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Substance used to diagnose, cure, treat, or prevent disease

  • 1,169PODCASTS
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  • Jul 4, 2022LATEST
drug administration

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    Best podcasts about drug administration

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    Latest podcast episodes about drug administration

    The Doctor's Farmacy with Mark Hyman, M.D.
    The Best Foods To Heal The Gut

    The Doctor's Farmacy with Mark Hyman, M.D.

    Play Episode Listen Later Jul 4, 2022 44:24


    This episode is brought to you by Gut Food, Rupa Health, ButcherBox, and InsideTracker. Our gut, and the tons of bacteria that reside within it, regulates many of our bodily functions, from creating vitamins to controlling our immune system, our brain function, and, of course, our metabolism and weight. The gut is the number-one place to investigate when healing the body of any chronic symptoms or diseases. If your gut isn't healthy, you're not healthy! In this episode of my Masterclass series, I am interviewed by my good friend and podcast host, Dhru Purohit, about why prebiotics are vital in creating a healthy gut. These are the things your good gut bugs love to munch on. In turn, they produce beneficial compounds such as short-chain fatty acids, which have been shown to help prevent things like colon cancer. Dhru Purohit is a podcast host, serial entrepreneur, and investor in the health and wellness industry. His podcast, The Dhru Purohit Podcast, is a top 50 global health podcast with over 30 million unique downloads. His interviews focus on the inner workings of the brain and the body and feature the brightest minds in wellness, medicine, and mindset. This episode is brought to you by Gut Food, Rupa Health, ButcherBox, and InsideTracker. Check out Gut Food at gutfood.com. Check out a free, live demo with a Q&A or create an account at RupaHealth.com. Sign up today for ButcherBox and get two ribeye steaks free in your first box by going to butcherbox.com/farmacy. Right now, InsideTracker is offering my community 20% off at insidetracker.com/drhyman. In this episode, we discuss (audio version / Apple Subscriber version):Why is gut health so crucial? (6:07 / 1:46)Resistant starch (9:48 / 5:33)How and why to increase short-chain fatty acids (13:56 / 9:42)The many benefits of acacia fiber (16:19 / 11:58)Galactooligosaccharides for gut health (18:22 / 14:00)Probiotics, prebiotics, and polyphenols in my meals (21:44 / 16:00)One prebiotic food that everyone should consider eating (24:39 / 19:00)Questions from my community (27:27 / 21:42) Podcasts, Products, & Research Mentioned Disclaimer: This podcast is for educational purposes only. This podcast is not a substitute for professional care by a doctor or other qualified medical professional. You should always speak with your physician or other healthcare professional before taking any medication or nutritional, herbal, or homeopathic supplement, or adopting any treatment for a health problem. The use of Gut Food or any other products or services purchased by you as a result of this podcast does not create a doctor-patient relationship between you and any of the physicians affiliated with this podcast. Information and statements regarding dietary supplements have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease. See acast.com/privacy for privacy and opt-out information.

    CEimpact Podcast
    Tirzepatide: A "Twincretin" GameChanger?

    CEimpact Podcast

    Play Episode Listen Later Jul 4, 2022 23:24


    Curious about tirzepatide and what it means for patients? Tirzepatide, a combination GLP-1 and GIP agonist, was just approved by the Food and Drug Administration for the treatment of diabetes. Tirzepatide has also gained attention for its weight-reducing effects. However, how does tirzepatide compare to other GLP-1 agonists? Is tirzepaide a GameChanger for type 2 diabetes management? Learn more with host, Geoff Wall.  The GameChanger Tirzepatide is the first in its class to hit the market and has been shown to be as or more effective than semaglutide in glycemic control and weight reduction.   Show Segments 00:00 – Introductions 01:15 – Type 2 Diabetes & Treatment 02:29 – Glucagon-like peptide-1 (GLP-1) Agonists 03:04 – Glucose-dependent insulinotropic polypeptide (GIP) Agonist   03:55 – Tirzepatide vs Semaglutide 14:27 -  Tirzepatide vs Insulin 21:15 – Retinopathy & Financial Considerations 22:30 – Closing Remarks  HostGeoff Wall, PharmD., BCPS, FCCP, CGP Professor of Pharmacy Practice, Drake University Internal Medicine/Critical Care, UnityPoint Health References and Resources Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes Once-Weekly Tirzeaptide Versus Once-Daily Insulin Degludec as Add-On to Metformin With or Without SGLT2 Inhibitors in Patients With Type 2 Diabetes (SURPASS-3): A Randomized, Open-Label, Parallel-Group, Phase 3 Trial  Efficacy and Safety of a Novel Dual GIP and GLP-1 Receptor Agonist Tirzepatide in Patients With Type 2 Diabetes (SURPASS-1): A Double-Blind, Randomised, Phase 3 Trial Effect of Subcutaneous Tirzepatide vs Placebo Added to Titrated Insulin Glargine on Glycemic Control in Patients With Type 2 Diabetes: The SURPASS-5 Randomized Clinical Trial Redeem your CPE or CME here CPE (Pharmacist)  CME (Physician)  Get a membership & earn CE for GameChangers Podcast episodes (30 mins/episode) Pharmacists: Get a membership Prescribers: Get a membership CE Information Learning Objectives Upon successful completion of this knowledge-based activity, participants should be able to: Describe the safety and efficacy of tirzepatide compared to GLP-1 agonists Discuss the use of tirzepatide compared to basal insulin for blood glucose control Select a patient who may be a candidate for tirzepatide therapy 0.05 CEU/0.5 HrUAN: 0107-0000-22-234-H01-P Initial release date: 06/27/2022 Expiration date: 06/27/2023 Additional CPE and CME details can be found here. 

    The Good Dirt
    98. Clothing with Soul: The Plant Dye Vibe with Allie Feldman and Sarah Arch of Rooted Botanics

    The Good Dirt

    Play Episode Listen Later Jul 1, 2022 71:34


    After observing the waste and unsustainable practices while working in the fashion industry, Sarah Arch and Allie Feldman decided to do something about it by starting Rooted Botanics, a fashion brand that gives ethically sourced vintage pieces new life through natural dyes. Both Sarah and Allie are dedicated to thoughtful sourcing, purposeful education about the history of natural dye, and creating beautiful garments while developing a business model designed to remain at a human scale. The relationships they have forged with plant dyes continue to advance a paradigm shift in the fashion industry - a shift that ultimately downplays harm and amplifies joy. Topics Covered: Discovering Natural Dyes Waste in the Fashion Industry Greenwashing and Microplastics Health Benefits of Natural Dyes and Fibers Embracing the Beauty and Unpredictability of Natural Dye Learning and Growing Into Slow Living Resources Mentioned:  https://lady-farmer.com/blogs/the-good-dirt-podcast/mairin-wilson (Christie Dawn Podcast Episode) https://lady-farmer.com/blogs/news/textiles-101-fiber-content (Textiles 101: Fiber Content) https://maiwa.com/ (Maiwa natural dyes) Connect with Rooted Botanics: https://rootedbotanics.com/ (https://rootedbotanics.com/ ) Instagram:https://www.instagram.com/rootedbotanics/?hl=en ( @rootedbotanics) About Lady Farmer: https://lady-farmer.com/blogs/the-good-dirt-podcast (Our Website) @weareladyfarmer on https://www.instagram.com/thegooddirtph/ (Instagram) Join http://almanac.lady-farmer.com/ (The Lady Farmer ALMANAC) Leave us a voicemail! Call 443-459-1950 and ask a question or share a shoutout. Submissions throughout the month of June will be entered to win a Slow Living Consult with Mary and Emma!  Email us at thegooddirtpodcast@gmail.com Original music by John Kingsley @jkingsley1026 Statements in this podcast have not been evaluated by the Food and Drug Administration and are not to be considered as medical or nutritional advice. This information is not intended to diagnose, treat, cure or prevent any disease, and should not be considered above the advice of your physician. Consult a medical professional when making dietary or lifestyle decisions that could affect your health and well being.

    RARECast
    Why Reforms to the Accelerated Approval Pathway Threaten Rare Disease Drug Development

    RARECast

    Play Episode Listen Later Jun 30, 2022 35:34


    The U.S. Food and Drug Administration's Accelerated Approval pathway allows for the use of surrogate endpoints to make therapies more quickly available for unmet medical needs. About 82 percent of the drugs approved under the designation have been for orphan indications. But controversy around its use to win approval for Biogen's Alzheimer's disease drug Aduhelm last year set lawmakers off on an effort to reform how the pathway is used and to place new requirements on drugmakers. The healthcare consulting firm Vital Transformation recently did an analysis on the effects potential changes to the Accelerated Approval pathway could have and found that as many as two-thirds of treatments approved this way would no longer reach patients. We spoke to Duane Schulthess, CEO of Vital Transformation, about proposed reforms to the Accelerated Approval pathway, the findings of his firms' analysis, and why these changes could have dire consequences for rare disease drug development.

    Closer Look with Rose Scott
    American Medical Women's Association responds to the overturning of Roe. V. Wade

    Closer Look with Rose Scott

    Play Episode Listen Later Jun 30, 2022 51:09


    Dr. Theresa Rohr-Kirchgraber, the president of the American Medical Women's Association and professor of medicine at the Augusta University and University of Georgia medical partnership, discusses the impact of the Supreme Court's decision to overturn Roe v. Wade and the restriction of access to reproductive healthcare. Plus, The Food and Drug Administration and the Centers for Disease Control and Prevention recently authorized the first COVID-19 vaccines for children under the age of five. Dr. Andi Shane and Dr. Jacob Eichenberger return to the program to answer some of the most frequently asked questions about vaccines.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

    Beyond Labels with Dr. Sina McCullough
    Episode #43: Joel & Sina on Rewiring the Brain to Dissolve Disease and Achieve your Dreams (Part ONE)

    Beyond Labels with Dr. Sina McCullough

    Play Episode Listen Later Jun 30, 2022 35:50


    Have you ever tried to change a habit and couldn't?  Or maybe you tried positive affirmations and they didn't work.  Maybe you have an ailment or disease and can't reverse it.  You can dissolve disease and achieve your wildest dreams by rewiring your brain.  And, it's easy to do!   In part ONE, Joel and Sina discuss what it means to have a dysregulated nervous system and how it stops you from being healthy, happy and free.  In part TWO, Joel and Sina share simple and easy steps to begin rewiring your brain. If you have questions, we'd love to answer them on the show!  Please email your questions to Sina at handsoffmyfood@1791.comWatch on YouTube HereWatch on Rumble HereFind Joel Here: www.polyfacefarms.comFind Sina Here: www.drsinamccullough.comOur Videographer: www.nolangfilmco.comDisclaimer:  The information provided by Joel Salatin and Sina McCullough, PhD is not intended to prevent, diagnose, treat, or cure any disease.  The information provided in the podcasts, videos, and show descriptions is for educational purposes only.  It is not intended to diagnose or treat any medical or psychological condition.  The information provided is not meant to prevent, treat, mitigate or cure such conditions.  The information provided is not medical advice nor is it designed to replace advice, information, or prescriptions you receive from your healthcare provider.  Consult your health care provider before making any changes to your diet, medication, or lifestyle.  Proceed at your own risk.Joel Salatin and Sina McCullough, Ph.D. specifically disclaim any liability, loss, or risk, personal or otherwise, that may be incurred as a consequence, directly or indirectly, of the use and application of any of the contents of their YouTube channel, Podcast, websites, books, Facebook pages, or any of the content during consulting sessions or speaking engagements.  Proceed at your own risk.  These statements have not been evaluated by the Food and Drug Administration.

