The Nuffield Council has released a key document on ethical implications of genome editing. You'll notice that it is an open document, a work in progress because technology is evolving. If you want an excerpt check this short guide.
It should be remembered that most prospective technologies fail, and that some lead to undesirable consequences, a fact often obscured by ‘whig’ histories that reconstruct the history of successful technologies and their beneficial social consequences. Scientific discovery and technological innovation is important but not inevitable. Most important among the factors shaping technological development is human agency. It is human agency, in terms of decisions that are made about directions of research, funding and investment, the setting of legal limits and regulatory principles, the design of institutions and programmes, and the desire for or acceptance of different possible states of affairs, that will determine whether, and which, prospective technologies emerge and, ultimately,
their historical significance.
Nuffield council work is of interest, meanwhile, China is already testing CRISPR technology in humans, no ethical concerns...
Last summer the Office of Health Economics released an inspiring paper on the value of diagnostic information related to companion diagnostics and next generation sequencing genomic tests. I read it recently and its appproach sheds additional light on a difficult issue:
Traditional cost-effectiveness analysis conducted as part of HTA focuses on three key elements:
1. Life years gained
2. Improvements in patient quality of life
3. Cost-savings within the healthcare system (also called “cost-offsets”).
Elements 1 and 2 are often combined in the quality-adjusted life year (QALY) by HTA bodies.
Elements 1, 2, and 3, plus the cost of the technology, are then used to assess the cost effectiveness of the technology.
The next element most often included is “productivity” or “time value”, reflecting gains and losses related to the value of the patient’s time either when receiving medical care or related to the impact of absenteeism or presenteeism due to illness. Another element - less commonly measured - is nonmedical cost-savings outside the healthcare sector, such as transport costs and family caregiving.
Based on our systematic literature review, we identified and defined five additional elements
related to the value of knowing and the value of information:
• Reduction in uncertainty - additional value from knowing a technology is more likely to work
• Value of hope - willingness to accept greater risk given a chance for a cure
• Real option value - the value of benefiting from future technologies due to life extension
• Insurance value - psychic value provided by invention of an innovative medical product and by the accompanying financial risk protection afforded by a new treatment
• Scientific spillovers - value due to other innovations that become possible once a new technology has been proven to work.
I have discussed many times such additional issues, specially the real option value. Unfortunately measurement of such items are not that easy. Anyway, it's good to take into account and let's hope new developments on this topic.
Today I would like to suggest you to read Barack Obama in his farewell speech. It's an inspiring piece to understand US and democracies in general. Inequality, racism and polarization are the three key isues to tackle.
He said:
For too many of us, it’s become safer to retreat into our own bubbles, whether in our neighborhoods or college campuses or places of worship or our social media feeds, surrounded by people who look like us and share the same political outlook and never challenge our assumptions. The rise of naked partisanship, increasing economic and regional stratification, the splintering of our media into a channel for every taste – all this makes this great sorting seem natural, even inevitable. And increasingly, we become so secure in our bubbles that we accept only information, whether true or not, that fits our opinions, instead of basing our opinions on the evidence that’s out there.
This trend represents a third threat to our democracy. Politics is a battle of ideas; in the course of a healthy debate, we’ll prioritize different goals, and the different means of reaching them. But without some common baseline of facts; without a willingness to admit new information, and concede that your opponent is making a fair point, and that science and reason matter, we’ll keep talking past each other, making common ground and compromise impossible.
Without a common baseline of facts there is no possibility to talk to your political opponent. Nowadays, fake news like health privatization are continuously spreading without any foundation. Our health minister speaks incredibly about that in our Parliament. Such obsession has driven to submit a new unnecessary law on health contracting.We are now in an obsession focused policy era.
To understand this phenomena, Sunstein wrote a book in 2008, before thee term post-truth era, that explains the basics and what to do. Cass Sunstein says in the book:
Rumors are nearly as old as human history, but with the rise of the Internet, they have become ubiquitous. In fact we are now awash in them. False rumors are especially troublesome; they impose real damage on individuals and institutions, and they often resist correction. They can threaten careers, relationships, policies, public officials, democracy, and sometimes even peace itself. Many of the most pervasive rumors involve governments—what officials are planning and why.
