Podcasts about Pharmacoeconomics

In this keynote episode, Professor Sebastian Schneeweiss from Harvard Medical School shares groundbreaking insights from his extensive research into emulating randomized controlled trials (RCTs) using real-world data (RWD). Recorded live at The Effective Statistician Conference 2024, this talk explores whether non-randomized studies based on electronic health records and claims data can reach conclusions as reliable as those from traditional RCTs. Prof. Schneeweiss, also Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, walks us through the RCT DUPLICATE project, a major FDA-funded initiative that evaluated whether regulatory decisions could be replicated through high-quality real-world evidence (RWE). From the successes to the limitations—and everything in between—this episode is packed with lessons for statisticians, regulators, and pharmaceutical leaders interested in the future of data-driven healthcare decisions.

Quando um novo medicamento ou tecnologia médica é aprovado por órgãos regulatórios, o caminho até sua disponibilização no sistema de saúde ainda envolve etapas decisivas. Uma das principais é a avaliação de custo-efetividade, base da economia da saúde.A ISPOR (International Society for Pharmacoeconomics and Outcomes Research) é a principal organização global dedicada ao avanço da economia da saúde e da pesquisa de desfechos em saúde. Ela reúne especialistas, gestores e formuladores de políticas para promover decisões baseadas em evidências sobre o valor de terapias e tecnologias médicas.Neste episódio do podcast Biotech and Health, Laura Murta e Camila Pepe conversam sobre o tema com Wilson Follador, presidente da ISPOR Brasil.

In dieser Folge spreche ich mit Florent Crépin, Geschäftsführer von Neurolite. Er stellt eine Depressions-Behandlung vor, die ohne Medikamente auskommt.Links :LinkedIn Instagram NeuroliteYoutube Instagram FlowFacebook FlowÜBER DEPRESSIONDepressionen.ch Stiftung Deutsche DepressionshilfeREFERENZENBarker et al. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May. Zur PublikationRush et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov. Zur PublikationFregni et al. Evidence-Based Guidelines and Secondary Meta-Analysis for the Use of Transcranial Direct Current Stimulation in Neurological and Psychiatric Disorders. Int J Neuropsychopharmacol. 2021 Apr. Zur PublikationWoodham et al. Home-based transcranial direct current stimulation treatment for major depressive disorder: a fully remote phase 2 randomized sham-controlled trial. Nat Med. 2025 Jan. Zur PublikationCipriani et al. Comparative Efficacy and Acceptability of 21 Antidepressant Drugs for the Acute Treatment of Adults With Major Depressive Disorder: A Systematic Review and Network Meta-Analysis. Focus (Am Psychiatr Publ). 2018 Oct. Zur PublikationSaelens et al. Relative effectiveness of antidepressant treatments in treatment-resistant depression: a systematic review and network meta-analysis of randomized controlled trials. Neuropsychopharmacology. 2024 Dec. Zur PublikationGriffiths et al. Self-Administered “Flow” Transcranial Direct Current Stimulation (tDCS) Depression Treatment in a Crisis Resolution & Home Treatment (CRT) Service: Functioning, and Health-Related Quality of Life Outcomes. Open Journal of Psychiatry. 2024 Nov. Zur PublikationTomonaga et al. The economic burden of depression in Switzerland. Pharmacoeconomics. 2013 Mar. Zur PublikationDeutsche S3-Leitlinie und Nationale VersorgungsLeitlinie (NVL)  Kurzfassung – Lass mir Feedback da :)Hat dir die Folge gefallen? Ich würde mich über eine 5-Sterne-Bewertung sehr freuen! :)Webseite: https://www.psychologieunddenn.ch/Whatsapp-Gruppe (offen für alle): https://chat.whatsapp.com/JBcjpAaIaSeCRxmQMQWGXuMöchtest du Werbung schalten oder mit mir zusammenarbeiten. Dann schau hier vorbei.

In this episode of The Aging Well Podcast, Dr. Jeff Armstrong is joined by Dr. Jerry Avorn, a professor of medicine at Harvard Medical School, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, and author of Rethinking Medications: Truth, Power, and the Drugs You Take. Dr. Avorn discusses his journey into medicine, particularly geriatrics, and the importance of rethinking how medications are evaluated and prescribed. He highlights the influence of the pharmaceutical industry, the complexities of drug safety, and the challenges posed by high drug prices in the U.S. The discussion also touches on the FDA's approval process, the role of politics in drug policy, and the importance of patient empowerment in managing medications. Dr. Avorn emphasizes the need for better communication between patients and healthcare providers, as well as the potential benefits and pitfalls of using AI and the internet for health information. In this conversation, Jerry Avorn and Jeff Armstrong discuss the complexities of health information in the age of AI, the misconceptions surrounding drug marketing, and the importance of scientific literacy. They explore the dangers of unregulated supplements, share case studies on opioids and cancer drugs, and delve into the potential of psychedelics. The discussion also covers practical steps for improving drug affordability and access, as well as necessary reforms in the drug approval process. Finally, they share insights on aging well, emphasizing the importance of diet, exercise, and social connections.BUY Rethinking Medications: Truth, Power, and the Drugs You Take on Amazon and support this podcast: https://amzn.to/4kAKXKv

Professor Michael Barry, Clinical Director of the National Centre for Pharmacoeconomics

Brian O'Connell, RTÉ reporter and Professor Michael Barry, Clinical Director of the National Centre for Pharmacoeconomics

How do we ensure that healthcare is accessible, effective, efficient, and affordable for all? How can a professional society shape global health policy while advancing scientific research?In this episode of Associations Thrive, host Joanna Pineda interviews Rob Abbott, CEO of ISPOR. Rob discusses:ISPOR's role as the professional society for Health Economics and Outcomes Research (HEOR), with a global reach spanning over 100 countries and 20,000 members.How ISPOR is a multi-stakeholder society that includes clinicians, researchers, policymakers, industry professionals, and investors, creating a broad and impactful membership base.The importance of health economics and outcomes research in informing healthcare policy and improving patient outcomes worldwide.ISPOR's recent rebranding from the International Society for Pharmacoeconomics and Outcomes Research to ISPOR – The Professional Society for Health Economics and Outcomes Research, making the organization more inclusive of healthcare professionals.The launch of ISPOR's 2030 strategic plan, which features a bold vision for a world where healthcare is accessible, effective, efficient, and affordable for all.How ISPOR is shifting from primarily curating scientific research to actively engaging in health policy discussions and advocating for evidence-based decision-making.The upcoming launch of ISPOR's Institute for Global Health in 2025, which will focus on emerging healthcare challenges and horizon scanning for high-impact policy interventions.How ISPOR is strengthening its global chapters and partnerships to ensure local expertise informs global policy.The evolution of ISPOR's conferences, including record-breaking attendance and new events in Asia and Latin America to expand engagement in underserved regions.How ISPOR is working to redefine the concept of ‘value' in healthcare, incorporating social determinants of health and a more holistic approach to decision-making.References:ISPOR WebsiteMusic from #Uppbeat (free for Creators!):https://uppbeat.io/t/paul-yudin/quiet-flightLicense code: KJRRI6GHC7WKCLDT

Dr. Michael McCarthy, Secretary of the Irish Society of Medical Oncology and Consultant Medical Oncologist and Professor Michael Barry, Clinical Director for the National Centre for Pharmacoeconomics

Historically, Vizient has published the Pharmacy Market Outlook biannually. This year, we are introducing the Spend Management Outlook, which integrates the comprehensive insights from the Pharmacy Market Outlook with the Vizient Budget Impact Report. This new report enhances strategic planning by aligning pricing projections across the healthcare supply chain and providing key market insights. Dr. Carina Dolan, Associate Vice President of Clinical Oncology, Pharmacoeconomics, & Market Insights, and Jeff King, Director of Research and Intelligence at Vizient, join Program Host Carolyn Liptak to discuss the unique features and critical importance of the new Spend Management Outlook.   Guest speakers:  Carina Dolan, Pharm. D., MS Pharm, BCOP Associate Vice President, Clinical Oncology, Pharmacoeconomics and Market Insights Vizient   Jeff King Research and Intelligence Director Vizient   Host: Carolyn Liptak, MBA, BS Pharm VerifiedRx Host   Show Notes:  [01:06-01:56] Jeff's background and role [01:57-02:50] The transition from Pharmacy Market Outlook and Budget Impact Report to Spend Management Outlook [02:51-03:28] Defining spend management [03:29-04:43] Key insights into spend management categories med-surg and laboratory [04:44-06:01] Key insights into spend management categories Capital equipment and physician preferences insights [06:02-07:23] Enhancements to pharmacy projections of this edition [07:24-08:39] Spend management projection methodology [08:40-09:34] The spend management projections   Links | Resources: Spend Management Outlook   Subscribe Today! Apple Podcasts Amazon Podcasts Spotify Android RSS Feed

Melanie Whittington, PhD, Head of the Leerink Center for Pharmacoeconomics interviews Holly Krasa, CEO of Blue Persimmon Group. In this episode they discuss the recent CPE Exclusive: Cobenfy™ for Adults Living with Schizophrenia, the need for innovation in schizophrenia, and the importance of listening to the stories from people living with schizophrenia.

Diane Vieira, Managing Director of Marketing & Communications at Leerink Partners, interviews Melanie Whittington, PhD, Head of the Leerink Center of Pharmacoeconomics. In this episode they discuss the origin of pharmacoeconomics, its societal importance, and staying true to your authentic self.

HealthLeaders CMO Editor Christopher Cheney discusses key issues related to cell and gene therapy with Carina Dolan, Associate Vice President of Clinical Oncology, Pharmacoeconomics and Market Insights at Vizient.

