Healthcare analytics, AI solutions for biological big data, providing an AI platform for the biotech, life sciences, medical and pharmaceutical industries, as well as for related technological approaches, i.e., curation and text analysis with machine learning and other activities related to AI applications to these industries.
AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class X: +300 Audio Podcasts Library: Interviews with Scientific Leaders
Curator: Aviva Lev-Ari, PhD, RN
We had researched the topic of AI Initiatives in Big Pharma in the following article:
Authentic Relevance of LPBI Group’s Portfolio of IP as Proprietary Training Data Corpus for AI Initiatives at Big Pharma
We are publishing a Series of Five articles that demonstrate the Authentic Relevance of Five of the Ten Digital IP Asset Classes in LPBI Group’s Portfolio of IP for AI Initiatives at Big Pharma.
For the Ten IP Asset Classes in LPBI Group’s Portfolio, See
This Corpus comprises of Live Repository of Domain Knowledge Expert-Written Clinical Interpretationsof Scientific Findings codified in the following five Digital IP ASSETS CLASSES:
• IP Asset Class V: 7,500 Biological Images in our Digital Art Media Gallery, as prior art. The Media Gallery resides in WordPress.com Cloud of LPBI Group’s Web site
BECAUSE THE ABOVE ASSETS ARE DIGITAL ASSETS they are ready for use as Proprietary TRAINING DATA and INFERENCE for AI Foundation Models in HealthCare.
Expert‑curated healthcare corpus mapped to a living ontology, already packaged for immediate model ingestion and suitable for safe pre-training, evals, fine‑tuning and inference. If healthcare domain data is on your roadmap, this is a rare, defensible asset.
The article TITLE of each of the five Digital IP Asset Classes matched to AI Initiatives in Big Pharma, an article per IP Asset Class are:
AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class I: PharmaceuticalIntelligence.com Journal, 2.5MM Views, 6,250 Scientific articles and Live Ontology
AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class II: 48 e-Books: English Edition & Spanish Edition. 152,000 pages downloaded under pay-per-view
AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class III: 100 e-Proceedings and 50 Tweet Collections of Top Biotech and Medical Global Conferences, 2013-2025
AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class V: 7,500 Biological Images in LPBI Group’s Digital Art Media Gallery, as prior art
AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class X: +300 Audio Podcasts Library: Interviews with Scientific Leaders
LPBI Group’s IP Asset Class X: A Library of Podcasts are a “live repository” primed for Big Pharma AI, fueling from R&D reviews to global equity. Technical Implications: Enables auditory-multimodal models for diagnostics/education. Business Implications: Accelerates $500M ROI; licensing for partnerships. Unique Insight: As unscripted leader interviews, they provide a “verbal moat” in AI—completing series’ holistic pharma data ecosystem.Promotional with links to podcast library/IP portfolio. Synthesizes series by emphasizing auditory human-AI synergy.
In the series of five articles, as above, we are presenting the key AI Initiatives in Big Pharma as it was created by our prompt to @Grok on 11/18/2025:
Generative AI tools that save scientists up to 16,000 hours annually in literature searches and data analysis.
Drug Discovery and Development Acceleration Pfizer uses AI, supercomputing, and ML to streamline R&D timelines
Clinical Trials and Regulatory Efficiency AI:
-Predictive Regulatory Tools
-Decentralize Trials
-inventory management
Disease Detection and Diagnostics:
– ATTR-CM Initiative
– Rare diseases
Generative AI and Operational Tools:
– Charlie Platform
– Scientific Data Cloud AWS powered ML on centralized data
– Amazon’s SageMaker /Bedrock for Manufacturing efficiency
– Global Health Grants:
Pfizer Foundation’s AI Learning Lab for equitable access to care and tools for community care
Partnerships and Education
– Collaborations: IMI Big Picture for 3M – sample disease database
– AI in Pharma AIPM Symposium: Drug discovery and Precision Medicine
– Webinars of AI for biomedical data integration
– Webinar on AI in Manufacturing
Strategic Focus:
– $500M R&D reinvestment by 2026 targets AI for Productivity
– Part of $7.7B cost savings
– Ethical AI, diverse DBs
– Global biotech advances: China’s AI in CRISPR
AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class X: +300 Audio Podcasts Library: Interviews with Scientific Leaders
AI Initiatives in Big Pharma @Grok prompt & Proprietary Training Data and Inference by LPBI Group’s IP Asset Class X: +300 Audio Podcasts Library: Interviews with Scientific Leaders
Overview: Final (fifth) in LPBI Group’s five-article series on AI-ready digital IP assets for pharma. This installment highlights IP Asset Class X—+300 audio podcasts of interviews with scientific leaders—as a proprietary, expert-curated auditory corpus for training and inference in healthcare AI models. Using a November 18, 2025, Grok prompt on Pfizer’s AI efforts, it maps the library to pharma applications, emphasizing audio ingestion for breakthroughs review, education, and platform integration. Unlike visual/text prior classes, this focuses on verbal expert insights for multimodal/hybrid AI, positioning them as a “rare, defensible” resource for ethical, diverse foundation models.Main Thesis and Key Arguments
Core Idea: LPBI’s +300 podcasts capture unscripted scientific discourse from leaders, forming a live repository of domain knowledge ideal for AI ingestion—enhancing Big Pharma’s shift from generic to human-curated models for R&D acceleration and equitable care.
Value Proposition: Part of ten IP classes (five AI-ready: I, II, III, V, X); podcasts equivalent to $50MM value in series benchmarks, with living ontology for semantic mapping. Unique for hybrid uses (e.g., education starters) and safe pre-training/fine-tuning, contrasting open-source data with proprietary, ethical inputs.
Broader Context: Caps series by adding auditory depth to text/visual assets; supports Pfizer’s $500M AI reinvestment via productivity gains (e.g., 16,000 hours saved).
AI Initiatives in Big Pharma (Focus on Pfizer) Reuses Grok prompt highlights, presented in an integrated mapping table (verbatim):
AI Initiative at Big Pharma i.e., Pfizer
Description
Generative AI tools
Save scientists up to 16,000 hours annually in literature searches and data analysis.
Drug Discovery and Development Acceleration
Pfizer uses AI, supercomputing, and ML to streamline R&D timelines.
Charlie Platform; Scientific Data Cloud AWS powered ML on centralized data; Amazon’s SageMaker/Bedrock for Manufacturing efficiency; Global Health Grants: Pfizer Foundation’s AI Learning Lab for equitable access to care and tools for community care.
Partnerships and Education
Collaborations: IMI Big Picture for 3M-sample disease database; AI in Pharma AIPM Symposium: Drug discovery and Precision Medicine; Webinars of AI for biomedical data integration; Webinar on AI in Manufacturing.
Strategic Focus
$500M R&D reinvestment by 2026 targets AI for Productivity; Part of $7.7B cost savings; Ethical AI, diverse DBs; Global biotech advances: China’s AI in CRISPR.
Mapping to LPBI’s Proprietary DataCore alignment table (verbatim extraction, linking Pfizer initiatives to Class X podcasts):
AI Initiative at Big Pharma i.e., Pfizer
Library of Audio and Video Podcasts N = +300
Generative AI tools (16,000 hours saved)
(No specific mapping provided.)
Drug Discovery and Development Acceleration
Review ALL SCIENTIFIC BREAKTHROUGHS.
Clinical Trials and Regulatory Efficiency
(No specific mapping provided.)
Disease Detection and Diagnostics (ATTR-CM, rare diseases)
(No specific mapping provided.)
Generative AI and Operational Tools (Charlie, AWS, etc.)
Ingest to Charlie Platform all +300 Podcasts.
Partnerships and Education (IMI, AIPM, webinars)
Use Podcast for Education; Use Podcast as Hybrid: Start presentation with a Podcast continue with a life interview.
Strategic Focus ($500M reinvestment, ethics)
(No specific mapping provided.)
Methodologies and Frameworks
AI Training Pipeline: Ingest audio into Charlie/AWS for pre-training (expert discourse corpus), fine-tuning (e.g., breakthrough reviews), and inference (e.g., educational hybrids). Use ontology for thematic mapping; Grok prompt for sourcing initiatives.
Productivity Model: Boosts Pfizer’s $7.7B savings via auditory data for diverse, ethical AI (e.g., Learning Lab grants); hybrid formats for webinars/symposia.
Insights: Quote from Dr. Stephen J. Williams, PhD: Assets as “codified digital treasures” for safe healthcare AI. Predicts revolution in verbal inference for precision medicine.
Conclusions and Implications
LPBI Group’s IP Asset Class X:
A Library of Podcasts are a “live repository” primed for Big Pharma AI, fueling from R&D reviews to global equity. Technical Implications: Enables auditory-multimodal models for diagnostics/education. Business Implications: Accelerates $500M ROI; licensing for partnerships. Unique Insight: As unscripted leader interviews, they provide a “verbal moat” in AI—completing series’ holistic pharma data ecosystem.Promotional with links to podcast library/IP portfolio. Synthesizes series by emphasizing auditory human-AI synergy.
@Grok was prompted to summarize the Table of Contents of the e-Book that present the Library of Podcast INDEX.
Overview of IP Asset Class X: +300 Audio Podcasts – Interviews with Scientific LeadersThe BioMed Audio Podcast Library from LPBI Group is a valuable intellectual property asset in the biomedical field, featuring over 301 audio podcasts created from interviews, curations, and discussions with prominent scientific leaders. This collection highlights breakthroughs in areas like genomics, cancer research, immunology, precision medicine, and public health policy. Curated by experts such as Aviva Lev-Ari, PhD, RN (197 podcasts), Larry H. Bernstein, MD, FCAP (48 podcasts), and Stephen J. Williams, PhD (38 podcasts), the library is organized into 21 thematic chapters for easy navigation.Key features include:
Search and Accessibility: Filter by chapter, curator, subject, or podcast ID. Each entry includes text-to-speech conversion and NLP-generated WordClouds for topic visualization.
Content Focus: Emphasizes Nobel laureates, key opinion leaders, and innovators discussing technologies like CRISPR-Cas9, mRNA vaccines, immunotherapy, and biotechnology ventures.
Format and Updates: Derived from articles on real-time events (e.g., COVID-19 impacts, award announcements). The library continues to expand, with no direct audio embeds—access via linked articles for full transcripts and playback.
Themes Covered: Public health policy, cardiovascular science, neuroscience, academic institutions, and more, with a strong emphasis on translational research and personalized medicine.
This asset represents a rich repository for researchers, students, and professionals seeking insights from leaders like Francis Collins, Jennifer Doudna, and Siddhartha Mukherjee.Selected Highlights by ChapterBelow are curated examples from key chapters, showcasing interviews with scientific leaders. For the full library (301+ entries), visit the source page.
Chapter 1: Public Health
Podcast ID
Curator
Title
Scientific Leader(s)
Brief Description
Link
17
Aviva Lev-Ari
LEADERS in Genome Sequencing of Genetic Mutations for Therapeutic Drug Selection in Cancer Personalized Treatment: Part 2
Leaders in genome sequencing
Explores genetic mutations’ role in personalized cancer therapies.
This selection captures the library’s depth, blending historical perspectives (e.g., Watson) with cutting-edge topics (e.g., CRISPR, immunotherapy). For deeper dives, use the site’s search tools to explore chapters like Cardiovascular Science (36 podcasts) or Immunology.
Amanda Paulovich, Professor, Aven Foundation Endowed Chair
Fred Hutchinson Cancer Center
Susan Monarezm Deputy Director ARPA-H
Henry Rodriguez, NCI/NIH
Eric Schadt, Pathos
Ezra Cohen, Tempus
Jennifer Leib, Innovation Policy Solutions
Nick Seddon, Optum Genomics
Giselle Sholler, Penn State Hershey Children’s Hospital
Janet Woodcock, formerly FDA
Amanda Paulovich: Frustrated by the variability in cancer therapy results. Decided to help improve cancer diagnostics
We have plateaued on relying on single gene single protein companion diagnostics
She considers that regulatory, economic, and cultural factors are hindering the innovation and resulting in the science way ahead of the clinical aspect of diagnostics
Diagnostic research is not as well funded as drug discovery
Biomarkers, the foundation for the new personalized medicine, should be at forefront Read the Tipping Point by Malcolm Gladwell
FDA is constrained by statutory mandates
Eric Schadt
Pathos
Multiple companies trying to chase different components of precision medicine strategy including all the one involved in AI
He is helping companies creating those mindmaps, knowledge graphs, and create more predictive systems
Population screening into population groups will be using high dimensional genomic data to determine risk in various population groups however 60% of genomic data has no reported ancestry
He founded Sema4 but many of these companies are losing $$ on these genomic diagnostics
So the market is not monetizing properly
Barriers to progress: arbitrary evidence thresholds for payers, big variation across health care system, regulatory framework
Beat Childhood Cancer Consortium Giselle
Consortium of university doctors in pediatrics
They had a molecular tumor board to look at the omics data
Showed example of choroid plexus tumor success with multi precision meds vs std chemo
Challenges: understanding differences in genomics test (WES, NGS, transcriptome etc.
Precision medicine needs to be incorporated in med education.. Fellowships.. Residency
She spends hours with the insurance companies providing more and more evidence to justify reimbursements
She says getting that evidence is a challenged; biomedical information needs to be better CURATED
Dr. Ezra Cohen, Tempest
HPV head and neck cancer, good prognosis, can use cituximab and radiation
$2 billion investment at Templest of AI driven algorithm to integrate all omics; used LLM models too
Dr. Janet Woodcock
Our theoretical problem with precision and personalized medicine is that we are trained to think of the average patient
ISPAT II trial a baysian trial; COVID was a platform trial
She said there should there be NIH sponsored trials on adaptive biomarker platform trials
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100+ Mass General Brigham Leading Experts Identify
Top Unmet Needs in Healthcare
Project from Harvard Medical School-affiliated clinicians and scientists in the Mass General Brigham healthcare system stimulates new consideration, urgency regarding
innovation in life sciences, healthcare
Top 10 List Announced at World Medical Innovation Forum
BOSTON, MA September 25, 2024 – Some of the most vexing challenges and transformational opportunities in healthcare are included in a new list, “Top Unmet Needs in Healthcare” released by leading experts at Mass General Brigham. Identified by more than 100 Harvard Medical School faculty at Mass General Brigham, the findings range from the need to expand and accelerate rare disease treatment, to the coming “gray tsunami” of aging patients and the implications for patient care, delivery, and technology. The project, revealed at the 10th annual World Medical Innovation Forum, is meant to stimulate new consideration and urgency regarding solving and advancing these issues for improved patient care.
Views from Leading Clinicians, Researchers, and Practitioners in Academic Medicine
The Top Unmet Needs emerge from structured one-on-one discussions with more than 100 Harvard faculty who practice medicine and conduct research at Mass General Brigham, the largest hospital system-based research enterprise in the U.S., with an annual research budget exceeding $2 billion, and five of the nation’s top hospitals according to US News & World Report.
Through one-on-one discussions with these key opinion leaders from diverse clinical and research fields, and subsequent analyses by internal teams of experts, Mass General Brigham has identified the following top 10 unmet clinical needs:
#1. Preparing for the ‘Gray Tsunami’
The need for better tools and therapies aimed at caring for geriatric populations and maintaining geriatric independence, with a particular focus on expanded hospital-at-home capabilities, and the need to better understand the pathways that lead to chronic and acute disease in geriatric patients to enable better and more proactive treatment.
#2. Defining and Maintaining Brain Health
The need for a model of brain health and neurological care that clearly defines not only what brain health is but also integrates our current understanding of the mechanisms and phases of neuroinflammatory and neurodegenerative diseases; enables better and earlier diagnoses and treatment; and propels the development of therapies that target these mechanisms and phases.
#3. A Paradigm Shift in Cancer Treatment
The need for a new framework for therapeutic development in cancer that is focused on improving curability as opposed to an exclusive focus on the development of drugs for metastatic disease. This
framework also requires effective tools for early-stage cancer detection across the board in all cancers, but especially in lung, ovarian, pancreatic, and GI cancers (esophagus, stomach and colon).
#4. Targeting Fibrosis, a Shared Culprit in Disease
The need for therapeutics that target fibrosis (tissue scarring), which is responsible for a significant percentage of deaths worldwide, representing diseases of the lung, liver, kidney, heart, and skin.
#5. New Approaches for Infectious Disease in a Changing World
The need for novel strategies for the rapid diagnoses, treatment, and even prevention of antibiotic-resistant infections, and the need for the next generation of globally deployable vaccines to enable pandemic preparedness.
#6. Striving for Equity in Healthcare
The need to radically rethink how, when, and where patients interact with healthcare services to optimize healthcare access and efficiency without diminishing its effectiveness, and to proactively meet the needs of currently underserved populations.
