CAR-T a preu assequible

Cutting-edge CAR-T cancer therapy is now made in India — at one-tenth the cost

Les teràpies CAR-T són una realitat i han modificat substancialment el curs de tractament del càncer. A la confrontació acadèmia-indústria s'hi afegeix ara un altre actor: Inmuno ACT, a Nature podeu trobar el detall del que representa: oferir el tractament a la desena part del seu cost. Després de l'acord amb l'hospital Clínic, amb Inmuneel (també de la Índia), ara aquesta empresa amb connexions amb el gegant industrial Tata, ofereix un salt rellevant.

NexCAR19 is similar to its US counterparts, yet distinct in key ways. Like four of the six CAR-T therapies approved by the US Food and Drug Administration (FDA), it is designed to target CD19, a marker found on B-cell cancers2. However, in existing commercial therapies, the antibody fragment at the end of a CAR is typically from mice, which limits its durability because the immune system recognizes it as foreign and eventually eliminates it. Therefore, in NexCAR19, Dwivedi and her colleagues added human proteins to the mouse antibody tips.

Tot plegat és l'anunci de la innovació que ve. Estem acostumats a que Índia i Xina siguin subministradors de principis actius genèrics. En realitat s'està teixint la base perquè els medicaments innovadors sorgeixin allà amb agilitat. I no només medicaments, també els subministraments mèdics.

 Joana Biarnés

Menjar millor per viure més (i millor?)

 Life expectancy can increase by up to 10 years following sustained shifts towards healthier diets in the United Kingdom

El titular d'aquest article de Nature és d'impacte, busca notorietat. Una dieta saludable pot augmentar fins a 10 anys la vida, diuen. Això depèn és clar de molts factors, alguns dels quals s'expliquen amb detall. El més interessant és que ha estat fet amb el UK biobank i una participació de 467.354 persones. Estem per tant davant d'un treball amb una gran mostra. I la conclusió és aquesta:

Our results showed that the longevity-associated dietary pattern had moderate intakes of whole grains, fruit, fish and white meat; a high intake of milk and dairy, vegetables, nuts and legumes; a relatively low intake of eggs, red meat and sugar-sweetened beverages; and a low intake of refined grains and processed meat. Analyses adjusting also for body mass index and energy (Supplementary Information) showed slight reductions in inverse associations with mortality for whole grains, vegetables and fruits, reductions in positive associations with mortality for red meat, and stronger inverse associations for both nuts and white meat. For several of the food groups associated with reduced mortality, the lowest intake quintiles were substantially different from the other quintiles. The unhealthy dietary pattern (that is, the quintile with the highest mortality associations) contained no or limited amounts of whole grains, vegetables, fruits, nuts, legumes, fish, milk and dairy, and white meat and substantial intakes of processed meat, eggs, refined grains and sugar-sweetened beverages. The strongest positive associations with mortality were for sugar-sweetened beverages and processed meat, while the strongest inverse associations with mortality were for whole grains and nuts.

Begudes ensucrades i ultraprocessats mostren reducció de la longevitat, i els fruits secs i cereals integrals l'allarguen, això diuen. Quan ho mires amb detall aleshores cal recordar que correlació no és causalitat, i som on érem. Les recomanacions genèriques poden funcionar més bé o no tant. Ben segur que és una mica més complicat tot això, ja ho vaig explicar fa uns dies al post "nutrició de precisió". En qualsevol cas el missatge és que cal millorar com mengem i què mengem.

Els medicaments que curen el mal dolent

 Addressing Challenges in Access to Oncology Medicines

ESMO-Magnitude of Clinical Benefit Scale version 1.1

La magnitud del benefici clínic dels medicaments és i ha de ser preocupació de tots, principalment dels clínics. En això els oncòlegs fa temps que hi han dedicat temps i esforços. La societat europea, la ESMO ja fa anys que va introduir una metodologia al respecte.

The  ESMO-  MCBS  grading  highlights  those  treatments  which  substantially  improve  the  duration  of  survival  and/or  the  quality  of  life  (QoL)  of  patients  with  cancer  and  aims  to  distinguish  them  from  trials  demonstrating  more  limited  and  sometimes  even  marginal  benefits. The  ESMO-MCBS  assigns categorical benefit scores to European Medicines Agency  (EMA) and US Food and Drugs Administration (since January 2020) approved cancer medicines,  based  on  results  from  ‘positive’ randomised clinical trials:

• superiority trials that have demonstrated a statistically significant result for the primary endpoint of the study, and/ or secondary in case of overall survival and 
• non-inferiority trials, reaching a conclusion of non-inferiority.

