Podcasts about icer

In this episode, we interview Sarah Emond, MPP, President and CEO of the Institute for Clinical and Economic Review (ICER). Sarah joined ICER over 15 years ago as Chief Operating Officer and was appointed to lead the organization following the retirement of Dr. Steven Pearson. Sarah outlines her vision for ICER and the priorities for strengthening the framework and collaboration to achieve their mission of evaluating the comparative effectiveness of new medicines. Sarah also discusses ICER’s efforts to expand patient engagement and the evaluation of payers to ensure fair access to medicine. Sarah Emond, MPP, President and CEO, Institute for Clinical Economic Review (ICER) Dr. Steven Pearson, Founder, President, Institute for Clinical and Economic Review (ICER) Barriers to Fair Access Report Gross-to-Net Bubble Pharmacy Benefit Managers (PBMs) Humira biosimilars Institute for Clinical and Economic Review (ICER) 340B Drug Pricing Program Questions or comments?Email us at comments@prescriptionforbetteraccess.com.Find us on social media! Follow us on X, LinkedIn, YouTube and Threads.

What clinical and economic evidence do US payers prefer to drive formulary decisions? How can you optimise your chances of preferential access in the US with the right evidence? How should evidence be generated, synthesised, and presented for the US market?In this episode, Clare Foy (Director – Global Market Access, Mtech Access) interviews colleagues Nicole Lodowski (Managing Director, Petauri Evidence) and Bob Nordyke (Senior Advisor, Petauri Evidence) about US payer evidence challenges.We explore the evolving evidence needs for US payers. Nicole and Bob share unique perspectives around their extensive experience of driving evidence strategies for US pharmaceutical and medical device launches. Additionally, Nicole and Bob share a ‘sneak peek' of exclusive insights from a recent Petauri US payer insights survey conducted to better understand the evidence landscape from the US payers' perspective.They explore:The evolving payer evidence landscape in the USPreferences for clinical and economic evidence by US payersKey differences between the US and other global markets with regard to evidence, HEOR, and market accessOpportunities and challenges when launching new medicines/medical devices/diagnostics in the USInnovative perspectives on evidence planning and strategy for the US marketUS payers' perspectives, with exclusive insights from Petauri Evidence's 2024 US payer surveyThis episode was first broadcast as a live webinar in October 2024. Learn more at: https://mtechaccess.co.uk/navigating-us-payer-evidence-needs/Explore more about launching in the US market: https://mtechaccess.co.uk/launching-healthcare-products-in-the-us/Subscribe to our newsletter to hear more news, insights and events from Mtech Access.

Patient rights: do you know about the rights you have in regard to healthcare? There is a lot of information for you that Sara and Thayer serve to you here, in terms you can understand.  They both work for the Partnership to Improve Patient Care, or PIPC (a coalition).Sara Traigle van Geertruyden is the Executive Director at PIPC. Thayer Roberts is the Deputy Director.  Sara, an attorney, joined PIPC in 2011 and serves at the firm, Thom Run Partners.  Sara focuses policies to advance a patient centered health system, from patient engagement in research to driving outcomes that matter to patients in healthcare payment and delivery.  Sara is a healthcare and welfare policy expert with over 25 years of experience, beginning her career on Capitol Hill working for former Senator John Breaux (D-LA) from 1996-2003, and later as an attorney at the law firm Patton Boggs.  Thayer joined PIPC in 2019. Thayer works with PIPC's diverse membership of patients, healthcare providers, researchers, and other groups to ensure that patient centricity is at the core of the nation's health care system.  Thayer has expertise in health care value assessments and their implications on patients and people with disabilities and continues to engage in this topic both at the Federal and State level. Chair of PIPC: (From their website) Tony Coelho is a former United States congressman from California, and primary author and sponsor of the Americans with Disabilities Act. Tony was elected to Congress in 1978 and served for six terms until 1989. He served on the Agriculture, Interior, Veterans Affairs, and Administration Committees during his tenure, specializing in disabled rights. In 1986, Tony was elected House Majority Whip. As the chief vote counter for his party, Tony oversaw a series of Democratic victories in the House on measures ranging from the budget to cutting off funds for the war in Central America. Tony was the original author of the Americans with Disabilities Act, signed into law by President George H.W. Bush. By 1994, the U.S. Census Bureau reported that some 800,000 more people with severe disabilities had found employment than were employed when the bill was first enacted. Tony currently serves as the DNC Disability Council Chair, seeking to ensure that the political process is accessible to people with disabilities. President Bill Clinton appointed Tony to serve as Chairman of the President's Committee on Employment of People with Disabilities, a position he held from 1994 to 2001. He also served as Vice Chair of the National Task Force on Employment of Adults with Disabilities. In 1998, Clinton appointed Tony as the United States Commissioner General at the 1998 World Expo in Portugal. Clinton also appointed Tony as Co-Chair to the U.S. Census Monitoring Board, a position he held until his appointment as general chairman of the Gore presidential campaign.Sara and PIPC work with nonprofit organizations, like The Bonnell Foundation to help us to understand and keep track of all the legislation on the books, and coming down the pipeline. To contact PIPC go to: https://www.pipcpatients.orgTo find PIPC on social media check them out at: @PIPCpatients (on twitter and LinkedIn)Another resource Sara and Thayer suggest: https://www.patientaccessproject.orgAcronym's used during this podcast: Prescription Drug Affordability Board (PDAB)Rare Disease Advisory Council (RDAC)National Association for State Health Policy (NASHP)Institute for Economic and Clinical Review (ICER)Equal Value of Life Year Gained (EVLYG)HR 485 Protecting Healthcare for all Patients Act   Read it here: https://www.congress.gov/bill/118th-congress/house-bill/485 Please like, subscribe, and comment on our podcasts!Please consider making a donation: https://thebonnellfoundation.org/donate/The Bonnell Foundation website:https://thebonnellfoundation.orgEmail us at: thebonnellfoundation@gmail.com Thanks to our sponsors:Vertex: https://www.vrtx.comViatris: https://www.viatris.com/en

In this episode, Joe interviews Ingmar Gorman, Ph.D.: clinical psychologist and co-founder and CEO of Fluence, a psychedelic education company. Gorman served as a co-principal investigator and study therapist on MAPS' Phase II and III clinical trials for MDMA-assisted psychotherapy for PTSD, and works with drug sponsors: training, developing the components for clinical trials, and designing therapy manuals. With his insider's perspective, he discusses the reasons why he believes the FDA rejected MDMA-assisted psychotherapy for PTSD: from ICER's 2.1 section of the report giving legitimacy to allegations they don't have the authority to research, to Lykos not being able to defend some accusations due to confidentiality, to the damage caused over time (which likely influenced the decision) from attacks against Lykos from dissenters. He discusses: How, despite abuse claims, the main allegations in the report were actually about the mishandling of data or influence of investigators on participants The complications of needing to follow study frameworks: Should your adverse experience be in the report if it happened outside the study window? How easily opposition can attack and demonize a faceless company, while forgetting the humanity of the people behind it Inner healing intelligence and the proposition that people have been indoctrinated into this concept by MAPS The need for journalists to research more and not just jump on a narrative and more! For links, head to the show notes page. 

In deze podcast bepreekt Koos van der Hoeven met Hans Severens over de vraag of de inzet van nieuwe geneesmiddelen en technologieën tot verdringingseffecten in de zorg leidt. Aan bod komen onder andere de marginale waarde van ziekenhuiszorg berekend uit een kwantitatief onderzoek van ZiN, een kwalitatief onderzoek onder een aantal stakeholders, en de begrippen incremental cost-effectiveness ratio (ICER) en quality adjusted life year (QALY).Referenties 1. Voortgangsbrief pakketbeheer van dure geneesmiddelen, d.d. 11 april 2024. Te raadplegen via: https://open.overheid.nl/documenten/40749f67-692d-44be-9cc7-16f7ede55aa0/file. 2. Adang E, et al. Verdringingseffecten binnen het Nederlandse zorgstelsel. November 2018. Te raadplegen via: https://www.zorginstituutnederland.nl/publicaties/publicatie/2018/04/17/verdringing-binnen-de-ziekenhuiszorg.Disclosures Dr. Hans Severens: Alexion, Amgen, AstraZeneca, Boehringer-Ingelheim, Daiichi Sankyo, Gilead, GSK, Hikma, Idorsia, MSD, Nova Nordisk, Pierre Fabre, Recor Medical, Sanofi, Takeda. Prof. dr. ir. Koos van der Hoeven: Astellas, Bayer, BMS, Daiichi Sankyo, Gilead, Novartis, Pfizer, Seagen, voorzitter Oncomid, lid Adviescollege VIG en lid RVT DICA.Deze podcast wordt u aangeboden door Gilead Sciences.NL-UNB-0796

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world.EPRO, or electronic patient-reported outcomes, is increasingly used in clinical trials to improve data accuracy, patient compliance, and reduce administrative burdens. Swing Therapeutics achieved 98% patient compliance in their pilot trial using EPRO, leading to an FDA de novo marketing authorization. EPRO boosts efficiency, saves costs, and improves trial outcomes.The BioSecure Act, which restricts contracts with certain Chinese companies in the US biotech industry, has advanced in the House but still needs Senate support. Bain Capital closed a $3 billion biotech fund and has been acquiring startup companies. Centessa's sleepiness drug showed promising results, lifting the company's shares. New data raise doubts about AstraZeneca and Daiichi's cancer treatment successor. Candid aims to prove the worth of bispecifics in autoimmune diseases.Roivant Sciences has acquired the rights to develop and commercialize Bayer's pulmonary hypertension drug, Mosliciguat, under an in-license agreement worth up to $294 million. Roivant has created a new "vant" called Vant to focus on this project. The Biosecure Act has passed through the U.S. House of Representatives and is set for a Senate vote. AstraZeneca and Daiichi Sankyo's Dato-Dxd failed to significantly improve overall survival in Phase III NSCLC trials, but there is still potential for FDA approval. Terns Pharmaceuticals announced a $125 million raise following positive Phase I data for their oral GLP-1 candidate for obesity.Old Navy is celebrating its 30th anniversary by throwing back to the '90s in a new collection and campaign to enhance its iconic brand. PayPal has launched its largest-ever US ad campaign featuring Will Ferrell, promoting the use of PayPal for both in-store and online transactions. Angela Zepeda, former Hyundai CMO, has been appointed as the global head of marketing for X. Pizza Hut is turning TikTok content into real-world currency for a promotion in the UAE, while Target is targeting pet owners with a collection designed by "fur-fluencers." Marketers are leveraging AI on mobile platforms and genAI is impacting marketing strategies.Merck's Keytruda, a leading immuno-oncology drug, has been highly successful in treating various cancers and has become the world's top-selling drug. However, determining the true value of a drug like Keytruda involves more than just sales numbers. U.S. drug pricing watchdog ICER tracks pricing decisions and their impact, but the industry is exploring new methods to factor in aspects like disability and income disparity. A new formula that considers "standard of living" is being explored to offer a different perspective on pricing in the pharmaceutical industry. As Keytruda celebrates its 10-year anniversary on the market, the impact of this cancer drug and other immunotherapies is being analyzed, along with the future direction of the field.

