September 22, 2022

Pharmaceutical innovation and value extraction

 Pharmaceutical innovation sourcing

Figure below shows that 23% of new medicines came from public bodies and private-private collaboration and they didn't apply for any marketing authorisation.




September 21, 2022

Managing the decline in Pharma R&D

Global Trends in R&D. OVERVIEW THROUGH 2021

A decade ago I posted this: Gestionar el declivi. John Kay said in 2011:

"When an industry model is broken, the best business strategy may be to manage its decline"

Now a new report confirms that the process continues after a decade.

From IQVIA report:

The composite success rate across all development phases and therapy areas declined to 5.0% in 2021, which can be attributed to an appetite for increased scientific risk in clinical development programs as the bar for efficacy and safety rises, as well as increased pauses in product development due to the pandemic.

Across disease areas, probability of success varies considerably, and 2021’s composite success rate fell below the 10-year trend in all areas except for vaccines and cardiovascular.

 That's all folks.





September 16, 2022

Human genomics vs. clinical genomics

 Today my suggestion is to read the post by Eric Topol with the same title. 

It begins with this statement:

We’re now well over 20 years since the first human genome was sequenced, but with few exceptions the massive amount of data that has been generated has not been transformed to routine patient care.

So, why?



September 2, 2022

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.






September 1, 2022

Value-based pricing: a controversial narrative

 Rethinking value in health innovation: from mystifications towards prescriptions

From the abstract:
Debates over value in health innovation in the U.S. and Europe have
become increasingly dominated by “value-based pricing”. We examine
this prevailing narrative and its weaknesses and then present an
alternative framework for rethinking value in health. Drawing on
scholarship from the political economy of innovation, we argue that
value in health must be considered in terms of both value creation
as a collective process amongst public and private actors, as well as
value extraction that occurs due to financialization. In building this
alternative framework, we pose three questions that present areas
for further research and public policy change


August 25, 2022

AI everywhere (16)

 The Doctor and the Algorithm. Promise, Peril, and the Future of Health AI


AI is a clear and present danger to health, safety, and equity. AI also has the potential to improve clinical care profoundly. Both of these statements are true, and both are false by dint of their incompleteness. This kind of indeterminacy is a common problem in medicine. Famously, pharmakon (the Ancient Greek word at the root of pharmacy) means “drug” but can connote either cure or poison. The Paracelsian maxim that “the dose makes the poison” is likewise a common, albeit misleading, trope of introductory pharmacology. In many ways, AI is a pharmakon. It can be both cure and poison. The indeterminacy of a pharmakon is inarguably a challenge for medicine, but it does not bring healthcare to a halt. Rather, doctors, researchers, and regulators have slowly built up, over the centuries, systems of checks and balances that ideally lead toward more pharmakon-qua-cure than pharmakon-qua-poison. Please do not misunderstand me. This has certainly not been some sort of steady progression toward a better world. I am not trying to sell a story about the inevitability of scientific progress.



August 17, 2022

Pandemethics (2)

