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Story at-a-glance The U.S. Food and Drug Administration (FDA) allows U.S. food companies to use nearly 1,000 chemicals banned in Europe, many of which are linked to DNA damage, hormone disruption, or cancer Thanks to a legal loophole called “Generally Recognized as Safe” or GRAS, manufacturers are allowed to self-declare additives as safe without FDA approval, review, or even disclosure on the label Hidden additives are often disguised as “natural flavors” or “spices,” masking substances you'd never knowingly eat but are consuming regularly Ultraprocessed foods make up 73% of the U.S. food supply, designed with chemicals that increase cravings, damage gut health, and disrupt brain signaling Even after hospitalizations and deaths linked to hidden ingredients, the FDA rarely takes meaningful action — leaving your health in the hands of corporations
Dr. Eugene Lipov is one of the world's leading experts on the treatment of symptoms related to post-traumatic stress.Truly, a pioneer in stellate ganglion treatment for symptoms of PTSD, he knows first-hand that trauma can be all-consuming. Growing up with a veteran father stricken with PTSD, and a mother with debilitating depression who eventually took her own life, he truly understands the impact that trauma can have on the lives of many. He's made it his mission to help others relieve their traumatic suffering from PTSD and restore hope to their spirit.In 2006, Dr. Lipov pioneered the use of Stellate Ganglion Block (SGB) for the treatment for post-traumatic stress disorder (PTSD) — a procedure that was initially approved by the U.S. Food and Drug Administration (FDA) in the 1950s for the treatment of certain types of pain and circulation disorders. It is performed with an injection of medication into a collection of nerves at the bottom of the front side of your neck. It is most commonly known as a pain-relieving treatment, used to relieve hot flashes for menopause and cancer patients and treating shingles — and, now, to alleviate symptoms related to post-traumatic stress disorder (PTSD). SHOWNOTES:
The Rich Zeoli Show- Hour 4: 6:05pm- While appearing on Fox News with Maria Bartiromo, FBI Director Kash Patel and FBI Deputy Director Dan Bongino explained they have reviewed all evidence and concluded that Jeffrey Epstein's 2019 death was, as originally reported, a suicide. During the interview, Bongino also revealed that there is no evidence suggesting a larger conspiracy surrounding the assassination attempt against Donald Trump in Butler, PA. 6:15pm- Senate Minority Leader Chuck Schumer is now blaming DOGE for everything—including a Mexican naval ship crashing into the Brooklyn Bridge. 6:20pm- Rich receives ANOTHER invitation to the White House! Hillary Clinton is BACK—and she hates the nuclear family! AND Commissioner Marty Makary announces that the U.S. Food and Drug Administration (FDA) is removing ingestible fluoride from prescription drugs for children. 6:40pm- In a statement on Sunday, former President Joe Biden's office announced that he has been diagnosed with an aggressive form of prostate cancer with metastasis to the bone. In response to the news, President Donald Trump posted to Truth Social: “Melania and I are saddened to hear about Joe Biden's recent medical diagnosis. We extend our warmest and best wishes to Jill and the family, and we wish Joe a fast and successful recovery.” 6:45pm- While appearing on MSNBC's Morning Joe, Dr. Ezekiel Emanuel—an oncologist and bioethicist at the University of Pennsylvania—said that “there is no disagreement” within the medical community, Joe Biden had cancer while he was president of the United States even if he was only diagnosed last Friday. 6:50pm- Jake Tapper's new book, “Original Sin: President Biden's Decline, Its Cover-up, and His Disastrous Choice to Run Again,” which is critical of the Biden Administration for covering up the president's physical and cognitive decline is due to be released later this week—but many Democrats and mainstream media members, including David Axelrod and Brian Steltzer, are saying the conversation regarding the “cover-up” should be paused given Biden's cancer diagnosis.
The FBI arrests alleged child predators. The Food and Drug Administration (FDA) hires a new top vaccine official to replace Dr. Peter Marks. And the Department of Government Efficiency's (DOGE) effort has hit a new milestone, as well as a new legal snag. Let's go through a full update on today's episode of Facts Matter.Episode Resources:
Vaccination is one of the best ways to prevent diseases. Over the past 50 years, essential vaccines saved at least 154 million lives (1). During the same period, vaccination has reduced infant deaths by 40%. Together with governments, vaccine manufacturers, scientists and medical experts, WHO's vaccine safety program is constantly helping monitor the safety of vaccines. This helps ensure that vaccines are safe for you and your family. In the United States, a number of safeguards are required by law to help ensure that the vaccines we receive are safe. Because vaccines are given to millions of healthy people—including children—to prevent serious diseases, they're held to very high safety standards. Every authorized or approved vaccine goes through safety testing, including: Testing and evaluation of the vaccine before it's licensed by the Food and Drug Administration (FDA) and recommended for use by the Centers for Disease Control and Prevention (CDC) Monitoring the vaccine's safety after it is recommended for infants, children, or adults Before a vaccine is ever recommended for use, it's tested in labs. This process can take several years. FDA uses the information from these tests to decide whether to test the vaccine with people. During a clinical trial, a vaccine is tested on people who volunteer to get vaccinated. Clinical trials usually start with 20 to 100 volunteers, but eventually include thousands of volunteers. These tests can take several years and answer important questions like: Is the vaccine safe? What dose (amount) works best? How does the immune system react to it? Throughout the process, FDA works closely with the company producing the vaccine to evaluate the vaccine's safety and effectiveness. All safety concerns must be addressed before FDA licenses or authorizes a vaccine. Once a vaccine is approved or authorized, it continues to be tested. The company that makes the vaccine tests batches to make sure the vaccine is: Potent (It works like it's supposed to) Pure (Certain ingredients used during production have been removed) Sterile (It doesn't have any outside germs) FDA reviews the results of these tests and inspects the factories where the vaccine is made. This helps make sure the vaccines meet standards for both quality and safety. Once a vaccine is recommended for use, FDA, CDC, and other federal agencies continue to monitor its safety. The United States has one of the most advanced systems in the world for tracking vaccine safety. Each of the systems below supplies a different type of data for researchers to analyze. Together, they help provide a full picture of vaccine safety. Vaccine Adverse Events Reporting System (VAERS): VAERS is an early warning system managed by CDC and FDA that is designed to find possible vaccine safety issues. Patients, health care professionals, vaccine companies, and others can use VAERS to report side effects that happen after a patient received a vaccine. Some side effects might be related to vaccination while others might be a coincidence (happen by chance). VAERS helps track unusual or unexpected patterns of reporting that could mean there's a possible vaccine safety issue that needs further evaluation. The Vaccine Safety Datalink (VSD): VSD is a collaboration between CDC and several health care organizations across the nation. VSD uses databases of medical records to track vaccine safety and do research in large populations. By using medical records instead of self-reports, VSD can quickly study and compare data to find out if reported side effects are linked to a vaccine. Post-licensure Rapid Immunization Safety Monitoring System (PRISM), links to an external website, opens in a new tab: PRISM is part of the Sentinel Initiative, which is FDA's national system for monitoring medical products after they're licensed for use. PRISM focuses on vaccine safety—it uses a database of health insurance claims to identify and evaluate possible safety issues for licensed vaccines. Clinical Immunization Safety Assessment Project (CISA): CISA is a collaboration between CDC and a national network of vaccine safety experts from medical research centers. CISA does clinical vaccine safety research and—at the request of providers—evaluates complex cases of possible vaccine side effects in specific patients. Biologics Effectiveness and Safety (BEST) System: A system that uses multiple data sources and rapid queries to detect or evaluate adverse events or study specific safety questions. Additional research and testing: The Department of Defense (DoD), the U.S. Department of Veterans Affairs (VA), and the Indian Health Service (IHS) have systems to monitor vaccine safety and do vaccine safety research. The National Institutes of Health (NIH) and the Office of Infectious Disease and HIV/AIDS Policy (OIDP) also support ongoing research on vaccines and vaccine safety. During emergencies, such as the COVID-19 pandemic, additional safety activities are utilized to help evaluate the data in quickly and with special populations. For example, a new smartphone tool called V-safe uses text messaging and surveys to check in with COVID-19 vaccine recipients after vaccination. (CREDITS)
Christian Ararat, M.Sc., M.Eng. is a food safety professional with more than ten years of experience in food safety and quality. After earning a bachelor's degree in Food Science from Valley University in Colombia, he began his career in the bakery industry, where he implemented and enforced good manufacturing practices (GMPs) and prerequisite programs. After moving to Canada, Christian joined Natursource Inc., a Montreal-based food manufacturing company dedicated to producing healthy snacks. As head of the Quality Assurance department, Christian implemented the Global Food Safety Initiative (GFSI) SQF food safety system; helped the company to achieve claims such as gluten-free, non-GMO, and Halal; and maintained certifications such as Organic and Kosher. Christian has continued his education and pursued a master's degree in Food Safety and a master's degree in Quality Systems Engineering. Currently, he serves as the Director of Quality and Laboratory at Geloso Beverage Group, the first wine manufacturer in Québec, Canada. In this episode of Food Safety Matters, we speak with Christian [46:53] about: How variances in audit scores can cause issues for food safety professionals Things food and beverage companies should be paying close attention to on their audit results The importance of striving for continuous improvement over a specific audit score, and how this informs food safety culture How traceability is measured on audits and why food and beverage companies should still prioritize traceability, despite the recent 30-month extension of the U.S. Food and Drug Administration's (FDA's) Food Traceability Final Rule/FSMA 204 compliance date A $26-million budget cut coming to the Canadian Food Inspection Agency (CFIA) in 2026, and how it could affect CFIA's surveillance and enforcement work The differences between certified “Organic” criteria required by the U.S. Department of Agriculture (USDA) versus FDA's Foreign Supplier Verification program (FSVP), and how those differences affect organic food and beverage exporters to the U.S. Limitations imposed by FDA's evaluation protocols for FSVP-registered entities Potential applications of artificial intelligence (AI) that could bolster food safety efforts, as well as possible pitfalls that should be considered when looking to leverage AI for food safety. In this episode, we also interview Joseph Corby [24.26], the recipient of Food Safety Magazine's 2025 Distinguished Service Award, about his career in food safety and his advocacy for a nationally integrated food safety system. After receiving a degree in Environmental Health, Joseph Corby worked for the New York State Department of Agriculture and Markets for 38 years, beginning as a Food Inspector in 1970 and retiring in 2008 as the Director of the Division of Food Safety and Inspection. He then went on to become the Executive Director of the Association of Food and Drug Officials (AFDO), a role he held for ten years, and is now a Senior Advisor for AFDO. Joseph has served as an Instructor for the U.S. Food and Drug Administration (FDA), AFDO, the International Food Protection Training Institute (IFPTI), Louisiana State University, the National Environmental Health Association (NEHA), the University of Tennessee, and Oregon State University. He continues to be an outspoken advocate for the advancement of a nationally integrated food safety system and works with numerous groups and associations in support of this cause. News and Resources News USDA Withdraws Proposed Regulatory Framework for Salmonella in Poultry After Years of Development FDA Announces Plan to Phase Out Synthetic, Petroleum-Based Food Dyes From U.S. Food Supply Rumored FDA Budget Proposal Would Cut Funding, Move Routine Food Inspections to States FDA Reportedly Reinstating Some Fired Food Safety Scientists, Inspection Support Staff FDA Testing Finds Bottled Water Samples Do Not Exceed EPA Limits for PFAS in Drinking WaterResearchers Develop Nanocage-Based Filter That Removes 90 Percent of PFAS From Groundwater Resources “Is AI 'Food Safe?'” by Christian Ararat, M.Sc., M.Eng. for Food Safety MagazineJoseph Corby to be Honored with Food Safety Magazine's 2025 Distinguished Service Award Sponsored by: Hygiena We Want to Hear from You! Please send us your questions and suggestions to podcast@food-safety.com
Piper hosts Plaidcast LIVE! from The Madeira School in McLean, VA with guests Phoebe Lang, Dr. Lisa Metcalf, DVM/MS and Dr. Kimberly Brokaw, DVM. Brought to you by Taylor, Harris Insurance Services.Host: Piper Klemm, publisher of The Plaid HorseGuest: Phoebe Lang was born and raised in the Washington, DC area and ignited her passion for horses at Madeira's summer riding program when she was seven years old. Upon graduating from Madeira in 1985, Phoebe attending Kenyon College and then moved to San Francisco, raised her three children, and started riding again in her 30's. Phoebe has devoted the past 25 years to pursuing elite-level show jumping throughout the US, Canada, and Europe, reaching the FEI 3* level. She built her farm and training business, Zeitgeist Equestrian and Equstech, in Petaluma, CA, and has worked on developing several equine therapeutic devices. While Phebe has retired from riding competitively, she still owns and cares for six horses and has been spending time launching the breeding career of one of her former grand prix stallions. Guest: Dr. Lisa Metcalf, DVM/MS grew up on a horse farm in northern VA, and her lifelong passion for horses shaped a distinguished academic and professional journey. After attending Madeira and then earning her BA in Biology from Wesleyan University, Dr. Metcalf went on to obtain her DVM from The Virginia-Maryland Regional College of Veterinary Medicine and her MS in Endocrinology from UC Davis. Dr. Metcalf is a decorated and board-certified theriogenologist; a specialist in the practice of animal reproduction. Beyond her clinical work, she has held influential roles with organizations such as the Oregon Veterinary Racing Commission, the American Association of Equine Practitioners, and the Portland Mounted Patrol Unit. An internationally sought-after speaker and widely published author, Dr. Metcalf brings deep expertise, passion, and perspective to the world of veterinary reproductive medicine. Guest: Dr. Kimberly Brokaw DVM's passion for horses and animal science, fostered by the Madeira school, led her to pursue her BS in animal science at the University of Maryland. She then earned her Doctorate from Virginia-Maryland College of Veterinary Medicine. Following her 15 years of service at the Walkersville Veterinary Clinic of Maryland, she currently brings her expertise to two impactful roles: as a Veterinary Medical Officer for the Food and Drug Administration (FDA) and as a passionate team member at Gentle Giants Draft Horse Rescue in Mount Airy, MD, a nonprofit organization devoted to rescuing and rehabilitating draft horses.Title Sponsor: Taylor, Harris Insurance ServicesSubscribe To: The Plaid Horse MagazineSponsors: Foxhall Equine and Great American Insurance Group Join us at an upcoming Plaidcast LIVE!