    KQED’s Forum
    Answering Your Covid Questions with UCSF's Dr. Peter Chin-Hong

    KQED’s Forum

    Play Episode Listen Later Jun 29, 2022 55:29


    The Food and Drug Administration's vaccines advisory committee decided Tuesday to recommend that covid vaccines be reformulated to better protect against the highly transmissible omicron variant. The vote comes as reported coronavirus cases top 10 million in California – a figure widely considered an undercount. We'll discuss what the vote means, as well as the latest on covid subvariants, boosters and long covid, with UCSF's Dr. Peter Chin-Hong. Guests: Dr. Peter Chin-Hong M.D., infectious disease specialist, UCSF Medical Center

    The Dirobi Health Show
    New Insights Into Movement Based Training with Andy Chan

    The Dirobi Health Show

    Play Episode Listen Later Jun 29, 2022 48:07


    No one can deny that emotional and physical health are closely knit together....If you're in a bad mood, the gym just isn't going to happen.  Tough day at work:  It's going to be a Netflix night.  The dog will not be going on a walk, and ice cream will be on the evening menu.  Andy is a certified strength and conditioning specialist, educator, and presenter from Hong Kong. With a master's degree in exercise science, Andy has a genuine passion for making a positive impact in the fitness industry through learning and sharing different unique methodologies. He currently teaches education courses on behalf of companies such as the National Academy of Sports Medicine, TRX, TriggerPoint Performance, and Power Plate. He has made guest appearances on Hong Kong television shows, as well as presenting at different public fitness events.Find episode links, notes and artwork at:https://blog.dirobi.comThis show is for informational purposes only. None of the information in this podcast should be construed as dispensing medical advice. These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

    The Thorne Podcast
    Fuel for an active lifestyle after the NFL with Greg Olsen

    The Thorne Podcast

    Play Episode Listen Later Jun 29, 2022 39:37


    Former NFL tight end Greg Olsen shares his advice for building a long career as a professional athlete, talks about his transition into the commentator's chair, and gives his thoughts on healthy aging as a retired football player in the Performance Edition of The Thorne Podcast. During this episode you'll learn about: Greg Olsen, 14-year veteran of the NFL [0:35] An investment in off-season training for on-the-field longevity [2:57] Help along the way from a diverse crew of trainers and coaches [5:29] Confidence in substance-free performance with NSF-certified supplements [8:38] How Greg fuels his post-NFL days with family time, tennis, and active movement [12:57] What healthy aging means for a retired football player [14:58] Questions from the community [17:55] The Youth Inc. podcast about youth sports athletes [18:28] Advice to young athletes on building long successful careers [19:30] Transitioning from football field to the commentator's booth [21:58] What Greg does now to stay active and mentally sharp [23:43] How to become the best mentor: Do first, keep learning, lead by example [25:27] Greg's favorite supplements [29:54] The HEARTest Yard: Greg's mission after his son was diagnosed with a congenital heart defect [35:01] Resources to topics mentioned in this episode: Q&A with World-Class Performance Coach Pete Bommarito How Does NSF Protect Athletes? The Surprising Blood Levels of Professional Football Players How Does Thorne's Biological Age Test Work? The Risks of Being Vitamin D Deficient as an Athlete The Joint Bundle: Because You Can't Compete Without Healthy Joints Links to products mentioned in this episode: : NiaCel, Joint Support Bundle, Catalyte, Biological Age Test, Protein Powders R4R: The Greg Olsen Foundation and The HEARTest Yard Youth Inc. podcast Subscribe To More Content Make sure to never miss an episode by subscribing to the show on your podcast app. You can also learn more about what we talked about by visiting Thorne.com and checking out the latest news, videos, and stories on Thorne's Take 5 Daily blog.   * These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

    KUNR Public Radio: Local News Feed
    FDA bans Juul e-cigarettes, impacts on Washoe County youth vaping

    KUNR Public Radio: Local News Feed

    Play Episode Listen Later Jun 28, 2022 2:12


    The Food and Drug Administration issued marketing denial orders for Juul on Thursday, June 23, forcing the company to stop selling and distributing its products.

    WSJ Minute Briefing
    Three People Arrested After 50 Migrants Found Dead in Trailer

    WSJ Minute Briefing

    Play Episode Listen Later Jun 28, 2022 3:09


    Plus: Ernst & Young agrees to pay a record $100 million fine in ethics exams-cheating scandal. Juul says the Food and Drug Administration mishandled its e-cigarette application. Elon Musk now has access to the Twitter data he said was needed to complete his $44 billion-dollar acquisition of the company. Trenae Nuri reports.  Learn more about your ad choices. Visit megaphone.fm/adchoices

    Slices of Wenatchee
    Demonstrators rallied in Wenatchee to support abortion rights; The latest on Juul Labs' appeal

    Slices of Wenatchee

    Play Episode Listen Later Jun 28, 2022 6:31


    Today - Demonstrators rallied in Wenatchee on Friday to support abortion rights after the Roe v. Wade decision. Later - Vape company Juul Labs, which is appealing Thursday's order by the Food and Drug Administration banning its products from store shelves, is facing some other push back. Support the show: https://www.wenatcheeworld.com/site/forms/subscription_services/ See omnystudio.com/listener for privacy information.

    ASCO eLearning Weekly Podcasts
    Oncology, Etc. - In Conversation with Dr. Richard Pazdur (Part 2)