 Pandemic Bioethics

Contents:
Chapter 1 Historical Epidemics
The Spanish Flu of 1918
Cholera
Plague
Smallpox
Yellow Fever
Malaria
Chapter 2 Modern Viral Pandemics
Polio
Asian Flu of 1957 and Hong Kong Flu of 1968
Ebola
Swine Flu of 1976
Human Immunodeficiency Virus (HIV)
SARS1
Swine Flu of 2009
Middle Eastern Respiratory Syndrome (MERS)
Zika
Other Viral Diseases Affecting Humans
Chapter 3 The Medical Nature of SARS2
Disputed Origins of SARS2
The Clinical Course of COVID-19
Transmission and Immunity
Chapter 4 Policies for Containment
Quarantine as a Preventive Allocation Strategy
Four Models of Fighting Pandemics
Successes and Failures around the World
Intermittent Lockdowns, Denial, and the American Confusion
Chapter 5 Who Should Live When Not All Can?
Ethical Theories as Guides
Historical Background: The God Committee and Social Worth
A Relevant Digression: “Sickest First” Allocation and UNOS
Enter Bioethicists
Saints and Sacrifice
Covid, Cognitively Challenged Patients, and Rights of Disabled Persons
Unexpected Allocation Issues
Chapter 6 Developing Vaccines
A Brief History of Vaccines
Kinds of Vaccines
Ethical Issues in Developing Vaccines
Speeding Up Development of Experimental Vaccines
Other Problems with Vaccine Trials
Politics and Vaccines for Covid
Chapter 7 Allocating Vaccines
Success with Quick Production of Vaccines
The CDC and the States
Ability to Pay and Access to Vaccines
Allocation Priorities
Vaccination Complexities
Mandatory Vaccinations
Global Vaccine Distribution
Possible Bad Scenarios
Chapter 8 Acts and Omissions, the Trolley Problem, and Prisoner’s Dilemmas
Acts vesus Omissions
The Trolley Problem
Prisoner’s Dilemmas and Vaccination Uptake
Chapter 9 Liberty and Privacy
Philosophical Positions on Liberty
Problems of Contact Tracing
Controlling Pandemics versus Protecting Privacy
Privacy of Genetic Information Collected during Testing in Pandemics
Chapter 10 Status Certificates
Defining Key Terms
What Is the Purpose of Status Certificates?
Benefits of Status Certificates
Problems with Status Certificates
Chapter 11 Structural Inequalities and Vulnerable Groups
Who Is Most Vulnerable in a Pandemic?
Differences in Efforts to Control Infection in Different Vulnerable Groups
Chapter 12 Leadership during Pandemics
Leadership and the Virtue of Trust
The WHO’s Leaders Made Mistakes
Donald Trump and American Leadership
Judgment of US Leaders during the Pandemic
Chapter 13 The Future
The Future of COVID-19
Lessons to Learn
More Pandemics Will Come
What Will Happen Next?


August 12, 2022

The ableist conflation

 The Life Worth Living. Disability, Pain, and Morality

The central argument of this book can be stated simply: the canonical idea that some lives are not worth living results from the ableist conflation of disability with pain and suffering. That is to say, the reason for this entrenched, tradition-spanning idea is the habit of thought wherein one conflates experiences of pain and suffering with experiences of disability—experiences whose form, mode, matter, or style of living is considered categorically outside ableist norms.

I offer the ableist conflation as a concept to capture the underlying presuppositions that guide ableist discourses and practices in philosophy; ethics; politics; medicine; local, national, and international policy; and beyond. Although it can take many forms, the ableist conflation involves some variation of at least the following four claims:

1. Disability necessarily involves a lack or deprivation of a natural good.

2. Deprivation of a natural good is a harm.

3. Harm causes or is itself a form of pain and suffering.6

4. Given 1–3, disability comes along with or directly causes pain and suffering.

The ableist conflation functions in part by capitalizing upon the ambiguity of the array of terms it involves. Disability, harm, pain, and suffering are all uncritically underdefined, as are the relations between them. A central goal of this book is to decouple disability and pain through phenomenological investigation and, by doing so, to dismantle the ableist conflation and the uncritical assumptions behind each of its operative terms.



August 2, 2022

Can capitalism be reimagined ?(5)

 Woke Capitalism. How Corporate Morality is Sabotaging Democracy

The Oxford dictionary’s definition woke refers to being ‘well informed’ or ‘alert to racial or social discrimination and injustice’.

Essentially, we have two opposing positions. One, from a liberal left position such as Elizabeth Warren’s, agrees that corporations should genuinely and authentically support the broad interests of society rather than just focusing on shareholders. Another, from a traditional right-wing perspective, believes that corporations should be purely economic entities and not interfere directly in social or political matters. This book has taken a third position. That is, despite how it looks on the surface, corporate engagement with progressive politics is harming democracy and preventing actual progress. What this means is that being critical of woke capitalism does have to necessitate a dismissal of  progressive politics. Waking up to the realities of woke capitalism means not being fooled into thinking that it represents any genuine underlying change to the primary interests that capitalist corporations are willing or able to pursue.