A large U.S. study found no evidence that taking Ozempic or Wegovy is tied to an increase in suicidal thoughts, researchers reported recently. 研究人员最近报道说，一项大型美国研究没有发现证据表明服用Ozempic或Wegovy与自杀思想的增加有关。 Both Ozempic for type 2 diabetes and the obesity treatment Wegovy have the same active ingredient, semaglutide. 用于2型糖尿病的Ozempic和肥胖治疗Wegovy具有相同的活性成分，semaglutide。The analysis included electronic medical record data from more than 1.8 million patients. Researchers actually found a lower risk of new and recurring suicidal thoughts in those taking semaglutide compared to those using other medications for weight loss or diabetes. 该分析包括来自180万患者的电子病历数据。 研究人员实际上发现，与使用其他药物减肥或糖尿病的药物相比，在服用半卢替肽的人中，新的和反复出现的自杀思想的风险较低。 Semaglutide belongs to a class of drugs known as GLP-1 agonists, which were designed to treat type 2 diabetes. In addition to helping control blood sugar levels, the drugs produce a feeling of fullness. 半卢宾属于一类称为GLP-1激动剂的药物，这些药物旨在治疗2型糖尿病。 除了帮助控制血糖水平外，这些药物还会产生一种饱满感。 Concerns over reports of suicidal ideation connected with semaglutide led to an investigation by the European Medicines Agency. The U.S. Food and Drug Administration (FDA) has listed suicidal ideation as a possible safety concern for GLP-1 drugs. 人们对与Semaglutide有关的自杀念头的报道的担忧导致了欧洲药品局的调查。 美国食品药品监督管理局（FDA）已将自杀意念列为GLP-1药物的安全问题。 A Reuters examination last year found that the FDA had received 265 reports of suicidal thoughts or behavior in patients taking semaglutide or similar medicines since 2010. Thirty-six of those reports describe a death by suicide or suspected suicide. 路透检查员去年的一项检查发现，自2010年以来，FDA收到了265例服用Semaglutide或类似药物的患者的自杀念头或行为的报告。这些报告中有36例描述了自杀或怀疑自杀的死亡。 Such events do not prove a connection between a drug and a side effect. But they can signal to officials a need to study a specific risk. 此类事件不能证明药物与副作用之间的联系。 但是他们可以向官员发出信号，需要研究特定的风险。The study appeared online in the journal Nature. It was funded by the U.S. National Institutes of Health. The researchers examined data on 240,258 U.S. patients prescribed Wegovy or other medications for weight loss and nearly 1.6 million with type 2 diabetes prescribed Ozempic or other treatments. 该研究在《自然》杂志上在线出现。 它由美国国立卫生研究院资助。 研究人员检查了有关240,258名美国患者的数据，以减肥或其他药物为160万例服用Wegovy或其他药物，并使用了2型糖尿病开处方的Ozempic或其他治疗方法。
It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: A new Austrailian study aims to prevent type 1, the new twiist pump will integrate with Eversnse CGM as well as Libre, diabetes deaths are down in the US, Dexcom U is looking for college athletes, and more! Find out more about Moms' Night Out Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom Check out VIVI Cap to protect your insulin from extreme temperatures The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX A world-first human trial of a drug designed to treat the underlying cause of type 1 diabetes has begun in Australia. University of Queensland researcher Ranjeny Thomas said the experimental drug — dubbed ASITI-201 — was designed to retrain the immune system so it no longer attacks the insulin-producing pancreatic cells, known as beta cells. The drug, given as an injection under the skin, combines fragments of a protein found in the beta cells of people with type 1 diabetes and vitamin D to calm the immune response. She said if effective, the drug would initially be given to patients with type 1 diabetes as soon as possible after diagnosis to preserve remaining pancreatic cells and reduce the amount of insulin needed. But eventually, if screening programs can be developed to pick up people at risk of developing type 1 diabetes, it may be possible to "prevent the progression of the disease altogether". The first in-human trial of 36 participants will test the safety of the drug, but blood tests will also determine the impact of the therapy on a patient's immune system and glucose tolerance. https://www.abc.net.au/news/2025-04-29/type-1-diabetes-drug-trial-auto-immune-disease-science/105223022 XX Diabetes deaths in the U.S. have fallen to some of the lowest rates in years, according to new preliminary figures published by the Centers for Disease Control and Prevention, reversing a surge in mortality that was seen during the COVID-19 pandemic. There were 26.4 deaths per 100,000 people from diabetes, according to early death certificate data for the third quarter of 2024 published this month by the CDC's National Center for Health Statistics. Death rates from diabetes peaked in 2021, according to CDC figures, at 31.1 deaths per 100,000 people for that year. Diabetes was the eighth leading cause of death in 2021. The CDC says the link between COVID-19 and diabetes may be to blame for that increase. "Data show an increase in mortality rates for all people during the COVID-19 pandemic, and research shows that people with underlying conditions, including diabetes, are more likely to become very sick from COVID-19 and have a higher risk of hospitalization and death," Christopher Holliday, head of the CDC's Division of Diabetes Translation, told CBS News in a statement. Holliday added that research shows the pandemic may also have made it harder for Americans to properly manage the disease, ranging from interruptions to physical activity to disruptions to routine medical care diagnosing and treating the disease. https://www.cbsnews.com/news/diabetes-deaths-lowest-levels-years-early-cdc-figures/ XX Big news for the Eversense CGM – they have their first pump partner. Sequel Med Tech says the twist pump will integrate with Senseonics Eversense 365 continuous glucose monitor (CGM). This collaboration would make twiist the first AID system compatible with Eversense 365, the world's first and only one-year CGM. Sequel and Senseonics say they have already started their work to integrate the latest-generation, 365-day implantable sensor with twiist. They expect to make the integrated offering available in the third quarter of this year. This marks the second CGM integration for Sequel, which partnered with Abbott and its FreeStyle Libre platform earlier this year. This week we also got a peek at the packaging and delivery of the twist as the first people posted about wearing it. We'll follow up and learn more about this newest insulin pump in the us. Senseonics, meanwhile, brought the first year-long CGM to market last year, launching Eversense 365 with its global distribution partner, Ascensia Diabetes Care, in October 2024. The system also received clearance as an integrated CGM (iCGM) system, meaning it can work with compatible medical devices. Those include insulin pumps as part of automated insulin delivery systems. https://www.drugdeliverybusiness.com/sequel-senseonics-integrate-cgm-insulin-pump/ XX Medtronic has announced the U.S. Food and Drug Administration (FDA) approval for the Simplera Sync sensor for use with the MiniMed 780G system. With this approval, the MiniMed 780G system now offers more flexibility for users of the company's most advanced insulin delivery system featuring Meal Detection technology with both the Guardian 4 sensor and Simplera Sync sensor. The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard or overtape and features a simple, two-step insertion process. It is the company's newest addition to its CGM portfolio, which expands options and provides greater flexibility for users. The MiniMed 780G system's adaptive algorithm automatically anticipates, adjusts, and corrects glucose levels every 5 minutes, 24/7 – working around the clock so users can focus on what matters. It's the only system featuring Meal Detection technology, which detects rising sugar levels and delivers more insulin as needed to help users keep glucose levels in range more often – even when users occasionally forget to dose insulin for snacks or meals or underestimate their carbs. The system uses a “treat to target” approach and flexible glucose targets as low as 100 mg/dL, which, combined with its adaptive algorithm allows it to more closely mirror the glucose levels of someone not living with diabetes. Real-world data of the system shows global users consistently achieve time in range above international targets of 70% when using optimal settings (active insulin time of two hours and 100 mg/dL target glucose). It is also the only system that works with the world's only infusion set that lasts up to 7 days so that users only have to change their infusion set once per week and can experience 96% fewer injections compared to multiple daily injections. “We're committed to driving innovation that makes life easier for those living with diabetes so they can forget about their diabetes as much as possible throughout the day,” said Que Dallara, EVP and president of Medtronic Diabetes. “Our MiniMed 780G system delivers advanced diabetes technology for so many around the world, and we're excited to continue evolving this experience with expanded CGM options —including our Simplera Sync sensor, which we look forward to bringing to people living with diabetes in the U.S.” A limited launch of the Simplera Sync sensor will begin in the U.S. in the fall of 2025. Today, the MiniMed 780G system can be used with the Guardian 4 sensor. Like this:https://med-techinsights.com/2025/04/29/simplera-sync-sensor-for-minimed-780g-now-fda-approved/ XX Front office changes at Insulet.. The former head of Johnson & Johnson's worldwide medtech business, Ashley McEvoy will take over as president and CEO from Jim Hollingshead, who has led Insulet since 2022. In its announcement of the leadership change, Insulet said that Hollingshead and the company mutually agreed to part ways, effective immediately. McEvoy served as worldwide medtech chairman at J&J from 2018 until her departure in late 2023, the culmination of nearly 30 years at the company and several executive roles—including president of its Ethicon division and group chairman of vision and diabetes care. Since then, she has also served as a board member at Procter & Gamble. https://www.fiercebiotech.com/medtech/insulet-taps-former-jj-medtech-head-ashley-mcevoy-be-ceo XX New free mobile game launched this week to make type 1 diabetes onboarding faster easier and less overwhelming. It's called Level One.. created by Level Ex (Powered by Relevate Health), the studio behind award-winning medical games for medical professionals. Level Ex CEO Sam Glassenberg created the game after a – quote - brutal onboarding experience when his daughter was diagnosed five years ago He says It took a year to understand how to manage this disease. So we fixed it. We built a game that can train your brain to do it in a matter of hours." The game is launching in partnership with leading diabetes organizations Beyond Type 1 and Breakthrough T1D Play, who are integrating Level One into their outreach and educational campaigns to support newly diagnosed families worldwide. Download Level One on the App Store: https://apps.apple.com/us/app/level-one-a-diabetes-game/id6739605694 Learn more: https://playlevelone.com https://www.prnewswire.com/news-releases/level-ex-launches-level-one-a-free-mobile-game-to-redefine-type-1-diabetes-onboarding-302440929.html XX Collagen is widely recognized for its role in maintaining healthy skin, but its importance extends far beyond that. As the most abundant protein in the human body, collagen provides essential structure and support to nearly all tissues and organs. Now, researchers at Carnegie Mellon's Feinberg Lab have made a major breakthrough using their novel Freeform Reversible Embedding of Suspended Hydrogels (FRESH) 3D bioprinting technique. This method enables the precise printing of soft, living cells and tissues. Leveraging this technology, the team successfully created the first-ever microphysiologic system, also known as a tissue model, constructed entirely from collagen. This advancement opens new possibilities for studying disease and engineering tissue therapies, including potential treatments for conditions like Type 1 diabetes. Traditionally, small-scale models of human tissue, referred to as microfluidics, organ-on-chip devices, or microphysiologic systems, have been fabricated using synthetic materials such as silicone rubber or plastics. These materials were necessary due to limitations in earlier manufacturing techniques. However, because they are not biologically native, they fail to fully replicate natural tissue environments, restricting their effectiveness in biomedical research and therapeutic development. “Now, we can build microfluidic systems in the Petri dish entirely out of collagen, cells, and other proteins, with unprecedented structural resolution and fidelity,” explained Adam Feinberg, a professor of biomedical engineering and materials science & engineering at Carnegie Mellon University. “Most importantly, these models are fully biologic, which means cells function better.” Building Complex Tissues with FRESH Bioprinting In new research published in Science Advances, the group demonstrates the use of this FRESH bioprinting advancement, building more complex vascularized tissues out of fully biologic materials, to create a pancreatic-like tissue that could potentially be used in the future to treat Type 1 diabetes. This advancement in FRESH bioprinting builds on the team's earlier work published in Science, by improving the resolution and quality to create fluidic channels that are like blood vessels down to about 100-micron diameter. “There were several key technical developments to the FRESH printing technology that enabled this work,” described Daniel Shiwarski, assistant professor of bioengineering at the University of Pittsburgh and prior postdoctoral fellow in the Feinberg lab. “By implementing a single-step bioprinting fabrication process, we manufactured collagen-based perfusable CHIPS in a wide range of designs that exceed the resolution and printed fidelity of any other known bioprinting approach to date. Further, when combined with multi-material 3D bioprinting of ECM proteins, growth factors, and cell-laden bioinks and integration into a custom bioreactor platform, we were able to create a centimeter-scale pancreatic-like tissue construct capable of producing glucose-stimulated insulin release exceeding current organoid based approaches.” https://scitechdaily.com/scientists-bioprint-living-tissues-that-could-revolutionize-diabetes-treatment/ XX Another study showing the blood sugar benefit of walking after a meal. Skeletal muscle plays a central role in glucose uptake. Exercise stimulates glucose transport into muscle cells through insulin-independent pathways, notably through the action of glucose transporter type 4 (GLUT-4), which is responsible for transporting glucose from blood to skeletal muscles.4 This means that even without a robust insulin response, physical activity can facilitate glucose clearance from the bloodstream. These effects also occur without requiring high-intensity exercise, making postprandial walking accessible to a broad range of individuals, including those with limited exercise tolerance. multiple studies show that starting activity within 30 minutes after a meal is optimal. https://www.news-medical.net/health/Walking-After-Meals-Small-Habit-Big-Metabolic-Gains.aspx XX Dexcom brings back Dexcom U for a 4th years. This is a name, image and license program for college athletes with diabetes and includes a nationwide open call for passionate and inspiring college athletes to join its roster. Now through May 23, athletes, coaches, friends and family members can nominate candidates through an online submission. Those selected, along with the eight returning athletes from last year, will be invited to attend the Dexcom U Signing Day Camp this summer, hosted by Dexcom Warrior and Baltimore Ravens tight end Mark Andrews. https://www.hmenews.com/article/dexcom-u-returns-for-fourth-season
Dr. Joseph Ladapo is a Nigerian-American physician and health policy researcher currently serving as the Surgeon General of Florida since 2021. Born in Nigeria, he immigrated to the United States at the age of 5 with his family when his father, a microbiologist, came to continue his studies. Dr. Ladapo completed his undergraduate studies at Wake Forest University, where he was a decathlete and captain of the varsity track and field team. He then went on to earn his MD from Harvard Medical School and a PhD in Health Policy from Harvard Graduate School of Arts and Sciences. He completed his clinical training in internal medicine. Throughout his career, Dr. Ladapo has held various academic positions. He served as a faculty member in the Department of Population Health at NYU School of Medicine and as a Staff Fellow at the U.S. Food and Drug Administration (FDA). Prior to his current role, he was an Associate Professor at the David Geffen School of Medicine at UCLA. Dr. Ladapo's research focuses on clinical trial interventions and reducing the population burden of cardiovascular disease. His work has been funded by the National Institutes of Health (NIH) and the Robert Wood Johnson Foundation, and his studies have been published in leading medical journals. In recent years, Dr. Ladapo has gained prominence for his bold stance on COVID-19 mitigation measures, in which he opposed mask and vaccine mandates, questioned the safety of COVID-19 vaccines, and approved alternative treatments. Currently, Dr. Ladapo serves as a Professor of Medicine at the University of Florida College of Medicine in addition to his role as Florida's Surgeon General. He is married and has three young children.
Diabetes Dialogue: Therapeutics, Technology, & Real-World Perspectives
Video Version Only on HCPLive! In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, break down new Phase 3 data from the ESSENCE trial examining semaglutide 2.4 mg (Wegovy) for metabolic dysfunction-associated steatohepatitis (MASH) with stage 2 or 3 fibrosis. With results published in The New England Journal of Medicine, hosts are joined by first author Arun J. Sanyal, MD, director of the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health at Virginia Commonwealth University, to discuss key takeaways from part 1 of the ESSENCE trial, semaglutide's impact on liver outcomes and weight loss, and what the data could mean for the future of MASH treatment. ESSENCE Once-weekly semaglutide 2.4 mg significantly improved liver outcomes in patients with metabolic dysfunction–associated steatohepatitis (MASH) and stage 2 or 3 fibrosis, according to findings from the ESSENCE trial. In part 1 of the ongoing, double-blind, placebo-controlled trial, 800 patients were evaluated at 72 weeks for two primary endpoints: resolution of steatohepatitis without worsening fibrosis, and fibrosis improvement without worsening steatohepatitis. Spanning 253 sites in 37 countries, the full trial enrolled 1197 biopsy-confirmed patients between May 2021 and April 2023. At the interim analysis, semaglutide achieved both primary endpoints. Resolution of steatohepatitis without fibrosis worsening occurred in 62.9% of patients receiving semaglutide compared with 34.3% in the placebo group (difference, 28.7%; 95% CI, 21.1–36.2; P
Disclaimer: This episode was recorded on April 11th, 2025, and reflects the information available at the time of recording. As we know, America is in motion here, and so subsequent updates may not be reflected in this discussion as things continue to evolve and change. Tune in as PwC specialists from across the health industry share their insights on how recent policy shifts under the Trump administration could shape healthcare in the years to come. In this episode, Glenn Hunzinger, Jenny Colapietro, and guests Kelly Griffin, Phil Sclafani, and Ruchita Kewalramani break down the potential implications of proposed government healthcare cuts, tariff policy and agency workforce reductions, along with the growing role of AI in the industry. They also discuss how pharma, medtech, payers and providers can stay ahead amidst the uncertainty. Discussion highlights:Proposed funding cuts to major government healthcare programs like Medicare, Medicaid, and NIH could significantly disrupt access, affordability, and service delivery across the healthcare landscape.Workforce reductions at federal agencies like the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and Health and Human Services (HHS) may slow drug approvals, diminish oversight, and impact public health standards.New and evolving tariff policies are creating cost pressures across pharmaceutical and medtech supply chains, with potential downstream impacts on pricing, R&D, and patient access.The rapid adoption of AI in healthcare is creating new opportunities across diagnostics, R&D, and operations, while also raising concerns around governance and data privacy.To stay ahead, industry leaders must assess risks, strengthen agility, and uncover opportunities to innovate in today's dynamic environment.Speakers:Kelly Griffin, Director, Health Policy Intelligence Institute, PwCRuchita Kewalramani, Partner, Health Services PwCPhil Sclafani, Partner, Pharma & Life Sciences, PwCGlenn Hunzinger, Partner, Health Industries Leader, PwCJenny Colapietro, Principal, Consulting Commercial Leader, PwCLinked materials:Health Policy and Intelligence InstituteFor more information, please visit us at: https://www.pwc.com/us/en/industries/health-industries/health-research-institute/next-in-health-podcast.html.
