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

Vaccine nationalism

 The Optimal Allocation of Covid-19 Vaccines

Covid-19 vaccine prioritization is key if the initial supply of the vaccine is limited. A consensus is emerging to first prioritize populations facing a high risk of severe illness in high-exposure occupations. The challenge is assigning priorities next among high-risk populations in low-exposure occupations and those that are young and healthy but work in high-exposure occupations. We estimate occupation-based infection risks and use age-based infection fatality rates in a model to assign priorities over populations with different occupations and ages. Among others, we find that 50-year-old food-processing workers and 60-year-old financial advisors are equally prioritized. Our model suggests a vaccine distribution that emphasizes age-based mortality risk more than occupation-based exposure risk.

Today we can confirm that the probability of such proposal is low. After reading FT, WHO framework has suffered a setback.

Banksy

Forming beliefs

The Value of Beliefs

Relevant article with key messages:

We construct our beliefs to meet two sometimes conflicting goals: forming accurate beliefs to inform our decisions and forming desirable beliefs that we value for their own sake. In this NeuroView, we consider emerging neuroscience evidence on how the brain motivates itself to form particular beliefs and why it does so.

Our beliefs are fundamental parts of what makes each of us unique. They are a major cause of both harmony and discord; shared beliefs bring people together, while divergent beliefs can spark revolutions. In this age of the internet and social media, the ability of beliefs to both invigorate and polarize is more apparent than ever. This raises a fundamental question: how do people arrive at their beliefs? A traditional approach to studying beliefs is grounded on the idea that people build an internal model of the world for the purpose of informing their decisions to help them achieve external goals, such as gaining rewards and avoiding punishments.

 In particular, individuals often prefer to hold positive beliefs and hold beliefs with high certainty. To achieve this, changes in information seeking and belief updating are motivated by tapping into the same circuits that drive primary reward seeking. However, unlike primary rewards such as food, beliefs on their own do not directly promote survival.

How advances in biological science are transforming economies and societies

The Bio Revolution: Innovations transforming economies, societies, and our lives

McKinsey Global Institute is well known by their excellent papers and analysis. Forget consultancy for a while, if you are interested in the disruptive knowledge, go to MGI. Recently they have released an excellent report on the Bio Revolution. This is a timely contribution for an issue that those that read this blog already know: we are within a huge change on how life has been considered. CRISPR technology, among others, are changing quickly the landscape.

The potential scope and scale of the (direct and indirect) impact of biological innovations appear very substantial. As much as 60 percent of the physical inputs to the global economy could be produced biologically. Around one-third of these inputs are biological materials (such as wood). The remaining two-thirds are not biological materials, but could, in principle, be produced using innovative biological processes (for instance, bioplastics).

A pipeline of about 400 use cases, almost all scientifically feasible today, is already visible. These applications alone could have direct economic impact of up to $4 trillion a year over the next ten to 20 years. More than half of this direct impact could be outside human health in domains such as agriculture and food, consumer products and services, and materials and energy production. Taking into account potential knock-on effects, new applications yet to emerge, and additional scientific breakthroughs, the full potential could be far larger.

A must read.

Climate change and health

Enviromedics: The Impact of Climate Change on Human Health

These are tough times for the relationship between mankind and the planet. Therefore, this is a good reason to know better the relationship between climate change and health. In this book you'll find the details on each topic.
These are the key issues:

Part I. Climate Change Cascade
2 Climate Change 101: A Primer
3 Heat Waves and Heat Stress
4 Extreme Weather
5 Vector-Borne Diseases
6 Mental Health
Part II. Clear and Present Pathogens
7 Air Degradation
8 Water Security
9 Food Security
10 Allergens
11 Harmful Algal Blooms 

 Many of these modern sources of environmental hazards share a common feature—they derive from human activity as much as or more than from nonhuman sources. Radiation exists in nature, but its concentrated forms on Earth are created by humans. Industries produce the goods that support modern life, while they spin off by-products that can harm the environment and humans. We celebrate the productivity of modern agriculture, but if the runoff of pesticides and antibiotics pollutes the water supply and encourages antimicrobial resistance, we pay a higher price than we realize for food.

Balancing this tradeoff is complicated by the fact that the individuals and interests who typically stand to benefit from a polluting activity are not the same as the ones who will suffer the adverse health and other consequences.

Global externalities and how to fix them. This is one of the greatest challenges nowadays.