#7. Riding the Wave of Clinical Data
The need to expand the scope of available clinical data to include historically understudied populations (including women) and to model and implement a cohesive, dynamic data “stream,” which flows as patients do between the different phases of health and clinical care, enabling comparisons of patients to their previously healthy selves and the development of AI/ML approaches to harness these data to improve diagnosis, prognosis, and treatment.
#8. A Systems-Level View of Human Disease
The need to rethink how we understand and treat disease — not only from an organ-specific standpoint but from a whole-body, systems-level view — and to fully elucidate the roles that inflammation and immune pathways play in autoimmune and infectious diseases and their effects on chronic and acute diseases in diverse human systems, such as the cardiovascular/circulatory and nervous systems.
#9. A New Approach to Psychiatric Disease
The need for novel treatments for psychiatric disease, improved biomarkers and minimally invasive and ambulatory ways of measuring them, and more productive interactions with industry to advance new therapies to the clinic. This includes hybrid therapies (therapies that combine elements such as talk therapy, novel biomarkers, and pharmacological treatments) as well as new diagnostic and treatment modalities, such as psychedelic therapeutics and precision psychiatry.
#10. Charting a Course in Rare Disease Treatment
The need for viable treatments for the 7,000 identified rare diseases, especially the roughly 70% of such diseases that are genetic and the effects of which are first observed in early childhood.
The Unmet Needs list also include the following honorable mentions which rose to significant rankings in the analysis:
Driving Innovation in Chronic Disease: Improved Diagnosis, Treatment, and Prevention
A New Era of Obesity Medicine
A New Generation of Pain Treatments
Unlocking Novel Treatments for the Skin
Overarching Themes
Addressing unmet clinical needs involves solving a number of common challenges, including commercialization hurdles, regulatory considerations, and funding. The Mass General Brigham project identified overarching themes to help address these challenges and support innovation across multiple sectors. These include:
Taking a systems view of human disease and the practice of system-medicine
Developing a global view of infectious disease, including antimicrobial resistance
An expansion in high-quality, real-world data that closes gaps in current data (particularly for women and other underserved populations) and ensures that data sets are sufficiently enabling for AI/ML
Improving health and healthcare across key populations, including geriatrics and rare genetic disease
Addressing major diseases of the brain, including both neurodegenerative and neuropsychiatric conditions; these include Alzheimer’s disease, Parkinson’s disease, ALS, as well as psychiatric and mental health disorders
Opening an era of precision medicine across disease areas that includes early diagnosis, treating staged disease, and biomarker discovery and utilization
Panel co-chairs José Florez, Physician-in-Chief and Co-Chair of the MGB Department of Medicine and the Jackson Professor of Clinical Medicine at Harvard Medical School, and Bruce Levy, Physician-In-Chief and Co-Chair of the MGB Department of Medicine and the Parker B. Francis Professor of Medicine at Harvard Medical School, noted how the observations of a broad and representative set of faculty help illuminate the innovation landscape ahead.
“As a leader in patient care and healthcare innovation, our goal is to build on the legacy of research and discovery that has shaped the hospitals of the Mass General Brigham healthcare system for more than a hundred years, and continue to bring breakthroughs forward that can help solve pressing needs,” said Dr. Florez.
Dr. Levy added that “This is a roadmap for the future that can inform discussions happening throughout the healthcare and investment ecosystem regarding the future of medicine.”
More than 2000 decision-makers from healthcare, industry, finance and government attended the World Medical Innovation Forum this week in Boston. A premier global event, the Forum highlights leading innovations in medicine and transformative advancements in patient care.
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About Mass General Brigham
Mass General Brigham is an integrated academic health care system, uniting great minds to solve the hardest problems in medicine for our communities and the world. Mass General Brigham connects a full continuum of care across a system of academic medical centers, community and specialty hospitals, a health insurance plan, physician networks, community health centers, home care, and long-term care services. Mass General Brigham is a nonprofit organization committed to patient care, research, teaching, and service to the community. In addition, Mass General Brigham is one of the nation’s leading biomedical research organizations with several Harvard Medical School teaching hospitals. For more information, please visit massgeneralbrigham.org.
Contact: Tracy Doyle Mass General Brigham Innovation
(262) 227-5514
Tdoyle5@mgb.org
SOURCE
From: “Doyle, Tracy” <tdoyle5@mgb.org> Date: Thursday, September 26, 2024 at 10:19 AM Cc: “Card, Matthew” <matthew.card@bofa.com> Subject: Unmet Needs in Healthcare — Press Release and link to panel
@@@@@@@
Invitation as MEDIA
From: “Doyle, Tracy” <tdoyle5@mgb.org> Date: Wednesday, August 14, 2024 at 4:04 PM Cc: “Doyle, Tracy” <tdoyle5@mgb.org>, “Card, Matthew” <matthew.card@bofa.com> Subject: Media Invite: World Medical Innovation Forum, Sept. 23-25, Boston — Hundreds of clinical experts, industry, investment leaders
Media Invite: World Medical Innovation Forum: Monday, Sept. 23—Wednesday, Sept. 25, Boston
At the intersection of innovation and investment in healthcare
Join Us!
Register Now: WMIF24 Media Registration
Mass General Brigham, one of the nation’s leading academic medical centers, is pleased to invite reporters to the 10th annual World Medical Innovation Forum (WMIF) Monday, Sept. 23–Wednesday, Sept. 25 at the Encore Boston Harbor in Boston. The event features expert discussions of scientific and investment trends for some of the hottest areas in healthcare, including
GLP-1s,
the cancer care revolution,
generative AI-enabled care paths,
xenotransplant,
community health,
hospital at home, and
therapeutic psychedelics, among many others.
The agenda includes nearly 175 executive speakers from healthcare, pharma, venture, start-ups, and the front lines of care, including many of Mass General Brigham’s Harvard Medical School-affiliated researchers and clinicians who this year will host 20+ focused sessions. Bank of America, presenting sponsor of the Forum, will provide additional expert insights on the investment landscape associated with healthcare innovation.
Forum highlights include:
1:1 and panel interviews with leading CEOs and government officials including:
Stéphane Bancel, CEO, Moderna
Albert Bourla, PhD, CEO, Pfizer
Marc Casper, CEO, Thermo Fisher
Deepak Chopra, MD, Founder, The Chopra Foundation
Scott Gottlieb, MD, PhD, Former Commissioner, FDA (2017-2019)
Maura Healey, Governor, Commonwealth of Massachusetts
David Hyman, MD, CMO, Eli Lilly
Haim Israel, Head of Global Thematic Investing Research, BofA Global Research
Reshma Kewalramani, MD, CEO, Vertex
Anne Klibanski, MD, President and CEO, Mass General Brigham
Peter Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, FDA
Tadaaki Taniguchi, MD, PhD, Chief Medical Officer, Astellas Pharma
Christophe Weber, CEO, Takeda
Renee Wegrzyn, PhD, Director, ARPA-H
Expert panels including:
Oncology’s New Paradigm
Gene Therapies for Rare Diseases
Future of Metabolic Therapies
Digital Transformation
Biologic Revolution in Radiotherapies
Cell Therapies for Autoimmune Diseases
Hospital Venture Funds
Leading biotech and venture speakers from companies including:
Abata Therapeutics
Atlas Venture
Be Biopharma
Everly Health
Flagship Pioneering
Fractyl Health
MindMed
Mirador Therapeutics
Regor Therapeutics
RH Capital
Transcend Therapeutics
Exclusive programming:
First Look – 15 rapid-fire presentations on the latest research from leading Mass General Brigham scientists
Un-Met Clinical Needs – 100+ key opinion leaders in healthcare weigh in on the top un-met clinical needs in medicine today
Emerging Tech Zone – Hands-on exploration of some of the latest digital and AI-based healthcare technologies
Liz Everett Krisberg, Head of Bank of America Institute
Record attendance this year
Introduction to Haim
Panelist
Haim Israel
Head of Global Thematic Investing Research, BofA Global Research
Concept of the Future and for the Future: Short-term and long-term
Humanity achievements in Ten Year: Data, Processing power and BRAIN – Long-term becomes Short-term – Last 10 years: 2012, 2014 solar system, 2015 medicine, 2019 blackhole, 2023 core of sun – star was created hotter than core sun
2022, 2024 – galaxy picture of the universe
Volume of data created every month in terrabyts every 18 month data is duplicating itself.
Olny 1% is used – imagine 2% or 3%
Processing power since Apollo 11 [one trillion] – getting cheaper – cost for calculation went down 16,000 fold since 1995
AMMOUNT of DATA goes up and Cost of COMPUTATION goes down – price per giga byte
Projections for the next 100 years
Negative for people and Negative for Companies who are concerned with quarterly financial data
Companies: Walmart, Alphabet, Home Depot – DATA larger that COuntries
Living in defining moment: started by iPhone revolution and 2023 by AI revolution – 6x outpaced Moore’s Law by GPT by 3000x
18 months into AI revolution – GPT in use
The next 10 years:
Aging population
2024 – birth rate low in US, Japan, CHina, S. Korea – Pension system will decline in size
2.2 millions new material were created by DeepMind at Alphabet by simulation of AI on molecule
Microsoft in 80 hours identified 18 materials winners for Batteries using AI from 32 million material candidates
AI- weather calculations in minutes 1,000x faster, cheaper and more accurate
2025 – GPT-6 AI surpass Human Brain
China is a big player in AI
Cyber CRIME is the 3rd largest economy in the World. Hackers are using ChatGPT to create fake pictures leading to ZERO privacy
PRIVACY: Deepfakes up 62x, social media
2024 – Global Grid – needs much more energy because AI consumes so much energy
Metals shortages: Nickel, Copper,
Scarcity of water for 2/3 of the planet
data centers consume water more than Japan
2025 – Genomics Data sequencing bigger that X.com or Youtube
2027 – Peak oil demand: needed to be scalable, cheaper 25%
2028 – 5G networks reaches full capacity, 6G will be needed
2029 – 25x more satellites in Orbit than today
2029 – Personalized AI medicines and treatments will manipulate death and revive LONGEVITY – AI will generate drugs and all treatments
2030 – Generative AI: re-skill 1 Billion people
2035 – Fusion energy, known technology since the atomic bomb, how to keep it stable in plasma state of material – not yet achieved, it is clean, cheap: to Power the World – equivalent of 11 barrels of oil
Large cities: Cable diameter 17cm wide to power a large city
AI will change scarcity into abundance
2037 – Artifitial SUPER Intelligence – AI to outsmart Life
Quantum computer – Consortium of NASA and other governmental agencies and Google on quantum computer design
David Brown, MD, President, Academic Medical Centers, Mass General Brigham; Mass General Trustees Professor of Emergency Medicine, Harvard Medical School
Hoe do you balance Private medicine with Public not for profit HealthCare
Healthcare delivery system can achieve that much in Human health
Resources for Equity: housing and services: Capacity and COst
Evolution of care close to home catalyst of the Pandemic – How government think about the right patient for the right care level
MGB 40-60 In-patients at Home – Largest Program in the State – product needs to scale across all population though some do not have food security at home
Panelist
Kate Walsh, Secretary of Health and Human Services, State of Massachusetts
Stuart Bankrupcy – pstioents and providers involvement – structure challenges
Race and ethnicity – disparities, access and equity
Identify the challenge for Race and ethnicity
Focus to identify resources
Medicare & Medicaid – Human needs equity involve housing, food and home care – Public and Private sector cooperation
Pay for Performance
MA vs NYC – resources for welcoming new populations to the State of MA
Help finding Housing vs Shelter people
MA is the only State in the Union that is a Shelter State
People in our COuntry LEGALLY are in and out of shelters, new arrivals of skilled labor – temporary assistance to get jobs that we can’t find people to fill: CNA as example
MA has a community of shelters and medical center in the communities
Services for people that are at risk due to past life in home countries
Support for kids that do not speak English
Care and location: Keep care at home or SNF at home or in the community
David Hyman, MD, Chief Medical Officer, Eli Lilly and Company
Cardio-metabolic – medicines redefining disease by medicines benefit to patients
Investment in manufacturing medicines for Obesity, demand continue to expand
Oral small molecule and scaling focus on Sleep apnea, half of the population have metabolic disease and heart failure
Extension Program with sustained weigh loss in pre-diabetes progressing into maintained weigh loss
Invest in R&D in the cardio-metabolic
Listed to community feedback on experience how the drugs in AD affected patients in the Community – learning about challenges in delivery innovation in AD – irreversible neurodegenerative diseases – prevent not to loose the patients entirely – brain function
Targeted therapies, genetic therapies
Past life Oncologist – delivered innovations into Cancer patients – genetic medicines
AD medicines are not accessible even to people of means, Drug delivery using PET spinal injections
Ten years horizons at Eli Lilly is common
Obligation to provide scientific evidence from clinical trials
Inventory of patients qualification to participate in Clinical trials
Oncology: Interactions in biologics, cell therapies, conjucate compounds
Renewal of Targeting antigens
In Oncology: Proportions of patients get long term disease control by molecules developed in Academic Centers.
Eli Lilly acquired a BioPharma with manufacturing capabilities
Innovations are core vs discount cash-flow, strategy is to look at the science due to capacity to develop innovations
Alec Stranahan, PhD, SMid-Cap Biotech Analyst, BofA Global Research
Caroline Apovian, MD, MGH, HMS
Last ten years, from metabolic lessons of Bariatric patients
Treat obesity before surgery
product composition
multidisciplinary approach to obesity needs to be like in Oncology – multiple dsciplines
Bariatric and weigh regain like stent stenosis after surgery
Obesity dysfunction inflammation Gut-Brain transfer of hormones from the gut do not reach the brain to carb hunger socieaty is not signaled in the Brain and eating continued to mitigate hunger
Insurance must cover
Obesity Medicine – training 25 new practitioners to treat Obesity – Standards of Care, life style change
Primary care providers do not have resources to treat Life style component of
To reduce mortality by 20% by Bariatric surgery – No reduce of mortality by stenting – THAT I DISAGREE with
Panelists
David Hyman, MD, Chief Medical Officer, Eli Lilly and Company
non-peptide agonist, bariatric level for obesity
peptide injecting device
hormones and peptids activan inhibitor
hundred of million of people – scaling up
Adolescence with obesity will develop CVD, NASH
Epidemic of obesity the medicines are combating the epidemic
Vials, differential pricing, orals vs injectables
Productivity of work force, coverage by employers health insurance vs Government to handle coverage
10 additional drug
Xiayang Qiu, PhD, CEO, Regor Therapeutics
six years ago, great opportunity peptide and biologics for lifetime disease of obesity
cardiovascular favorably = affected by reduction in weigh
Medicines that works start early at age 35
Harith Rajagopalan, MD, PhD, CEO & Co-Founder, Fractyl Health
Diet & Life Style
Eli Lilly and Novo Nordik – have great drugs
Patients stop using them before they see the benefit
durable long term of mentainance long-tern to stay on the drug
Past life coronary cardiologist: PCI vs surgery choice of care angioplasty vs open heart surgery
Bariatric surgery vs great medicines
may be angioplasty for Bariatric patients
Obesity is different than CVD
BC-BS coverage of obesity drugs because weight is gained back vs Statins – continual use control cholestrol
maintenance drugs in the field of Obesity are needed
cost of drugs will come down
more evidence on obesity drugs will affect Formulary
Jason Zemansky, PhD, SMid-Cap Biotech Analyst, BofA Global Research
Patrick Ellinor, MD, PhD, MGH, HMS
Panelists
Craig Basson, MD, PhD, Chief Medical Officer, Bitterroot Bio
17,000 patients obese no DM
prior CVD followed 3 yrs of treatment 6% mortality during the Trial
Death from CVD endpoint
weight at joining the trial, loss during the trial, benefir from the drug’
improve CVD not weigh loss
mechanism of Inflammation – drug, reduced atherosclerosis and reduced plaque and cytokins and inflammation improve CVD status
combination of life style and drugs GI axis systemic
cardiac artery disease: cholesterol, inhibit inflammatory signals plaque build on top of itself – approaches to remove debris macrophages in the plaque for artherosclerosis mechanism as CVD risk
Joshua Cohen, Co-CEO, Amylyx Pharmaceuticals
Bariatric surgery lower obesity
genetics, eating habits,
GLP-1 agonist developed
Punit Dhillon, CEO, Skye Bioscience
Phase II study combination therapy CVD and Obesity
optimize body composition – more productive on the body periphery
subtypes metabolic gains
Pharmacotherapy for obesity: mechanisms complementary life style change is a must have for long-term benefits
weight loss as a start before obesity treatment
co-morbidities of obesity
Justin Klee, Co-CEO, Amylyx Pharmaceuticals
Parkinson’s CNS peripheral Brain access therapies
revolution in metabolic disease treatment options, more studies for pathways to target the right patients for the right treatment
GLP-1 is energy regulator, Hypoglycemia is very dangerous
Rohan Palekar, CEO, 89bio
applications to obesity – data support
bariatric surgery intervention is not enough, NASH will not be impacted only by the surgery
NASH is a disease taking 25 years to develop
risk of fibrosis to set in Cirrhosis which is not curable
Liz Kwo, MD, Chief Commercial Officer, Everly Health
Infrastructure
AI used for
Panelists
Anna Åsberg, Vice President, AstraZeneca Pharmaceuticals
Massive data bases organize
AI to augment intelligence inside the data
Tyler Bryson, Corporate Vice President, US Health & Public Sector Industries, Microsoft Corporation
Do we have platforms to serve new problem
Regulatory changes require visiting use cases
Pharma has the research data, providers have EMR – Microsoft builds new models using that data
Tumor imaging data was processed and new pattern recognition done on data of these tumors. New patterns are now a subject for research, just identified inside the data
Trust in Healthcare
NYC and Microsoft developed a System for small businesses to access city resources
Works with Academic institutions: Programs at Harvard and Princeton to train students by Microsoft employees on MIcrosoft AI technologies that as they graduate there will be trained new AI-trained employees
collaborations
Aditya Bhasin, BofA
AI in Banking: Bias, security
AI virtual system analytics to provide insight for scaling
Jane Moran, MGH
Network, Data structure needs updates
technology to help clinicians
care team to work with Generative AI to assist in e-mail reading and problem solving
Healthcare equity – avoid Bias
AI is not an answer to every problem
innovate at scale: using Epic and Microsoft
Clinical data structure for LLM, AI to renovate administrative processes inside MGH
John Bishai, PhD, Global Healthcare Investment Banking, BofA Securities
Umar Mahmood, MD, PhD, MGH, HMS
Panelists
Amos Hedt, Chief Business Strategy Officer, Perspective Therapeutics
imaging used to deliver the therapeutics before the drug touch the patient to calculate toxicity
PL-1 combined with radiotherapy synergistics results
immunogenic combination therapy, in presence of these agents, immune response reaction in the immune cells
Matthew Roden, PhD, President & CEO, Aktis Oncology
Conjugates – delivery direct to tumors
Opportunity two targets: (1) SSTA2 marker (2) xx
WHen agent inside the tumor, shrinkage and no emergence of cell nascent
optimization design
Treatment break for patients and families
Philip Kantoff, MD, Co-Founder & CEO, Convergent Therapeutics
Radio-pharmeceutics : 10 days half-life carrier not a target for small molecules Data on 120 patient, namo robust response synergy of antibody and molecule
image alphas
durable responses
Matt Vincent, PhD, AdvanCell Isotopes
ROS species generated in the tumor
peptides, protein binders
paradigm shift in delivery of oncology therapeutics directly to tumors
Lena Janes, PhD, Abdera Therapeutics
isotope will deliver the payload without damaging the DNA and healthy tissue
target different types of tumors, different half-life
Radiation therapy using isotopes id one of two modalities: tumor in and tumor out approach
screen for patient for the translational therapy
Next generation of products will come, now it is the beginning of these agents
Michael Ryskin, Life Science Tools & Diagnostics Analyst, BofA Global Research
Precision Medicine was it a paradigm shift??