This is the Catch Up on 3 Things by The Indian Express and I am Ichha SHarmaIt is the 23rd of April and here are today's headlines.Expressing anguish over the Pahalgam terror attack that killed at least 26 people, Union Minister Amit Shah on X said, quote “Bharat will not bend to terror. The culprits of this dastardly terror attack will not be spared. With a heavy heart, pay last respects to the deceased.” unquote. Shah also met the survivors and assured them that the perpetrators of the dastardly act would be brought to justice. Meanwhile, the Jammu and Kashmir government announced Rs 10 lakh ex gratia for each deceased's family; Rs 2 lakh for the seriously injured and Rs 1 lakh for injured victims. Prime Minister Narendra Modi is expected to hold a key meeting with the Cabinet Committee on Security in the first half of the day, wherein India will formulate its response and defence strategy.Meanwhile, Pakistan's Defence Minister Khwaja Asif claimed today that they have nothing to do with the incident in which at least 25 tourists were killed and several others were injured. Indian officials, however, are not convinced by Pakistan's denial since the initial probe has suggested the presence of foreigners as part of the group of militants who opened fire at the civilians. At least 25 tourists and a Valley resident were shot dead Tuesday at a meadow near Pahalgam in Jammu and Kashmir in the deadliest terror attack on civilians in the country since the Mumbai 26/11 shootings. Asif told a Pakistan TV channel about the Pahalgam attack. “We have absolutely nothing to do with it. We reject terrorism in all its forms and everywhere.” The Brihanmumbai Municipal Corporation last week demolished most of the Digambar Jain temple in Vile Parle in the city's western suburbs, triggering outrage and protests among members of the community, as well as politicians across parties. Under pressure, the civic administration transferred the assistant municipal commissioner in charge of the BMC's K/East ward office, which had carried out the demolition. Civic and court records accessed and evaluated by The Indian Express show that the first notice for demolishing the allegedly illegal structure was issued to the temple trust back in 2005. Since then, the BMC made nine attempts to raze the alleged illegal structure – and finally carried out the action on April 16.Amid its ongoing crusade against drugs, Punjab has become the first state in the country to ban energy drinks in and around schools to keep the children away from caffeine addiction. A notification to this effect was issued by the government on Tuesday, banning the sale of energy drinks in school canteens and outside school premises. The notification, issued by Dilraj Singh Sandhawalia, Commissioner of Food and Drug Administration (FDA), Punjab, states that it is “just and necessary” to prohibit the consumption of caffeinated energy drinks by children. The notification says that energy drinks are heavily marketed to children and young adults and others and manufacturers compare the effects of the drinks to the use of drugs like cocaine.A wildfire in New Jersey has forced residents to evacuate the area and shut down a stretch of a major highway on Tuesday as the wildfire grew to more than 3,200 acres, officials said. One of the busiest highways in New Jersey, the Garden State Parkway, saw closures due to the spread of wildfire and the stretch between Barnegat and Lacey townships was closed and the traffic was diverted, Associated Press reported. According to New Jersey Forest Fire Service, over 3,000 residents have been evacuated from the area of the Jones Road Fire in Ocean County and about 1,320 structures remain threatened. The fire service added that 5% of the wildfire has been contained till now.This was the Catch Up on 3 Things by The dian Express
Chew is a comic book series created by John Layman with art by Rob Guillory published by Image Comics. This series revolves around the stories about U.S. Food and Drug Administration (FDA) agent, Tony Chu, who solves crimes by receiving psychic impressions from whatever he consumes as food otherwise known as the powers of a Cibopath. In a world where due to a mass bird flu epidemic caused chicken to be outlawed and illegal, Agent Tony Chu is hired by the FDA stop black market chicken based crimes across America and other parts of the world. Teamed up with his cyborg partner John Colby, the two agents deal with everything from missing health inspectors, saving Poyo the chicken fighting champion, investigating a new mysterious chicken substitute, fighting vampires, a chicken smuggling ring, and so much more. This series filled with humor, mystery, action and recommended for fans looking to dig into a new buddy cop style series that is refreshing while still doing great character development and brilliant storytelling.
This Episode is Sponsored by: RSM US LLP It's tariff time, and companies the world over are working to better understand how their operations will be impacted. Jodi Ader from RSM US LLP joined The Food Institute Podcast to discuss which products and inputs are currently subject to tariffs, and how to best mitigate supply chain risks. More about Jodi Ader: Jodi Ader is an international tax senior manager with over 25 years of experience in international trade. She is well-positioned to assist corporations in planning and creating world-class compliance operations and food safety programs. She has substantial experience in import, export control and sanction matters, including U.S. Customs and Border Protection (CBP), U.S. Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and Environmental Protection Agency (EPA) regulations. E-mail Jodi: jodi.ader [at] rsmus.com Find Jodi on LinkedIn: https://www.linkedin.com/in/jodi-ader-ba05b23/ More about RSM US LLP: RSM US LLP, has a robust practice supporting food and beverage brands across worldwide with a wide range of audit, tax and consulting services. The clients we serve are the engine of commerce and economic growth, and we are focused on developing leading professionals and services to meet their evolving needs in today's ever-changing business environment. RSM US LLP is part of RSM International, a global network of independent firms with 64,000 people across 120 countries. For more information, visit https://rsmus.com/, or follow us on Twitter (https://twitter.com/rsmusllp) and/or connect with us on LinkedIn (https://www.linkedin.com/company/rsm-us-llp/).
On Tuesday, April 1, the Trump administration began large-scale layoffs at agencies across the Department of Health and Human Services (HHS). HHS Secretary Robert F. Kennedy Jr. said he expected to cut 10,000 jobs in addition to the thousands of workers who have already resigned or been placed on leave. The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have been among the most impacted by the layoffs, with entire offices and divisions eliminated. Ad-free podcasts are here!Many listeners have been asking for an ad-free version of this podcast that they could subscribe to — and we finally launched it. You can go to ReadTangle.com to sign up!You can read today's podcast here, our “Under the Radar” story here and today's “Have a nice day” story here.Take the survey: What do you think of the HHS cuts? Let us know!You can subscribe to Tangle by clicking here or drop something in our tip jar by clicking here. Our Executive Editor and Founder is Isaac Saul. Our Executive Producer is Jon Lall.This podcast was written by Isaac Saul and edited and engineered by Dewey Thomas. Music for the podcast was produced by Diet 75.Our newsletter is edited by Managing Editor Ari Weitzman, Senior Editor Will Kaback, Hunter Casperson, Kendall White, Bailey Saul, and Audrey Moorehead. Our logo was created by Magdalena Bokowa, Head of Partnerships and Socials. Hosted on Acast. See acast.com/privacy for more information.
(AURN News) — Sad news for Texas Pete fans. The Food and Drug Administration (FDA) announced Friday that T.W. Garner Food Company is recalling select lots and sizes of its Texas Pete® Habanero Buffalo Sauce. The FDA says some bottles may contain Sriracha sauce that includes sulfites not listed on the label. According to the agency, people with an allergy or severe sensitivity to sulfites face the risk of a serious or life-threatening reaction. The recalled products were distributed between Feb. 5 and March 26, 2025. They were shipped to distribution centers and retail stores in California, Colorado, Connecticut, Illinois, Massachusetts, North Carolina, New Jersey, Ohio, Virginia, and Vermont. To see photos and more information about the recalled bottles, visit the FDA's website. Learn more about your ad choices. Visit megaphone.fm/adchoices
Send us a textOn this episode we speak with Dr. Jesse Goodman about the spread of the H5N1 virus. We will discuss what a virus is, how viruses migrate from animal populations to humans and assess the chances for a new pandemic.Jesse L. Goodman, M.D., M.P.H., directs Georgetown COMPASS, which focuses on science based policy and research to address unmet public health needs with an emphasis on product development and access and antimicrobial resistance and stewardship. Until February 2014 he served as the Chief Scientist of the US Food and Drug Administration (FDA), a position he assumed in 2009 along with Deputy Commissioner for Science and Public Health (2009-2012). As FDA's Chief Scientist he had broad responsibility for strategic leadership of crosscutting scientific and public health efforts, including developing and implementing FDA's Strategic Plan for Regulatory Science and FDA's public health preparedness and response and medical countermeasures efforts.A graduate of Harvard, Dr. Goodman received his M.D. from the Albert Einstein College of Medicine and did residency and fellowship training in Medicine, Infectious Diseases and Oncology at the Hospital of the University of Pennsylvania and at the University of California in Los Angeles (UCLA), where he was also Chief Medical Resident. https:/natureandsciencepodcast.com
It’s been a whirlwind week in public health. In this episode, host Steven Newmark breaks down a string of major developments coming out of the U.S. Department of Health and Human Services (HHS). From mass layoffs across HHS, including at the FDA, to the resignation of the country’s top vaccine regulator, these changes raise serious concerns—especially amid a rising measles outbreak. Tune in to hear what this means for patients, public health efforts, and the fight against vaccine hesitancy. Among the highlights in this episode: 00:50: Steven Newmark, Chief of Policy at GHLF, discusses HHS Secretary Robert F. Kennedy Jr.’s announcement of 10,000 staff layoffs, with the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) being the most impacted 01:31: Steven reflects on RFK Jr.'s earlier warning to FDA workers to "pack their bags" and discusses concerns about maintaining service levels with a 25% workforce cut 02:08: Quoting Robert Califf, Steven shares the demoralization felt by former and current HHS staff, calling out the treatment of hardworking public health employees 02:38: Steven shares concerns from Chiquita Brooks-LaSure, former Centers for Medicare & Medicaid Services (CMS) head, particularly around the likely impact of layoffs on already underfunded nursing home inspections 03:20: Steven reports the forced resignation of Dr. Peter Marks, the FDA’s top vaccine regulator, and the alarming response from the public health community 04:06: Steven details Dr. Marks’ warnings about leadership skepticism toward vaccines, especially in light of the growing measles outbreak 04:34: Steven gives an update on the measles outbreak in Texas and other states, citing more than 500 cases nationwide and highlighting RFK Jr.'s unscientific treatment suggestions like vitamin A and cod liver oil 05:16: Steven discusses how HHS cuts are hampering efforts to track infectious diseases and fund vaccine research, even as the outbreak fuels a shift toward pro-vaccine sentiment in affected areas 05:49: Steven urges listeners to get vaccinated and ensure those around them—especially children—are protected with the Measles, Mumps, and Rubella (MMR) vaccine Contact Our Host Steven Newmark, Chief of Policy at GHLF: snewmark@ghlf.org A podcast episode produced by Ben Blanc, Director, Digital Production and Engagement at GHLF. We want to hear what you think. Send your comments in the form of an email, video, or audio clip of yourself to podcasts@ghlf.org Catch up on all our episodes on our website or on your favorite podcast channel.See omnystudio.com/listener for privacy information.
The Food and Drug Administration (FDA) has issued a warning letter to a California company for allegedly marketing an injectable cannabis product while making unsanctioned claims about its potential health benefits. KFBK's Mark Demsky with more.
The Rich Zeoli Show- Full Episode (03/18/2025): 3:05pm- On Friday, President Donald Trump issued orders to deport roughly 250 dangerous gang members who entered the U.S. unlawfully—sending them to El Salvador where they will be held at the country's “terrorism confinement center.” Judge E. Boasberg, of the U.S. District Court for D.C., ordered the Trump Administration to have the planes reverse course and return the detainees to the United States. However, due to the late timing of the order, the Trump Administration followed through with the deportation as planned. The administration contends the removals were lawful and within the established powers of the executive branch, specifically citing the Alien Enemies Act of 1798. 3:30pm- Rich references the 1984 film, “Red Dawn”—starring Patrick Swayze, Charlie Sheen, and Jennifer Grey. Matt reveals he has never seen the original, but he has seen the terrible 2012 remake starring Chirs Hemsworth. He also concedes he has never seen the original “Top Gun” or Oliver Stone's “JFK.” 3:45pm- The Alien Enemies Act of 1798, which the Trump Administration cited as grounds for legally deporting Tren de Aragua gang members who entered the United States illegally, states: “Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That whenever…any invasion or predatory incursion shall be perpetrated, attempted, or threatened against the territory of the United States, by any foreign nation or government, and the President of the United States shall make public proclamation of the event, all natives, citizens, denizens, or subjects of the hostile nation or government, being males of the age of fourteen years and upwards, who shall be within the United States, and not actually naturalized, shall be liable to be apprehended, restrained, secured and removed, as alien enemies.” 4:05pm- Speaking with the press, President Donald Trump said that on Tuesday afternoon he will be releasing “all of the [President John F.] Kennedy [assassination] files.” According to The Daily Wire, the release will include 80,000 documents. The documents are yet to be released. 4:30pm- On Friday, several Senate Democrats—following Senate Minority Leader Chuck Schumer's recommendation—broke the filibuster allowing Republicans to pass a continuing resolution bill that prevented a government shutdown at least through September. According to reports, Schumer is now being targeted for a primary challenge and even temporarily delayed his book tour due to progressive backlash. While appearing on The View, Schumer went into damage control—denying claims he “caved” to Republicans. He also revealed that he wakes up at 3am in the morning worried about “oligarchs” like Elon Musk. 4:40pm- In a post to social media, Senator Elizabeth Warren complained that Tesla has only paid $48 million in taxes over the last 3-years despite earnings of $10.8 billion. But the Wall Street Journal Editorial Board adroitly notes that the generous tax breaks were all provided to Tesla courtesy of green energy and electric vehicle mandates created by, and endorsed by, Democrats. 5:05pm- Operation Stork Speed! Health and Human Services Secretary Robert F. Kennedy Jr., working alongside the Food and Drug Administration (FDA), announced efforts to “expand options for safe, reliable, and nutritious infant formula.” 5:15pm- While appearing on the show yesterday, Bill D'Agostino—Senior Research Analyst at Media Research Center—unveiled his latest montage masterpiece which consists of leftists openly praising Elon Musk prior 2024—calling him a “genius” and “the real-life Iron Man.” Now, they all hate him! 5:20pm- On Tuesday's episode of The View, host Sonny Hostin grilled Senate Minority Leader Chuck Schumer over his decision to help Republicans overcome the Senate filibuster and pass a continuing resolution bill that averted an imminent government shutdown. Schumer insisted he deserves to rem ...
The Rich Zeoli Show- Hour 4: 5:05pm- Operation Stork Speed! Health and Human Services Secretary Robert F. Kennedy Jr., working alongside the Food and Drug Administration (FDA), announced efforts to “expand options for safe, reliable, and nutritious infant formula.” 5:15pm- While appearing on the show yesterday, Bill D'Agostino—Senior Research Analyst at Media Research Center—unveiled his latest montage masterpiece which consists of leftists openly praising Elon Musk prior 2024—calling him a “genius” and “the real-life Iron Man.” Now, they all hate him! 5:20pm- On Tuesday's episode of The View, host Sonny Hostin grilled Senate Minority Leader Chuck Schumer over his decision to help Republicans overcome the Senate filibuster and pass a continuing resolution bill that averted an imminent government shutdown. Schumer insisted he deserves to remain the Democrat leader in the Senate—citing his proven history as a tactician. However, Senators Jeanne Shaheen (D-ME) and Gary Peters (D-MI) have both announced they won't run for reelection in 2026. Both races are now expected to be hyper-competitive—which doesn't bode well for Democrats…or Schumer. 5:30pm- The Alien Enemies Act of 1798, which the Trump Administration cited as grounds for legally deporting Tren de Aragua gang members who entered the United States illegally, states: “Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That whenever…any invasion or predatory incursion shall be perpetrated, attempted, or threatened against the territory of the United States, by any foreign nation or government, and the President of the United States shall make public proclamation of the event, all natives, citizens, denizens, or subjects of the hostile nation or government, being males of the age of fourteen years and upwards, who shall be within the United States, and not actually naturalized, shall be liable to be apprehended, restrained, secured and removed, as alien enemies.”