Have you ever wondered what it takes for a startup, particularly in a niche field like women's health, to secure the necessary funding to move forward and make a meaningful impact? In this episode of The Angel Next Door Podcast, Marcia Dawood sits down with Mark Gannott, who brings a unique blend of neuroscience, economics, and entrepreneurship to the table. From navigating the complex landscape of women's health financing to shedding light on economic modeling and network strategies, Mark's insights are invaluable for anyone looking to understand the intricacies of funding in highly specialized areas.Mark Gannott, an economist and pharmacoeconomist, has a scholarly background in neuroscience and economics. His career took a pivotal turn following a personal tragedy that shifted his focus from medical school to the financing side of healthcare. With a side project in managing a massively popular social media page focused on dogs and mental health, Mark works on critical health issues, including cannabis economics and underfunded areas like endometriosis. His drive to bring more financial resources to women's health startups sets him apart as a thought leader in this space.In this enlightening conversation, Mark explores why women's health is still struggling to garner sufficient funding despite its massive economic potential. He talks about his work as a pharmacoeconomist and the significance of building financial models that make compelling cases for investment in women's health. Additionally, the episode highlights the importance of network analysis in connecting the right people to foster successful startups. Whether you're an investor, an entrepreneur, or someone passionate about women's health, this episode provides crucial insights into an often-overlooked yet vital sector. Mark's forward-thinking approach to financing and network building makes this episode a must-listen for anyone interested in transforming the landscape for women's health. To get the latest from Mark Gannott, you can follow him below!LinkedIn - https://www.linkedin.com/in/markgannott/ Sign up for Marcia's newsletter to receive tips and the latest on Angel Investing!Website: www.marciadawood.comLearn more about the documentary Show Her the Money: www.showherthemoneymovie.comAnd don't forget to follow us wherever you are!Apple Podcasts: https://pod.link/1586445642.appleSpotify: https://pod.link/1586445642.spotifyLinkedIn: https://www.linkedin.com/company/angel-next-door-podcast/Instagram: https://www.instagram.com/theangelnextdoorpodcast/TikTok: https://www.tiktok.com/@marciadawood

Prof. Michael Barry, National Centre for Pharmacoeconomics.

Send us a Text Message.Have you ever felt that your passion for healthcare doesn't fit neatly into the traditional roles of doctors and nurses? If so, you're not alone. The healthcare field is vast and dynamic, offering myriad opportunities that are often overlooked. In this episode, we'll uncover some of the most rewarding and impactful alternative careers in health that go beyond the conventional paths. Connect With Kapeel GuptaWhat You May Learn0:00 Introduction1:20 Mission Statement1:47 -  1. Clinical Pharmacist3:19 - 2. Pharmacy Informatics Specialist4:49 - 3. Regulatory affairs Specialist6:15 - 4. Medical Science Liaison7:30 - 5. Pharmacoeconomics & Outcomes research specialist8:40 - 6. Medication Safety officer9:51 - Conclusion10:25 - Call to ActionSupport the Show.

Send us a Text Message.Dr. William Padula, PhD, MS, MSc, is Assistant Professor, Pharmaceutical & Health Economics and Fellow, Schaeffer Center for Health Policy & Economics, at the Alfred E. Mann School of Pharmacy & Pharmaceutical Sciences, University of Southern California ( https://healthpolicy.usc.edu/author/william-padula-phd/ ). His research explores the theoretical foundations of medical cost-effectiveness analysis, especially pertaining to issues around the value of vaccines, healthcare delivery and patient safety in hospitals for acquired conditions such as pressure injuries. He has received grant funding in the form of a Career Development Award from the National Institutes of Health (NIH), the Bill & Melinda Gates Foundation, and the PhRMA Foundation Frontier Award. He has authored 100+ scientific papers, letters and book chapters that have been published in leading medical, economic, and health policy journals. Dr. Padula is also Co-Founder & Principal of Stage Analytics ( https://stageanalytics.com/william-v-padula-phd/ ), a consulting firm that is committed to providing the highest quality of scientific solutions to advance health care. Dr. Padula is an Associate Editor of Value in Health, and serves on the editorial boards of Applied Health Economics and Health Policy and Journal of Clinical Nursing. His work has been featured in the New York Times, The Atlantic, The Hill, Forbes and other media. He is a past recipient of the Award for Excellence in Health Economics and Outcomes Research from the International Society of Pharmacoeconomics and Outcomes Research (ISPOR); the Academy Health Outstanding Dissertation Award; and the Society for Advancement in Wound Care (SAWC) Young Investigator Award. He served as President for the U.S. National Pressure Injury Advisory Panel (NPIAP) from 2021-2022. He was also Commissioner for the American Nurses Credentialing Center (ANCC) Magnet® Recognition Program from 2016-2019. Dr. Padula has previously held appointments as an Assistant Professor at the Johns Hopkins Bloomberg School of Public Health in Baltimore, USA, and as a postdoctoral fellow at The University of Chicago. He was a visiting scholar at the University of York Centre for Health Economics in York, UK, the Oxford Institute for Nursing, Midwifery and Allied Health in Oxford, UK, and the University of Technology Sydney in Sydney, Australia. He received his B.S. in Chemical Engineering from Northwestern University, M.S. in Evaluative Clinical Science from Dartmouth College, M.S. in Data Analytics from University of Chicago, and Ph.D. in Pharmaceutical Economics from University of Colorado. #HealthEconomics #USC #WoundCare #Pharmacy #PressureSores #Pharmaceuticals #WilliamPadula #HealthcareValue #Outcomes #WastefulSpending #Medicare #Medicaid #progresspotentialandpossibilities #IraPastor #podcast #podcaster #viralpodcast #STEM #Innovation #Technology #Science #Research Support the Show.

Les Martin, Father of Cathal & Ciaran with a rare condition and Prof Michael Barry, Clinical Director of the National Centre for Pharmacoeconomics

Pat Leahy, political editor with the Irish Times & Prof Michael Barry, Director of the National Centre for Pharmacoeconomics

In this episode, Kyle Molina, PharmD, BCIDP, discusses key considerations for successful implementation of long-acting lipoglycopeptides into clinical practice. Listen as he gives perspectives on:Reasons to consider use of long-acting lipoglycopeptides (eg, poor adherence to oral antibiotics, PICC-related costs and complications)Data supporting and challenging cost effectiveness of long-acting lipoglycopeptides Identifying the target patient populationSelecting the right location to provide long-acting lipoglycopeptides Strategies to maximize institutional impact with key stakeholders (eg, hospital avoidance, reduced ED and hospital length of stay) Key characteristics of available long-acting lipoglycopeptides Addressing logistical challenges, including navigating the reimbursement process Faculty:Kyle Molina, PharmD, BCIDPInfectious Diseases Clinical PharmacistScripps Green HospitalLa Jolla, CaliforniaLink to full program: CCO: https://bit.ly/3J4mg8hProCE: https://bit.ly/3P0vB4E

What is the cost to an employer of chronic presenteeism, where a person is well enough to go to work but isn't really productive? What is the dollar value to a patient of being married in terms of health outcomes? How do you figure that out? There are so many factors to consider. When we read that condition [fill in the blank] accounts for X dollars of lost productivity per year, I always wonder, “where does that number come from and who came up with it?” In this episode, we find out.Lemar Ashar, a previous guest on Life Science Marketing Radio introduced me to Mark Gannott, to talk about pharmacoeconomics. We explored the cost and value of medical interventions, particularly drugs, from various stakeholders' perspectives (patients, healthcare providers, insurance companies, and healthcare systems). I was curious about the challenges of estimating disease costs and treatment impacts, where the data comes from and how it's used to make decisions.Genomics, including genome-wide association studies (GWAS), and polygenic risk scores also play a role, potentially improving health outcomes and reducing side effects. We touched on a few specific use cases, such as the treatment of endometriosis and the use of polygenic risk scores in depression. I found it fascinating to get a glimpse into how decisions around the development and use of different drugs are made. Mark thinks that in the future, a field called precision pharmacoeconomics will incorporate personalized genomics data to assess the cost-effectiveness of drug therapies. If you want a (sort of) quick intro into the topic, this is the episode for you. This is a public episode. If you would like to discuss this with other subscribers or get access to bonus episodes, visit cclifescience.substack.com

Episode 1: Severe pediatric asthma-burden of disease, adherence issues, and comorbidities   Description: Though severe pediatric asthma only represents from 2 to 5% of the children suffering with this condition, it represents a major share of the cost, resource utilization, and morbidity. It is important that allergists have a good gasp of this condition and how it differs from the adult population. Topics include appropriate workup, comorbidities, steroid burden.   Learning Objectives: Be able to discuss the burden of severe pediatric asthma and issues in optimal medication adherence in this population Be able to evaluate the child with severe asthma and screen for corticosteroid overuse in and remedies to decrease it in this population Be able to interpret the mechanisms of action, applicable pediatric population, dosing, outcome data, and adverse effects of current and future treatments beyond standard therapy in severe pediatric asthma References:               Perry, R., Braileanu, G., Palmer, T. et al. The Economic Burden of Pediatric Asthma in the United States: Literature Review of Current Evidence. PharmacoEconomics 37, 155–167 (2019). Yao T, Wang J, Chang S, et al. Association of Oral Corticosteroid Bursts With Severe Adverse Events in Children. JAMA Pediatr. Published online April 19, 2021. Katial RK, Bensch GW, Busse WW, Chipps BE, Denson JL, Gerber AN, et al. Changing paradigms in the treatment of severe asthma: the role of biologic therapies. J Allergy Clin Immunol Pract 2017;5:S1–S14. Licari, A., Manti, S., Castagnoli, R. et al. Targeted Therapy for Severe Asthma in Children and Adolescents: Current and Future Perspectives. Pediatr Drugs 21, 215–237 (2019)