The real effects of woke capitalism are not about the success of left activism in gaining support from big business. They are about ensuring that there is no fundamental reform of the dominant neoliberal world order that has exacerbated inequality, fuelled fascist populism, and stood by as the climate crisis escalates. Dismissing woke capitalism as just another example of virtue signalling is counterproductive in that it fails to take seriously the real damage that woke capitalism can do. Laughing at corporate progressiveness as a superficial and inauthentic business practice entirely underestimates its real power. This is not simply about the short-term profitability assumed by the ‘go woke, or go broke’ credo. Going woke is about ensuring that market capitalism can continue on the trajectory that it has been on for the past 40 years. Woke capitalism is a strategy for maintaining the economic and political status quo and for quelling criticism.



July 29, 2022

Against patents, again (3)

 Patent Politics. Life Forms, Markets, and the Public Interest in the United States and Europe

Comparing battles over patents on animals, human embryonic stem cells, human genes, and plants in the United States and Europe, she shows how political culture, ideology, and history shape patent system politics. Clashes over whose voices and which values matter in the patent system, as well as what counts as knowledge and whose expertise is important, look quite different in these two places. And through these debates, the United States and Europe are developing very different approaches to patent and innovation governance. Not just the first comprehensive look at the controversies swirling around biotechnology patents, Patent Politics is also the first in-depth analysis of the political underpinnings and implications of modern patent systems, and provides a timely analysis of how we can reform these systems around the world to maximize the public interest.



July 28, 2022

Against patents (2)

 Medical Monopoly. Intellectual Property Rights and the Origins of the Modern Pharmaceutical Industry

Medical Monopoly combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today. Joseph M. Gabriel provides the first detailed history of patent and trademark law as it relates to the nineteenth-century pharmaceutical industry as well as a unique interpretation of medical ethics, therapeutic reform, and the efforts to regulate the market in pharmaceuticals before World War I. His book will be of interest not only to historians of medicine and science and intellectual property scholars but also to anyone following contemporary debates about the pharmaceutical industry, the patenting of scientific discoveries, and the role of advertising in the marketplace.



 

July 25, 2022

On epigenetics and health (2)

 The Epigenetics Revolution. How Modern Biology Is Rewriting Our Understanding of Genetics, Disease, and Inheritance

The ‘epi’ in epigenetics is derived from Greek and means at, on, to, upon, over or beside. The DNA in our cells is not some pure, unadulterated molecule. Small chemical groups can be added at specific regions of DNA. Our DNA is also smothered in special proteins. These proteins can themselves be covered with additional small chemicals. None of these molecular amendments changes the underlying genetic code. But adding these chemical groups to the DNA, or to the associated proteins, or removing them, changes the expression of nearby genes. These changes in gene expression alter the functions of cells, and the very nature of the cells themselves. Sometimes, if these patterns of chemical modifications are put on or taken off at a critical period in development, the pattern can be set for the rest of our lives, even if we live to be over a hundred years of age.

There’s no debate that the DNA blueprint is a starting point. A very important starting point and absolutely necessary, without a doubt. But it isn’t a sufficient explanation for all the sometimes wonderful, sometimes awful, complexity of life. If the DNA sequence was all that mattered, identical twins would always be absolutely identical in every way. 



June 18, 2022

Human differences

Inequality. A Genetic History


The book explores the ancestral shifts associated with migration and describes the gender bias unearthed in these migrations—the brutal sexual asymmetries, for example, between male European explorers and the women of Latin America that are revealed by DNA analysis. He considers social structures, and the evidence that high social standing was inherited—the ancient world was not a meritocracy. He untangles social and genetic factors to consider whether wealth is an advantage in reproduction, showing why we are more likely to be descended from a king than a peasant. And explores the effects of ancient inequality on the human gene pool. Marshaling a range of evidence, Lalueza-Fox shows that understanding past inequalities is key to understanding present differences.