This small book has two goals. The first is to answer these questions: Why do ordinary human beings accept rumors, even false, destructive, and bizarre ones? Why do some groups, and even nations, accept rumors that other groups and nations deem preposterous? The second is to answer this question: What can we do to protect ourselves against the harmful effects of false rumors? As we shall see, part of the answer lies in recognizing that a “chilling effect” on those who would spread destructive falsehoods can be a truly excellent idea, especially if those falsehoods amount to libel.
Sensible people believe rumors, whether or not they are true. On the Internet, self-interested, malicious, and altruistic propagators find it increasingly easy to spread rumors about prominent people and institutions. Such rumors cast doubt on their target’s honesty, decency, fairness, patriotism, and sometimes even sanity; often they portray public figures as fundamentally confused or corrupt. Those who are not in the public sphere are similarly vulnerable.
Rumor transmission frequently occurs as a result of cascade effects and group polarization. Indeed, rumors spread as a textbook example of an informational cascade: imperfectly or entirely uninformed people accept a rumor that they hear from others, and as more and more people accept that rumor, the informational signal becomes very strong, and it is hard for the rest of us to resist it, even if it is false.
Group polarization also plays a large role, as people strengthen their commitment to a rumor simply because of discussions with like-minded others.
If you want people to move away from their prior convictions, and to correct a false rumor, it is best to present them not with the opinions of their usual adversaries, whom they can dismiss, but instead with the views of people with whom they closely identify
The signal of the rumor may be so strong that though reality is absolutely different, and everybody is finally conceding it the value of truth. This is sadly what has happened to health privatization debate.
Too often people talk about the value of health, and few are those that try to measure it. Now you have the opportunity to have a look at the book that summarises the state of the art on measuring health from different perspectives, clinical and research, epidemiology and economics (resource allocation). The implications of health in well being are explored, and the author says:
Valuing health states by their average consequences for well-being has the unfortunate implication that disabilities count as significant health problems only if the people who have them are significantly worse off than the people without them. With respect to disabilities, such as blindness, to which people adapt, this implication leaves the health analyst with a choice between asserting falsely that the blind necessarily have lower levels of well-being or asserting falsely that blindness is not a serious disability.
This unfortunate implication, coupled with the difficulties in measuring the value of health by eliciting preferences or by measuring subjective experience, raises doubts about the project of valuing health by its bearing on well-being, which chapter
10 explores. The value of health differs in important ways from well-being and indeed appears to be easier to measure than well-being.
And we all agree that health is a crucial factor for well-being, though its measurement is uncertain up to now.
Last book by Gary Taubes takes a difficult way, how to demonstrate sugar as a toxic substance for our health. Although he tries to show evidence for his words, he finally concedes the following conclusion:
Ultimately and obviously, the question of how much is too much becomes a personal decision, just as we all decide as adults what level of alcohol, caffeine, or cigarettes we’ll ingest. I’ve argued here that enough evidence exists for us to consider sugar very likely to be a toxic substance, and to make an informed decision about how best to balance the likely risks with the benefits. To know what those benefits are, though, it helps to see how life feels without sugar.
The "very likely" expression is crucial. Unfortunately we don't have a explicit causal explanation of the impact of sugar on metabolic syndrome, for example. I think that epigenetics will provide neew perspectives on the issue, however we will have to wait. Meanwhile reducing exposure is the best advice.
K. J. Arrow passed away this Wednesday. He is one of the giants of economics and the founder of health economics. It is difficult to summarise his works in few words. You'll find obituaries in the Post and NYT. Josep M. Colomer has written an interesting post in his blog (social choice perspective). Tony Culyer has published also his obituary (health economics perspective)
An interview in a recent book reviews his works and opinions. Regarding healt economics, he says:
I was asked to study, as a theoretical economist, health care. This was a paper that I regard very highly, one of the best things I ever did. I think I mentioned that in fact, afair amount of my research is the result of people asking me these kinds of questions. I studied Social Choice because somebody asked me a question. A now retired professor, Victor Fuchs, was then at the Ford Foundation, and they wanted to get studies done of social problems. They wanted studies of welfare—in the ordinary sense of the word—of medical care and of education. For each of these areas, they wanted one study by somebody who had worked in the field and one by a theorist, and I’m a theorist who had not necessarily worked with people.
