Vital Health Podcast

The U.S. Congress and Biden Administration’s attacks on IP and Drug Pricing continue unabated as the 2024 election approaches. In this Vital Health Podcast, VT’s Grumpy Old Men (Duane Schulthess, Joe Hammang, and Harry P. Bowen) are particularly grumpy about the current state of affairs and dig into their research findings on the Inflation Reduction Act. They also ruminate on what the continued ratcheting-up of rhetoric and legislation against the industry means for tough-to-treat neurological disorders, late-stage cancers, and orphan diseases.See omnystudio.com/listener for privacy information.

In this Vital Health Podcast, Duane Schulthess speaks with Rachel King, the Interim CEO of the Biotechnology Innovation Organization (BIO), who is steering the organization through the increasingly choppy waters of the DC drug pricing debate. With mounting regulatory pressure from all angles towards the global biopharma sector, Washington DC’s BIO sits at the center of the tempest. Rachel King comes to BIO with a wealth of experience as the former Chair of BIO’s Board of Directors. She has worked as a VC, and was both the co-founder and CEO of GlycoMimetics. She was also a senior VP at Novartis. See omnystudio.com/listener for privacy information.

In this Best-Of edition of the Vital Health Podcast, we’re looking back on the outbreak of the COVID-19 pandemic and discussions we had with statistician Miriam Sturkenboom and Ivor Cummings, both of whom, in very different ways, were at the center of COVID-19 as to the appropriate response to the pandemic. Miriam Sturkenboom, who’s vaccine safety monitoring platform VAC4EU, found herself at the center of a tsunami of vaccine rollouts and safety studies in Europe, providing evidence to the European Medicines Agency and other public health bodies. This podcast was first broadcast in October of 2021. Now an internet and social media legend, it’s likely you’ve stumbled onto Ivor Cummins dissecting the impact of the response to the pandemic with detailed graphs and analysis on YouTube or X (f/k/a Twitter). Before the COVID-19 era, Ivor was a biochemical engineer and had a large following as a presenter on cardiovascular disease, diabetes, and obesity on his popular website, ‘The Fat Emperor.’ The interview with Ivor was first broadcast in February of 2021.See omnystudio.com/listener for privacy information.

In this Best-Of edition of the Vital Health Podcast, we're looking back on the outbreak of the COVID-19 pandemic, and conversations with Epidemiologist Martin Kulldorff, and Political Scientist Wilfred Reilly.  By spring of 2020, there were already serious questions being asked about COVID-19 policies, and both men were expressing skepticism of the political approaches being advocated by governments. Martin Kulldorff is a world renown biostatistician at the Harvard Medical School and a co-author of the Great Barrington Declaration. Martin was one of the co-defendants in the recent Federal 1st Amendment case, State of Missouri v. Joseph R. Biden, Jr., et al, which found that he and his colleagues' rights were violated when his opinions regarding COVID-19 were censored on social media by the Biden Administration. This interview was first broadcast on June 19th, 2020. Political scientist Wilfred Reilly is a well-known contrarian on twitter, aka X. He is an Associate Professor of Political Science at Kentucky State University and was an outspoken critic of lockdowns on the basis of his research which found no evidence of their effectiveness. He is the author of several best-selling books on race, politics, and culture in America.  This interview was first broadcast on May 22, 2020.See omnystudio.com/listener for privacy information.

In this Vital Health Podcast, Duane Schulthess speaks with John Dwyer. John is a serial entrepreneur, having successfully built and sold two healthcare start-ups to 3M and Aetna. He’s now a key player in The Global CEO Initiative on Alzheimer’s Disease, and also serves an active role in the patient advocacy organization U.S. Against Alzheimer’s. John outlines the continued controversy surrounding the Center for Medicare and Medicaid Services' intransigence regarding its coverage decision on the next generation treatments for Alzheimer's disease, despite the recent FDA approval for the drug Leqembi, which includes clinical data showing a significant positive impact on patient outcomes.  We also outline how the Inflation Reduction Act is changing the investment decisions for new orphan medicines, and the potential fate of recent Senate proposals such as the Smart Pricing Act.See omnystudio.com/listener for privacy information.