    ASCO eLearning Weekly Podcasts

    Play Episode Listen Later Jun 28, 2022 20:18


    In part two this ASCO Education Podcast episode, hosts Dr. David Johnson and Dr. Patrick Loehrer continue their conversation with Dr. Richard Pazdur, director of the U.S. Food and Drug Administration's Oncology Center of Excellence, focusing on his leadership and vision for improving cancer care worldwide. The conversation includes reflection on drug toxicities, approval processes, and complexity of clinical trials. If you liked this episode, please subscribe. Learn more at https://education.asco.org, or email us at education@asco.org.   TRANSCRIPT Dr. Pat Loehrer: Hi. I'm Pat Loehrer, the Director of Global Oncology and Health Equity at Indiana University. Dr. Dave Johnson: And hi. I'm Dave Johnson at UT Southwestern in Dallas, Texas. Dr. Pat Loehrer: This is the second half of our Oncology, Etc. conversation with Dr. Rick Pazdur, who's the director of the FDA's Oncology Center of Excellence. In Part 1, we chatted with Dr. Pazdur about his upbringing and his early career. Today, we're going to focus on his leadership and vision for improving cancer care worldwide. But first, we'll discuss how cancer has impacted his life personally.   I want to flash-forward. I had the pleasure of knowing Mary. And there was no question, if you had a problem in oncology, you would go to Mary and not Rick Pazdur when you were a house staff member. But moving forward a bit, I'm not sure if all the listeners know that Mary came down with ovarian cancer. Dave himself had cancer. My wife had breast cancer. It is incredibly hard to be an oncologist I think when your spouse or someone who's close to you has cancer, and particularly, being married to a medical oncology nurse. Maybe just share a little bit about that journey of being a husband of a- Dr. Richard Pazdur: Yeah. It is interesting because going back to the Rush story, the first patient that my wife and I had in common, and this is so ironic, was a patient with ovarian cancer. The last patient that we had in common was her, which is some ironic fate, so to speak. And the story began of her illness was right around Labor Day. We had gone to Chicago in February driving back from Chicago. I noticed that she kept on taking a whole bunch of Tums and then saying - Oh, I just got a lot of GI symptoms, and she went to see her gastroenterologist or GP and he said, ‘Oh, this is just, you know, indigestion.' And two weeks after that or not even that, she was in the hospital with a massive amount of ascites, needed an intensive care unit. It was readily apparent just on getting her CA 125 what she had and she wound up one day in debulking surgery and then IP chemotherapy, etc. I think something that I learned, and I think we knew from the very beginning that this was not going to be a curable illness, and how to deal with that on an emotional level. And I have to give my wife credit. She spared me a lot of the emotion because she was such a strong person. She made all of her own calls as far as what she wanted. She would ask me what I thought, but she would do her own research, she would go to her own doctors' appointments. She said, ‘You don't really need to come with me. I'm self-sufficient.' She was very much interested in helping other cancer patients, and after she died, I think one of the most cherished conversations I had was a group of women that came to me and said how much she helped them during their support group because she was a nurse. She knew she was dying. She had emotional maturity not to fall apart but to accept the inevitable in a very strong way. My wife was a very religious person, had gone to Catholic schools, really embraced religion during those terminal years basically. And I think that was a great sense of comfort to her. But it did teach me a lot of lessons when you take care of somebody that has cancer, and that is, what a bad job we do with drug toxicities. Drug toxicities to medical oncologists and especially the people at the FDA are numbered, Grade 3, Grade 4, Grade 1. These toxicities are tolerable, tolerable to who, so to speak. And how to manage these toxicities and how they interrupt your life is one of the lasting experience I have, which I always will remember. And that has been one of my roles recently is forming several programs that we have in the OCE to look at dosing, to look at what is this definition if the drug is tolerable or well-tolerated or if the toxicities could be managed. I always say, yeah, every toxicity could be managed, even death. You call the undertaker to manage it. So what do you really mean by that statement. But I think the issue of toxicity is an important one. And then also going on clinical trials and having people considering what you want to go on, what risk you want to take, and what is actually in the informed consent and how meaningful that is. Dr. Dave Johnson: Really glad you brought that up, Rick. That matches my own experience with lymphoma and going through chemotherapy. And as an oncologist, one would think I would know what the side effects are. I'd recounted them dozens and dozens of times to people over the years, but until you've actually experienced them either personally or up close as you did with Mary, it's impossible to fully understand. I'll give you one example. Fatigue. Everybody thinks they know what fatigue is, but until you've had chemotherapy-induced fatigue, the fatigue that never abates, you just don't understand what it is. It's debilitating in ways that are unimaginable to most people. So I'm sure that experience certainly shaped your view and your role at the FDA. Dr. Richard Pazdur: Correct. Dr. Dave Johnson: I wonder, if you might share, you initiated a number of programs recently, including programs to try to improve coordination and co-operation amongst the pharmaceutical companies. Could you speak to some of those programs for us? Dr. Richard Pazdur: I think one of my favorite programs is Project Orbis. Project Orbis is an idea I had when I was walking down the street. It just hit me. When I came to the FDA, one of the things I rapidly noticed is how isolated the FDA was, even from the rest from the regulatory agencies throughout the world. There was very little cross-fertilization there. So one of the very first things that I did was set up a monthly tele-conference first with the EMA, the European Medicines Agency, and then we ended on Health Canada, Australia, Japan, Singapore, you name it. And one of the things that became really apparent to me, we at the FDA got applications always first—always. That's obvious. You know why they had given it to us first? The money. That's where the finances are going to be. So we got the application first, and it could be 2 years, 18 months, 12 months, that these other countries, Canada, Australia, Switzerland, and Brazil, Israel, would get these applications. And I said, well, this isn't right, really, because these people, they have cancer. They have every right to get these medications as soon as possible, and also we have such a large agency. We have 80 to 100 oncologists that work there, and most of these agencies have one or two oncologists. So our expertise in oncology at the FDA is so much greater than these other regulatory agencies. How can we leverage that to help these other countries? So we started Project Orbis, and what it was is that companies come in and they submit an application and they simultaneously submit the same application to the countries that want to participate in the program. They are all preselected and have confidentiality agreements with each other. And we worked together on the applications, basically reviewing the applications. So we had many meetings, tele-conversations, telephone conversations with countries. So that expedites these drugs. This has really had a lasting impact because from a worldwide perspective, it's really promoted more rapid development of drugs and rapid approval of drugs, and that's important because that establishes sooner new standards of care that will impact future trials. So in addition to the humanitarian issue of improving healthcare for patients in these countries, it has an impact on the global clinical trial system by having new standards approved much faster and accepted by world authorities. Dr. Pat Loehrer: Let me just jump on that for a second, just to make a comment. Back when we were growing up, there would be like three to five drugs approved- Dr. Richard Pazdur: Yeah. Dr. Pat Loehrer: And today, it's like once a week, there's a new indication for oncologists. Dr. Dave Johnson: Our listeners have another question that might be appropriate to ask at this time. What is the most common mistake that drug companies make in their applications to the FDA or in the process of trying to get their drug approved? Is there a frequent mistake that you can advise them? Dr. Richard Pazdur: Well, they don't come and talk to us. That's number one. They want, not necessarily what the best registration pathway is, but what the quickest registration pathway is. And sometimes the quickest registration pathway, especially single arm trials, are not the best registrations pathway. So my advice is rather than playing games with the FDA, to put it in the vernacular, just do the right thing and say, what is the optimal information that patients need when I develop this drug. We're seeing a lot of problems now with various drugs where people are developing in a refractory disease setting a drug, and they plan on getting accelerated approval on a response rate. So they push and push the dose. And with a single arm study, you can't really evaluate safety that well. Everything is attributed to the drug, and they want to get the highest response rate. And they get it, and there's a confirmatory study, and the arm of the confirmatory study, the control arm may not be as toxic as theirs, and we're seeing a wave of drugs that now have inferior survival compared to controls, which probably is predicated upon, they got the wrong dose. And I think that is one of the major programs that we have, that we need to address is dosing in oncology, this ‘More is better, more is better,' and ‘Let's push the dose as high as possible.' More isn't even probably good in cytotoxic days, but certainly, not a good idea in targeted therapies and certainly not a good idea in biological therapy. So we've really got to think about dosing more, penetration of targets, what's the optimal dose rather than what's the highest dose. You know as well as I do, pharmaceutical companies want to go with the highest dose because the major hurdle is the demonstration of efficacy, even in a randomized study. So nobody wants to be blamed by saying, well, you spent $100 million on a Phase 3 study and it's negative because you used too low of a dose. But then at the end of the day, we don't have a really good tolerable dose, and it's really hard to go backwards and look at dosing after a drug was already approved because the efficacy study has already been done. Dr. Pat Loehrer: The other aspect of drug companies is not only getting the dosage there, but also the duration. There is motivation for money, and so patients are going to and- Dr. Richard Pazdur: Oh, count on that. Dr. Pat Loehrer: So it begs a question, and I know the FDA can't do this, but in other countries, there is a monetary review together with the toxicity review. Can you reflect a little bit about that to the best of your ability? Dr. Richard Pazdur: Well, even within our simpler agencies, they may communicate more than we do with CMS, but all oncology drugs that when they're approved are then paid for by CMS, okay? In these other countries, that is not so. They may get approval and then they have to go to these health assessment agencies that will decide and argue with the companies what the pricing of the drug is. I think it's a mistake, honestly, for the FDA to get into pricing. We have a hard enough time with efficacy and safety, and pricing is a very ephemeral concept because it could change on a dialing. Somebody could promise you, you should approve their drug because it's much cheaper on Monday, and on Friday, they could say, 'Oops, we made a mistake. We really think that this dose has to be X number of dollars.' And you could see competition hasn't worked well in oncology with seven PD-1 drugs approved, pricing has not really been of any movement here. Dr. Pat Loehrer: I'm sorry. Dave may have another question, but let me ask you this. Going back to the clinical trials and what industry asked you- the complexity of clinical trials is going up logarithmically compared to the way they were in the ‘70s and ‘80s. In many of the trials where we have to get all this data in order to soothe the FDA, what are your thoughts about simplifying clinical trials? Dr. Richard Pazdur: Oh yeah. I'm for it. I am for it. If you really look at it, these are not FDA requirements for the most part. The companies want them, all of this data because it's controlled. They don't want to be blamed at the end of the day for not capturing this data or that data. They have developed complicated bureaucracies, going back in my sociology days there, complicated bureaucracies to gather all of this data, the whole CRO industry to go out and pester you guys in practice by doing site visits. It's a complicated situation and it's really predicated a lot on the history and bureaucracies that have been built up and not money to strip away those bureaucracies for fear of failure, so to speak, of not catching something. Dr. Dave Johnson: So Rick, we're coming to the end of our time that we've scheduled. I actually have two questions for you. We've asked all of our previous guests, the first of which would be if you could talk to your 21-year-old self today, what advice would you give yourself? After you've done that, we'd like to know what books have you been reading lately or is there some documentary that you've seen that you would recommend to us and our listeners? Dr. Richard Pazdur: I would tell myself, when I was 21 years old, relax and be less anxious. All things pass. I think we get so anxious when we're young about relatively small things. I remember my first ASCO presentation, I was petrified. My heart was beating out of my chest. I was sweating. And like relax. It's one of a thousand presentations at ASCO. We tend to magnify things, and I think age puts things in perspective. This in the reality of the world is a small thing, and people probably won't even remember it. Dr. Dave Johnson: Excellent advice. Dr. Richard Pazdur: My favorite author that I'm reading now for the last couple of months is a presidential historical author, Doris Kearns Goodwin. I think many of you know, she's written many books. I love her writing style. And I like non-fiction. I like biographies and I like history books, history stories rather than mysteries or things like that, fantasy books. The two books that I really enjoyed, the first one was No Ordinary Time: Franklin and Eleanor Roosevelt: The Home Front in World War II. I don't know if anybody's read that. It's an excellent book. Most of our attention in World War II is directed toward Europe and what was going on in Europe, the battlefields, etc., which I'm not a big fan of reading about battles and stuff, but this was what was going on in The White House and the relationships of all of the people that came there. It was like a hotel almost with the personalities that were flowing through including Churchill and various princes and queens, etc. But also the interesting relation, the fascinating relationship that Eleanor and Franklin Roosevelt had, I don't know how to describe the relationship. It truly was an unconventional relationship based on some past history that they had of affairs etc., but it was just a fascinating one. The best book, though, again I'm reading now, is written also by Doris Kearns Goodwin, and it is Lyndon Johnson and the American Dream. Doris Kearns Johnson was his biographer and spent a great deal of time with him in The White House as well as when he left The White House. But it's an excellent book on management and reading people, success. One of the things that is most interesting about Lyndon Johnson, and especially when he was running the senate before he became president, was his ability to know what motivated people and how to use that to form a consensus. Does this person want to go on this trip. I'll give it to him and then he could help me with this. Does this person want to go to this party or get on this position in congress? So it was really a skillset that he had, which I think most leaders need to know. You have to motivate people. You can't lead by an autocratic masthead, but you've got to lead from what do people want and to make sure that they feel you have a personal relationship with them. As I say to my staff, everything in life is personal—everything. Dr. Dave Johnson: Well, it's been a great session, Rick. We so much appreciate your willingness to spend time with us. We wish we had twice as much time. I'm sure we could go on for hours. Thanks again, and we appreciate all you do at the FDA. You've been a fabulous leader, and we hope you continue on for many years to come. Dr. Richard Pazdur: Thank you so much, Dave, and thank you so much, Pat. Dr. Pat Loehrer: Great to see you. Dr. Dave Johnson: Pat, before we leave, any idea why our patients seem to get sick on Saturday and Sunday? Dr. Pat Loehrer: I have no clue. Do you know the answer, Dave? Dr. Dave Johnson: Yes. They have a weekend immunity. Thank you for listening to the ASCO Education Podcast. To stay up to date with the latest episodes, please click subscribe. Let us know what you think by leaving a review. For more information, visit the Comprehensive Education Center at education.asco.org. The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions. Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy should not be construed as an ASCO endorsement.    

    LA Public Health
    COVID-19 Vaccines for Children Age 6 Months - 5 Years Old

    LA Public Health

    Play Episode Listen Later Jun 28, 2022 26:38


    Last week the Food and Drug Administration approved COVID-19 vaccines for young children age 6 months to 5 years old.  Our team reached out via social media to collect your questions and in this episode we get answers from Dr. Nava Yeganeh, Medical Director of Vaccine Preventable Disease Control in the Acute Communicable Disease Control Program in the Los Angeles County Department of Public Health. Links discussed during the show: www.VaccinateLACounty.com LA Public Health's Vaccine Service Locator LA Public Health Vaccine Call Center: (833) 540-0473 LA Public Health's how to get vaccinated page Home visiting programs: https://edirectory.homevisitingla.org/ Homebound vaccination program online request form In-home vaccination web page in English and Spanish Coping with stress during the COVID-19 pandemic? The Department of Mental Health has online resources to help. Follow our department across all social media platforms @lapublichealth.

    The Doctor's Farmacy with Mark Hyman, M.D.
    Do You Need To Take Probiotics?

    The Doctor's Farmacy with Mark Hyman, M.D.