La proposta és d'interès però a la pràctica no trascendeix més enllà dels clínics i el motiu entre d'altres és que es basa en una puntuació categòrica d'experts, que desconeixem si els experts fossin uns altres quina puntuació  sortiria. En el fons el que pretén ESMO és arribar a algun consens sobre l'efectivitat relativa dels medicaments aprovats i com a mecanisme de consens professional, res a afegir.

L'OCDE per la seva part va fer un document que revisava com es trobava l'accés als medicaments oncològics en diferents països. Allà es mostra amb molt de detall què fan i com ho fan (excepte Espanya que no va contestar el qüestionari).

Aquests són els reptes que l'informe va identificar i que cal tenir en compte com a temes pendents de resoldre:

Hi ha molts més temes dins l'informe, en especial els temes relatius a diferències d'accés estan ben tractats. Els fabricants de medicaments europeus EFPIA també van fer l'abril passat un document al respecte. Fa setmanes parlava de l'elevat preu dels medicaments oncológics, i aquest tema acaba copsant tot l'interès, però n'hi ha d'altres, que convé que siguin resolts.

Aturem el genocidi armeni (una altra vegada)

 The humanitarian crisis in Nagorno-Karabakh

La situació de Nagorno-Karavag és un genocidi del poble armeni. I no és la primera vegada. Aquesta és la carta publicada al Lancet i que crec rellevant de destacar a data d'avui:

We want to bring the attention of doctors to the humanitarian crisis happening in Nagorno-Karabakh. Nagorno-Karabakh, an area of 1700 square miles between Armenia and Azerbaijan, is home to about 120 000 people, including about 30 000 children. Nagorno-Karabakh, also known as Artsakh, was a region in the former Soviet Union with a predominately Armenian population that had restricted self-governance. However, since the dissolution of the Soviet Union, its status has been a contentious issue between Armenia and Azerbaijan.

Since 1991, Nagorno-Karabakh has been a de facto independent state. A 44-day war in 2020, started by Azerbaijan during the COVID-19 pandemic, resulted in thousands of deaths, more than 10 000 injuries, and the displacement of many more people.1 After the ceasefire, the only supply route for food, medicine, and fuel connecting Nagorno-Karabakh to Armenia was the Lachin corridor.2,  3

In December, 2022, Azerbaijan began a blockade of the Lachin corridor that has resulted in starvation, with inhabitants forced to wait in long queues for food and medicine. The public transportation system has collapsed and there is concern about fuel for heating homes in the winter. Local doctors report that malnutrition is causing miscarriages, people who are pregnant are unable to reach hospitals to give birth, there is no infant formula, and that the lack of adequate nutrition has impeded breastfeeding.4

People with chronic illnesses cannot access basic medicines, such as insulin. People with suspected cancers cannot have diagnostic studies and people with cancer have little access to simple anti-cancer drugs.5 Access to cancer services in Armenia is now blocked. The Red Cross, the only operational relief organisation in this area, cannot guarantee the safe transportation of people who are critically ill to Armenia. Even before the current crisis, this region had challenges in providing adequate health care to the population; the blockade has driven it to a crucial point. On Aug 7, 2023, the former chief prosecutor of the International Criminal Court stated “there is an ongoing genocide against 120 000 Armenians living in Nagorno-Karabakh”. Although most people think genocide implies mass killing, this notion is wrong. The legal definition of genocide in the 1948 Genocide Convention is “acts committed with intent to destroy, in whole or in part, a particular national, ethnical, racial or religious group”. It is obvious that the objective of the blockade is to starve the resident Armenian people so that they die or flee.

We are not alone in our assessment of the situation in Nagorno-Karabakh.6 The International Association of Genocide Scholars warned of the “risk of genocide”, the Lemkin Institute for Genocide Prevention issued an active genocide alert, and Genocide Watch has declared a genocide emergency.

We urge the global medical community to voice concern and take action that might help end the blockade of the Lachin corridor until a reasonable compromise can be reached between authorities in Nagorno-Karabakh and Azerbaijan. We need to stop this genocide.

La societat no hauria d'acceptar passivament fets com aquests. Les Nacions Unides fan el paper de la trista figura, amb un mecanisme de veto inadmisible a data d'avui.

