Claiming for global regulation of genome editing

Genome editing and human reproduction

The Nuffield Council of Bioethics release last July a key document on Bioethics of Genetics. Now that a chinese "scientist" claims to have edited the genomes of twin baby girls is the right moment to read it. And the key principles are:

Principle 1: The welfare of the future person

Gametes or embryos that have been subject to genome editing procedures (or that are derived from cells that have been subject to such procedures) should be used only where the procedure is carried out in a manner and for a purpose that is intended to secure the welfare of and is consistent with the welfare of a person who may be born as a consequence of treatment using those cells.

Principle 2: Social justice and solidarity

The use of gametes or embryos that have been subject to genome editing procedures (or that are derived from cells that have been subject to such procedures) should be permitted only in circumstances in which it cannot reasonably be expected to produce or exacerbate social division or the unmitigated marginalisation or disadvantage of groups within society.

New concerns are arising from CRISPR application and international regulations would be necessary to cope with them. The Association for responsible research and innovation in genome editing is precisely requesting this effort. The only precedents are the Declaration of Human Rights and it seems that it will not be an easy task to fulfill.

PS. Check the former post on Nuffield reports on this topic

Ageing policies, a long way ahead

WILL POPULATION AGEING SPELL THE END OF THE WELFARE STATE?

A new book by WHO provides some insights about the impact of ageing. The frame of the message is built around these questions:

1. What are the implications of population ageing for health and long-term care needs and costs?
2. What are the implications of population ageing for paid and unpaid work?
3. What are the implications of population ageing for the acceptability, equity and
effectiveness of financing care and consumption?
4. The policy options: How can decision-makers respond to population ageing?
5. Building on what we know and improving the evidence base for policy-making.

And these are the policies they suggest:

I. Policies to promote healthy and active ageing
II. Policies to promote cost-effective health and long-term care interventions
III. Policies that support paid and unpaid work
IV. Policies to support acceptable, equitable and efficient funding and income transfers

This is just a start. Since ageing is a multidimensional issue, governmental policies should embrace a wider multisector strategy (that the book forgets). There is a long way ahead.

Doctor Prats - Caminem junts

Driving evidence-based health policy

Driving Better Health Policy: “It’s the Evidence, Stupid”

Baicker and Chandra are backing an evidence-based health policy. I reviewed it in a previous post. Now the Uwe Reinhardt Memorial Lecture insists on it.

Speaking in favor of evidence-based health policy can be more controversial than one might think. Health policy analysts, health services researchers, and economists in particular often get in trouble by trying to quantify what many hold as unquantifiable and trying to put a price tag on what many think should be priceless.

This is the ouline of the lecture:

WHAT IS AND IS NOT A POLICY
Slogans are Not Policies
Differentiating Between Goals and Policies
EVIDENCE IS INHERENTLY EMPIRICAL
Evidence is Rarely Straightforward
Fact Patterns Alone Do Not Reveal Policy Effects
WORKING TO BASE POLICY ON EVIDENCE
Separating Evidence from Preferences
Using Evidence to Inform Policy

And these are the take-away messages:

• Serious policy assessment requires a detailed description of the policy—slogans are not policies.
• Clearly articulating and differentiating between goals and policies is crucial to evaluating the most effective way to achieve policy goals.
• Evidence is often mixed or ambiguous. Researchers should not let their own policy preferences bias their interpretation or synthesis of the evidence. 
• Evidence does not speak for itself. Researchers need to dedicate effort to timely, accessible, reliable translation.

Agreed. Unfortunately, our close politicians are not interested in evidence if it goes against their ideological criteria. Therefore, claiming evidence for health policy is useless, unless the premise of "politicians will take into account evidence" is really credible. The lecture forgot this "minor" issue, the cognitive biases of health policy.