Acquisition of manufacturing capabilities
research, manufacturinf line blurred
WHat excites you the most
Panelist
Marc Casper, Chairman, President & CEO, Thermo Fisher Scientific
Enabling Life sceinces, Pharmaceutical industries $1.5Billion internal investment annually
AI increasing knowledge
How is Precision Medicine applied? Sequencing in Cancer accelerated the Genomics information in use for 24 hours response of the sequence – adopted around the World.
at MGH lung cancers are treated with genomic sequencing
identification of the patients suitability for a targeted treatment
treatment during pregnacy at home vs hospitalization
History of company: Tools first: Mass spectrometry, one year for one sequence, protein identification and carrying to Mass spectrometry
Interactions need understanding acquiring electro spectrometry allowing analytical chemistry on proteins
Broad range of products: Clinical research to meet regulatory requirements entry into Reagents products.
Clinical Trials made effective by Thermo Scientific Products
Capabilities in registries, patient safety in psoriasis
Large role in experimental medicine drives efficiency in LABS
SIze of customers: small Biotech and large Pharma
Manufacture medicines: work with partnersbuilt by acquisitions small molecules,
100 engagements research, supply chain making medicines available at sites
Role for AI at Thermo Scientific:
Productivity – Cost effective for processes in use by 120,000 employees
Super customer interaction perfected by interogations with internal manuals to provide answers quickly
Improvement of products
Excitement Points: Responsiveness to COVID pandemic
Tazeen Ahmad, SMid-Cap Biotech Analyst, BofA Global Research
Are you using AI
Neuroinflammation
Cynthia Lemere, PhD, BWH, HMS
What systems are primarily impacted by the Immunes system
Drug delivery for inflammation huge area
Getting antibodies to the Brain
Precision medicine, genetics,specific person with specific immune disease
Panelists
Jo Viney, PhD, Cofounder, President & CEO, Seismic Therapeutic
Pandemics highlighted the impact of the immune system
Targeting cytokines in specific locations – hew approach
Modalities on hand: protein degradation mediation by bringing two cells together
AI is used for Patient stratification
AI to be used in Pathways involved in disease process to identify Biologics, PROTAC,
AI and ML for training models from interaction between proteins
ChatGPT to predict interactions among proteins
Immune disease and remission bust the immune system to improve quality of life of patient undergoing interventions
T-cell engaggers – in cases of refractory – great approach for boosting the immune system: removal of antibidies, recycling antibodies,
Two ends: Cell depletion vs Early detection
Therapy is every 6 months, cell depletion takes 3 months to come back.
Target immune system in the periphery,
Immune system in neurodegenerative diseases: Parkinson’s local modulation to penetrate neurological system
Markers to cross the BBB or not cross in neurological diseases
Immune disease is POLYGENIC multiple o=etiologies, mutation, genetics, which cell and which pathway to target a therapeutics: Biologics
Patient stratification is key for Precision Medicine at the cell level
T-cell, B-cell, Cytokines and antibodies mediated disease
ADGs degradation
9:45 AM – 10:10 AM
Picasso Ballroom
H. Jeffrey Wilkins, MD, Abcuro
Inflammation play a role in activating the immune system
zin the days of Medical School: inhibition of cytokines
Today: specificity to target cells for depletion
Specific biomarkers for response to therapies
cell types by mutations and physiology and causality in the inflammation area: we know why they have inflammation we need to learn interventions for inflammation
Asthma in the 40s as an inflammatory disease
assess treatment of inflammation
Neuro-inflammation – not well understood
What is the cause that drive the disease: understanding encephalitis?
NiranJana Nagarajan, PhD, MGB Ventures
Biology is the driver not AI
depletion of cells in a certain stage
Translation from disease to other diseases in the case of cell therapy potential – active area companies are trying solutions
Daniel Kuritzkes, MD, Chief, Division of Infectious Diseases, Brigham and Women’s Hospital; Harriet Ryan Albee Professor of Medicine, Harvard Medical School
Pathways in vaccine design
How to educate population on Vaccines
other approaches than vaccines
Alec Stranahan, PhD, SMid-Cap Biotech Analyst, BofA Global Research
Vaccine approval
Next generation vaccines
Panelist
Stéphane Bancel, CEO, Moderna
Vaccine design: long term vaccines weakens in aged population
data on role of AVV in Multiple Sclerosis
working on in the US vs France, Netherland in Europe different approaches
Vaccine for HIV
Vaccine was approved last year for children, pharmacies shortage
Season of FLu three times more vaccines in use
Employees run vaccine clinics on site
Vaccines not related to COVID
Misinformation from COVID vaccine
5% of COVID hospitalized were on the booster
Combination vaccines for high risk populations
Healthcare providers need to be involved in Education, many do not have an interest in the education on vaccines
Local stories from Vaccine manufectures and developer to be used in education in the communities
Individual DNA cancer celll signature of the cancer – data over time for development of vaccine to cancer many more tumor types are needed
Checkpoints in early disease
biopsy are too expensive
Side effect studies going on
mono-therapy vs immunotherapy costs involved
Naive virus to get into the Liver two diseases – cassets for sose management
Recombinant antibodies technology from the 70s
PD-1
COVID – was nto in the plan for development – design in silicon in two weeks – no change after this design
Large/SMid-Cap Biotech and Major Pharma Analyst, BofA Global Research
TCM
CAR-T
advantages of each cell type
Angele Shen, MGB Innovations
CAR-T
What would be a quick breakthrough?
Panelists
Jeff Bluestone, PhD, CEO & President, Sonoma Biotherapeutics
Cell therapy for cell depletion elimination of B-cells like its role in Multiple Sclerosis
Working with regulatory T-cells
Population of cells to study: T-cells master regulator in multiple ways – produce metabolic factors, infection tone in activation of other cells
Biology of cell: RNA, DNA
TCR – target antigens in tissues they are in in immune suppression
FInding the right peptide bindes to a certain MAC
CAR-T – recornize the cells in the local milieu like in patients with RA as an autoimmune disease
Clinical models ascertain cell types involvement leading to clinical trial insights then to therapies on a decision tree
recent data on CAR-T immune response in allogeneic for potential use in neurodegenerative diseases
patients and companies over react on immune therapy: Patients and Science vs hype
next generation: POC,
Gene therapy specificities vs Cell therapies – each approach will develop a different drug
FDA and NIH has in 11/2023 a meeting on Regulation of Cell therapy on stability and their approach to immune disease where there are already several drugs
approvals challenges companies
Price, too expensive a treatment is cell therapy
Chad Cowan, PhD, Executive Advisor, Century Therapeutics
use Natural Killer cells to elicit long-term immune response, T-cells,
active Beta cells]Regulatory monitoring use
DM – regulatory cells made from Stem cells
mission durable response
Clinical issues – not easy way for treatment wiht a cell line and bioreactors and modalities less similar to autologoous celles
CAR-T in oncology lessons now are transferred to Immune disease
Cell therapy requires technologies to mature multiple modalities and multiple drugs not one cell therapy for all immune diseases
Stability of the therapy vs rejection by immune system
FDA making cells is not as making drugs – higher level of scrutiny for cell therapy
SYNTHETIC BIOLOGY on B-cells for future breakthrough
Samantha Singer, President & CEO, Abata Therapeutics
Immune response involve many cell types in many diseases
Oncology the use of T-cells as tissue residents staying in tissue long time
Specific biology of the disease and regulatory cells receptors optimizing TCR presentation in pathology of tissue residents phyno types
activate in nervous system or in pancreas – intersection of cell biology with disease biology
Market feasibility – scaling, biology, pathology for reimbursement
antibody therapy may be appropriate than cell therapy is only a novel option
Cell manufacturing requires optimization of process, companies commercializing across all cell types
comprehensive approach for systemic immune suppression
: healthy tissue vs diseased tissue with cell theray implanted cells as residents in tissue
clinical data on product performance and on the biology reactions
Jose Florez, MD, PhD, Physician-in-Chief and Chair, Department of Medicine, Massachusetts General Hospital; Professor, Harvard Medical School
40 minutes to deal with big needs collected from 100 faculties at Harvard Medical School
The ten issues on one slide
How could we use compute to distill data
Bruce Levy, MD, Physician-In-Chief and Co-Chair, Department of Medicine, Brigham and Women’s Hospital; Parker B. Francis Professor of Medicine, Harvard Medical School
Transformation from the Present to the Future
identifying the needs
Infectious diseases: Rapid diagnostics need
resistance to antibiotics and metabolic reactions endogenous
Pandemics globally of diseases erradicated in the past: Pox, polio
Improving health in Geriatrics, not population growing but geriatric population growing. Beyong age 60 a citizen will use 1 or 2 physicians each
7,000 diseases, Genetic diseases requires integration and innovations in therapy
Innovations in Home devices
Panelists
Rox Anderson, MD, Lancer Endowed Chair of Dermatology;, Director, Wellman Center for Photomedicine, MGH; Professor of Dermatology, HMS
Access to data across institutions
Nicole Davis, PhD, Biomedical Communications
We asked 104 expert practitioners, content collected was analyzed
detection early
keeping the Human brain healthy
geriatrics Medicine, aging and compound effects on health system with aging and Health equity
Bias in Data
Jean-François Formela, MD, Partner, Atlas Venture
genetic information used in therapeutics design
Steven Greenberg, MD, Neurologist, Brigham and Women’s Hospital; Professor of Neurology, Harvard Medical School
Human genome completed in 1999, human genetic diseases were discovered learn about the disease at the tissue level with genomics and a system approach
Pathogenic drivers, systme integration by therapeutics approaches to pathways multiple cytokines in allergic reactions Pfizer had two biomarkers and therapies for systemic biology of disease
Pediatrics has its own challenges
Imaging medicine
Living longer at a lower cost – HOW TO ACHIEVE THAT?
growth abnormality in children: Body growth and Skull shrink
John Lepore, MD, CEO, ProFound Therapeutics;, CEO-Partner, Flagship Pioneering
Pathway, targeting therapy to patients in a System biological approach
Database of systme biology has missing components not included in the Human genome project – completion of the Data
Definition of End points needs revisiting
Identifying specific populations vs getting quickly to market
Diseases of aging: Muscles diseases – how to promote improvement in muscle mass
CONCLUSIONS
Gray Tsunami
Brain health
Cancer treatment paradigm shift
Fibrosis in many diseases
infectious disease in changing World
Equity in HC
Clinical Data is VAST
Systemic view of Human disease
New approaches to Psychaitry
Rare disease treatment needs a charter
In addition,
new generation of pain treatment
skin treatment new drugs
Chronic disease: improve treatment and prevention.
Tazeen Ahmad, SMid-Cap Biotech Analyst, BofA Global Research
FDA sets criteria – How is that done?
Autoimmune disease therapies – What is in the horizon?
Paul Anderson, MD, PhD, Chief Academic Officer, Mass General Brigham;
drug development
drug pricing in Europe
New book
RA needs more medicines
UNCONTROLLED SPREAD
In Uncontrolled Spread, a New York Times Best Seller, Dr. Scott Gottlieb identifies the reasons why the US was caught unprepared for the pandemic and how the country can improve its strategic planning to prepare for future viral threats.
Panelist
Scott Gottlieb, MD, Physician; Former Commissioner, Food and Drug Administration (2017-2019)
FDA approval 1st gene therapy in his tenure
Price of drugs: efficatious vs time to deveop
competitors in the marketplace are there for market share
New Book: Episodes in the FDA, appproval process at FDA, Gene therapy 1st in class approved – a special moment. Back in 1980s era translated to antibodies, to T-cell pioneering work.
Publisher worried it will not sell very well
FDA had concerns about manufacturing aspects
In 2024 we understand Biologics on novel platforms
Worries that Medicare will not reimbursement and cover the new therapies: Cell therapy
Statins approval had a known very large market vs Cell therapy not known which Cancer patients will benefit???
Black box involved in Autoimmune, studies bring exciting results
In 2018 – needs arise for early approved of drugs in AD, amyloid plaque – change in thinking and is controversial
In early 2020, change in settings of clinical trials, placido no more the only way for Randomized trials
Approval for AD drug vs othe indication – the process is difference (DMD a case to think about)
AI & NLP: Train on data of 10,000 lesions
FDA choose not to regulate AI the physician is in the Middle
Who is wrong: CHatGPT or the clinician ?
Data set on gene may represents NEW biologies that Physicians had not seen before
Data validation on medical devices and their approval after regulating them
Diagnostics tests: Validation Panels are involved
Regulated on input data vs Output data and validate the input data
Platforms are needed for regulation of AI involvement in the drug discovery and the drug approval process
investment in this platforms will be done by Whom?? It will come
Framework for AI at FDA: Regulatory gray data for applications and standards for output – not a novel regulatory concept
If AI will be applied widely, I/O accuracy is a must have
may be achievable soon?
FDA is evolutionary organization in its decision process NOT a REVOLUTIONARY organization. Simulation work started in 2003, 40 people doing that then.