 

Les decisions de política sanitària que cal prendre

 La sanidad en la encrucijada post-COVID. Financiación, organización y gestión

Els que es dediquen a la política sanitària també necessiten "aliments per pensar", food for thought, o almenys així m'agradaria de creure-ho. Tinc la impressió que llegeixen poc i escolten encara menys als experts. En canvi, es basen en marcs mentals restrictius i sovint sectaris, fonamentats des de la premsa, aparells de partit i grups d'influència. No vull dir amb això que cal escoltar tots els experts i sempre, tant sols vull dir que és una veu a considerar. I tampoc vull dir que tots els polítics són iguals.

Però si hi ha una reflexió de política sanitària del moment que no pot passar per alt és la que fan Meneu-Ortún-Urbanos en aquest llibre. Cal comprendre bé com l'epidèmia ha capgirat les decisions i quines conseqüències ha tingut i pot tenir. El llibre reflexiona serenament sobre tot plegat i si només hagués d'escollir un capítol, el 3 i una secció, agafaria la "3.5. Adhesión inquebrantable a la ‘gestión directa’: mal pronóstico". Allà expliquen amb prou detall un dels aspectes que no volen parlar els que es dediquen a la política sanitària, com millorar l'organització. I aquest és precisament l'aspecte crucial que caldria al sector públic. 

Al darrer capítol es fa èmfasi en la importància d'oferir informació al públic. I jo miro ara mateix la Central de Resultats i des de fa 4 anys no hi ha dades. Algú ha apagat l'estadística. I si fos només això. I ja no dic res més.

Llegiu-lo sencer, paga la pena, recomaneu-lo a qui correspongui. I tant de bo algú escolti i tingui impacte el que proposen.

Polític sanitari exhaust fent la becaina després de tant "food for thought"

The decline of pharma R&D productivity (2)

Science needs to move beyond luck if it is to design better drugs for the brain

The Economist:

Between 2011 and 2020 the likelihood of a drug in psychiatry being approved by the Food and Drug Administration was 7.3%. In neurology it was 5.9%. (The industry average is 7.9%.) As well as being less likely to succeed in trials (see chart), neurology drugs also take much longer, on average, to develop, further decreasing their appeal

According to the Global Burden of Disease project 12 mental-health disorders affect about 970m people. Their prevalence has increased by 48% since 1990 as the population has grown. With more than one in ten people on the planet affected, it is a global problem, although what data are available suggest it is more marked in Western countries (see map).

Political determinants of health

 The Political Determinants of Health

In this book, Daniel E. Dawes argues that political determinants of health create the social drivers—including poor environmental conditions, inadequate transportation, unsafe neighborhoods, and lack of healthy food options—that affect all other dynamics of health. By understanding these determinants, their origins, and their impact on the equitable distribution of opportunities and resources, we will be better equipped to develop and implement actionable solutions to close the health gap.

Pharma, big pharma (10)

 Inside the FDA: The Business and Politics Behind the Drugs We Take and the Food We Eat

Inside the FDA takes a closer look at the practices, people, and politics of this crucial watchdog in light of the competing pressures and trends of modern society, revealing what the FDA is supposed to do, what it actually does-and fails to do-who it influences, and how it could better fulfill its mandate. The decisions that the FDA makes are literally life and death. Inside the FDA provides a sophisticated account of how this vitally important agency struggles to balance bureaucracy and politics with its overriding mission to promote the country's health.

 

Stop misuse of antibiotics

 Antimicrobial Resistance in the EU/EEA: A One Health Response

Misuse of antibiotics is among the main drivers underpinning the development of antimicrobial resistance (AMR). Resistance to last-line antibiotics also compromises the effectiveness of life saving medical interventions such as intensive care, cancer treatment and organ transplantation. 

Overall consumption of antibiotics in humans in the European Union/European Economic Area (EU/EEA) decreased by 23% between 2011 and 2020, especially during the Coronavirus Disease 2019 (COVID-19) pandemic (between 2019 and 2020, the mean total consumption of antibiotics dropped by almost 18%). However, relative use of broad-spectrum antibiotics has increased and significant variability across countries suggests that reductions are still possible.

Efforts to reduce unnecessary use of antibiotics in food-producing animals have resulted in a 43% decrease in use between 2011 and 2020 in 25 countries with consistent reporting.

Despite reductions in antibiotic consumption in both humans and food-producing animals, AMR in bacteria from humans in the EU/EEA has increased for many antibiotic-bacterium combinations since 2011. Particularly worrisome is the rise in resistance to critically important antibiotics used to treat common healthcare-associated infections. 