Josep Segú

On free genetic sequencing, opioids and the Hockney portrait

Selected links

FROM GENE EDITING TO A.I., HOW WILL TECHNOLOGY TRANSFORM HUMANITY?
FIVE BIG THINKERS — REGINA BARZILAY, GEORGE CHURCH, JENNIFER EGAN, CATHERINE MOHR AND SIDDHARTHA MUKHERJEE — PUZZLE OVER THE FUTURE OF THE FUTURE.

Mortality risk, insurance, and the value of life

Opioid nation by Marcia Angell

Genetics Start-Up Wants to Sequence People’s Genomes for Free

THESE DNA STARTUPS WANT TO PUT ALL OF YOU ON THE BLOCKCHAIN

Hockney

In favour of positive discrimination for troublemakers

IN DEFENSE OF TROUBLEMAKERS: The Power of Dissent in Life and Business
L'Illusion du consensus

Charlan Nemeth has done a great job explaining the role of dissent in life and organizations. Her last book shows exactly what happens when we emphasize excessively the consensus.

Rather than worry about appeasing others or making sure we do not offend by disagreeing with them, the message of this book is that there is importance and value in authentic debate. The idea that dissent causes irritation and conflict is only partially accurate. Dissent and debate also bring joy and invigorate discussion. Best of all, genuine dissent and debate not only make us think but make us think well. We become free to “know what we know.” We make better decisions, find more creative solutions, and are better able to render justice.

The topic has strong connections with political correctness and hate. The book by Chantal Mouffe addresses this issue with precision.

Afin d’éviter toute confusion, je devrais peut-être préciser que, contrairement à certains penseurs postmodernes qui envisagent un pluralisme sans aucune frontière, je ne crois pas qu’une politique démocratique doive considérer comme légitimes toutes les revendications formulées dans un société donnée. Le pluralisme que je défends exige de discriminer parmi ces demandes celles que l’on peut accepter comme faisant partie du débat démocratique et celles qui doivent en être exclues. Une société démocratique ne peut pas traiter comme des adversaires légitimes ceux qui remettent en question ses institutions de base. L’approche agonistique ne prétend pas englober toutes les différences ni abolir toutes formes d’exclusion. Mais les exclusions sont envisagées en termes politiques et non pas en termes moraux. Certaines revendications se trouvent exclues de fait, non parce qu’elles sont « mauvaises », mais parce qu’elles défient les institutions constitutives de l’association politique démocratique. Entendons-nous bien, la nature des institutions fait aussi partie du débat agonistique, mais pour qu’un tel débat puisse avoir lieu, l’existence d’un espace symbolique partagé est nécessaire. C’est cette idée que j’ai voulu exprimer quand j’ai soutenu, dans le chapitre 1, que la démocratie nécessitait un « consensus conflictuel » : consensus sur les valeurs éthico-politiques de liberté et d’égalité pour tous mais dissensus sur leur interprétation. Il faut par conséquent tracer une ligne de démarcation entre ceux qui rejettent complètement ces valeurs et ceux qui, tout en les acceptant, en défendent des interprétations opposées.

Troublemakers as dissenters in politics are welcome. Though, if they want to undermine democracy, then forget any positive discrimination. This is not their place.

PS. Bad blood wins the Business book of the year contest.

Oriol Romaní

"Going Dutch" in regulating the mandatory coverage

Can universal access be achieved in a voluntary private health insurance market? Dutch private insurers caught between competing logics

Healthcare in The Netherlands is widely seen as a benchmark for many scholars. Though it is expensive, it combines mandatory coverage with the choice of private insurance coverage. Sounds of interest, though the devil is in the details.
This article explains the main issues surrounding such model:

The Dutch history of voluntary private health insurance shows both the strengths and weaknesses of public–private health insurance systems, especially in the context of a rising demand for (universal) access to health care. As we have explained, social and private health insurance are based on two divergent logics of different institutional orders (the market and the state).
The Dutch case strongly  suggests that universal access can only be achieved in a competitive individual private health insurance market if this market is effectively regulated. The tension between adverse selection and universal access that had vexed the Dutch private health insurance industry throughout its existence was resolved by combining elements from both the insurance logic and the welfare state logic: i.e. an individual mandate, guaranteed issue, community-rated premiums, income-related subsidies and a sophisticated risk equalization scheme .
Achieving universal access in a competitive private health insurance market is institutionally complex and requires broad political and societal support.