In this episode, Joe interviews Erica Rex, MA: award-winning journalist, past guest, thought leader on psychedelic medicine, and participant in one of the first clinical trials using psilocybin to treat cancer-related depression. She tells the story of her recent harrowing experience, brought on by 6 times the amount of Syrian rue that was recommended: from entities threatening her, to a sense of terror she was going to die, to finding her way out of it with time, and most importantly, context to process and a strong support system. She and Joe emphasize the reality that bad trips can happen at any time, with any dose, for any reason, and that – if you can make your way through the experience without being traumatized – you can learn a lot about yourself during those states. She discusses: Methods to help others having a bad experience Her skepticism about psychedelic therapy being in a medical context at all Her thoughts on the recent ICER recommendation against approving MDMA and the multiple topics not addressed Possible complications from MDMA use nobody talks about, from cytotoxic effects to even sudden-onset psychosis The pathologizing of anything outside the ordinary, to the point that we're trying to suppress natural human emotions and reactions and more!  For links, head to the show notes page.

In this compelling episode of The Psychedelic Report, Dr. Dave Rabin delves into the evolving landscape of psychedelic-assisted therapies with special guest Jon Lubecki, a veteran and prominent advocate for such treatments in Ukraine. The discussion centers on the recent FDA advisory committee setback, which resulted in a 10 to 1 vote against MDMA-assisted therapy due to lingering concerns about its safety and efficacy, particularly in post-treatment activities like driving. Jon provides a nuanced analysis of the hearing, pointing out significant conflicts of interest among some opponents who failed to disclose their affiliations with competing therapies like psilocybin and ketamine. He also examines the critical role of influential organizations such as ICER and Symposia, whose biased reports have swayed public and regulatory opinions against MDMA trials. With a fervent focus on the broader implications for mental health, especially for veterans suffering from PTSD, Jon underscores the inadequacy of current treatments and the transformative potential of MDMA-assisted therapy. He shares his personal journey from struggling with PTSD to becoming a leading advocate, passionately calling for the democratization of access to these promising therapies, transcending political and social boundaries.Instagram: https://www.instagram.com/jonathanlubecky/Web: www.mdmaptsd.orgTwitter: https://twitter.com/DrDavidRabinInstagram: https://www.instagram.com/drdavidrabinWeb: https://www.drdave.io/Web: www.ApolloNeuro.comCongressman Dan Crenshaw speaks out on the MDMA-assisted therapy controversy and the anti-Veteran agenda : https://www.instagram.com/reel/C8zsu2Wu7M0/?utm_source=ig_web_copy_link&igsh=MzRlODBiNWFlZA==

In today's episode of the Psychedelic Therapy Frontiers podcast Dr. Steve Thayer and Dr. Reid Robison  talk about the recent FDA psychopharmacologic drugs advisory committee meeting that resulted in a majority vote against the approval of MDMA-assisted therapy for PTSD based on MAPS/Lykos study data. They discuss what the committee's concerns were, the Institute for Clinical and Economic Review's (ICER) criticisms of the studies, the challenges of conducting psychedelic clinical trials, functional unblinding, how research and rater bias affects study data, and much more.https://psychedelicalpha.com/news/exclusive-therapists-and-trialists-from-lykos-phase-3-mdma-assisted-therapy-studies-push-back-on-icers-critical-draft-reportLearn more about our podcast at https://numinus.com/podcast/Learn more about psychedelic therapy training opportunities at https://numinus.com/training/Learn more about our clinical trials at https://www.numinus.com/clinical-trials Learn more about Numinus at https://numinus.com/Email us at ptfpodcast@numinus.com Follow us on Instagram: https://www.instagram.com/drstevethayer/https://www.instagram.com/innerspacedoctor/https://www.instagram.com/numinushealth/

Host Fred Goldstein Invites Sarah Edmonds, President and CEO of ICER to discuss ICERs, Health Technology Assessments and determing value as we seek to move to a value based healthcare system. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

Curious about the forces driving healthcare pricing and access? Join us for an enlightening conversation with Sarah Emond, President and CEO of the Institute for Clinical and Economic Review (ICER). Sarah's upbringing in a family passionate about policy and social justice laid the foundation for her impactful career in health policy. We explore her educational journey from Smith College to Brandeis University's Heller School, and how her professional experiences in clinical research and biopharmaceutical consulting shaped her path to ICER.Unravel the complex world of health technology assessment (HTA) in the US as Sarah breaks down the challenges and opportunities within a fragmented healthcare system. ICER's pivotal role in evaluating new medical technologies is discussed in depth, including its interactions with international agencies like the UK's NICE. Sarah sheds light on ICER's evolution from a small initiative within Mass General Hospital to a powerful voice in global HTA practices, emphasizing the importance of fair pricing, patient access, and sustainable innovation funding.Equity in healthcare takes center stage as Sarah introduces ICER's updated value assessment framework. Learn about new tools like the clinical trial diversity rating and the Health Improvement Distribution Index (HIDI) designed to promote representation of diverse populations in clinical trials. We also tackle the high costs and value-based pricing of innovative treatments, including gene and cell therapies, and the necessity of evolving payment systems to ensure continuous innovation. Tune in to gain a comprehensive understanding of the pressing challenges and future directions in healthcare pricing, equity, and access.Host David E. Williams is president of healthcare strategy consulting firm Health Business Group. Produced by Dafna Williams.

Sarah Emond (President and CEO, ICER) delves into the efficacy of gene therapy in enhancing patient outcomes and discusses the necessary adjustments the healthcare industry must make to accommodate the cost.

In this episode, Pam Divack sits down with Sarah Emond, President and CEO of ICER (the Institute for Clinical and Economic Review), an independent non-profit research organization that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices, and health system delivery innovations. They discuss the history of ICER and how it collaborates with stakeholders across the healthcare ecosystem, the key trends and industry pressures giving rise to an increased need for value assessments and comparative effectiveness research, how ICER is working to improve the US Healthcare System, and why this work is critical for aspiring healthcare leaders to track.

This conversation touches on two important subjects: the impact of different potential resmetirom prices on the size and structure of the treatable MASH population, and the impact GLP-1s are having (and will have) on clinical trial recruitment and basic patient treatment. It starts with Naim Alkhouri expressing concern over the $39-52K price he has heard for resmetirom, which ICER has deemed cost-effective. He mentions another paper that says a price of $19,000 would be cost-effective. To Naim, this magnifies a question that is already quite widely considered: when to prescribe resmetirom vs. a GLP-1 agent. He discusses some patient factors that might go into his decision. Naim describes ways that GLP-1 use, which can be sporadic or episodic, is affecting clinical trial recruitment. Ian Rowe discusses the current use of GLP-1s in the UK and suggests that if the price for resmetirom is high enough, GLP-1s will receive significant use. Naim Alkhouri shifts direction slightly, from discussing current GLP-1s to exciting recent clinical trial report. He focuses on two: survodutide from Boehringer Ingelheim and efruxifermin from Akero Therapeutics. Recent exciting results from BI and Akero suggest to Naim and others that the future for drugs is bright. Ian Rowe anticipates a significant amount of co-prescription of GLP-1s and resmetirom in this population. GLP-1s have already demonstrated clear cardiovascular, weight loss, and HbA1c-lowering benefits. To Ian, that creates sufficient motivation to prescribe GLP-1s to multimorbid patients with diabetes, obesity and most likely MASLD or MASH. To him, the price of resmetirom will have a tremendous impact on how often UK physicians rely on GLP-1s alone.

EPISODE #1017 UK PILOTS REPORTING UFOS Richard speaks with a magazine editor,researcher and international UFO lecturer who has launched a new UAP reporting platform for military, commercial, and civilian pilots in the United Kingdom. GUEST: Gary Heseltine is a former RAF Police and British Transport Police officer. He was a detective for 19 years and a former advanced interviewer of suspects and witnesses. In 2002 he launched an unofficial national police database for British police officers to report and collate their UFO/UAP reports. In April 2013 following his retirement from the police he launched UFO Truth Magazine (bi-monthly ezine). In 2021 he was one of the co-founders of ICER, the International Coalition for Extraterrestrial Research. He currently holds the position of Vice President. ICER is an international NGO comprising scientists, academics and leading UFO/UAP researchers with national representatives in the 30 countries. In February 2023, he published his first book 'NON-HUMAN The Rendlesham Forest UFO Incidents: 42 years of Denial' following a five-year re-investigation of Britain's most famous UFO case - The Rendlesham Forest Incident (Only on Amazon) In December 2023 he founded UK Pilots Reporting UAP which went 'live' on 12/02/2024. WEBSITES: https://www.ukpilotsreportinguap.co.uk http://prufospolicedatabase.co.uk https://www.ufotruthmagazine.co.uk BOOK: NON-HUMAN: The Rendlesham Forest UFO Incidents: 42 Years of Denial BIRCH GOLD GROUP - The Precious Metal IRA Specialists Diversify a portion of your savings into GOLD with Birch Gold Group. Gold is your hedge against inflation, and Birch Gold makes it EASY to own. Text STRANGE to 989898 and get your free info-kit on gold, then talk to a precious metals specialist on how to protect your savings from persistent inflation with gold. Text STRANGE to 989898 now. THE DEAD FILES On The Dead Files, physical medium Amy Allan and retired homicide detective Steve DiSchiavi solve unexplained paranormal phenomena in haunted locations across America. LISTEN TO THE DEAD FILES WHEREVER YOU GET YOUR PODCASTS BECOME A PREMIUM SUBSCRIBER!!! https://strangeplanet.supportingcast.fm Three monthly subscriptions to choose from. Commercial Free Listening, Bonus Episodes and a Subscription to my monthly newsletter, InnerSanctum. Visit Use the discount code "Planet" to receive one month off the first subscription. We and our partners use cookies to personalize your experience, to show you ads based on your interests, and for measurement and analytics purposes. By using our website and services, you agree to our use of cookies as described in our Cookie Policy. Learn more about your ad choices. Visit megaphone.fm/adchoices Learn more about your ad choices. Visit megaphone.fm/adchoices Support our show by becoming a premium member! https://strangeplanet.supportingcast.fm/

Three guests from a recent radio show - J M DeBord on some new research about external interactions with dreaming people... Gary Heseltine from ICER on a new initiative to help pilots report UAP sightings... And Glenn Steckling talks about his family's long involvement with the work of George Adamski - world-famous 20th Century Ufologist and contactee...

