of disproportionality analysis.In another Drug Safety paper, Michele and colleagues show how directed acyclic graphs (DAGs) can help map and address biases in disproportionality analysis.Michele also reviewed the method's limitations in Uppsala Reports, where he argues that ‘pharmacovigilance must move past crude disproportionality'.Last year, Retraction Watch covered the spike in pharmacovigilance studies in the literature and why some journals decided to ban drug safety database papers.Previously on Drug Safety Matters, Michele and Daniele Sartori discussed the READUS-PV guidelines for reporting disproportionality analyses.In 2016, the IMI PROTECT project published recommendations to improve signal detection practices, especially for quantitative methods like disproportionality analysis.UMC's guidebook on signal detection in small datasets offers step-by-step advice for qualitative methods and manual case review.Got a story to share?We're always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!About UMCUppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

On the Evolving Wellness Podcast, host Sarah interviews board-certified psychiatrist Dr. Josef Dering, who previously worked in the pharmaceutical industry and as an FDA medical officer in psychiatry drug safety. He explains why he now believes psychiatric medications don't work for most conditions and describes how time-pressured, checklist-based care and “chemical imbalance” narratives lead to escalating drug cocktails without addressing root causes. He warns that benzodiazepines may help short term but can worsen anxiety over time, cause interdose withdrawal, degrade sleep architecture, and impair concentration, making them a “Faustian bargain,” and stresses slow, supervised tapering due to difficult withdrawal. Dering outlines non-drug approaches targeting body, mind, and “soul” (health behaviors, skills-based therapies, relationships, and meaning). He also argues high-potency THC cannabis increases psychosis risk and may lead to long recoveries and misdiagnosis.Connect withj Dr Josef - https://www.youtube.com/@taperclinichttps://www.instagram.com/drjosefwittdoerring/ _________Sponsored By:→ Bon Charge | Go to https://boncharge.com/products/demi-red-light-device?rfsn=8108115.26608d & use code SARAHKLEINER for 15% off storewide.→ VivaRays | This episode is sponsored by VivaRays - VivaRays Blue - code YOGI https://vivarays.com/ → Organifi | For an exclusive offer, go to https://www.organifi.com/SARAHK for 20% off your order._________Timestamp:00:00 Benzos Quick Relief00:55 Episode Setup Disclaimer02:29 Podcast Intro Housekeeping03:42 Meet Dr Dering04:30 Why He Questions Meds07:19 FDA Safety Reality Check08:44 Host Story Benzos12:16 Sponsor Red Light14:29 Benzos Faustian Bargain15:48 Body Mind Soul Framework21:42 Sponsor Blue Blockers23:09 Motivation Rock Bottom26:30 Medical Trust Broken29:12 Suicidality on Med Cocktails31:23 Withdrawal Trap and Tapering34:20 PR Narrative Around Antidepressants36:22 Meds and Mass Violence Debate39:27 Gender Ideology in Schools42:57 Cannabis Mental Health Risks44:26 THC Potency and Psychosis Data48:54 Paranoia as Warning Sign51:34 Safe Tapering and Final Advice——— This video is not medical advice & as a supporter to you and your health journey - I encourage you to monitor your labs and work with a professional!________________________________________Get all my free guides and product recommendations to get started on your journey!https://www.sarahkleinerwellness.com/all-free-resourcesCheck out all my courses to understand how to improve your mitochondrial health & experience long lasting health! (Use code PODCAST to save 10%) -  https://www.sarahkleinerwellness.com/coursesMy free product guide with all product recommendations and discount codes:https://www.canva.com/design/DAF7mlgZpJI/xVyE4tiQFEWJmh_Xwx8Kbw/view?utm_content=DAF7mlgZpJIFree Webinar on Light & Health (includes free light bulb guide) - https://www.sarahkleinerwellness.com/mycircadianapp-free-webinarGet Early Access to Podcast Episodes & my Seasonal Food Course + UVB+Red Light Therapy course for free -  https://open.substack.com/pub/sarahkleinerwellness/p/uvbred-light-protocol?r=5eztl9&utm_campaign=post&utm_medium=web&showWelcomeOnShare=true

Officers from a UK medicine regulator raided two sites in February during an ongoing investigation into a criminal network that manufactures and distributes unlicensed weight-loss medicines, also known as “skinny jabs.”The Medicines and Healthcare products Regulatory Agency (MHRA) stated that the operation, which targeted farm and residential properties in Lincolnshire and Nottinghamshire, resulted in the seizure of nearly 2,000 doses of unauthorized weight-loss medicines, including retatrutide, tirzepatide and peptide products. The agency added that officers also confiscated manufacturing equipment, suspected pharmaceutical ingredients, packaging and commercial vehicles. #MHRA #WeightLossDrugs #SkinnyJabs #IllegalMedicines #DrugSafety #PublicHealth #Tirzepatide #Retatrutide #GLP1 #PharmaceuticalCrime #HealthcareNews #MedicalRegulation #CounterfeitDrugs #FDA #UKNews #DrugEnforcement #HealthRisks #RegulatoryAction #LawEnforcement #MedicineSafety

Send a text message to the show!Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk. In this two-part episode, Omar Aimer, President of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe.Tune in to find out:How reporting for medical devices differs from medicines and vaccinesHow AI may be used for predictive safety monitoringWhy regulatory and data harmonisation remains the key to improving medical device safetyWant to know more?Listen to the first part of the interview here.If you would like to learn more about the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports.Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their Nature paper.Founded in 2018, ISoP's Medical Device Safety Special Interest Group works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.Got a story to share?We're always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!About UMCUppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Here is a podcast episode description for your episode, "The Children of Thalidomide: A Medical Tragedy," tailored for your History Ignited podcast:Episode Description:"Children of thalidomide." It's one of the most sobering lines in Billy Joel's history-spanning anthem, We Didn't Start the Fire. But what is the story behind this medical catastrophe that shook the world in the late 1950s and early 1960s?In this episode of History Ignited, we dive into the dark history of Thalidomide—a drug once marketed as a "wonder cure" for morning sickness that led to thousands of children being born with severe limb deformities and other health complications.We explore:The Global Crisis: How the drug was developed in West Germany and distributed to over 40 countries.The FDA Hero: The story of Dr. Frances Kelsey, the medical officer who stood her ground against pharmaceutical pressure to keep Thalidomide out of the United States.The Aftermath: The lasting impact on the survivors, known as "Thalidomide Babies," and how the tragedy revolutionized drug safety regulations and the way we test medicine today.Join us as we break down the history behind the lyrics and honor the resilience of those affected by this avoidable tragedy.Thanks for tuning in to History Ignited!