Recently, new team in Agency working of Safety with tools and technologies that are common in Science – Approvals to drug labels and off labels that 20 years ago would not have happened
Tolerance for higher prices is to support Private sector that brings the innovating drugs to market
Chief Medical & Digital Officer, UC San Diego Health
Kevin Mahoney
CEO, University of Pennsylvania Health System
Niall Martin, PhD
CEO, Artios Pharma
James Mawson
CEO, Global Corporate Venturing
Mark McKenna
Chairman & CEO, Mirador Therapeutics
Jane Moran
Chief Information and Digital Officer, Mass General Brigham
William Morris, MD
Chief Medical Information Officer, Google Cloud
Rohan Palekar
CEO, 89bio
Raju Prasad, PhD
Chief Financial Officer, CRISPR Therapeutics
Xiayang Qiu, PhD
CEO, Regor Therapeutics
Harith Rajagopalan MD, PhD
CEO & Co-Founder, Fractyl Health
Shiv Rao, MD
CEO & Founder, Abridge
Kerry Ressler, MD, PhD
Chief Scientific Officer, McLean Hospital; Professor of Psychiatry, Harvard Medical School
Matthew Roden, PhD
President & CEO, Aktis Oncology
Sandi See Tai, MD
Chief Development Officer, Lexeo Therapeutics
Samantha Singer
President & CEO, Abata Therapeutics
Joanne Smith-Farrell, PhD
CEO & Director, Be Biopharma
Emma Somers-Roy
Chief Investment Officer, Mass General Brigham
Adam Steensberg, MD
President & CEO, Zealand Pharma
Tadaaki Taniguchi, MD, PhD
Chief Medical Officer, Astellas Pharma
Elsie Taveras, MD
Chief Community Health & Health Equity Officer, Mass General Brigham; Conrad Taff Endowed Chair and Professor of Pediatrics, Harvard Medical School
Jo Viney, PhD
Cofounder, President & CEO, Seismic Therapeutic
Ron Walls, MD
Chief Operating Officer, Mass General Brigham; Neskey Family Professor of Emergency Medicine, Harvard Medical School
Christophe Weber
President & CEO, Takeda
Fraser Wright, PhD
Chief Gene Therapy Officer, Kriya Therapeutics
Speakers
Anna Åsberg
Vice President, AstraZeneca Pharmaceuticals
Tazeen Ahmad
SMid-Cap Biotech Analyst, BofA Global Research
Jessica Allegretti, MD
Director, Crohn’s and Colitis Center, Brigham and Women’s Hospital; Associate Professor of Medicine, Harvard Medical School
Rox Anderson, MD
Lancer Endowed Chair of Dermatology; Director, Wellman Center for Photomedicine, MGH; Professor of Dermatology, HMS
Katherine Andriole, PhD
Director of Academic Research and Education, Mass General Brigham Data Science Office; Associate Professor, Harvard Medical School
Caroline Apovian, MD
Co-Director, Center for Weight Management and Wellness, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School
Vanita Aroda, MD
Director, Diabetes Clinical Research, Brigham and Women’s Hospital; Associate Professor, Harvard Medical School
Natalie Artzi, PhD
Associate Professor of Medicine, Brigham and Women’s Hospital & Harvard Medical School
John Bishai, PhD
Global Healthcare Investment Banking, BofA Securities
David Blumenthal, MD
Professor of Practice of Public Health and Health Policy, Harvard TH Chan School of Public Health; Research Fellow, Harvard Kennedy School of Government; Samuel O. Thier Professor of Medicine, Emeritus, Harvard Medical School
Giles Boland, MD
President, Brigham and Women’s Hospital and Brigham and Women’s Physicians Organization; Philip H. Cook Distinguished Professor of Radiology, Harvard Medical School
Andrew Bressler
Washington Healthcare Policy Analyst, BofA Global Research
James Brink, MD
Enterprise Chief, Radiology, Mass General Brigham; Juan M. Taveras Professor of Radiology, Harvard Medical School
David Brown, MD
President, Academic Medical Centers, Mass General Brigham; Mass General Trustees Professor of Emergency Medicine, Harvard Medical School
Tyler Bryson
Corporate Vice President, US Health & Public Sector Industries, Microsoft Corporation
Jonathan Carlson, MD, PhD
Director of Chemistry, Center for Systems Biology, Massachusetts General Hospital; Assistant Professor of Medicine, Harvard Medical School
Miceal Chamberlain
President of Massachusetts, Bank of America
Moitreyee Chatterjee-Kishore, PhD
Head of Development, Immuno-Oncology and Cancer Cell Therapy, Astellas Pharma Inc.
Dong Feng Chen, MD, PhD
Associate Scientist, Massachusetts Eye and Ear; Associate Professor, Harvard Medical School
Jasmeer Chhatwal, MD, PhD
Associate Neurologist, Massachusetts General Hospital; Associate Professor of Neurology, Harvard Medical School
E. Antonio Chiocca, MD, PhD
Chair, Department of Neurosurgery, Brigham and Women’s Hospital; Harvey W. Cushing Professor of Neurosurgery, Harvard Medical School
Bryan Choi, MD, PhD
Associate Director, Center for Brain Tumor Immunology and Immunotherapy, Massachusetts General Hospital; Assistant Professor of Neurosurgery, Harvard Medical School
Deepak Chopra, MD
Founder, The Chopra Foundation
Yolonda Colson, MD, PhD
Chief, Division of Thoracic Surgery, Massachusetts General Hospital; Hermes C. Grillo Professor of Surgery, Harvard Medical School
Chad Cowan, PhD
Executive Advisor, Century Therapeutics
Cristina Cusin, MD
Director, MGH Ketamine Clinic and Psychiatrist, Depression Clinical and Research Program, Massachusetts General Hospital; Associate Professor in Psychiatry, Harvard Medical School
Nicole Davis, PhD
Biomedical Communications
Marcela del Carmen, MD
President, Massachusetts General Hospital and Massachusetts General Physicians Organization (MGPO); Executive Vice President, Mass General Brigham; Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School
Gerard Doherty, MD
Surgeon-in-Chief, Mass General Brigham Cancer; Surgeon-in-Chief, Brigham and Women’s Hospital; Moseley Professor of Surgery, Harvard Medical School
Liz Everett Krisberg
Head of Bank of America Institute
Maurizio Fava, MD
Chair, Department of Psychiatry, Massachusetts General Hospital; Slater Family Professor of Psychiatry, Harvard Medical School
Keith Flaherty, MD
Director of Clinical Research, Mass General Cancer Center; Professor of Medicine, Harvard Medical School
Jose Florez, MD, PhD
Physician-in-Chief and Chair, Department of Medicine, Massachusetts General Hospital; Professor, Harvard Medical School
Jean-François Formela, MD
Partner, Atlas Venture
Fritz François, MD
Executive Vice President and Vice Dean, Chief of Hospital Operations, NYU Langone Health
Joanna Gajuk
Health Care Facilities and Managed Care Analyst, BofA Global Research
Jason Gerberry
Specialty Pharma and SMid-Cap Biotech Analyst, BofA Global Research
Gad Getz, PhD
Director of Bioinformatics, Krantz Center for Cancer Research and Department of Pathology; Paul C. Zamecnik Chair in Cancer Research, Mass General Cancer Center; Professor of Pathology, Harvard Medical School
Alexandra Golby, MD
Neurosurgeon; Director of Image-guided Neurosurgery, Brigham and Women’s Hospital; Professor of Neurosurgery, Professor of Radiology, Harvard Medical School
Allan Goldstein, MD
Chief of Pediatric Surgery, Massachusetts General Hospital; Surgeon-in-Chief, Mass General for Children; Marshall K. Bartlett Professor of Surgery, Harvard Medical School
Scott Gottlieb, MD
Physician; Former Commissioner, Food and Drug Administration (2017-2019)
David Grayzel, MD
Partner, Atlas Venture
Steven Greenberg, MD
Neurologist, Brigham and Women’s Hospital; Professor of Neurology, Harvard Medical School
Steven Grinspoon, MD
Chief, Metabolism Unit, Massachusetts General Hospital; Professor of Medicine, Harvard Medical School
Daphne Haas-Kogan, MD
Chief, Enterprise Radiation Oncology, Mass General Brigham; Professor, Harvard Medical School
Roger Hajjar, MD
Director, Gene & Cell Therapy Institute, Mass General Brigham
John Hanna, MD, PhD
Associate Professor, Brigham and Women’s Hospital & Harvard Medical School
Yvonne Hao
Secretary of Economic Development, Commonwealth of Massachusetts
Nobuhiko Hata PhD
Director, Surgical Navigation and Robotics Laboratory, Brigham and Women’s Hospital; Professor of Radiology, Harvard Medical School
Maura Healey
Governor of the Commonwealth of Massachusetts
Elizabeth Henske, MD
Director, Center for LAM Research and Clinical Care, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School
Leigh Hochberg MD, PhD
Director of Neurotechnology and Neurorecovery, Massachusetts General Hospital; Senior Lecturer on Neurology, Harvard Medical School
Daphne Holt, MD, PhD
Director of the Resilience and Prevention Program, Massachusetts General Hospital; Associate Professor of Psychiatry, Harvard Medical School
Susan Huang, MD
EVP, Chief Executive, Providence Clinical Network, Providence Southern CA
Keith Isaacson, MD
Director of Minimally Invasive Gynecologic Surgery and Infertility, Newton Wellesley Hospital; Associate Professor of Obstetrics, Gynecology and Reproductive Biology, Harvard Medical School
Ole Isacson, MD-PhD
Founding Director, Neuroregeneration Research Institute, McLean Hospital; Professor of Neurology and Neuroscience, Harvard Medical School
Haim Israel
Head of Global Thematic Investing Research, BofA Global Research
Farouc Jaffer, MD, PhD
Director, Coronary Intervention, Massachusetts General Hospital; Associate Professor of Medicine, Harvard Medical School
Russell Jenkins, MD, PhD
Krantz Family Center for Cancer Research, Massachusetts General Hospital; Mass General Cancer Center, Center for Melanoma; Assistant Professor of Medicine, Harvard Medical School
Hadine Joffe, MD
Executive Director of the Connors Center for Women’s Health and Gender Biology; Interim Chair, Department of Psychiatry, Brigham and Women’s Hospital; Paula A. Johnson Professor of Psychiatry in the Field of Women’s Health, Harvard Medical School
Benjamin Kann, MD
Assistant Professor, Brigham and Women’s Hospital & Harvard Medical School
Tatsuo Kawai, MD, PhD
Director of the Legorreta Center for Clinical Transplantation Tolerance, A.Benedict Cosimi Chair in Transplant Surgery, Massachusetts General Hospital; Professor of Surgery, Harvard Medical School
Albert Kim, MD
Assistant Physician, Mass General Cancer Center; Assistant Professor, Harvard Medical School
Roger Kitterman
Senior Vice President, Ventures and Business Development & Licensing, Mass General Brigham Managing Partner, Mass General Brigham Ventures
Lotte Bjerre Knudsen, DMSc
Chief Scientific Advisor, Novo Nordisk
Vesela Kovacheva, MD, PhD
Director of Translational and Clinical Research, Mass General Brigham; Assistant Professor of Anesthesia, Harvard Medical School
Jonathan Kraft
President, The Kraft Group; Board Chair, Massachusetts General Hospital
John Krystal, MD
Chair, Department of Psychiatry, Yale School of Medicine
Daniel Kuritzkes, MD
Chief, Division of Infectious Diseases, Brigham and Women’s Hospital; Harriet Ryan Albee Professor of Medicine, Harvard Medical School
Bruce Levy, MD
Physician-In-Chief and Co-Chair, Department of Medicine, Brigham and Women’s Hospital; Parker B. Francis Professor of Medicine, Harvard Medical School
Katherine Liao, MD
Associate Physician, Department of Rheumatology, Inflammation, and Immunity, Brigham and Women’s Hospital; Associate Professor of Medicine and Biomedical Informatics, Harvard Medical School
David Louis, MD
Enterprise Chief, Pathology, Mass General Brigham Benjamin Castleman Professor of Pathology, Harvard Medical School
Tim Luker, PhD
VP, Ventures & West Coast Head, Eli Lilly
Andrew Luster, MD, PhD
Chief, Division of Rheumatology, Allergy and Immunology; Director, Center for Immunology and Inflammatory Diseases, Massachusetts General Hospital; Persis, Cyrus and Marlow B. Harrison Professor of Medicine, Harvard Medical School
Allen Lutz
Health Care Services Analyst, BofA Global Research
Calum MacRae MD, PhD
Vice Chair for Scientific Innovation, Department of Medicine, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School
Joren Madsen, MD, PhD
Director, MGH Transplant Center; Paul S. Russell/Warner-Lambert Professor of Surgery, Harvard Medical School
Faisal Mahmood, PhD
Associate Professor, Brigham and Women’s Hospital & Harvard Medical School
Peter Marks, MD, PhD
Director, Center for Biologics Evaluation and Research, FDA
Marcela Maus, MD, PhD
Director of Cellular Therapy and Paula O’Keeffe Chair in Cancer Research, Krantz Family Center for Cancer Research and Mass General Cancer Center; Associate Director, Gene and Cell Therapy Institute, Mass General Brigham; Associate Professor, Harvard Medical School
Thorsten Mempel, MD, PhD
Associate Director, Center for Immunology and Inflammatory Diseases, Massachusetts General Hospital; Professor of Medicine, Harvard Medical School
Rebecca Mishuris, MD
Chief Medical Information Officer, Mass General Brigham; Member of the Faculty, Harvard Medical School
Pradeep Natarajan, MD
Director of Preventive Cardiology, Paul & Phyllis Fireman Endowed Chair in Vascular Medicine, Massachusetts General Hospital; Associate Professor of Medicine, Harvard Medical School
Nawal Nour, MD
Chair, Department of Obstetrics and Gynecology, Brigham and Women’s Hospital; Associate Professor, Kate Macy Ladd Professorship, Harvard Medical School
Heather O’Sullivan, MS, RN, AGNP
President, Mass General Brigham Healthcare at Home
Anne Oxrider
Senior Vice President, Benefits Executive, Bank of America
Claire-Cecile Pierre, MD
Vice President, Community Health Programs, Mass General Brigham; Instructor in Medicine, Harvard Medical School
Richard Pierson III, MD
Scientific Director, Center for Transplantation Sciences, Massachusetts General Hospital; Professor of Surgery, Harvard Medical School
Mark Poznansky, MD, PhD
Director, Vaccine and Immunotherapy Center, Massachusetts General Hospital; Steve and Deborah Gorlin MGH Research Scholar; Professor of Medicine, Harvard Medical School
Yakeel Quiroz, PhD
Director, Familial Dementia Neuroimaging Lab and Director, Multicultural Alzheimer’s Prevention Program, Massachusetts General Hospital; Paul B. and Sandra M. Edgerley MGH Research Scholar; Associate Professor, Harvard Medical School
Heidi Rehm, PhD
Chief Genomics Officer, Massachusetts General Hospital; Professor of Pathology, Harvard Medical School
Leonardo Riella, MD, PhD
Medical Director of Kidney Transplantation, Massachusetts General Hospital; Harold and Ellen Danser Endowed Chair in Transplantation, Harvard Medical School
Jorge Rodriguez, MD
Clinician-investigator, Brigham and Women’s Hospital; Assistant Professor, Harvard Medical School
Adam Ron
Health Care Facilities and Managed Care Analyst, BofA Global Research
David Ryan, MD
Physician-in-Chief, Mass General Brigham Cancer; Professor of Medicine, Harvard Medical School
Michael Ryskin
Life Science Tools & Diagnostics Analyst, BofA Global Research
Alkesh Shah
Head of US Equity Software Research, BofA Global Research
Angela Shen, MD
Vice President, Strategic Innovation Leaders, Mass General Brigham Innovation
Gregory Simon
President, Simonovation
Prabhjot Singh, MD, PhD
Senior Advisor, Strategic Initiatives Peterson Health Technology Institute
Brendan Singleton
Healthcare Equity Capital Markets, BofA Securities
Caroline Sokol, MD, PhD
Assistant Physician, Massachusetts General Hospital; Assistant Professor, Harvard Medical School
Daniel Solomon, MD
Matthew H. Liang Distinguished Chair in Arthritis and Population Health, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School
Scott Solomon, MD
Director, Clinical Trials Outcomes Center; Edward D. Frohlich Distinguished Chair in Cardiovascular Pathophysiology, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School
Fatima Cody Stanford, MD
Obesity Medicine Physician Scientist, Massachusetts General Hospital; Associate Professor of Medicine and Pediatrics, Harvard Medical School
Shannon Stott, PhD
Associate Investigator, Krantz Family Center for Cancer Research and Mass General Cancer Center; d’Arbeloff Research Scholar, Massachusetts General Hospital; Associate Investigator, Krantz Family Center for Cancer Research Harvard Medical School
Alec Stranahan, PhD
SMid-Cap Biotech Analyst, BofA Global Research
Marc Succi, MD
Executive Director, Mass General Brigham MESH Incubator; Associate Chair of Innovation & Commercialization, Mass General Brigham Radiology; Assistant Professor, Harvard Medical School
Guillermo Tearney, MD, PhD
Principal Investigator, Wellman Center for Photomedicine, Massachusetts General Hospital; Remondi Family Endowed MGH Research Institute Chair; Professor of Pathology, Harvard Medical School
David Ting, MD
Associate Clinical Director for Innovation, Mass General Cancer Center; Associate Professor of Medicine, Harvard Medical School
Raul Uppot, MD
Interventional Radiologist, Massachusetts General Hospital; Associate Professor, Harvard Medical School
Chris Varma, PhD
Co-founder, Chairman & CEO, Frontier Medicines
Kaveeta Vasisht, MD, PharmD
Associate Commissioner, Women’s Health, U.S. Food and Drug Administration
Alexandra-Chloé Villani PhD
Investigator, Massachusetts General Hospital; Assistant Professor, Harvard Medical School
Kate Walsh
Secretary of Health and Human Services, State of Massachusetts
David Walt, PhD
Professor of Pathology, Brigham and Women’s Hospital; Hansjörg Wyss Professor of Biologically Inspired Engineering, Harvard Medical School
The Continued Impact and Possibilities of AI in Medical and Pharmaceutical Industry Practices
Reporter: Adam P. Tubman, MSc Biotechnology, Research Associate 3, Computer Graphics and AI in Drug Discovery
Researchers have been able to discover many ways to incorporate AI into the practices of healthcare, both in terms of medical healthcare and also in pharmaceutical drug development. For example, given the situation where a doctor provides an inaccurate diagnosis to a patient because the doctor had an incomplete or inaccurate medical record/history, AI presents a solution that has the potential to rapidly and correctly account for human error and predict the correct diagnosis based on the patterns identified in other patient’s medical history to disease diagnosis indication. In the pharmaceutical industry, companies are changing and expanding approaches to drug discovery and development given the possibilities that AI can offer. One company, Reverie Labs, located in Cambridge, MA, is a pharmaceutical company utilizing AI for application of machine learning and computational chemistry to discover new possible compounds to be used in the development of cancer treatments.