    Play Episode Listen Later Jun 27, 2022 37:56


    This episode is brought to you by Gut Food, Rupa Health, Athletic Greens, and InsideTracker. Probiotics are critical to protecting and rebuilding the gut. They compete with bad gut bugs and yeast, modulate intestinal function, and are essential to changing and improving immune function. They are also anti-inflammatory, they help us break down food, and they build nutrients. In this episode of my Masterclass series, the second in a series on gut health, I am interviewed by my good friend and podcast host, Dhru Purohit, about how probiotics work in the gut, the best fermented foods to eat, and much more. Dhru Purohit is a podcast host, serial entrepreneur, and investor in the health and wellness industry. His podcast, The Dhru Purohit Podcast, is a top 50 global health podcast with over 30 million unique downloads. His interviews focus on the inner workings of the brain and the body and feature the brightest minds in wellness, medicine, and mindset. This episode is brought to you by Gut Food, Rupa Health, Athletic Greens, and InsideTracker. Check out Gut Food at gutfood.com. Check out a free, live demo with a Q&A or create an account at RupaHealth.com. When you purchase AG1 from Athletic Greens, you will receive 10 FREE travel packs with your first purchase by visiting athleticgreens.com/hyman. InsideTracker is offering my community 20% off at insidetracker.com/drhyman. In this episode, we discuss (audio version / Apple Subscriber version):Why we need probiotics (5:32 / 1:52)Top insults to our gut (7:04 / 3:25)Evaluating store-bought probiotics, including kombucha (8:08 / 4:26)What probiotics do (10:06 / 6:28) Different strains for different symptoms (14:43 / 10:50) The top fermented foods (18:34 / 14:46)Bacteria in the gut and your immune system (24:05 / 18:51)Who shouldn't eat fermented foods (26:25 / 20:18)Steps to shape up our guts (28:48 / 23:46) The downside of antibiotics and supporting the gut (34:15 / 28:57) Products and Research Studies Mentioned in This Episode Disclaimer: This podcast is for educational purposes only. This podcast is not a substitute for professional care by a doctor or other qualified medical professional. You should always speak with your physician or other healthcare professional before taking any medication or nutritional, herbal, or homeopathic supplement, or adopting any treatment for a health problem. The use of Gut Food or any other products or services purchased by you as a result of this podcast does not create a doctor-patient relationship between you and any of the physicians affiliated with this podcast. Information and statements regarding dietary supplements have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease. See acast.com/privacy for privacy and opt-out information.