Alan Cassels reveals how pharma creates disease markets and spins stats to make marginal drugs look life-saving. #PharmaMarketing #DrugOveruse #HealthPolicy #HealthTalks

Three facts are scientifically undisputed: Serotonin is essential for fetal brain development. SSRIs disrupt the serotonin system. SSRIs freely cross the placenta. So why are pregnant women being told these drugs carry "little or no risk"?In this rare head-to-head debate, Dr. Adam Urato—maternal-fetal medicine specialist and FDA expert panelist—faces off against Dr. Robert Chen, a psychiatry resident willing to do what most of his colleagues won't: step into the arena and defend the establishment position.What unfolds is a striking conversation where both physicians actually agree on more than you'd expect—including that informed consent is failing pregnant women, that the chemical imbalance theory is dead, and that "untreated depression" is a misleading frame designed to sell drugs. The uncomfortable question neither side can fully answer: If SSRIs are correcting depression, why does the research show worse outcomes for women who stay on them?This isn't anti-medication propaganda. It's the conversation your doctor isn't trained to have with you.Listen before you fill that prescription. Visit Center for Integrated Behavioral HealthDr. Roger McFillin / Radically Genuine WebsiteYouTube @RadicallyGenuineDr. Roger McFillin (@DrMcFillin) / XSubstack | Radically Genuine | Dr. Roger McFillinInstagram @radicallygenuineContact Radically GenuineConscious Clinician CollectivePLEASE SUPPORT OUR PARTNERS15% Off Pure Spectrum CBD (Code: RadicallyGenuine)10% off Lovetuner click here

Alan Cassels and Pam Popper define disease mongering, critique cholesterol myths, and explain how medical systems expand diagnoses to sell more treatment. #DiseaseMongering #InformedConsent #MedicalOverreach #HealthTalks

Send a text message to the show!Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can leave patients vulnerable.  In this two-part episode, Omar Aimer, president of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe. Tune in to find out:What defines a medical device and how prevalent they are in our societyWhy device safety monitoring is different from medicines and vaccines, and where current surveillance still falls shortHow global initiatives aim to strengthen safety monitoring standardsWant to know more? If you would like to learn more on the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports.Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their Nature paper.Founded in 2018, ISoP's Medical Device Safety Special Interest Group works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”. Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

Artificial Intelligence (AI) is no longer a futuristic concept in life sciences—it's here, transforming drug safety and pharmacovigilance at an unprecedented pace. But as the industry embraces automation and advanced analytics, one truth stands firm: innovation without governance is a risk no one can afford.In this episode of The Top Line, we explore how AI is reshaping drug safety while governance sets the guardrails for ethical, compliant, and sustainable adoption. Our featured guest, Marie Flanagan, Regulatory and AI Governance Lead at IQVIA Safety Technologies, dives deep into why governance isn't just a checkbox—it's the backbone of responsible AI deployment in healthcare.Key Themes You'll Discover:The Dual Imperative: Innovation and OversightAI promises speed, accuracy, and scalability in pharmacovigilance, from case intake to signal detection. Yet, without robust governance frameworks, these benefits can quickly turn into liabilities. Learn why embedding governance into AI design from day one is critical—and why retrofitting controls later is a recipe for risk.Shared Responsibility Across StakeholdersGovernance isn't the job of one team. Flanagan explains how compliance, technology, business units, and regulators must collaborate to ensure AI systems are ethically designed, technically validated, and transparent. Discover how this multi-layered approach builds trust and resilience in a rapidly evolving regulatory landscape.Principles That Matter: Human Oversight, Fairness, AccountabilityFrom mitigating bias to ensuring explainability, guiding principles are more than buzzwords—they're operational necessities. We unpack how these principles translate into practical steps, including continuous monitoring, feedback loops, and adaptive controls that evolve with technology.Compliance as an Enabler, Not a BarrierTraditionally seen as a brake on innovation, compliance teams can become catalysts for safe progress. Hear how organizations are reframing compliance roles to support innovation while safeguarding patient safety and regulatory integrity.Global Regulatory ContextWith frameworks like the EU AI Act and U.S. federal memoranda shaping expectations, companies must navigate a complex web of international standards. Flanagan shares insights on harmonizing governance strategies across jurisdictions without slowing down innovation.Practical Playbook for Life SciencesFrom zero-touch case processing to agentic AI in signal workflows, we spotlight real-world use cases that demonstrate how governance and technology can coexist—and thrive. Learn how IQVIA's Vigilance Platform integrates governance into every layer of AI-driven pharmacovigilance.Why This Matters NowAI adoption in pharma is accelerating, with 85% of top companies prioritizing AI as a strategic imperative. But speed without structure can lead to compliance gaps, reputational damage, and patient risk. This episode equips you with the insights to innovate responsibly, ensuring your AI journey is both ambitious and anchored in governance.Tune in for actionable strategies, expert perspectives, and a candid conversation on the future of drug safety in the AI era. Whether you're a regulatory leader, technology strategist, or business decision-maker, this episode will help you balance the promise of AI with the principles that protect patients and preserve trust.

Skin Deep: How Melanin Impacts Your Body's Response To DrugsScientific research is becoming more inclusive, but one area that's still lacking this diversity is pre-clinical research. Without knowing how medications will react to different ancestries and skin tones, millions of people are being put at risk. Our experts discuss the effect melanin has on a drug's efficacy and changes the industry can implement right now that will make a big difference.  Does Birth Control Cause PCOS? Facts And Misconceptions Of The Disorder  Polycystic ovarian syndrome affects at least one in ten women – probably more since it's so underdiagnosed. Sadly, many women are told that having PCOS means they'll never become pregnant. However, our expert this week dispels this and other misinformation that's widespread about PCOS.  Medical Notes: Robots Are Outperforming Doctors, The Dangerous Additives In Ultra-Processed Foods, And How Happiness Supports Your Brain HealthHow scientists could catch Schizophrenia sooner than ever before. Ultra-processed foods may be raising your blood sugar levels. How happiness supports your brain health. Are robots better doctors? Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

Skin Deep: How Melanin Impacts Your Body's Response To DrugsScientific research is becoming more inclusive, but one area that's still lacking this diversity is pre-clinical research. Without knowing how medications will react to different ancestries and skin tones, millions of people are being put at risk. Our experts discuss the effect melanin has on a drug's efficacy and changes the industry can implement right now that will make a big difference.  Host: Elizabeth Westfield.  Producer: Kristen Farrah.  Guests: Sophie Zaaijer, Molecular Biologist, Consultant for Diversity, Equity, and Inclusion and Clinical Trials; Simon Groen, Assistant Professor of Evolutionary Systems Biology, University of California at Riverside Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

In this week's Talking Health, Jessica discusses health experts' warnings regarding taking cold and flu medicine or painkillers correctly.

Despite evidence that adverse drug events manifest with greater severity in pediatric populations than in adults, fewer than 50% of drugs have been systematically studied for pediatric use. The lack of robust drug safety data may result in suboptimal or harmful treatment strategies. Saurabh Rahurkar and Pallavi Jonnalagadda share their team's efforts to address this issue. This podcast and article specifically address the use of benzonatate in pediatric patients. Read the full text open access manuscript at: https://accpjournals.onlinelibrary.wiley.com/doi/10.1002/phar.70061.

Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities but also increased the stakes. How do we use them without losing trust and where do we set the limits?In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn't – go next.Tune in to find out:How to keep up with rapid developments in AI technologyWhy model and performance transparency both matterHow to protect sensitive patient data when using AIWant to know more?Listen to the first part of the interview here.In May 2025, the CIOMS Working Group XIV drafted guidelines for the use of AI in pharmacovigilance. The draft report received more than a thousand comments during public consultation and is now being finalised.Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare.Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article.Other recent UMC publications cited in the interview or relevant to the topic include:a pre-print on the revised vigiMatch algorithm for duplicate detectionan article on the pitfalls of disproportionality analysisa pre-print on critically appraising AI applications for rare-event recognitionFor more on the ‘black box' issue and maintaining trust in AI, revisit this interview with GSK's Michael Glaser from the Drug Safety Matters archive. Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

Most people assume that if a drug sits on the shelf at Costco or Walgreens, it must be pretty safe. But what if some of the most common over-the-counter (OTC) medications are among the riskiest drugs in America? On this episode of Vitality Radio, Jared exposes the hidden dangers behind everyday pain relievers, sleep aids, and heartburn drugs—medicines that cause thousands of deaths every year when misused or taken long-term. You'll learn how a drug becomes “OTC,” what happens when pharmaceutical companies push for that switch, and why the FDA's approval process might not tell the whole story. Jared dives into the startling realities of PPIs like Prilosec, NSAIDs like ibuprofen, and acetaminophen (Tylenol)—uncovering their risks to the liver, kidneys, bones, and brain. He also discusses how marketing convinces consumers these drugs are harmless. Finally, Jared offers a resource for safe, natural alternatives for reflux, pain, inflammation, sleep, and immune support—options that nourish the body instead of depleting it. This episode will change the way you look at “harmless” OTC drugs and help you take real control of your health.Just Ingredients Lemon Swish Protein Powder Vitality Radio POW! Product of the Week $29.99 per bag (regular price $59.99) with PROMO CODE: POW15Additional Information:#341: Your Digestive Health Supplement User's Guide. From IBS to Acid Reflux - Learn How to Balance Your Gut Health With Natural Products. #522: Q&A Show #5 - Jared Answers Your Questions About Energy and Sleep!#471: Boosting Your Immune System Ahead of Winter #553: Boswellia & Curcumin: Nature's Dream Team for Pain & Inflammation with Dr. Lexi LochVisit the podcast website here: VitalityRadio.comYou can follow @vitalitynutritionbountiful and @vitalityradio on Instagram, or Vitality Radio and Vitality Nutrition on Facebook. Join us also in the Vitality Radio Podcast Listener Community on Facebook. Shop the products that Jared mentions at vitalitynutrition.com. Let us know your thoughts about this episode using the hashtag #vitalityradio and please rate and review us on Apple Podcasts. Thank you!Just a reminder that this podcast is for educational purposes only. The FDA has not evaluated the podcast. The information is not intended to diagnose, treat, cure, or prevent any disease. The advice given is not intended to replace the advice of your medical professional.

Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities, but they have also increased the stakes. How do we use them without losing trust and where do we set the limits?In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn't – go next.Tune in to find out:Why pharmacovigilance needs specific AI guidelinesHow a risk-based approach to AI regulation worksWhere in the PV cycle is human oversight most neededWant to know more?In May 2025, the CIOMS Working Group XIV drafted guidelines for the use of AI in pharmacovigilance. The draft report received more than a thousand comments during public consultation and is now being finalised.Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare.Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article. His favourite definition of AI remains the one proposed by Jeffrey Aronson in Drug Safety.For more on maintaining trust in AI, revisit this interview with GSK's Michael Glaser from the Drug Safety Matters archive.The AI methods developed by UMC and cited in the interview include: vigiMatch for duplicate detectionvigiGroup for clusteringvigiRank for signal detectionvigiGrade for case report completeness scoringWHODrug Koda for automated coding Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

Artificial intelligence is reshaping drug safety, but governance is just as critical as innovation, according to Marie Flanagan of IQVIA Safety Technologies. Speaking on The Top Line podcast, Flanagan said responsibility for AI in healthcare must be shared across compliance, technology, business teams and regulators. Strong governance, she said, ensures AI systems are ethically designed, technically validated, transparent and adaptable to continuous oversight. Organizations can prepare by grounding their strategies in guiding principles such as human oversight, fairness and accountability, Flanagan said. She emphasized the need to embed governance in AI design from the start, rather than adding controls later. Compliance teams, she added, can shift from being seen as barriers to acting as enablers of safe innovation. From constant monitoring to feedback loops, the conversation highlights practical steps for managing AI in life sciences. Hear the full episode of The Top Line for a deeper look at how companies can balance innovation and responsibility.See omnystudio.com/listener for privacy information.

How is a decades-old scientific tool that revolutionized organ transplantation now being used in cancer immunotherapy and autoimmune disease?In this episode of Science with a Twist, host Terri Somers talks to experts in immunogenetics and histocompatibility about human leukocyte antigens, or HLAs, which are biomarkers on our cells that provide crucial information about our immune system. HLAs have been used for decades now to match the right donated organ or cells to a patient in need. As science has gained a deeper understanding of the immune system, the utility of HLAs has expanded significantly, helping to transform healthcare.Guests-at-a-Glance Name: Marcelo Fernandez Vina

In this episode, BioSpace's head of insights Lori Ellis discusses the evolving role of local qualified persons for pharmacovigilance with ⁠Ana Pedro Jesuíno⁠, global head local QPPV network at IQVIA.

Broadcast from KSQD on 9-04-2025: Dr. Dawn opens by criticizing new FDA restrictions on simultaneous COVID and flu vaccinations, calling out vaccine regulator Vinay Prasad for creating artificial shortages. She explains that while no formal studies test multiple vaccines together, decades of safe practice demonstrate effectiveness. The FDA's requirement for separate testing ignores practical evidence and threatens vaccine supply chains during critical flu season. She discusses Oregon research suggesting adults may not need tetanus boosters every 10 years, but warns this misses the pertussis component. Dr. Dawn explains that acellular pertussis vaccines only provide 4-year immunity, making adult boosters essential to prevent whooping cough transmission to vulnerable infants. The focus should remain on pertussis prevention rather than tetanus economics. California, Oregon, and Washington announced a West Coast Health Alliance to maintain scientific integrity in public health policy amid federal changes. Dr. Dawn supports this states' rights approach to vaccination recommendations based on trusted medical organizations, expressing concern about potential vaccine shortages if manufacturers reduce production due to uncertain federal demand. An emailer shares an AI-generated analysis comparing tuberculosis and Lyme disease. Dr. Dawn critiques the AI's inaccuracies, noting that while tuberculosis may be present in 25% of people globally s the AI reports (she did not fact check this), the distribution is very uneven and cases in the US are low which we know since accurate latent TB testing is readily available in the US. She warns against AI's tendency to incorporate conspiracy theories due to a bias which favors frequency vs accuracy and emphasizes the importance of fact-checking AI-generated medical content. Dr. Dawn addresses FDA concerns about unregulated GLP-1 drugs, warning about counterfeit semaglutide and tirzepatide from questionable sources. She discusses dosing errors, non-FDA-approved compounds appearing in gray markets, and the rare but serious cancer risk for people with multiple endocrine neoplasia syndromes - affecting 1 in 30,000 people who could develop hormone-producing cancers. A caller asks about genetic testing for GLP-1 cancer risk. Dr. Dawn explains that complete genome testing costs around $1,000 and requires professional interpretation. She discusses the economic challenges of testing 30,000 people to prevent one cancer case, while acknowledging that obesity's health risks generally outweigh the small cancer risk for most patients. She examines FDA challenges in approving MDMA for PTSD treatment, explaining the "Catch-22" of blinding studies when drugs cause obvious consciousness changes. Dr. Dawn describes how psychedelic research faces unique obstacles requiring 8-10 hour supervised sessions with therapists, making traditional double-blind studies nearly impossible to conduct properly. An emailer asks about B vitamin effects on brain and heart health. Dr. Dawn warns about high-dose biotin interfering with thyroid tests and troponin levels used to diagnose heart attacks. She explains how B12 deficiency affects 40% of people over 80, recommending methylmalonic acid testing for accurate assessment rather than standard blood levels. She discusses research showing coastal living extends life expectancy by over a year compared to inland areas, attributed to cleaner air and better recreational opportunities. However, living near inland waterways may slightly decrease lifespan due to flood risks and environmental factors, suggesting ocean proximity specifically provides health benefits.