June 16, 2022

Unfair War

 Who Should Die?. The Ethics of Killing in War

This volume collects in one place the most influential and groundbreaking philosophical work being done on the question of killing in war, offering a "who's who" of contemporary scholars debating the foundational ethical questions surrounding liability to harm. In ten essays, it expands upon and provides new and updated analyses that have yet to be captured in a single work. Essays explore questions such as: Are some soldiers more deserving of death than others? Should states allow soldiers to conscientiously object (to opt out of war) on a case-by-case basis? Can a theory of rights best explain when it is permissible to kill in war? When are we allowed to violently resist oppression that is itself nonviolent? Is there anything wrong with targeting people with autonomous weapons?

Who Should Die? Editors' Introduction

Chapter 1: "Liability to Deadly Force in War"

Leonard Kahn

Chapter 2: "Jus in Bello: Actual vs. Hypothetical Contract"

Yitzhak Benbaji

Chapter 3: "Do Some Soldiers Deserve to Die More Than Others? Selective

David Whetham

Chapter 4: "Defensive Liability: Four Common Mistakes"

Kai Draper

Chapter 5: "Fighting for One's Self"

Michael Robillard

Chapter 6: "An Axiomatic Theory of Just War: Forfeiture Theory"

Stephen Kershnar

Chapter 7: "Dignity, Self-Respect, and Bloodless Invasions"

Saba Bazargan

Chapter 8: "What is the Moral Problem with Killer Robots?"

Susanne Burri

Chapter 9: "Distributing the Cost of Rescue"

Lars Christie

Chapter 10: "Legality, Justice, and the War on Terrorism"

Lionel K. McPherson




June 15, 2022

June 13, 2022

Sharing health risks

 Mutualism and health care. Hospital contributory schemes in twentieth-century Britain

The British hospital contributory schemes movement was described in 1936 as ‘one of the most outstanding examples of social organisation during the last two or three decades’.1 Contributory schemes had flourished in response to the considerable financial challenges faced by the voluntary hospitals in the twentieth century, although their roots lay in the nineteenth-century Hospital Saturday and Sunday funds (described in chapter 2).2 The aim was to elicit the support of working-class subscribers (people whose incomes were insufficient for them to be able to pay for treatment by a private medical practitioner) in the form of regular contributions to hospital finances. A small weekly contribution was levied, typically 2d or 3d, or a penny in the pound of wages, mostly through payroll deductions. The funds raised were either handed over directly to individual hospitals or pooled for distribution between groups of hospitals. The principal benefit of membership was free treatment in a voluntary hospital, without having to pass the means test set by the hospital almoner



June 9, 2022

Longevity medicine scams

 The Price of Immortality. THE RACE TO LIVE FOREVER

Peter Ward immerses himself into an eccentric world of startups, scam artists, scientific institutions, and tech billionaires to deliver this deeply reported, nuanced, and sometimes very funny exploration of the race for immortality — and the potentially devastating consequences should humanity realize its ultimate dream.




June 8, 2022

Valuing health

 Measuring and Valuing Health Benefits for Economic Evaluation

This book addresses the theoretical and practical considerations in the measurement and valuation of health benefit with empirical examples and applications to help clarify understanding and make relevant links to the real world. It includes a glossary of key terms and provides guidance on the use of different methods and instruments. This updated edition provides an-up-to date review of the theoretical basis of the QALY; the definition of health; the techniques of valuation (including ordinal); the modelling of health state values (including mapping between measures); a detailed review of generic preference-based measures and other instruments for obtaining health state utility values (with recent developments); cross-cultural issues (including the disability-adjusted life year); the aggregation of QALYs; and the practical issues surrounding the use of utility values in cost-effectiveness models. The book concludes with a discussion on the way forward in light of the substantial methodological differences, the role of normative judgements, and where further research is most likely to take forward this fascinating component of health economics.



May 9, 2022

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.



 

May 8, 2022

Pharma, big pharma (9)

 Devalued and Distrusted: Can the Pharmaceutical Industry Restore its Broken Image?