The world is fat

 The Heavy Burden of Obesity – The Economics of Prevention

Almost a decade after the publication of the first OECD report on obesity, a new one has been released. This are the facts:

More than half the population is now overweight in 34 out of 36 OECD countries and almost one in four people is obese. Average rates of adult obesity in OECD countries have increased from 21% in 2010 to 24% in 2016, so an additional 50 million people are now obese. Despite a drive in the last decade to deal with increased obesity, more needs to be done amid sedentary lifestyles and an almost 20% increase in calorie supply – i.e. calories available for consumption – in the OECD over the past 50 years.

So what?

The OECD identifies four categories of policies to tackle the problem and gauges the effect of three promising “policy packages” to help countries achieve greater impact and coherence in tackling the obesity epidemic. Food and menu labelling, regulation of advertising of unhealthy foods to children and the promotion of exercise, including by doctors and schools, are among the measures analysed.

Most of the strategies requires a confrontation with the food industry, and governments usually try to avoid it. We'll see what happens.

Medicine as a data science (6)

Adapting to Artificial Intelligence: Radiologists and Pathologists as Information Specialists

While some physicians are lobbying for creating more specialties, Jah and Topol argue exactly the opposite. Radiology, pathology and in vitro diagnostics should be under the same umbrella: "the information specialists":

Because pathology and radiology have a similar past and a common destiny,
perhaps these specialties should be mergedinto a single entity, the “information specialist,” whose responsibility will not be so much to extract information from images and histology but to manage the information extracted by artificial intelligence in the clinical context of the patient.

 There may be resistance to merging 2 distinct medical specialties, each of which has unique pedagogy, tradition, accreditation,and reimbursement.However, artificial intelligence will change these diagnostic fields. The merger is a natural fusion of human talent and artificial intelligence. United, radiologists and pathologists can thrive with the rise of artificial intelligence. 

The history of automation in the broader economy has a reassuring message. Jobs are not lost; rather, roles are redefined; humans are displaced to tasks needing a human element. Radiologists and pathologists need not fear artificial intelligence but rather must adapt incrementally to artificial intelligence, retaining their own services for cognitively challenging tasks.A unified discipline, information specialists would best be able to captain artificial intelligence and guide medical information to improve patient care.

You may agree or not. Technology is breaking barriers and creating bridges. Food for thought.

Josep Segú - Brooklyn Bridge

Exhibition at Sala Parés

Times of resistance

When All Else Fails: THE ETHICS OF RESISTANCE TO STATE INJUSTICE

The economist Albert O. Hirschman famously argued that citizens of democracies have only three possible responses to injustice or wrongdoing by their governments: we may leave, complain, or comply. But in When All Else Fails, Jason Brennan argues that there is a fourth option. When governments violate our rights, we may resist. We may even have a moral duty to do so.
For centuries, almost everyone has believed that we must allow the government and its representatives to act without interference, no matter how they behave. We may complain, protest, sue, or vote officials out, but we can’t fight back. But Brennan makes the case that we have no duty to allow the state or its agents to commit injustice. We have every right to react with acts of “uncivil disobedience.” We may resist arrest for violation of unjust laws. We may disobey orders, sabotage government property, or reveal classified information. We may deceive ignorant, irrational, or malicious voters. We may even use force in self-defense or to defend others.
The result is a provocative challenge to long-held beliefs about how citizens may respond when government officials behave unjustly or abuse their power.

Food for thought.

Docuncert Txarango 

Research and results

The Biomedical Bubble: Why UK research and innovation needs a greater diversity of priorities, politics, places and people

More resources for research are needed. This is the usual mantra. However, what about outcomes?. Since this is not so easy to measure it really lies in an uncertain land. A new report tries to put things clearer, at least for UK. It explains the mismatch about research funding and what is needed to improve health. This is exactly what I consider the right approach. It is useless to ask for more money unless we explain and focus on the priorities for achieveing better health.

A biomedical bubble has developed, which threatens to unbalance the UK’s research and
innovation system, by crowding out the space and funding for alternative priorities. This
is not a speculative bubble, as developed for tulips in the 1630s, or dotcoms in the early
2000s; there is far too much substance in the biomedical sciences for this. But it is a social, political and epistemic bubble (similar to the ‘Westminster bubble’, or the ‘filter bubble’), in which supporters of biomedical science create reinforcing networks, feedback loops and commitments beyond anything that can be rationalised through cost-benefit analysis.

The biomedical bubble represents a risky bet on the continued success of the pharmaceutical industry, despite mounting evidence that this sector faces a deepening
crisis of R&D productivity, and is cutting its own investment. And it favours a particular approach to the commercialisation of science, based on protectable intellectual property and venture capital based spinouts – despite the evidence that this model rarely works. Our health and social care system is under growing strain, and as the NHS marks its 70th birthday this month, there is renewed debate about its long-term affordability. Too often, the biomedical bubble distracts attention and draws resources away from alternative ways of improving health outcomes. Only 5 per cent of health research funding is spent on researching ways of preventing poor health. And more than half is spent in three cities - London, Oxford and Cambridge - despite variations in life expectancies of up to eight years across the country. This paper argues for a more balanced distribution, aligned to what the evidence clearly shows are crucial social, economic, environmental and behavioural determinants of better health outcomes.