In my case, I was asked to work on medical care. I read up on the literature, and gradually a pattern emerged that essentially the parties know different things. The physician knows a lot that the patient doesn’t, and therefore the patient can’t check on the quality of medical care in the same way we buy a loaf of bread. It’s not like I’ll buy that loaf again. But with medical care, you can’t be sure because you don’t know that much. It’s the same thing between the insurer and the physician or the patient. So I said that with medical care, noneconomic factors, essentially ethical codes, play a role in keeping the system together. But I didn’t have a theory at the time, I just had a statement. It was pretty clear to me that non-economic factors do play a major role. What is considered good practice, that’s what keeps the system going. The trouble is that I’ve seen the limits of economic analysis. I could see one solution, but it was very different from market kinds of solutions. But I did have a theory about it.
When I look at other people, they don’t have theories either, or they have rather vague theories. When I try to impart this to students, of course it’s a very confusing message. That’s one of the reasons I don’t think I’ve been a great teacher. I’ve perhaps had students who did appreciate what I was doing, although they tended to pick up the more technical parts of it. I’m a little disappointed they haven’t tried to tackle the broader picture. If they’re working with it, they’ve done very fine work, going well beyond what I did. So I’d say that would be a rather lengthy answer to your question. I see myself primarily as a scholar, as a thinker about things, trying to enlist others in this thinking. Yes, I think I would say that more so than others.
Last week the US patent office ruled that hotly disputed patents on the CRISPR revolutionary genome-editing technology belong to the Broad Institute of Harvard and MIT. In a former post I explained the dispute. Genome editing in my opinion shouldn't be patented and will see exactly the impact of such ruling in US and elsewhere in the next future.
If you want to know in detail what does genome editing means for the future of life sciences, have a look at NASEM book.
It is now possible to insert or delete single nucleotides,interrupt a gene or genetic element, make a single-stranded break in DNA, modify a nucleotide, or make epigenetic changes to gene expression. In the realm of biomedicine, genome editing could be used for three broad purposes: for basic research, for somatic interventions, and for germline interventions.
CRISPR (which stands for clustered regularly interspaced short palindromic repeats) refers to short, repeated segments of DNA originally discovered in bacteria. These segments provided the foundation for the development of a system that combines short RNA sequences paired with Cas9 (CRISPR associated protein 9, an RNA-directed nuclease), or with similar nucleases, and can readily be programmed to edit specific segments of DNA. The CRISPR/Cas9 genome-editing system offers several advantages over previous strategies for making changes to the genome and has been at the center of much discussion concerning how genome editing could be applied to promote human health.
I would just want to say that these patents destroy the soul of science, since access should be available with no barriers for the development of innovation. Patents are not the incentive for discovery in this case, as I explained in my post, natural processes should'nt be patented. And this is why today is a really sad day.
Publication bias (Wikipedia dixit): Publication bias is a type of bias that occurs in published academic research. It occurs when the outcome of an experiment or research study influences the decision whether to publish or otherwise distribute it. Publication bias matters because literature reviews regarding support for a hypothesis can be biased if the original literature is contaminated by publication bias. Publishing only results that show a significant finding disturbs the balance of findings
We've just surpassed such conventional view and have published a new article on integrated care and I've prepared a short post in the blog of Gaceta Sanitaria (in castillian):
La integración asistencial a examen
Todo estudio experimental tiene un contexto, y antes de entrar en el detalle resulta crucial comprenderlo para evaluar sus resultados. Hay dos términos usuales en la política sanitaria de nuestros días: integración asistencial y cronicidad. En Gaceta Sanitaria encontrareis el artículo: “Evaluación de la efectividad de un programa de atención integrada y proactiva a pacientes crónicos complejos”. El programa tiene lugar en el Baix Empordà, en una organización sanitaria integrada y si comparamos indicadores de utilización y calidad seleccionados (Tabla 4) observaremos que superan sustancialmente la media del sistema sanitario público catalán. Este ya es un primer reto en sí mismo, mejorar cuando se parte de una posición de ventaja relativa.
Los profesionales están acostumbrados a dos décadas de práctica asistencial integrada. Esto significa que cualquier aproximación organizativa alternativa se internaliza y se difunde, lo que dificulta aislar el impacto.
Se aplicó un modelo predictivo que resultó ser el punto de partida para la selección de pacientes. Es previsible que en un futuro próximo sea posible la estimación probabilística de trayectorias y episodios para los enfermos crónicos complejos. Esto nos aportaría mayor precisión a la estratificación dinámica de pacientes.