Today, AI uses have had many other applications in medicine including managing healthcare data and performing robotic surgery, both of which transform the in-person patient and doctor experience. AI has even been used to change in-person cancer patient experiences. For example, Freenome, a company in San Francisco, CA uses AI in initial screenings, blood tests and diagnostic tests when a patient is being initially tested for cancer. The hope is that this technology will aide in speeding up cancer diagnoses and lead to new treatment developments.
The future will continue to bring many possibilities of AI, provided an acceptable level of accuracy is still maintained by AI technologies and that the technology remains beneficial. If research continues to focus on diagnosing diseases at a faster rate given the potential human errors in having an inaccurate or incomplete medical record upon diagnosis, AI could provide an improved experience for patients given the quicker diagnosis and treatment combined with less time spent either treating the wrong underlying condition or not knowing what condition to treat when accounting for an incomplete medical record. If this technology is proven to be successful not just in theory, but in practice, technology would then be available and could be beneficially applied to all diagnoses and treatment plans, across the world.
However, the reality regarding AI development is that its evolution depends on how much human effort is involved in its development. Therefore, the world won’t know or see the full benefits of AI until it is developed and actively applied. Similarly, the impact that AI will have in medical and pharmaceutical practices won’t be known until scientists fully develop and apply the technologies. Many possibilities, including a possible drastic lowering of the cost for pharmaceutical drugs across the board once drugs are much more readily discovered and produced, may carry a profound benefit to patients who currently struggle to afford their own treatment plans. Additionally, unforeseen advances in the medicinal and pharmaceutical fields because of AI development will lead to unforeseen effects on the global economy and many other life changing variables for the entire world.
For more information on this topic, please check out the article below.
Optimism for Future Equality of Access to Healthcare in the Inaugural address as AMA President, Jesse M. Ehrenfeld, MD, MPH | AMA 2023 Annual Meeting of House of Delegates
In his inaugural address as AMA President, Jesse M. Ehrenfeld, MD, MPH, highlights the need for a more inclusive and equitable future in medicine. He shares personal experiences of discrimination and emphasizes the importance of advocacy, addressing health disparities, and fighting against disinformation to ensure equitable care for all patients.
Health Care Policy Analysis derived from the Farewell remarks from AMA President Jack Resneck Jr., MD | AMA 2023 Annual Meeting
Curators: Aviva Lev-Ari, PhD, RN, Stephen J. Williams, PhD and Prof. Marcus W. Feldman
Article ID #301: Health Care Policy Analysis derived from the Farewell remarks from AMA President Jack Resneck Jr., MD | AMA 2023 Annual Meeting. Published on 6/10/23
WordCloud Image Produced by Adam Tubman
Bot Name: ChatGPT, GPT-4
Date of Update: 07/03/2023 Programmer’s Name: Frason K. Human Verifier: Aviva Lev-Ari & Dr. Stephen J. Williams
On June 10, 2023, I watched the video, below which represents the delivery of the Farewell remarks from AMA by the AMA President, Jack Resneck Jr., MD at the AMA 2023 Annual Meeting on 6/10/2023.
Upon completion of watching this video, I concluded that I should include it as an embedded video in this article as a new Audio Podcast in our Library of 300 “Interviews with Scientific Leaders” same title of a research category in the ontology of LPBI Group’s PharmaceuticalIntelligence.com Journal.
The context for the decision made in favor of embedding the video of AMA President, Jack Resneck Jr., MD, Farewell remarks from AMA at the AMA 2023 Annual Meeting on 6/10/2023 is one of Policy Analysis of the Health Care system in the US in 2023.
Aligned with this decision was to qualify Dr. Resneck Jr, MD speech to be an equivalent to an “Interview with a Scientific Leader in the domain of Health Policy” to be included in LPBI Group’s Library of 300 audio podcast Interviews planned to be published in July 2023.
Key points made by Dr. Resneck Jr, MD in the video
growing number of states and courts forcing themselves into the most intimate and difficult conversations patients and physicians
The challenges facing the medical profession and delivery of care by Providers:
A dysfunctional health care environment, and
The climate of anti-science aggression
In his own words: Dr. Resneck Jr, MD
We need to fix what’s broken in health care, and it’s NOT the doctor.
The Wisconsin Supreme Court agreed with us that patients and judges can’t force physicians to administer substandard care.
Courts have invalidated parts of No Surprises Act rules that plainly ignored Congressional intent and put a thumb on the scale to favor insurance companies… thank you Texas Medical Association and AMA!
The 5th Circuit Court is staying- for now – an egregious ruling that would have stripped patients of the right to access preventive care service with no out-of-pocket costs, a key piece of the Affordable Care Act.
The U.S. Supreme Court is delaying attempts by a single district judge with no scientific or medical training to take mifepristone off the market nationally and upend our entire FDA drug regulatory process.
We’ve helped shift the national conversation about protecting patient data and making sure digital health and AI tools are proven BEFORE being deployed.
We’ve broadened and intensified our work to embed equity and racial justice, and to push upstream to affect structural and social drivers of health inequities.
The AMA doesn’t win every battle. But we are more resolute in our work because of the threats to our profession and our patients.
I’m still appalled by the Medicare cuts. What on earth was Congress thinking? Practices are on the brink. Our workforce is at risk. Access to care stands in the balance
Physician burnout
One in five physicians plans to leave their practice within two years, while one in three is reducing hours.
Only 57 percent of doctors today would choose medicine again if they were just starting their careers.
two in five physicians go beyond mere daydreams of another career to wishing they had never chosen this path in the first place
And shame on political leaders, fueling fear and sowing division by making enemies of public health officials, of transgender adolescents, of physicians doing anti-racism work, and of women making personal decisions about their pregnancies.
The burnout and the moral injury are real … I’ve felt it myself. I hear this concern in the voices of medical students, residents, and even young physicians when they ask me … “Am I going to be okay?” “Have I made the right career choice?”
Medicare payment reform for “a dilapidated Medicare payment system”
fighting for long overdue fixes to a broken Medicare payment system, and obnoxious prior auth abuses, even when policymakers have neglected the problems for decades.
We absolutely must tie future Medicare payments to inflation, and we’re readying a major national campaign to finally achieve Congressional action.
Linking physician payment to inflation is an absolute top priority, an existential must to keep practices afloat, and pillar #1 of our plan. An important step on that path was the recent introduction of a bipartisan bill to finally align the Medicare fee schedule with MEI.
key role in legislation to extend Medicare Telehealth coverage.
State after state is making progress to constrain prior authorization, and CMS issued rules to do the same in Medicare Advantage plans.
Medicaid work requirements that conflict with AMA policy were kept out of the debt ceiling bill.
Scope of practice expansions
In partnership with states and specialties, our advocacy has helped protect patients from outrageous and broad scope expansions more than 50 times so far this year.
defending against broad scope expansions that put patients at risk, even when it requires gearing up again and again, in state after state.
When politicians force their way into our exam rooms Interfering with the sacred patient-doctor relationship is about CONTROL. : battling in state legislatures and courthouses for the very soul of our nation and our profession – to protect patients from those outside influences wanting to dictate the terms of their care … …telling them what medical treatments their physicians can provide … …what FDA-approved medicines we can prescribe…. …even what words we can use …
I loved traveling to Mississippi and witnessing their progress from startling COVID inequities to achieving one of the nation’s top vaccination rates among Black residents.
And we have been instrumental in helping create confidential wellness programs for physicians and removing outdated questions from past impairment from licensing and credentialing forms.
Gun Violence Victims – Preventable and needless homicides and suicides continue, and the political inaction is atrocious.
But solid majorities of Americans believe in commonsense gun reforms in line with our AMA recommendations.
You wouldn’t know it from 20 state legislatures racing to criminalize abortion and rob women of access to reproductive health care… But most people in this country support our policies and the fundamental rights of patients to make their own decisions about their health.
>> Insurance impact on delivery of care by providers
m health insurers still bullying us with prior auth delays and denying care …
We’ve joined others in suing Cigna for shortchanging doctors and patients.
The Voice of Dr. Stephen J. Williams
The outgoing president of the AMA, Dr. Jack Resneck, gives an impassioned speech about his concerns for the present and future of medicine, his profession, and the issues which will face future physicians, and all involved in healthcare. These issues have been building up for decades now in the U.S. and his remarks hopefully will be taken more to heart by those who can enact change, instead of wafting in the ongoing partisan debates in Washington. He eventually outlines the actions which could be taken but ultimately laments the inaction of many parties involved, including business, the political class, and his own physician profession. Dr. Resneck rightly states that the AMA must carry the burden of equitable and sustainable healthcare into the future and must continue the fight in this regard. He likens this fight for equitable and sustainable medicine like a marathon, where there is no defined end, no finish tape for medical professionals except to persevere in their task.
However, there are more extraneous issues to the profession where the physician has to
get back up, shake the dust off, and keep running
He notes some of the problems occurring not in direct control of the profession are
the constant onslaught and tiresome battle against disinformation
large insurers
a political class that has jeapardized the physician/patient relationship with either their action and inaction
the financial burdens placed on the small physician practice of rising third party “inflators” like higher rents, increased drug prices, higher operating costs
These laments have been felt by many parallel professions where the standards and practice to the profession have been subjugated and hijacked by other outside interests (middle men). And when the ultimate decisions of conduct are not governed by the constituents or stakeholders of the profession but by a cadre of business people, profiteers or social engineers problems like this result. As such, Dr. Resneck sees the draconian Medicare cuts as such an onslaught. This has been voiced in an earlier posting describing how these problems have crept in the biomedicine and biotech field as well as in medical care in Can the Public Benefit Company Structure Save US Healthcare?
One must consider then, as Dr. Resneck had, is it time to reinvent the healthcare structure in this country to allow more equitable, sustainable delivery of healthcare and to stave off a potential crisis in the number of physicians staying in the profession? As such he had suggested the AMA move forward with their “revival plan” in order to force legislation to reform Medicare as well as individual regulatory reform. To date there has been some success by the AMA to this effect, but as he eluded to, these efforts have been rather piecemeal instead of an overall reform.
The Voice of Aviva Lev-Ari, PhD, RN
Gun Violence, all should not have to happen and burden the care delivery system designed to deal with chronic and acute diagnoses.
As Supervisor of a Long Term Acute Hospital in Waltham, MA in 2010:
I became familiar with care plans of patients victims of gun violence and the life long disabilities cause by ONE gun shot to the brain or to the spine. Accidents that are preventable and needless.
I found Dr. Resneck’s address to be a call for continuation of a long term fight the AMA is involved in, with all the constituents of the Medical profession. They are very many and very powerful:
Big Pharma,
FDA,
State and Federal legislators,
HMOs,
Health Insurers,
For-profit, and
not-for-profit institutions
all having interests that are private and public and often conflicting ones, chiefly are the following:
Gun reforms made impossible by The National Rifle Association (NRA)’s supporters linking the defense to bear arms with the Constitution
20 state legislatures racing to criminalize abortion and rob women of access to reproductive health care…
Drug pricing and Insurance denying coverage
Need for redesign of the Curriculum of in Medical School to include the rapid change in technology, medical devices, knowledge base in life sciences and more
Dr Resneck’s talk has three components: two are rather pessimistic and concern Medicine as a profession and Health-care as a goal of medicine. The positive part, which was quite brief, concerned the continuing work of the AMA in its advocacy for better conditions for physicians and for a more equitable distribution of health care.
Medicine as a part of science continues to be assailed by anti-science political groups. 57% of doctors surveyed said they would not choose Medicine as a profession if given the chance to relive their lives. Part of this is the failure of Medicare and other insurance mechanisms to properly compensate physicians. Part is due to attacks on the profession by anti-science anti education social media and state legislatures. Whereas Medicine was once the profession of choice for the best students, universities are seeing the premed majors overtaken by computer-related fields. Dr. Resneck also referred to the importance of maintaining high standards of medical ethics, which is increasingly difficult in today’s political and economic climate.
With respect to the specifics of health care, Dr. Resneck stressed the attack on the medical professions by laws and regulations that outlaw people rights to their own bodies, manifest in anti-abortion and anti-gender affirming procedures, anti-education book banning, political opposition to measures, supported by the majority of Americans, that would reduce gun violence, and the difficulty of achieving improvements in government procedures for reimbursement of health care services. The AMA is involved in trying to elicit medically sound decisions on these.
Dr Resneck was positive, if not very optimistic about the AMA’s important role in advocacy for reform of Medicare and the Health-Care system, reform that is essential for the sustainability of Medicine as a profession.
We recommend AMA to add to their Library resources from LPBI Group:
Big pharma companies are snapping up collaborations with firms using AI to speed up drug discovery, with one of the latest being Sanofi’s pact with Exscientia.
Tech giants are placing big bets on digital health analysis firms, such as Oracle’s €25.42B ($28.3B) takeover of Cerner in the US.
There’s also a steady flow of financing going to startups taking new directions with AI and bioinformatics, with the latest example being a €20M Series A round by SeqOne Genomics in France.
“IBM Watson uses a philosophy that is diametrically opposed to SeqOne’s,” said Jean-Marc Holder, CSO of SeqOne. “[IBM Watson seems] to rely on analysis of large amounts of relatively unstructured data and bet on the volume of data delivering the right result. By opposition, SeqOne strongly believes that data must be curated and structured in order to deliver good results in genomics.”
Francisco Partners is picking up a range of databases and analytics tools – including
Health Insights,
MarketScan,
Clinical Development,
Social Programme Management,
Micromedex and
other imaging and radiology tools, for an undisclosed sum estimated to be in the region of $1 billion.
IBM said the sell-off is tagged as “a clear next step” as it focuses on its platform-based hybrid cloud and artificial intelligence strategy, but it’s no secret that Watson Health has failed to live up to its early promise.
The sale also marks a retreat from healthcare for the tech giant, which is remarkable given that it once said it viewed health as second only to financial services market as a market opportunity.
IBM said it “remains committed to Watson, our broader AI business, and to the clients and partners we support in healthcare IT.”
The company reportedly invested billions of dollars in Watson, but according to a Wall Street Journal report last year, the health business – which provided cloud-based access to the supercomputer and a range of analytics services – has struggled to build market share and reach profitability.
An investigation by Stat meanwhile suggested that Watson Health’s early push into cancer for example was affected by a premature launch, interoperability challenges and over-reliance on human input to generate results.
For its part, IBM has said that the Watson for Oncology product has been improving year-on-year as the AI crunches more and more data.
That is backed up by a meta analysis of its performance published last year in Nature found that the treatment recommendations delivered by the tool were largely in line with human doctors for several cancer types.
However, the study also found that there was less consistency in more advanced cancers, and the authors noted the system “still needs further improvement.”
Watson Health offers a range of other services of course, including
tools for genomic analysis and
running clinical trials that have found favour with a number of pharma companies.