 Food for thought.

Shomei Tomatsu in Barcelona

Public funding of succesful Pharma R&D

Contribution of NIH funding to new drug approvals 2010–2016

If we consider the 210 new molecular entities (NMEs) approved by the Food and Drug Administration from 2010–2016, then you'll find that NIH funding contributed to published research associated with every one. A PNAS article explains that:

Collectively, this research involved 200,000 years of grant funding totaling more than $100 billion. The analysis shows that 90% of this funding represents basic research related to the biological targets for drug action rather than the drugs themselves. The role of NIH funding thus complements industry research and development, which focuses predominantly on applied research. This work underscores the breath and significance
of public investment in the development of new therapeutics and the risk that reduced research funding would slow the pipeline for treating morbid disease.

This public funding is forgotten in the costs of a new molecule. Although in the price, the manufacturer surplus doesn't remunerate such contribution. Some adjustment should be applied, to be fair.

 Brassai at Mapfre Foundation in Barcelona

The apocalypse and our true fate, who knows?

THE FIVE HORSEMEN OF THE MODERN WORLD: Climate, Food, Water, Disease, and Obesity

In the book of Revelation or Apocalypse of John, you'll find the seven bowls. Seven angels are thus given seven bowls of God's wrath, each consisting of judgements full of the wrath of God poured onto Earth:

First Bowl: A "foul and malignant sore" afflicts the followers of the Beast. (16:1–2)
Second Bowl: The Sea turns to blood and everything within it dies. (16:3)
Third Bowl: All fresh water turns to blood. (16:4–7)
Fourth Bowl: The Sun scorches the Earth with intense heat and even burns some people with fire. (16:8–9)
Fifth Bowl: There is total darkness and great pain in the Beast's kingdom. (16:10–11)
Sixth Bowl: The Great River Euphrates is dried up and preparations are made for the kings of the East and the final battle at Armageddon between the forces of good and evil. (16:12–16)
Seventh Bowl: A great earthquake and heavy hailstorm: "every island fled away and the mountains were not found." (16:17–21)

As you may notice Apocalypse is just that, a book. Daniel Callahan set a title of five horsemen of the modern world as a metaphor of current evils. Global warming, food shortages, water shortages and quality, chronic illness, and obesity could be the key ingredients of our fate?.
At the end, Daniel Callahan calls for a diplomatic model:

to persuade the research, academic, and policy communities to accept what I will call the diplomatic model of relationships, typically now seen between and among nations, and to open a serious dialogue with the business community

Agree.

When science and regulation don't talk to each other

An Evidence Framework for Genetic Testing

National Academy of Sciences and Food and Drug Administration don't talk to each other. At the same time that NASEM publishes a report on how to assess genetic testing, FDA clears genetic testing for 23andme without any precise assessment, for the following tests:

• Parkinson’s disease, a nervous system disorder impacting movement
• Late-onset Alzheimer’s disease, a progressive brain disorder that destroys memory and thinking skills
• Celiac disease, a disorder resulting in the inability to digest gluten
• Alpha-1 antitrypsin deficiency, a disorder that raises the risk of lung and liver disease
• Early-onset primary dystonia, a movement disorder involving involuntary muscle contractions and other uncontrolled movements
• Factor XI deficiency, a blood clotting disorder
• Gaucher disease type 1, an organ and tissue disorder
• Glucose-6-Phosphate Dehydrogenase deficiency, also known as G6PD, a red blood cell condition
• Hereditary hemochromatosis, an iron overload disorder
• Hereditary thrombophilia, a blood clot disorder

Meanwhile NASEM recommends a decision framework for the use of genetic tests in clinical care:

1. Define genetic test scenarios on the basis of the clinical setting, the purpose of the test, the population, the outcomes of interest, and comparablealternative methods.
2. For each genetic test scenario, conduct an initial structured assessment to determine whether the test should be covered, denied, or subject to additional evaluation.
3. Conduct or support evidence-based systematic reviews for genetic test scenarios that require additional evaluation.
4. Conduct or support a structured decision process to produce clinical guidance for a genetic test scenario.
5. Publicly share resulting decisions and justification about evaluated genetic test scenarios, and retain decisions in a repository.
6. Implement timely review and revision of decisions on the basis of new data.
7. Identify evidence gaps to be addressed by research.