Therefore, unless there is a smart regulator, forget it...

PS. Spanish embroglio at Marginal revolution.

PS. How is Obamacare doing?

From Lisa Eckdahl latest album

Provider payment strategies to improve health

Value-based provider payment: towards a theoretically preferred design

The case for improving health is related, among many things, with the incentive structure of the whole system (people, professionals and providers). If we focus our aim towards providers, then we need to reassess current flaws in the system, and ask what do we have to do. A new article tries to address these issues.

In order to tackle the problems related to current payment methods, worldwide, policymakers and purchasers of care are exploring alternative payment strategies to help steering health care systems towards value . A well-known endeavour in this regard is pay-for-performance (P4P), in which providers are explicitly rewarded for ‘doing a better job’. Although P4P is an appealing idea, explicit financial incentives for value should in principle be used only modestly in provider payment methods because of the multitasking problem. Therefore, it is not surprising that in practice, the majority of provider revenues (typically referred to as the base payment) is not explicitly linked to value. This base payment, however, does create implicit (dis)incentives for value, because each payment method influences providers’ behaviour through incentives.

The article reflects a conceptual framework of key components and design features of a theoretically preferred Value Based Payment method. And the key message is:

We conclude that value is ideally conceptualised as a multifaceted concept, comprising not only high quality of care at the lowest possible costs but also efficient cooperation, innovation and health promotion. Second, starting from these value dimensions, we derived various design features of a theoretically preferred VBP model. We conclude that in order to stimulate value in a broad sense, the payment should consist of two main components that must be carefully designed. The first component is a risk-adjusted global base payment with risk-sharing elements paid to a multidisciplinary provider group for the provision of (virtually) the full continuum of care to a certain population. The second component is a relatively low-powered variable payment that explicitly rewards aspects of value that can be adequately measured.

I fully agree with what they say. Close politicians and officials should take this message into consideration regarding the next primary care physicians' strike, and forget the current confusing approach.

Norman Rockwell 

TIRED SALESGIRL ON CHRISTMAS EVE

Estimate $5,000,000 — 7,000,000

(It may be yours, upcoming auction at Sotheby's)

Living with dementia

Care Needed. Improving the lives of people with dementia

Across the OECD, nearly 19 million people are living with dementia. Millions of family members and friends provide care and support to loved ones with dementia throughout their lives. Until a cure or disease-modifying treatment for dementia is developed, the progress of the disease cannot be stopped. 

We all know cases of close relatives with dementia, and we understand the suffering that surrounds the disease. OECD has made a good job coping with this difficult topic.
These are the three key chapters:

• Identifying people with dementia 
• Helping people with dementia live well in the community 
• Health and long-term care services for advanced dementia are poor

As people live at home longer, communities need to be better equipped to meet the needs
of people living with dementia. Post-diagnostic care pathways can help connect people with dementia and their families with available services. But communities themselves must also adapt: community-friendly initiatives that train local populations and businesses to respond more effectively to people with dementia can help to reduce stigma around dementia while making the environment safer and more welcoming. Aging at home also means that informal carers will play an important role in supporting people with dementia. Informal carers should receive the support they need, and governments should assess whether existing services for carers are also adequate for carers of people with dementia, who may have unique needs.

Definitely, every country needs to develop a strategy for this disease. Catalonia has already defined its strategy, though resources are not enough.

