The narrative behind vaccine hesitancy

 VACCINE HESITANCY. Public Trust, Expertise, and the War on Science

The message:

The dominant framework that currently shapes scholarly and popular discourses on the problem of vaccine hesitancy employs a war metaphor to capture the intractability of the problem. The war metaphor also entrenches an “us” (science) versus “them” (publics) division that is not conducive to engagement and resolution. The “war on science” metaphor described a scientized (chapter 4) captured in three popular explanations for vaccine hesitancy: public misunderstanding of science (chapter 1), the influence of cognitive biases on the publics’ reasoning about vaccines (chapter 2), and antiexpertise and science denialism among the publics (chapter 3). All three narratives point to the publics as the problem (and even the enemy), with little attention to “us,” the courageous defenders of science. Yet, as I have shown, the scientizing force of “evidence-based everything” and the linear model of science-to-policy contribute to antagonizing science-publics relations

Take care... 

Genethics in practice

 The ethics of genomic medicine: redefining values and norms in the UK and France

This paper presents a joint position of the UK-France Genomics and Ethics Network (UK-FR GENE), which has been set up to reflect on the ethical and social issues arising from the integration of genomics into routine clinical care in the UK and France. In 2018, the two countries announced enhanced cooperation between their national strategies, Genomics England and Plan France Médecine Génomique 2025, which offers a unique opportunity to study the impact of genomic medicine and relevant policies in different national contexts. The paper provides first insights into the two national strategies and the norms, values and principles at stake in each country. It discusses the impact of genomic medicine on established relationships and existing regulations, and examines its effects on solidarity and trust in public healthcare systems. 

A must read for neighbour countries that have forgotten their homework. 

Business rules

 The Six New Rules of Business. Creating Real Value in a Changing World

1. Intangibles drive value, not the balance sheet: Reputation, trust, and other intangibles—not profit—drive business value and cannot be measured in traditional ways

2. Purpose over profits: Businesses serve many objectives beyond shareholder value. Purpose is more than a slogan; it is revealed through how the company operates and the decisions it makes. Taken seriously, the Purpose signals long term goals and helps the company prevail over short-term pressures.

3. Corporate Responsibility is more than your carbon footprint: Corporate responsibility is defined far outside the business gates—extending through the supply chain and ecosystem to an engaged public.

4. Employees are more than 'stakeholders' -- they are the business: Employees are corporate allies that hold businesses accountable, connect social and environmental issues to business priorities and give voice to risk and competitive advantage in a culture of growing inequality and social unrest.

5. Culture is King: Competition for talent and a focus on innovation and the human element take precedence over capital markets.

6. Co-create, don't compete: When the system is at risk, enlist business partners along the supply chain to raise the bar for the industry as a whole, and win.

 

Trust in professions

 In the UK, nurses and doctors are the most trusted professions, with 93 per cent and 91 per cent of the public saying that they trust them to tell the truth. Advertising executives, politicians and journalists receive the lowest scores

In Spain, doctors as well.

In a set of 12 countries, scientists first.

Digitization and health professionals

 Empowering the health workforce Strategies to make the most of the digital revolution

From the latest OECD report: 

In order to enable a successful digital transformation of health systems and overcome barriers governments need to provide the necessary political leadership and implement a range of policy actions to support three main objectives:

• build trust in the benefits of digital transformation among health workers and patients whileminimising any risks, which requires guaranteeing proper assessment of technology;
• advance the expertise and skills needed for the safe and effective use of digital health technologies;
• adapt the institutional environment – i.e. the legal, financial, and organisational frameworks –to enable the full potential of the technologies

 These messages sound familiar and general, details inside the report. However, there is a long way to go in order to achieve a real digital transformation.

Bill Brandt 

A nation that failed too many of its citizens

THE HEALTH OF A NATION. A President Looks Back on His Toughest Fight. The story behind the Obama Administration’s most enduring—and most contested—legacy: reforming American health care.

This is the case of US and health reform. In the last issue of New Yorker, Barack Obama explains why health reform was so difficult when he proposed Obamacare, in few words:

"one person’s waste and inefficiency was another person’s profit or convenience"

A lot of details inside the article. Useful hints to understand the intricated world of Washington politics. 

"both the politics and the substance of health care were mind numbingly complicated. I was going to have to explain to the American people, including those with high-quality health insurance, why and how reform could work"

 One thing felt certain: a pretty big chunk of the American people, including some of the very folks I was trying to help, didn’t trust a word I said. One night, I watched a news report on a charitable  organization called Remote Area Medical, which provided medical services in temporary pop-up clinics around the country, operating out of trailers parked at fairgrounds and arenas. Almost all the patients in the report were white Southerners from places like Tennessee and Georgia—men and women who had jobs but no employer based insurance or had insurance with deductibles they couldn’t afford. Many had driven hundreds of miles to join crowds of people lined up before dawn to see one of the volunteer doctors, who might pull an infected tooth, diagnose debilitating abdominal pain, or examine a breast lump. The demand was so great that patients who arrived after sunup sometimes got turned away. I found the story both  heartbreaking and maddening, an indictment of a wealthy nation that failed too many of its citizens.

Now that somebody wants to block its application, there is a need to emphasize the great job that was done.