Francisco said in a statement that it offers “a market leading team [that] provides its customers with mission critical products and outstanding service.”
The deal is expected to close in the second quarter, with the current management of Watson Health retaining “similar roles” in the new standalone company, according to the investment company.
IBM’s step back from health comes as tech rivals are still piling into the sector.
@pharma_BI is asking: What will be the future of WATSON Health?
@AVIVA1950 says on 1/26/2022:
Aviva believes plausible scenarios will be that Francisco Partners will:
A. Invest in Watson Health – Like New Mountains Capital (NMC) did with Cytel
B. Acquire several other complementary businesses – Like New Mountains Capital (NMC) did with Cytel
C. Hold and grow – Like New Mountains Capital (NMC) is doing with Cytel since 2018.
D. Sell it in 7 years to @Illumina or @Nvidia or Google’s Parent @AlphaBet
1/21/2022
IBM said Friday it will sell the core data assets of its Watson Health division to a San Francisco-based private equity firm, marking the staggering collapse of its ambitious artificial intelligence effort that failed to live up to its promises to transform everything from drug discovery to cancer care.
IBM has reached an agreement to sell its Watson Health data and analytics business to the private-equity firm Francisco Partners. … He said the deal will give Francisco Partners data and analytics assets that will benefit from “the enhanced investment and expertise of a healthcare industry focused portfolio.”5 days ago
5 days ago — IBM has been trying to find buyers for the Watson Health business for more than a year. And it was seeking a sale price of about $1 billion, The …Missing: Statement | Must include: Statement
5 days ago — IBM Watson Health – Certain Assets Sold: Executive Perspectives. In a prepared statement about the deal, Tom Rosamilia, senior VP, IBM Software, …
Feb 18, 2021 — International Business Machines Corp. is exploring a potential sale of its IBM Watson Health business, according to people familiar with the …
3 days ago — Nuance played a part in building watson in supplying the speech recognition component of Watson. Through the years, Nuance has done some serious …
Can the Public Benefit Company Structure Save US Healthcare?
Curator: Stephen J. Williams, Ph.D.
UPDATED 11/05/2023
Public Benefit Corporation structure in healthcare has actually been around since the 1970s in New Yourk State, when New York City’s new Health and Hospitals Corporation took over the city Department of Hospitals and today runs 11 hospitals and four long-term care facitlites in the city. The following link to an article describes however the problems occuring with Nassau and Westchester hosptial systems, which were converted to New York PBC status in the 1990s. As the article states the financial problems in 2004 which these hospitals encountered
do not stem from their unusual status as public benefit corporations, and might have been even worse off had they not converted
The New York Times article of 2004 “At 2 Hospitals, Fiscal Troubles in the Glare of Public View” highlight in fact the growing problem that all hospitals are encountering, especially on the fiscal side. But it does highlight how to better structure these entities and why full commitment to the PBC structure is necessary.
In 2003 New York State had a record closure of hospitals, and in 2004 Nassau and WestChester were having such fiscal problems it threatened the bond status of those counties. Despite the regular problems hospitals had, critics had said there were two major contributing factors to their woes
the two agencies had not completed their transition from government operations to fully competitve hospitals
as a PBC they bear a costly mission of serving the uninsured
As a PBC the structure allows one to shed cumbersome government rules, giving them the flexibility to conduct business like other hospitals.
In addition they are no longer dependent, in fact now forced, to forgo dependence on public funding and look for independent means of investment. With their semi-independence from government the agencies also are more insulted from political pressure.
However this seemed to be the problem. These agencies were still to dependent on their local government and there was still local political influence on their boards.
UPDATED 3/15/2023
According to Centers for Medicare and Medicare Services (CMS.gov) healthcare spending per capita has reached 17.7percent of GDP with, according to CMS data:
From 1960 through 2013, health spending rose from $147 per person to $9,255 per person, an average annual increase of 8.1 percent.
the National Health Expenditure Accounts (NHEA) are the official estimates of total health care spending in the United States. Dating back to 1960, the NHEA measures annual U.S. expenditures for health care goods and services, public health activities, government administration, the net cost of health insurance, and investment related to health care. The data are presented by type of service, sources of funding, and type of sponsor.
Graph: US National Healthcare Expenditures as a percent of Gross Domestic Product from 1960 to current. Recession periods are shown in bars. Note that the general trend has been increasing healthcare expenditures with only small times of decrease for example 2020 in year of COVID19 pandemic. In addition most of the years have been inflationary with almost no deflationary periods, either according to CPI or healthcare costs, specifically.
U.S. health care spending grew 4.6 percent in 2019, reaching $3.8 trillion or $11,582 per person. As a share of the nation’s Gross Domestic Product, health spending accounted for 17.7 percent.
And as this spending grew (demand for health care services) associated costs also rose but as the statistical analyses shows there was little improvement in many health outcome metrics during the same time.
Graph of the Growth of National Health Expenditures (NHE) versus the growth of GDP. Note most years from 1960 growth rate of NHE has always been higher than GDP, resulting in a seemingly hyperinflationary effect of healthcare. Also note how there are years when this disconnect is even greater, as there were years when NHE grew while there were recessionary periods in the general economy.
It appears that US healthcare may be on the precipice of a transformational shift, but what will this shift look like? The following post examines if the corporate structure of US healthcare needs to be changed and what role does a Public Benefit Company have in this much needed transformation.
Hippocratic Oath
I swear by Apollo the physician, and Asclepius, and Hygieia and Panacea and all the gods and goddesses as my witnesses, that, according to my ability and judgement, I will keep this Oath and this contract:
To hold him who taught me this art equally dear to me as my parents, to be a partner in life with him, and to fulfill his needs when required; to look upon his offspring as equals to my own siblings, and to teach them this art, if they shall wish to learn it, without fee or contract; and that by the set rules, lectures, and every other mode of instruction, I will impart a knowledge of the art to my own sons, and those of my teachers, and to students bound by this contract and having sworn this Oath to the law of medicine, but to no others.
I will use those dietary regimens which will benefit my patients according to my greatest ability and judgement, and I will do no harm or injustice to them.
I will not give a lethal drug to anyone if I am asked, nor will I advise such a plan; and similarly I will not give a woman a pessary to cause an abortion.
In purity and according to divine law will I carry out my life and my art.
I will not use the knife, even upon those suffering from stones, but I will leave this to those who are trained in this craft.
Into whatever homes I go, I will enter them for the benefit of the sick, avoiding any voluntary act of impropriety or corruption, including the seduction of women or men, whether they are free men or slaves.
Whatever I see or hear in the lives of my patients, whether in connection with my professional practice or not, which ought not to be spoken of outside, I will keep secret, as considering all such things to be private.
So long as I maintain this Oath faithfully and without corruption, may it be granted to me to partake of life fully and the practice of my art, gaining the respect of all men for all time. However, should I transgress this Oath and violate it, may the opposite be my fate.
Translated by Michael North, National Library of Medicine, 2002.
Much of the following information can be found on the Health AffairsBlog in a post entitled
Limitations of For Profit and Non-Profit Hospitals
For profit represent ~ 25% of US hospitals and are owned and governed by shareholders, and can raise equity through stock and bond markets.
According to most annual reports, the CEOs incorrectly assume they are legally bound as fiduciaries to maximize shareholder value. This was a paradigm shift in priorities of companies which started around the mid 1980s,aphenomenon discussed below.
A by-product of this business goal, to maximize shareholder value, is that CEO pay and compensation is naturally tied to equity markets. A means for this is promoting cost efficiencies, even in the midst of financial hardships.
A clear example of the failure of this system can be seen during the 2020- current COVID19 pandemic in the US. According to the Medicare Payment Advisory Commission, four large US hospitals were able to decrease their operating expenses by $2.3 billion just in Q2 2020. This amounted to 65% of their revenue; in comparison three large NONPROFIT hospitals reduced their operating expense by an aggregate $13 million (only 1% of their revenue), evident that in lean times for-profit will resort to drastic cost cutting at expense of service, even in times of critical demands for healthcare.
Because of their tax structure and perceived fiduciary responsibilities, for-profit organizations (unlike non-profit and public benefit corporations) are not legally required to conduct community health need assessments, establish financial assistance policies, nor limit hospital charges for those eligible for financial assistance. In addition to the difference in tax liability, for-profit, unlike their non-profit counterparts, at least with hospitals, are not funded in part by state or local government. As we will see, a large part of operating revenue for non-profit university based hospitals is state and city funding.
Therefore risk for financial responsibility is usually assumed by the patient, and in worst case, by the marginalized patient populations on to the public sector.
Tax Structure Considerations of for-profit healthcare
Financials of major for-profit healthcare entities (2020 annual)
Non-profit Healthcare systems
Nonprofits represent about half of all hospitals in the US. Most of these exist as a university structure, so retain the benefits of being private health systems and retaining the funding and tax benefits attributed to most systems of higher education. And these nonprofits can be very profitable. After taking in consideration the state, local, and federal tax exemptions these nonprofits enjoy, as well as tax-free donations from contributors (including large personal trust funds), a nonprofit can accumulate a large amount of revenue after expenses. In fact 82 nonprofit hospitals had $33 billion of net asset increase year-over-year (20% increase) from 2016 to 2017. The caveat is that this revenue over expenses is usually spent on research or increased patient services (this may mean expanding the physical infrastructure of the hospital or disseminating internal grant money to clinical investigators, expanding the hospital/university research assets which could result in securing even larger amount of external funding from government sources.
And although this model may work well for intercity university/healthcare systems, it is usually a struggle for the rural nonprofit hospitals. In 2020, ten out of 17 rural hospitals that went under were nonprofits. And this is not just true in the tough pandemic year. Over the past two decades multitude of nonprofit rural hospitals had to sell and be taken over by larger for-profit entities.
Hospital consolidation has led to a worse patient experience and no real significant changes in readmission or mortality data. (The article below is how over 130 rural hospitals have closed since 2010, creating a medical emergency in rural US healthcare)
And according to the article below it is only to get worse
The authors of the Health Affairs blog feel a major disadvantage of both the for-profit and non-profit healthcare systems is “that both face limited accountability with respect to anticompettive mergers and acquisitions.”
More hospital consolidation is expected post-pandemic
Hospital deal volume is likely to accelerate due to the financial damage inflicted by the coronavirus pandemic.
The anticipated increase in volume did not show up in the latest quarter, when deals were sharply down.
The pandemic may have given hospitals leverage in coming policy fights over billing and the creation of “public option” health plans.
Hospital consolidation is likely to increase after the COVID-19 pandemic, say both critics and supporters of the merger-and-acquisition (M&A) trend.
The financial effects of the coronavirus pandemic are expected to drive more consolidation between and among hospitals and physician practices, a group of policy professionals told a recent Washington, D.C.-based web briefing sponsored by the Alliance for Health Policy.
“There is a real danger that this could lead to more consolidation, which if we’re not careful could lead to higher prices,” said Karyn Schwartz, a senior fellow at the Kaiser Family Foundation (KFF).
Schwartz cited a recent KFF analysis of available research that concluded “provider consolidation leads to higher health care prices for private insurance; this is true for both horizontal and vertical consolidation.”
Kenneth Kaufman, managing director and chair of Kaufman Hall, noted that crises tend to push financially struggling organizations “further behind.”
“I wouldn’t be surprised at all if that happens,” Kaufman said. “That will lead to further consolidation in the provider market.”
The initial rounds of federal assistance from the CARES Act, which were based first on Medicare revenue and then on net patient revenue, may fuel consolidation, said Mark Miller, PhD, executive vice president of healthcare for Arnold Ventures. That’s because the funding formulas favored organizations that already had higher revenues, he said, and provided less assistance to low-revenue organizations.
HHS has distributed $116.2 billion from the $175 billion in provider funding available through the CARES Act and the Paycheck Protection Program and Health Care Enhancement Act. The largest distributions used the two revenue formulas cited by Miller.
No surge in M&A yet
The expected burst in hospital M&A activity has yet to occur. Kaufman Hall identified 14 transactions in the second quarter of 2020, far fewer than in the same quarter in any of the four preceding years, when second-quarter transactions totaled between 19 and 31. The latest deals were not focused on small hospitals, with average seller revenue of more than $800 million — far larger than the previous second-quarter high of $409 million in 2018.
Six of the 14 announced transactions were divestitures by major for-profit health systems, including Community Health Systems, Quorum and HCA.
Kaufman Hall’s analysis of the recent deals identified another pandemic-related factor that may fuel hospital M&A: closer ties between hospitals. The analysis cited the example of Lifespan and Care New England, which had suspended merger talks in 2019. More recently, in a joint announcement, the CEOs of the two systems noted that because of the COVID-19 crisis, the two systems “have been working together in unprecedented ways” and “have agreed to enter into an exploration process to understand the pros and cons of what a formal continuation of this collaboration could look like in the future.”
The M&A outlook for rural hospitals
The pandemic has had less of a negative effect on the finances of rural hospitals that previously joined larger health systems, said Suzie Desai, senior director of not-for-profit healthcare for S&P Global.
A CEO of a health system with a large rural network told Kaufman the federal grants that the system received for its rural hospitals were much larger than the grants paid through the general provider fund.
“If that was true across the board, then the federal government recognized that many rural hospitals could be at risk of not being able to make payroll; actually running out of money,” Kaufman said. “And they seem to have bent over backwards to make sure that didn’t happen.”
Other CARES Act funding distributed to providers included:
$12.8 billion for 959 safety net hospitals
$11 billion to almost 4,000 rural healthcare providers and hospitals in urban areas that have certain special rural designations in Medicare
Telehealth has helped rural hospitals but has not been sufficient to address the financial losses inflicted by the pandemic, Desai said.
Other coming trends include a sharper cost focus
Desai expects an increasing focus “over the next couple years” on hospital costs because of the rising share of revenue received from Medicare and Medicaid. She expects increased efforts to use technology and data to lower costs.
Billy Wynne, JD, chairman of Wynne Health Group, expects telehealth restrictions to remain relaxed after the pandemic.
Also, the perceptions of the public and politicians about the financial health of hospitals are likely to give those organizations leverage in coming policy fights over changes such as banning surprise billing and creating so-called public-option health plans, Wynne said. As an example, he cited the Colorado legislature’s suspension of the launch of a public option “in part because of sensitivities around hospital finances in the COVID pandemic.”
“Once the dust settles, it’ll be interesting to see if their leverage has increased or decreased due to what we’ve been through,” Wynne said.
About the Author
Rich Daly, HFMA Senior Writer and Editor,
is based in the Washington, D.C., office. Follow Rich on Twitter: @rdalyhealthcare
The quality of care at hospitals acquired during a recent wave of consolidations has gotten worse or stayed the same, according to a study led by Harvard Medical School scientists published Jan. 2 in NEJM.
The findings deal a blow to the often-cited arguments that hospital consolidation would improve care. A flurry of earlier studies showed that mergers increase prices. Now after analyzing patient outcomes after hundreds of hospital mergers, the new research also dashes the hopes that this more expensive care might be of higher quality.
Get more HMS news here
“Our findings call into question claims that hospital mergers are good for patients—and beg the question of what we are getting from higher hospital prices,” said study senior author J. Michael McWilliams, the Warren Alpert Foundation Professor of Health Care Policy in the Blavatnik Institute at HMS and an HMS professor of medicine and a practicing general internist at Brigham and Women’s Hospital.
McWilliams noted that rising hospital prices have been one of the leading drivers of unsustainable growth in U.S. health spending.
To examine the impact of hospital mergers on quality of care, researchers from HMS and Harvard Business School examined patient outcomes from nearly 250 hospital mergers that took place between 2009 and 2013. Using data collected by the Centers for Medicare and Medicaid Services, they analyzed variables such as 30-day readmission and mortality rates among patients discharged from a hospital, as well as clinical measures such as timely antibiotic treatment of patients with bacterial pneumonia. The researchers also factored in patient experiences, such as whether those who received care at a given hospital would recommend it to others. For their analysis, the team compared trends in these indicators between 246 hospitals acquired in merger transactions and unaffected hospitals.
The verdict? Consolidation did not improve hospital performance, and patient-experience scores deteriorated somewhat after the mergers.
The study was not designed to examine the reasons behind the worsening in patient experience. Weakening of competition due to hospital mergers could have contributed, the researchers said, but deeper exploration suggested other potential mechanisms. Notably, the analysis found the decline in patient-experience scores occurred mainly in hospitals acquired by hospitals that already had a poor patient-experience score—a finding that suggests acquisitions facilitate the spread of low quality care but not of high quality care.
The researchers caution that isolated, individual mergers may have still yielded positive results—something that an aggregate analysis is not powered to capture. And the researchers could only examine measurable aspects of quality. The trend in hospital performance on these standard measures, however, appears to point to a net effect of overall decline, the team said.