This conversation is part of a March, 2023 interview between co-hosts Louise Campbell and Roger Green and Jeff McIntyre of Global Liver Institute, one of the guests on the S5 E2 panel. This particular conversation focuses largely on Jeff's insights around the imminent anticipated drug approvals of obeticholic acid (which was withdrawn several months later) and resmetirom (whose PDUFA date is next month). Jeff's analysis includes mixed levels of enthusiasm around a draft report from ICER which includes pricing estimates for these drugs. The contention lies in the draft's reference to NASH as a non-progressive disease - a position which the panelists readily refute. Jeff's positive note is that the report carefully considers patient perspective and he was able to participate as an expert reviewer.The conversation shifts to speculations around the future standard for noninvasive testing and biomarkers. Jeff emphasizes the “need for a noninvasive that can be scaled with the least amount of burden to primary care providers and the patient populations that need them.” Roger Green points to the various guidelines' referral to FIB-4 as such a test. This summons quote of Quentin Anstee's repeated admonition that “we not let the perfect be the enemy of the good.” For whatever shortcomings of FIB-4, if it can be done now and it's two generations of successive approximation of what we've had before.As the session winds down, Louise Campbell asserts further comments around the ICER draft and NASH as a progressive disease. She recollects the podcast's recent conversation with Tim Jobson, founder of Predictive Health Intelligence, (S4 E5) which discusses developing a simple tool to identify patients at risk of liver disease by analyzing the results of blood tests given throughout their lives.

As it turns out, UFOs don't just land in America! In this episode with Thiago Luiz Tichetti we take a good look at Brazilian Ufology. Then journey with us back to the US as we discuss the recent events in Miami 2024. Was it just reckless teens? Was it ETs? Or is there something else behind all this? Find out in this episode. Then be sure to stick around for the end for an interesting discussion about the government's involvement in Steven Spielberg's famous film E.T. Here at First Contact we believe that the power to initiate contact with non-human intelligence is in your hands! Activate your ability to connect with the 5D Empire Vault. Here you will find 100+ Frequency Activations to activate your Merkaba Lightbody, access your Multidimensional Inner Heart, Quantum leap your abundance, and more. Join the 5D Empire Vault today: https://go.eeshapatel.com/5demembervault About Thiago: Thiago Luiz Ticchetti, whose father was a pilot in the Brazilian air force, has been researching the UFO phenomenon for almost 30 years. He is the National Director of MUFON in Brazil, STAR TEAM and ERT MUFON member, Delegate of ICER in Brazil, Director of CIFER, and president of the Brazilian Commission of Ufologists (CBU). Thiago is also co-editor and columnist for Revista UFO magazine and columnist for UFO Truth magazine. He has published dozens of articles for UFO Magazine and foreign publications. Author of 14 books: “Quedas de UFOs I", "Quedas de UFOs II", “Guia da Tipologia Extraterrestre”, "Guia da Tipologia Extraterrestre - 2ª edição", "Guia da Tipologia Extraterrestre - 3ª edição", "Guia da Tipologia dos UFOs", “Arquivos UFO: casos ufológicos - Volume I”, "Arquivos UFO: casos ufológicos - Vol. II", "Arquivos UFO: casos ufológicos - Vol. III", "Universo Insólito: livro de bordo - Parte 1 e 2", "UFO Contacts in Brazil", "Contacts OVNIs au Brésil" and “Cartas Para Claudeir Covo”. About Eesha: Eesha Patel is a Galactic Contact Expert. Her work has been featured in prominent media including Channel 10, Channel 7, Radio Fremantle and Coast to Coast AM with George Noory. Eesha is a trailblazer and thought leader in the field of galactic consciousness. Her work has received endorsements from prominent researchers in UAP/UFOs, including Professor Abraham Loeb. Eesha is host of the podcast First Contact which is leading the conversation around how humanity can peacefully awaken and connect with our intergalactic family. Eesha leads visionary entrepreneurs into discovering their own galactic soul family through her bespoke and luxury galactic experiences. You can connect with Eesha Patel at www.eeshapatel.com. To invite Eesha for an interview please connect with her at contact@eeshapatel.com.

Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Today we have a packed episode with news from the healthcare industry. Let's dive in.Integra is set to acquire J&J's Acclarent for $275 million, making them a market leader in ENT procedures. Illumina is divesting its acquisition, Grail, following orders from regulators. Zimvie has received clearance for its spinal fixation system through a collaboration with Brainlab. Crispr Therapeutics and Vertex Pharmaceuticals have developed a sickle cell disease therapy using Crispr technology. Heart device makers are investing in left atrial appendage closure as a potential $6 billion market by 2030. Activist investor Engaged Capital has taken a stake in Nevro.Pfizer is planning to deepen its cost cuts after sales forecasts missed expectations. Vertex Pharmaceuticals is building a case for a non-opioid pain drug. Doctors at the ASH meeting have praised new sickle cell gene therapies. Biotech mergers and acquisitions are picking back up, with Astrazeneca's acquisition of Icosavax being the first large buyout of a vaccine developer since GSK's purchase of Affinivax. Tome Biosciences has debuted with $213 million in funding.Centene attempted to ease concerns about the potential overhaul of the ACA. KKR is reportedly in talks to buy a stake in Cotiviti. Google has revealed new generative AI models for healthcare called MedLM. Cerner is expected to be a growth story for Oracle after this fiscal year. There have been reports of hackers having access to patient information in a cyberattack on a New York hospital.Pfizer's stock price dropped after providing its full-year 2024 guidance. Johnson & Johnson and Genmab released data from a phase III study of their darzalex faspro-based quadruplet therapy. The FDA has created the Genetic Metabolic Diseases Advisory Committee. Biopharma companies are shifting their advertising budgets away from Xplus. South Africa is moving towards greater local biopharmaceutical production.AstraZeneca is set to acquire vaccine maker Icosavax. The FTC has led Sanofi to terminate a drug research deal with Maze Therapeutics. Editas presented its gene therapy for sickle cell disease at the ASH23 conference. Tome Biosciences has debuted with $213 million in funding. Bristol Myers Squibb has paid SystImmune $800 million in a deal involving ADCs. AbbVie's Humira leads ICER's list of "unsupported" price hikes. Pfizer presented new data at the ASH conference.Bristol Myers Squibb has acquired the rights to develop SystImmune's bi-specific ADC. Pfizer's acquisition of Seagen has cleared regulatory hurdles. Sanofi has dropped its acquisition of Maze Therapeutics' Pompe disease drug. AstraZeneca has entered the RSV vaccine market with its purchase of Icosavax. Sino Biological has developed three HEK293 expression-based platforms.The Daily Dive newsletter from Marketing Dive highlights several key stories. Oscar Mayer and Mint Mobile are teaming up for a national campaign called "A Side of Bacon." Frito-Lay is reaffirming its commitment to diverse creators with a new campaign called "My Joy." IPG Mediabrands has struck a deal with Amazon for ad-supported streaming. The newsletter also includes an opinion piece on retail media networks and an upcoming virtual event on generative AI in marketing.The pharmaceutical industry is preparing for upcoming changes and challenges. The cost of medicine is expected to be a major debate point in the 2024 presidential election. Bristol Myers Squibb's Chief Commercial Officer discusses the industry's shifting approach. The article includes sponsored content from AstraZeneca, highlighting their expansion in blood cancer care. The text concludes with links to other resources and press releases.And that's all for today's episode. Stay tuned for more important news from the Pharma and Biotech world. Goodbye!

Terry Wilcox, Patients Rising CEO, along with Rick Chapman, the Chief Science Officer at the Innovation and Value Initiative, and Darius Lakdawalla, the Chief Scientific Officer at EntityRisk, hold a patient advocate event focused on the need to improve ICER; and the Patient Access and Affordability Project's new report on discriminatory formulary practices. Healthcare Policy Pop Episode: Biosimilars Slow Uptake (GRACE Model) Patient Access and Affordability Project Report: Equitable Access: Examining Discriminatory & Restrictive Practices in Prescription Drug Formularies  

Andy & Dan look through a few weeks of news including; New David Grusch interview with ICER Sean Kirkpatrick leaving AARO Greek/Roman God comments Ross Coulthart on February Shoot downs Much, much more Get in touch with the show; Twitter: @UFOUAPAM Facebook, YouTube & Instagram: "That UFO Podcast" YouTube: ⁠⁠YouTube.com/c/ThatUFOPodcast⁠⁠ Email: ⁠⁠UFOUAPAM@gmail.com All podcast links & associated links; ⁠⁠Linktr.ee/ufouapam⁠ ⁠⁠ThatUFOPodcast.com⁠⁠ ⁠⁠Linktr.ee/TheZignal⁠⁠ ⁠⁠UAPMedia.UK Don't forget to subscribe, like and leave a review of the show, Enjoy folks, Andy

BMS's acquisition of Mirati for up to $5.8 billion not only gives the big pharma a potential best-in-class KRAS inhibitor in a field that appears to be opening up, but also a clinical program against one of the hottest targets in precision cancer, PRMT5. On the latest BioCentury This Week podcast, BioCentury's editors discuss what Bristol Myers Squibb stands to gain from its acquisition of Mirati Therapeutics, which had rumors swirling about its potential takeout last week. BioCentury's editors also discuss their 4Q23 Public Markets Preview, including how private biopharma companies looking to go public in the next 12 months should be managing their path to that transition. Following last week's analysis of the companies leading the transition of CAR T therapies into the autoimmune space, BioCentury's editors also touch on the targets and technologies coming up behind the leading programs that could expand use of CAR Ts to a wider set of autoimmune indications. They also discuss takeaways from ICER's report on how CMS might approach drug price negotiation under the Inflation Reduction Act.