Episode 2:       Severe pediatric asthma-evaluation of the child, diagnostic testing, assessing steroid side effects   Description: Though severe pediatric asthma only represents from 2 to 5% of the children suffering with this condition, it represents a major share of the cost, resource utilization, and morbidity. It is important that allergists have a good gasp of this condition and how it differs from the adult population. Topics include appropriate workup, comorbidities, steroid burden.   Learning Objectives: Be able to discuss the burden of severe pediatric asthma and issues in optimal medication adherence in this population Be able to evaluate the child with severe asthma and screen for corticosteroid overuse in and remedies to decrease it in this population Be able to interpret the mechanisms of action, applicable pediatric population, dosing, outcome data, and adverse effects of current and future treatments beyond standard therapy in severe pediatric asthma References:               Perry, R., Braileanu, G., Palmer, T. et al. The Economic Burden of Pediatric Asthma in the United States: Literature Review of Current Evidence. PharmacoEconomics 37, 155–167 (2019). Yao T, Wang J, Chang S, et al. Association of Oral Corticosteroid Bursts With Severe Adverse Events in Children. JAMA Pediatr. Published online April 19, 2021. Katial RK, Bensch GW, Busse WW, Chipps BE, Denson JL, Gerber AN, et al. Changing paradigms in the treatment of severe asthma: the role of biologic therapies. J Allergy Clin Immunol Pract 2017;5:S1–S14. Licari, A., Manti, S., Castagnoli, R. et al. Targeted Therapy for Severe Asthma in Children and Adolescents: Current and Future Perspectives. Pediatr Drugs 21, 215–237 (2019)

Episode 3: Severe pediatric asthma-beyond standard therapy, the role of current and future therapies including biologics Description: Though severe pediatric asthma only represents from 2 to 5% of the children suffering with this condition, it represents a major share of the cost, resource utilization, and morbidity. It is important that allergists have a good gasp of this condition and how it differs from the adult population. Topics include appropriate workup, comorbidities, steroid burden.   Learning Objectives: Be able to discuss the burden of severe pediatric asthma and issues in optimal medication adherence in this population Be able to evaluate the child with severe asthma and screen for corticosteroid overuse in and remedies to decrease it in this population Be able to interpret the mechanisms of action, applicable pediatric population, dosing, outcome data, and adverse effects of current and future treatments beyond standard therapy in severe pediatric asthma References:               Perry, R., Braileanu, G., Palmer, T. et al. The Economic Burden of Pediatric Asthma in the United States: Literature Review of Current Evidence. PharmacoEconomics 37, 155–167 (2019). Yao T, Wang J, Chang S, et al. Association of Oral Corticosteroid Bursts With Severe Adverse Events in Children. JAMA Pediatr. Published online April 19, 2021. Katial RK, Bensch GW, Busse WW, Chipps BE, Denson JL, Gerber AN, et al. Changing paradigms in the treatment of severe asthma: the role of biologic therapies. J Allergy Clin Immunol Pract 2017;5:S1–S14. Licari, A., Manti, S., Castagnoli, R. et al. Targeted Therapy for Severe Asthma in Children and Adolescents: Current and Future Perspectives. Pediatr Drugs 21, 215–237 (2019)

Somebody wrote on Twitter the other day that he was gonna give a talk on the use of evidence in drug policy, and Barrett Montgomery replied, “That'll be a short talk then!” So, let's talk about the IRA (Inflation Reduction Act) for a moment, specifically the “CMS can negotiate for drugs for Medicare patients” part of the IRA. There's one topic I don't hear discussed what I would consider maybe often enough. Will these negotiations result in pricing that is evidence based? Will good drugs that companies developed using less taxpayer money for R&D, drugs that positively impact the patient lives or have spillover benefits for society or save downstream medical costs, drugs that have solid comparative evidence data, drugs that are a meaningful therapeutic advancement over competitors ... will these drugs be priced in line with that value? Everything I just mentioned, by the way, are things that CMS is supposed to take into account during its negotiations. So, that's what this show is all about. To have this conversation, I invited Dr. Peter Neumann on the podcast because Dr. Neumann (along with his two coauthors, Joshua Cohen and Daniel Ollendorf) just wrote a book about pharmaceutical pricing entitled The Right Price. I convinced Dr. Neumann to come on the show and talk about what the likely impact the IRA will have on these right drug prices. And short version, Dr. Neumann told me that “presumably drugs that offer more therapeutic advances will do better under these negotiations.” Here's a really, really top-line summary of the negotiation provisions that are in the IRA: CMS will negotiate prices on the highest gross spend top 10 Part D drugs in 2026, 15 Part D drugs in 2027, and 15 drugs from Medicare Part B and D for 2028. Small molecule drugs become negotiation contenders after 9 years, and biologics after 13 years. Once a generic or biosimilar comes out (ie, the patent is well and truly expired), then this negotiation provision is no longer in play. Now, CMS is given some discretion over how it's going to do things, and they will issue guidance and figure out how to implement the law over the next couple of years. As with so many things (and Chris Deacon talked about this recently on LinkedIn), it's how that law is operationalized that actually determines if it achieves this “right price” goal and/or—and Dr. Neumann, my guest in this healthcare podcast, makes this point really clearly, too—maybe the point of the law is as much about cost containment, frankly, as it is about achieving value-based “right” prices. And cost containment and value-based pricing are not the same thing. I'm gonna do a show on this coming up. So, what are the likely effects of the IRA pharma price negotiation provisions? And not talking about the whole IRA here and the cadre of other stuff like patient out-of-pocket caps and inflation caps. This show is complicated enough just talking about the negotiation portion and just talking about its potential to achieve pricing based on “value.” Here's a summary of likely impact of Medicare drugs being negotiated, some of which we talk about in this episode. There's “seven-ish” main implications: 1. “Some Medicare patients will benefit substantially from negotiations …, as a reduction in the drug's price will result in lower coinsurance and liability during the deductible phase.” Okay … this makes sense. 2. “Overall, negotiations are projected by the CBO [Congressional Budget Office] to reduce premiums, resulting in lower costs for all Medicare beneficiaries.” References: CBO estimates drug savings for reconciliation. Committee for a responsible federal budget. Accessed April 11, 2023. https://www.crfb.org/blogs/cbo-estimates-drug-savings-reconciliation  Congressional Budget Office. Estimated budgetary effects of Public Law 117-169, to provide for reconciliation pursuant to Title II of S. Con. Res. 14. Published 2022. Accessed April 11, 2023. https://www.cbo.gov/system/files/2022-09/PL117-169_9-7-22.pdf Okay … so, this #2 here is kind of thought provoking, especially when it's unclear at this time whether the negotiated price will refer to the list price, the AWP (average wholesale price), or the rebated price (ie, the price after rebates are applied). There are many, many implications if the negotiated price is before or after rebates, just given how “addicted” plans are to rebates and use the rebates, and cost shifting to patients, in a convoluted and super-inefficient way to try to keep premiums down. Listen to the show with Chris Sloan (EP216) for more on this. 3. There's more incentive to go after biologics than small molecule drugs—obvious, due to the 9-year versus 13-year thing. There's additionally some incentive for rare-disease and orphan drugs, most of which are biologics, in other parts of the IRA. 4. More interest in drugs for non-Medicare markets (ie, drugs for diseases of younger populations, perhaps) 5. Possibly less pharma innovation, fewer drug launches Oh, boy, with this one. Listen to the show with Mark Miller, PhD (EP380), for many, many nuances here. But let me give you a few things to think through, and I'd start with four words: We are chasing Goldilocks. There are two ends of the spectrum, and neither are good. On one end, Pharma charges way too much and the system gets bankrupted while pharma shareholders get rich. On the other side of the spectrum, there's not enough returns for any investors to invest in new drug development. It's all about moderation—finding the sweet spot in the middle—something the healthcare industry has a super hard time with. Bottom line, we want to incent meaningful innovation, drugs that actually work. If we pay a ton of money for drugs that don't work particularly well, then what's the incentive to find good drugs? As per my earlier point, if this legislation does as was intended, then good drugs should get rewarded and less comparatively effective drugs should be less rewarded. Let's cross our fingers, shall we? 6. Will Pharma raise its launch prices because the negotiations center on discounts? A higher price times the discount means a higher discounted price, after all. This one could be exacerbated by the part of the IRA that mandates inflation caps. There is some evidence that higher launch prices are already happening. 7. Manufacturers wait to launch until they have all their indications ready to go. If you didn't understand this, we explain in more detail during the interview. 8. There are incentives for Pharma to jack up commercial prices. Because they're making less money in Medicare, they try to make more money in the commercial market. But as Dr. Neumann says, you'd think that if Pharma could do that, they already would have done it. Or let me say that a different way: You'd think that if Pharma could have raised their commercial prices more than they already have been raising their commercial prices, they would have already done it. So, I think whether cost shifting actually increases here is a sizable question mark. 9. There's also less incentive for Pharma to innovate me-too kinds of drugs. If a drug in the same class for the same disease is being negotiated, then a new drug coming out in that same category might sort of have to charge a price similar to the negotiated price of the other drug. Dr. Peter Neumann, my guest in this episode, has a background in health economics and currently directs a research center that's focused on health economic issues. His group does a lot of work trying to understand the cost effectiveness of drugs and other health interventions. Other shows you should, for sure, listen to here are the ones with Mark Miller, PhD (EP380); Anna Kaltenboeck (EP303); Bruce Rector, MD (EP300); Scott Haas (EP365); and Chris Sloan (EP216). These shows offer context and adjacencies that are extremely relevant right now if you're gonna understand the potential impact of the IRA. Here's a quote from the book The Right Price (written by Dr. Peter Neumann and his coauthors, Joshua Cohen and Daniel Ollendorf) that I thought summed up some of the issues here very nicely: If there existed a Rorschach test for drug prices, it might conjure one of two images. Some people might perceive prices as a compass directing companies to invest in products that people value most. Aligning prices with value is akin to a “true north” orientation of the compass's arrow. Failure to link prices with value sends misleading signals to drug producers. Others might regard drug prices as a wall preventing patients from accessing the drugs they need. For them, the barrier should be as low as possible. But aligning prices with value might have little effect in lowering the wall. How then to accomplish that goal?   You can learn more at cevr.tuftsmedicalcenter.org or by reading The Right Price.   Peter J. Neumann, ScD, is director of the Center for the Evaluation of Value and Risk in Health (CEVR) at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center and professor of medicine at Tufts University School of Medicine. He is the founder and director of the Cost-Effectiveness Analysis Registry, a comprehensive database of cost-effectiveness analyses in healthcare. Dr. Neumann has written widely on the role of clinical and economic evidence in pharmaceutical decision-making and on regulatory and reimbursement issues in healthcare. He served as co-chair of the 2nd Panel on Cost-Effectiveness in Health and Medicine. He is the author or coauthor of over 300 papers in the medical literature and the author or coauthor of three books: Using Cost-Effectiveness Analysis to Improve Health Care (Oxford University Press, 2005); Cost-Effectiveness in Health and Medicine, 2nd edition (Oxford University Press, 2017); and The Right Price: A Value-Based Prescription for Drug Costs (Oxford University Press, 2021). Dr. Neumann has served as president of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). He is a member of the editorial advisory board of Health Affairs and the panel of health advisors at the Congressional Budget Office. He has also held several policy positions in Washington, DC, including special assistant to the administrator at the Health Care Financing Administration. He received his doctorate in health policy and management from Harvard University.   09:33 Is it imperative that drugs whose patents are expiring have their prices negotiated? 10:50 “We need innovation; we want to encourage innovation.” 11:01 Does this new law strike a balance between innovation and price regulation? 11:21 How are we assessing cost effectiveness and innovation in the drug space? 12:29 What's the problem with the current drug markets? 13:14 Why can't you rely on the drug market for the cost effectiveness of a drug? 14:13 Why very expensive drugs do not equate to poor value. 15:06 What are the likely outcomes of the IRA? 18:33 How does pharmacy budget factor into high-value drugs? 19:26 “Value-based pricing doesn't mean necessarily lower spending overall.” 22:59 What are the types of drugs that will be excluded from the IRA? 23:22 Who will the law create problems for? 24:44 What have pharmacy benefit managers (PBMs) been doing to move forward with the new law? 26:04 What are plan sponsors doing right now? 28:32 What are the most important value metrics according to Dr. Neumann?   You can learn more at cevr.tuftsmedicalcenter.org or by reading The Right Price.   @PeterNeumann11 discusses #drugprice #negotiations on our #healthcarepodcast. #healthcare #podcast   Recent past interviews: Click a guest's name for their latest RHV episode! Stacey Richter (EP400), Dawn Cornelis (Encore! EP285), Stacey Richter (EP399), Dr Jacob Asher, Paul Holmes, Anna Hyde, Dea Belazi (Encore! EP293), Brennan Bilberry, Dr Vikas Saini and Judith Garber, David Muhlestein  