With the Inflation Reduction Act now law, there are mounting concerns that its drug pricing revisions will have a huge negative impact on the California Biotech ecosystem, arguably, the globe’s leading hub for innovative biotech. Joseph Panetta is President & CEO of Biocom, the San Diego, California organization leading 1200 companies, service sector firms, universities and research institutes working in the biotechnology sector. Joe’s been the head of Biocom since 1999 and is universally regarded as one of the world’s biotech thought leaders. In this Vital Health Podcast, Joe Panetta and Duane Schulthess discuss the IRA, the Smart Pricing Act, PBM reform, march-in rights, WTO’s waiver of COVID-19 MRA intellectual property, and the seemingly never-ending federal challenges being foisted upon the innovative biopharma sector in California. In this wide-ranging discussion, Joe and Duane even manage to find time to discuss San Diego’s weather.See omnystudio.com/listener for privacy information.

Amitabh Chandra is the director of health policy research at the Harvard Kennedy School of Government, and a professor of business administration at Harvard Business School. Dr Chandra is a rare voice sounding an alarm about the unintended consequences of the drug pricing provisions of the inflation reduction act.   In this Vital Health Podcast, Amitabh highlights the enormous disincentives for small molecules created by the IRA, as companies will receive four fewer years of revenue when compared to large molecules. As well, we touch on the challenges of PBM rebates due to their lack of transparency, and how this is creating political issues for the biopharma sector.See omnystudio.com/listener for privacy information.

In this Vital Health Podcast, we speak with Debbie Hart, President & CEO of BioNJ about the direct impacts of the Inflation Reduction Act upon her members. Under Debbie’s leadership, BioNJ has earned the reputation as the trusted voice of the life sciences industry in New Jersey. Most recently, she was named by Governor Murphy as the new Chair of the New Jersey Commission on Science, Innovation and Technology which supports innovation with grants and other programs. According to the trade journal BioSpace, “New Jersey is one of the most important states in the U.S. pharmaceutical industry. The state is home to 14 of the 20 largest pharmaceutical companies in the U.S., and the New Jersey pharmaceutical industry generates over $120.9 billion in revenue each year, with 63,415 jobs directly linked to the industry.”  See omnystudio.com/listener for privacy information.

A Boston Success story, Rhythm Pharmaceuticals brought to market an innovative orphan therapy treating an extremely rare genetic disorder which causes hyperphagia, a pathological hunger that leads to abnormal food-seeking behaviors, and severe obesity. In this Vital Health Podcast, we have a conversation with Dr. Meeker, the Chairman, President & CEO of Rhythm Pharmaceuticals, who was also formerly the President and CEO of Genzyme. David is one of the world’s leading experts in the successful development of therapies for ultra-rare diseases.   David gives his vital insights on the risks posed by the Inflation Reduction Act on the development of orphan therapies, as well as the many uncertainties it creates for biopharmaceuticals investors. We also discuss the problems caused by CMS’ continued encroachment into roles normally managed by the FDA, and the implications of Medicare being run like a European-style HTA in the future. As well, we highlight the growing innovative capacity of China in developing next generation therapies, and how this contrasts with the current regulatory pressures being place upon the innovative U.S. biopharma ecosystem.See omnystudio.com/listener for privacy information.

This Vital Health Podcast was recorded at the BIO international Conference on the afternoon of the release of Vital Transformation’s research study outlining the impacts of the Inflation Reduction Act on U.S. biopharma innovation. It features Duane Schulthess, Nick Shipley, the Executive Vice President of BIO, and Joe Hammang, Vital Transformation’s U.S. Business Director. The podcast provides an overview of the IRA’s chilling effect on R&D in orphan oncology, and how mandated negotiations at year 9 for small molecules will create an exodus of research funding in neurological disorders, a therapeutic area of high unmet medical need. The discussion also touches on Merck’s lawsuit challenging the legality of the IRA in Federal court, as well as the potential changes that need to be made to the law in the near term to minimize the IRA’s many negative unintended consequences for patients.See omnystudio.com/listener for privacy information.