Children deserve the safest possible healthcare, yet they remain one of the most vulnerable patient populations when it comes to medicines safety. Ahead of World Patient Safety Day on 17 September, we discuss challenges and solutions in paediatric pharmacovigilance with ISoP president Angela Caro-Rojas.Tune in to find out:Why we need a Patient Safety DayHow to prevent common medication errors in childrenHow to build child-friendly healthcare environmentsWant to know more?Visit the World Health Organization's campaign website to learn more about World Patient Safety Day and download campaign materials.You can also show support for the campaign by joining ISoP's free virtual event on September 18 and 19, or visit ISoP's YouTube channel to access recordings from previous Patient Safety Day events.For more on paediatric pharmacovigilance and ISoP's activities, check out these episodes from the Drug Safety Matters archive:The KIDs ListWhat's trending in pharmacovigilance? Join the conversation on social mediaFollow us on Facebook, LinkedIn, X, or Bluesky and share your thoughts about the show with the hashtag #DrugSafetyMatters.Got a story to share?We're always looking for new content and interesting people to interview. If you have a great idea for a show, get in touch!About UMCRead more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.

The FDA held a panel discussion on antidepressants used during pregnancy. I was one of the expert presenters, and what I witnessed should alarm anyone who cares about honest medicine. In this episode, I break down the mainstream media response and what they kept out: SSRIs cross the placenta, change fetal brain development, and there is no proof they work at all- let alone prevent postpartum depression. You'll also hear why this is bigger than one drug class. It's about a system that medicalizes emotions and protects profit over people. If you want the truth the headlines won't give you, start here. Dr. Roger McFillin / Radically Genuine WebsiteYouTube @RadicallyGenuineDr. Roger McFillin (@DrMcFillin) / XSubstack | Radically Genuine | Dr. Roger McFillinInstagram @radicallygenuineContact Radically GenuineConscious Clinician CollectivePLEASE SUPPORT OUR PARTNERS15% Off Pure Spectrum CBD (Code: RadicallyGenuine)10% off Lovetuner click here

In this podcast accompanying the August issue of DTB (https://dtb.bmj.com/content/63/8), David Phizackerley (DTB Editor) is joined by James Cave (former DTB Editor-in-Chief). David and James discuss an editorial generated by artificial intelligence (AI) (https://dtb.bmj.com/content/63/8/114) which looks at the role of AI in publishing. They talk about a DTB Forum article (https://dtb.bmj.com/content/63/8/115) that explores some of the practical problems of implementing drug safety alerts.  A DTB Select article (https://dtb.bmj.com/content/63/8/117) provides an overview of a double-blind, randomised, placebo-controlled trial of tirzepatide for weight reduction in people without diabetes. They finish by reviewing the main article (https://dtb.bmj.com/content/63/8/118) that provides an overview of the evidence for lecanemab for the treatment of mild cognitive impairment and mild dementia due to Alzheimer's disease.   Link BMJ policy on AI use: https://www.bmj.com/content/ai-use 

Today's guest is Marie Flanagan, Director of Product Management in Digital Projects and Solutions at IQVIA. Marie returns to the program to unpack how AI and automation technologies are transforming drug safety workflows. Together with Emerj Editorial Director Matthew DeMello, she shares how IQVIA uses natural language processing (NLP) built on safety-specific training data to surface early signals from massive, multilingual datasets. She also explains why combining NLP with automation tools, such as RPA and OCR, leads to higher accuracy in adverse event detection, especially across social media and non-traditional data channels. 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 the ‘AI in Business' podcast! If you've enjoyed or benefited from some of the insights of this episode, consider leaving us a five-star review on Apple Podcasts, and let us know what you learned, found helpful, or liked most about this show!

This episode focuses on how AI is transforming pharmacovigilance (PV) on a global scale, particularly focusing on the evolving role of local qualified persons for pharmacovigilance in the EU.This episode is presented in partnership with IQVIA.Host⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestAna Pedro Jesuíno, Global Head Local QPPV Network, IQVIADisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Creative Director Ryan Weaver talks about removing the stigma and increasing accessibility

Support the show and get 50% off MCT oil with free shipping—just leave us a review on iTunes and let us know!https://podcasts.apple.com/us/podcast/live-beyond-the-norms/id1714886566 I never imagined I'd be talking to someone who's advised the FDA, challenged medical orthodoxy, and lived through one of the most devastating pharmaceutical disasters in history, but Suzanne Robotti is that person.She's not just an FDA advisor. She's also the founder of MedShadow Foundation, a nonprofit that helps people understand the real risks of medications without the spin of pharmaceutical companies. And it's personal for her.Suzanne was born into this fight. A drug called DES, prescribed to her mother during pregnancy, led to her own infertility. That experience set her on a decades-long mission to stop another DES from ever happening again. She got trained, joined FDA drug safety committees, and built a trusted platform to empower millions of patients to make informed choices.In this episode, we talk about how few people participate in drug trials before the meds hit the market, what “post-approval” means, and how patients unknowingly become participants in phase 4 drug experiments. We also dig into the real story behind ADHD diagnoses, Ritalin overuse, and what happened when Suzanne was told to medicate her teenage nephew or risk getting him kicked out of school.This is a deeply honest conversation about what it means to become your own health advocate.“ The real effects of medicines are often kept in the shadows.” ~ Suzanne RobottiAbout Suzanne Robotti:Suzanne Robotti is a nationally recognized drug safety advocate, consumer representative to the FDA, and the founder of MedShadow Foundation — a nonprofit media organization dedicated to informing the public about the risks and side effects of medications. Her journey began after discovering that she was infertile because of prenatal DES exposure. Today, Suzanne speaks widely on the importance of transparency in medicine, shared decision-making, and empowering patients to ask better questions.Connect with Suzanne Robotti:- Website: https://medshadow.org - FDA Advocacy: https://desaction.org - Instagram: https://www.instagram.com/medshadowfoundation/ - TikTok: https://www.tiktok.com/@medshadow_foundation - Facebook: https://www.facebook.com/medshadow.foundation - YouTube: https://www.youtube.com/MedShadowFoundation Connect with Chris Burres:- Website: https://www.myvitalc.com/ - Website: http://www.livebeyondthenorms.com/ - Instagram: https://www.instagram.com/chrisburres/ - TikTok: https://www.tiktok.com/@myvitalc - LinkedIn: https://www.linkedin.com/in/chrisburres/ 