John O'Brien, President and CEO of the National Pharmaceutical Council, weighs in on ICER's latest update that we are calling a “faux update”; The American Enterprise Institute has released its perspective on last year's Inflation Reduction Act; and The National Institute on Minority Health and Health Disparities has officially designated people with disabilities as a population with health disparities. National Pharmaceutical Council Webpage: NPC Evaluates ICER's Revised 2023 Value Assessment Framework American Enterprise Institute Webpage: What Does the Inflation Reduction Act Mean for Patients and Physicians? National Institutes of Health Webpage: NIH designates people with disabilities as a population with health disparities  

With the Open Enrollment Period fast approaching, Levi Peterson, a Resource Coordinator for our Patient Helpline walks us through what everyone needs to know about Medicaid and Medicare eligibility, PPOs and HMOs, and how to pick a health plan that best fits your needs. We also discuss a so-called ICER update that doesn't do much updating and still doesn't help patients. Patients Rising Now Statement | ICER ‘Updates' are Thinly Veiled Strategy to Continue Discriminatory Tactics  ICER's Updated Treatment Assessment Still Ignores Patient Concerns    Need help? The successful patient is one who can get what they need when they need it. We all know insurance slows us down, so why not take matters into your own hands? Our Navigator is an online tool that allows you to search a massive network of health-related resources using your zip code so you get local results. Get proactive and become a more successful patient right now at the Patients Rising Helpline. Have a question or comment about the show, or want to suggest a show topic or share your story as a patient correspondent? Drop us a line: podcast@patientsrising.org The views and opinions expressed herein are those of the guest(s)/ author(s) and do not reflect the official policy or position of Patients Rising, nor do the views and opinions stated on this show reflect the opinions of a guest's current or previous employers.  

Bill Smith, Director of the Life Sciences Initiative at the Pioneer Institute, dives into the so-called update to ICER's value assessment framework; Congresswoman Cathy McMorris Rodgers explained earlier this year why she was against the QALY measurement; and Patients Rising Now along with several other groups have issued statements denouncing the ICER update. Pioneer Institute Webpage Patients Rising Podcast Episode: Healthcare Protections for Rare Diseases with Rep. Cathy McMorris Rodgers Patients Rising Now Webpage: Patients Rising Now Statement – ICER's ‘Updates' are Thinly Veiled Strategy to Continue Discriminatory Tactics National Pharmaceutical Council Webpage: NPC Evaluates ICER's Revised 2023 Value Assessment Framework – A Missed Opportunity for Patients and the Field Biotechnology Innovation Organization Webpage: ICER's updated treatment assessment still ignores patient concerns  

In the wake of Medicare's announcement of the first 10 drugs subject to price negotiations, Patients Rising CEO Terry Wilcox outlines the need for greater patient involvement in this process; Taylor Schwartz of Avalere explains a new white paper that analyzes the use of patient-centered outcomes in ICER reviews; CMS issues draft guidance on new Medicare Part D smoothing program. Patients Rising Calls on CMS to Engage with Patients in Drug Price Negotiations Patients Rising Now Comments: Medicare Drug Price Negotiation Program Guidance Memo CMS Webpage: Medicare Drug Price Negotiation Program Avalere Webpage: Use of Patient-Centered Outcomes in ICER Assessments

Today we welcome special guest Gary Heseltine to discuss his time in the Royal Air Force Police & His time as a Transportation Police officer. After retiring Gary created PRUFO or "Police Reporting UFO Sightings" which caters for serving & retired British Police so they can report there sightings. Gary is also the Founder & editor for the famous "UFO Truth" Magazine which we will discuss some of his work and how he came to be involved in the field of Ufology. Gary is now the current Vice President of ICER, and is currently working with Colonel Charles Halt to piece together the Rendlesham Incident, so we plan to discuss whats going on with that and what we can expect moving forward. So with that being said, Strap on Those Seat belts, were going for a Ride! - SPONSORED BY: "SPIRITUAL CONSCIOUSNESS: A PERSONAL JOURNEY" By: Kevin J. Briggs - GET YOUR COPY AT: www.KevinJBriggs.com GARY'S BIO: Gary Heseltine is served in the RAF Police between 1983-89 before joining the British Transport Police in 1989. He went on to have a 24-year career in the police, mostly as a Detective Constable who was also an advanced interviewer of suspects and witnesses. In 2013 he retired from the police early to launch UFO Truth Magazine, a bi-monthly ezine (www.ufotruthmagazine.co.uk). In 2020 he became the Vice President of the International Coalition for Extraterrestrial Research (ICER), a not-for-profit NGO with national representatives in 30 countries. In February 2023, after a five-year re-investigation of the Rendlesham Forest Incident he released his first book, NON-HUMAN The Rendlesham Forest UFO Incidents: 42 Years of Denial. UFO TRUTH MAGAZINE - www.ufotruthmagazine.co.uk Gary's Book - https://www.amazon.co.uk/NON-HUMAN.../dp/B0BVDF6W2Z/ref=sr_1 - SPONSORED BY: "SPIRITUAL CONSCIOUSNESS: A PERSONAL JOURNEY" By: Kevin J. Briggs - GET YOUR COPY AT: www.KevinJBriggs.com - DONATE/SPONSOR THE SHOW AT - https://paypal.me/JessePmufonFI - IT WILL HELP KEEP THE SHOW GOING, PLUS YOU GET A "SHOUT OUT" ON THE SHOW AND A PLACE ON THE WEBSITE! CONTACT ME: TWITTER - @AATPEAK WEBSITE - UFOENCOUNTERSWORLDWIDE.WORDPRESS.COM EMAIL - UFOENCOUNTERSWORLDWIDE@GMAIL.COM --- Support this podcast: https://podcasters.spotify.com/pod/show/ufoencountersworldwide/support

Avalere releases a study focused on ICER assessments and whether or not they take into account the patient experience when creating their reports; Wayne Winegarden, a Senior Fellow with the Pacific Research Institute explains how new Humira biosimilars have affected the market and their possible effect on PBMs; and drug shortages are worsening, and this time they're affecting diabetes medications. Avalere Webpage: Use of Patient-Centered Outcomes in ICER Assessments Patients Rising Now Comments Fierce Pharma News Article: Eli Lilly's Mounjaro shortage worsens ahead of potential obesity FDA approval  

In a monumental moment for combatting Fatty Liver disease, NICE has published the much anticipated evidence-based recommendations on FibroScan for assessing liver fibrosis and cirrhosis outside secondary and specialist care. Such a positive announcement comes at no better time than the start of the Surfing NASH ongoing coverage of International #NASHDay 2023 . To kick off the occasion, this first episode features hepatology researcher and KOL, William Alazawi, and new guest Vanessa Hebditch who serves as Director of Communications and Policy at the British Liver Trust. The panelists, alongside Louise Campbell and Roger Green, celebrate and comment on the new guidance on FibroScan use in the UK.This conversation continues focus on the concerns around appropriate data collection and analysis to discover the best path forward. Will describes the need to collect the kinds of data that will assess the value of the process and the right way to execute as processes are built and implemented. Vanessa agrees, but asks that we not let the perfect be the enemy of the good and that we keep in mind how many patients with advanced fibrosis are not getting diagnosed today and need the support of this program. One point that clearly emerges in dialogue with Will is that other countries will look to NICE and the UK experience to inform their own decisions. This only amplifies the need to collect data well and wisely. Louise states that she would also like to see data about the effect of this initiative on related metabolic conditions. She likens FibroScan scoring to dropping a pebble in a pond and seeks to explore the ripples it makes in related diseases and conditions, particularly for endocrinology and cardiology. Roger remarks on how refreshing it is to hear a conversation where multiple stakeholders are aligned to find the best approach to the disease. He goes on to contrast this topic to the role of ICER. Finally, Roger asks questions around Louise's pond metaphor and mentions comments that Stephen Harrison and Mazen Noureddin made last autumn that had suggested that FAST may be a better first line test. Will suggests that many questions need to be answered before determining the accuracy of the tests or what the best way to perform them is.If you have questions or interest around NICE and FibroScan use, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.Stay Safe and Surf On!

Sheryl Gottschall has had a life-long interest in the paranormal and began studying the phenomenon of Near Death Experiences (NDEs) in 1980, soon after becoming a member of the International Association of Near Death Studies (IANDs). In 1995 she hosted IANDS co-founder, Dr Ken Ring while he was on tour in Australia presenting research for his future book Mindsight: Near Death and Out Of Body Experiences In The Blind. Little did she know she would experience an NDE for herself the following year during a serious decade long illness. Sheryl's interest in NDEs paralleled her interest in UFOs, so in 1988 she joined the Brisbane based organisation, UFO Research Queensland (Australia). At that time the organization was soon overrun with ever growing reports of alien abduction experiences so in 1992 Sheryl, with her late husband Dr Martin Gottschall, established the first close encounter support group in Brisbane which they facilitated over the years, on and off, as needs arose. Expanding her interest in the UFO subject and the move towards disclosure, Sheryl was invited to fill the role of the Australian representative for the International Association of Extra-terrestrial Research (ICER) which launched in May 2021, and is the first truly international group of UFO researchers from 30 countries working together. Sheryl loves media and has been a weekly guest on the Spooky Action radio show (2018), co-hosted the Strange Encounters radio show (2019), the Insomnia radio show 2022 (current) and now co-hosts the fortnightly show – Strange Encounters Downunder. These shows have served as a further catalyst for members of the public to report their experiences to her, many of who have never shared them before. https://www.youtube.com/@UFOResearchQueenslandThis show is part of the Spreaker Prime Network, if you are interested in advertising on this podcast, contact us at https://www.spreaker.com/show/4602609/advertisement

Donna Cryer joins Jörn Schattenberg, Louise Campbell and Roger Green for an impactful episode which weighs the complexities of competing needs across all Fatty Liver stakeholders. The session expands discourse on the recently discussed ICER draft report to consider a developing landscape around nomenclature consensus and other important and impending decisions. Critically, the group grapples with challenges associated with honoring the precedence of patient-centricity.Donna opens this conversation with several calls to action for patient advocacy in the NASH community. Her first recommendation is to recruit different disciplines to administer and evaluate an impact report regarding nomenclature consensus. Next, and more broadly, she asks all stakeholders to consider how to genuinely and effectively build an inclusive advocacy community. Roger asks Jörn what he believes to be realistic that the field can do for these aims today. First, Jörn notes that many different societies can agree on what is considered to be a severe patient and what an unfavorable outcome is in terms of liver disease. He goes on to say that with therapies in the pipeline and tests like FIB-4 available and widely implementable now, we have indeed come a long way as a field. The risks he perceives with topics such as the ICER draft report and nomenclature consensus revolve around slowing, detouring or dismantling the tremendous progress that has been made. As the session wraps up, Donna offers her thoughts on where this is all heading. Listen to the full feature to engage with these impactful moments. If you enjoy the episode, have questions or interest around endocrinology and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.Stay Safe and Surf On!