Jaume Plensa at Madison Square Park

Next generation sequencing is knocking at the door (and the door is open)

Genetic testing: Opportunities to unlock value in precision medicine
Next-Generation Sequencing to Diagnose Suspected Genetic Disorders
Documento de consenso sobre la implementación de la secuenciación masiva de nueva generación en el diagnóstico genético de la predisposición hereditaria al cáncer

This week I've been reading three pieces on the same topic. First, a McKinsey insight on genetic testing, second a NEJM basic article that reviews the whole state of the issue, and third a consensus by three societies on how to implement next generation sequencing .
All of them are required reading for anyone interested in the topic. You'll notice that technology is knocking at the door and we do need to understand how to manage it. Otherwise it will enter anyway (without knocking) and then it will be more value extraction (by others) than value creation (for patients).
Unfortunately, what you'll not find in these articles is how to manage the introduction of the technology with organizational patterns, allocation and coordination of tasks and decisions. If you want some clues on this, read my previous post on Geisinger, they are applying what it seems to me the most appropriate perspective.

Sense Sal-Fins que surti el sol

The Cost of End-of-Life Care

The Myth Regarding the High Cost of End-of-Life Care
Systematic review of high-cost patients’ characteristics and healthcare utilisation

The size of the healthcare costs at the end of life is properly reflected in this article (forget exaggerations):

We estimated that in 2011, among those with the highest costs, only 11% were in their last year of life, and approximately 13% of the $1.6 trillion spent on personal healthcare costs in the United States was devoted to care of individuals in their last year of life.

Longitudinal analyses of spending show that the population with the highest annual health care costs can be divided into 3 broad illness trajectories:

• individuals who have high health care costs because it is their last year of life (population at the end of life), 
• individuals who experience a significant health event during a given year but who return to stable health (population with a discrete high-cost event and,
• individuals who persistently generate high annual health care costs owing to chronic conditions, functional limitations, or other conditions but who are not in their last year of life and live for several years generating high health care expenses (population with persistent high costs).

Understanding individual costs is a required step for the analysis and improvement of healthcare delivery. Unfortunately it is a marginal practice. For a systematic review, check this article.

‘Windrush: A Celebration’, Barbican,

London, November 17, barbican.org .uk

Pharmarketing impact on prescribing behaviour

Influence of pharmaceutical marketing on Medicare prescriptions in the District of Columbia

Gifts from pharmaceutical companies are believed to influence prescribing behavior, but few studies have addressed the association between industry gifts to physicians and drug costs, prescription volume, or preference for generic drugs

Governments in USA and EU have enacted laws for greater transparency of the relationship between pharma firms and physicians. Unfortunately evidence is limited about the concrete impact of gifts on physicians prescribing decisions.
This article sheds light on the issue and its conclusions say:

In 2013, 1,122 (39.1%) of 2,873 Medicare Part D prescribers received gifts from pharmaceutical companies totaling $3.9 million in 2013. Compared to non-gift recipients, gift recipients prescribed 2.3 more claims per patient, prescribed medications costing $50 more per claim, and prescribed 7.8% more branded drugs. In six specialties (General Internal Medicine, Family Medicine, Obstetrics/Gynecology, Urology, Ophthalmology, and Dermatology), gifts were associated with a significantly increased average cost of claims. For Internal Medicine, Family Medicine, and Ophthalmology, gifts were associated with more branded claims. Gift acceptance was associated with increased average cost per claim for PAs and NPs. Gift acceptance was also associated with higher proportion of branded claims for PAs but not NPs. Physicians who received small gifts (less than $500 annually) had more expensive claims ($114 vs. $85) and more branded claims (30.3% vs. 25.7%) than physicians who received no gifts. Those receiving large gifts (greater than $500 annually) had the highest average costs per claim ($189) and branded claims (39.9%) than other groups.

If gifts from pharmaceutical companies are associated with more prescriptions per patient, more costly prescriptions, and a higher proportion of branded prescriptions, then all of us as patients have to be concerned. And my impression is that regulation is not enough. Maybe one day the doors of  physician offices will reflect current pharma payments to the patients. Right now they have to look at the web.
Beyond this, I suggest you check this news and you'll see the current flaws between pharma and research.