While recent trends have been encouraging, resistance to commonly used antibiotics in bacteria from food-producing animals remains high (>20% to 50%) or very high (>50% to 70%), and there is significant regional variation across the EU/EEA region. 

 

The world is fat (2)

 Can the Obesity Crisis Be Reversed?

From conclusions: 

Ending the obesity epidemic will take both individual and collective action. Neither alone is sufficient. Individuals try to lose weight and keep it off, but the system is working against them. The route to population-wide weight loss will not be through trendy, unsustainable diets. It will be through widespread, appropriate, personalized, and comprehensive approaches.

The first action we all must take, no matter our size, is to educate ourselves about obesity—and you’ve been doing that by reading this book. People need to understand the structural, environmental, and genetic components of obesity. They need to see the ways in which systemic factors contribute to weight gain. The idea that obesity is a choice or a matter of willpower has been thoroughly disproved. The unfortunate fact that many people still believe this actively harms efforts to reduce obesity rates.

The government should first seek to change the public perception of obesity. Obesity is largely a result of structural forces, not just individual actions. A shared awareness of its origins could foster greater support for interventions that allow people to make healthier choices.

People and institutions need to work together to make healthy foods more accessible, affordable, appetizing, and convenient than unhealthy foods. Reversing the obesity crisis will require environments that promote physical activity and social movements that encourage people to get more exercise. We need to devote more resources to preventive efforts for all ages to improve our health.

To reverse the obesity crisis, we will need an all-hands-on-deck approach. Pharmacological advances, surgery, and other treatments should complement new policies, societal practices, and population-wide interventions that promote healthier diets and decrease food consumption. Improving the nation’s health may require implementing policies perceived as restricting personal freedoms that have long been granted to industries and individuals. But these policies will be essential to keeping the population healthy.

For individuals, the goal should be to reach and maintain your optimum weight, meaning the weight at which your body the optimal physical and mental health. 

Outline of free ebook:

INTRODUCTION: Struggling with Obesity

CHAPTER 1: How Do People Gain Excess Weight?

CHAPTER 2: Why Are People Getting Heavier?

CHAPTER 3: What Are the Consequences of Obesity?

CHAPTER 4: What Are the Best Ways to Lose Weight?

CHAPTER 5: How to Reverse the Obesity Crisis

The Dahlgren and Whitehead model 30 years after

 The Dahlgren-Whitehead model of health determinants: 30 years on and still chasing rainbows

From the authors review:

Reflection on the past 30 years has helped us identify where to go from here, to develop the model so that it is adapted to the burning issues of the day. First, we need to find ways to better illustrate the vertical links between the social, economic and cultural determinants of health and those of lifestyle. This is needed to reinforce the point that many lifestyles are structurally determined. There is a  common, flawed assumption that the lifestyles of different socio-economic groups are freely chosen, ignoring the reality that lifestyles are shaped in important ways by the social and economic  environments in which people live.

Second, there is a current debate about the importance of the commercial determinants of health and whether they have been neglected by the public health community, including a critique of these not being given sufficient prominence in the Dahlgren and Whitehead model (Maani et al., 202015). By ‘commercial determinants’, Maani and colleagues refer to factors that adversely influence health, which stems from the profit motive; the examples they give concentrate on the strategies of tobacco, alcohol and food and beverage producers to promote their products. While we acknowledge that the impact of commercial interests should always be analysed, we deliberately do not define ‘commercial interests’ as a determinant in its own right to be included in the  rainbow model. In a rebuttal to Maani and colleagues, we explain how we consider profit-driven commercial interests as ‘driving forces’ that are related to almost all determinants of health except genetic factors.

 

Matching supply and demand for plasma

 From deficit to contribution: the case for voluntary compensated plasma collections in Spain

Summary of the report:

The Covid pandemic has exposed the threat to security of plasma supply that national blood operators have been warning about for years, resulting in a 25% decline in plasma donations in the United States. Since the US provides 75% of the world’s supply of plasma for the manufacture of plasma therapies, such a decline represents a threat to patients all over the world. Today only five countries allow the voluntary compensation of plasma donations: US, Austria, Czech Republic, Hungary, and Germany. These countries represent 5% of the world’s population but contribute to over 90% of plasma used for therapies. If the pharmaceutical industry can attend to current demand for plasma products like albumin and immunoglobulin, it is only thanks to the plasma collected in these countries.