Top headlines for Monday, June 2, 2025In this episode, former First Lady Michelle Obama's recent comments on the capabilities of a woman's reproductive system have sparked intense reactions from pro-life advocates, highlighting the ongoing debate over reproductive rights. In response, a pro-life organization has published a peer-reviewed report challenging the narrative around the safety of abortion medications, comparing them to common pain relievers. Additionally, we explore the spiritual journey of former megachurch pastor Francis Chan, who shares his reasons for moving away from the megachurch model of worship.00:12 Michelle Obama says creating life is 'least of' what women can do01:05 California Supreme Court rejects appeal from Christian baker01:53 Report refutes 'baseless' claim that abortion pill is 'safer than02:47 FBI will investigate Supreme Court Dobbs leak, other cases03:41 ERLC president says it's time to 'ban pornography'04:33 Pastor Jamal Bryant pushes electronic protest of Dollar General05:32 Francis Chan reveals why he left his megachurchSubscribe to this PodcastApple PodcastsSpotifyGoogle PodcastsOvercastFollow Us on Social Media@ChristianPost on TwitterChristian Post on Facebook@ChristianPostIntl on InstagramSubscribe on YouTubeGet the Edifi AppDownload for iPhoneDownload for AndroidSubscribe to Our NewsletterSubscribe to the Freedom Post, delivered every Monday and ThursdayClick here to get the top headlines delivered to your inbox every morning!Links to the NewsMichelle Obama says creating life is 'least of' what women can do | PoliticsCalifornia Supreme Court rejects appeal from Christian baker | U.S.Report refutes 'baseless' claim that abortion pill is 'safer than | PoliticsFBI will investigate Supreme Court Dobbs leak, other cases | PoliticsERLC president says it's time to 'ban pornography' | Church & MinistriesPastor Jamal Bryant pushes electronic protest of Dollar General | BusinessFrancis Chan reveals why he left his megachurch | Podcast

The Radically Genuine podcast welcomes back renowned Maternal-Fetal Medicine (MFM) physician Dr. Adam Urato as he pulls back the curtain on what pregnant women aren't being told about medication risks. Why are doctors spending less than ten minutes on "informed consent" when your child's future is at stake? What caused one medical intervention to be injected into 350,000 pregnant women despite not actually working? Dr. Urato reveals why corporate medicine makes it nearly impossible for physicians to tell patients the truth and explains his bold mission to change FDA labeling. This conversation will force you to question everything you thought you knew about "safe" medications during pregnancy.Chapters00:00 The Vulnerability of Unborn Children02:30 Introduction of Dr. Adam Urato04:08 The Case of McKenna: A Systemic Failure11:17 The Need for Rigorous Safety Evaluations16:33 Chronic Disease Epidemic and Chemical Exposures23:16 Mental Health and Pregnancy: A Complex Debate39:14 Fear Provocation and Informed Consent43:20 Informed Consent and Patient Empowerment46:36 The Challenges of Time in Medical Practice53:09 Risks and Benefits of Psychiatric Medications01:01:05 The Role of Physicians in Patient Advocacy01:06:04 Citizen's Petition and FDA Labeling Changes01:18:00 The Importance of Open Dialogue in Medicine RADICALLY GENUINE PODCASTDr. Roger McFillin / Radically Genuine WebsiteYouTube @RadicallyGenuineDr. Roger McFillin (@DrMcFillin) / XSubstack | Radically Genuine | Dr. Roger McFillinInstagram @radicallygenuineContact Radically GenuineConscious Clinician CollectivePLEASE SUPPORT OUR PARTNERS15% Off Pure Spectrum CBD (Code: RadicallyGenuine)10% off Lovetuner click here—-----------FREE DOWNLOAD! DISTRESS TOLERANCE SKILLS

Medication safety remains a cornerstone of anesthesia practice with complex environments and high-stakes decisions requiring vigilant attention to prevent errors. This collaboration between APSF and OpenAnesthesia spotlights critical aspects of perioperative drug safety with practical insights from Dr. Juan Li, a cardiothoracic anesthesia fellow at Beth Israel Deaconess Medical Center.• Perioperative anaphylaxis requires immediate recognition of cardiovascular, respiratory, and cutaneous manifestations• Neuromuscular blocking agents and antibiotics represent common triggers for anaphylactic reactions• Preoperative assessment must include thorough allergy history, medication reconciliation, and identification of drug-drug interactions• Standardized drug concentrations, preparation methods, and equipment minimize medication errors• Technology integration through barcode readers and computerized decision support enhances safety• Pharmacy support with pre-mixed solutions and pre-filled syringes reduces preparation errors• Post-operative monitoring remains critical for catching delayed medication reactions• Safety culture should emphasize root cause analysis rather than punishment for medication errors• Implementation of standard protocols is essential for managing new medications with limited safety dataVisit APSF.org and Openanesthesia.org for detailed information and resources on medication safety in anesthesia practice.

A Texas child's measles-related death, the first in the U.S. since 2015, highlights rising cases amid declining vaccination rates. AstraZeneca's Serena 6 trial found camizestrant, delayed disease progression in HR-positive HER2-negative breast cancer. A BMJ study found no link between GLP-1 receptor agonists and increased suicidality in diabetes patients. The CDC reports an 80% decline in high-risk cervical precancers, confirming HPV vaccination success.

Jo Cheah talks to Debra Kennedy, director of MotherSafe, about her paper on drug safety in pregnancy. Debra discusses the key considerations when stopping or starting a medicine during pregnancy, and the ways in which medicines can affect developing fetuses. Debra also explains the Australian categorisation system for prescribing medicines in pregnancy. Read the full article by Debra and her co-author, Ronald Batagol, in Australian Prescriber.

PJ talks about the upskirt photo investigation centred on MacCurtain St, chats to Grace an amazing lady who is thanking the Mercy after her son, brother and husband had cancer, discusses with George Patterson how drugs policy should help both drug users and those who live in the city. And more... Hosted on Acast. See acast.com/privacy for more information.