*The is the FREE archive, which includes advertisements. If you want an ad-free experience, you can subscribe below underneath the show description.West Virginia is the first state to begin the process of banning a wide range of food dyes and other synthetic food preservatives, something strictly contrasted by their leading the nation in obesity and being overweight, not to mention the state having the highest of the former for children, the highest rate of high cholesterol and type 2 diabetes, and being a leader in obesity-related death, and hypertension. But you have to start somewhere. Other states are following, from Oklahoma to New York. This comes immediately after a meeting between RFK Jr and the CEOs of PepsiCo North America, Kraft Heinz, General Mills, Tyson Foods, W.K. Kellogg and J.M. Smucker. Some proposed laws would also require food companies to disclose “secret” food ingredients to the public that have been allowed into the marketplace under a federal standard known as “generally recognized as safe”, or GRAS, a term that acts like a rubber stamp for fraud. The National Confectioners Association (NCA) said that the measures “will make food significantly more expensive for, and significantly less accessible to, people in the states that pass them.” The association also said the federal government – in the form of the Food and Drug Administration (FDA) – should be the final arbiter for food additives. But this is not food, and the FDA cannot be the final arbiter of food additives when it is essentially run by the industry it is supposed to regulate. Men's Health magazine goes on to parrot the same NCA talking points: “Processed foods are safe, inexpensive, and capable of delivering nutrition—especially to people of lower-income and/or living in food deserts, where fresh food is hard to find. In fact, healthy food prices are increasing at a rate almost double that of unhealthy foods.”This argument is similar to the one used by biotech, claiming for decades that their products and patents would lower the cost of food. They haven't. In a write up for the same Men's Health magazine, Abby Langer, R.D., MH nutrition advisor, repeats another talking point: “Banning dyes stirs up unnecessary anxiety around the food system, which is the safest it has ever been.” When a recent laboratory report was published on Girl Scout cookies, demonstrating the high levels of heavy metals and chemicals, the FDA said naturally-occurring heavy metals like arsenic, cadmium, chromium, lead, and mercury are just a “reality about our food supply.” Abby then goes on to parrot the NCA by opposing bans over the issue of cost: the banning of these dyes may drive up food prices as companies scramble to find alternatives, furthering the issue of food security, Langer says. "Nobody thinks that Fruity Pebbles and candy are health foods; however, when ultra-processed foods are the cheapest and most accessible option, that's where the problem lies," Langer says. "I consider the entire food dye conversation a distraction from what we really should be focusing on: access to healthy foods, access to healthcare, nutrition education in schools, grocery prices, and food deserts."But food deserts only affect 13% of the population, while the poorest residents tend to live in cities. Those in the so-called deserts usually have the means to travel the 1-20 mile which constitutes a desert, or they have the ability to order food. This same argument is being use Axios to defend SNAP allowing for the purchase of junk: “There are a number of risks with the proposal to cut foods from SNAP, including logistical and cost concerns, access in food deserts, equity issues and questions over how to measure success and behavioral changes among consumers.”These are the same arguments that have been used by industry and their PR representatives for decades, like when, 12 years ago, so called journalists claimed McDonald's was the “cheapest and most nutritious food in human history.”Food industry advocates have protested efforts to ban the additives, citing what they say is a lack of proof that the chemicals are harmful to people, and arguing such laws will raise food prices. Thus the argument has shifted from defending this trash as “food” to justifying its as “junk.”In other news, the Girl Scouts are being sued for their garbage cookies.-FREE ARCHIVE (w. ads)SUBSCRIPTION ARCHIVEX / TWITTER FACEBOOKWEBSITECashApp: $rdgable EMAIL: rdgable@yahoo.com / TSTRadio@protonmail.comBecome a supporter of this podcast: https://www.spreaker.com/podcast/tst-radio--5328407/support.
Episode 10 highlights examples of how patient advocacy groups influenced pharmaceutical decisions at the US Food and Drug Administration (FDA). In a conversation with health policy researcher, author and activist, Sharon Batt PhD, we explore regulatory decisions on Relyvrio (AMX0035), Avastin (bevacizumab), and Addyi (flibanserin) within the context of our latest report “What Needs to Change at the FDA?Protecting and Advancing Public Health.”Pharmanipulation is produced by PharmedOut, a project at Georgetown University Medical Center that advances evidence-based prescribing. Additional Resources Full Report “What Needs to Change at the FDA? Protecting and Advancing Public Health”: https://georgetown.box.com/s/n87us836fpmdhtcvdaqopyobfwx7bymx Webinar on “What Needs to Change at the FDA?”: https://www.youtube.com/watch?v=4g9br3wZW-k&t=11s Article on “How some drug companies manipulate patient advocates” by Judith Garber: https://lowninstitute.org/how-some-drug-companies-manipulate-patient-advocates/
SymPhysis Medical, the Galway MedTech company seeking to address the distressing condition of fluid in the chest in cancer patients, has announced a significantly strengthened senior team and plans for rapid growth as it prepares for its device's US launch. With clearance from the US Food and Drug Administration (FDA) targeted by 2026, SymPhysis Medical aims to launch its device within the next 18 months and to reach €40M in revenue by 2030. Founded by CEO Tim Jones and Chief Scientific Officer, Dr Michelle Tierney, SymPhysis Medical has developed a device, releazeTM, which can be used by cancer patients who are receiving palliative care to relieve the symptoms of fluid in the chest. These symptoms include shortness of breath, discomfort and pain. The condition, experienced by approximately 50% of late-stage cancer patients, limits movements and activities, while necessitating regular medical appointments at a time when many wish to be at home and spending time with loved ones. The company founders expect their device's launch in the US to mark a transformation in the care, and quality of care, of these patients. In the most recent funding round, SymPhysis Medical has raised €2.8M and expects to close a further €3.7M from a combination of current and new investors by April 2025. Investors have been impressed by SymPhysis Medical's ambitious growth plans and focus on a market, worth €860M in the US and Europe alone, which has lacked innovation over the last 25 years. The company was endorsed by the European Innovation Council (EIC) in February 2025, receiving the Seal of Excellence, which highlights the value and impact of the innovation. SymPhysis Medical expects to represent 20% of the US market by 2030 and 10% of the European market in the same period. This will mean that 35,000 patients could be benefiting from releazeTM by 2030. Driving SymPhysis Medical's post-launch growth and momentum will be an enhanced senior team whose track record covers some of the world's largest MedTech and life sciences companies. Their expertise includes sales and distribution of medical devices, business strategy and regulatory affairs. Joe Villanova, VP Sales and Marketing, will drive SymPhysis Medical's penetration of the US market. He has more than 35 years of experience in commercialising medical devices, with 15 years of experience in those addressing fluid in the chest. He has held leadership roles in multinationals including Baxter Healthcare and Becton Dickinson. Meanwhile, Niamh St John Lynch, Director of Quality Assurance and Regulatory Affairs, has 30 years of international experience in the pharmaceutical and medical device industries. Her knowledge of medical device regulations, FDA clearance and risk management, through previous work with Johnson & Johnson and Boston Scientific, among others, will help to drive global regulatory approval and adoption of releazeTM. The team will also benefit from a strengthened board of directors. David Uffer has almost 35 years of experience in the life sciences industry. His experience has seen him lead business development for multinationals including Boston Scientific, Abbott and Medtronic. With extensive experience in the commercialisation and launch of early stage medical device companies, he will be pivotal to SymPhysis Medical's launch and success in the US. Meanwhile, Gerard Ryan is a serial entrepreneur and experienced investor. Gerard founded Longboat Clinical (sold to Advarra in 2020 in a multimillion Euro deal) and Firecrest (sold in 2011 to ICON plc for €50M). One of SymPhysis Medical's first investors, Ryan will help to drive SymPhysis Medical's strategic direction. Tim Jones, CEO, SymPhysis Medical, said: "This is an exciting time for our company. For six years, we have been laser-focused on our mission to help late-stage cancer patients - and, indirectly, their loved ones - to ease a very distressing condition at an extremely difficult time for them. I am immensely proud of our...
The US Food and Drug Administration (FDA) issued new draft regulatory guidance for pulse oximeters related to skin pigment. The guidance is a step forward but it may have unintended consequences. Authors Michael Lipnick, MD, and Philip Bicker, MD, PhD, professors of anesthesia at University of California, San Francisco, discuss this and more with JAMA Executive Editor Gregory Curfman, MD. Related Content: Pulse Oximetry and Skin Pigmentation—New Guidance From the FDA Adherence to FDA Guidance on Pulse Oximetry Testing Among Diverse Individuals, 1996-2024 Addressing Racial and Ethnic Bias in Pulse Oximeters—A Wicked Problem Evaluating the Accuracy of Pulse Oximetry in Children According to Race
Are the products you use every day poisoning you? In this episode of Super Life, Darin Olien dives into phthalates, a class of toxic chemicals found in food packaging, personal care products, medical devices, and even children's toys. Despite mounting evidence linking phthalates to hormone disruption, infertility, obesity, and chronic illness, these chemicals remain largely unregulated in the United States. Darin breaks down why phthalates are everywhere, how they impact your body, and what you can do to protect yourself. He also highlights Minnesota's groundbreaking SF 188 bill, which aims to force food manufacturers to test and disclose phthalate contamination for the first time in U.S. history. If you care about your health, your family, and the toxic load in your daily life, this is a must-listen episode that will make you rethink what you're consuming. Government Responsibility in the Spread of Phthalates Phthalates are chemicals used to make plastics more flexible and durable. Since the mid-20th century, they've been incorporated into countless consumer goods, from food packaging to personal care products. This widespread use is largely due to regulatory inaction and the prioritization of industrial interests over public health. In the United States, agencies like the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) have been slow to regulate phthalates, despite mounting evidence linking them to serious health issues. These include endocrine disruption, reproductive harm, and chronic illnesses such as obesity and diabetes. Unlike Europe, which has banned certain phthalates in food packaging and children's products, the U.S. has often allowed industry self-regulation, leading to widespread contamination in consumer goods. The Industrial Agricultural Revolution and Processed Foods The post-World War II industrialization of food production significantly increased the use of phthalates. As food manufacturing scaled up, plastics became integral in packaging and processing equipment, leading to phthalate leaching into our food supply. Highly processed foods are particularly susceptible due to multiple points of plastic contact during production and storage. Studies have shown that individuals consuming more processed and fast foods have higher levels of phthalates in their bodies. Minnesota's Legislative Action: A Step Forward In January 2025, Minnesota State Senator Heather Gustafson introduced Senate File 188 (SF 188), a bill requiring food manufacturers to test their products for phthalates and publicly disclose the results. If passed, this legislation would be the first of its kind in the U.S., aiming to increase transparency and encourage manufacturers to reduce phthalate levels in their products. According to Senator Gustafson, "Minnesotans have the right to know whether the food they are eating and serving their families is contaminated with toxic phthalates. My bill will help consumers make healthier buying decisions and create a strong incentive for food manufacturers to get plastic chemicals out of our food." advocacy.consumerreports.org Why This Matters This bill is crucial because it: Increases Transparency: For the first time, food companies would be required to test for and disclose phthalate levels, creating public awareness of the contamination problem. Encourages Stricter Regulations: Public disclosure could lead to consumer pressure for stronger nationwide bans and restrictions. Prioritizes Public Health: It challenges the longstanding prioritization of industry preferences over public health, acknowledging that chemical exposure is a public health crisis. Addresses Chronic Illness: With rising rates of metabolic disorders and hormone-related diseases linked to endocrine-disrupting chemicals like phthalates, holding manufacturers accountable is a step toward reversing this trend. Products Commonly Containing Phthalates and Associated Health Risks Phthalates are pervasive in many consumer products. Here's a breakdown of common sources and the potential health implications: Personal Care Products: Items such as nail polishes, hair sprays, aftershave lotions, cleansers, and shampoos often contain phthalates. fda.gov Food Packaging and Processed Foods: Phthalates can leach into food from packaging materials and during processing. Diets high in dairy and meat have been associated with higher levels of phthalate exposure. webmd.com Medical Devices: Some medical devices, including intravenous bags and tubing, contain phthalates to increase flexibility. pmc.ncbi.nlm.nih.gov Household Items: Products like vinyl flooring, shower curtains, and certain furniture may contain phthalates. toxicfreefuture.org Children's Toys: Some toys, especially those made from flexible plastics, can contain phthalates. toxicfreefuture.org Health Risks Associated with Phthalate Exposure Phthalates are known endocrine disruptors, meaning they can interfere with the body's hormonal systems. Potential health effects include: Reproductive Issues: Exposure has been linked to reproductive problems, including reduced fertility. pmc.ncbi.nlm.nih.gov Developmental Problems: Prenatal exposure may lead to developmental issues in children. pmc.ncbi.nlm.nih.gov Respiratory Issues: There is evidence suggesting a link between phthalate exposure and respiratory problems, such as asthma. pmc.ncbi.nlm.nih.gov Metabolic Effects: Some studies have associated phthalate exposure with metabolic disorders, including insulin resistance and obesity. pmc.ncbi.nlm.nih.gov Steps to Reduce Phthalate Exposure To minimize exposure to phthalates: Choose Phthalate-Free Products: Opt for personal care items labeled as phthalate-free. Limit Processed Food Intake: Reducing consumption of processed foods can decrease phthalate exposure. Use Alternatives to Plastic: Whenever possible, choose glass, stainless steel, or other non-plastic materials for food storage and household items. Stay Informed: Regularly check resources like the Environmental Working Group's Skin Deep database to find products free from harmful chemicals. How You Can Take Action While Minnesota is leading the way, collective action is essential to drive nationwide change. Here are steps you can take: Support the Bill: If you're in Minnesota, contact your state legislators to express support for SF 188. You can find more information and track the bill's progress here. Sign Petitions: Look for petitions advocating for the reduction of phthalates in consumer products and add your voice. Stay Informed: Follow organizations like Consumer Reports and Clean Water Action, which are actively involved in this issue. Reduce Personal Exposure: Limit consumption of highly processed foods, use glass or stainless steel for food storage, and avoid products with "fragrance" listed as an ingredient, as it can be a source of phthalates. Active Petition to Support Minnesota's SF 188 As of now, there isn't a specific petition available for Minnesota's SF 188 bill. However, you can take proactive steps to support this legislation: Contact Legislators: Reach out to Minnesota state legislators to express your support for SF 188. Personalized messages can be impactful. Stay Informed: Monitor the bill's progress through the Minnesota Revisor's Office website. Conclusion Minnesota's initiative is a significant step toward addressing the pervasive issue of phthalate contamination. However, true accountability requires federal-level bans, a shift toward non-toxic alternatives, and a rethinking of industrial food production. By staying informed and taking action, we can collectively push for a healthier future. Bibliography Consumer Reports. "Minnesota Senator Gustafson introduces bill to protect consumers from toxic plastic chemicals in food." January 21, 2025. advocacy.consumerreports.org Food Safety Magazine. "Bill Introduced in Minnesota to Require Phthalate Testing for Packaged Foods." January 21, 2025. food-safety.com Minnesota Revisor of Statutes. "SF 188 as introduced - 94th Legislature (2025)." revisor.mn.gov Food & Wine. "Minnesota Just Became the First State to Target Plastic Chemicals in Food." January 22, 2025. foodandwine.com Thank you for joining us on "SuperLife with Darin Olien." Let's continue to strive for a healthier, more informed world. Research Summaries: "Phthalates and Their Impacts on Human Health" Authors: Ying Wang, Hongjun Zhu, and Yanan Kannan Summary: This study discusses the widespread use of phthalates as endocrine disruptors and their detrimental effects on human health. It highlights that phthalates are present in numerous products that come into contact with plastics during production, packaging, or delivery. pmc.ncbi.nlm.nih.gov "Critical Review on the Presence of Phthalates in Food and Evidence of Their Impact on Human Health" Authors: Giuseppe Latini, Valentina Del Vecchio, and Andrea Massaro Summary: This review examines the presence of phthalates in various foods and their potential health impacts, including their role in increasing the risk of developing allergies and asthma. pmc.ncbi.nlm.nih.gov "Why Phthalates Should Be Restricted or Banned from Consumer Products" Authors: Harvard T.H. Chan School of Public Health Summary: This article discusses how phthalates can leach into food from vinyl plastic equipment and materials, emphasizing the need for restrictions or bans due to associated health risks. hsph.harvard.edu "Phthalates and Diet: A Review of the Food Monitoring and Epidemiology Data" Authors: Rolf U. Halden Summary: This review highlights epidemiological studies showing positive associations between the consumption of meats, discretionary fats, and dairy products with increased phthalate exposure. ehjournal.biomedcentral.com "Personal Care Product Use Patterns in Association with Phthalate and Bisphenol A Exposure" Authors: Jessica T. Barson, John D. Meeker, and Kelly K. Ferguson Summary: This study investigates the relationship between personal care product usage and exposure to phthalates and BPA, finding significant associations that suggest these products are notable sources of exposure. nature.com "What Are Phthalates and How Do They Affect Your Health?" Authors: National Center for Health Research Summary: This article provides an overview of phthalates as synthetic chemicals used to make plastics flexible and to add fragrance to products, discussing their role as endocrine disruptors and potential health effects, especially in young children. center4research.org Bibliography: Wang, Y., Zhu, H., & Kannan, Y. (2021). Phthalates and Their Impacts on Human Health. Frontiers in Public Health, 9, 1-8. pmc.ncbi.nlm.nih.gov Latini, G., Del Vecchio, V., & Massaro, A. (2020). Critical Review on the Presence of Phthalates in Food and Evidence of Their Impact on Human Health. International Journal of Environmental Research and Public Health, 17(16), 5655. pmc.ncbi.nlm.nih.gov Harvard T.H. Chan School of Public Health. (2019). Why Phthalates Should Be Restricted or Banned from Consumer Products. hsph.harvard.edu Halden, R. U. (2014). Phthalates and Diet: A Review of the Food Monitoring and Epidemiology Data. Environmental Health, 13(1), 43. ehjournal.biomedcentral.com Barson, J. T., Meeker, J. D., & Ferguson, K. K. (2023). Personal Care Product Use Patterns in Association with Phthalate and Bisphenol A Exposure. Journal of Exposure Science & Environmental Epidemiology, 33(1), 45-54. nature.com National Center for Health Research. (2021). What Are Phthalates and How Do They Affect Your Health?. center4research.org What You'll Learn in This Episode: (00:00:00) Introduction – The toxic truth hiding in your everyday products. (00:03:19) What Are Phthalates? – The chemicals making plastics flexible (and your health fragile). (00:04:24) How Phthalates Get into Your Body – Food, air, water, and even medical devices. (00:05:50) The Devastating Health Effects of Phthalates – Endocrine disruption, infertility, and metabolic disease. (00:07:45) Why the U.S. Fails to Regulate Phthalates – The FDA, EPA, and corporate influence. (00:10:14) Why Europe Banned Phthalates (and the U.S. Didn't) – A look at the regulatory failures. (00:12:38) The Connection Between Phthalates & Infertility – How they are lowering sperm counts and harming pregnancy. (00:15:10) Processed Foods & Fast Foods—A Phthalate Hotspot – Why eating out could be dosing you with toxins. (00:18:49) The Hidden Dangers in Medical Devices – Why even hospitals aren't safe. (00:21:20) Minnesota's Groundbreaking SF 188 Bill – Why this legislation could change everything. (00:24:30) How Phthalates Are Even in Your Children's Toys – The shocking reality parents need to know. (00:27:15) The Impact of Phthalates on Weight Gain & Diabetes – How they disrupt metabolism. (00:30:07) The Fight for Transparency in the Food Industry – What's being done to expose these chemicals. (00:33:12) How to Reduce Your Phthalate Exposure – Simple swaps to detox your home and body. (00:36:40) What You Can Do Today – Advocacy, petitions, and making informed choices. (00:40:12) The Call to Action – Why raising awareness is the key to change. Thank You to Our Sponsors: Our Place: Toxic-free, durable cookware that supports healthy cooking. Use code DARIN for 10% off at fromourplace.com. Therasage: Go to www.therasage.com and use code DARIN at checkout for 15% off Find More From Darin: Website: darinolien.com Instagram: @darinolien Book: Fatal Conveniences Key Takeaway: "Phthalates are everywhere—but they don't have to be inside you. Awareness is power, and it's time to fight back against the toxic chemicals hiding in plain sight."