    Congressional Dish
    CD254: Baby Formula Shortage

    Congressional Dish

    Play Episode Listen Later Jun 26, 2022 85:17


    After multiple formula-related infant deaths were reported to the FDA in February, samples from Abbott Laboratories' Sturgis, Michigan baby formula production facility tested positive for cronobacter, triggering a recall and a subsequent formula shortage. In this episode, Jen uncovers monopoly and neglect in the baby formula production industry, lack of oversight by the FDA, and the United States' refusal to adopt the World Health Organization's International Code of Marketing of Breast-Milk Substitutes. Please Support Congressional Dish – Quick Links Contribute monthly or a lump sum via PayPal Support Congressional Dish via Patreon (donations per episode) Send Zelle payments to: Donation@congressionaldish.com Send Venmo payments to: @Jennifer-Briney Send Cash App payments to: $CongressionalDish or Donation@congressionaldish.com Use your bank's online bill pay function to mail contributions to: 5753 Hwy 85 North, Number 4576, Crestview, FL 32536. Please make checks payable to Congressional Dish Thank you for supporting truly independent media! View the shownotes on our website at https://congressionaldish.com/cd254-baby-formula-shortage Background Sources Recommended Congressional Dish Episodes CD234: AWOL Recall: The Rock and Play Sleeper The Formula Shortage Abbott. Jun 15, 2022. “Update on Abbott's Sturgis Plant and Formula Production.” “Testimony of Robert M. Califf, M.D., Commissioner of Food and Drugs, Food and Drug Administration, Department of Health and Human Services, before the Committee on Health, Education, Labor & Pensions, Infant Formula Crisis: Addressing the Shortages and Getting Formula on Shelves.” May 26, 2022. U.S. Senate. Center for Food Safety and Applied Nutrition. May 18, 2022. “Guidance for Industry: Infant Formula Enforcement Discretion Policy” [FDA–2022–D–0814]. U.S. Food and Drug Administration. Annie Gasparro and Jaewon Kang. May 12, 2022. “Baby Formula Shortage Could Leave Parents Scrambling for Months.” The Wall Street Journal. U.S. Food and Drug Administration. Feb 2022. “FDA Investigation of Cronobacter Infections: Powdered Infant Formula.” Baby Formula Monopoly Matt Stoller. May 13, 2022. “Big Bottle: The Baby Formula Nightmare.” BIG by Matt Stoler on Substack. Sam Knight. Apr 23, 2022. “Company Responsible for Tainted Baby Formula Has Monopoly Over Aid Program Sales.” Truthout. FDA Failure Letter from Rep. Raja Krishnamoorthi to FDA Commissioner Robert Califf. March 24, 2022. U.S. House of Representatives. Poisoned Baby Food House Committee on Oversight and Reform, Subcommittee on Economic and Consumer Policy Staff. Feb 4, 2021. “Report: Baby Foods Are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium, and Mercury.” Operation Fly Formula Brenda Goodman and Deidre McPhillips. Jun 10, 2022. “How far will Operation Fly Formula shipments really go to fill America's store shelves?” CNN. The White House. May 22, 2022. “Biden Administration Announces Second Operation Fly Formula Flight.” White House Briefing Room: Statements and Releases. 60 minutes Segment Bill Whitaker. May 22, 2022. “Medical Middlemen: Broken system making it harder for hospitals and patients to get some life-saving drugs.” 60 Minutes. The WHO Code and Formula Marketing The World Health Organization. Apr 28, 2022. “Scope and impact of digital marketing strategies for promoting breastmilk substitutes.” The World Health Organization. Apr 28, 2022. “WHO reveals shocking extent of exploitative formula milk marketing.” The World Health Organization. #EndExploitativeMarketing Petition. La Leche League International. “International WHO Code.” Bonnie Goldstein. Jul 13, 2018. Paper Cuts: No Match for Mother's Milk. Project on Government Oversight. Baby-Friendly USA website. The World Health Organization. Jan 27, 1981. “International Code of Marketing of Breast-Milk Substitutes.” Fisher-Price Update Katie Porter [@RepKatiePorter]. Jun 15, 2022. “Following yesterday's news of previously unreported infant deaths in Fisher-Price products, I'm calling on the company to immediately recall all…” Twitter. Laws H.R.7791: Access to Baby Formula Act of 2022 Jen's Highlighted PDF of Public Law 117–129 H.R.3182: Safe Sleep for Babies Act of 2021 Audio Sources INFANT FORMULA CRISIS May 26, 2022 Senate Committee on Health, Education, Labor, and Pensions The committee concluded a hearing to examine the infant formula crisis, focusing on addressing the shortage and getting formula on shelves. Witnesses: Robert M. Califf, Commissioner of Food and Drugs, Food and Drug Administration Clips 37:26 Dr. Robert Califf: Frankly, the inspection results were shocking. Standing water, cracks in key equipment that presented the potential for bacterial contamination to persist, particularly in the presence of moisture, leaks in the roof, a previous citation of inadequate hand washing and current poor foot sanitation, bacteria growing from multiple sides, and many signs of a disappointing lack of attention to the culture of safety in this product that is so essential to the lives of our most precious people. 38:14 Dr. Robert Califf: As soon as we receive positive cronobacter results from environmental samples at the facility that we collected during the inspection, we contacted Abbott to ask the company to issue a voluntary recall. The need to take urgent action to protect the most vulnerable of all of our people -- infants -- presented a dilemma. This was the largest plant of the dominant manufacturer, and it was the sole source of a number of metabolic formulas essential for viability of infants with no substitution possible, because Abbott had no backup plan. We knew that ceasing plant operations would create supply problems, but we had no choice given the unsanitary conditions. 50:50 Sen. Richard Burr (R-NC): Why haven't you waived labeling requirements from trusted manufacturers in countries like the UK, Australia or Canada? Couldn't manufacturers provide temporary labels on imported formula? Cans if the label is printed in a language other than English until US manufacturing is restored? Some countries have higher nutritional requirements. Why can't we provide a waiver for their products to come into the country? Dr. Robert Califf: We've waived many of the requirements that are the ones that make sense, but the directions have to be clear to Americans in language that's understandable so the formula can be mixed correctly. An error in mixing up the formula for example, can lead to a very sick infant not getting the right nutrition. 2:16:18 Dr. Robert Califf: We saw the lack of quality in the system and the lack of accountability for the problems that were there. And so we had to invoke the Justice Department to negotiate a consent decree, which is essentially Abbott saying, “Yes, we had all these problems. Here's exactly what we're going to do to fix them.” For legal reasons, I can't discuss the exact details of the negotiation, but let's just say that it took a little armwrestling to get to the point where the Justice Department got Abbott to sign the consent decree. FORMULA SAFETY AND SUPPLY: PROTECTING THE HEALTH OF AMERICA'S BABIES May 25, 2022 Committee on Energy and Commerce: Subcommittee on Oversight and Investigations Witnesses: Robert M. Califf, Commissioner, Food and Drug Administration Frank Yiannas, Deputy Commissioner, Food Policy and Response, Food and Drug Administration Susan Mayne, Director, Center for Food Safety and Applied Nutrition, Food and Drug Administration Chris Calamari, Senior Vice President of U.S. Nutrition, Abbott Robert Cleveland, Senior Vice President of the Nutrition Business Unit for the US and Europe, Mead Johnson Nutrition Scott Fitz, Vice President of Technical and Production, Gerber Clips 41:55 Robert Califf: Because of the lack of the diversification of this market in the absence of a central hub for integrating supply chains, we concluded early on that getting the Sturgis facility up and running safely was a top priority. But we had no confidence in the integrity of the Abbott quality program at this facility. Accordingly, we initiated proceedings toward a consent decree, which requires Abbott to undertake steps to assure safe production of formula, including hiring an outside expert with reporting to FDA. 43:03 Robert Califf: Despite the overall numbers showing diminished but steady supply, we knew that distribution was an issue. Some areas were experiencing significant shortages, but overall, there was enough formula to go around. About a month ago, the reports of shortages on the shelf proliferated, although there was not a drop in production. This increase in consumption most likely represents heightened concern of parents and caregivers about shortages, leading to an understandable effort to purchase ahead to ensure adequate supply at home. This type of cycle has happened with other products throughout the pandemic, and we realize that the only solution is to have adequate supply to make sure shelves are stocked. 45:57 Robert Califf: Abbott's enormous market share left it with a responsibility for producing safe infant formula that was not met. We will do everything in our power to work with Abbott to make this happen as quickly and as safely possible, but this timing is an Abbott's control. 46:35 Robert Califf: Across the industry we regulate, we are seeing evidence that the just-in-time distribution system, market concentration, and sole-source contracting are leading to shortages. Multiple reports to Congress call for improved supply chain management. Until regulatory agencies have digital access to critical supply chain information and personnel to do the work, we will continue to react to supply chain disruptions rather than intervening to prevent them. 1:01:113 Robert Califf: It's really important for people to go to the HHS website: hhs.gov/formula. There you'll find the hotline for all the manufacturers and helpful information about where to go. 1:04:12 Robert Califf: You would be surprised to know there's no just-in-time system where all the FDA employees can see what's going on. What we really need is access to the information that the manufacturers have about each of their individual supply chains. They each have their individual supply chains, but there is no national system to make sure the supplies getting where it needs to go. 1:05:11 Rep. Cathy McMorris Rodgers (R-WA): Did FDA not have a data analytics tool to monitor the supply chains of various products, including infant formula? Robert Califf: We requested funding for a tool and because we didn't get the funding, we cobbled it together. It's a start, but it's nowhere near — you know, again, I was at Google for five years. The technology at FDA, and in many federal agencies is outmoded and needs an upfit, there's just no question about. 1:07:33 Susan Mayne: We have been in discussion with infant formula manufacturers throughout COVID, but discussion is not the same thing as data and we do not have the authorities to demand data from the companies to get necessarily all the information that you would want to have to really monitor the supply chains as Dr. Califf indicated. 1:10:30 Robert Califf: But given what we saw, the only way we could have confidence was through a consent decree, where we literally have oversight of every single step. When we met with the CEO yesterday, there were hundreds of steps that they went through that they're having to do, many of which have already been done. So it's only if we have direct oversight over it that I would have confidence, but I do have confidence that we are seeing every single step both physically in-person, and also through following the documentation and the outside expert. 1:10:53 Rep. David B. McKinley (R-WV): How will the passage of last week's FDA Bill increase the production of baby formula? Robert Califf: Production is increasing already — Rep. David McKinley The criticism, that they said that on these various tweets — it was not just one there were several — that said it was unnecessary. So I want to know, how do we increase, how do we get back to production? How to put in $28 million? How would that how's that gonna increase production? Robert Califf: Well, remember, the Abbot plant needs to get up and running, we've got to oversee and micro detail to make sure that it's done correctly. And as we bring in supply from other countries, remember, we already have overseas plants that we import from on a regular basis, almost double digits. So as we bring that product in, we've got to inspect it, make sure it's of the quality that we expect in America of formula and we need to upgrade our information systems, as I've already said, to make sure that as all this goes on, we can keep track of it and make sure that we're coordinated. 1:44:55 Rep. Kim Schrier (D-WA): Is there any early warning system for products like baby formula? And not just the ingredients but for formula itself or manufacturer would let you know if they're running short or anticipate a shortage? Robert Califf: First of all, let me thank you for being a pediatrician. I sometimes call the Academy of Pediatrics just for the positive vibes that you all exude as a profession. But no, there is not such a warning system. We've repeatedly asked for that authority and have not been granted it. The industry by and large has opposed it. 1:52:21 Susan Mayne: What the data show is, we can't rule in or rule out whether or not those infants, their cronobacter was caused by this plant. The data just simply can't be used to inform it. Rep. John Joyce (R-PA): But the genetic testing you did. It does not match from the plant, correct? Susan Mayne: That is correct. But what we did not have is any sampling done at the same time that the product was manufactured that was consumed by the individuals who got sick, so we didn't have that every director 2:08:57 Rep. Ann Kuster (D-NH): I know that in this part of the country, I'm in New Hampshire, we have milk banks of mother's breast milk. And I'm wondering what is the regulation by the FDA? And can we assure our constituents that breast milk from milk bank is safe and is thoroughly vetted by the FDA? Robert Califf: You're asking some very good questions. I'm gonna refer this to Dr. Mayne who probably would have the best answer. Susan Mayne: Thank you, Congresswoman. So human breast milk is regulated as a food. And so that is reassuring and they have to have proper screening protocols and things like that in place to make sure that the donors that are donating the milk, get that, that's critical for human food safety. So that's how I would respond. Thank you. 2:26:28 Robert Califf: You would think that a critical industry like this would have resilience plans, redundancy, but we don't even have legal authority right now to require that the firms have a plan for potential failures and resilience. That's something we've asked Congress for every year for a while, and we're asking for it again. So I hope that it happens this time. I'd also add that this is not unique to this industry. We are seeing this across the entire device and medical supply industry with frequent failures as exemplified by the 60 minutes show and the contrast medium problem that I talked about. We have gone to a just-in-time, large single source contracts that lead to lack of diversification in the industry and the industry has fought us tooth and nail on requiring that there be insight into their supply chains, so that the sum of all of the industries leads to the the avoidance of preemption. We'd like to be able to stress test and prevent these things from happening rather than waiting until they happen, and then scrambling. 2:58:58 Susan Mayne: What we've seen is, first the strain of the COVID 19 pandemic, then the strain of the recall, and now we've got the Russia-Ukraine conflict. And one of the things that we know is the Ukraine region is one of the world's biggest exporters of products like sunflower oil. Sunflower oil is used as an ingredient in many food products, including infant formula. And so we have been working with the manufacturers should they be unable to maintain their supply of sunflower oil, what they would replace it with and make sure that that would meet the nutritional requirements for infant formula. 3:26:28 Chris Calamari: We plan to start production at Sturgis the first week of June. We will begin with the production of EleCare, before turning to the production of other formulas and Similac. From restart, we estimate that it will take six to eight weeks before product is available on shelves. 4:28:51 Rep. Paul Tonko (D-NY): Your testimony also mentions global supply chain challenges as a factor the company has had to contend with. What, if any, steps has Gerber taken to maintain its production and distribution supply? Scott Fitz: Thank you for the question. Certainly, our industry is not immune to the global supply chain challenges brought on by the pandemic. We struggled with materials supply issues, intermittent materials supply issues, whether it be ingredients or packaging components, we struggled struggled with the material quality issues related to the pandemic, we've had transportation and logistics issues, just getting trucks and truck drivers available to move the products and supplies that we need. And we've had COVID related labor challenges and higher turnover than normal are all things that have impacted us. Through the course of the pandemic though we've we've resolved these on an ongoing basis, one at a time as they've come up. We are putting trying to put in more robust business continuity plans in place for critical components and ones that we know we will have challenges with in the future. 4:30:50 Rep. Paul Tonko (D-NY): Did you not think the FDA should be notified or at least aware of your struggle? Scott Fitz: Should FDA be aware of our struggle? Rep. Tonko: Yeah, should you have shared those concerns for supply chain? Scott Fitz: If it could help, we would certainly be willing to do that. Yes. Rep. Tonko: What should you have told us during the last year? Scott Fitz: Well, as I testified, the issues that have come up for us, we've been able to resolve. Through the last six months our in-stock rates have averaged 86%. 4:35:55 Chris Calamari: On the horizon, we see in the manufacture of infant formula agricultural oils are absolutely essential, paper is absolutely essential, the cost of fuel to supply and distribute the product is essential. So I would call out those key elements ranging from agricultural oils to the cost to deliver the product would be the biggest areas of focus. 4:41:42 Robert Cleveland: We reached out and spoke to the USDA almost immediately seeking flexibility, for example in the size format. And while that sounds small, it's very significant because what that means is the WIC consumer doesn't have to look for one particular size of product at the shelf. They can find any size of the shelf to fulfill their their benefits with and that's allowed us to continue production and step up to meet the requirements of those consumers. We've since worked with the USDA to find a number of other ways to flexibly administer the program, because really, the focus for the WIC consumer is the same as the others, making sure she has safe access to formula and doesn't have to compete with non-WIC consumers to get it. So the more sizes, the more formats, the more manufacturers that the program can support, the more likely she is to have her needs met. 4:47:35 Rep. Kim Schrier (D-WA): The baby formula industry in our country is really unique in that about 90% of the product is made right here in the United States. And the vast majority is made by your three companies [Abbott, Gerber, and Mead Johnson]. And so it should be no surprise that when something goes wrong, like what happened in Sturgis, it really rocks the whole industry and the facility in Sturgis is responsible for 40% of Abbott's formula on the market and makes up about 20% of the total formula on the market in the US, and that is really significant, especially when this year Similac has the contract with WIC. 5:10:40 Rep. Buddy Carter (R-GA): Okay, the supply chain issues, is that because some of the ingredients were coming from other countries? Chris Calamari: Representative, yes, so global supply chains are such that we have ingredients coming from global sources and that is the nature of our supply chain. 5:19:29 Rep. Diana DeGette (D-CO): Let's say my daughter, who has a six-week-old baby, called me up and said, “I need to get some formula for my baby. And my store shelves are bare.” What can we tell them between now and all of the emergency measures we put into place to start putting formula on the shelves? Who should they call? Where can they go to try to get some of this limited product right now? What's the practical suggestion? Robert Cleveland: It's very unfortunate that you have to answer that question or ask that question, but let me do my best to answer it. I think the shelves — the reality is they don't have anywhere near the product that they do. So one of the things I've often said during this crisis is it takes a village to raise a child. In this case, sometimes it's taking a village to find infant formula. So the first thing to do is work with your network of family and friends, and as they go to the stores, look for the product that's there. And I've seen many mothers and grandmothers and fathers and cousins doing this on the shelf. You can call our Consumer Response Center. Now to be fair, those folks are doing a phenomenal job of fielding waves and waves of calls. But we will help you if you call. That's one other resource. The physician's office is another. Sometimes they do have the samples that are required, and they can help transition between finding product on the shelf. And then I would be sure to look online as well as in-person at the store and be open to other formats. Many mothers and fathers have a particular type of format they like. You may need to be more flexible in the format that you use. But all infant formula regulated by the FDA is safe for your infant, whether it's a liquid or a powder or what size it's in. And so I would say shop widely. See your doctor or enroll your family friends, give us a call if you need to, and be flexible. THE INFANT FORMULA CRISIS May 25, 2022 Committee on Appropriations: Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Witnesses: Ginger Carney, Director of Clinical Nutrition, St. Jude Children's Research Hospital Sarah Chamberlin, Executive Director, National PKU News Michael Gay, Owner and Manager, Food Fresh Brian Ronholm, Director of Food Policy, Consumer Reports Linkedin Clips 32:29 Michael Gay: WIC's rigid rules have made it difficult for the program to be responsive to critical shortages throughout the pandemic and now during the formula crisis. Substitutions may be easily available when situations like this arise. The emergency waivers instituted by the USDA during the pandemic have provided flexibility in some states, but those waivers were only available because of the pandemic. To prevent this issue from happening in the future, Congress should allow WIC vendors operating during severe supply shortages, disasters or public health emergencies to automatically substitute limited WIC approved products impacted by supply chain disruptions. The USDA should direct states to include product substitutions for WIC in their emergency preparedness plan. These changes would have allowed families to immediately switch to another formula in states with shortages allowing for smooth continuation of feeding infants. 33:27 Michael Gay: Secondly, there's a significant need for USDA to examine the long term effects of cost containment, competitiveness and peer grouping formulas for WIC vendors. States operate a peer group system to monitor vendor prices and determine reimbursements are cost competitive. These cost containment measures have led to reduced retail embursement and reduced retailer participation in the program, leading to fewer locations for families to access formula. 33:55 Michael Gay: WIC infant formula cost containment measures have led to extreme consolidation in the formula marketplace, leaving it highly vulnerable to supply disruptions like we are experiencing now. These contracting policies must be reviewed to ensure future food security of the nation's babies and families. 41:50 Brian Ronholm: The evidence suggests that the agency was too slow to act, failed to take this issue seriously, and was not forthcoming with information to parents and caregivers. The infant formula crisis exposed a greater structure and culture problem that has long existed FDA. This was merely one symptom of the overall problem, and it is clear that confidence in the food program at the FDA is eroding. A big reason for this is the food program has second class status within FDA, and it's resulted in serious problems. The FDA also lacks a single, full-time, fully empowered expert leader of all aspects of the food program. As you know, in recent decades, most FDA commissioners have been medical specialists who naturally focus on the programs impacting medical products. This is certainly warranted considering the impact these programs have on public health. And the pandemic is a perfect example of this. However, this usually results in intense competition for the commissioner's time and support and focus on the food program is typically what has suffered under this dynamic. It has become impossible for an FDA commissioner to possess the bandwidth to provide leadership and accountability to a set of offices that regulates 80% of our food supply. 51:45 Ginger Carney: I would want to warn parents not to make homemade formulas — the American Academy of Pediatrics warns against that — they should not dilute the formula, as both of these situations can lead to disastrous results and lead possibly to hospital admissions. 56:40 Brian Ronholm: Splitting out the food safety functions of the agency as it exists now and creating separate agencies while still remaining under the HHS umbrella would be an effective approach that would get to the issues that I think everyone has become aware of during this crisis. 59:32 Rep. Rosa DeLauro (D-CT): We now have 15 agencies at the federal level who deal with some form of food safety, the principal ones are USDA and FDA. It should be one single agency! 1:06:30 Michael Gay: In a rural area such as ours, probably 85-90% of my formula is WIC formula, which is just down to one type of formula. So even like today, for example, or my truck Monday, I got about 20 cases of Gerber formula in a different variety, but that's not approved on what and the Georgia WIC office just approved some substitutions for formulas that were, you know, prescribed by the doctor with the contract formula. So therein lies the problem is there's no easy way to substitute that for the customer. 1:23:29 Brian Ronholm: Four companies that control 90% of the market and only three of them actually bid on WIC rebate contracts. Abbott is by far the largest one and I believe they have contracts in 30 or 31 states, I think it was the latest figure. So when those contracts come up, these companies submit based on their ability to meet the demand in a particular state, and Abbott is usually the only one that's big enough to do that. We mentioned that they have a large part of the market, I think when it comes to the WIC market, they have approximately 55 to 60% of the WIC market. So that's a significant size of the market that it really needs to be examined so when situations like this hit, how does it impact that particular….And it's obviously going to have a bigger impact because these companies use the WIC market to get into the overall non-WIC market to even increase the share of their market, so that creates further shortage problems. 1:40:35 Ginger Carney: One thing that we really haven't talked about is the WHO code for marketing breast milk substitutes. And that's what these formulas are, they're breast milk substitutes. So if we look at the WHO code in other countries, other developed countries are abiding by the WHO code and this gives guidelines for how companies can market their infant formulas in a safe way. So maybe we should go back to that and think about what is it about the WHO code that would benefit all of our families in the country so that they are assured when they do have to reach for infant formula when breastfeeding cannot be an option or will not be an option? What are the things that are marketed directly to our families that tell them about the formula? 1:44:20 Rep. Debbie Wasserman Schultz (D-FL): Half of all US formula consumption goes through the WIC program, which provides free infant formula as we've been talking about today, where states negotiate bulk discounts in exchange for market exclusivity. Now, I'll take you back to 1989 when Republican President George Bush enacted legislation requiring all state WIC programs to use competitive bidding for the purchase of infant formula. In practice, this means that the state of Florida for example is required to use a single supplier for the entire state supply of WIC baby formula. The competitive bidding process has yielded $1.3 billion to $2 billion a year in savings and allowing WIC to serve about 2 million more participants annually because of the discounts. However, when there's a supply shock caused by one of the four market participants, like what happened with Abbott in this case, it creates a serious risk to infant health across the country. 1:48:00 Rep. Debbie Wasserman Schultz (D-FL): We know that in Europe, they consistently produce a baby formula surplus. But there are rigid labeling and nutritional requirements for formula containers here in the US that the FDA requires and they prohibit the sale of many European-made products, even though the formulas themselves meet FDA nutritional and purity standards. So what sort of policy changes would you like to see undertaken to ease restrictions on baby formula imports, while still ensuring that the product meets our safety standards? Brian Ronholm: Yeah, I think it's critical that we maintain those safety standards that FDA has set on infant formula, that's absolutely critical. There's a comfort level with consumers when they're able to purchase something that they know is an FDA inspected facility overseas. But to your point, sometimes these regulations, these really strict regulations are thinly disguised trade protection measures. And so you know, that's certainly an issue that we'd have to examine carefully to make sure that we can have that access. Cover Art Design by Only Child Imaginations Music Presented in This Episode Intro & Exit: Tired of Being Lied To by David Ippolito (found on Music Alley by mevio)