Despite being home to Grífols, a world leader in plasma therapies, and despite the innovative approach that characterizes its organ donation and transplantation system, Spain and Catalonia employ an antiquated, inefficient, and ineffective model for plasma collection. The demand of immunoglobulin in Spain has increased 11.7% per year on average between 2015 and 2019. Relying entirely on non-compensated donors will lead to shortages and negatively impact R&D on new plasma-derived therapies.

The policy report published by The Ostrom Institute and coordinated by Peter Jaworski, Associate Teaching Professor at Georgetown University, provides empirical evidence on why Spain should allow the voluntary compensation of plasma donors and proposes a series of policy reforms. In short, Spain and Catalonia should mimic the Czech model of plasma collections and reform the Royal Decree 1088/2005 to allow voluntary compensation of plasma donors.

Food for thought.

 

 

Models for population health

 Models for Population Health Improvement by Health Care Systems and Partners: Tensions and Promise on the Path Upstream

The Roundtable on Population Health Improvement of the National Academies of Sciences, Engineering, and Medicine hosted a public workshop on September 19, 2019 titled Models for Population Health Improvement by Health Care Systems and Partners: Tensions and Promise on the Path Upstream. The term upstream refers to the higher levels of action to improve health. Medical services act downstream (i.e., at the patient level) in improving population health, while such activities as screening and referring to social and human services (e.g., for housing, food assistance) are situated midstream, and the work of changing laws, policies, and regulations (e.g., toward affordable housing, expanding healthy food access) to improve the community conditions for health represents upstream action.

The workshop explored the growing attention on population health, from health care delivery and health insurance organizations to the social determinants of health and their individual-level manifestation as health-related social needs, such as patients' needs. The workshop showcased collaborative population health improvement efforts, each of which included one or more health systems. This publication summarizes the presentations and discussions from the workshop.

Health behaviors and behavior change

 Behavioral Economics and Public Health

Health behaviors and practices constitute the foundation of good physical and mental health. The leading contributors to the global burden of disease include tobacco smoking, low-quality diets, alcohol abuse, physical inactivity, and obesity. Accordingly, encouraging people to adopt—and maintain—healthy behaviors is a major objective of public health. 

Today I recommend this book and this is what you'll find inside:

Chapter 1: An Introduction to Behavioral Economics and Public Health. Christina A. Roberto and Ichiro Kawachi

Chapter 2: Intertemporal Choices for Health. Justin S. White and William H. Dow

Chapter 3: Maintenance of Healthy Behaviors: Forming and Changing Habits. Dennis Rünger and Wendy Wood

Chapter 4: Emotions and Health Decision-Making: Extending the Appraisal Tendency Framework to Improve Health and Health Care. Rebecca Ferrer, William Klein, Jennifer Lerner, Valerie Reyna, and Dacher Keltner

Chapter 5: Social Norms, Beliefs, and Health. Brent McFerran

Chapter 6: Communicating for action: the importance of memorability and actionability. Jason Riis and Rebecca K. Ratner

Chapter 7:Nudging Individuals Toward Healthier Food Choices with the 4Ps Framework for Behavior Change. Zoë Chance, Ravi Dhar, Michelle Hatzis, and Kim Huskey

Chapter 8: Incentivizing Health Behaviors. Kristina Lewis and Jason Block

Chapter 9: Slim By Design: Moving from Can't to CAN.Brian Wansink

Chapter 10: Applying Behavioural Economics in a Health Policy Context: Dispatches from the front lines. Michael Sanders and Michael Hallsworth

Chapter 11: From Choice Architecture to Policy Infrastructure: Multi-Level Theory and the Political Economy of Health Behaviors. Frederick J. Zimmerman

The world (dis)order after COVID-19

 COVID-19 AND WORLD ORDER. THE FUTURE OF CONFLICT, COMPETITION, AND COOPERATION

A free book of interest:

Part I. Applied History and Future Scenarios

Chapter 1. Ends of Epidemics

Jeremy A. Greene and Dora Vargha

Chapter 2. The World after COVID: A Perspective from History

Margaret MacMillan

Chapter 3. Future Scenarios: "We are all failed states, now"

Philip Bobbitt

Part II. Global Public Health and Mitigation Strategies

Chapter 4. Make Pandemics Lose Their Power

Tom Inglesby

Chapter 5. Origins of the COVID-19 Pandemic and the Path Forward: A Global Public Health Policy Perspective

Lainie Rutkow

Chapter 6. Bioethics in a Post-COVID World: Time for Future-Facing Global Health Ethics