Prof Michael Barry, Director of the National Centre for Pharmacoeconomics

Savva Kerdemelidis, Founder & CEO of Crowd Funded Cures, explores the concepts of interventional pharmacoeconomics and pay-for-success contracts to fund new uses for off-patent drugs and other unmonopolizable therapies. Savva Kerdemelidis: https://www.linkedin.com/in/savvak/Crowd Funded Cures: https://crowdfundedcures.org/Impetus Digital has been delivering best-in-class virtual and hybrid meetings, events, and programs for global life science companies since 2008. We work closely with clinical, market access, medical affairs, marketing, medical education, and many other departments to virtualize their internal and external stakeholder meetings, such as advisory boards, learning programs, working groups, and congress engagement initiatives. We partner with clients at all stages of the product life cycle, from R&D to loss of exclusivity. Click the social media buttons to share this episode with your network! To learn more about Impetus, our services, and our tools: https://www.meetwithimpetus.com Natalie Yeadon LinkedIn: https://www.linkedin.com/in/natalieyeadon/ Impetus Digital Website: Home Page LinkedIn: https://www.linkedin.com/company/impetus-digital/ Twitter: impetus_digital YouTube: Impetus Digital

I love talking to fellow podcasters and on this episode, I was joined by Dr. Stefan Walzer, the CEO of MArS Market Access & Pricing Strategy. Stefan discusses: Discounts, Rebates, and how Co-Payment is different in Europe How data is presented to payers in Europe and European Reimbursement Germany/AMNOG Process Negotiation Dr. Stefan Walzer is a healthcare economist, podcaster, and CEO of MArS Market Access & Pricing Strategy GmbH based in Germany. He previously worked as a payer consultant for various global pharmaceutical and medical device / diagnostic companies, successfully launching their products across the world. Dr. Walzer was also the Global Payer Strategy Leader for various products and compounds of F. Hoffmann – La Roche AG, where he successfully developed early payer strategies as well as launching and maintaining the reimbursement process for top brands and early compounds. Dr. Walzer is experienced in the development of early payer strategies and the related evidence generation. Furthermore he is also capable in translating the clinical and economic evidence into successful reimbursement submissions and pricing negotiations especially in Austria, Germany and Switzerland. Additionally he also teaches at the Master course of Consumer Health Care at the Charité in Berlin (Germany) and is a tutor in market access and health technology assessment at the State University of Baden-Wuerttemberg (Germany). From 2018-2019 Dr. Walzer was the head of the committee “Inpatient care” of the German Health Economic Association (DGGÖ). Furthermore he is a leading member of the Special Interest group for Medicial Nutritions at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Dr. Walzer is also a member of the Austrian Health Economic Association (ATHEA) and the newly founded Swiss Health Economic Association. Additionally, he is also a member of the Access Advisory Committee of the Global Pneumonia Prevention Coalition. Dr. Walzer received a Master of Science in Economics from the University of Tuebingen (Germany), a PhD in Health Economics from the University of Zurich (Switzerland) and a Diploma in Clinical Trials from the London School of Hygiene and Tropical Medicine (UK). He is co-author of more than 40 peer-reviewed scientific articles and more than 100 scientific abstracts. Furthermore Dr. Walzer is the Editor in Chief of the German Journal of ClinicoEconomics (www.germanjournal-clinicoeconomics.de) and the lead author of the book chapter “Vergütungshöhe und Preissetzung” [Reimbursement value and pricing] in Business Planning in Health Care (http://www.springer.com/de/book/9783658081850). MAP Podcast: Link MAP Youtube Channel: Link

Report from Brian O'Connell and Prof. Michael Barry, Director at the National Centre for Pharmacoeconomics.