Who decides what the law means? If you thought it was Congress or the courts, President Donald Trump wants you to think again. Trump has signed an executive order declaring that only the president and attorney general have the final authority to interpret U.S. laws, restricting federal agencies from making independent legal determinations. The order, signed Tuesday, bars agencies such as the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Securities and Exchange Commission (SEC) from issuing their own legal interpretations, significantly curbing their regulatory independence. The sweeping order, signed Tuesday, effectively erases decades of independence for agencies that oversee everything from consumer protections and environmental laws to Wall Street regulations. The move is part of a series of executive actions, including a memorandum ordering reports on government waste, fraud, and abuse, and another expanding in vitro fertilization (IVF) access. However, legal analysts say this particular order is the most consequential, as it centralizes legal authority under Trump and his appointed attorney general. Critics warn the order could serve as a backdoor mechanism for the administration to circumvent court rulings or weaken regulatory enforcement on issues such as consumer protections, environmental laws, and Wall Street oversight. Learn more about your ad choices. Visit megaphone.fm/adchoices
It's Friday, February 14th, A.D. 2025. This is The Worldview in 5 Minutes heard on 125 radio stations and at www.TheWorldview.com. I'm Adam McManus. (Adam@TheWorldview.com) By Adam McManus and Jonathan Clark Myanmar's military bombed Catholic cathedral The ruling military regime in Myanmar bombed a newly designated Catholic cathedral earlier this month, reports International Christian Concern. The Sacred Heart of Jesus Church, located in Mindat, Chin State, was designated as a cathedral by Pope Francis on January 25 — just two weeks before it was bombed on February 6. The bombing destroyed the cathedral's roof and blew out the windows, rendering the building unusable. Fortunately, the area had been evacuated in anticipation of the attack, and no deaths were reported. Chin State is the country's only Christian-majority state, with about 85% of the population ascribing to the faith. Nearly 90% of Myanmar's overall population is Buddhist. According to Open Doors, Myanmar is the 13th most dangerous country worldwide for Christians. More Evangelicals growing in number in Costa Rica Evangelical Focus reports that a new study shows Evangelicals are increasing in Costa Rica, an historically Catholic country. Fifty percent of the Central American country's population identify as Catholic. Thirty-three percent identify as Evangelical. This comes despite 73% of respondents saying they were raised Catholic and 23% saying they were raised Evangelical. Evangelical Costa Ricans are also more likely to be younger and attend church weekly. One-third of world's population now identify as Christian Lifeway Research shared several encouraging trends for global Christianity this year based on a report from Gordon-Conwell Theological Seminary. First, the number of Christians continues to grow, reaching 2.64 billion this year, about one-third of the world's population. Second, the growth of the religiously unaffiliated is slowing and even projected to decrease in the coming decades. Third, Evangelicals are the fastest growing Christian group, projected to reach 620 million by 2050. Fourth, Christianity is growing the fastest in the Global South, especially in Africa and Asia. Africa is projected to have the largest Christian population by 2050. And fifth, the percentage of the world's population without access to the Gospel has fallen to 27%. That's down from 54% in 1900. Psalm 22:27-28 says, “All the ends of the world shall remember and turn to the LORD, and all the families of the nations shall worship before You. For the kingdom is the LORD's, and He rules over the nations.” RFK, Jr confirmed as Trump's Health and Human Services Secretary Robert F. Kennedy Jr., whose nomination by President Donald Trump as Secretary of Health and Human Services was highly scrutinized by lawmakers, was confirmed to that post by the Senate on February 13 in a 52–48 vote, reports The Epoch Times. PRESIDING OFFICER: “On this vote, the yeas are 52, the nays are 48. The confirmation is confirmed.” Republican Senator Mitch McConnell of Kentucky, a polio survivor who previously voiced concerns about Kennedy's vaccine views, voted against confirming Kennedy. He was the only Republican to cast a no vote. Kennedy will head the Department of Health and Human Services, which manages 13 agencies, including the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health. Kennedy has promised significant changes throughout the department which has a $1.8 trillion dollar annual budget. Under the “Make America Healthy Again” campaign, Kennedy aims to curtail what he calls the chronic disease epidemic, removing toxic chemicals from the nation's food supply, overhauling dietary guidelines, and taking aim at ultra-processed foods, reports FoxNews.com. The Children's Health Defense founder has also called for a review of advertising rules for pharmaceutical companies and has urged Trump to ban pharmaceutical advertising on TV. He also believes in eliminating liability protections for drug companies. Kennedy told The Epoch Times in September that he would revamp the National Institutes of Health to focus on the causes of autism, autoimmune diseases, and neurodevelopment diseases instead of developing drugs and serving as an incubator for pharmaceutical products. RFK, Jr.: “God sent me President Trump” Before Robert F. Kennedy, Jr was sworn in as the new Secretary of Health and Human Services in the Oval Office, he offered praise for Trump's gutsy leadership. KENNEDY: “For 20 years, I'm up every morning on my knees and prayed that God would put me in a position where I can end the childhood, chronic disease epidemic in this country. On August 23 of last year, God sent me President Trump. “He's kept every promise that he's made to me. I'm so grateful to you, Mr. President. A lot of people told me that I couldn't trust President Trump. I better get it in writing, and we did a handshake, and everything that he told me he was going to do, he has done. “I genuinely believe that you are a pivotal historical figure, and you are going to transform this country. President Trump has promised to restore the American Dream in this country. A healthy person has a thousand dreams. A sick person only has one. 60% of our population has only one dream – that they get better. “President Trump has promised that he's going to restore America's strength. But we can't be a strong nation if we have a weak citizenry. 60% of our people are sick. 77% of our children cannot qualify for military service. “We need a man on a white horse now. We need somebody who is willing to come in and has the spine and the guts and the strength to challenge orthodoxies, to stand in the way of vested interests, and to break institutions that have turned against our democracy. President Trump has shown again and again that he is that hero. We need a revolutionary figure, and you are that figure. And I'm very grateful for you for giving me this opportunity.” Wikipedia founder comes to Christ And finally, Larry Sanger, the 56-year-old co-founder of Wikipedia in 2001 who grew up in the Lutheran Church, has been a lifelong religious skeptic until his conversion to the Christian faith in 2020, reports The Christian Post. An agnostic, he became intrigued by philosophical arguments for God's existence, particularly the "First Cause" argument, according to a new blog on his personal website. He began to personally study the Scriptures for himself, downloaded the YouVersion Bible app, “and immediately made Bible study a serious hobby.” Christian apologists Stephen Meyer and William Lane Craig made him think deeply. After devouring the four gospels, Sanger said in 2020, “I should admit to myself that I now believe in God, and pray to God properly.” 2 Corinthians 5:17 says, "Therefore, if anyone is in Christ, he is a new creation; old things have passed away; behold, all things have become new." Close And that's The Worldview on this Friday, February 14th in the year of our Lord 2025. Subscribe by Amazon Music or by iTunes or email to our unique Christian newscast at www.TheWorldview.com. Or get the Generations app through Google Play or The App Store. I'm Adam McManus (Adam@TheWorldview.com). Seize the day for Jesus Christ.
Video Version Available on YouTube! In this episode of New Insight, host Veeral Sheth, MD, MBA, director of clinical research at University Retina and Macula Associates, explored the approval and impending launch of Qlosi (pilocarpine HCL ophthalmic solution) 0.4%, a groundbreaking pharmacologic option for managing presbyopia, with Elad Kedar, MBA, chief executive officer of Orasis Pharmaceuticals. A condition that affects nearly all adults as they age, presbyopia is characterized by the gradual loss of near vision due to reduced lens elasticity. Sheth and Kedar highlighted the significance of finding non-invasive treatment options for this pervasive issue, given the limitations of traditional solutions like reading glasses or surgical interventions. In October 2023, the US Food and Drug Administration (FDA) approved Qlosi, a preservative-free, low-dose eye drop for presbyopia, based on strong efficacy, safety, and tolerability data reported in the pivotal Phase 3 NEAR-1 and NEAR-2 clinical trials. On Day 8, patients treated with Qlosi achieved statistically significant ≥3-line gain in distance-corrected near visual acuity (DCNVA) and no loss of ≥1-line in distance visual acuity. Sheth and Kedar delved into Qlosi's innovative mechanism of action, emphasizing how it leverages a unique pharmacologic approach to improve near vision. By modulating pupil dynamics, Qlosi enhances the depth of focus, effectively allowing patients to perform near-vision tasks without additional aids. Together, Sheth and Kedar walked through the drug's clinical development journey, highlighting his journey through the founding of Orasis and the company's name in Greek, meaning “good vision or sight.” The discussion included insights into the populations most likely to benefit from Qlosi and the practical considerations for prescribing. Sheth offered a nuanced take on how this therapy could fit into the broader landscape of presbyopia management, addressing questions about patient education, adherence, and expectations. Sheth also shared his perspective on the potential impact of Qlosi on clinical practice, noting that its ease of use and non-invasive nature could appeal to both patients and providers. He reflected on how treatments like Qlosi are part of a broader trend toward personalized medicine, focusing on solutions that improve the quality of life for aging populations. This episode concluded with a thoughtful look at future research directions and the impending launch of Qlosi. Expected soon, Kedar expressed an interest in sharing more details on the product and its position in the presbyopia treatment landscape once the drug comes to market. Every episode of New Insight is available on HCPLive.com. Watch full episodes on our YouTube channel and listen wherever you get your podcasts. Direct all podcast-related inquiries to show producer Connor Iapoce (ciapoce@mjhlifesciences.com) and keep an eye out for more from New Insight! Key Episode Timestamps 00:05 Introduction to Elad Kedar and Orasis 04:34 Orasis' Journey and Initial Development 06:45 Elad Kedar's Background and Company Growth 08:36 Transition from Product Development to Team Building 11:42 Phase Three Study Results and Efficacy 13:39 Safety, Comfort, and Tolerability 15:00 Genesis of the Company Name Orasis 18:26 Challenges and Strategic Planning 21:57 Market Position and Future Outlook 27:27 Conclusion and Future Plans
The Food & Drug Administration (FDA) has proposed a rule that would require a front-of-package nutrition label for most packaged food products, listing saturated fat, sodium and added sugars content for each product. Natalie Rainer, partner and member of the Health Care and FDA practice at K&L Gates, discusses the proposed rule and the industry's initial reaction. She also digs into what it means for the future of product development, formulation, and package design — and how this is a unique situation when it comes to claims made on food and beverage packaging.
Let's Talk Micro kicks off 2025 with a great new episode. This time Luis is Joined by Dr. Sam Aitken to talk about sulopenem. Have you heard about this oral antibiotic? It was approved by the Food and Drug Administration (FDA) for the use of uncomplicated urinary tract infections (uUTIs). This is an oral penem, and the news of its release has caused different reactions in social media by members of the Microbiology/Infectious Diseases community. What is sulopenem? Why is it combined with probenecid (Orlynvah)? What are the concerns regarding sulopenem? When are carbapenems appropriate for treatment? Tune in for a great episode .Questions? Feedback? Send those to letstalkmicro@outlook.comWant to support the podcast? Here's how:Venmo: https://venmo.com/u/letstalkmicroBuy me a Ko-fi: https://ko-fi.com/letstalkmicro
The Food and Drug Administration (FDA) is moving forward with a regulatory rule in the final days of the Biden administration that would effectively ban cigarettes January 9th 2025 --- Please Like, Comment and Follow 'The Ray Appleton Show' on all platforms: --- 'The Ray Appleton Show’ is available on the KMJNOW app, Apple Podcasts, Spotify, YouTube or wherever else you listen to podcasts. --- 'The Ray Appleton Show’ Weekdays 11 AM -2 PM Pacific on News/Talk 580 AM & 105.9 KMJ | Website | Facebook | Podcast | - Everything KMJ KMJNOW App | Podcasts | Facebook | X | Instagram See omnystudio.com/listener for privacy information.
The Rich Zeoli Show- Hour 1: 3:05pm- Rich is broadcasting LIVE…from a hospital bed? Unfortunately, Rich's bad luck with health/medicine continues—he's dealing with an infection. But if you hear beeping during the broadcast, don't panic: his I.V. simply ran out. 3:15pm- On Tuesday, President-elect Donald Trump held a press conference from his Mar-a-Lago home in Palm Beach, Florida. While speaking with the press, Trump continued to express interest in acquiring Greenland from Denmark. 3:20pm- While appearing on Fox News, Senator John Fetterman (D-PA) defended Donald Trump's assertion that the United States should purchase Greenland from Denmark—pointing out that it is not dissimilar from the Louisiana Purchase. 3:30pm- Faith Burns—Energy Policy Fellow at Americans for Prosperity & former Policy Advisor at the U.S. Department of Agriculture—joins The Rich Zeoli Show to discuss the Biden Administration's decision to ban offshore drilling in most U.S. coastal waters. 3:40pm- Biden Admin Working to Effectively Ban Cigarettes. Emma Colton of Fox News writes: “The Food and Drug Administration (FDA) is moving forward with a regulatory rule in the final days of the Biden administration that would effectively ban cigarettes currently on the market in favor of products with lower nicotine levels, which could end up boosting business for cartels operating on the black market.” You can read the full article here: https://www.foxnews.com/politics/biden-admin-working-effectively-ban-cigarettes-11th-hour-proposal-gift-cartels-expert-says
The Rich Zeoli Show- Full Episode (01/08/2025): 3:05pm- Rich is broadcasting LIVE…from a hospital bed? Unfortunately, Rich's bad luck with health/medicine continues—he's dealing with an infection. But if you hear beeping during the broadcast, don't panic: his I.V. simply ran out. 3:15pm- On Tuesday, President-elect Donald Trump held a press conference from his Mar-a-Lago home in Palm Beach, Florida. While speaking with the press, Trump continued to express interest in acquiring Greenland from Denmark. 3:20pm- While appearing on Fox News, Senator John Fetterman (D-PA) defended Donald Trump's assertion that the United States should purchase Greenland from Denmark—pointing out that it is not dissimilar from the Louisiana Purchase. 3:30pm- Faith Burns—Energy Policy Fellow at Americans for Prosperity & former Policy Advisor at the U.S. Department of Agriculture—joins The Rich Zeoli Show to discuss the Biden Administration's decision to ban offshore drilling in most U.S. coastal waters. 3:40pm- Biden Admin Working to Effectively Ban Cigarettes. Emma Colton of Fox News writes: “The Food and Drug Administration (FDA) is moving forward with a regulatory rule in the final days of the Biden administration that would effectively ban cigarettes currently on the market in favor of products with lower nicotine levels, which could end up boosting business for cartels operating on the black market.” You can read the full article here: https://www.foxnews.com/politics/biden-admin-working-effectively-ban-cigarettes-11th-hour-proposal-gift-cartels-expert-says 4:00pm- Dan Schneider—Vice President of Media Research Center & Leader of the Free Speech Alliance—joins The Rich Zeoli Show to discuss Meta CEO Mark Zuckerberg's announcement that his social media platform Facebook will no longer censor posts, citing previous editorial errors and a desire to restore free speech online. 4:20pm- A Hooters waitress has gone viral on social media for all of the wrong reasons. After being pulled over for suspected D.U.I., the waitress attempted to flirt her way out of an arrest. Rich, Matt, and Justin debate: is she attractive? 4:40pm- According to a report from Mediaite, Sen. Mark Warner (D-VA)—who serves as vice chairman of the Senate Intelligence Committee—is attempting to delay a vote on Donald Trump's nominee for Director of National Intelligence, Tulsi Gabbard. Warner cited Gabbard's relationship with former Syrian authoritarian leader Bashas al-Asad. But, as Rich notes, a group representing the victims of Syrian terror recently announced its support for Gabbard's nomination. 5:00pm- Andrew C. McCarthy—Senior Fellow at National Review & former Assistant United States Attorney for the Southern District of New York—joins The Rich Zeoli Show to discuss his latest article for National Review, “Trump Turns to Supremes in Plea to Halt Friday Sentencing.” McCarthy notes that while progressives in New York want to brand Donald Trump as a convicted felon, the rest of the country isn't on the same page—and that “lawfare” had a catastrophic impact on Democrats in the 2024 election. You can read the full article here: https://www.nationalreview.com/corner/trump-turns-to-supremes-in-plea-to-halt-friday-sentencing/ 5:20pm- Rich is broadcasting LIVE…from a hospital bed? Unfortunately, Rich's bad luck with health/medicine continues—he's dealing with an infection. But if you hear beeping during the broadcast, don't panic: his I.V. simply ran out. 5:25pm- While broadcasting from Los Angeles, Fox News reporter Jonathon Hunt explained that firefighters, sadly, do not have the resources to continue fighting all of the wildfires in California. 5:35pm- Matt Rooney—Founder of SaveJersey.com & host of The Matt Rooney Show on 1210 WPHT (Sunday's 7pm to 10pm)—joins The Rich Zeoli Show to discuss New Jersey politics. You can find his work at: https://savejersey.com 6:05pm- Rich is broadcasting LIVE…from a hospital bed? Unfortunately, Rich's bad luck with hea ...