Jeffrey P. Kahn, Anna C. Mastroianni, and Sridhar Venkatapuram

Part III. Transnational Issues: Technology, Climate, and Food

Chapter 7. Global Climate and Energy Policy after the COVID-19 Pandemic: The Tug-of-War between Markets and Politics

Johannes Urpelainen

Chapter 8. No Food Security, No World Order

Jessica Fanzo

Chapter 9. Flat No Longer: Technology in the Post-COVID World

Christine Fox and Thayer Scott

Part IV. The Future of the Global Economy

Chapter 10. Models for a Post-COVID US Foreign Economic Policy

Benn Steil

Chapter 11. Prospects for the United States' Post-COVID-19 Policies: Strengthening the G20 Leaders Process

John Lipsky

Part V. Global Politics and Governance

Chapter 12. When the World Stumbled: COVID-19 and the Failure of the International System

Anne Applebaum

Chapter 13. Public Governance and Global Politics after COVID-19

Henry Farrell and Hahrie Han

Chapter 14. Take It Off-Site: World Order and International Institutions after COVID-19

Janice Gross Stein

Chapter 15. A "Good Enough" World Order: A Gardener's Manual

James B. Steinberg

Part VI. Grand Strategy and American Statecraft

Chapter 16. Maybe It Won't Be So Bad: A Modestly Optimistic Take on COVID and World Order

Hal Brands, Peter Feaver, and William Inboden

Chapter 17. COVID-19's Impact on Great-Power Competition

Thomas Wright

Chapter 18. Building a More Globalized Order

Kori Schake

Chapter 19. Could the Pandemic Reshape World Order, American Security, and National Defense?

Kathleen H. Hicks

Part VII. Sino-American Rivalry

Chapter 20. The United States, China, and the Great Values Game

Elizabeth Economy

Chapter 21. The US-China Relationship after Coronavirus: Clues from History

Graham Allison

Chapter 22. Building a New Technological Relationship and Rivalry: US-China Relations in the Aftermath of COVID

Eric Schmidt

Chapter 23. From COVID War to Cold War: The New Three-Body Problem

Niall Ferguson

What the hell do these people actually mean by "value" in healthcare?

 On the Much Used (and Abused) Word "Value" in Healthcare 

A must read speech by Uwe Reinhardt (RIP). Selected statements:

Now, when I listen to all this prattle on value among people of the real world, I ask myself, what the hell do these people actually mean by that? Well, you typically find it defined as outcomes relative to cost, and then encompassing efficiency. Now, you can have fun with this expression in New England as I had, there were all providers, they were all from the supply side and I said, “It’s a great expression, I never thought of it as an economist but let me play with it. See what you can do with this.” So let’s look at this equation. The first thing you’ll know is that quality is multi-dimensional, it’s a vector. We geeks, have a certain aversion to dividing a vector by a dollar figure. Somehow it is hard to teach this, so we invented this little magic machine that can mush up vectors of quality with vectors of utility, feelings, and out comes this thing called a “qaly” (quality adjusted live year). And you know, Bismarck says you should never inquire how laws are made it’s like making sausages. This is worse, this is actually a little bit like making dog food, but you know earnings per share on an income statement is worse in terms of its reliabilities. So let us look at this ratio where we have value equalling qaly over cost, which, by the way, the inverse of that is just what we call cost effectiveness. 

The more you think about this ratio, you run into a very famous law, Alfred E. Newman’s. Now, who in this audience knows Alfred E. Newman? You’re the most educated. You know kids nowadays don’t know anything, no wonder they’re so weird. They’re not well-read. We all grew up on Mad Magazine which kept us sane. If you hadn’t read Mad Magazine you’d all be nuts by now because Alfred E. Newman understood the world. Here is this famous law, one person’s healthcare cost is another ones healthcare income. Now that’s worth a Nobel laureate. So following Alfred E. Newman’s law, I’m going to write it like this and you can do that to healthcare providers and you see their little eyes ask, could this be true? Who here has ever served on a hospital board? I have on both for profit and not for profit. At any health clinic, what do they talk about: growth, growth, growth. It means revenue, so they don’t want to hear this. They want more qalys and more revenue, that’s what they really want. So, ask yourself this question; has anyone ever thought that the supply side folks want to create value for the patient by cutting their own revenue? I’ve never heard of that. 