SUMMARY--What diuretic do you usually write for during CHF hospitalizations??   If you said furosemide you are not alone  One in a study in JACC 2013 looked at HF hospitalizations in 2009 and 2010 – In total 251,472 patients got a loop diuretic during their hospitalization and almost 87% got just furosemide, about 3% only got bumex, while only 0.4 received only torsemide.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4038646/#R11  What is the difference between bumetanide and furosemide? Nothing—or at least nothing we care about. No hard outcomes, no patient oriented outcomes.  Bumetanide is stronger—An article from 2015 in American Heart Journal states bumetanide is about 40 times stronger than furosemide- thus at times you might have your sphincter tighten when you go to write for 120-160mg of furosemide but feel comfortable writing for 3-4mg of bumex. They also discuss how bumetanide also appears to have a higher more consistent bioavailability at around 80-100% while furosemide seems to range from 10-100% depending on the study. Conclusion: the benefits for bumetanide are there in theory but no hard outcomes that I could find. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4346710/  What about torsemide??The bioavailability of torsemide is 76% to 96% and as I mentioned before furosemide hangs out around 10% to 100%. In addition, furosemide bioavailability can decrease by up to 30% with food while torsemide is not affected by food consumption.https://oce.ovid.com/article/00006562-199701000-00009https://pubmed.ncbi.nlm.nih.gov/3709617/  HOWEVER, no patient cares about bioavailability they want to know if they will live longer or live better (patient oriented outcomes)??  First paper- 2001 Nov;111(7):513-20.American Journal of Medicine we have a paper titled“Open-label randomized trial of torsemide compared with furosemide therapy for patients with heart failure” This was open-label trial of 234 patients who were randomized to torsemide or furosemide and followed for 1 yr. The outcome was heart failure readmissions and it occurred significantly less in the torsemide group, only 17% of the time compared to 32% in the furosemide group. https://pubmed.ncbi.nlm.nih.gov/11705426/ That is almost a 50% relative reduction for heart failure hospitalization at one year! This is an outcome both patients and hospitalist would love to see! Second paper-In 2002- a year later-European Journal of Heart Failure a paper titledTorasemide in chronic heart failure: results of the TORIC studyThis was the published results of the ‘TOrasemide In Congestive Heart Failure (TORIC)' study- It was an open-label, non-randomised, post-marketing surveillance trial. The individuals who were prescribed torsemide on top of their other CHF medications for 12 months had almost a 50% relative reduction in mortality!! That may not seem like a lot but remember this is only 12 months and the outcome was DEATH! In absolute terms roughly 2% of participants died in the torsemide group and 4% died in the furosemide/other diuretic group. PLUS, those in the torsemide group also had an improvement in their NYHA functional heart class.https://pubmed.ncbi.nlm.nih.gov/12167392/  Finally, there is a meta-analysis from 2019 in Journal of Cardiovascular Medicine titledTorsemide versus furosemide and intermediate-term outcomes in patients with heart failure: an updated meta-analysis  Which looked at a total of 14 randomized trials and just over 8000 pts and found torsemide to have both fewer heart failure hospitalizations and those individuals taking torsemide were more likely to have an improvement in their new york heart association class but they didnt find a difference in mortality.https://pubmed.ncbi.nlm.nih.gov/30950982/ Currently there is 6000 pt randomized trial that is underway and will be done in august 2023. https://clinicaltrials.gov/ct2/show/NCT03296813  That is it, that is all that I could find!!!! However, with the evidence clearly in favor of torsemide, why have I never even considered it before doing this lecture?? Likely 2 problems 1) It is what we have always done and it is hard to change practice! Furosemide was approved for medical use in 1964.Torsemide was approved in 1993. We as providers get into a rut, the next drug we prescribe is likely to be one of the most recent drugs we prescribed. If you show me the last 10 hypertension medications you prescribed then with almost 90-100% certainty I can guess the next one that you are going to prescribe.  2) There use to be a cost issue when furosemide was generic and torsemide was not. However, now these are both old drugs and per goodrx down here in Florida they only differ by about 1.50$ per month, but we are saving hospitalizations which cost 1000$.  A paper from 2000 in Pharmacoeconomics titled “Healthcare costs of patients with heart failure treated with torasemide or furosemide” found torsemide average hospitalization cost per patient each year was $1000 while those in the furosemide group had an average cost of $1500 dollars, and this was back when torsemide wasn't nearly as cheap as it is now.  I know I have given you a lot of numbers but a good take away is- Torsemide compared to furosemide has a NNT at 10.5 months to prevent a heart failure hospitalization around 6!!! https://pubmed.ncbi.nlm.nih.gov/10977385/ https://www.medscape.com/viewarticle/771976_8  Even if the number is off a little because of study design flaws like blinding and sample size the evidence does appear to continually point the direction of benefit towards torsemide. Even if you doubled it, a NNT of 12, it is still really good.

Why should community leaders focus on mental health as an important economic issue? According to a study published by PharmacoEconomics, latest estimates show that the incremental economic burden of adults with major depressive disorders (MDD) was $326 billion in 2018, 38 percent higher than in 2010. On this week's CDI Podcast, we explore why supporting mental health should be a crucial piece of every leader's community and economic development plans.

In this first episode of season 2 we discuss Health Technology Assessment, a multidisciplinary, transparent process for evaluating therapeutic agents and technologies in terms of efficacy and value in treating the indicated population, within the wider context of a country's healthcare system. Joining us to discuss this is Dalia Dawoud, Senior Scientific Advisor at NICE, the National Institute for for Health and Care Excellence in London, and Eline van Overbeeke, Health Economics and Outcomes Research Manager, Pfizer, both co-leading work package 2 in EHDEN focusing on evidence generation in HTA and outcomes benchmarking. In a broad ranging conversation Dalia and Eline, viewing this from a HTA agency and a biopharmaceutical company, cover what is 'HTA', and how RWD is rapidly growing as a data source for evidence generation to support contextual insights into therapeutic areas, longer term evaluation in-market, especially also where RCT data is minimal or absent, and in validation of modelling and assumptions. Challenges in utilising RWD are discussed, and how EHDEN is responding to this, for instance as addressed in the PharmacoEconomics paper of late 2019. Finally, we focus on the learning curve for all concerned and a forthcoming, initial module of courses related to HTA and use of RWD/RWE to be launched in the EHDEN Academy. The views expressed by the participants are personal and not necessarily reflective of their organisations.

Dr. Prince Chijioke is the Associate Director of Innovation at Allergan Aesthetics, an AbbVie company. He is responsible for driving commercial strategy initiatives related to the company's facial aesthetic portfolio which includes well-known brands such as Botox, CoolSculpting, and Latisse. Prior to this role, Dr. Chijioke worked as a Program Manager of Pharmacoeconomics and Pharmacy Informatics for the United States Department of Veterans Affairs and as a Consultant for BCG. He has proudly served as a Pharmacy Officer for the United States Army Reserve and as a Member for the City of El Paso's Capital Improvements Advisory Committee. Dr. Chijioke holds a Doctor of Pharmacy degree from Howard University and was recognized in 2018 as one El Paso's “30 Under 30”. He is an advocate for developing young black professionals and believes that doing well professionally can coexist while also pursuing outside interests, especially in the creative space. Connect with Dr. Chijioke today at https://www.linkedin.com/in/princechijioke/ Are you a healthcare professional or healthcare executive looking to advance your career, build a better brand, or create a leadership legacy? Iqbal can help! Schedule your FREE CONSULTATION at https://calendly.com/iqbalatcha/initial_consultation or visit http://www.atchainternational.com for more information. Connect with Iqbal on: - Linked at https://www.linkedin.com/in/iqbalatcha/ - Instagram at https://www.instagram.com/iqbalatcha1 - Twitter at https://twitter.com/IqbalAtcha1 Join us next week for another exciting episode of the "Healthcare and Higher" podcast! #HealthcareAndHigher #IqbalsInterviews Song Credits: "Life Is A Dream" by Michael Ramir C. "Stay With Me" by Michael Ramir C. --- This episode is sponsored by · Anchor: The easiest way to make a podcast. https://anchor.fm/app Support this podcast: https://anchor.fm/iqbal-atcha/support

Margaret L. Brandeau is Coleman F. Fung Professor of Engineering and Professor of Medicine (by Courtesy) at Stanford University. Her research focuses on the development of applied mathematical and economic models to support health policy decisions. Her recent work has examined HIV and drug abuse prevention and treatment programs, programs to control the opioid epidemic, and COVID-19 response strategies. She is a Fellow of INFORMS (The Institute for Operations Research and Management Science) and a member of the Omega Rho Honor Society for Operations Research and Management Science. From INFORMS, she has received the Philip McCord Morse Lectureship Award, the President's Award (for contributions to the welfare of society), the Pierskalla Prize (for research excellence in healthcare management science, in two separate years), and the Award for the Advancement of Women in Operations Research and the Management Sciences. She has also received the Award for Excellence in Application of Pharmacoeconomics and Health Outcomes Research from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and a Presidential Young Investigator Award from the National Science Foundation, among other awards. At Stanford she has received the Eugene L. Grant Faculty Teaching Award from the School of Engineering and the Graduate Teaching Award from the Department of Management Science and Engineering. Professor Brandeau earned a BS in Mathematics and an MS in Operations Research from MIT, and a PhD in Engineering-Economic Systems from Stanford.

In this podcast episode we talked about : ● What is happiness? ● Crucial life skills ● The false security of comfort ● How to increase happiness ● Quitting the Coron@ committee in Belgium Lieven Annemans is Senior Full Professor of Health Economics at the faculties of medicine of the Vrije Universiteit Brussel and at Ghent University.  He conducts research related to health promotion, financial incentives in healthcare, and the factors that can improve overall well-being.  He is Past-President of ISPOR (International Society of PharmacoEconomics and Outcomes Research), was chairman of the Flemish health council, and is currently chairman of the Flemish committee for societal revival.  He received twice the Francqui Chair, a Belgian award for academic excellence. He is the author or co-author of > 300 papers in peer-reviewed journals and published four books on health economics, among which “health economics for non-economists” (Pelckmans Pro, 2018). Recently he published the book “Geluk vinden zonder het te zoeken” (finding happiness without pursuit) [only in Dutch for now].    ☟ Find out more about Prof. Lieven Annemans at☟ ◼︎ His book “Geluk vinden zonder het te zoeken” (finding happiness without pursuit) [only in Dutch].  See https://borgerhoff-lamberigts.be/boeken/geluk-vinden-zonder-het-te-zoeken  ◼ https://www.linkedin.com/in/lieven-annemans-3376b46/?originalSubdomain=be ☞ SUBSCRIBE, SHARE OR LEAVE A REVIEW ON APPLE PODCASTS ☜ If you like this podcast, don't forget to subscribe and support our mission of freedom of speech.  

Rules for the regulation of medical devices, such as hip prostheses and implantable defibrillators, are complex and differ from those for drugs. Aaron Kesselheim, MD, JD, MPH, and Jonathan Darrow, SJD, LLM, JD, MBA, both faculty members in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham & Women's Hospital, review device classes and approval pathways used by the US Food and Drug Administration (FDA), and prospects for improvements and reform in the agency's processes. Related Content: FDA Regulation and Approval of Medical Devices

Tara Cowling is a member of the American Medical Writer's Association (AMWA), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) – and one of Canada's top entrepreneurs. In 2008, Tara founded Medlior Health Outcomes Research Ltd with a priority for providing value and insight to health outcomes research projects through robust methodology. The community-based research organization with headquarters in Calgary, Alberta is comprised of health-system trained statisticians, epidemiologists, health economists, clinical researchers, and successfully challenges the industry status quo with its female leadership representation. From unconventional advice about how to handle the word “no” – to divulging lessons that are priceless to anyone with an entrepreneurial mindset – this episode is your introduction to an inspiring leader. As a Top 100 Female Entrepreneur in Canada, Tara Cowling and her organization are soon becoming a household name. Meet her in our latest episode of The Leadership Standard.