Donna Cryer joins Jörn Schattenberg, Louise Campbell and Roger Green for an impactful episode which weighs the complexities of competing needs across all Fatty Liver stakeholders. The session expands discourse on the recently discussed ICER draft report to consider a developing landscape around nomenclature consensus and other important and impending decisions. Critically, the group grapples with challenges associated with honoring the precedence of patient-centricity.This final conversation begins with Roger's note that while patient stories are driven with emotion and impact, the actual patient journey through diagnosis to treatment can unfortunately be a mechanistic and confusing process. With this in mind, Roger asks how do we bring a more holistic sense of what it means to be a patient or patient advocate to all of these issues discussed as they continue to amplify in a bigger, broader way. Donna's moving response and the various final thoughts from the other panelists encapsulates the need for patients to be respected for the professional skills they possess which can contribute real impact on how the field moves forward in a stronger, more multi-disciplinary fashion. Listen to the full segment to hear the moving statements.If you enjoy the episode, have questions or interest around endocrinology and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.Stay Safe and Surf On! 

Donna Cryer joins Jörn Schattenberg, Louise Campbell and Roger Green for an impactful episode which weighs the complexities of competing needs across all Fatty Liver stakeholders. The session expands discourse on the recently discussed ICER draft report to consider a developing landscape around nomenclature consensus and other important and impending decisions. Critically, the group grapples with challenges associated with honoring the precedence of patient-centricity.Roger prefaces this conversation with a brief recap of Season 4 Episode 19 where a panel of patient advocates (Wayne Eskridge, Michael Betel and Anthony Villiotti) dissected glaring inaccuracies and shortcomings within the ICER draft report. Roger goes on to introduce the rollout of the nomenclature consensus work and candidly shares that it is appearing to be a compromised solution between academics. He reasons it's not clear that it takes into account what other stakeholders need and the practicality behind approving drugs, educating patients and moving the management of the disease forward. From here, Donna describes her frustrations with the weight and value allotted (or lack-thereof) to patient inputs on such important matters. Her statement is powerful and urgent, and describing it in words does not capture the gravity of the moment.Listen to the full feature to engage with many more insightful moments. If you enjoy the episode, have questions or interest around endocrinology and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.Stay Safe and Surf On!

Donna Cryer joins Jörn Schattenberg, Louise Campbell and Roger Green for an impactful episode which weighs the complexities of competing needs across all Fatty Liver stakeholders. The session expands discourse on the recently discussed ICER draft report to consider a developing landscape around nomenclature consensus and other important and impending decisions. Critically, the group grapples with challenges associated with honoring the precedence of patient-centricity.This conversation begins with Jörn's response to a preceding and powerful statement by Donna around the undervalued input of the patient community. Roger and Donna go on to define in different ways what and why it is that they are concerned about in both the context of the ICER draft report and the nomenclature consensus process. Roger relates this contention to the sociology of in-groups and out-groups. Louise adds her thoughts from the allied health perspective. Her main point is that the role of the nurse is to “listen to both sides” between the physician and the patient while ultimately serving the patients' “well-being, thoughts, feelings and the way they want things to be portrayed.” Not all patients have advocate family members present in hospitals and therefore critical that nurses and other allied health professionals be supported and present to bolster the patient voice. One way to achieve this would be by featuring stronger presence and representation of these groups in panels.  Listen to the full feature to engage with many more insightful moments. If you enjoy the episode, have questions or interest around endocrinology and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.Stay Safe and Surf On!

Donna Cryer joins Jörn Schattenberg, Louise Campbell and Roger Green for an impactful episode which weighs the complexities of competing needs across all Fatty Liver stakeholders. The session expands discourse on the recently discussed ICER draft report to consider a developing landscape around nomenclature consensus and other important and impending decisions. Critically, the group grapples with challenges associated with honoring the precedence of patient-centricity.Roger begins this conversation by pointing to Jörn's diversifying role in the NASH community. Specifically, Jörn is prompted to elaborate on his unique perspective in regards to what sort of forward thinking is required in getting “questions asked in a different way.” Jörn first reminds that nomenclature consensus is an ongoing process that has yet to yield a definitive conclusion. More broadly, he goes on to underscore the importance of promoting awareness, education and advocacy around the real impact of Fatty Liver disease on patients and wider communities.From here the group considers how the nomenclature debate emerged and what cultural and systemic differences may be impacted by a decision going forward. In example, Roger notes that in some countries the word nonalcoholic is useful in that it lifts stigma. The panelists also note the nuances and challenges nomenclature poses to the pediatric population. As the session winds down, Roger states that when dealing with a multi-stakeholder world, you need to start with a truly diffuse, multi-stakeholder solution. Finally, Donna closes with a quote from The Color Purple: “I shouldn't have to fight in my own house. And that's how I feel like as a patient in the NASH community right now.”Listen to the full feature to engage with these impactful moments. If you enjoy the episode, have questions or interest around endocrinology and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.Stay Safe and Surf On!

This week, Donna Cryer (Global Liver Institute) joins Jörn Schattenberg, Louise Campbell and Roger Green for an impassioned and sobering episode which weighs the complexities of competing needs across all Fatty Liver stakeholders. This powerful and at times emotional session expands recent discourse on the ICER draft report to also consider a developing landscape around nomenclature consensus and other important and impending decisions. Critically, the group grapples with challenges associated with honoring the precedence of fighting Fatty Liver through patient-centricity. Among this rich and tremendously honest discussion are the following themes:00:00 Introduction07:40 Who is going to be the Larry Kramer of NASH?17:38 Allied Health for Patient Empowerment26:59 Generating Data to Demonstrate Patient Needs and Inform Public Health36:55 Donna's Call to Action42:37 Can we absorb enough different perspectives into a common discussion and give them each the weight they deserve?Listen to the full feature to engage with the many insightful moments. If you enjoy the episode, have questions or interest around patient advocacy, allied health and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.Stay Safe and Surf On!

Back in March 2023, Jeff McIntyre (GLI) introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. The Surfers dedicated an episode to expand on the contents, its shortcomings and potential implications with special guests Veronica Miller (Liver Forum) and Hannah Mamuszka (Alva10). This week, SurfingNASHrevisits the topic after a public comments session took place last week. In doing so, patient advocates and friends of the podcast Mike Betel (Fatty Liver Alliance), Tony Villiotti (NASHkNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join co-hosts Louise Campbell and Roger Green to share a range of impressions.This final conversation focuses on the most important thing each panelist would like ICER to learn before another NASH drug analysis. In our first conversation with Jeff McIntyre, he said that it while it was appreciated that patients have a voice, it's not the same as having a vote. The patient advocate comments in this conversation make it clear exactly how wide the gap between the two is right now. Fortunately, as Veronica miller noted during that preceding episode, ICER reporting has no impact on FDA decisions. However, as we discuss during this conversation, it might have an impact on payers.If you enjoy the episode, have questions or interest around patient advocacy and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.Stay Safe and Surf On!

In March 2023, Jeff McIntyre (GLI) introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. The Surfers dedicated an episode to expand on the contents, its shortcomings and potential implications with special guests Veronica Miller (Liver Forum) and Hannah Mamuszka (Alva10). In this conversation, SurfingNASHrevisits the topic after a public comments session took place last week. In doing so, patient advocates and friends of the podcast Mike Betel (Fatty Liver Alliance), Tony Villiotti (NASHkNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join co-hosts Louise Campbell and Roger Green to share a range of impressions.Roger leads by asking the panelists how each came to give commentary and be involved in the process. Both Wayne and Tony disclose that they have previously worked with ICER through different interviews and seamlessly discovered the opportunity to speak on this occasion as a patient advocate. Wayne subsequently invited Mike to deliver a testimony as well. Next, Roger provides a soft introduction which teases the group to consider their feelings about the document and why each chose to comment on the items in which they noted in their testimonies. Similar to the reactions on our first episode on the Draft Report, it immediately becomes clear that the patient advocates also hold reservations regarding a number of different aspects that comprise the document. On one positive note, Tony commends ICER's willingness to engage with the patient advocate community on a certain level.If you enjoy the episode, have questions or interest around patient advocacy and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.Stay Safe and Surf On!

In March 2023, Jeff McIntyre (GLI) introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. The Surfers dedicated an episode to expand on the contents, its shortcomings and potential implications with special guests Veronica Miller (Liver Forum) and Hannah Mamuszka (Alva10). In this conversation, SurfingNASHrevisits the topic after a public comments session took place last week. In doing so, patient advocates and friends of the podcast Mike Betel (Fatty Liver Alliance), Tony Villiotti (NASHkNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join co-hosts Louise Campbell and Roger Green to share a range of impressions.Roger begins with the note that if the cost of biopsy is factored into the cost of diagnosing a patient, the cost of diagnosis will be absurd. The group goes on to more extensively explore the role of biopsy in prescribing NASH therapeutics. Wayne shares the idea that lifestyle adjustments take time and can be tremendously difficult to maintain. He asserts that because of this, it would be incredibly valuable if there were a therapeutic option that at least halted progression and in turn provides the time to successfully see through lifestyle interventions. Roger relates this perspective to how we consider trial endpoints. Louise adds comments around the recurring idea that while not every patient is symptomatic, we know this is a progressive disease which doesn't necessarily fit the sort of spectrum described by ICER. Towards the end of the episode, Mike notes that the public comments session as a whole was rather liver-centric and siloed from more holistic metabolic thinking.If you enjoy the episode, have questions or interest around patient advocacy and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.Stay Safe and Surf On!