Las conclusiones del estudio muestran ligeras reducciones en la utilización hospitalaria fruto del programa. Pero mantienen patrones similares entre los distintos grupos sujetos a intervención. Es por ello que destacaría dos afirmaciones del artículo: “una situación general de alta calidad asistencial previa y mantenida en el ámbito de la intervención, y una inevitable contaminación entre grupos, dificultaron la demostración de una efectividad marginal del programa” y “la estratificación de la población con una identificación explícita de los pacientes crónicos complejos puede ayudar a avanzar los resultados, y el criterio clínico los hace extensivos a todos los pacientes de características similares”.
Esto nos lleva a confirmar las dificultades de los estudios experimentales en los que deseamos probar el impacto de un cambio organizativo. Este estudio sería candidato a no ser publicado, porque su resultado mantiene una ambivalencia y no permite pronunciarse con claridad sobre la opción defendida con carácter general en nuestros días: la superioridad de la atención integrada y proactiva de los pacientes crónicos complejos frente a otras alternativas. Sin embargo, su publicación además de alertar sobre la dificultad de este tipo de estudios, nos señala nuevas pistas. Más allá de los cambios en la utilización y coste que representa la integración asistencial, necesitamos medir los resultados en salud y la calidad en los episodios asistenciales, comprender el impacto en salud de estas estrategias organizativas. Esta es la tarea más relevante y sobre la que se deberían enfocar nuevos estudios. Es por ello que las investigaciones las estamos centrando en la medida de los cambios en la esperanza de vida de buena salud a lo largo del tiempo y en la medida de los episodios. Este tipo de medidas agregadas, junto con otras de carácter fisiológico y de percepción de salud y bienestar tienen que permitir alcanzar una visión más completa de lo que aporta la integración asistencial.
The survey has a clear message: the more you have choice on healthcare, the more you are satisfied (in general). The Netherlands leads the ranking every year in the last decade. The european countries that spend most on health per capita are Luxembourg (6.023€), Germany (4.003€) and Netherlands (3.983€). Luxembourg lies behind in satisfaction, while Switzerland (choice) is in the second position and the third is for Norway (not so strong in choice).
Choice may provide satisfaction, but you have to agree on a model that supports it, and be able to pay the bill. Personally, I'm not so sure about choice as a general construct to support decision making and satisfaction, a former post explains my doubts.
Long time ago the European Union made surveys on satisfaction, and decided to stop, because it was an easy policy tool for the opponents. Right now we do have only the Euro Health Consumer Index 2016. Unfortunately you'll not find data on Catalonia, it will appear in a next edition.
1. Make care coordination a high priority for patients with complex needs
2. Identify patients at greatest need of proactive, coordinated care
3. Train more primary care physicians and geriatricians
4. Improve communication between providers, e.g. integrated clinical records
5. Engage patients in decisions about their care
6. Provide better support for carers
7. Redesign funding mechanisms for patients with complex needs
8. Integrate health and social care, and physical and mental healthcare
9. Engage clinicians in change, train and support clinical leaders
10.Learn from experience; scale up successful projects
Once again, the issue is not about what, but about how, according to the specific setting. This is the reason why change implies modify incentives and coordination mechanisms. This is the hardest part, with cost and benefits uneven distributed over time and people. And this is the reason why recommendations fail so often in its implementation.
Key messages from the last OECD report on quality:
Systemic changes on where and how health care is delivered will optimise both quality and efficiency
Lesson 1: High-performing health care systems offer primary care as a specialist service that provides comprehensive care to patients with complex needs
Lesson 2: Patient-centred care requires more effective primary and secondary prevention in primary care.