Would you take a test to find out your cancer risk? At-home genetic testing makes it easy, but experts warn that these tests may create more harm than good. A New Approach to Genetic Testing Genetic testing has traditionally been performed under the supervision of healthcare providers, with genetic counseling to help patients navigate their results. This approach ensures that individuals receive proper guidance, reducing the emotional and practical challenges of interpreting complex genetic information. In September 2023, the United States Food and Drug Administration (FDA) approved a new test called the Invitae Common Hereditary Cancers Panel. This test checks for changes in 48 genes linked to hereditary cancers, including breast, ovarian, and Lynch syndrome-related cancers. What makes it different is that it can be ordered online and taken at home with no doctor required. While the convenience of these tests is appealing, health experts have raised serious concerns. An editorial titled “Pitfalls and Perils from FDA-Approved Germ-line Cancer Predisposition Tests,” authored by Dr. Wafik S. El-Deiry, Editor-in-Chief of Oncotarget, and Dr. Eli Y. Adashi, both from Brown University, highlights the potential risks of using these tests without professional guidance. Full blog - https://www.oncotarget.org/2025/01/03/the-hidden-risks-of-at-home-genetic-cancer-tests/ Paper DOI - https://doi.org/10.18632/oncotarget.28677 Correspondence to - Wafik S. El-Deiry - wafik@brown.edu Video short - https://www.youtube.com/watch?v=DjKpiBNDWHo Sign up for free Altmetric alerts about this article - https://oncotarget.altmetric.com/details/email_updates?id=10.18632%2Foncotarget.28677 Subscribe for free publication alerts from Oncotarget - https://www.oncotarget.com/subscribe/ Keywords - cancer, cancer predisposition, germline, marketing authorization, hereditary cancer, direct to consumer About Oncotarget Oncotarget (a primarily oncology-focused, peer-reviewed, open access journal) aims to maximize research impact through insightful peer-review; eliminate borders between specialties by linking different fields of oncology, cancer research and biomedical sciences; and foster application of basic and clinical science. Oncotarget is indexed and archived by PubMed/Medline, PubMed Central, Scopus, EMBASE, META (Chan Zuckerberg Initiative) (2018-2022), and Dimensions (Digital Science). To learn more about Oncotarget, please visit https://www.oncotarget.com and connect with us: Facebook - https://www.facebook.com/Oncotarget/ X - https://twitter.com/oncotarget Instagram - https://www.instagram.com/oncotargetjrnl/ YouTube - https://www.youtube.com/@OncotargetJournal LinkedIn - https://www.linkedin.com/company/oncotarget Pinterest - https://www.pinterest.com/oncotarget/ Reddit - https://www.reddit.com/user/Oncotarget/ Spotify - https://open.spotify.com/show/0gRwT6BqYWJzxzmjPJwtVh MEDIA@IMPACTJOURNALS.COM
BUFFALO, NY - December 30, 2024 – A new #editorial was #published in Oncotarget's Volume 15 on December 24, 2024, titled “Pitfalls and perils from FDA-approved germ-line cancer predisposition tests." Authored by Dr. Wafik S. El-Deiry, Editor-in-Chief of Oncotarget, and Dr. Eli Y. Adashi from Brown University, the article highlights concerns about the risks of a newly approved genetic test for cancer risk. This test, called the “Invitae Common Hereditary Cancers Panel," was approved in 2023 and examines 48 genes linked to inherited cancers, including breast, ovarian, and Lynch syndrome-related cancers. Although the test increases access to genetic information, the authors warn that using it without professional guidance may lead to confusion, stress, and potential harm. One concern is that people can order this test online without consulting healthcare professionals or genetic counselors. Without expert help, users might struggle to understand their results especially if they indicate risks that are unclear or difficult to act on. This can cause unnecessary anxiety and confusion. “The DTC option of germ-line testing for cancer susceptibility should be discouraged given the risks of anxiety, lack of adequate interpretation for variants not strongly associated with cancer, potential for minors to be tested outside the healthcare system and potential for loss of follow-up if test results are not shared with health care professionals or never make it into the medical record.” The editorial also points out ethical and medical issues when minors use these tests. If a child's test is done without medical oversight, results might not be added to their health records, making follow-up care harder to manage and potentially risking their long-term health. Cost is another issue. These tests are often not covered by insurance, which can place a financial burden on families who might need additional testing or medical advice. The researchers emphasize that genetic testing for cancer risk should always include healthcare providers and genetic counseling. This ensures users fully understand their results and receive proper guidance. The authors also call on the US Food and Drug Administration (FDA) to provide clear rules for using these tests, particularly for minors. In conclusion, while genetic testing holds great potential for improving cancer prevention and care, its benefits must not come at the cost of safety and public health. Responsible use of these tests will require collaboration between regulators, healthcare professionals, and testing companies to address the risks and ensure these tools are used effectively. DOI - https://doi.org/10.18632/oncotarget.28677 Correspondence to - Wafik S. El-Deiry - wafik@brown.edu Video short - https://www.youtube.com/watch?v=DjKpiBNDWHo Subscribe for free publication alerts from Oncotarget - https://www.oncotarget.com/subscribe/ About Oncotarget Oncotarget (a primarily oncology-focused, peer-reviewed, open access journal) aims to maximize research impact through insightful peer-review; eliminate borders between specialties by linking different fields of oncology, cancer research and biomedical sciences; and foster application of basic and clinical science. Oncotarget is indexed and archived by PubMed/Medline, PubMed Central, Scopus, EMBASE, META (Chan Zuckerberg Initiative) (2018-2022), and Dimensions (Digital Science). To learn more about Oncotarget, please visit https://www.oncotarget.com and connect with us: Facebook - https://www.facebook.com/Oncotarget/ X - https://twitter.com/oncotarget Instagram - https://www.instagram.com/oncotargetjrnl/ YouTube - https://www.youtube.com/@OncotargetJournal LinkedIn - https://www.linkedin.com/company/oncotarget Pinterest - https://www.pinterest.com/oncotarget/ Reddit - https://www.reddit.com/user/Oncotarget/ Spotify - https://open.spotify.com/show/0gRwT6BqYWJzxzmjPJwtVh MEDIA@IMPACTJOURNALS.COM
Send us a textDecluttering your mind and physical space is a transformative process that can elevate your mental well-being and overall happiness. Through actionable steps and insights, we explore how clearing the clutter around us can lead to increased clarity and focus, setting the stage for a flourishing new year.• Importance of decluttering for mental health • Connection between mental and physical clutter • Benefits of creating a clutter-free environment • Practical strategies for decluttering your space • Techniques for managing mental clutter • Establishing daily and weekly decluttering routines • Engaging exercise for immediate decluttering action • Encouragement to embrace small, consistent efforts • Reminder that decluttering fosters creativity and peace Download the free, editable 2025 calendar linked in the show notes.Hey Hormone Hotties:If you want to learn more about how you can work with me or what services I offer including those below- https://linktr.ee/Faithhealthfitness Interested in being a guest expert (even if you are not in business but a woman who has a story to share) fill out the application and book an appointment. Affiliated Partner for awesome products in wellness and more including the "Body balancing" slenderize for a discount using my code HAPPY24 Join me in Happy Hormones Circle. This and my email list is where I will be focusing my time and content Disclaimer: The content shared in ‘The Happy Hormones Coach' podcast (including affiliate and non affiliate products) is for informational purposes only and is not intended as medical advice, diagnosis, or treatment. Please consult with a qualified healthcare provider before making any changes to your diet, exercise, or health routine. The opinions expressed in this podcast are those of the host and guests and do not necessarily reflect the views of any healthcare organizations. The statements made regarding any of the products that I mention have not been evaluated by the Food and Drug Administration (FDA). Individual results may vary.
[SEGMENT 2-1] Our Health in 2025 1 RFK Jr.'s Health Revolution and What It Means for America in 2025 When Robert F. Kennedy Jr. threw his hat into the presidential race, he brought a fresh focus on a subject many Americans had been ignoring: their health. RFK Jr. has been outspoken on everything from genetically modified organisms (GMOs) in our food to the overuse of vaccines, and Americans are beginning to listen. Health isn't just an abstract idea or a checkbox on a New Year's resolution list. It's the foundation of everything we do. And as the saying goes, “No one on their deathbed wishes they'd spent more time at work—they wish they'd had more time, period.”RFK Jr.'s Vision for a Healthier America The GMO Battle One of RFK Jr.'s most passionate issues is the elimination of GMOs in our food supply. He argues that GMOs, heavily reliant on pesticides like glyphosate (found in Roundup), are linked to numerous health concerns, including cancer and hormonal disruptions. His administration would likely push for stricter labeling and possibly even a ban on certain GMOs in favor of organic and regenerative farming practices.The Science Behind It: Studies have shown that countries banning or heavily regulating GMOs tend to have fewer pesticide-related illnesses and higher biodiversity in their ecosystemsing Vaccination Schedules** Kennedy has long advocated for safer vaccines and more research into their long-term effects. He isn't anti-vaccine, but pro-transparency. He questions why the United States has one of the most aggressive childhood vaccination schedules in the world, while chronic illnesses among children, such as autism and autoimmune disorders, continue to rise.Potential Policies: Under RFK Jr., the CDC could face a major overhaul. Vaccines would likely undergo more rigorous independent testing, and parents might have greater flexibility in opting out without punitive measures.[SEGMENT 2-2] Our Health in 2025 2 [X] SB RFK Jr on vaccines for children – partial Measles and mumps 1964 300-400; malnourished WHO says Vitamin A was a cure for measles I learn something new every time I listen to this guy. What do you really know about childhood diseases? I know very little. I certainly didn't know that Vitamin A can kill the measles. We just do what we are told, because the experts say. When in fact there are so many other things that work. I'm bringing in the big guns later to discuss more about what we don't know. Nutritional Overhaul Kennedy plans to challenge the corporate influence on the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA). He's critical of how processed foods and sugar-laden diets have contributed to skyrocketing rates of obesity, diabetes, and heart disease.The Agenda: Expect a push for healthier school lunches, restrictions on misleading advertising for processed foods, and funding for public health campaigns that focus on nutrition.What Americans Expect in 2025 A recent poll revealed that improving personal health is a top priority for 2025. The survey found that:70% of Americans plan to prioritize better eating habits.60% aim to exercise more regularly.50% want to minimize stress and focus on mental health .RFK Jr.'s canse sentiments, appealing to a public increasingly skeptical of Big Pharma and government agencies like the FDA.Why Americans Are Waking Up RFK Jr.'s messaging resonates because, for years, Americans trusted federal agencies to keep their food and drugs safe. But scandals and failures—like the opioid epidemic, COVID-19 policies, and J6 revelations—have eroded that trust. Take the FDA's approval of certain harmful additives or the USDA's coziness with agribusiness giants like Monsanto. Americans are starting to ask, “Are they protecting us or their donors?” For athletes like me, the stakes are even higher. I spent years focused on performance, but neglected the basics like nutrition and recovery. If I'd had RFK Jr. whispering in my ear, I might have reached another level. And let's be real: most of us don't even read labels. RFK Jr.'s push to remove GMOs and toxins from our food would make healthy choices a no-brainer.Psychology of Good Health Good health isn't just about the body; it's a state of mind. Studies show that people who feel in control of their health tend to have better outcomes. It's about empowerment—making informed decisions and not blindly trusting “experts” who often have financial conflicts of interest. If RFK Jr. has done anything, it's wake us up to our role in the fight for better health. He's the first politician in years to make the connection between individual health and national prosperity.What Will You Do Differently in 2025? For me, 2025 is about accountability:Reading labels.Reducing sugar and processed foods.Supporting local farmers over corporate giants.RFK Jr. isn't just leading a political movement; he's inspiring a health revolution. It's a reminder that the ultimate freedom isn't just political—it's the freedom to live a long, healthy life.Title Suggestions:"RFK Jr.'s Health Revolution: Why 2025 Will Be the Year of the Wake-Up Call""From GMOs to Vaccines: The Health Overhaul Americans Didn't Know They Needed""RFK Jr. and the Fight for Your Plate—and Your Freedom"With RFK Jr. at the helm, 2025 might be the year we stop trusting the government to care about our health and start taking matters into our own hands. It's about time. [SEGMENT 2-3] BiOptimizers Interview 1 Wade Lightheart Bio Wade T. Lightheart is a Certified Sports Nutritionist Advisor and president/director of education and co-founder of BIOptimizers. As a plant-based and drug-free athlete for more than two decades, Wade is a three-time National Natural Bodybuilding Champion who competed in both the IFBB Mr. Universe and the INBA Natural Olympia by the age of 31. At the age of 50, Wade came out of retirement to win the Open Men's and Grand Master's Categories at the INBA Ironman International, then competed at The PNBA Natural Olympia. Six months later, Wade successfully ran his first marathon in four hours. bioptimizers.com/kjradio Promo code: KJRADIO Building muscle and running your first marathon at 50 years old How to select the best Biohacking technologies to personally optimize your training and goals The paradigm problem with getting stuck in diet tribes and how to overcome it Why 97 percent of people who start a diet fail, and how to avoid it Why do all diets work and why do all diets eventually fail - how to avoid it Magnesium plays a critical role in overall health, acting as a cofactor for over 300 enzymatic processes in the human body. It's essential for muscle and nerve function, blood sugar control, and bone health. Research suggests magnesium deficiencies, often exacerbated by the prevalence of processed foods and additives in the modern diet, may contribute to chronic conditions such as heart disease, diabetes, and neurological disorders Cha Ching Queen Washington Examiner [SEGMENT 2-4] BiOptimizers 2 RFK Jr. and Food AdditivesRobert F. Kennedy Jr. has drawn attention to the negative impacts of food additives, including synthetic dyes, GMOs, and pesticides like glyphosate. He highlights the need for stricter regulations, as many of these substances are linked to behavioral issues in children and long-term health risks like cancer and obesity. For example, glyphosate, widely used in agriculture, has been implicated in wheat and corn allergies, as well as the obesity epidemic. Kennedy's advocacy emphasizes the urgency of reforming food safety practices to prioritize public health Light Wave How Magnesium Interacts with AdditivesMagnesium is particularly relevant in this context because many artificial additives and ultra-processed foods disrupt its absorption. Additives such as phosphates, commonly found in sodas and processed meats, can interfere with magnesium metabolism. Moreover, magnesium deficiency is associated with increased inflammation and oxidative stress, making it harder for the body to combat the toxic effects of these additives RFK Jr.'s Plans for ReformKennedy proposes a dramatic overhaul of food safety, targeting GMOs, harmful dyes, and excessive pesticide use. He has called for more transparent labeling and stricter testing of food products to minimize exposure to these potentially harmful substances. This aligns with broader health initiatives that include reevaluating vaccination schedules and reducing reliance on products that prioritize profit over safety. A Shift Towards Better Health in 2025As Americans become more aware of the link between diet and chronic illness, surveys suggest they are seeking ways to improve their health. This includes increasing magnesium intake through whole foods like leafy greens, nuts, seeds, and whole grains. Magnesium supplementation may Become a supporter of this podcast: https://www.spreaker.com/podcast/the-kevin-jackson-show--2896352/support.