Back in March 2023, Jeff McIntyre (GLI) introduced a draft report from the Institute for Clinical and Economic Review (ICER) on resmetirom and obeticholic acid for NASH. The Surfers dedicated an episode to expand on the contents, its shortcomings and potential implications with special guests Veronica Miller (Liver Forum) and Hannah Mamuszka (Alva10). This week, SurfingNASHrevisits the topic after a public comments session took place last week. In doing so, patient advocates and friends of the podcast Mike Betel (Fatty Liver Alliance), Tony Villiotti (NASHkNOWledge) and Wayne Eskridge (Fatty Liver Foundation) join co-hosts Louise Campbell and Roger Green to share a range of impressions. 00:00 Introduction05:28 How did each come to give commentary and be involved in the events of last Friday? 09:46 Reactions to the word 'empathy' in context of the discussion 17:58 The role of biopsy and economics of diagnosing patients25:19 What motivated each patient advocate to deliver the testimonies which they specifically chose to? 34:00 The role of ICER , the FDA and final thoughts Tune in for the full extent of the insightful discourse. If you enjoy the episode, have questions or interest around patient advocacy and Fatty Liver disease, we kindly ask that you submit reviews wherever you download the discourse. Alternatively, you can write to us directly at questions@SurfingNASH.com.Stay Safe and Surf On!

Donna Cryer, CEO of the Global Liver Institute, previews liver disease patient advocates' testimonies ahead of an ICER meeting on two new treatments; the House Health, Employment, Labor and Pensions Subcommittee holds a hearing titled Reducing Health Care Costs for Working Americans and Their Families; the House Energy and Commerce Health Subcommittee hosted its own meeting about the importance of addressing unaffordable costs in healthcare; and correspondent Kathi Luis lives in Michigan's 9th district and sees how Copay Accumulator programs are hurting patients. Global Liver Institute Webpage CNBC News Article: FDA grants accelerated approval for Biogen ALS drug that treats rare form of the disease Patients Rising Webpage: Patients Rising Stories

In this episode, we interview Dr. Steven Pearson, the founder and President of the Institute for Clinical and Economic Review (ICER). Over the past 16 years, ICER has evolved from a Harvard research program to the independent authority on cost-effectiveness and value of new drugs. Dr. Pearson has been an advocate of “Fair Pricing for Fair Access” and in January 2023, ICER published their 2nd Annual Assessment of Barriers to Fair Access Within US Commercial Insurance Prescription Drug Coverage. Dr. Steven Pearson, Founder, President, Institute for Clinical and Economic Review (ICER) Institute for Clinical and Economic Review (ICER) Barriers to Fair Access Report Gross-to-Net Bubble Like this episode and want to hear more? Check out our past episodes here! Do you have a prescription for better access? Share your ideas with us at comments@prescriptionforbetteraccess.com Follow us on social media! We’re on YouTube, LinkedIn and @RX4BetterAccess (X)