“Since our study estimated the average effects of mergers, we can’t rule out the possibility that some mergers are good for patient care,” said first author Nancy Beaulieu, research associate in health care policy at HMS. “But this evidence should give us pause when considering arguments for hospitals mergers.”
The work was supported by the Agency for Healthcare Research and Quality (grant no. U19HS024072).
Co-investigators included Bruce Landon and Jesse Dalton from HMS, Ifedayo Kuye, from the University of California, San Francisco, and Leemore Dafny from Harvard Business School and the National Bureau of Economic Research.
Public benefit corporations (versus Benefit Corporate status, which is more of a pledge) are separate legal entities which exist as a hybrid, for-profit/nonprofit company but is mandated to
Pursue a general or specific public benefit
Consider the non-financial interests of its shareholders and other STAKEHOLDERS when making decision
report how well it is achieving its overall public benefit objectives
Have limited fiduciary responsibility to investors that remains IN SCOPE of public benefit goal
In essence, the public benefit corporations executives are mandated to run the company for the benefit of STAKEHOLDERS first, if those STAKEHOLDERS are the public beneficiary of the company’s goals. This in essence moves the needle away from the traditional C-Corp overvaluing the needs of shareholders and brings back the mission of the company and in the case of healthcare, the needs of its stakeholders, the consumers of healthcare.
PBCs are legal entities recognized by states rather than by the federal government. So far, in 2020 about 37 states allow companies to incorporate as a PBC. Stipulations of the charter include semiannual reporting of the public benefits bestowed by the company and how well it is achieving its public benefit mandate. There are about 3,000 US PBCs. Some companies have felt it was in their company mission and financial interest to change incorporation as a PBC.
Some well known PBCs include
Ben and Jerry’s Ice Cream
American Red Cross
Susan B. Komen Foundation
Allbirds (a shoe startup valued at $1.7 billion when made switch)
Bombas (the sock company that donates extra socks when you buy a pair)
Lemonade (a publicly traded insurance PBC that has beneficiaries select a nonprofit that the company will donate to)
Although the number of PBCs in the healthcare arena is increasing
Not many PBCs are in the area of healthcare delivery
Noone is quite sure what the economic model would look like for a healthcare delivery PBC
Some example of hospital PBC include NYC Health + Hospitals and Community First Medical Center in Chicago.
Benefits of moving a hospital to PBC Status
PBCs are held legally accountable to a predefined public benefit. For hospitals this could be delivering cost-effective quality of care and affordable to a local citizenry or an economically disadvantaged population. PBCs must produce at least an annual report on the public benefits it has achieved contrasted against a third party standard. For example a hospital could include data of Medicaid related mortality risks, data neither the C-corp nor the nonprofit 501c would have to report on. Most nonprofits and charities report their taxes on a schedule H or Form 990, which only has to report the officer’s compensation as well as monies given to charitable organizations, or other 501 organizations. The nonprofit would show a balance of zero as the donated money for that year would be allocated out for various purposes. Hospitals, even as nonprofits, are not required to submit all this data. Right now in US the ACA just requires any hospital that receives government or ACA insurance payments to report certain outcome statistics. Although varying state by state, a PBC should have a “benefit officer” to make sure the mandate is being met. In some cases a PBC benefit officer could sue the board for putting shareholder interest over the public benefit mandate.
A PBC can include community stakeholders in the articles of incorporation thus giving a voice to local community members. This would be especially beneficial for a hospital serving, say, a rural community.
PBCs do have advantages of the for-profit companies as they are not limited to non-equity forms of investment. A PBC can raise money in the equity markets or take on debt and finance it. These financial instruments are unavailable to the non-profit. Yet one interesting aspect is that PBCs require a HIGHER voting threshold by shareholders than a traditional for profit company in the ability to change their public benefit or convert their PBC back to a for-profit.
Limitations of the PBC
Little incentive financially for current and future hospitals to incorporate as a PBC. Herein lies a huge roadblock given the state of our reimbursement structure in this country. Although there may be an incentive with regard to hiring and retention of staff drawn to the organization’s social purpose. There have been, in the past, suggestions to allow hospitals that incorporate at PBC to receive some tax benefit, but this legislation has not gone through either at state or federal level. (put link to tax article).
In order for there to be value to constituents (patients) there must be strong accountability measures. This will require the utmost in ethical behavior by a board and executives. We have witnessed, through M&A by large health groups, anticompetitive and near monopoly behavior.
There are no federal guidelines but varying guidelines from state to state. There must be some federal recognition of the PBC status when it comes to healthcare, such as that the government is one of the biggest payers of US healthcare.
This is a great interview with ArcHealth, a PBC healthcare system.
Arc Health PBC is a public benefit corporation, a mission-driven for-profit company that utilizes a market-driven approach to achieving our short and long-term social goals. As a public benefit corporation, Arc Health is also a social enterprise working to further our mission of providing healthcare to rural, underserved, and indigenous communities through business practices that improve the recruitment and retention of quality healthcare providers.
What is a Social Enterprise?
While there is no one exact definition, according to the Social Enterprise Alliance, a social enterprise is an “organization that addresses a basic unmet need or solves a social or environmental problem through a market-driven approach.” A social enterprise is not a distinct legal entity, but instead, an “ideological spectrum marrying commercial approaches with social good.” Social enterprises foster a dual-bottom-line – simultaneously seeking profits and social impact. Arc Health, like many social enterprises, seeks to be self–sustainable.
Two primary structures fall under the social enterprise umbrella: nonprofits and for-profit organizations. There are also related entities within both structures that could be considered social enterprises. Any of these listed structures can be regarded as a social enterprise depending on if and how involved they are with socially beneficial programs.
What is a Public Benefit Corporation?
Public Benefit Corporations (PBCs), also known as benefit corporations, are “for-profit companies that balance maximizing value to stakeholders with a legally binding commitment to a social or environmental mission.” PBCs operate as for-profit entities with no tax advantages or exemptions. Still, they must have a “purpose of creating general public benefit,” such as promoting the arts or science, preserving the environment, or providing benefits to underserved communities. PBCs must attain a higher degree of corporate purpose, expanded accountability, and expected transparency.
There are now over 3,000 registered PBCs, comprising approximately 0.1% of American businesses.
As a PBC, Arc Health expects to access capital through individual investors who seek financial returns, rather than through donations. Arc Health’s investors make investments with a clear understanding of the balance the company must strike between financial returns (I.e., profitability) and social purpose. Therefore, investors expect the company to be operationally profitable to ensure a financial return on their investments, while also making clear to all stakeholders and the public that generating social impact is the priority.
What is the difference between a Social Enterprise and PBC?
Social enterprises and PBCs emulate similar ideals that value the importance and need to invoke social change vis-a-vis working in a market-driven industry. Public benefit corporations fall under the social enterprise umbrella. An organization may choose to use a social enterprise model and incorporate itself as either a not-for-profit, C-Corp, PBC, or other corporate structure.
How did Arc Health Become a Public Benefit Corporation?
Arc Health was initially formed as a C-Corp. In 2019, Arc Health’s CEO and Co-Founder, Dave Shaffer, guided the conversion from a C-Corp to a PBC, incorporated in Delaware. Today, Arc Health follows guidelines and expectations for PBCs, including adhering to the State of Delaware’s requirements for PBCs.
Why is Arc Health a Social Enterprise and Public Benefit Corporation?
Arc Health believes it is essential to commit ourselves to our mission and demonstrate our dedication through our actions. We work to adhere to the core values of accountability, transparency, and purpose. As a registered public benefit company and a social enterprise, we execute our drive to achieve health equity in tangible and effective ways that the communities we work with, our stakeholders, and our providers expect of us.
90% of Americans say that companies must not only say a product or service is beneficial, but they also need to prove its benefit.
When we partner with health clinics and hospitals, we aim to provide services that enact lasting change. For example, we work with healthcare providers who desire to contribute both clinical and non-clinical skills. In 2020, Arc Health clinicians developed COVID-19 response protocols and educational materials about the vaccines. They participated in pain management working groups. They identified and followed up with kids in the community who were overdue for a well-child check. Arc Health providers should be driven by a desire to develop a long-term relationship with a healthcare service provider and participate in its successes and challenges.
Paradigm Shift in the 1980’s: Companies Start to Emphasize Shareholders Over Stakeholders
So earlier in this post we had mentioned about a shift in philosophy at the corporate boardroom that affected how comparate thought, value, and responsibility: Companies in the 1980s started to shift their focus and value only the needs of corporate ShAREHOLDERS at the expense of their traditional STAKEHOLDERS (customers, clients). Many movies and books have been written on this and debatable if deliberate or a by-product of M&A, hostile takeovers, and the stock market in general but the effect was that the consumer was relegated as having less value, even though marketing budgets are very high. The fiduciary responsibility of the executive was now defined in terms of satisfying shareholders, who were now big huge and powerful brokerage houses, private equity, and hedge funds. A good explanation by Medium.com Tyler Lasicki is given below.
In a famous 1970 New York Times Article, Milton Friedman postulated that the CEO, as an employee of the shareholder, must strive to provide the highest possible return for all shareholders. Since that article, the United States has embraced this idea as the fundamental philosophy supporting the ultimate purpose of businesses — The Shareholders Come First.
In August of 2019, the Business Roundtable, a group made up of the most influential U.S CEOs, published a letter shifting their stance on the purpose of a corporation. Regardless of whether this piece of paper will actually result in any systematic changes has yet to be seen, however this newly stated purpose of business is a dramatic shift from the position Milton Friedman took in 1970. According to the statement, these corporations will no longer prioritize maximizing profits for shareholders, but instead turn their focus to benefiting all stakeholders — including citizens, customers, suppliers, employees, on par with shareholders.
Now the social responsibility of a company and the CEO was to maxiimize the profits even at the expense of any previous social responsibility they once had.
Small sample of the 181 Signatures attached to the Business Roundtable’s letter
What has happened over the past 50 years that has led to such a fundamental change in ideology? What has happened to make the CEO’s of America’s largest corporations suddenly change their stance on such a foundational principle of what it means to be an American business?
Since diving into this subject, I have come to find that the “American fundamental principle” of putting shareholders first is one that is actually not all that fundamental. In fact, for a large portion of our nation’s history this ideology was actually seen as the unpopular position.
Key ideological shifts in U.S. history
This post dives into a brief history of these two contrasting ideological viewpoints in an attempt to contextualize the forces behind both sides — specifically, the most recent shift (1970–2019). This basic idea of what is most important; the stakeholder or the shareholder, is the underlying reason as to why many things are the way they are today. A corporation’s priority of shareholder or stakeholder ultimately impacts employee salaries, benefits, quality of life within communities, environmental conditions, even the access to education children can receive. It affects our lives in a breadth and depth of ways and now that corporations may be changing positions (yet again) to focus on a model that prioritizes the stakeholder, it is important to understand why.
Looking forward, if stakeholder priority ends up being the popular position among American businesses, how long will it last for? What could lead to its downfall? And what will managers do to ensure a long term stakeholder-friendly business model?
It is clear to me the reasons that have led to these shifts in ideology are rather nuanced, however I want to highlight a few trends that have had a major impact on businesses changing their priorities while also providing context as to why things have shifted.
The Ascendancy of Shareholder Value
Following the 1929 stock market crash and the Great Depression, stakeholder primacy became the popular perspective within corporate America. Stakeholder primacy is the idea that corporations are to consider a wider group of interested parties (not just shareholders) whose positions need to be taken into consideration by corporate governance. According to this point of view, rather than solely being an agent for shareholders, management’s responsibilities were to be dispersed among all of its constituencies, even if it meant a reduction in shareholder value. This ideology lasted as the dominant position for roughly 40 years, in part due to public opinion and strong views on corporate responsibility, but also through state adoption of stakeholder laws.
By the mid-1970s, falling corporate profitability and stagnant share prices had been the norm for a decade. This poor economic performance influenced a growing concern in the U.S. regarding the perceived divergence between manager and shareholder interest. Many held the position that profits and share prices were suffering as a result of corporation’s increased attention on stakeholder groups.
This noticeable divergence in interests sparked many academics to focus their research on corporate management’s motivations in decision making regarding their allocation of resources. This branch of research would later be known as agency theory, which focused on the relationship between principals (shareholders) and their agents (management). Research at the time outlined how over the previous decades corporate management had pursued strategies that were not likely to optimize resources from a shareholder’s perspective. These findings were part of a seismic shift of corporate philosophy, changing priority from the stakeholders of a business to the shareholders.
By 1982, the U.S. economy started to recover from a prolonged period of high inflation and low economic growth. This recovery acted as a catalyst for change in many industries, leaving many corporate management teams to struggle in response to these changes. Their business performance suffered as a result. These distressed businesses became targets for a group of new investors…private equity firms.
Now the paradigm shift had its biggest backer…. private equity! And private equity care about ONE thing….. THEIR OWN SHARE VALUE and subsequently meaning corporate profit, which became the most important directive for the CEO.
So it is all hopeless now? Can there be a shift back to the good ‘ol days?
Well some changes are taking place at top corporate levels which may help the stakeholders to have a voice at the table, as the following IRMagazine article states.
And once again this is being led by the Business Roundtable, the same Business Roundtable that proposed the shift back in the 1970s.
n a major corporate shift, shareholder value is no longer the main objective of the US’ top company CEOs, according to the Business Roundtable, which instead emphasizes the ‘purpose of a corporation’ and a stakeholder-focused model.
The influential body – a group of chief executive officers from major US corporations – has stressed the idea of a corporation dropping the age-old notion that corporations function first and foremost to serve their shareholders and maximize profits.
Rather, the focus should be on investing in employees, delivering value to customers, dealing ethically with suppliers and supporting outside communities as the vanguard of American business, according to a Business Roundtable statement.
‘While each of our individual companies serves its own corporate purpose, we share a fundamental commitment to all of our stakeholders,’ reads the statement, signed by 181 CEOs. ‘We commit to deliver value to all of them, for the future success of our companies, our communities and our country.’
Gary LaBranche, president and CEO of NIRI, tells IR Magazine that this is part of a wider trend: ‘The redefinition of purpose from shareholder-focused to stakeholder-focused is not new to NIRI members. For example, a 2014 IR Update article by the late Professor Lynn Stout urges a more inclusive way of thinking about corporate purpose.’
NIRI has also addressed this concept at many venues, including the senior roundtable annual meeting and the NIRI Annual Conference, adds LaBranche. This trend was further seen in the NIRI policy statement on ESG disclosure, released in January this year.
Analyzing the meaning of this change in more detail, LaBranche adds: ‘The statement is a revolutionary break with the Business Roundtable’s previous position that the purpose of the corporation is to create value for shareholders, which was a long-held position championed by Milton Friedman.
‘The challenge is that Friedman’s thought leadership helped to inspire the legal and regulatory regime that places wealth creation for shareholders as the ‘prime directive’ for corporate executives.
‘Thus, commentators like Mike Allen of Axios are quick to point out that some shareholders may actually use the new statement to accuse CEOs of worrying about things beyond increasing the value of their shares, which, Allen reminds us, is the CEOs’ fiduciary responsibility.
‘So while the new Business Roundtable statement reflects a much-needed rebalancing and modernization that speaks to the comprehensive responsibilities of corporate citizens, we can expect that some shareholders will push back on this more inclusive view of who should benefit from corporate efforts and the capital that makes it happen. The new statement may not mark the dawn of a new day, but it perhaps signals the twilight of the Friedman era.’
In a similarly reflective way, Jamie Dimon, chairman and CEO of JPMorgan Chase & Co and chairman of the Business Roundtable, says: ‘The American dream is alive, but fraying. Major employers are investing in their workers and communities because they know it is the only way to be successful over the long term. These modernized principles reflect the business community’s unwavering commitment to continue to push for an economy that serves all Americans.’
Note: Mr Dimon has been very vocal for many years on corporate social responsibility, especially since the financial troubles of 2009.
Impact of New Regulatory Trends in M&A Deals
The following podcast from Pricewaterhouse Cooper Health Research Institute (called Next in Health) discusses some of the trends in healthcare M&A and is a great listen. However from 6:30 on the podcast discusses a new trend which is occuring in the healthcare company boardroom, which is this new focus on integrating companies that have proven ESG (or environmental, social, governance) functions within their organzations. As stated, doing an M&A deal with a company with strong ESG is looked favorably among regulators now.
Please click on the following link to hear a Google Podcast Next in Health episode
Heather shows the feasability of this model with multiple biotech and healthtech startups, including one founded by Mark Cuban.
Health tech unicorn Aledade recently announced that it made the strategic decision to become a public benefit corporation (PBC).
The company joins just a handful of others in healthcare that are structured this way.
So what exactly is a PBC, and why does it matter?