If you want further details, check Mathew Herper blog. My first impression after reading it is that this move, paves the way for recreational genetic testing. An approach that should be completely banned by legislation. If FDA has done so, let's wait for what it may happen in Europe where the regulator is still planning a change of the regulation in 2022!!! Meanwhile, the door is open (to the worst for citizens).

New album by Txarango. Enjoy it!

How bad health regulation leads to unsafety medical devices in Europe

Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Unión and United States: cohort study

The topic sould be at the top of health policy agenda (at least as it is in this blog). New evidence confirms the additional safety risks of european bad regulation.

In the European Union, medical devices are approved by private notified bodies if they meet performance criteria and are likely to be safe, but notified bodies generally do not require evidence of effectiveness for most devices. Many high risk devices are approved faster in the EU than in the United States, where the Food and Drug Administration usually requires prospective clinical trials of such devices.

And the results are in BMJ:

The unadjusted rate of safety alerts and recalls for devices approved first in the EU was 27% (62/232) compared with 14% (11/77) for devices approved first in the US. The adjusted hazard ratio for safety alerts and recalls was 2.9 (95% confidence interval 1.4 to 6.2) for devices approved first in the EU.

This means exactly 2.9-fold greater rate of safety alerts and recalls and a 4.6-fold greater rate of recalls than devices approved first in the US  (and if you look at the confidence intervals you'll get more worried).  How can we trust the european regulator?. For decades, European Union has leaved its citizens with less safety protection than is required for medical devices. A perfectly designed absurdity to disseminate risk for european citizens that the new proposed regulation is unable to correct.

PS. If you wnat to understand the differences between EU and US regulation, read this NEJM article or Milbank one..

Food and risk perception

Food and the Risk Society: The Power of Risk Perception

This is the main message of the book: Do not send generic messages on food and its risks, the time for segmentation has arrived,

A generic approach, involving the provision of vast amounts of information to the general public, stands a real risk of leading to information overload, bewilderment and lack of interest among mainstream consumers. A more effective approach to change consumer food buying and consumption behaviour, is to focus on segmenting the population according to their information needs, and developing information with high levels of personal relevance to specific groups of respondents who may be at greater risk than the rest of the population. Such information is more likely to create attitudinal change and subsequent behavioural change as the perceived personal relevance is high.

Is the government already prepared for the task?

Introducing nudging in the law

Nudge and the Law. A European Perspective

Alberto Alemanno is an HEC law professor focused on issues on behavioral policies and regulation. Now he has edited an interesting book. You can check it from this index:

1. The Emergence of Behavioural Policy-Making:A European Perspective

Part I: Integrating Behavioural Sciences into EU Law-Making
2. Behavioural Sciences in Practice: Lessons for EU Rulemakers
3. Nudging and Evidence-Based Policy in Europe: Problems of Normative Legitimacy and Effectiveness
4 . Judge the Nudge: In Search of the Legal Limits of Paternalistic Nudging in the EU

Part II: De-Biasing Through EU Law and Beyond
5. Can Experts be Trusted and what can be done about it? Insights from the Biases and Heuristics Literature
6. Overcoming Illusions of Control: How to Nudge and Teach Regulatory Humility

Part III: The Impact of Behavioural Sciences on EU Policies
7. Behavioural Sciences and EU Data Protection Law: Challenges and Opportunities
8. Behavioural Sciences and the Regulation of Privacy on the Internet
9. EU Consumer Protection and Behavioural Sciences:Revolution or Reform?
10. What can EU Health Law Learn from Behavioural Sciences? The Case of EU Lifestyle Regulation
11. Conduct of Business Rules in EU Financial Services Regulation: Behavioural Rules Devoid of Behavioural Analysis?

Part IV: Problems with Behaviourally Informed Regulation
12 . Making Sense of Nudge-Scepticism: Three Challenges to EU Law ’ s Learning from Behavioural Sciences
13. Behavioural Trade-Offs: Beyond the Land of Nudges Spans the World of Law and Psychology
14. Epilogue: The Legitimacy and Practicability of EU Behavioural Policy-Making

The book deserves time reading it, specially if you are interested in latest trends on nudging and regulation. However, if you don't have enough time, go straight to chapter 10. This is what you should read about implications of nudging on Public Health. He says,

Our previous analysis made a case for more experimentation in behaviourally informed regulation in the EU lifestyle policy. This seems particularly true when examined in light of the limited results attained by self-regulatory schemes led by the food, alcohol, and tobacco industries. While the evidence of what works in terms of behaviour change strategies is limited and too often anecdotal, several success factors have progressively been identified in policy-making.

 These success factors are those we have to check in our close environment and test wether it is worth taking this regulatory approach.