This week on Mehmooni I speak with Parastoo Rezai who is the author of the debut novel Remembering Hope (@rememberinghope). She lives in San Diego, California, with her devoted husband, two heart-warming children, and one rambunctious puppy who follows her around like a shadow wherever she may go. Parastoo received her bachelor's degree in Biochemistry from UCSD, a Doctor of Pharmacy degree from the University of Southern California, and a Master's degree in Pharmacoeconomics from the University of Florida. For much of her career, Parastoo has worked as a Clinical Pharmacist, serving various disciplines within the profession. When not working, she devotes much of her time to pursue other passions such as reading, writing, traveling, and spending time with family and friends. Her inspiration for this novel comes from deep empathy for individuals coping with hardships and how triumphing after each struggle is possible if hope continues to reside in our hearts. Find out more about Parastoo and her book by following the link below: https://linktr.ee/p2rezaibooks Tune in to ‘Mehmooni' every Friday available to listen to on: @applepodcasts @spotifypodcasts Google Podcast Raadio Public Pocket Casts Breaker ________________________ Mehmooni is a podcast series where I speak with professional Iranians & hyphenated-Iranians about their journeys. @MehmooniPodcast @Banni_Adam_ Host: @fvrro #podcasts #podcast #podcasting #podcastlife #podcastersofinstagram #podcaster #podcasters #podcastshow #spotify #applepodcasts #youtube #itunes #music #podcastinglife #podcastaddict #radio #newpodcast #podcastlove #applepodcast #spotifypodcast #podcastsofinstagram #podcastmovement #podcasthost #Mehmooni #podcastnetwork #podernfamily #Persian #Iranian #author #rememberinghope

Dr Rishi Desai, is an Assistant Professor of Medicine at Harvard Medical School and an Associate Epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Join Professor Peter Nash as he interviews authors of recent notable papers in rheumatology. In this edition, Dr Rishi Desai discusses Risk of venous thromboembolism associated with tofacitinib in patients with RA

Prescription drug prices are at unprecedented levels. There is a huge human impact to not being able to afford medications: according to a new study by West Health, over 1.1 million people insured by Medicare could die over the next decade because they cannot afford their prescription medications. For some time, drug spending in Medicare Parts D and B has grown faster than overall Medicare spending. Rather than negotiate drug prices itself, Medicare allows private insurers to negotiate prices on its behalf for pharmacy drugs under the Medicare Part D program. For drugs administered by physicians under the Medicare Part B program, Medicare currently pays whatever manufacturers charge, with no negotiation at all. This episode covers how negotiation rules could better serve patients and taxpayers, and what policy strategies might help drive costs down.Host: Leanne Clark Shirley, PhD, Vice President, Programs & Thought Leadership, American Society on AgingGuest: Ameet Sarpatwari, PhD, JD, is an Assistant Professor of Medicine at Harvard Medical School and the Assistant Director of the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital in Boston. ASARPATWARI@BWH.HARVARD.EDU This episode was sponsored by West Health Policy CenterResourcesGenerations Supplement Article: A Modest Proposal: Negotiate Medicare Drug PricesHigh Drug Prices and Patient Costs: Millions of Lives and Billions of Dollars Lost Competition and price among brand-name drugs in the same class: A systematic review of the evidence H.R. 3 Elijah E. Cummings Lower Drug Costs Now Act 

Martin Kulldorff, PhD, is a professor of medicine at Harvard Medical School and a biostatistician and epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital. His research centers on developing and applying new disease surveillance methods for post-market drug and vaccine safety surveillance and for the early detection and monitoring of infectious disease outbreaks. Dr. Kulldorff has developed new sequential statistical methods for near real-time post-market drug and vaccine safety surveillance, where the purpose is to use weekly or other frequent data feeds to find potential safety problems as soon as possible. He has also developed tree-based scan statistic data mining methods for post-market drug and vaccine safety surveillance. Keeping the outcome definitions flexible, the methods simultaneously evaluates thousands of potential adverse events and groups of related events, adjusting for the multiple testing inherent in such an approach.Another major research area is spatial and spatio-temporal disease surveillance, for which he has developed various scan statistics for disease cluster detection and evaluation; and for the early detection and monitoring of infectious disease outbreaks. These methods are used by most federal and state public health agencies around the world, and by many local public health departments and hospital epidemiologists. Dr. Kulldorff is the developer of the free SaTScan software for geographical and hospital disease surveillance as well as the TreeScan data mining software. He is a co-developer of the R-Sequential package for exact sequential analysis. Dr. Kulldorff received his bachelor's degree in mathematical statistics from Umeå University in Sweden, and his doctorate in operations research from Cornell University.

Dr. William Feldman is a physician and researcher in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Stephen Morrissey, the interviewer, is the Executive Managing Editor of the Journal. W.B. Feldman and Others. The Future of Drug-Pricing Transparency. N Engl J Med 2021;384:489-491.

Welcome all to IS PHARMACOLOGY DIFFICULT Podcast! I am Dr Radhika Vijay. What is the first thing or picture strikes you when you hear terms familiar something like Pharmacognosy, Pharmacogenetics or Pharmacy, etc. You might have heard these so important and many more like these, I will tell you about these and all familiar important branches of pharmacology today. Talking firstly about Pharmacognosy, its the study of drug sources, it also covers identification of drugs from different sources like animal and plant origin. Second, Pharmacogenetics is study of differences/ variations and resulting changes in drug responses and drug metabolism, which can occur at individual and/or at population level.Depending on sensitivity of individual, what is developed is individual Drug therapy. Right example at right time explains the whole story well! Next word of thought is all dedicated to details about Pharmacogenomics in which genomic technology is used to explore more drug characteristics, a good example tells it all....Next set of information is all about Pharmacoeconomics, centred around cost effectiveness of drug and drug therapy. As I approach the end talks, I will disclose my real talks about practical aspect of the subject too, about Pharmacy, in disguise I will spill over discussion focus towards Pharmaceutics. Then I will shift the conversation string towards Clinical Pharmacy and Closing words will sing songs about Biopharmaceutics. I will give you a second to recollect and count the number of branches I told you all about today, give a try! Its countable on fingers, I am sure! With an indication to talk something different, new, crispy next time, I will call it for the day! For all the updates and latest episodes of my podcast, please visit www.ispharmacologydifficult.com where you can also sign up for a free monthly newsletter of mine. It actually contains lot of updates about the medical sciences, drug information and my podcast updates also. You can follow me on different social media handles like twitter, insta, facebook and linkedin. They all are with same name "IS PHARMACOLOGY DIFFICULT". If you are listening for the first time, do follow me here, whatever platform you are consuming this episode, stay tuned, do rate and review on ITunes, Apple podcasts, stay safe, stay happy, stay enlightened, Thank you!!

Welcome all to IS PHARMACOLOGY DIFFICULT Podcast! I am Dr Radhika Vijay.What is the first thing or picture strikes you when you hear terms familiar something like Pharmacognosy, Pharmacogenetics or Pharmacy, etc. You might have heard these so important and many more like these, I will tell you about these and all familiar important branches of pharmacology today. Talking firstly about Pharmacognosy, its the study of drug sources, it also covers identification of drugs from different sources like animal and plant origin. Second, Pharmacogenetics is study of differences/ variations and resulting changes in drug responses and drug metabolism, which can occur at individual and/or at population level.Depending on sensitivity of individual, what is developed is individual Drug therapy. Right example at right time explains the whole story well! Next word of thought is all dedicated to details about Pharmacogenomics in which genomic technology is used to explore more drug characteristics, a good  example  tells it all....Next set of information is all about Pharmacoeconomics, centred around cost effectiveness of drug and drug therapy. As I approach the end talks, I will disclose my real talks about practical aspect of the subject too, about Pharmacy, in disguise I will spill over discussion focus towards Pharmaceutics. Then I will shift the conversation string towards Clinical Pharmacy and Closing words will sing songs about Biopharmaceutics. I will give you a second to recollect and count the number of branches I told you all about today, give a try! Its countable on fingers, I am sure! With an indication to talk something different, new, crispy next time, I will call it for the day!For all the updates and latest episodes of my podcast, please visit www.ispharmacologydifficult.com where you can also sign up for a free monthly newsletter of mine. It actually contains lot of updates about the medical sciences, drug information and my podcast updates also. You can follow me on different social media handles like twitter, insta, facebook and linkedin. They all are with same name "IS PHARMACOLOGY DIFFICULT". If you are listening for the first time, do follow me here, whatever platform you are consuming this episode, stay tuned, do rate and review on ITunes, Apple podcasts, stay safe, stay happy, stay enlightened, Thank you!!