This is the Weight and Healthcare newsletter! If you like what you are reading, please consider subscribing and/or sharing!In part 1 we talked about a request that has been submitted for the World Health Organization (WHO) to add diet drugs (specifically GLP1 agonists like Novo Nordisk's Saxenda and Wegovy) to their list of “essential medicines.” We discussed who was making this request and the justification that they were using. In part 2 we took a deeper dive into the research that they used to try to support this request, and in this final installment, we will look at the research around efficacy, harm, and cost-effectiveness.First I'll offer a summary for each issue and then I'll give a breakdowns of the research that they cite.  Just a quick reminder that this request is asking the World Health Organization (WHO) to add these drugs to their list of “essential medications” globally.Before we get into the sections, I want to mention two overarching issues that are found throughout the entirety of this request and the studies that are used to support it.First, in general, a belief has been fomented (predominantly by those in the weight loss industry) that being higher-weight is so terrible then it's worth “throwing anything at the problem.” This leads to acceptance of poor, short-term, and/or incomplete data as “good enough” to foist recommendations onto higher-weight people, which means that part of weight stigma in healthcare is that higher-weight people are afforded less right to ethical, evidence-based medicine than thinner people.Second, is clinging to correlation (without any mechanism of causation) when it comes to weight, health, and health outcomes, including the abject failure to consider confounding variables. So throughout these studies “being higher-weight is associated with [health issue(s)]” stated uncritically in support of weight loss interventions. There is an utter failure to explore the idea that the reason for the outcome differences is not weight itself but, instead, exposure to weight stigma, weight cycling (which these medications actually perpetuate by their own admission,) and healthcare inequalities.  Issues with research supporting effectiveness, harms, and benefitsStudy Duration:This is the main issue. While there was one study that went up to 106 weeks, the vast majority of the studies are between 14 and 56 weeks. We know that these drugs can have significant, even life-threatening side effects (earning them the FDA's strongest warning.) 14-56 weeks is not not nearly enough time to capture the danger of long-term effects, or to capture long-term trends around weight loss/weight regain.Study PopulationMany of the studies included have small samples. Many have study populations are overwhelmingly white, which is a huge issue when making a global recommendations.Small effect and overlapMany of the studies show only a bit of weight loss (often 15lbs or less) and often there was overlap in weight lost between the treatment group and the placebo group. Even using the “ob*sity” construct that this request is based on, for many people, this amount of weight loss wouldn't even change their “class” of “ob*sity.”Failure to capture adverse eventsMuch of the research they use to support their claims of safety didn't actually capture individual adverse events or serious adverse events. Often they only captured subjects who reported leaving treatment due to side effects.Issues with research supporting cost effectivenessThe cost-effectiveness analyses they cite are based on Quality Adjusted Life Years (QALYs). This is a measurement of the effectiveness of a medical intervention to lengthen and/or improve patients' lives.The calculation for this is [Years of Life * Utility Value = #QALY]So if a treatment gives someone 3 extra years of life with a Health-Related Quality of Life (HRQL) score of 0.7, then the treatment is said to generate 2.1 [3 x 0.7] QALYs.This is a complicated and problematic concept that deserves its own post sometime in the future, but looking just at this request I think it's important to note that they are working on two main unproven assumptions:1. That being higher weight causes lower health-related quality of life and/or shorter life span (rather than any lower HRQL being related to experiences that higher-weight people have including weight stigma, weight cycling, healthcare inequalities et al.) 2. That this treatment induces weight loss and/or health benefits that increase the life span and/or health-related quality of life of those who take it.I don't believe either of these assumptions are proven by the material cited in the request to the WHO. Specifically, it's very possible that it's not living in a higher-weight body, but rather the experiences that higher-weight people are more likely to have (weight stigma, weight cycling, healthcare inequalities) that impact their HRQL.Further, the short-term efficacy data available (and Novo Nordisk's own admission about high rates of regain) fall far short of proving any assumptions about these drugs ability to actually improve or extend life. Further, the failure of the literature to adequately capture negative side effects of the drugs, both short and long-term, means that this calculation cannot be properly made.Incremental Cost-Effectiveness Ratio (ICER)ICER is how QALYs are turned into a monetary value. It is calculated by dividing the difference in total costs by the difference in the chosen measure of health outcome or effect.[(Cost of intervention A -Cost of Intervention B) / (Effectiveness of Intervention A – Effectiveness of Intervention B)]The result is a ratio of extra cost per extra unit of health effect of a more vs less expensive treatment which can then be measured in QALYs.Again, this is worthy of its own post because there are all kinds of ethical issues around things like how we value life, how we define “healthy” and the ethics of determining whether or not prolonging someone's life is “cost effective.” I'm not going to do a deep dive into that today, but I do want to note that it is a serious issue in these kinds of calculations.In this specific case, even if one was to get past the ethical issues, an accurate calculation is impossible to make on both of the measures of the equation.Cost of these drugs varies wildly between countries and sometimes within countries because, for example, Novo Nordisk is a for-profit corporation whose goal is to create as much profit as possible.  Per the WHO request letter, the monthly cost of liraglutide is $126 in Norway and $709 in the US. Semaglutide is $95 per 30 days in Turkey, but $804 per 30 days in US.When it comes to effectiveness of the treatment, again, there is virtually no long-term data. We do know that in Novo Nordisk's own studies, weight is regained rapidly and cardiometabolic benefits are lost when the drugs are discontinued and even when people stay on the drugs, weight loss levels off after about a year, at 68 weeks weight cycling begins, and at 104 weeks (when follow-up ended) weight was trending up. It's possible that these drugs are utterly ineffective over the long-term and/or that the prevalence of long-term side effects renders any treatment effects moot. We simply do not know.I do not think that this is a remotely appropriate basis from which to request that these drugs be declared globally essential by the WHO.Here are the citation breakdowns. These are not deep dives since there are enough issues with the research on a simple surface analysis.Breakdowns of evidence of comparative effectivenessEffects of liraglutide in the treatment of ob*sity: a randomised, double-blind, placebo-controlled study, Astrup et al.)This is a 20-week study funded by Novo Nordisk. It included 564 people on various doses of liraglutide and a placebo group who didn't get the drug and a group on orlistat. There were no more than 90-98 people in each group.The study explains “Participants on liraglutide lost significantly more weight than did those on placebo” by which they meant that those on the highest dose of liraglutide lose about 9.7lbs more than those on the placebo over the 20 weeks.III LEAD studiesThese are four studies that look at liraglutide in combination with other drugs for the treatment of Type 2 Diabetes that also included some information on weight changes. One was 52 weeks, the others were  26, the maximum amount of weight lost was only about 5lbs.   The first [Liraglutide, a once-daily human GLP-1 analogue, added to a sulphonylurea over 26 weeks produces greater improvements in glycaemic and weight control compared with adding rosiglitazone or placebo in subjects with Type 2 diabetes (LEAD-1 SU), Marre et al] was a study that looked at the efficacy of adding liraglutide or rosiglitazone 4 to glimiperide in subjects with Type 2 Diabetes to test effects on blood sugar and body size.The study followed 1041 adults for 26 weeks. The study found that those on .6mg of liraglutide gained 0.7kg, those on 1.2mg gained 0.3kg, and those on 1.8mg of liraglutide lost 0.2kg, while those on placebo lost 0.1kg.The second [Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care, 2009. 32(1): p. 84-90. Nauck, M., et al.,]looked at the efficacy of adding liraglutide to metformin therapy for those with Type 2 Diabetes. They found that over the 26-week study those on liraglutide lost 1.8 ± 0.2, 2.6 ± 0.2, and 2.8 ± 0.2 kg for 0.6, 1.2, and 1.8 mg doses. Those on placebo lost 1.5 ± 0.3kg.The third [Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. Lancet, 2009. 373(9662): p. 473-81. Garber, A., et al.,] This was a study of the comparative effectiveness of Liraglutide versus glimepiride for type 2 diabetes, with small weight loss as an ancillary finding. Those in the liraglutide group lost an average of 2kg.The final study [Efficacy and safety of the human glucagon-like peptide-1 analog liraglutide in combination with metformin and thiazolidinedione in patients with type 2 diabetes (LEAD-4 Met+TZD), Zinman et al.]  was a 26-week study with 533 total subjects. The goal was to study the efficacy of liraglutide when added to metformin and rosiglitazone for people with type 2 diabetes. They found that those on liraglutide lost between 0.7 and 2.3kg (1.5lbs to 5.1lbs) in 26 weeks.Meta-Analyses and Systematic Review FindingsEfficacy of Liraglutide in Non-Diabetic Ob*se Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Barboza, J.J., et al., None of the included studies were more than 56 weeks and one was only 14 weeks. One had as many as 3731 subjects, but one had only 40. Some had body weight loss as a primary outcome, but some did not. Maximum doses ranged from 1.8 to 3.0mg. The mean body weight reduction was  3.35 kg (7.4lbs) but in one study there was no difference in weight loss. The maximum difference was 6.3kg (13.9lbs)They also refer to Iqbal et al which we discussed in part 2.Effects of glucagon-like peptide-1 receptor agonists on weight loss: systematic review and meta-analyses of randomised controlled trials. Vilsbøll, T., et al.The included studies are between 20 and 53 weeks long, and include some of the studies they already cited individually above. Of the 25 included studies only 3 had “ob*sity” as the main inclusion criteria, the rest were Type 2 Diabetes.The mean weight loss for those on the highest dose of the drug was between 0.2kg and 7.2kg. For those in the control group it was 2.9 kg, so there was actually overlap between the treatment and placebo groups.Summary of evidence of safety and harmsThey begin with the claim “The safety profile of GLP-1 receptor agonists is also well studied”To support this they cite: Efficacy and Safety of Liraglutide 3.0 mg in Patients with Overweight and Ob*se with or without Diabetes: A Systematic Review and Meta-Analysis, Konwar, M., et al.,This included 14 total studies, many of which the authors of the WHO request had cited individually and were included in other systematic reviews and meta-analyses above. The smallest study included 19 people, the largest included 2,487. The total number of subjects was 4,142.Their conclusion was “Liraglutide in 3.0 mg subcutaneous dose demonstrated significant weight reduction with a reasonable safety profile for patients with overweight or ob*sity regardless of diabetic status compared to placebo.”Their methodology says that they omitted studies from analysis due to “short duration.” They included studies that had a minimum of 12 weeks and a maximum of 56 weeks of follow-up.While they included 14 studies, only 11 of them actually included information about adverse events.In terms of adverse effects (AEs,) they found that the pooled estimate of nine studies in nondiabetic patients and two studies in diabetic patients revealed a significant proportion of patients experiencing the adverse events in liraglutide 3.0 mg group when compared with placebo., and the pooled estimate of the eleven studies showed that liraglutide 3.0 mg had higher risk of AEs compared to placebo.When it came to “serious adverse events” they found that there was a similar risk level between the drug and placebo groups, but remember that's for only 12 to 56 weeks, and Novo Nordisk is recommending that people take these drugs for the rest of their lives. A few months to a little over a year is not enough time to capture long-term serious adverse events.The efficacy and safety of liraglutide in the ob*se, non-diabetic individuals: a systematic review and meta-analysis. Zhang, P., et al.,This included five RCTs (which were included in various of the above systemic reviews and meta-analyses) ranging in follow-up from 14 to 56 weeks.The only adverse event information captured was the number of people who withdrew from treatment due to adverse events (which they found was similar between drug and placebo) and nausea (which was experienced more by people on the drug.)So, in addition to being short in duration, this was far from a comprehensive list of side effects. They made no attempt to capture serious adverse side effects and their short-term nature would have made this difficult anyway.Association of Pharmacological Treatments for Ob*sity With Weight Loss and Adverse Events: A Systematic Review and Meta-analysis. Khera, R., et al.This looked at weight loss and adverse events with a number of different weight loss drugs. Interestingly liraglutide did not show the highest amount of weight loss but was associated with the highest odds of adverse event–related treatment discontinuation. It should also be noted that high drop-out rates of 30-45% plagued all of the trials which the study authors admit means that “studies were considered to be at high risk of bias.“Given that those who drafted the WHO request are asking that these drugs be considered essential globally, it is disappointing that they included this study and didn't bother to mention this issue in their written request.This included 28 RCTs (most of which were included in other citations above) and only 3 that included liraglutide. They didn't capture individual adverse events, but only “Discontinuation of Therapy Due to Adverse Events.” They only evaluated a year of data so, again, while it is likely that these studies would have captured common adverse events had they bothered to try, there isn't long enough follow-up to have any information about serious (possibly life-threatening) long-term adverse events.Association of Glucagon-like Peptide 1 Analogs and Agonists Administered for Ob*sity with Weight Loss and Adverse Events: A Systematic Review and Network Meta-analysis. Vosoughi, K., et al.,This study included 64 RCTs with durations from 12 to 160 weeks, with a median of 26 weeks. As is common in these studies, the majority of the sample (74.9%) was white.Like those above, they only looked at treatment discontinuation from adverse events, they did not capture specific adverse events (common or serious.) Of the seven GLP-1 drugs they tested, liraglutide was tied with taspoglutide for the highest discontinuation of treatment due to adverse events.The study authors also note that “Risk of bias was high or unclear for random sequence generation (29.7%), allocation concealment (26.6%), and incomplete outcome data (26.6%).”Breakdowns for Comparative Cost-effectiveness StudiesFirst, the WHO request authors themselves admit that when it comes to cost-effectiveness, “the analyses have generally been performed only for high-income countries.” This is significant since they are asking the WHO to consider these drugs essential for the entire world.It's also important to understand that none of the data looks at a comparison of cost effectiveness for weight-neutral health interventions to these drugs. Without that information there is no way to calculate actual “cost effectiveness” since it's possible that weight-neutral health interventions would have greater benefits with less risk and dramatically lower cost.  NICE's guidance:  Liraglutide for managing overweight and ob*sity Technology appraisal guidance [TA664]Published: 09 December 2020.Do recall that NICE is involved in the current scandal with Novo Nordisk for influence peddling.These guidelines are created based on a submission of evidence by Novo Nordisk. The committee's understanding of “clinical need” was based on the testimony of a single “patient expert” who “explained that living with ob*sity is challenging and restrictive. There is stigma associated with being ob*se.”Once again we see a rush to blame body size for any “challenges” and “restrictions” of living in a higher-weight body, accompanied by the immediate decision that those bodies should be subjected to healthcare interventions that risk their lives and quality of life in order to be made (temporarily, by Novo and NICE's own admission) thinner.  There did not seem to be a patient expert to discuss the weight-neutral options.It was not immediately apparent if the patient expert was provided/paid by Novo Nordisk, but they certainly forwarded their narrative that simply living in a higher-weight body is a disease requiring treatment.It should be noted that while the trial Novo Nordisk submitted covered a wider range of people, they specifically submitted for this recommendation only the subgroup of that population who were diagnosed with “ob*sity,”  pre-diabetes, and a “high risk of cardiovascular disease based on risk factors such as hypertension and dyslipidaemia.”So, even if we accept this guidance as true, the WHO Essential Medicines request applies to a population much wider than this and so this fails to justify the cost-effectiveness for that population.This guidance is also based on the costs associated with obtaining the drugs through a “specialist weight management service” since an agreement is in place for Novo Nordisk to give a discount to these services.In calculating the ICER per QALY gained, the recommendations note that “Because of the uncertainties in the modelling assumptions, particularly what happens after stopping liraglutide and the calculation of long-term benefits, the committee agreed that an acceptable ICER would not be higher than £20,000 per QALY gained”Again, this recommendation is based on a trial submitted by Novo Nordisk that included 3,721 people and lasted for three years, but only 800 met the criteria for this cost-effectiveness recommendation. The trial failed to show a significant reduction in cardiovascular events. Novo's calculation of risk reduction was based on surrogate outcomes, which NICE points out “introduces uncertainty because causal inference requires direct evidence that liraglutide reduces cardiovascular events. This was not provided in the company submission because of lack of long-term evidence.”The NICE committee admits “relying on surrogates is uncertain but accepted that surrogate outcomes were the only available evidence to estimate cardiovascular benefits.”I just want to point out that another option would be to refuse to experiment on higher-weight people without appropriate evidence.These cost-effectiveness calculations are based on someone using the drug for two years, with no actual data on reduction in cardiovascular events, and with the admitted assumption that “any weight loss returned to the base weight 3 years after treatment discontinuation.” Said another way, this committee decided that it was cost effective to spend up to £20,000 per QALY for people to take a weight loss drug with significant side effects for two years, with no direct evidence of reduced cardiovascular events, and with the acknowledgment that people will be gaining all of their weight back when they stop taking it.Those who wrote the request for WHO to consider these drugs “essential” chose to characterize this as “At the chosen threshold of £20,000 per quality-adjusted life year (QALY) gained, the report concluded that liraglutide is cost-effective for the management of ob*sity.” I do not think that is an accurate characterization of the findings.The request cites “A report by the Canadian Agency for Drugs and Technologies in Health (CADTH) found that compared to standard care, the ICER for liraglutide was $196,876 per QALY gained”For the US, they cite a study that found that to achieve ICERs between $100,000 and $150,000 perQALY or evLY gained, the health-benefit price benchmark range for semaglutide was estimated as $7500 - $9800 per year, which would require a discount of 28-45% from the current US net price.They also cite “Cost-effectiveness analysis of semaglutide 2.4 mg for the treatment of adult patients with overweight and ob*sity in the United States, Kim et al.Let's take a look at their conflict of interest disclosure (emphasis mine)“Financial support for this research was provided by Novo Nordisk Inc. The study sponsor [that means Novo Nordisk] was involved in several aspects of the research, including the study design, the interpretation of data, the writing of the manuscript, and the decision to submit the manuscript for publication.Dr Kim and Ms Ramasamy are employees of Novo Nordisk Inc. Ms Kumar and Dr Burudpakdee were employees of Novo Nordisk Inc at the time this study was conducted. Dr Sullivan received research support from Novo Nordisk Inc for this study. Drs Wang, Song, Wu, Ms Xie, and Ms Sun are employees of Analysis Group, Inc, who received consultancy fees from Novo Nordisk Inc in connection with this study.”Given that, you probably won't be shocked to learn that this concluded that Novo Nordisk's drug, semaglutide, was cost-effective. The reason I bolded the text above is that this study is based on modeling – they are taking what is, by their own admission, a “new drug” and making predictions for 30 years. Everything was simulated based on trial data (you know, those trials that we've been discussing that often have horrendous methodology…) and “other relevant literature.” The construction of the modeling and the interpretation of the results was directed by the company who stands to benefit financially from the findings, and carried out by that company's employees and consultants.  Also, and I'll just quote again here since I don't think I can improve on their text “Cost-effectiveness was examined with a willingness-to-pay (WTP) threshold of $150,000 per QALY gained” I do not think that this WTP is based on a global assessment.In their (and by their I mean Novo Nordisk's) modeling they find that semaglutide was estimated to improve QALYs by 0.138 to 0.925 and incur higher costs by $3,254 to $25,086 over the 30-year time horizon vs comparators.And, again, this is without any kind of actual long-term data. I think that the best way to characterize this information is “back of the envelope calculations” at best.To sum up, I do not think that the research they cite comes anywhere close to proving that these drugs have levels of efficacy, safety, or cost-effectiveness that warrant their addition to the WHO list of essential medicines. I believe that if the WHO grants this request I think it will be an affront to medical science, it will cheapen the concept of “essential medicines,” and it will harm untold numbers of higher-weight people all over the world.Did you find this post helpful? You can subscribe for free to get future posts delivered direct to your inbox, or choose a paid subscription to support the newsletter and get special benefits! Click the Subscribe button below for details:Liked this piece? Share this piece:More research and resources:https://haeshealthsheets.com/resources/*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings' Fearing the Black Body – the Racial Origins of Fat Phobia and Da'Shaun Harrison's Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this. Get full access to Weight and Healthcare at weightandhealthcare.substack.com/subscribe