Imagine a hospital board with an agenda item: 30 minutes on enhancing value for patients by lowering our revenue. Not thinkable. Has anyone ever seen such a board, or even an agenda item? I have served for over a decade on these boards, and not once. You know growth usually gets an hour; patient safety now gets a half hour. But efficiency, not once have I ever heard of it. It gets worse. We have this equation: revenue equals price times quantity times volume. Can you imagine how obscene that is to a hospital executive? Because they ask, “You mean we can create value by cutting prices? Aren’t prices and quality positively correlated?” And you say, “Why would you say that?” Even if you’re drunk, why would you ever say that? You know, so the hospital raises its price and you get more value.

 Highly recommended!

Pharma, Big Pharma (2)

 Government, Big Pharma, and The People. A Century of Dis-Ease

A book to read, with this Table of Contents:

Dedication
Acknowledgements
Preface
Chapter One – Introductions
Health
Woman as a Biological and Social Entity
A Different Paradigm
Health Care and Rights
Drugs and Their Role in Society
Drug Policy
Big Pharma
Drug-Related Problems
The People
What’s Ahead
Conclusion
Chapter Two – The Four "P’s"
Introduction
Marketing as an Actualizing Process
The Marketing Mix/The Four "P’s"
Government and the Four "P’s"
Conclusion
Chapter Three – Investigators and Investigations
Introduction
The Hearings
The Grand Inquisitor
Gaylord Nelson – Son of Torquemada
The Fountain Hearings
Senator Kennedy Joins the Fray
Small Business Problems – Dingell
Drug Efficacy Problems – Fountain
Moss on Drug Abuse
Fountain Redux
Congressman Rogers on Transition
Senator Humphrey and the Literature
A Newcomer – Congressman Van Deerlin
Senator Fountain – "One More Time"
Senator Kennedy Returns
FDA Under the Microscope Again
Kennedy – Not Too Tranquil
Gore on Pharmaceutical R & D
Senator Fountain Again
Claude Pepper for the Old Folks
Zomax in the Spotlight
A Pryor Engatement
The Task Force on Prescription Drugs
Research Findings and Recommendations
Conclusion
Chapter Four – Legislators and Legislation
Introduction
Laws and Policy
Bills and Sponsors
The Process
Conclusion
Chapter Five – Regulators and Regulations
Introduction
The Food and Drug Administration
Other Regulators and Regulations
Federal Trade Commission
Federal Communications Commission
Drug Enforcement Administration
Centers for Medicare and Medicaid Services
Patents and Trademarks
State Regulations
Drug Names
Conclusion
Chapter Six – Non-Government Influence
Introduction
Self-Regulation
Third Parties – Managed Care Controls
Formularies and Prescription Limitations
Lawyers
Advocates and Adversaries
Mail Order Pharmacy
Pharmacy Benefit Managers and Outcomes Management
Conclusion
Chapter Seven – The People and Their Drugs
Introduction
The People as Patients
Health Belief Model
Case – Health Belief Model
Attitudes and Evaluation of Drugs
The Sickness Career
The Sick Role
The Sick Role in Acute and Chronic Illness
Compliance with Medication Regimens
Other Influences on Medication Use
What to Do
Death or Maybe Not
Conclusion
Chapter Eight – Response of Big Pharma
Introduction
Response to Government
Big Pharma Speaks
Response of Big Pharma to the People
Some Ideas for Big Pharma
PMA Monographs
Statesmanship
Conclusion
Chapter Nine – Little Pharma and Friends
Introduction
Generic Pharma – Not So Little
Big Bio
What is Special about Specialty Drugs?
Little Boutiques
Back to the Future – Compounding Pharmacists
Friends
Conclusion
Chapter Ten – Greedy Big Pharma
Introduction
Two Parts of Greedy
AARP and Greedy Big Pharma
Congress and Greedy Big Pharma
Risk vs. Reward
Greedy Big Tech
Conclusion
Chapter Eleven – Whence the Drugs?
Introduction
Origins of Drugs
Drug Product Development
Marketing in the Last Century
Invention, Discovery, Development
Curiosities and Surprises
Recommended Reading
Conclusion
Chapter Twelve – Drugs of the Future
Introduction
But Seriously
Drugs in an Aging Society
Future Drugs for the Aged
Lifestyle Drugs
Conclusion
Chapter Thirteen – The Non-Prescription Products Market-Dr. W. Steven Pray
Introduction
Patent Medicines
Laws That Regulated Non-Prescription Products
FDA’s Review of O-T-C Products
The Prescription to O-T-C Switch
A Third Class of Drugs
Quackery – Lacking Proof of Efficacy
Quackery – New Names Confer False Respectability
Conclusion
Chapter Fourteen – Issues and Studies in Pharmacoeconomics
Introduction
The Emergence of Pharmacoeconomic Research
The Cost of Illness
Quality of Life Assessment
The Economics of Non-Compliance
Economic Epidemiology
Conclusion
Chapter Fifteen – On Drug Prices – Dr. E. M. "Mick" Kolassa
Pricing: The Forgotten "P"
The Growing Importance of Pharmaceutical Prices
Prices, Politics and Problems
Pricing Terminology
What is a Pharmaceutical Price?
Price Decision Making
The Value of Pharmaceuticals
The Future of Pharmaceutical Pricing
Chapter Sixteen – Summary, Ruminations and Apologia
Introduction
Ruminations
Trends
What If’s
Apologia