Lesson 3: High-quality mental health care systems require strong health information systems and mental health training in primary care
Lesson 4: New models of shared care are required to promote co-ordination across health and social care systems
Health care systems need to engage patients as active players in improving health care, while modernising the role of health professionals
Lesson 5: A strong patient voice is a priority to keep health care systems focussed on quality when financial pressures are acute
Lesson 6: Measuring what matters to people delivers the outcomes that patients expect
Lesson 7: Health literacy helps drive high-value care
Lesson 8: Continuous professional development and evolving practice maximise the contribution of health professionals
Health care systems need to better employ transparency and incentives as key quality-improvement tools
Lesson 9: High-performing health care systems have strong information infrastructures that are linked to quality-improvement tools
Lesson 10: Linking patient data is a pre-requisite for improving quality across pathways of care
Lesson 11: External evaluation of health care organisation needs to be fed into continuous quality-improvement cycles
Lesson 12: Improving patient safety requires greater effort to collect, analyse and learn from adverse events
It may sound as a dejà-vu, and the difficult part is how, not what to do to improve quality. However if you want to read an article on health care quality comparisons, check this one. Comparing quality is crucial because we are used to compare expenditure without a detailed knowledge of quality achievement. We'll have to follow next reports on the issue.
If we look at European Union, the right to health is heterogeneous. The size of the difference among countries depends on many factors, and path dependence explains mostly such diversity. If you want to check beyond EU, a new book explains how countries define health risck coverage under different arrangements.
Looking at health through a human rights lens tells us something about the nature of illness that epidemiology and biology cannot: it encourages us to consider to what extent illness is unjust. It also frames illness and disease within the political, social, cultural, and economic conditions that surround it; considers the power dynamics that perpetuate illness and disease; and focuses the attention on marginalized and vulnerable groups that may exist outside of medical research priorities or beyond the target demographics of political decisions, at greatest risk of becoming invisible. Worse still, history has shown us that in extreme situations medical professionals can be used as tools of the state to cover up or even inflict abuse. Considering the complex relationship between justice and health, using the international framework for the right to health offers the possibility of mitigating some of the effects of deeply embedded inequalities and discrimination and promoting environments in which anyone can achieve their highest level of health.
There is a major misunderstanding about the frame of the right to health. Somebody should specify that we are talking mostly of right to health care and state at the same time about the individual duties on health. Anyway, let's imagine a country that close to 2% of population are il.legal immigrants that have the right to health care accepted as any citizen, this is my country. Unfortunately such unique level of generosity and solidarity you'll not find it in this book:
PS. Somebody should ask at the same time if going beyond such level of generosity is financially sustainable. However this is an inconvenient question, a politically incorrect one.
You may find information on quality of healthcare in many websites. Catalonia has developed a broad strategy in this topic. You may check "Central de Resultats", and you'll find details about it. However, what about patients perspectives on quality?.
OECD has started an approach known as Patient Reported indicators survey. We'll have to wait for more details, but this initiative will cover a range of topics that provider led information forgets.
And this approach is only a tool from a wide set of recommendations about the future of health statistics. Sounds good.
Ko Maeda has made the case that ‘research on the determinants of democratic durability can be advanced by paying closer attention to the manner by which democracies are terminated.’ Specifically for Maeda, we need to pay closer attention to two distinct types of democratic breakdowns: endogenous termination and exogenous termination
Exogenous termination: when democracy and its popularly elected government are overthrown by forces external to the democracy and government. Spain suffered a coup d'état in February 23rd, 1981.
Endogenous termination:‘where democratically elected leaders ended the democratic process themselves’,endogenous terminations occur most frequently as the result of acts ‘suspending the constitution, arresting the opposition politicians, restricting the activities of the mass media, or rigging electoral results’. Against the conventional assumption that democracies do not self-immolate, there has been little or at least a great deal less attention paid to breakdowns of democracies whose source stems from democratic practices and institutions themselves. But as Maeda is quick to identify, this assumption has been problematic given the empirical data, which suggests that some 40 per cent of all democratic breakdowns which occurred between 1950 and 2004 were due to endogenous factors. Democracies fail, and they do so not because of some extrinsic or exogenous factor. Indeed, almost half of all democracies that have collapsed during the last half century have done so as a result of endogenous causes: that is, democratic reasons and processes. In other words, there is something intrinsic to democracy that makes it prone to self-destruct.
When incapable of redressing the political crises they have manufactured themselves,whether because of individual freedoms, bureaucratic morass or the sluggishness of democratic politics, the claim is that democracies can die by their own hand. They have, in Keane’s words, ‘suffered and died under several bad moons’, another of which he claims ‘is now rising over all democracy’ In contrast to its more common meaning – the murder of a person or people by their government – the theory of democide put forward in this book focuses instead on a people who elect, by more or less democratic means, to murder their democracy.