    Extra News On Demand
    News at Noon for Friday June 24 2022

    Extra News On Demand

    Play Episode Listen Later Jun 24, 2022 7:45


    A U-S Supreme Court ruling effectively overturns the nearly 50 year old Roe v. Wade abortion precedent... A two-day manhunt in Warrick County ends with an exchange of gunfire with law enforcement that left a suspect dead... EVSC officials back an order by the Food and Drug Administration banning some vaping products from store shelves... See omnystudio.com/listener for privacy information.

    ASHPOfficial
    Standardize 4 Safety: Taking Aim at Strategies for Adoption

    ASHPOfficial

    Play Episode Listen Later Jun 24, 2022 29:07


    Safety is at the forefront of all processes in the pharmacy department. ASHP has been a champion of safety since the organization originated more than 75 years ago.  ASHP received funding from the Food and Drug Administration's (FDA) Safe Use Initiative to develop and implement national standardized concentrations for IV. and oral liquid medications. This is the first national inter-professional (physicians, pharmacists, nurses) initiative to standardize medication concentrations with the goal of reducing prescribing, dispensing, and medication errors for patients of all ages in settings ranging from hospital to home. This outstanding program, called Standardize 4 Safety, will have substantial downstream effects on safety, cost, efficiency, and error-reduction. Standardization will result in consolidated/converged product demand from hospitals, and more instances of ready-for-use drug preparations from manufacturers, simpler drug libraries, improvements to automatic drug recognition by infusion pumps, and improved clinical information system data exchange.  The information presented during the podcast reflects solely the opinions of the presenter. The information and materials are not, and are not intended as, a comprehensive source of drug information on this topic. The contents of the podcast have not been reviewed by ASHP, and should neither be interpreted as the official policies of ASHP, nor an endorsement of any product(s), nor should they be considered as a substitute for the professional judgment of the pharmacist or physician.

    #WakeUpCLT To Go
    First monkeypox case in North Carolina reported, state health leaders say: Friday, June 24

    #WakeUpCLT To Go

    Play Episode Listen Later Jun 24, 2022 2:16


    North Carolina now has its first case of monkeypox. The state's Department of Health and Human Services (NCDHHS) announced it confirmed the infection through the State Laboratory of Public Health. While the agency did not disclose where in the state the infected person lives, Atrium Health said Thursday that the case is not from Charlotte.  The patient's health care providers are now reaching out to possible close contacts. "Though this is the first confirmed case in North Carolina, we know there are likely other cases in the state," Dr. Zack Moore, State Epidemiologist and Epidemiology Section Chief, said. "We are encouraging doctors to consider this in people who have a rash or skin lesion that looks like monkeypox." READ MORE: https://www.wcnc.com/article/news/health/nc-monkeypox-case-health-regional/275-78ac7d47-26cf-4bda-b412-e04bf77d42fb Federal health officials on Thursday ordered Juul to pull its electronic cigarettes from the U.S. market, the latest blow to the embattled company widely blamed for sparking a national surge in teen vaping. The action is part of a sweeping effort by the Food and Drug Administration to bring scientific scrutiny to the multibillion-dollar vaping industry after years of regulatory delays. The FDA said Juul must stop selling its vaping device and its tobacco and menthol flavored cartridges. Those already on the market must be removed. Consumers aren't restricted from having or using Juul's products, the agency said. To stay on the market, companies must show that their e-cigarettes benefit public health. In practice, that means proving that adult smokers who use them are likely to quit or reduce their smoking, while teens are unlikely to get hooked on them. The FDA noted that some of the biggest sellers like Juul may have played a “disproportionate″ role in the rise in teen vaping. The agency said Thursday that Juul's application didn't have enough evidence to show that marketing its products “would be appropriate for the protection of the public health.” READ MORE: https://www.wcnc.com/article/news/nation-world/fda-bans-juul-e-cigarettes/507-3cdfe242-14b4-473d-9ebf-94d481c762a1 Watch Wake Up Charlotte each weekday morning from 4:30 to 7 a.m. on WCNC Charlotte, and as always, join the conversation on social media using #WakeUpCLT! 

    The Good Dirt
    97. Bringing the Magic and Power of Plants Into Your Life with Herbalist and Chef Spencre McGowan

    The Good Dirt

    Play Episode Listen Later Jun 24, 2022 70:32


    Herbalist, artist, and cookbook author Spencre McGowan tells us about her herbal allies and the ways that living in relationship with plants has shaped her slow living journey. After receiving informal training in cooking with herbs in Sweden and attending herb school in California, Spencre began exploring her own personal relationships to herbs through writing and creating zines, one of which became her first book (Blotto Botany, a guide to herbal infusions and cordials). Spencre is passionate about the accessibility of herbal medicine, and encourages listeners to get to know a few herbs personally, whether or not they have access to their own garden. She also advocates for the use of herbs within their cultural context. Her honesty about her slow living journey has gained her a large following on TikTok, where she works to share openly about the difficulties and joys of living closely with herbs and plants. Topics Covered: Self-Expression Through Zines Herbal Cordials and Infusions The Beauty of Tulsi, or Holy Basil Our Healing Relationships with Herbs Getting to Know Our Herbal Allies Cultural Responsibility In Herbalism TikTok and Slow Living Diverse Uses for Nettles Resources Mentioned:  https://bookshop.org/books/blotto-botany-a-lesson-in-healing-cordials-and-plant-magic/9780062740618 (Blotto Botany) https://bookshop.org/books/forest-home-cultivating-an-herbal-kitchen/9781524867652 (Forest + Home: Cultivating an Herbal Kitchen) (Available for Pre-Order) https://www.gingertooth.com/shop/verdant-feasts-workshop (Verdant Feasts Workshop) Connect with Spencre McGowan: https://www.gingertooth.com/ (https://www.gingertooth.com/) Instagram: https://www.instagram.com/gingertooth_/?hl=en (@gingertooth) TikTok: https://www.tiktok.com/@spencrelinnea (@spencrelinnea) About Lady Farmer: https://lady-farmer.com/blogs/the-good-dirt-podcast (Our Website) @weareladyfarmer on https://www.instagram.com/thegooddirtph/ (Instagram) Join http://almanac.lady-farmer.com/ (The Lady Farmer ALMANAC) Leave us a voicemail! Call 443-459-1950 and ask a question or share a shoutout. Submissions throughout the month of June will be entered to win a Slow Living Consult with Mary and Emma!  Email us at thegooddirtpodcast@gmail.com Original music by John Kingsley @jkingsley1026 Statements in this podcast have not been evaluated by the Food and Drug Administration and are not to be considered as medical or nutritional advice. This information is not intended to diagnose, treat, cure or prevent any disease, and should not be considered above the advice of your physician. Consult a medical professional when making dietary or lifestyle decisions that could affect your health and well being. Mentioned in this episode: Join The ALMANAC Community https://the-good-dirt-sustainable-living-explained.captivate.fm/almanac (ALMANAC TGD Discount)

    PBS NewsHour - Segments
    FDA bans Juul vaping products as part of nicotine crackdown

    PBS NewsHour - Segments

    Play Episode Listen Later Jun 23, 2022 6:42


    After a two-year review, the Food and Drug Administration announced Thursday it will ban all vaping and e-cigarette products sold by Juul. It's part of a series of more aggressive moves by the FDA to target vaping and smoking. Matthew Myers, president of the Campaign for Tobacco-Free Kids, joins William Brangham to discuss. PBS NewsHour is supported by - https://www.pbs.org/newshour/about/funders

    PBS NewsHour - Health
    FDA bans Juul vaping products as part of nicotine crackdown

    PBS NewsHour - Health

    Play Episode Listen Later Jun 23, 2022 6:42


    After a two-year review, the Food and Drug Administration announced Thursday it will ban all vaping and e-cigarette products sold by Juul. It's part of a series of more aggressive moves by the FDA to target vaping and smoking. Matthew Myers, president of the Campaign for Tobacco-Free Kids, joins William Brangham to discuss. PBS NewsHour is supported by - https://www.pbs.org/newshour/about/funders

    Marketplace All-in-One
    Is a gas tax holiday even worth it?