Welcome all to IS PHARMACOLOGY DIFFICULT Podcast! I am Dr Radhika Vijay. What is the first thing or picture strikes you when you hear terms familiar something like Pharmacognosy, Pharmacogenetics or Pharmacy, etc. You might have heard these so important and many more like these, I will tell you about these and all familiar important branches of pharmacology today. Talking firstly about Pharmacognosy, its the study of drug sources, it also covers identification of drugs from different sources like animal and plant origin. Second, Pharmacogenetics is study of differences/ variations and resulting changes in drug responses and drug metabolism, which can occur at individual and/or at population level.Depending on sensitivity of individual, what is developed is individual Drug therapy. Right example at right time explains the whole story well! Next word of thought is all dedicated to details about Pharmacogenomics in which genomic technology is used to explore more drug characteristics, a good example tells it all....Next set of information is all about Pharmacoeconomics, centred around cost effectiveness of drug and drug therapy. As I approach the end talks, I will disclose my real talks about practical aspect of the subject too, about Pharmacy, in disguise I will spill over discussion focus towards Pharmaceutics. Then I will shift the conversation string towards Clinical Pharmacy and Closing words will sing songs about Biopharmaceutics. I will give you a second to recollect and count the number of branches I told you all about today, give a try! Its countable on fingers, I am sure! With an indication to talk something different, new, crispy next time, I will call it for the day! For all the updates and latest episodes of my podcast, please visit www.ispharmacologydifficult.com where you can also sign up for a free monthly newsletter of mine. It actually contains lot of updates about the medical sciences, drug information and my podcast updates also. You can follow me on different social media handles like twitter, insta, facebook and linkedin. They all are with same name "IS PHARMACOLOGY DIFFICULT". If you are listening for the first time, do follow me here, whatever platform you are consuming this episode, stay tuned, do rate and review on ITunes, Apple podcasts, stay safe, stay happy, stay enlightened, Thank you!!

It’s hard to pronounce, but don’t let that stop you from learning about this important pharmacy topic. In this podcast, Jackie Lee talks about with Mark Millman and Karl Gregor as they explore what PE is, how to evaluate it, and how it can impact actuaries.

Martin Kulldorff, PhD, is a world-renowned biostatistician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Harvard Medical School. His research centers on developing new statistical methods for disease surveillance, including methods for disease cluster evaluation and the early detection of disease outbreaks. His methods are used by the Centers for Disease Control and Prevention (CDC) in the US and almost every country in the world. Recently, he has turned his prodigious analytical skills to the Covid-19 pandemic, serving on the CDC´s working group to evaluate the safety of any future Covid-19 vaccine. He has also been a strong advocate for age-specific approaches to managing the spread of the disease, both in major newspapers in his native Sweden and in Spiked magazine. In this podcast we discuss the ‘anti-herders’ who view herd immunity as a misguided strategy rather than a scientifically proven phenomenon that can prevent unnecessary deaths, and Dr Kulldorff’s firm belief that the approach taken by Sweden is the correct one. Additionally, we point out recent data showing that suicides are more frequent than Covid-19 deaths as a consequence of lockdowns, and allowing those under 50 to practice safe social distancing while protecting the elderly is society’s best option. Martin Kulldorff also outlines how our approach to dealing with the pandemic is putting a heavy burden on the working classes, who are ultimately bearing the largest burden of the Covid-19 policies.

Season 2 Episode 16 As a medication safety officer, Dr. Cicely Williams works hard from within her organization to keep her patients safe. Her story is featured on this episode of Brown Skin Stories: Representing Women Pharmacists. Connect with Dr. Williams: Connect with Cicely on Instagram Connect with Cicely on Facebook International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Opinions expressed on this podcast are those of me or my guests and do not reflect the views and opinions of our respective employers

Daniel Goldstein, MD, discusses the ability of interventional pharmacoeconomics to lower drug costs and increase access around the world, as well as the dilemma physicians face for treating patients with a person-centered vs a population health approach.

Welcome to AiArthritis Voices 360. This week, join your host, Tiffany, as she and co-host Suz Schrandt talk about the variety of opportunities that exist for patients who want to become active in medical research, education, and advocacy. Regardless of your background, there are opportunities for you to get involved and help shape the future of  medicine and science regarding autoimmune and autoinflammatory arthritis. Your voice matters, and you can make a difference. Pull up a chair to find out how to get started and where your journey could take you. AiArthritis Voices 360 is produced by the International Foundation for Autoimmune and Autoinflammatory Arthritis (IFAA).  Find us on the web at www.aiarthritis.org/podcast, where you can take a seat “at the table” by joining post-episode conversations, nominate future co-hosts, join the official podcast Club and more! Show Notes: Episode 8 – “Where Can Patients Use Their Voice?  Everywhere!” 00:53 – Tiffany welcomes listeners and co-host, Suz Schrandt01:12 – Suz is the Senior Patient Engagement Advisor for the Society to Improve Diagnosis in Medicine (SIDM) and Founder of a patient engagement initiative, ExPPect01:31 – Suz explains the mission of ExPPect04:39 – Suz explains how she got involved with patient engagement07:47 - Tiffany explains how she started working with PCORI (Patient-Centered Outcomes Research Institute)  09:55 - Patient research partners are equal members of research teams10:22 - There are many opportunities to get involved in patient-centered research11:00 - Patients can become ambassadors for PCORI 13:00 - European Patients Academy on Therapeutic Innovation, the European Patients Forum, and the Innovative Medicines Initiative are all European resources for getting involved as a patient researcher14:00 - International Society for Pharmacoeconomics and Outcomes Research (ISPOR) hosts patient representative round-tables all over the globe15:56 - The US Food and Drug Administration (FDA) also has opportunities for patient involvement in the development and approval process for new medications17:06 - Patients can partner directly with pharmaceutical companies to conduct research19:03 - Most of these opportunities include some preliminary training to equip patients with the skills they need to fully participate 20:56  - The US does not have a singular Health Technology Assessment body like many other countries.21:37 - Patients in countries that have an HTA body can serve as co-reviewers to help determine which therapies will be funded24:08 - Instead, the US has the Institute for Clinical and Economic Review (ICER) which has some opportunities for patient participation25:03 - Patients can be Advocates for the American College of Rheumatology 25:37 - Patients can provide input when medical specialty organizations are developing their clinical practice guidelines 27:05 - Patients can serve as Medical Educators by joining local hospital patient and family advisory councils 29:51 - Patient Focused Medicines Development (PFMD) has a repository of people, projects, and best practice guidelines for patient engagement called SYNaPsE 31:13 - Tiffany thanks Suz for coming onto the show to talk about patient engagement opportunities31:26 - Tiffany thanks listeners and invites everyone to visit www.aiarthritis.org/podcast to access resources and provide your thoughts on this topic32:00  - IFAA is recruiting patients to join AiArthritisVoices.org to get involved

27 de novembro é o Dia Nacional de Combate ao Câncer, data criada com intuito de demonstrar a importância de ações que minimizem as chances de desenvolver a doença. Relembrando a data, o Podcast QRContent de hoje traz um bate papo com os principais pontos sobre o combate ao câncer entre Stephen Stefani, oncologista da Residência médica do Hospital do Câncer Mãe de Deus (HCMD), e  Luciana Holtz, fundadora, presidente e diretora executiva do Instituto Oncoguia.  Quem é Stephen Stefani?É Oncologista e preceptor da Residência Médica do Hospital do Câncer Mãe de Deus (HCMD). Ex-fellow da University of California/ San Francisco, atuou como especialista em Auditoria Médica e Economia da Saúde. Presidente do capítulo Brasil da International Society of Pharmacoeconomics and Outcome Research (ISPOR) e Professor da Fundação Universidade UNIMED. Também faz parte do Board da America Health Foundation Quem é Luciana Holtz? Fundadora, presidente e diretora executiva do Instituto Oncoguia, uma ONG e portal informativo e interativo voltado para a qualidade de vida do paciente com câncer, seus familiares e público em geral.

Dr. Jerry Avorn is a professor of medicine at Harvard Medical School and a member of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. J. Avorn, A. Kesselheim, and A. Sarpatwari. The FDA Amendments Act of 2007 - Assessing Its Effects a Decade Later. N Engl J Med 2018;379:1097-9.

Dr. Jerry Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. J. Avorn. The Psychology of Clinical Decision Making - Implications for Medication Use. N Engl J Med 2018;378:689-91.

“Don’t be afraid to try new things” - James Hasegawa This is a special episode in Health Economics and Outcomes Research (HEOR) with James Hasegawa. James is a director at Abbott and is responsible for HEOR projects. In this episode, James shares insights on how healthcare reimbursement works as it related to clinical trials. We also dig into the world of Health Technology Assessment (HTA) groups and what it takes to model reimbursement for a medical product. If you’re interested in breaking from the silos of clinical research and learn about important adjacent functions such as HEOR, this episode is for you. Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing “save as.” Selected Links from the Episode Connect with James LinkedIn Medicare International Society for Pharmacoeconomics and Outcomes Research (IPSOR) BIO conference Stanford Biodesign Program Centre for Health Economics at University of York The National Institute for Health and Care Excellence (NICE) What is a MAC? Hospital Readmissions Reduction Program Books Mentioned: Leading at Mach 2 by Steve Sullivan Good to Great by Jim Collins The Tipping Point: How Little Things Can Make a Big Difference by Malcolm Gladwell Biodesign: The Process of Innovating Medical Technologies by Paul G. Yock and Stefanos Zenios Methods for the Economic Evaluation of Health Care Programmes (Oxford Medical Publications) by Michael F. Drummond,‎ Mark J. Sculpher,‎ Karl Claxton,‎ Greg L. Stoddart,‎ George W. Torrance Show Notes: What is Health Economics [01:52] James’s personal story: career path to HEOR [06:09] Daily routine of HEOR professionals [13:26] NICE and other HTA [14:30] HTA in the United States [15:15] HTA vs. MAC [16:30] The future of HEOR [18:59] Hospital Readmissions Reduction Program (HRRP) [19:58] Economic value and what should a medical product start-up do? [24:17] How to find HEOR consultants [25:00] Qualities of HEOR people [28:06] Health economic model: how to make one? [28:57] Working with Medicare Administrative Contractor (MAC) [31:38] The future of HEOR (continued) [33:20] On Big Data [34:57] Leveraging HEOR data in countries such as US and Japan [36:52] How does HTA function in the US [38:26] Resources and guidance documents on HTAs [40:23] HTA review process in Japan [43:30] Trick to learning other therapeutic areas [47:55] What was most useful for you in this episode? Leave me a comment below and thanks for listening.