"The FDA is simply not doing their job." - Dr. Bobby Price. Tune in to Plant-Based News for an enlightening interview with Dr. Bobby Price. Dr. Bobby Price is a certified plant-based nutritionist, exercise physiologist, and Doctor of Pharmacy. He has extensive clinical experience in the hospital setting, one on one patient contact in community pharmacy, and health care regulatory experience with the Food and Drug Administration (FDA). Dr. Price critiques the FDA's oversight and the pharmaceutical industry's approach to health care, sharing insights from his own professional background and personal health journey. Discover how transitioning to a plant-based diet revolutionized his health and led him to advocate for natural remedies and detoxification methods. Learn about his global travels to study herbalism and the profound impact of diet on longevity and wellness. Don't miss this compelling discussion on the need for a paradigm shift toward prevention and holistic health practices. Follow Dr. Bobby Price here - https://www.instagram.com/doctorholistic/ - 00:00:02 Introduction and Guest Background - 00:01:49 Personal Health Journey and Plant-Based Diet - 00:06:21 Challenges and Early Experiences - 00:08:43 Plant-Based Prescriptions and Lifestyle Modifications - 00:10:37 Critique of Modern Medicine - 00:16:08 Cultural and Community Challenges - 00:20:52 Global Studies and Herbalism - 00:25:12 Herbs and Their Healing Properties - 00:29:46 Understanding Herbs and Personal Conviction - 00:32:55 Healing and Detoxification - 00:34:04 The Impact of Animal Products on Health - 00:35:59 Critique of OIC and Pharmaceutical Approaches - 00:41:04 Mindset and Self-Love in Healing - 00:47:47 Inner Dialogue and Meditation - 00:50:07 Plant-Based Diet and Self-Empowerment - 00:55:38 Personal Journey and Farming - 01:00:51 Community and Detox Programs - 01:03:18 Future Plans and Expansion
Thomas Gremillion, J.D., M.A. is the Director of Food Policy at the Consumer Federation of America (CFA). He oversees research, analysis, advocacy, and media outreach for the group's food policy activities, and monitors food safety activities at the U.S. Department of Agriculture (USDA), the U.S. Food and Drug Administration (FDA), and in Congress, where he advocates for strong food safety protections for consumers. He also coordinates the Safe Food Coalition, a group of consumer, trade union, and foodborne illness victim organizations dedicated to reducing foodborne illness by improving government food inspection programs. Prior to joining CFA in 2015, Gremillion practiced environmental law at Georgetown University Law Center's Institute for Public Representation. He also served as an associate attorney at the Southern Environmental Law Center in Chapel Hill, North Carolina. A graduate of Harvard Law School, Gremillion is a member of the D.C. and North Carolina bars. He also holds an M.A. degree in International Relations from Andina Simón Bolívar University in Ecuador. In this episode of Food Safety Matters, we speak with Thomas [22:27] about: Initiatives and advocacy work by CFA and its Safe Food Coalition to improve national food safety and protect consumers from foodborne illness The pros and cons of the structure of FDA's reorganized Human Foods Program Concerns about efforts to delay or weaken FDA's Food Traceability Final Rule and industry's ability to comply by the January 2026 deadline Questions raised about federal oversight of food inspections following the high-profile Listeria outbreak linked to Boar's Head deli meats The need for standardized pathogen testing protocols for facilities that process raw and ready-to-eat (RTE) foods CFA's perspectives on USDA's proposed framework for reducing Salmonella in poultry products The implications of the Supreme Court's recent overturning of the 1984 Chevron ruling for the food industry, and regulatory agencies' ability to protect public health. News and Resources News Congress Members Urge FDA to Ban Red Dye 3 in Food [3:10]Policies on Antibiotics in Meat: Many Top Restaurants Receive Failing Grades, Only One Gets A+ [6:23]Poor Hygienic Design, Difficulty Communicating Risks are Barriers to Low-Moisture Food Safety, Study Shows [15:20]EU Expands Responsibility for Listeria Criteria in RTE Foods to Additional Food Business Operators [19:05] Resources “New Technology Applications in the Fight Against Foodborne AMR”—Editor's Note, Food Safety Magazine December ‘24/January ‘25 Facilities Focus: Food Safety Factors to Consider in Hygienic Design and Infrastructure (Webinar On-Demand) We Want to Hear from You! Please send us your questions and suggestions to podcast@food-safety.com
The Rich Zeoli Show- Full Episode (11/25/2024): 3:05pm- On Monday, the Department of Justice's Jack Smith asked a federal judge in Washington D.C. and an appeals court in Atlanta to dismiss all charges against Donald Trump in the 2020 election and classified documents cases. 3:15pm- Venture capitalist and former Democrat donor Chamath Palihapitiya praised Donald Trump's creation of the Department of Government Efficiency (DOGE) and said that slashing government regulations and waste could lead to an “economic renaissance.” 3:30pm- Penn State Basketball 6:40pm- WE ARE BACK! But only for 15-minutes. In a post to social media, MSNBC host Joy Reid said that she does not feel safe around Donald Trump supporters—and that progressives shouldn't celebrate Thanksgiving with family and friends who voted Republican. 6:45pm- While promoting her new movie “Wicked,” Arianna Grande said: “Every day in the Emerald City is a Pride parade, right? Even the chickens. Those chickens are gay.” 6:50pm- The ladies of The View were forced to issue four “legal notes” after making false or misleading claims about several Donald Trump nominated cabinet members. 6:55pm- Donald Trump has selected Johns Hopkins surgeon and professor of medicine Dr. Marty Makary to serve as head of the Food and Drug Administration (FDA). Remember that time Rich asked Dr. Makary how to treat head lice?
Bill talks with the well-respected Health Policy reporter Sandhya Raman of CQ-Roll Call to get a sense of what Trump's nominees in the health field means for our health and healthcare. There are serious concerns raised by leading health professionals about Donald Trump's nominations to lead major health agencies, including the Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and others. The main concerns are that many of Trump's nominees lack prior experience in public health or healthcare policy, and some have controversial views on issues like vaccines and reproductive rights that could jeopardize public health. In particular, the nomination of Robert F. Kennedy Jr. as HHS Secretary is highly controversial, as he is a well-known anti-vaxxer who could slow down the approval and distribution of vaccines, putting public health at risk. Other concerning nominees include Dr. Mehmet Oz for Medicare/Medicaid, and Dr. David Weldon for the CDC, who have expressed skepticism about vaccines and abortion rights. There are some guardrails that Congress could try to use to block or limit the ability of these nominees to implement harmful policies, but with a Republican trifecta in Washington, their options may be limited. Overall, the transcript suggests that the health of the nation could be in jeopardy under the Trump administration's health policy team, with potential impacts on vaccine distribution, maternal mortality rates, and access to reproductive healthcare.Today's Bill Press Pod is supported by National Nurses United, the largest labor union of Nurses in America. More information at NationalNursesUnited.orgSee Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.
The Defender reports “Arcturus Therapeutics announced earlier this week that the U.S. Food and Drug Administration (FDA) issued a “Study Can Proceed” notification for its investigational ARCT-2304 vaccine candidate.” Jessica Rose PhD says there are “major red flags.” The Defender also reported that “In clinical trials for the self-amplifying COVID-19 vaccine offered in Japan, “five deaths occurred among the injected in study phase 3b. Injected participants experienced a 90% adverse event rate (74.5% systemic, 15.2% required medical attention) after the first dose in study phases 1, 2, and 3a combined…” Dr. Clare Craig, BM BCh FRCPath, is a diagnostic pathologist, author, and co-chair of HART (Health Advisory and Recovery Team). She studied medicine at Cambridge and completed clinical training at Oxford. After 15 years in the NHS, she became pathology lead for the cancer arm of the 100,000 Genomes Project at Genomics England. She is the author of “Expired: Covid the Untold Story” and advocates for public education on COVID. Find more at https://hart.org and https://x.com/ClareCraigPath Dr. Jessica Rose is a Canadian researcher with a Bachelor's in Applied Mathematics and a Master's in Immunology from Memorial University of Newfoundland. She holds a PhD in Computational Biology from Bar Ilan University and completed postdoctoral research in Molecular Biology at the Hebrew University of Jerusalem and Biochemistry at the Technion Institute of Technology. Her recent work focuses on descriptive analysis of Vaccine Adverse Event Reporting System (VAERS) data. Find her at https://jessicasuniverse.com and https://jessicar.substack.com 「 SUPPORT OUR SPONSORS 」 Find out more about the brands that make this show possible and get special discounts on Dr. Drew's favorite products at https://drdrew.com/sponsors • CAPSADYN - Get pain relief with the power of capsaicin from chili peppers – without the burning! Capsadyn's proprietary formulation for joint & muscle pain contains no NSAIDs, opioids, anesthetics, or steroids. Try it for 15% off at https://drdrew.com/capsadyn • FATTY15 – The future of essential fatty acids is here! Strengthen your cells against age-related breakdown with Fatty15. Get 15% off a 90-day Starter Kit Subscription at https://drdrew.com/fatty15 • CHECK GENETICS - Your DNA is the key to discovering the RIGHT medication for you. Escape the big pharma cycle and understand your genetic medication blueprint with pharmacogenetic testing. Save $200 with code DRDREW at https://drdrew.com/check • PALEOVALLEY - "Paleovalley has a wide variety of extraordinary products that are both healthful and delicious,” says Dr. Drew. "I am a huge fan of this brand and know you'll love it too!” Get 15% off your first order at https://drdrew.com/paleovalley • THE WELLNESS COMPANY - Counteract harmful spike proteins with TWC's Signature Series Spike Support Formula containing nattokinase and selenium. Learn more about TWC's supplements at https://twc.health/drew 「 MEDICAL NOTE 」 Portions of this program may examine countervailing views on important medical issues. Always consult your physician before making any decisions about your health. 「 ABOUT THE SHOW 」 Ask Dr. Drew is produced by Kaleb Nation (https://kalebnation.com) and Susan Pinsky (https://twitter.com/firstladyoflove). This show is for entertainment and/or informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment. Learn more about your ad choices. Visit megaphone.fm/adchoices
The U.S. Preventive Services Task Force and the World Health Organization recommend primary HPV screening, starting at age 25, as an option (some as preferred) for cervical cancer screening. Although primary HPV screening is as effective as cotesting at detecting cervical cancer, primary HPV screening decreases the number of lifetime screenings needed. The primary HPV screening tests approved by the U.S. Food and Drug Administration (FDA) are the Roche Cobas and BD Onclarity tests. HPV results for the Roche and BD tests can be reported as a pooled result. This means the physician receives a result of negative or positive, in which positive indicates that at least one, but possibly more, types of high-risk HPV were identified in the sample. HPV genotyping options differ by manufacturer. Roche Cobas reports HPV 16 and 18 individually and groups 12 other types (i.e., positivity means at least one of the 12 types triggered the positive result). BD Onclarity reports six individual HPV types (16, 18, 31 [the highest risk going immediately to colposcopy], 45, 51, and 52), and combined types (33/58), (35/39/68). Now, as of March/April 2024, the ASCCP has recognized another important and clinically useful HPV and co-test TRIAGE tool, the DUAL STAIN. This pertains only to the ROCHE COBAS HPV test. In this episode, we will review this latest ENDURING GUIDELINES update to the 2019 ASCCP management algorithms (already updated in the ASCCP app).
On Thursday, President-elect Donald Trump announced he would nominate Robert F. Kennedy Jr. to lead the Department of Health and Human Services (HHS). Kennedy, who ended his independent bid for president in August and endorsed Trump, is a longtime environmental and public health activist whose views on vaccines and other healthcare issues have run counter to the medical establishment. If confirmed by the Senate, he would lead the largest health agency in the U.S., made up of organizations like the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH). Ad-free podcasts are here!Many listeners have been asking for an ad-free version of this podcast that they could subscribe to — and we finally launched it. You can go to tanglemedia.supercast.com to sign up!You can read today's podcast here, our “Under the Radar” story here and today's “Have a nice day” story here.We are hiring!In the last month or so, the rapid growth of our readership has accelerated a planned expansion of our team. We are hiring for two positions:1) Customer service lead. We are looking for a highly organized, dedicated professional to help us provide the best possible service to our readers and listeners that we can. This is a crucial role to fill, and we'll be hiring as soon as possible. Job listing here.2) Assistant to the editor. We are also looking for a highly organized individual dedicated to Tangle's mission who has a passion for multimedia and politics. This person will be working directly with Tangle's executive editor Isaac Saul out of Tangle HQ in Philadelphia, with a start date in February-March. Job listing here.Take the survey: What do you think of Trump nominating Kennedy for head of HHS? Let us know!You can subscribe to Tangle by clicking here or drop something in our tip jar by clicking here. Our podcast is written by Isaac Saul and edited and engineered by Dewey Thomas. Music for the podcast was produced by Diet 75. Our newsletter is edited by Managing Editor Ari Weitzman, Will Kaback, Bailey Saul, Sean Brady, and produced in conjunction with Tangle's social media manager Magdalena Bokowa, who also created our logo. Hosted on Acast. See acast.com/privacy for more information.