    Marketplace All-in-One

    Play Episode Listen Later Jun 23, 2022 7:11


    President Biden’s call for a suspension of the gas tax holiday probably sounds like an awesome way to ease the pain of high gas prices, but it might not be as productive as it sounds. In fact, it could make some things worse. The Food and Drug Administration is poised to ban Juul e-cigarettes from store shelves. Dr. Trevon Logan of The Ohio State University joins us to discuss some history behind the Fed’s interest rate raises. Your donation powers the journalism you rely on. Give today to support Marketplace Morning Report.

    Marketplace Morning Report
    Is a gas tax holiday even worth it?

    Marketplace Morning Report

    Play Episode Listen Later Jun 23, 2022 7:11


    President Biden’s call for a suspension of the gas tax holiday probably sounds like an awesome way to ease the pain of high gas prices, but it might not be as productive as it sounds. In fact, it could make some things worse. The Food and Drug Administration is poised to ban Juul e-cigarettes from store shelves. Dr. Trevon Logan of The Ohio State University joins us to discuss some history behind the Fed’s interest rate raises. Your donation powers the journalism you rely on. Give today to support Marketplace Morning Report.

    The Daily Sun-Up
    FDA grants emergency authorization for COVID vaccines for young kids; The Colorado-Big Thompson Project

    The Daily Sun-Up

    Play Episode Listen Later Jun 23, 2022 13:32


    The U.S. Food and Drug Administration recently granted emergency authorization for both the Pfizer and Moderna vaccines for young children. What are the differences between the two different vaccines? What about any potential side effects? How effective are these vaccines in young kids? Colorado Sun reporters Chris Outcalt and John Ingold talk through these questions and more in the wake of the recent FDA announcement. See omnystudio.com/listener for privacy information.

    Beyond Labels with Dr. Sina McCullough
    Episode #42: SUCCESS STORY: Lyme, Co-Infections & Food Allergies REVERSED (Mark)

    Beyond Labels with Dr. Sina McCullough

    Play Episode Listen Later Jun 23, 2022 36:25


    Sina chats with Mark about the many tools and techniques he used to reverse Lyme, Bartonella, Mycoplasma Pneumonia, Chlamydia Pneumonia, high levels of heavy metals and food allergies.Watch on YouTube HereWatch on Rumble HereIf you have questions, we'd love to answer them on the show!  Please email your questions to Sina at handsoffmyfood@1791.comFind Joel Here: www.polyfacefarms.comFind Sina Here: www.drsinamccullough.comOur Videographer: www.nolangfilmco.comDisclaimer:  The information provided by Joel Salatin and Sina McCullough, PhD is not intended to prevent, diagnose, treat, or cure any disease.  The information provided in the podcasts, videos, and show descriptions is for educational purposes only.  It is not intended to diagnose or treat any medical or psychological condition.  The information provided is not meant to prevent, treat, mitigate or cure such conditions.  The information provided is not medical advice nor is it designed to replace advice, information, or prescriptions you receive from your healthcare provider.  Consult your health care provider before making any changes to your diet, medication, or lifestyle.  Proceed at your own risk.Joel Salatin and Sina McCullough, Ph.D. specifically disclaim any liability, loss, or risk, personal or otherwise, that may be incurred as a consequence, directly or indirectly, of the use and application of any of the contents of their YouTube channel, Podcast, websites, books, Facebook pages, or any of the content during consulting sessions or speaking engagements.  Proceed at your own risk.  These statements have not been evaluated by the Food and Drug Administration.

    Loving Liberty Radio Network
    06-21-2022 Liberty RoundTable with Sam Bushman

    Loving Liberty Radio Network

    Play Episode Listen Later Jun 22, 2022 109:38


    Hour 1 * Guest: Richard Mack Founder and President of CSPOA – A partnership between citizens and local law enforcement, especially sheriffs. Mack encourages those not in law enforcement to stand with their sheriffs. – CSPOA.org * Juneteenth: Only 24 States Give Workers the Day Off Since Biden Declared a Federal Holiday in 2021. * Red flag laws are Unconstitutional! * Police in Uvalde, Texas, never attempted to unlock the door to two classrooms where a gunman shot and killed 21 people on May 24, the San Antonio Express-News reported. * Joe Biden Releases Over 1 Million Illegal Border Crossers into US Since Taking Office. * Airlines continue canceling flights, blame bad weather and pilot shortage – Thousands of flights cancelled over holiday travel chaos. * Can Ron Beat Don in 24 or Will Mitt get the Prize? * Pentagon FINALLY Admits, 46 US Funded Bio Labs in Ukraine – After months of denials as well as claims over and over again by fact-checkers that they were fake news, the pentagon has finally admitted that the US is helping fund and support bio-labs in Ukraine, and not a few, but 46. The same biolabs that up until last week we were told over and over again did not exist. * DeSantis: White House lying about COVID shots for kids – Governor ‘not surprised that legacy media would amplify the lie' – Art Moore, WND.com * This COVID shot will be available – NEVER! – ‘These drugs will not be manufactured' – WND.com * Health experts claimed that the Food and Drug Administration had “fully approved” the Pfizer Inc.-BioNTech COVID-19 shots called Comirnaty. But the drug company now has revealed they simply won't be available. * “As Liberty Counsel has stated from the beginning, there is no FDA approved COVID shot available. All COVID shots are under Emergency Use Authorization (EUA), which means people have the right to refuse them,” the legal team explained. Hour 2 * Hillary Clinton is refusing to back down from claims that she did not fairly win the 2016 presidential election, claiming in an interview published Friday that her losses in two key states were due to voter suppression. Clinton failed to provide any evidence for her claims. * Guests: Jennifer Orten and Sophie Anderson, Have put up an amazing fight for records, in Utah – Fighting Evil, and Exposing Corruption – TwoRedPills.org * Guest: Utah Rep. Phil Lyman – Lyman is a CPA and a member of the American Institute of Certified Public Accountants and has worked as an AICPA Personal Financial Specialist. * Utah Rep. Phil Lyman, of Blanding, introduced HB 371 that would return voting to in-person, paper ballot voting and place strict requirements on absentee ballots. * GOP state lawmaker Phil Lyman, who is sponsoring another bill that would implement regular audits, said his concerns go beyond the 2020 election and include funding for electronic systems where voter registration data in Utah and elsewhere is housed. * Two Utah Moms File Open Records Requests on Election Records – State Lt. Gov. Tips Off Reporter, Blocks Them from Access, and Feds Are Called In – Jim Hoft founder and editor of The Gateway Pundit. * Jen filed GRAMA requests with all 29 counties in Utah to secure those record before they were deleted. She asked for ballot images, cast vote records, tabulator data, drop box videos, and a copy of “Project” backup database. None of these contain private voter information. These are the election configurations and settings typically provided to auditors. * Even ESS Machines Have Modems, Documents Show – Alex Newman, Liberty Sentinel --- Support this podcast: https://anchor.fm/loving-liberty/support

    Liberty Roundtable Podcast
    Radio Show Hour 1 – 06/21/2022

    Liberty Roundtable Podcast

    Play Episode Listen Later Jun 21, 2022 54:48


    * Guest: Richard Mack Founder and President of CSPOA - A partnership between citizens and local law enforcement, especially sheriffs. Mack encourages those not in law enforcement to stand with their sheriffs. - CSPOA.org * Juneteenth: Only 24 States Give Workers the Day Off Since Biden Declared a Federal Holiday in 2021. * Red flag laws are Unconstitutional! * Police in Uvalde, Texas, never attempted to unlock the door to two classrooms where a gunman shot and killed 21 people on May 24, the San Antonio Express-News reported. * Joe Biden Releases Over 1 Million Illegal Border Crossers into US Since Taking Office. * Airlines continue canceling flights, blame bad weather and pilot shortage - Thousands of flights cancelled over holiday travel chaos. * Can Ron Beat Don in 24 or Will Mitt get the Prize? * Pentagon FINALLY Admits, 46 US Funded Bio Labs in Ukraine - After months of denials as well as claims over and over again by fact-checkers that they were fake news, the pentagon has finally admitted that the US is helping fund and support bio-labs in Ukraine, and not a few, but 46. The same biolabs that up until last week we were told over and over again did not exist. * DeSantis: White House lying about COVID shots for kids - Governor 'not surprised that legacy media would amplify the lie' - Art Moore, WND.com * This COVID shot will be available – NEVER! - 'These drugs will not be manufactured' - WND.com * Health experts claimed that the Food and Drug Administration had "fully approved" the Pfizer Inc.-BioNTech COVID-19 shots called Comirnaty. But the drug company now has revealed they simply won't be available. * "As Liberty Counsel has stated from the beginning, there is no FDA approved COVID shot available. All COVID shots are under Emergency Use Authorization (EUA), which means people have the right to refuse them," the legal team explained.

    DocTalk Podcast
    How the Newest Dupilumab Approval Solves an "Unmet Need" in Children with AD

    DocTalk Podcast

    Play Episode Listen Later Jun 20, 2022 17:14


    Earlier this month, dupilumab became the first and only biologic medicine approved by the US Food and Drug Administration for the treatment of atopic dermatitis in patients of all ages, from infancy through adulthood. The approval of dupilumab as an add-on maintenance therapy for children 6 months to 5 years with moderate to severe atopic dermatitis was described as “a tremendous advancement” by Mercades E. Gonzalez, MD, FAAD, pediatric dermatologist at Pediatric Dermatology of Miami. Gonzalez joined the DocTalk program to speak on the unmet need for therapies such as dupilumab for young children affected by AD, and the various psychological and mental burdens of the skin disease.