How monopolies make our lives harder every day & destroy our future

Monopolies Suck. 7 Ways Big Corporations Rule Your Life and How to Take Back Control

7 Key messages from the book: 

ONE: MONOPOLIES TAKE YOUR MONEY

TWO: MONOPOLIES GOUGE YOU WHEN YOU’RE SICK

THREE: MONOPOLIES LOWER YOUR PAY AND CRUSH THE AMERICAN DREAM

FOUR: MONOPOLIES SPY ON AND MANIPULATE YOU

FIVE: MONOPOLIES THREATEN DEMOCRACY AND YOUR FREEDOM

SIX: MONOPOLIES DESTROY OUR PLANET AND CONTROL YOUR FOOD

SEVEN: MONOPOLIES RAMP UP INEQUALITY

So what? You'll find the details on how to take back control in Chapter 8, a set of clear tools to fight the monopolistic pandemic.

Drug approval and geographic differences

 Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States

We know that the regulation of medical devices is quite different between US and Europe, and with COVID tests we have experienced such divide. In drugs, one could expect a closer approach to approval. However, this is not the case. 

Regulatory agencies may have limited evidence on the clinical benefits and harms of new drugs when deciding whether new therapeutic agents are allowed to enter the market and under which conditions, including whether approval is granted under special regulatory pathways and obligations to address knowledge gaps through postmarketing studies are imposed.

In a matched comparison of marketing applications for cancer drugs of uncertain therapeutic value reviewed by both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), we found frequent discordance between the two agencies on regulatory outcomes and the use of special regulatory pathways. Both agencies often granted regular approval, even when the other agency judged there to be substantial uncertainty about drug benefits and risks that needed to be resolved through additional studies in the postmarketing period.

Postmarketing studies imposed by regulators under special approval pathways to address remaining questions of efficacy and safety may not be suited to deliver timely, confirmatory evidence due to shortcomings in study design and delays, raising questions over the suitability of the FDA’s Accelerated Approval and the EMA’s Conditional Marketing Authorization as tools for allowing early market access for cancer drugs while maintaining rigorous regulatory standards.

 Hockney

Machine learning for clinical labs

 Machine Learning Takes Laboratory Automation to the Next Level

Good article on ML applications for microbiology lab.

There are two commercially available Food and Drug Administration (FDA)-approved microbiology laboratory automation platforms in the United States, namely, WASPLab (Copan Diagnostics Inc.) and Kiestra (Becton Dickinson) (6). Each system is highly customizable and consists of front-end processing, “smart” incubation according to laboratory protocol, and plate imaging. The processing unit performs medium selection, application of patient information and barcodes for tracking, medium inoculation, and plate streaking. Automation of these processes cuts down on and improves the consistency of repetitive tasks previously performed by technologists.

Image analysis software is not currently FDA approved, so the algorithm it deploys qualifies as a high-complexity laboratory-developed test when used to make definitive calls about microorganism presence/absence or culture significance. In this context, the end user need not understand the internal workings any more than they understand the inner workings of most computers. Additionally, as with most laboratory software, manufacturer assistance is provided in training the algorithm. Labs may, therefore, validate performance according to familiar sensitivity and specificity (for significant growth), precision and accuracy (for quantification), and procedural variation (coefficients of variation, Kappa statistics). As with any test, revalidation must be performed if components of the test change. The number of samples needed to train the algorithm (hundreds to thousands) will be algorithm dependent but easily available due to their common nature, facilitating both initial and revalidation using new plate images. Validation of machine learning image analysis for laboratory automation may, overall, be comparable to that performed for whole-slide imaging as used in histopathology, where the object of validation is a process as much as a machine (12) and where modest interobserver agreement may set a similarly modest benchmark for machine learning performance.

 Eivissa autèntica, Joaquim Gomis