Gary Heseltine from UFO Truth Magazine and ICER talks about his fresh investigation of the Rendlesham Forest UK/US airbase "close encounter" of December 1980 - and his new book "Non Human" (available on Amazon) Plus - an exclusive interview with a retired US serviceman - James Stewart - who says he experienced deeply disturbing events at the Woodbrige base Rendlesham) one year before...

SHOW NOTES: Kitchen Island Design: Add extra food prep space with a versatile kitchen island that's affordable and user-friendly. Driveway Markers: Get ideas for eye-catching driveway markers to add curb appeal and increase home safety. De-Icing Tips: Find out how to quickly thaw a frozen windshield with this easy DIY solution. Plus, answers to your home improvement questions. Home Addition ROI: Finished basement or second-floor addition: which one offers a better ROI? We think Matthew's home will gain more value by adding bedrooms and bathrooms on a second floor. Rodents: Kathryn wonders if an ultrasonic device would help control the mice in her basement. Along with baits and poison, it would be more effective to eliminate nesting areas, plug up any openings, and avoid leaving any food or water in the house or garage that could attract pests. Gutters: Joe's roof shingles don't extend far enough to direct water into the gutters. We suggest using a flat bar to pry up the edges and insert flashing under the shingles to create a bridge to the gutters. Countertops: Is there a way to remove scratches in a Corian countertop? Gayla can try a deep cleaning product to make them less obvious or have a professional lightly sand and repolish the surface. Deck Cleaning: What's the best way to clean algae and mold from a pressure-treated wood deck and a stone patio? Bill needs a pressure washer with a bleach solution to remove the stains. Wallpaper Removal: Jan wants to remove a layer of wallpaper liner without damaging the drywall. If it's adhered well, she should be able to add a textured surface right over it. Fascia Board: Is it possible to remove a rotted fascia board without removing the spacer and gutter? It will all need to come off, but then Derwin can replace the wood fascia with a cellular PVC board that will last without rotting. Dry Rot: What causes dry rot and how to tell if you have it? Joan learns there's no such thing as dry rot, only wet wood that dries out and starts to decay. Shower Renovation: Is flashing needed around a prefabricated shower stall base to prevent moisture issues? Randy should be fine installing the pan over the backer board and adhering tile directly onto the board.   Do you have a home improvement or decor question? Call the show 24/7 at 888-MONEY-PIT (888-666-3974) or post your question here. Learn more about your ad choices. Visit podcastchoices.com/adchoices

January 2023 UAP Round Table with UFO Thinker & PotP - Mosul Orb, The 2022 UAP report, San Marino, NIM Flying Saucer Patch updatesHere is this month's roundtable discussion in conjunction with Frank @UFO Thinker Podcast and we're joined by Dave and Ash (UK UAP) for this one too. We discussed The Mosul Orb, The 2022 UAP report, San Marino, as well as a few other bits along the way.hope you enjoy! you can find us on twitter- Frank @UFOthinker Ash @identifiedUFO Greg @paranormalGregT Dave @dsmethurst66 Ash @UK_UAP

A new whistleblower law in the US, following last year's historic disclosures by the Pentagon, could trigger an avalanche of truths about extraterrestrial activity. ”We have been lied to for 75 years”, says British UFO expert Gary Heseltine. Gary began his UFO investigations–which were then unofficial–when he was still a police detective. In 2013 he left the police force and launched the online magazine UFO Truth Magazine. ”I've made my passion into my job.” This passion has its roots in a strange experience he had when he was 16. He then saw a strange white light that appeared to trigger a number of power cuts in the area where he was living. Following the light, he was able to predict the cuts. Today, Gary Heseltine is also the vice president of ICER, the International Coalition for Extraterrestrial Research. ”It is a mixture of UFO experts, scientists and academics, which is a very unusual mix in this subject”, Gary says. This episode is recorded in Cusco, Peru, with its many mysteriously advanced megalithic structures. Gary is open to the possibility that these structures were built with extraterrestrial help, possibly thousands of years ago, but he and ICER concentrate on UFO sightings during the modern era, basically from 1947 onwards. 1947 was the year of the famous Roswell incident, the event that kicked off the UFO discussion in the modern era. To Gary, there is no doubt Roswell was real. ”We will never prove they retrieved bodies. But we suspect they did.” ”Personally I believe the US government has lied to the public. There has been a campaign of disinformation–maybe for our benefit, but the bottom line is you can't keep lying. I think due to technology we're close to them losing control.” ICER's broader aim is to prepare people for such a coming paradigm shift: the E.T. Disclosure with a big D, when the media will report 24/7 about a nonhuman presence on planet Earth. ”The world is vastly underprepared”, Gary says. ”Considering what's taking place in America, it's a real possibility that there will be an acknowledgement within the next two years that we are dealing with a nonhuman interaction. But this subject has been so ridiculed for so long, so there will be a culture shock if we are not careful.” According to Heseltine, he and others in the coalition have meetings with diplomats behind the scenes. In June of 2021, the Pentagon released three videos of unidentified aerial phenomena (UAPs) and a briefing admitting to 143 unexplained encounters with UAPs. Legislation is in the pipeline entailing that the intelligence community must produce yearly reports about UAP sightings to the Congress plus a right for whistleblowers in the military and intelligence organizations to come forward without reprisals. To Gary Heseltine, this development is a historic game changer. ”For example, the public will be able to hear direct testimony for the first time from people who have been involved in nuclear weapon shutdowns by UFO intervention, like captain Robert Salas was in 1967.” What are we then seeing in the Pentagon clips? Who is visiting us? ”We believe we are dealing with something nonhuman. When you look at the broad abduction scenario across the world, there are at least five main species that seem to be identified. I think governments, especially the Americans, know a hell of a lot more than they say”, Gary says. When the truth comes out, some people will be scared or even panic. ”Because they've been lied to for 75 years, a proportion of the population will feel very vulnerable”, Gary thinks. ”We need to start preparing the public for what will be a huge shock. People could become very angry.”

¿Qué pasó con el Ovni de China de 2009? Se vió desde un observatorio y no hubo más respuestas... Además, ¿Cónoces el ICER? Hablamos con Paolo Guizzardi, uno de sus miembros. Ellos quieren llevar el debate sobre los ovnis a los estratos más altos de la política internacional, esucha!

James Maple, sitting in for Amy, and Patrick present the audio from BloodStream's Diversity, Equity, and Inclusivity panel during National Hemophilia Foundation's Bleeding Disorders Conference as well as the latest from the Let's Talk mental health segment. Plus, news from ICER on gene therapy!   Show Notes: Subscribe: The BloodStream Podcast   Article: Hemophilia gene therapies from BioMarin, CSL pick up an early ICER endorsement    Presenting Sponsor: - Takeda, visit bleedingdisorders.com to learn more.   Episode and Segment Sponsors: - CSL Behring, visit HemEvolution.com to learn more about gene therapy, or ProtraitsofProgress.com for a virtual photo exhibition chronicling hemophilia's history - Sanofi, visit ShareYourWhy.com to meet the CoRe team and hear stories from the hemophilia community. - Pfizer, if you have sickle cell disease, how often do painful crises have you visiting the doctor? Learn more at ClinicalTrialSCD.com    Connect with BloodStream Media: BloodStreamMedia.com BloodStream on Facebook  BloodStream on Twitter 

This week Jeremy revisits testimony provided by ALS advocates and ALS Association leaders at a recent public forum to consider ICER's flawed analysis of AMX0035 and oral edaravone. Watch the public forum in its entirety at https://www.youtube.com/watch?v=iqmXcxgkMPY&t=13s Learn more about the fight for access to therapies at als.org/icer Learn more about Steve Kowalski at https://www.als.org/blog/theres-still-lot-life-be-lived-steve-kowalskis-story Read some of Sunny's story at https://www.als.org/blog/sunny-brous-erasmus-long-were-here-were-together Follow Sunny's journey at https://sunnystrong.com/This episode is brought to you by The ALS Association in partnership with CitizenRacecar.