People are suffering. From a feeling of hopelessness. From depression and anxiety. Add to that a despair that no one supports them, and you have a desperate individual at an increased risk of committing suicide. This topic hits close to home for Nadine, as she lost a nephew to suicide in 2007. Ian struggled with addiction issues, and he took his life at the age of 19. Because her family is predisposed to celiac disease, Nadine wonders if undiagnosed celiac disease may have been partially to blame for her nephew’s issues. Today she explores the mental health disorders that are associated with gluten getting through the blood-brain barrier. She also explains how undiagnosed celiac disease puts patients at an increased risk for morbidity, and stresses the fact that celiac disease can—and will—kill you if it goes untreated. Listen in as the Gluten Free RN tells her own story of improved mental health on a gluten-free diet. She also covers the types of cancers that might be prevented by going gluten-free, the connection between AFib and celiac disease, and how dermatitis herpetiformis affects patients. Listen and learn the best diet to help you get better, faster, and why medical professionals need to pay more attention to the intestines! What’s Discussed:  How to define morbidity and mortality Morbidity = sickness Mortality = death People with undiagnosed celiac disease have increased risk for morbidity How morbidity presents itself in undiagnosed celiac patients Chronic anemia Fatigue Osteoporosis Failure to thrive, grow Infertility Thyroid issues Autoimmune disorders Type 1 diabetes Lupus MS Sjögren’s Information from the World Health Organization (WHO) Diarrheal diseases are #1 killer of children Only funded one celiac study 1:19 rate in pediatric patients of Sahrawi descent The prominent mental health issues associated with celiac disease Depression Anxiety Anti-social behavior Suicide How removing gluten from her diet improved Nadine’s mental health Brain fog went away ‘Got brain back’ Embrace all life has to offer Freeing to know cause of symptoms The grains that contain gluten Wheat Barley Rye Oats (cross-contamination) The Paleo diet Nadine suggests for celiac and gluten-sensitive patients Whole food Focus on local, fresh 100% grass-fed meat (no antibiotic, no hormone) Fish and eggs Nuts and seeds 100% organic fruits and vegetables Nadine’s experience with celiac disease Multi-system organ failure, seven auto-immune disorders Dermatitis herpetiformis Diagnosed by dermatologist Tests negative, but HLA-DQ2.5 gene carrier (both parents) The connection between AFib and celiac disease AFib puts patient at risk for stroke, sudden death Check for magnesium RBC deficiency Can be corrected with gluten-free diet Resolve without pharmaceuticals How dermatitis herpetiformis affects patients Extremely painful, itchy skin Manifestation of celiac disease Suicide rate higher in patients with DH Dapsone alone will not heal Must also go gluten-free Prolonged use of Dapsone is toxic to liver (bowel cancer, lymphoma) The cancers that are potentially preventable on a gluten-free diet Lymphoma Small intestinal adenocarcinoma Esophageal cancer Oral pharyngeal The genes that indicate a predisposition to celiac disease HLA-DQ2 HLA-DQ8 Other disorders that could be mitigated by a gluten-free diet Chronic anemia Osteoporosis Osteomalacia Thyroid disorder Dementia Alzheimer’s MS Type 1 diabetes How long it takes to receive celiac diagnosis in US 9-15 years The risks for patients diagnosed with celiac disease in childhood Threefold increased risk of death (suicide, accidental death, violence) Nadine’s research around celiac testing in autopsy Couldn’t get straight answer from medical examiner (state of Oregon) Study conducted in 1974 concluded that despite systematically positive response to gluten-free diet, some patients ended up with lymphoma How Nadine periodically gives her system a detox Limited fast (three to seven days) Give organs, immune system a rest Why medical professionals should give more attention to the intestines Vast majority of signs, symptoms originate in intestines 70-90% of immune system in intestines Homocysteine levels higher in newly diagnosed celiac patients, related to other health issues The issues that can result from undiagnosed celiac disease Heart attack Stroke Appendix removed Gall bladder removed The definition of refractory celiac disease Intestines don’t heal even on gluten-free diet Sometimes caused by continued exposure to trace amounts of gluten Some patients past point of being able to heal Why it’s crucial to remove all gluten from the environment Celiac patients should feel safe where live, work and go to school Even trace amounts cause continued symptoms, early death Takes an emotional toll to be hypervigilant, mocked by loved ones The connection between undiagnosed celiac disease the despair that leads to suicide No hope of getting better Don’t feel supported, believed (celiac is real disease) Depression, anxiety and other mental health disorders More vulnerable if undiagnosed and enduring abusive relationship What happens when gluten gets through a leaky blood-brain barrier Inflammation of the brain Hypoxia (decreased oxygen flow) Low end—brain fog, anxiety, depression, fatigue High end—bipolar disease, antisocial behavior, learning disabilities, schizophrenia The risks associated with eating traditionally grown fruits and vegetables Glyphosate in Roundup causes leaky gut The goals of the first six months on a gluten-free diet Remove all gluten Allow villi to grow back Heal inflammation Repair immune system Resources:   Celiac Disease and Gluten Sensitivity in Down, Turner and Williams Syndrome WHO Celiac Disease Study “Necropsy Studies on Adult Coeliac Disease” in the Journal of Clinical Pathology “Mortality in Celiac Disease” in Gastroenterology “The Global Burden of Celiac Disease” in PLoSONE “The Unknown Burden and Cost of Celiac Disease in the US”  in Expert Review of Pharmacoeconomics and Outcomes Research “Long-Term Mortality in People with Celiac Disease Diagnosed in Childhood Compared with Adulthood” in the American Journal of Gastroenterology “Increased Risk of Atrial Fibrillation in Patients with Coeliac Disease: A Nationwide Cohort Study” in the European Heart Journal “Increased Suicide Risk in Coeliac Disease—A Swedish Nationwide Cohort Study” in Digestive and Liver Disease “The Burden of Celiac Disease and the Value of Having It Diagnosed” by Fredrik Norström of UMEA University “Complications of Coeliac Disease: Are All Patients at Risk?” “Evidence-Informed Expert Recommendations for the Management of Celiac Disease in Children” in Pediatrics Connect with Nadine:  Instagram Facebook Contact via Email ‘Your Skin on Gluten’ on YouTube Melodies of the Danube Gluten-Free Cruise with Nadine Books by Nadine: Dough Nation: A Nurse's Memoir of Celiac Disease from Missed Diagnosis to Food and Health Activism

Drs Harrington and Kesselheim discuss the varied reasons why prescription drugs are so pricey and whether policies can interrupt this alarming trend.

From being critiqued by Bernie Sanders to the controversial Duchenne drug approval decision, Dr Califf recounts his experiences as FDA commissioner.

Dr. Ameet Sarpatwari is an epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. A. Sarpatwari, J. Avorn, and A.S. Kesselheim. State Initiatives to Control Medication Costs — Can Transparency Legislation Help? N Engl J Med 2016;374:2301-4.

This episode features Aaron S. Kesselheim of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital discussing the 21st Century Cures Act. Read his commentary in CPT here. Listen and subscribe for free on iTunes and Google Play

This episode features Aaron S. Kesselheim of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital discussing the 21st Century Cures Act. Read his commentary in CPT here. Listen and subscribe for free on iTunes and Google Play

Jerry Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. J. Avorn and A.S. Kesselheim. The 21st Century Cures Act - Will It Take Us Back in Time? N Engl J Med 2015;372:2473-5.

Aaron Kesselheim is an associate professor of medicine at Harvard Medical School and a member of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. A. Sarpatwari, J. Avorn, and A.S. Kesselheim. Progress and Hurdles for Follow-on Biologics. N Engl J Med 2015;372:2380-2.

Jerry Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. J. Avorn. The $2.6 Billion Pill - Methodologic and Policy Considerations. N Engl J Med 2015;372:1877-9.

Dr. Sebastian Schneeweiss is a professor of medicine and epidemiology at Harvard Medical School and vice chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. S. Schneeweiss. Learning from Big Health Care Data. N Engl J Med 2014;370:2161-3.

Dr. Jerry Avorn is a professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital in Boston. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. E. Colman and others. The FDA's Assessment of Two Drugs for Chronic Weight Management. N Engl J Med 2012;367:1577-9.

Dr. Aaron Kesselheim is an assistant professor in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital and Harvard Medical School. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. A.S. Kesselheim and J. Karlawish. Biomarkers Unbound - The Supreme Court's Ruling on Diagnostic-Test Patents. N Engl J Med 2012;366:2338-40.

Dr. Jerry Avorn is Professor of Medicine at Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital, both in Boston. Stephen Morrissey, the interviewer, is the Managing Editor of the Journal. Supplement to: Avorn J. Learning about the Safety of Drugs - A Half-Century of Evolution. N Engl J Med 2011;365:2151-3.

Video Podcast Part 1Aired date: 5/13/2011 8:00:00 AM Eastern Time

Audio Podcast Part 2Aired date: 5/13/2011 8:00:00 AM Eastern Time

Audio Podcast Part 1Aired date: 5/13/2011 8:00:00 AM Eastern Time

Video Podcast Part 2Aired date: 5/13/2011 8:00:00 AM Eastern Time