MEDBOARD: https://www.medboard.com/ EUROPE TEAM-NB high level position - Making Medical Devices Safer and Faster: https://www.team-nb.org/wp-content/uploads/2024/12/Team-NB-HighLevel-Strategy- PositionPaper-20241130.pdf -   MDCG 2024-15 - Reporting Medical Device Trials Made Easy!: https://health.ec.europa.eu/document/download/0e076d19-62dc-4ff9-83f2-be6072a45993_en? filename=mdcg_2024-15_en.pdf -   EMA activities on Combination products - Reminder on Drug-Device assessment.: https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day- session-4-ema-activities-medical-devices_en.pdf -   MDCG 2024-16 Interruption or Discontinuation - For certain devices: https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en? filename=mdr_qna-article10a_mdr-ivdr_en.pdf and annex https://health.ec.europa.eu/document/download/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16 _annex_en.pdf -   Joint Paper from 9 Member states - Council of the European Union: https://data.consilium.europa.eu/doc/document/ST-15380-2024-INIT/en/pdf Reduction of Administrative Burdens Centralization of System Management to the EMA Predictable Certification Procedures Enhanced Coordination and Support Impact Assessment and Resource Allocation   -   MDCG 2024-14 Master UDI-DI - Contact lenses: https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14 _en.pdf Master UDI-DI Assignment Labelling Requirements Vigilance Reporting EUDAMED Registration Implementation Timeline   -   Artificial Intelligence in Medical Devices . Joint publication Team NB and IG-NB: https://www.team-nb.org/wp-content/uploads/2024/11/Team-NB-PositionPaper-AI-in-MDQuestionnaire-V1-20241125.pdf -   Gradual Roll-out of EUDAMED - Be ready to start: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf -   Spain application for in-house devices - For hospitals: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-una-nueva-aplicacion-para-la-comunicacion-de-fabricacion-de-productos-sanitarios-in-house-por-hospitales/ SMARTEYE - Eqms Smarteye: https://eqms-smarteye.com/ EVENTS - Arab Health - January 27 to 30th, 2025: https://medtechconf.com/event/total-radiology-conference/ TRAINING -  Mini-Course MDR: https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/ ROW -   US - Some healthcare software are not devices - WARNING: https://www.fda.gov/media/184083/download?attachment Administrative support in healthcare settings. Promoting healthy lifestyles without direct links to disease management. Serving as electronic patient records without interpreting or analyzing data. Transferring, storing, converting, or displaying medical data without interpretation. Providing limited clinical decision support to healthcare providers without interpreting clinical tests or device data.   -   US - PCCP Final guidance - Submit a PCCP with your submission: https://www.fda.gov/media/166704/download • Webinar January 14, 2025 - https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin - South Korea Guidance - Enhancing Medical Device Safety!: https://www.mfds.go.kr/law/board/boardDetail.do?menuKey=29&brdId=data0011&seq=15564 we're talking about new guidance from South Korea's Ministry of Food and Drug Safety, or MFDS. They just released a document to help improve the safety and quality of medical devices." "This guidance focuses on stricter standards for manufacturing and testing medical devices to ensure they are safe and effective for patients." "The MFDS is also emphasizing the importance of proper documentation and reporting, so that any issues can be quickly identified and addressed." The MFDS aims to make medical devices safer through several key measures: Stricter Standards: They are implementing more rigorous manufacturing and testing standards to ensure devices meet high safety and quality benc Enhanced Oversight: Increased oversight and regular inspections of manufacturing processes ensure compliance with safety regulations. Training and Education: Providing training and resources to manufacturers to help them understand and meet the new standards. These steps are designed to ensure that medical devices are safe, effective, and reliable for patients. "In short, this new guidance aims to make medical devices safer and more reliable for everyone." -  Australia - Guidelines for Medical Devices - Bookmark the link: https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-medical-devices- argmd -  Australia - Submit Custom-made device - Guidance step-by-step: https://www.tga.gov.au/resources/resource/user-guide/how-submit-custom-made-medical-device-notification -  Malaysia - Advertisement application - Approve your Advertising: https://www.mda.gov.my/index.php/industry/medical-device-advertisements/medical-device-advertisement PODCAST -  How MDR and IVDR code can save you money? Stefan Bolleininger: https://podcast.easymedicaldevice.com/309-2/ -  Is FMEA bad for your Risk Management? Rod Beuzeval: https://podcast.easymedicaldevice.com/310-2/ -  How to build the perfect Quality Management System? https://podcast.easymedicaldevice.com/311-2/ -  IEC 60601-1-8 How to test your Medical Device Alarms? Beat Keller https://podcast.easymedicaldevice.com/312-2/ -  PCCP - The magic tool for planned changes in the US? Maria Diez: https://podcast.easymedicaldevice.com/313-2/ Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. ## Breakthrough in Cancer Treatment ##Researchers have discovered a new combination therapy that has shown promising results in treating certain types of cancer. The therapy combines immunotherapy with targeted therapy, enhancing the body's immune response to cancer cells while also attacking the tumors directly. This breakthrough could potentially revolutionize cancer treatment and improve outcomes for patients.## FDA Approves New Drug for Rare Disease ##The FDA has approved a new drug for the treatment of a rare genetic disease that affects a small subset of the population. The drug has shown significant efficacy in clinical trials, providing hope for patients who previously had limited treatment options. This approval marks a milestone in the advancement of precision medicine and personalized healthcare.## Biotech Company Announces Partnership ##A leading biotech company has announced a new partnership with a pharmaceutical giant to collaborate on the development of a groundbreaking gene therapy. The partnership will combine the expertise and resources of both companies to accelerate the development and commercialization of this potentially life-changing therapy. This collaboration highlights the importance of industry partnerships in driving innovation and advancing medical research.## Clinical Trial Shows Promising Results ##A recent clinical trial has demonstrated promising results for a new drug candidate aimed at treating a common chronic condition. The drug showed significant efficacy in reducing symptoms and improving quality of life for patients, with minimal side effects reported. These findings suggest that the drug could become a valuable treatment option for millions of individuals suffering from this condition.## Regulatory Update: FDA Issues Warning ##The FDA has issued a warning regarding the potential risks associated with a popular over-the-counter medication. The warning highlights concerns about potential side effects and interactions with other medications, urging healthcare providers to exercise caution when prescribing this drug. This regulatory update serves as a reminder of the importance of monitoring drug safety and efficacy to protect patient health.## Industry News: Merger Announcement ##Two major pharmaceutical companies have announced plans to merge, creating one of the largest pharmaceutical companies in the world. The merger is expected to result in significant cost savings and synergies, as well as enhance research and development capabilities. This industry news underscores the ongoing trend of consolidation within the pharmaceutical industry and the impact it can have on innovation and competition.## Research Breakthrough: New Drug Target Identified ##Researchers have identified a promising new drug target for the treatment of a complex neurological disorder. By targeting this specific pathway, researchers believe they can develop more effective treatments with fewer side effects. This discovery represents a significant step forward in understanding the underlying mechanisms of this disorder and could lead to improved therapeutic options for patients in the future.## Market Update: Biotech Stocks Surge ##Biotech stocks have surged following positive news from several companies regarding clinical trial results and regulatory approvals. Investors are optimistic about the future potential of these companies' pipelines and are driving up stock prices as a result. This market update reflects the strong investor interest in biotech companies and their potential for growth and innovation in the healthcare sector.In conclusion, these recent developments in the Pharma and Biotech world demonstrate the ongoing progress and innovation happening within the industry. From breakthrough treatments to regulatory updates, industry partnerships to market

In this episode, Dr. Jessica Steier and Dr. Sarah Scheinman welcome Dr. Namandjé Bumpus, Principal Deputy Commissioner of the FDA, who shares insights into the agency's operations and her path from academia to FDA leadership. The scientists explore the complexities of drug approval processes, the FDA's organizational structure, and its commitment to safety and transparency. Dr. Bumpus discusses the agency's efforts to advance health equity and adapt to emerging technologies, while addressing the critical challenge of maintaining public trust. This conversation offers listeners a unique glimpse into the inner workings of the FDA and its role in protecting public health.All our sources from this episode are available at: https://www.unbiasedscipod.com/episodes/(00:00) Introduction (03:31) Dr. Bumpus' Academic and Professional Journey(06:19) Transition from Academia to FDA Leadership(09:10) The Role of Pharmacology in Public Health(12:26) Overview of FDA Offices and Centers(15:10) Understanding the Drug Approval Process(18:12) Post-Market Surveillance and Drug Safety(21:20) Building Trust in Government Agencies(24:27) Examples of FDA's Impact on Public Health(27:16) Ensuring Transparency in FDA Processes(30:27) The Human Foods Program and Its Importance(33:08) Adapting to Rapidly Evolving Technologies(36:16) Challenges Facing the FDA and Public Health(38:42) Final ThoughtsInterested in advertising with us? Please reach out to advertising@airwavemedia.com, with “Unbiased Science” in the subject line.PLEASE NOTE: The discussion and information provided in this podcast are for general educational, scientific, and informational purposes only and are not intended as, and should not be treated as, medical or other professional advice for any particular individual or individuals. Every person and medical issue is different, and diagnosis and treatment requires consideration of specific facts often unique to the individual. As such, the information contained in this podcast should not be used as a substitute for consultation with and/or treatment by a doctor or other medical professional. If you are experiencing any medical issue or have any medical concern, you should consult with a doctor or other medical professional.Further, due to the inherent limitations of a podcast such as this as well as ongoing scientific developments, we do not guarantee the completeness or accuracy of the information or analysis provided in this podcast, although, of course we always endeavor to provide comprehensive information and analysis. In no event may Unbiased Science or any of the participants in this podcast be held liable to the listener or anyone else for any decision allegedly made or action allegedly taken or not taken allegedly in reliance on the discussion or information in this podcast or for any damages allegedly resulting from such reliance. The information provided herein do not represent the views of our employers. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