PBCs are a type of for-profit corporate entity that has also adopted a public benefit purpose and is currently authorized by 35 states and the District of Columbia. A PBC must consider the nonfinancial interests of its shareholders and other stakeholders when making decisions. As a public benefit corporation, companies have to weigh their social/environmental objectives alongside maximizing value for shareholders.
While PBC and B Corp. are often used interchangeably, they are not the same. A B Corp. is a certification provided to eligible companies by the nonprofit, B Lab. A PBC is an actual legal entity that bakes into its certificate of incorporation a “public benefit,” according to Rubicon Law Group.
“I don’t think that there is a trade-off between either you do things that are good for society or you make profits in your business.” —Farzad Mostashari, M.D.
PBCs also are required to provide a report to shareholders every two years that detail how well the company is achieving its overall public benefit objectives. In some states, the report must be assessed against a third-party standard and be made publicly available. Delaware PBCs are not required to report publicly or against a third-party standard.
Aledade launched in 2014 and uses data analytics to help independent doctors’ offices transition to value-based care models. The company currently partners with more than 1,000 independent primary care practices comprising over 11,000 physicians and has nearly 150 contracts covering more than 1.7 million patients and $17 billion in total healthcare spending. Last June, the company raised $123 million in a series E round, boosting its valuation to $3.1 billion.
In a blog post, Aledade CEO and co-founder Farzad Mostashari, M.D., explained the company’s reasoning behind the move and said the corporate structure of a PBC is “well suited to mission-oriented companies where alignment with stakeholders is a key driver of the business model.”
“Aledade’s public benefit purpose means that we must weigh the interests of our primary care practice partners, their patients, our employees, and those who bear the burden of rising health care costs, alongside those of our shareholders, when we make decisions,” Mostashari said in an interview. This duty extends to all significant board decisions, including decisions on whether to go public, to make acquisitions or to sell the company, he noted.
The PBC structure helps create alignment among stakeholders and build trust, he said. “I don’t think that there is a trade-off between either you do things that are good for society or you make profits in your business. That might be true for fee-for-service businesses. It’s not true for Aledade,” he said.
He added, “For businesses that are built on trust and alignment, not considering stakeholder benefits gets you neither social good nor profits. If you’re in a business like our business where it’s actually really important that everybody have faith and belief that you are doing what’s best for patients, that you are actually in it for the long-term for practices, that’s what makes us successful as a business.”
Mark Cuban Cost Plus Drugs, which launched in January 2022 to offer low-cost rivals to overpriced generic drugs, also is structured as a public benefit corporation. The company’s founder and CEO Alexander Oshmyansky started the company in 2015 as a nonprofit, according to a feature story in D Magazine. Through Y Combinator, investors told Oshmyansky that the nonprofit model wouldn’t be able to raise the needed funds. He then reworked the business model to a PBC and launched Osh’s Affordable Pharmaceuticals in 2018.
Some other companies that are biotech drug development companies that operate under the PBC model include
Even a traditional for-profit C corporation can work toward a public mission without becoming a PBC. But, in an industry like healthcare, too often the duty to maximize financial returns for shareholders or investors can be in conflict with what is best for patients, executives say.
“With a startup, it might limit the ability to sell their business to a larger company in the future because there might be some limitations on what the larger company could do with the organization.”—Jodi Daniel, a partner in Crowell & Moring’s Health Care Group
According to some healthcare experts, PBCs offer a promising alternative as a business model for healthcare companies by providing a “North Star” by which a company can navigate critical business decisions.
“I think it really helps to drive accountability,” Huang, Osmind’s chief executive, said. “I think that’s important, especially in healthcare where it’s easy sometimes to get misaligned with all the different stakeholders that are involved in the industry. We wanted to make sure we had something to be accountable to. Second, it’s ingrained in the culture. The third element of why it was so helpful for us from the beginning is just on focus and alignment. I think we can be much more clear and transparent about what we’re focused on, our values, how we try to use that transparently to influence our decisions and how we can build a business that really ties all of that together.”
In a Health Affairs article, medical researchers at Stanford, including Jimmy Qian, a co-founder of Osmind, laid out the case for why PBCs may simultaneously improve individual patient outcomes and collective benefit without sacrificing institutions’ financial stability.
PBCs are held legally accountable to a predefined public benefit, which, for hospitals, could involve delivering high-quality, affordable care to local populations. PBCs are required to produce annual benefits reports that are assessed against a third-party standard. “These reports could be used by regulatory agencies such as the Centers for Medicare and Medicaid Services (CMS) or local health authorities to evaluate whether the PBC is making progress toward its stated mission and respond accordingly,” the researchers wrote.
But are there any trade-offs?
Having a public benefit obligation could potentially “tie the hands” of board members who can’t just focus on profits and must focus on those dual responsibilities, noted Jodi Daniel, a partner in Crowell & Moring’s Health Care Group.
“Companies that transition to being a public benefit corporation are intentionally trying to ensure that that the company’s mission doesn’t get diminished over time because it’s in their charter. So it helps [the mission] to endure. But there are pros and cons to that. It is somewhat binding the future board members and executives to follow that mission,” she said.
Daniel said she has spoken with several healthcare companies recently that are weighing the possibility of transitioning to a PBC. “Companies often don’t want to necessarily limit their options in their decision-making in the future. With a startup, it might limit the ability to sell their business to a larger company in the future because there might be some limitations on what the larger company could do with the organization,” she said in an interview.
By making decisions based on interests outside of financial ones, organizations may put themselves at a margin disadvantage as compared to pure for-profit players in the space, wrote Hospitalogy founder Blake Madden.
Faddis with Veeva said the company hasn’t seen any financial or performance trade-off as a result of operating as a PBC. He noted that the move has been good for recruiting, spurred more long-term conversations with customers and has been a source of new ideas.
“Prior to the conversion, you had employees who were thinking of new products or new functionality with the mindset of getting to be commercially successful,” Faddis said. “Now, you also have people thinking about it from the angle of, ‘Does it further one of our PBC purposes and then maybe it’s also going to be commercially successful?'”
Converting to a PBC also can be a tactic to build trust, Daniel noted, especially in healthcare, and that holds the potential to drive business.
One factor that isn’t clear is whether there is sufficient oversight to hold these companies accountable to their stated public mission. Who checks to make sure companies are making progress toward their objectives to improve healthcare?
Osmind publishes its benefit corporation report on its website to make it available to the public even though it is not required to do so. “I think that really highlights the accountability piece of you need to tell the world or at least tell your shareholders how you’re really trying to uphold your public benefit,” Huang said.
Other related articles published on this Open Access Online Scientific Journal on Healthcare Issues include the following:
C.D.C. Reviewing Cases of Heart Problem in Youngsters After Getting Vaccinated and AHA Reassures that Benefits Overwhelm the Risks of Vaccination
Reporter: Amandeep Kaur, B.Sc. , M.Sc.
The latest article in New York times reported by Apoorva Mandavilli outlines the statement of officials that C.D.C. agency is investigating few cases of young adults and teenagers who might have developed myocarditis after getting vaccinated. It is not confirmed by the agency that whether this condition is caused by vaccine or not.
According to the vaccine safety group of the Centers for Disease Control and Prevention, the reports of heart problems experienced by youngsters is relatively very small in number. The group stated that these cases could be unlinked to vaccination. The condition of inflammation of heart muscle which can occur due to certain infections is known as myocarditis.
Moreover, the agency still has to determine any evidence related to vaccines causing the heart issues. The C.D.C. has posted on its website the updated guidance for doctors and clinicians, urging them to be alert to uncommon symptoms related to heart cases among teenagers who are vaccine recipients.
In New York, Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center stated that “It may simply be a coincidence that some people are developing myocarditis after vaccination. It’s more likely for something like that to happen by chance, because so many people are getting vaccinated right now.”
The article reported that the cases appeared mainly in young adults after about four days of their second shot of mRNA vaccines, made by Moderna and Pfizer-BioNTech. Such cases are more prevalent in males as compared to females.
The vaccine safety group stated “Most cases appear to be mild, and follow-up of cases is ongoing.” It is strongly recommended by C.D.C. that American young adults from the age of 12 and above should get vaccinated against COVID-19.
Dr. Yvonne Maldonado, chair of the American Academy of Pediatrics’s Committee on Infectious Diseases stated “We look forward to seeing more data about these cases, so we can better understand if they are related to the vaccine or if they are coincidental. Meanwhile, it’s important for pediatricians and other clinicians to report any health concerns that arise after vaccination.”
Experts affirmed that the potentially uncommon side effects of myocarditis get insignificant compared to the potential risks of SARS-CoV-2 infection, including the continuous syndrome known as “long Covid.” It is reported in the article that acute Covid can lead to myocarditis.
According to the data collected by A.A.P, about 16 thousand children were hospitalized and more than 3.9 million children were infected by coronavirus till the second week of May. In the United States, about 300 children died of SARS-CoV-2 infection, which makes it among the top 10 death causes in children since the start of pandemic.
Dr. Jeremy Faust, an emergency medicine physician at Brigham and Women’s Hospital in Boston stated that “And that’s in the context of all the mitigation measures taken.”
According to researchers, about 10 to 20 of every 1 lakh people each year develop myocarditis in the general population, facing symptoms from fatigue and chest pain to arrhythmias and cardiac arrest, whereas some have mild symptoms which remain undiagnosed.
Currently, the number of reports of myocarditis after vaccination is less than that reported normally in young adults, confirmed by C.D.C. The article reported that the members of vaccine safety group felt to communicate the information about upcoming cases of myocarditis to the providers.
The C.D.C. has not yet specified the ages of the patients involved in reporting. Since December 2020, the Pfizer-BioNTech vaccine was authorized for young people of age 16 and above. The Food and Drug Administration extended the authorization to children of age 12 to 15 years, by the starting of this month.
On 14th May, the clinicians have been alerted by C.D.C. regarding the probable link between myocarditis and vaccination. Within three days, the team started reviewing data on myocarditis, reports filed with the Vaccine Adverse Event Reporting System and others from the Department of Defense.
A report on seven cases has been submitted to the journal Pediatrics for review and State health departments in Washington, Oregon and California have notified emergency providers and cardiologists about the potential problem.
In an interview, Dr. Liam Yore, past president of the Washington State chapter of the American College of Emergency Physicians detailed a case of teenager with myocarditis after vaccination. The patient was provided treatment for mild inflammation of the inner lining of the heart and was discharged afterwards. Later, the young adult returned for care due to decrease in the heart’s output. Dr. Yore reported that still he had come across worse cases in youngsters with Covid, including in a 9-year-old child who arrived at the hospital after a cardiac arrest last winter.
He stated that “The relative risk is a lot in favor of getting the vaccine, especially considering how coronavirus vaccine have been administered.”
In the United States, more than 161 million people have received their first shot of vaccine in which about 4.5 million people were between the age 12 to 18 years.
Benefits Overwhelm Risks of COVID Vaccination, AHA Reassures
The latest statement of American Heart Association (AHA)/ American Stroke Association (ASA) on May 23rd states that the benefits of COVID-19 vaccination enormously outweigh the rare risk for myocarditis cases, which followed the C.D.C. report that the agency is tracking the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for myocarditis cases linked with mRNA vaccines against coronavirus.
The myocarditis cases in young adults are more often observed after the second dose of vaccine rather than the first one, and have more cases of males than females. The CDC’s COVID-19 Vaccine Safety Technical Work Group (VaST) observed such heart complications after 4 days of vaccination.
CDC reported that “Within CDC safety monitoring systems, rates of myocarditis reports in the window following COVID-19 vaccination have not differed from expected baseline rates.”
The CDC team stated that “The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection, and Strongly urged all young adults and children 12 years and above to get vaccinated as soon as possible.”
Even though the analysis of myocarditis reports related to coronavirus vaccine is in progress, the AHA/ASA stated that “myocarditis is typically the result of an actual viral infection, and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine.”
Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation (RWJF) and former acting director of the CDC stated on ABC’s Good Morning America “We’ve lost hundreds of children and there have been thousands who have been hospitalized, thousands who developed an inflammatory syndrome, and one of the pieces of that can be myocarditis.” He added “still, from my perspective, the risk of COVID is so much greater than any theoretical risk from the vaccine.”
After COVID-19 vaccination the symptoms that occur include tiredness, muscle pain, headaches, chills, nausea and fever. The AHA/ASA stated that “typically appear within 24 to 48 hours and usually pass within 36-48 hours after receiving the vaccine.”
All healthcare providers are suggested to be aware of the rare adverse symptoms such as myocarditis, low platelets, blood clots, and severe inflammation. The agency stated that “Healthcare professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly.”
President Mitchell S.V. Elkind, M.D., M.S., FAHA, FAAN, Immediate Past President Robert A. Harrington, M.D., FAHA, President-Elect Donald M. Lloyd-Jones, M.D., Sc.M., FAHA, Chief Science and Medical Officer Mariell Jessup, M.D., FAHA, and Chief Medical Officer for Prevention Eduardo Sanchez, M.D, M.P.H., FAAFP are science leaders of AHA/ASA and reflected their views in the following statements:
We strongly urge all adults and children ages 12 and older in the U.S. to receive a COVID vaccine as soon as they can receive it, as recently approved by the U.S. Food and Drug Administration and the CDC. The evidence continues to indicate that the COVID-19 vaccines are nearly 100% effective at preventing death and hospitalization due to COVID-19 infection. According to the CDC as of May 22, 2021, over 283 million doses of COVID-19 vaccines have been administered in the U.S. since December 14, 2020, and more than 129 million Americans are fully vaccinated (i.e., they have received either two doses of the Pfizer-BioNTech or Moderna COVID-19 vaccine, or the single-dose Johnson & Johnson/Janssen COVID-19 vaccine).
We remain confident that the benefits of vaccination far exceed the very small, rare risks. The risks of vaccination are also far smaller than the risks of COVID-19 infection itself, including its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including myocarditis. The recommendation for vaccination specifically includes people with cardiovascular risk factors such as high blood pressure, obesity and type 2 diabetes, those with heart disease, and heart attack and stroke survivors, because they are at much greater risk of an adverse outcome from the COVID-19 virus than they are from the vaccine.
We commend the CDC’s continual monitoring for adverse events related to the COVID-19 vaccines through VAERS and VSD, and the consistent meetings of ACIP’s VaST Work Group, demonstrating transparent and robust attention to any and all health events possibly related to a COVID-19 vaccine. The few cases of myocarditis that have been reported after COVID-19 vaccination are being investigated. However, myocarditis is usually the result of a viral infection, and it is yet to be determined if these cases have any correlation to receiving a COVID-19 vaccine, especially since the COVID-19 vaccines authorized in the U.S. do not contain any live virus.
We also encourage everyone to keep in touch with their primary care professionals and seek care immediately if they have any of these symptoms in the weeks after receiving the COVID-19 vaccine:chest pain including sudden, sharp, stabbing pains;difficulty breathing/shortness of breath;abnormal heartbeat;severe headache;blurry vision;fainting or loss of consciousness;weakness or sensory changes;confusion or trouble speaking;seizures;unexplained abdominal pain; ornew leg pain or swelling.
We will stay up to date with the CDC’s recommendations regarding all potential complications related to COVID-19 vaccines, including myocarditis, pericarditis, central venous sinus thrombosis (CVST) and other blood clotting events, thrombosis thrombocytopenia syndrome (TTS), and vaccine-induced immune thrombosis thrombocytopenia (VITT).
The American Heart Associationrecommends all health care professionals be aware of these very rare adverse events that may be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, or symptoms of severe inflammation. Health care professionals should strongly consider inquiring about the timing of any recent COVID vaccination among patients presenting with these conditions, as needed, in order to provide appropriate treatment quickly. As detailed in last month’s AHA/ASA statement, all suspected CVST or blood clots associated with the COVID-19 vaccine should be treated initially using non-heparin anticoagulants. Heparin products should not be administered in any dose if TTS/VITT is suspected, until appropriate testing can be done to exclude heparin-induced antibodies. In addition, health care professionals are required to report suspected vaccine-related adverse events to the Vaccine Adverse Event Reporting System, in accordance with federal regulations.
Individuals should refer to their local and state health departments for specific information about when and where they can get vaccinated. We implore everyone ages 12 and older to get vaccinated so we can return to being together, in person – enjoying life with little to no risk of severe COVID-19 infection, hospitalization or death.
We also support the CDC recommendations last week that loosen restrictions on mask wearing and social distancing for people who are fully vaccinated. For those who are unable to be vaccinated, we reiterate the importance of handwashing, social distancing and wearing masks, particularly for people at high risk of infection and/or severe COVID-19. These simple precautions remain crucial to protecting people who are not vaccinated from the virus that causes COVID-19.
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