Museu Picasso. Barcelona

The "secret sauce" of Kaiser Permanente

Financing and Payment Strategies to Support High-Quality
Care for People with Serious Illness: Proceedings of a
Workshop

A recent report by NASEM explains in one paragraph what is the key factor of succesful Kaiser Permanente model:

The “secret sauce” that enables Kaiser Permanente to deliver high quality care, explained Annet Arakelian, executive director of Medicare strategy and care delivery at Kaiser, is the way it has aligned its revenues and expenses. Kaiser’s revenue comes from the Kaiser Foundation health plan that collects premiums from groups, individual members, and some prospective contracts with government payers. Expenses go through a hospital
service agreement with Kaiser Foundation hospitals and a capitated medical service agreement with the Permanente Medical Groups that employ the physicians who work at Kaiser hospitals and clinics. The hospitals and foundation are nonprofit organizations, while the medical groups are for profit agencies with their own board of directors and governance processes. Incentives are aligned across the hospitals, health plan, and medical groups on quality metrics, as well as financial and regulatory initiatives.

Great definition. This is the ingredient for success. And you'll understand why it is so difficult to replicate in a private world with vested interests between different stakeholders: insurers and providers. The nonprofit element of the foundation and hospitals is crucial.

Second statement. Regarding the report on how to pay for serious illness:

Susan Wang, regional lead for shared decision making at the Southern
California Permanente Medical Group, explained that Kaiser’s approach to
comprehensive financing of serious illness care begins with a population
health perspective, which stems from the capitated arrangement that features
a fixed payment per person enrolled in its medical groups. “Because
we are capitated, we are accountable for our entire membership, it behooves
us to touch our patients at every opportunity,” said Wang

Summary: Kaiser has a patient centered strategy. Finance follows the patient not the specific illness. Great. Agree.

The media and the Theranos incredible deception

On Theranos failure, highly recommended for journalists.
From CBSNEWS, a basic piece to understand the power of the media in creating and destroying (false) value:

Was the media duped by Elizabeth Holmes?
A conversation with 60 Minutes about media coverage of the rise and fall of Elizabeth Holmes and her hot startup, Theranos

The biggest financial heist in history

BILLION DOLLAR WHALE
The Man Who Fooled Wall Street, Hollywood, and the World

In 2009, with the dust yet to settle on the financial crisis, a baby-faced, seemingly mild-mannered Wharton grad began setting in motion a fraud of unprecedented gall and magnitude – one that would come to symbolize the next great threat to the global financial system. His name is Jho Low, a man whose behavior was so preposterous he might seem made up.

An epic true-tale of hubris and greed from two Pulitzer-finalist Wall Street Journal reporters, Billion Dollar Whale reveals how a young social climber pulled off one of the biggest financial heists in history–right under the nose of the global financial industry–exposing the shocking secret nexus of elite wealth, banking, Hollywood, and politics

This book is specially helpful to understand our times. There are value creators and at the same time value extractors. Beyond them there is the greatest fraudster, Jho Low, a guy that stole $3.5 billion from Malaysian sovereign fund 1MDB, and helped former Malaysia president to get $700m.The total amount of the heist could be $6.5 billion, 2.5% of Malaysian GDP. If you want to know the details, just read the book.
It is strongly recommended to understand the corruption of the global financial system and audit firms  (Goldman Sachs, Deloitte et al.). This guy would not have been able to commit any theft without their help.
Once you have started the book it will be difficult to stop. Right now, there are others following Jho Low's path and value extractors are among us. Our institutions are extremely fragile tackling these issues. Just take this week cum/ex fraud:.

The German finance ministry said it was aware of 418 different cases of cum-ex tax fraud with a combined value of €5.7bn, adding that any guess about the total damage caused was “speculation” as the investigations were still ongoing.

An investigation published on Thursday by Correctiv, a German non-profit investigative journalism group, and 19 news organisations, cited leaked spreadsheets that show “an organised theft from the tax coffers of at least ten European states, besides Germany” that it claimed had cost taxpayers about €55.2bn.