    Midday
    Healthwatch: Dr. Leana Wen on the COVID vax for infants & toddlers

    Midday

    Play Episode Listen Later Jun 20, 2022 48:32


    Happy Juneteenth! It's another edition of our monthly Midday Healthwatch, with Dr. Leana Wen. The latest surge in the COVID-19 variant known as omicron is beginning to show signs it is receding, but the highly transmissible BA.2 variant has led the CDC to estimate that nearly 60% of Americans have already been infected. For children, the infection rate is even higher: closer to 75%. And help for our youngest children is on the way. On Friday, an advisory committee of the Food and Drug Administration emergency use authorization (EUA) to the Moderna and Pfizer-BioNTech coronavirus vaccines for children under the age of five. The CDC signed off on the panel's recommendation on Saturday. This comes as a relief to many parents, and it presents a dilemma for many others, who may be vaccinated themselves, but who are hesitant about vaccinating their kids. Dr. Wen is herself the parent of two children under the age of five. She is a former health commissioner of Baltimore, an emergency physician, and she teaches at the George Washington University's Milken Institute School of Public Health. Dr. Wen is also a columnist for the Washington Post,a medical analyst for CNN, a Senior Fellow at the Brookings Institution and the author of Lifelines: A Doctor's Journey in the Fight for Public Health. Dr. Leana Wen joins us on Zoom… See omnystudio.com/listener for privacy information.

    Wintrust Business Lunch
    Wintrust Business Minute: Illinois is trying to rename Asian carp

    Wintrust Business Lunch

    Play Episode Listen Later Jun 20, 2022


    Steve Grzanich has the business news of the day with the Wintrust Business Minute. Illinois is trying to get the Asian carp renamed as part of a marketing campaign that’ll help land the fish in restaurants and on dinner tables. The Illinois Department of Natural Resources will apply to the Food and Drug Administration by […]

    The Doctor's Farmacy with Mark Hyman, M.D.
    Why Gut Issues Are On The Rise And How To Fix It

    The Doctor's Farmacy with Mark Hyman, M.D.

    Play Episode Listen Later Jun 20, 2022 77:50


    The gut microbiome plays a role in every disease, so why aren't we doing more to protect and restore it? One third to one half of all Americans have gut issues due to the constant consumption of industrialized foods, glyphosate, food additives, and more. This is a problem—and it's time for us to take action.In this episode of my Masterclass series, the first in a series on gut health, I am interviewed by my good friend and podcast host, Dhru Purohit, about the importance of polyphenols for our gut health. We also discuss my gut-health journey, which led me to dig deep into understanding the value of a healthy gut and diverse microbiome, and how to get there.Dhru Purohit is a podcast host, serial entrepreneur, and investor in the health and wellness industry. His podcast, The Dhru Purohit Podcast, is a top 50 global health podcast with over 30 million unique downloads. His interviews focus on the inner workings of the brain and the body and feature the brightest minds in wellness, medicine, and mindset.This episode is brought to you by Rupa Health, Thrive Market, and InsideTracker. You can check out a free, live demo with a Q&A or create an account at RupaHealth.com. Join Thrive Market today at thrivemarket.com/hyman to receive an extra $80 of free groceries off with your first order. Right now, InsideTracker is offering my community 20% off at insidetracker.com/drhyman. In this episode, we discuss (audio version / Apple Subscriber version):The number-one thing that causes gut issues (3:57 / 1:28)Why are we in this mess? (5:08 / 2:37)My gut-health journey (12:29 / 9:43)What the research shows us about polyphenols (18:50 / 15:45)Compounds and phytochemicals in food that act like medicine (28:14 / 23:44)Two things that change a microbiome for the better (35:06 / 30:31)The best foods to incorporate into our diets (39:57 / 35:18)Zonulin and how it contributes to a leaky gut (51:11 / 45:55)Prebiotics, probiotics, and polyphenols found in Gut Food (1:02:38 / 57:58)The importance of powerful polyphenols (1:12:25 / 1:06:42)Mentioned in this episode:Therapeutic Potential of Rosmarinic Acid: A Comprehensive ReviewGut FoodDisclaimer: This podcast is for educational purposes only. This podcast is not a substitute for professional care by a doctor, or other qualified medical professional. You should always speak with your physician or other healthcare professional before taking any medication or nutritional, herbal or homeopathic supplement, or adopting any treatment for a health problem. The use of Gut Food or any other products or services purchased by you as a result of this podcast does not create a doctor-patient relationship between you and any of the physicians affiliated with this podcast. Information and statements regarding dietary supplements have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease. See acast.com/privacy for privacy and opt-out information.

    Montana Public Radio News
    Montana children under 5 could begin receiving COVID-19 vaccines next week

    Montana Public Radio News

    Play Episode Listen Later Jun 18, 2022 1:30


    The U.S. Food and Drug Administration greenlighted both Moderna and Pfizer's shots for young children today and the federal Centers for Disease Control and Prevention is expected to follow suit this weekend.

    PBS NewsHour - World
    News Wrap: FDA authorizes first COVID-19 vaccines for children under age 5

    PBS NewsHour - World

    Play Episode Listen Later Jun 17, 2022 4:12


    In our news wrap Friday, the Food and Drug Administration authorized the first COVID-19 vaccines for children under age 5, the Federal Reserve doubled down on its pledge to curb soaring inflation, former Trump adviser Peter Navarro pleaded not guilty to contempt of Congress, and the British government approved the extradition of Wikileaks founder Julian Assange to the U.S on spying charges. PBS NewsHour is supported by - https://www.pbs.org/newshour/about/funders

    PBS NewsHour - Segments
    News Wrap: FDA authorizes first COVID-19 vaccines for children under age 5

    PBS NewsHour - Segments

    Play Episode Listen Later Jun 17, 2022 4:12


    In our news wrap Friday, the Food and Drug Administration authorized the first COVID-19 vaccines for children under age 5, the Federal Reserve doubled down on its pledge to curb soaring inflation, former Trump adviser Peter Navarro pleaded not guilty to contempt of Congress, and the British government approved the extradition of Wikileaks founder Julian Assange to the U.S on spying charges. PBS NewsHour is supported by - https://www.pbs.org/newshour/about/funders

    PBS NewsHour - Health
    News Wrap: FDA authorizes first COVID-19 vaccines for children under age 5

    PBS NewsHour - Health

    Play Episode Listen Later Jun 17, 2022 4:12


    In our news wrap Friday, the Food and Drug Administration authorized the first COVID-19 vaccines for children under age 5, the Federal Reserve doubled down on its pledge to curb soaring inflation, former Trump adviser Peter Navarro pleaded not guilty to contempt of Congress, and the British government approved the extradition of Wikileaks founder Julian Assange to the U.S on spying charges. PBS NewsHour is supported by - https://www.pbs.org/newshour/about/funders

    1A
    The News Roundup For June 17, 2022

    1A

    Play Episode Listen Later Jun 17, 2022 88:14


    The House committee investigating the events of the Jan. 6 insurrection met twice this week. We learned new details surrounding payments made to Trump surrogates, Ginni Thomas' correspondence on the day, and former President Donald Trump's pressure on his vice president, Mike Pence.The Senate continues to work on a bipartisan framework for a bill on gun control. The plan currently has support from Senate Minority Leader Mitch McConnell. However, GOP Sen. John Cornyn says it may need to slim down before it gains more support.The Food and Drug Administration voted to recommend Moderna COVID-19 vaccines for young children. The vaccination plan consists of two shots administered four weeks apart for kids six months through five years old.Meanwhile, leaders from European nations such as France, Germany, and Italy are all in the Ukrainian capital of Kyiv to meet with Ukrainian officials about aid in the country's continuing conflict with Russia. They're also discussing a path forward for Ukraine to join the European Union.We cover all this and more during the News Roundup. Want to support 1A? Give to your local public radio station and subscribe to this podcast. Have questions? Find us on Twitter @1A.

    Marketplace Minute
    Stocks open mixed - Midday - Marketplace Minute - June 17, 2022

    Marketplace Minute

    Play Episode Listen Later Jun 17, 2022 1:50


    The Food and Drug Administration is giving emergency use authorization for vaccines for the very young; the European Union's executive arm recommends that Ukraine and Moldova be allowed to join; retailers face backlash for selling Juneteenth merchandise. Learn more about your ad choices. Visit podcastchoices.com/adchoices

    The Good Dirt
    96. Lessons from Life in Spain: Slow Food, Slow Living and Seasonal Eating with Chef Marti Buckley

    The Good Dirt

    Play Episode Listen Later Jun 17, 2022 70:16


    Marti Buckley captivates us as she portrays the rich culinary traditions of the Basque country of Spain, where slow living and seasonal eating are key ingredients to community life. Marti fell in love with Basque culture when she studied abroad in college, and has now lived in San Sebastian, Spain, for over ten years, where she has written two cookbooks about Basque cuisine. She hopes to give visibility to the little-known food, history, and culture of Basque country. Marti takes us on a journey through the way to eat in Basque country - from pintxos (similar to tapas) to dining societies, Basque traditions around eating provide inspiration and creativity to those of us looking for ways to slow down, eat closer to home, and delve deeply into community life. Topics Covered: Basque Culture and Cuisine The American Food Industry and the Myth of Convenience Slow Living and Long Lunches in Basque Country The Art of the Pintxo Connecting With Friends Through Traditional Basque DIning Societies Relearning Seasonal Eating Slow Living To Boost Nutrition and Well-Being Resources Mentioned:  https://bookshop.org/books/basque-country-a-culinary-journey-through-a-food-lover-s-paradise/9781579657772?gclid=CjwKCAjw46CVBhB1EiwAgy6M4gNtXT1anjSv05u4uSy-Zt6NMb1W1KNW5vJhVdxTSX3a3BXYWFUlShoCxFYQAvD_BwE (Basque Country) (Marti's First Book)  https://www.educacionyfp.gob.es/eeuu/convocatorias-programas/convocatorias-eeuu/nalcap.html (Auxiliares Program) https://bottegarestaurant.com/ (Bottega Restaurant) (Birmingham, AL) Connect with Marti Buckley: https://www.travelcookeat.com/ ( https://www.travelcookeat.com/) Email: geauxmarti@msn.com Instagram:https://www.instagram.com/martibuckley/?hl=en (@martibuckley) About Lady Farmer: https://lady-farmer.com/blogs/the-good-dirt-podcast (Our Website) @weareladyfarmer on https://www.instagram.com/thegooddirtph/ (Instagram) Join http://almanac.lady-farmer.com/ (The Lady Farmer ALMANAC) Leave us a voicemail! Call 443-459-1950 and ask a question or share a shoutout. Submissions throughout the month of June will be entered to win a Slow Living Consult with Mary and Emma!  Email us at thegooddirtpodcast@gmail.com Original music by John Kingsley @jkingsley1026 Statements in this podcast have not been evaluated by the Food and Drug Administration and are not to be considered as medical or nutritional advice. This information is not intended to diagnose, treat, cure or prevent any disease, and should not be considered above the advice of your physician. Consult a medical professional when making dietary or lifestyle decisions that could affect your health and well being. Mentioned in this episode: Join The ALMANAC Community https://the-good-dirt-sustainable-living-explained.captivate.fm/almanac (ALMANAC TGD Discount)