In this episode, Dr. Jessica Steier and Dr. Sarah Scheinman welcome Dr. Namandjé Bumpus, Principal Deputy Commissioner of the FDA, who shares insights into the agency's operations and her path from academia to FDA leadership. The scientists explore the complexities of drug approval processes, the FDA's organizational structure, and its commitment to safety and transparency. Dr. Bumpus discusses the agency's efforts to advance health equity and adapt to emerging technologies, while addressing the critical challenge of maintaining public trust. This conversation offers listeners a unique glimpse into the inner workings of the FDA and its role in protecting public health. All our sources from this episode are available at: https://www.unbiasedscipod.com/episodes/ (00:00) Introduction  (03:31) Dr. Bumpus' Academic and Professional Journey (06:19) Transition from Academia to FDA Leadership (09:10) The Role of Pharmacology in Public Health (12:26) Overview of FDA Offices and Centers (15:10) Understanding the Drug Approval Process (18:12) Post-Market Surveillance and Drug Safety (21:20) Building Trust in Government Agencies (24:27) Examples of FDA's Impact on Public Health (27:16) Ensuring Transparency in FDA Processes (30:27) The Human Foods Program and Its Importance (33:08) Adapting to Rapidly Evolving Technologies (36:16) Challenges Facing the FDA and Public Health (38:42) Final Thoughts Interested in advertising with us? Please reach out to advertising@airwavemedia.com, with “Unbiased Science” in the subject line. PLEASE NOTE: The discussion and information provided in this podcast are for general educational, scientific, and informational purposes only and are not intended as, and should not be treated as, medical or other professional advice for any particular individual or individuals. Every person and medical issue is different, and diagnosis and treatment requires consideration of specific facts often unique to the individual. As such, the information contained in this podcast should not be used as a substitute for consultation with and/or treatment by a doctor or other medical professional. If you are experiencing any medical issue or have any medical concern, you should consult with a doctor or other medical professional. Further, due to the inherent limitations of a podcast such as this as well as ongoing scientific developments, we do not guarantee the completeness or accuracy of the information or analysis provided in this podcast, although, of course we always endeavor to provide comprehensive information and analysis. In no event may Unbiased Science or any of the participants in this podcast be held liable to the listener or anyone else for any decision allegedly made or action allegedly taken or not taken allegedly in reliance on the discussion or information in this podcast or for any damages allegedly resulting from such reliance. The information provided herein do not represent the views of our employers. Learn more about your ad choices. Visit megaphone.fm/adchoices

The horseshoe crab has endured for over 450 million years. It has survived several mass extinctions including the one that killed off the dinosaurs. One reason for their incredible resiliency is their ability to fend off bacterial infection. Their blood contains cells that clot around invading bacteria, thereby protecting them from the attacking toxins.In this episode we talk with three experts about how this animal's unique blue blood has become essential to modern medicine. We also talk about why horseshoe crab populations are dwindling, and what biotech is doing to address the shortfall.Follow us on LinkedIn, X, Facebook and Instagram. Visit us at https://www.bio.org/

In this episode of Vibe Science, Ryan Alford andChris Hansen sit down with Kat Murti, Executive Director of Students for Sensible Drug Policy (SSP), and Gina Giorgio to dive into the topic of drug policy reform. Kat shares SSP's mission to end the war on drugs and advance policies that prioritize human rights and harm reduction. The discussion explores the historical background of drug laws, racial disparities in enforcement, and the critical role of education and community support in tackling addiction. The guests advocate for a compassionate, evidence-based approach to drug use, questioning the effectiveness of punitive policies and calling for change.TAKEAWAYSDrug policy reform and its societal implicationsThe mission and role of Students for Sensible Drug Policy (SSP)Historical context of drug laws and their impact on societyRacial disparities in drug enforcement and sentencingThe negative consequences of punitive drug policies on individuals and communitiesThe relationship between addiction and environmental factorsThe concept of "set and setting" in drug use experiencesThe critique of the criminal model of drug policyThe importance of education and harm reduction in addressing drug useThe need for a compassionate and informed societal approach to drug use and addiction Follow us on Instagram: @Vibe.Science Subscribe to our YouTube Page: www.youtube.com/@Vibe.Science

In this episode of The Amberly Lago Show: Stories of True Grit and Grace, host Amberly Lago sits down with Kim Witczak to explore the profound journey of turning grief into advocacy and healing. Kim shares her touching story following the tragic loss of her husband, Woody, and how this life-altering event propelled her into challenging big pharmaceutical companies for better drug safety. They discuss the importance of faith, community, and finding hope in moments of despair. Kim also reflects on the symbolism of butterflies as signs from her late husband and the transformative power of personal growth through adversity. Join Amberly and Kim as they delve into topics of resilience, advocacy, and the emotional pathways of healing in this moving and empowering conversation. If you are ready to leave your mark by discovering your message and sharing it with the world, you've come to the right place!! Let's work together to build your influence, your impact, and your income! Join the tribe you have been waiting for to activate your highest potential and live the life you deserve! Join the “Unstoppable Life Mastermind!” and let us know you are ready for greatness! Read the “True Grit and Grace” book here and learn how you can turn tragedy into triumph!  Thank you for joining us on The Amberly Lago Show: Stories of True Grit and Grace! If you find value in today's episode, don't forget to share the show with your friends and tap that subscribe button so you don't miss an episode! You can also head over to amberlylago.com to join my newsletter and access free downloadable resources that can help you elevate your life, business, and relationships! Want to see the behind-the-scenes and keep the conversation going?  Head over to Instagram @amberlylagomotivation! Audible @True-Grit-and-Grace-Audiobook  Website @amberlylago.com Instagram @amberlylagomotivation Facebook @AmberlyLagoSpeaker