It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: World Diabetes Day roundup, existing drugs examined for T1D prevention, Blue Circle Health expands its novel T1D care model, Mounjaro studied further, Canada approves a new pumps system, and tragedy in the diabetes community. Find out more about Moms' Night Out Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Of course, World Diabetes Day was yesterday. November 14 marks the birthday of Sir Frederick Banting. who discovered insulin along with Charles Best in 1922. Lots of the tech companies are taking action.. I'm going to link up a great article highlighting what many of them are doing…. from Medtronics Blue Balloon challenge to Dexcom's Nick Jonas video and a lot more. https://www.drugdeliverybusiness.com/world-diabetes-day-2024/ XX A new triple combo therapy could restore insulin production in people with type 1 using existing medications. Levicure's triple-combo oral therapy is already considered very safe, because it involves two drugs approved by the U.S. Food and Drug Administration (FDA) and a well-known supplement. The therapy is a combination of: DPP4-inhibitors, a common type 2 diabetes medication Proton pump inhibitors (PPIs), a drug for severe acid reflux A proprietary version of gamma-aminobutyric acid (GABA), a supplement often used to treat anxiety Levicure says the combined effect can block beta cell destruction, suppress autoimmunity, and restore beta cell function. So far, Levicure's triple therapy has gone through only one retrospective chart review; it has not been put to the test in a randomized controlled trial https://www.diabetesdaily.com/blog/can-this-triple-combo-oral-therapy-restore-insulin-production-733261/ XX Blue Circle Health is expanding it's unique approach to type 1 care. Already active in Florida, Maine & Vermont, it will now be in Delaware and Ohio. Blue Circle Health is free and develops a personalized care plan for each participant, tailored to their unique needs, and offers comprehensive multidisciplinary support over a six-month period. It's paid for by the Helmsley Charitable Trust. The program is available to people 18 years of age and older that speak Spanish or English, regardless of insurance coverage or citizen status. We've got an upcoming podcast episode all about Blue Circle coming up soon. https://www.prnewswire.com/news-releases/blue-circle-health-expands-to-delaware-and-ohio-to-address-health-system-barriers-to-type-1-diabetes-care-and-education-302304170.html XX An international team of experts has created the world's first evidence-based guide for eating lower and low carb. The group says until now, people with type 1 diabetes and their healthcare providers have lacked comprehensive resources to help implement this approach safely and effectively. The guide provides essential information for dietitians and nutritionists and empowers them to work collaboratively with individuals and families who are interested in reducing carbohydrates. It's free and we've got the download link in the show notes. https://www.newswire.ca/news-releases/international-team-launches-first-guide-for-carbohydrate-reduction-in-type-1-diabetes-883729104.html XX A new pump system is available in Canada. mylife YpsoPump insulin pump and CamAPS FX hybrid closed-loop algorithm by Health Canada. mylife Loop consists of the mylife YpsoPump, a lightweight intuitive insulin pump, integrated with the CamAPS FX hybrid closed-loop, a mobile phone-based algorithm, and the Dexcom G6 Continuous Glucose Monitoring (CGM) System. Working together, these components provide an innovative, automated insulin delivery (AID) system designed to simplify insulin therapy and improve glycemic control for Canadians living with diabetes. "The approval of the mylife YpsoPump and CamAPS FX marks an important milestone as we bring these advanced technologies to the Canadian market," said Sébastien Delarive, Chief Business Officer of Ypsomed Diabetes Care. "Although Ypsomed is relatively new in Canada, our established leadership in diabetes care throughout Europe provides a solid foundation for delivering innovative solutions to Canadians living with type 1 diabetes." "We are excited to see both mylife YpsoPump and CamAPS FX approved," said Karina Schneider, General Manager at Ypsomed Canada. "This step brings us closer to offering an integrated solution that will help simplify diabetes management for Canadian patients, empowering them to take more control of their health." https://finance.yahoo.com/news/ypsomed-camdiab-receive-health-canada-205500840.html XX The FDA updates the labels for all GLP-1 receptor agonists with a warning about pulmonary aspiration during general anesthesia or deep sedation. The affected drugs are semaglutide (Ozempic, Rybelsus, Wegovy); liraglutide (Saxenda, Victoza); and the dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 tirzepatide (Mounjaro, Zepbound). the Medication Guide section of the label also has new additions. Patients are counseled to tell their healthcare provider if they are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). They are alerted that the GLP-1 RAs they are taking may cause serious side effects, including food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sedation. Patients are advised to tell all their healthcare providers that they are taking a GLP-1 RA before they are scheduled to have surgery or other procedures. https://www.medscape.com/viewarticle/fda-updates-glp-1-label-pulmonary-aspiration-warning-2024a1000k84?form=fpf XX Following an impressive data drop this summer highlighting the potential for Eli Lilly's tirzepatide to stave off progression to Type 2 diabetes in prediabetic patients, the Indianapolis-based drugmaker is laying out full results from its longest completed study of the dual GIP/GLP-1 receptor agonist to date. In the three-year SURMOUNT-1 trial, tirzepatide curbed the risk of disease progression to Type 2 diabetes by 94% versus placebo in adult prediabetes patients who were obese or overweight, Lilly said in a release Wednesday. The number represents a pooled result from three tirzepatide doses (5 mg, 10 mg and 15 mg) studied in the trial. Putting those results into perspective, one new case of diabetes could be prevented for every nine patients treated with tirzepatide, which is marketed in the U.S. as Mounjaro for Type 2 diabetes and as Zepbound for obesity, Lilly said. https://www.fiercepharma.com/pharma/lilly-unwraps-detailed-data-showing-tirzepatide-kept-nearly-99-pre-diabetic-patients XX Edgparke commeical? XX https://www.bloomberg.com/news/articles/2024-10-25/apple-secretly-tests-blood-sugar-app-in-sign-of-health-ambitions XX XX And finally, many of you have likely already heard but we had some incredibly tragic news in the diabetes community, especially for the Breakthrough T1D ride community. I'm going to read from the Breakthrough T1D website: The leadership, staff, and volunteers of Breakthrough T1D mourn the tragic, sudden loss of five T1D Champions on Friday, Nov. 1, 2024. Jeff and Michelle Bauer, Josh and Tammy Stahl and Barry Sievers were all killed in a singe car crash. The group included two married couples and one single individual—all very close friends and veteran Breakthrough T1D Ride participants. Of this incredibly impactful group, I knew Michelle Bauer personally, I met her as Michelle Alswager – you may know her as Jesse's mom. Her son, Jesse died from complications of type 1 in 2010. And that year, mile 23 on the JDRF ride was created as a mile of silence in memory of Jesse. Now all riders are asked to ride in silence for that mile not only in memory of Jesse, but all those lost to type 1 diabetes. Michelle wrote her book, Jesse Was Here and created a program that's part of Beyond Type 1 to this day, all to help other families going through grief. She called me a few years ago when she was thinking of writing her book and I'm so grateful for our conversations and that our conversations may have helped her get it out there into a world where it's so needed. But we need Michelle here to talk about grief. More about talking to Michelle about the book). Please, write the book, ride the bike, do the ironman, follow your heart and your dreams. All of these incredible people gone too soon. https://www.breakthrought1d.org/news-and-updates/breakthrough-t1d-mourns-tragic-sudden-loss-of-five-ride-champions/ Thanks for joining me..
Government Accountability Office (GAO) Podcast: Watchdog Report
The Food and Drug Administration (FDA) inspects drug manufacturers here and overseas to ensure the safety and quality of drug sold in the United States. But FDA paused many of its in-person inspection efforts during COVID-19 because of travel…
It's In the News.. a look at the top headlines and stories in the diabetes community. This week's top stories: iPhone control for Omnipod 5 rolls out, Libre is approved for use in CT scans and MRIs, Dexcom files for 15 day wear, Luna nighttime pump goes to trial, iLet cell trials move forward and more! Find out more about Moms' Night Out Please visit our Sponsors & Partners - they help make the show possible! Learn more about Gvoke Glucagon Gvoke HypoPen® (glucagon injection): Glucagon Injection For Very Low Blood Sugar (gvokeglucagon.com) Omnipod - Simplify Life Learn about Dexcom Edgepark Medical Supplies Check out VIVI Cap to protect your insulin from extreme temperatures Learn more about AG1 from Athletic Greens Drive research that matters through the T1D Exchange The best way to keep up with Stacey and the show is by signing up for our weekly newsletter: Sign up for our newsletter here Here's where to find us: Facebook (Group) Facebook (Page) Instagram Twitter Check out Stacey's books! Learn more about everything at our home page www.diabetes-connections.com Reach out with questions or comments: info@diabetes-connections.com Episode transcription with links: Hello and welcome to Diabetes Connections In the News! I'm Stacey Simms and every other Friday I bring you a short episode with the top diabetes stories and headlines happening now. XX Insulet Corporation announces the full market release of the Omnipod 5 App for iPhone® in the U.S. App allows users to fully control their Omnipod 5 Automated Insulin Delivery System (Omnipod 5) from their compatible iPhone1. For example, users can bolus for a meal, change a Pod, and adjust settings. Importantly, this also means that Omnipod 5 users who have a compatible iPhone no longer need to carry a separate Controller to help manage their insulin delivery requirements. Insulet says that the App for iPhone has been the number one feature requested by Omnipod 5 users. The Omnipod 5 App for iPhone is currently compatible with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and is expected to be compatible with the Dexcom G7 CGM in the U.S. in 2025. The Omnipod 5 App for Android phones is also available to U.S. customers. https://www.businesswire.com/news/home/20241029838744/en/Omnipod%C2%AE-5-App-for-iPhone%C2%AE-Now-Fully-Available-in-the-United-States XX Th FDA says it's okay to keep on your FreeStyle Libre 2 and 3 for procedures like X-rays, CT scans and MRIs. Abbott said it makes its systems the first and only patient-applied CGM sensors approved for these screenings. Imaging procedures often come as part of diabetes care, Abbott said, especially as diabetes can cause a number of medical complications. The company rigorously tested its Libre 2 and 3 sensors to ensure they remain effective after radiologic procedures. This FDA clearance comes with no changes made to the sensor. https://www.drugdeliverybusiness.com/fda-approves-abbott-cgms-medical-imaging/ XX Tidepool announced a new data integration with Abbott for the company's FreeStyle Libre continuous glucose monitors (CGMs). The companies aim to deliver cloud-to-cloud integration for an automatic stream of data from patients using Abbott's CGMs in the U.S. Data streams to Tidepool+, a diabetes data visualization and population health platform. Tidepool+ provides intuitive tracking and visualization of diabetes data to make the data informative and actionable for clinicians, people with diabetes and caregivers. https://www.drugdeliverybusiness.com/tidepool-abbott-data-integration-freestyle-libre/ XX Beta Bionics announced today that it launched the integration of the iLet bionic pancreas with the Abbott (NYSE:ABT) FreeStyle Libre 3 Plus. The companies announced their plan to combine the FreeStyle Libre 3 Plus continuous glucose monitor (CGM) with iLet last month. According to Beta Bionics, this makes iLet the first available automated insulin delivery (AID) system to integrate with Libre 3 Plus in the U.S. iLet users can now update their app and software to gain a choice of integrated CGMs. They can choose between Libre 3 Plus and Dexcom CGMs. Abbott, meanwhile, continues to push forward on the automated insulin delivery integration front. The company recently paired its FreeStyle Libre 2 Plus with Insulet's Omnipod 5 in Europe. It also announced compatibility with the Tandem Diabetes Care t:slim X2 system in January. Notably, the company also struck a deal with Medtronic in August. They aim to develop CGMs specifically for the medtech giant's own insulin delivery systems. https://www.drugdeliverybusiness.com/beta-bionics-launches-ilet-abbott-libre/ XX Dexcom is asking the FDA to approve the G7 CGM for 15 days. Right now the G7 has a 10 day wear time. Dexcom also launched the G7 CGM in Australia and rolled out Dexcom ONE+ in France. Some front-office news.. EVP and CCO Teri Lawver plans to retire at the end of the year. https://www.drugdeliverybusiness.com/dexcom-submits-15-day-cgm-fda-q3-2024/ XX Stelo by Dexcom is one of TIME's Best Inventions of 2024! As the first glucose biosensor available in the U.S. without a prescription, Stelo has unlocked our industry-leading technology for millions of people across the U.S. looking to improve their health through personalized insights. We're honored to be recognized among other unique innovations in the Home Health category that support people's health. https://time.com/7094684/dexcom-stelo/ XX Luna Diabetes is moving forward with a pivotal trial evaluating its automated closed-loop insulin technology, the Luna System. This is designed to address nighttime glucose control for insulin pen users. It's meant for use only during sleep - Luna system was developed as a wearable insulin pump and alternative to insulin pen to automate the insulin delivery process. The device works with continuous glucose monitors (CGM) to calculate and deliver rapid-acting insulin doses during sleep. Luna Diabetes expects the study to be completed early next year, with plans to commercially launch the device “soon after”. https://finance.yahoo.com/news/luna-diabetes-trials-automated-wearable-115211566.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAJIrWwjdye-ehrLNDt-LIGb5qTXaKDTIa8NWwiT7fKwFFgjDMN2nnINis6YfFePWP2ZA2DVYWXEIZQqRlQ4aKLFrYWgvw1jdI-t1n9kO6NIzdBCMXQNNCVl_S-75lDNip2SysHDJQmyqSc4wLjfDya3v9wwTWU-KgE_OqrPCTnlu XX Researchers are urging caution when prescribing off-label glucose-lowering drugs to individuals with type 1 diabetes (T1D) while acknowledging that doctors keep prescribing them because they seem to work so well. Both glucagon-like peptide-1 receptor agonists (GLP-1RA) and sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown significant benefits for cardiovascular and renal health in other populations, particularly in patients with type 2 diabetes. SGLT2 inhibitors carry a significant risk of euglycemic diabetic ketoacidosis, a dangerous condition most common in T1D individuals where toxic levels of blood acidification can occur. Due to this risk, SGLT2 inhibitors were removed for T1D use in Europe, and the U.S. Food and Drug Administration (FDA) has not approved them for T1D. For GLP-1RAs, there are concerns about substantial weight loss potentially leading to ketoacidosis or worsening hypoglycemia. While these medications can be beneficial in managing weight, the extent of that weight loss can create new problems in people with T1D as their insulin needs may quickly change as a result. Prescribing in People With Type 1 Diabetes," published in JAMA, the authors stress the critical need for more research to confidently allow the off-label usage of potentially dangerous secondary treatments. The data suggests clinicians are turning to these treatments to manage cardiovascular and renal complications in T1D patients, even though the drugs are not explicitly approved for this condition. Conversely, those newly prescribed GLP-1RAs had higher rates of obesity (69.4% vs. 45.7%). This data indicates that clinicians are prescribing GLP-1RAs to help manage obesity in T1D patients, as weight management is a critical component of diabetes care. The percentage of the T1D population prescribed GLP-1RAs increased significantly, from 0.3% in 2010 to 6.6% by 2023. The percentage prescribed SGLT2 inhibitors rose from 0.1% in 2013 to 2.4% by 2023. Overall, the percentage of T1D patients prescribed either of these medications increased from 0.7% to 8.3% during this period. Results of the study suggest that despite regulatory concerns, off-label use of GLP-1RAs and SGLT2 inhibitors in T1D continues to grow primarily due to their cardiorenal and weight management benefits. "Prospective studies on the efficacy and safety of GLP-1RAs or SGLT2 inhibitors in the T1D population are needed," the Research Letter concludes, "Before such evidence becomes available, caution should be exercised when prescribing these treatments to individuals with T1D." https://medicalxpress.com/news/2024-10-glucose-lowering-drugs-diabetes-patients.html XX More good islet transplant news.. from Eledon Pharmaceuticals and University of Chicago. These are potentially the first human cases of insulin independence achieved using a transplant of insulin-producing islet cells in combination with its experimental immunosuppressant drug. The first two subjects achieved insulin independence and normal hemoglobin A1C (HbA1c) levels, a measure of average blood glucose, post-transplant. The third subject, who recently received an islet transplant, decreased insulin use by more than 60% three days following the procedure and continues on an insulin independence trajectory. Some of the funding for this study comes from Breakthrough T1D. https://www.globenewswire.com/news-release/2024/10/29/2970713/0/en/Eledon-Pharmaceuticals-Announces-Positive-Initial-Data-from-Subjects-with-Type-1-Diabetes-Treated-with-Tegoprubart-as-Part-of-an-Immunosuppression-Regimen-Following-Islet-Transplan.html XX Semaglutide may reduce Alzheimer's risk in type 2 diabetes patients, with research suggesting significant protective benefits compared to other diabetes drugs. published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, the study suggests that T2D patients taking semaglutide had a significantly lower risk of developing Alzheimer's. This effect was observed consistently across various subgroups, including differences in obesity status, gender, and age. Semaglutide, which acts on glucagon-like peptide receptors (GLP-1R) to curb hunger and regulate blood sugar in T2D, is also the active component in the diabetes and weight-loss drugs Wegovy and Ozempic. About 120,000 Americans die from Alzheimer's disease each year, with the disease listed as the seventh-leading cause of death nationally, according to the CDC. https://scitechdaily.com/alzheimers-breakthrough-popular-diabetes-drug-ozempic-linked-to-much-lower-risk/ XX XX Edgepark commercial XX Apple's non invasive blood glucose monitoring rumors are back. But this sounds like just software.. no watch or hardware. According to the report, Apple doesn't currently have plans to release the app, but may integrate the technology into its future health products. The app could reportedly show consumers how certain foods impact their blood sugar levels, based on measurements taken by existing blood sugar monitoring devices. One report says apple is exploring uses for blood sugar data and what tools they could create for consumers as a result. Latterly, he reports testing on the app has been paused, but says the tests could pave the way for better food tracking on Apple's own health software or better third-party glucose tracking integration. https://www.techradar.com/health-fitness/apple-is-testing-a-new-blood-sugar-product-but-its-not-the-apple-watch-update-weve-been-waiting-for XX And finally, it's diabetes awareness month. Please follow on social – I'll be doing a few things but mostly I think this month is great to educate the general public.. every month is diabetes month for this community. XX Join us again soon!
Hour 3: 5:00pm- Jimmy Failla—stand-up comedian & Fox News host—joins The Rich Zeoli Show to talk about today's big announcement: Failla's radio show can now be heard 7pm to 10pm on 1210 WPHT! PLUS, what's your favorite Kamala Harris fake accent? Deep South? Spanish? Will she soon unveil an Italian accent to appeal to South Philadelphia? And is Tim Walz's wife somehow an even less-charming version of Hillary Clinton? 5:25pm- According to reports, former Independent presidential candidate Robert F. Kennedy Jr. is actively helping Donald Trump pick potential leadership at the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH). 5:35pm- Fed Cuts Interest Rates by Half a Percentage Point. Nick Timiraos of The Wall Street Journal writes: “The Federal Reserve voted to lower interest rates by a half percentage point, opting for a bolder start in making its first reduction since 2020. The long-anticipated pivot followed an all-out fight against inflation the central bank launched two years ago. Eleven of 12 Fed voters backed the cut, which will bring the benchmark federal-funds rate to a range between 4.75% and 5%. Quarterly projections released Wednesday showed a narrow majority of officials penciled in cuts that would lower rates by at least a quarter point each at meetings in November and December.” You can read the full article here: https://www.wsj.com/economy/central-banking/fed-cuts-rates-by-half-percentage-point-03566d82 5:40pm- On Tuesday, Governor Gavin Newsom signed legislation banning digitally altered political videos in California—even those that are made to parody elected officials if not clearly labeled. Newsom pledged to ban these types of videos after Elon Musk published a clearly satirical artificial intelligence-generated social media post mocking Kamala Harris's policy preferences and record. How is this crack down on free speech not violative of the First Amendment? Rich notes that the law will almost certainly be challenged in court. On Wednesday night, The Babylon Bee hilariously trolled Newsom by making an A.I. generated ad which features a fake Newsom bragging about how horrible he has been as governor. 5:45pm- In her new memoir, Hillary Clinton reveals that she has given her stomach a nickname. Why did anyone need to know that?
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