Starting with "4 Secrets that Drug Companies Don't Want You to Know," Devalued and Distrusted provides a fact-based account of how the pharmaceutical industry works and the challenges it faces. It addresses such critical issues as:

  • Why pharmaceutical R&D productivity has declined
  • Where pharmaceutical companies need to invest their resources
  • What can be done to solve core health challenges, including cancer, diabetes, and neurodegenerative diseases
  • How the pharmaceutical industry can regain public trust and resuscitate its image

Our understanding of human health and disease grows daily; however, converting science into medicine is increasingly challenging. Reading Devalued and Distrusted, you'll not only gain a greater appreciation of those challenges, but also the role that the pharmaceutical industry currently plays and can play in solving those challenges.



 

May 7, 2022

Pharma, big pharma (8)

 Drug Truths: Dispelling the Myths About Pharma R & D

This book answers the questions about the process and costs of pharmaceutical R & D in a compelling narrative focused on the discovery and development of important new medicines. It gives an insider's account of the pharmaceutical industry drug discovery process, the very real costs of misperceptions about the industry, the high stakes--both economic and scientific--of developing drugs, the triumphs that come when new compounds reach the market and save lives, and the despair that follows when new compounds fail. In the book, John LaMattina, former president of Pfizer Global Research and Development, weaves themes critical to a vital drug discovery environment in the context. This is a story that Dr. LaMattina is uniquely qualified to tell.

TABLE OF CONTENTS

PART I A MATTER OF THE HEART 1

CHAPTER 1 CHOLESTEROL DRUGS ARE UNNECESSARY 3

CHAPTER 2 INDUSTRY IS MORE INTERESTED IN "ME-TOO" DRUGS THAN IN INNOVATION 13

CHAPTER 3 IT TAKES INDUSTRY TOO LONG TO DISCOVER NEW DRUGS 23

PART II THE ROLE OF PHARMACEUTICAL R&D IN HEALTH CARE 39

CHAPTER 4 DRUGS ARE DISCOVERED BY ACADEMIA 41

CHAPTER 5 NEW MEDICINES ADD COSTS BUT LITTLE BENEFIT 50

CHAPTER 6 BIG PHARMA HAS FAILED AND SHOULD LEARN FROM BIOTECH SUCCESS 59

PART III THE PROFIT MOTIVE 69

CHAPTER 7 THE INDUSTRY INVENTS DISEASES 71

CHAPTER 8 NEW DRUGS ARE LESS SAFE THAN TRADITIONAL MEDICINES 79

CHAPTER 9 INDUSTRY SPENDS MORE ON ADVERTISING THAN ON R&D 91

CHAPTER 10 INDUSTRY DOES NOT CARE ABOUT DISEASES OF THE DEVELOPING WORLD 100

PART IV THE FUTURE 109

CHAPTER 11 BIG PHARMA'S DAY HAS PASSED 111

CHAPTER 12 FINAL REFLECTIONS 122



May 6, 2022

Two-tier healthcare, or paying twice for the same (2)

 Are we heading for a two tier healthcare system in the UK?

Private healthcare boom adds to fears of two-tier system in UK

Extrapolation from a recent poll suggests that about 16 million adults in the UK found it difficult to access healthcare services during the pandemic, and of these, one in eight opted to access private healthcare.1 This could create the conditions for a two tier system, whereby those with the means to pay have access to healthcare more quickly than those who don’t. This would jeopardise the high levels of support the NHS has enjoyed since its establishment and have serious implications for equity in access to healthcare services.

 

 

May 5, 2022

Two-tier healthcare, or paying twice for the same

 Is Two-Tier Health Care the Future?

In this book, leading researchers explore the public and private mix in Canada and within countries such as Australia, Germany, France and Ireland. We explain the history and complexity of interactions between public and private funding of health care. We also explain the many regulations and policies found in different countries used to both inhibit and sometimes to encourage two-tier care (for example, tax breaks). If a Canadian court strikes down laws restrictive of two-tier, Canadian governments can (i) permit and even encourage two-tier care to grow; (ii) pass new regulations that allow a small measure of two-tier care; or (iii) take positive steps to eliminate wait times in Canadian health care, and thereby reduce demand for two-tier care. We argue for option three as the best means to ensure Canadian principles of equity in access, ensure timely care, and fend off constitutional challenges.