Are we given true informed consent with every drug we are offered? Are the known side effects always disclosed? It would be nice to think so, but the truth is, Big Pharma and the FDA actually go to great lengths to keep us in the dark about certain truths that can harm us because they harm their bottom line. On this episode of Vitality Radio, Jared invites Kim Witczak to join him in an important discussion about this issue. After the sudden death of her husband due to an undisclosed side effect of an antidepressant, Kim Witczak became an advocate for pharmaceutical drug safety and reform. Jared and Kim discuss the impact antidepressants have on suicide and violence. As Kim says, healthcare is a business, and we are customers. She is not anti-drug but pro-information and she continues to stand up to the Big Pharma and FDA machines to demand honesty, transparency, reform and accountability - for all of us.Additional Information:Websites: www.kimwitczak.comwww.woodymatters.comTwitter: @woodymattersInstagram: @kim_witczakSubstack: (UN)acceptable Collateral Damage#381: VR Vintage: The Truth and Theory Behind Antidepressants#264: Emotional Vitality: Jen's Story Part 1 - From Addiction and Mental Illness to VitalityVisit the podcast website here: VitalityRadio.comYou can follow @vitalityradio and @vitalitynutritionbountiful on Instagram, or Vitality Radio and Vitality Nutrition on Facebook. Join us also in the Vitality Radio Podcast Listener Community on Facebook. Shop the products that Jared mentions at vitalitynutrition.com. Let us know your thoughts about this episode using the hashtag #vitalityradio and please rate and review us on Apple Podcasts. Thank you!Please also join us on the Dearly Discarded Podcast with Jared St. Clair.Just a reminder that this podcast is for educational purposes only. The FDA has not evaluated the podcast. The information is not intended to diagnose, treat, cure, or prevent any disease. The advice given is not intended to replace the advice of your medical professional.

Suzanne Robotti is an FDA Consumer Representative, Drug Side Effects Expert, DES Daughter, and founder of MedShadow Foundation, a nonprofit organization which encourages people to think for themselves, not to believe everything you read online, do your own diligent research, and balance the benefits with the risks of medications. She launched MedShadow Foundation in 2013 because she herself was harmed by a medication called DES that was given to her mother when she was pregnant with Su. At the young age of 13, Su learned that she would never be able to have children because of the harmful side effects of DES. Generations later, DES has been found to cause rare cancers, autoimmune diseases, and infertility. In 2017 Su was appointed to the FDA Advisory Committee on Drug Safety and Risk Management as the lone consumer representative on a panel of doctors and pharmacists. She considers it a privilege to have a seat at the table when the FDA is deciding if a drug is safe and effective enough to use.   Su shares her own personal story of dealing with the harmful side effects of DES, as well as the many other side effects that other DES mothers, children, grandchildren, and great-grandchildren continue to deal with, only because “modern medicine” believed that medications were not able to cross from an expectant mother to her unborn child. This led to not only one generation being impacted by the harmful effects of the first synthetically manufactured estrogen which was given to pregnant women between 1940 to 1971 to prevent miscarriage and related complications of pregnancy.   Su explains how her own experience caused her to look deeper into medications which are prescribed, as well as potential side effects. Her research and due diligence went into high gear when her nephew who was living with her and her husband, was diagnosed with ADHD at the age of 12. He was subscribed large doses of approved ADHD medications, the doctors told Su and her family that he would keep trying various medications to “get that kid under control.” When Su asked what the potential side effects were, the doctor assured her that there weren't any. When she asked to see the studies, he laughed and said there weren't any, but again reassured her that they were perfectly safe. Download this informative episode to hear Su's story, and discover how she and her family were able to help their nephew deal with his ADHD without medication, the importance and impact of healthy living, how to become your own health advocate, how to get involved with your own medication regime by collaborating and communicating with both your doctor and pharmacist, why it's important to consider your options, how to balance the benefits with the risks of medications.         https://medshadow.org/ https://www.facebook.com/medshadow.foundation https://www.tiktok.com/@medshadow_foundation?lang=en https://www.instagram.com/medshadowfoundation/?hl=en https://twitter.com/Med_Shadow? https://www.linkedin.com/in/suzannerobotti/ https://www.youtube.com/user/MedShadowFoundation  

About this episode: One in five U.S. adults is taking five or more prescription drugs at a time, often for years without reassessment of need, dosage, or possible interactions. Today, a look at polypharmacy and why it's important for physicians to periodically check in with patients about all the prescription—and nonprescription—drugs they're taking. The guests also discuss the importance of considering non-pharmaceutical treatments like physical or talk therapy, and empowering patients and their care partners to ask questions about what they're being prescribed. Guests: Dr. Cynthia Boyd is a geriatrician and faculty at Johns Hopkins Medicine. She is also a senior associate with the Johns Hopkins Center on Aging and Health. Dr. Ariel Green is a geriatrician and faculty at Johns Hopkins Medicine. She is also a core faculty member of the Johns Hopkins Bloomberg School of Public Health Center for Drug Safety and Effectiveness. Host: Stephanie Desmon, MA, is a former journalist, author, and the director of public relations and communications for the Johns Hopkins Center for Communication Programs, the largest center at the Johns Hopkins Bloomberg School of Public Health. Show links and related content: Taking Multiple Medications? You May Need to Scale Back.—The New York Times Taking more than 5 pills in a day? ‘Deprescribing' can prevent harm—especially for older people—The Conversation Contact us: Have a question about something you heard? Want to suggest a topic or guest? Contact us via email or visit our website. Follow us: @‌PublicHealthPod on X @‌JohnsHopkinsSPH on Instagram @‌JohnsHopkinsSPH on Facebook @‌PublicHealthOnCall on YouTube Here's our RSS feed

We are delighted to partner with Soundable Health for our milestone 100th episode of the Prostate Health Podcast! Did you know that you can now monitor the health of your prostate and bladder in the comfort of your home?  We have a special guest, Dr. Catherine Song, joining us today to introduce and guide you through the features of a cutting-edge new mobile app called proudP, which has demonstrated its value for men as a personal prostate health monitor, and for urologists, providing valuable uroflow data without the need for expensive and cumbersome equipment. Dr. Song is the Founder and CEO of Soundable Health, a digital health startup developing digital audible biomarkers. Dr. Song has a Ph.D. in electrical and electronics engineering from Korea Advanced Institute of Science and Technology. She brings a wealth of experience to the show, having served previously as the Chief Operating Officer at HUINNO, a Boston Seoul-based digital health startup, and as a member of the digital health advisory committee at the Ministry of Food and Drug Safety for two years. She also spent over ten years as a Senior Strategic Operations Manager at Lam Research Corporation, a NASDAQ company and global leader in semiconductor equipment, and in various technology and product leadership roles in LG Electronics in the high technology and consumer electronics field.  Stay tuned to learn all you need to know about the innovative new proudP mobile app. Disclaimer: The Prostate Health Podcast is for informational purposes only. Nothing in this podcast should be construed as medical advice. By listening to the podcast, no physician-patient relationship has been formed. For more information and counseling, you must contact your personal physician or urologist with questions about your unique situation. Show Highlights: Dr. Song explains how AI detects subtle changes in urine flow and sound to measure flow speed and amount with proudP Dr. Song shares the story behind proudP The limitations of office-based uroflow practices The accuracy of the uroflow data captured with proudP Why objective data is essential for BPH treatments The implications for urologists of implementing the proudP technology within the urology space  Where can the proudP app be obtained? Links:  Get your free What To Expect Guide or find the link on our podcast website.  Join our Facebook group.  Follow Dr. Pohlman on Twitter and Instagram. (@gpohlmanmd) Go to the Prostate Health Academy to sign up.  You can access Dr. Pohlman's free mini webinar, where he discusses his top three tips to promote men's prostate health, longevity, and quality of life here. Soundable Health proudP