President Obama in the Oval Office as a vote on the Affordable Care Act approached. Proposals for some sort of universal health care in the U.S. stretched back a century but had always been defeated.Photograph by Pete Souza

Measuring and improving efficiency in health care

 TOOLS AND METHODOLOGIES TO ASSESS THE EFFICIENCY OF HEALTH CARE SERVICES IN EUROPE

An EU approach to health system performance assessment: Building trust and learning from each other

Inefficiency in a health care system can arise for two distinct, yet related reasons. Inefficiency materialises 1) when the  maximum possible improvement in outcome is not obtained from a fixed set of inputs (or, in other words, when the same – or even greater – outcome could be produced consuming less resources), and 2) when health resources are spent on a mix of services that fails to maximise societal health gains in aggregate. As explained in more detail below, these two types are conventionally referred to in the health economics literature as, respectively, technical and allocative efficiency.

Can capitalism be reimagined? (3)

The future of capitalism

Martin Wolf said that this book was one of his main references. And I agree, it contains many well structured messages. Specially, it links economics with politics, quite a difficult issue:

 Our political systems are democratic, but the details of their architecture have increasingly inclined them to polarization. Most of our voting systems favour the two largest parties. So, the menu of choice facing voters depends upon what these two parties offer. The key dangerous step has been that, in the name of greater democracy, in many countries the major political parties have empowered their members to elect their leaders. This has replaced a system in which the leader of a party was drawn from among its most experienced people, and often chosen by its elected representatives.

Leaders can promote new narratives, but the decline of trust in political leaders has inverted authority; people pay more attention to those at the hub of their social networks than to the talking heads on the television. The networks, however, have become self-contained echo-chambers and so we even lack the common space in which to communicate. This is enormously damaging because participation in a common network constitutes the common knowledge that we all hear the same narratives.

 Reduced to a sentence, shared identity becomes the foundation for far-sighted reciprocity. Societies that succeed in building such belief systems work better than those based on either individualism or any of the revivalist ideologies. Individualist societies forfeit the vast potential of public goods. The revivalist ideologies are each based on hatred of some other part of society and are culs-de-sac to conflict. In a healthy society, those who become successful have been reared into acceptance of that web of reciprocal obligations.

 In contrast to the Utilitarian vision of autonomous individuals, each generating utility from their own consumption, and counting equally in the great moral arithmetic of total utility, the atoms of a real society are relationships. In contrast to the psychopathic selfishness of economic man restrained by the Platonic guardians of social paternalism, normal people recognize that relationships bring obligations, and that meeting them is central to our sense of purpose in life. The toxic combination of Platonic Guardians and economic man that has dominated public policy has inexorably stripped people of moral responsibility, shifting obligations to the paternalist state. In a bizarre parody of medieval religion, ordinary people are cast as sinners who need to be ruled by exceptional people – the moral meritocracy.

He is in favour of inclusive politics. Me too. Definitely, capitalism can be reimagined.

Succesful populists: the age of elected despots

These are selected paragraphs from Martin Wolf excellent op-ed Elected despots feed off our fear and rage:

To be successful, a populist demagogue has to project belief in himself as a man of destiny. Self-obsession and even megalomania help; they may well be essential. In a compelling book, Disordered Minds, the Irish writer Ian Hughes suggests such men are narcissists or psychopaths. To a non-expert eye, they do appear deranged. How else can one sell the idea that “I alone am the people’s salvation” to oneself?

If such a leader wishes to subvert democracy, it is, alas, not that hard to do, as Harvard’s Steven Levitsky and Daniel Ziblatt argue in How Democracies Die. First, capture the referees (the judiciary, tax authorities, intelligence agencies and law enforcement). Second, sideline or eliminate political opponents and, above all, the media. Third, subvert the electoral rules. Supporting these assaults will be a fierce insistence on the illegitimacy of the opposition and the “fakeness” of information that does not align with whatever the leader finds useful to state.

People will want to trust such a leader whenever they desperately wish to believe that someone powerful is on their side in an unjust world. That is what happens when trust in the institutions and norms of a complex democracy falters. When faith in sober policymaking disappears, the charismatic figure emerges as the oldest kind of leader of all: the tribal chieftain. When things become this elementary, the difference between developing and so-called advanced democracies can well melt away. True, the latter have stronger institutions and norms and a more educated electorate. In normal circumstances, that may be enough to resist. Some argue it will remain enough. Yet, we are human. Humans adore charismatic despots; they always have.

The bioethics of machine clinical decision making

Artificial intelligence (AI) in healthcare and research
Regulation of predictive analytics in medicine

This is what a brief note from Nuffield Council of Bioethics says about artificial intelligence in healthcare:

The use of AI raises ethical issues, including:

• the potential for AI to make erroneous decisions; 

• the question of who is responsible when AI is used to support decision-making; 

• difficulties in validating the outputs of AI systems; inherent biases in the data used to train AI systems; 

• ensuring the protection of potentially sensitive data; 

• securing public trust in the development and use of AI; 

• effects on people’s sense of dignity and social isolation in care situations; 

• effects on the roles and skill-requirements of healthcare professionals; 

• and the potential for AI to be used for malicious purposes.

A key challenge will be ensuring that AI is developed and used in a way that is transparent and compatible with the public interest, whilst stimulating and driving innovation in the sector.

This statement is naive.(From m-w, naive:  marked by unaffected simplicity : INGENUOUS). Up to now, have you seen any transparent algorithm available for imaging, triage or any medical app? For sure not. Therefore, the real key challenge is to stop introducing such algorithms -to ban apps- unless there is a regulatory body that takes into account the quality assurance or effectiveness side (sensitivity and specificity) and the required transparency for citizens.
Until now Nuffield has released only a brief. Let's wait for the report.
If you want a quick answer, check Science this week:

To unlock the potential of advanced analytics while protecting patient safety, regulatory and professional bodies should ensure that advanced algorithms meet accepted standards of clinical benefit, just as they do for clinical therapeutics and predictive biomarkers. External validation and prospective testing of advanced algorithms are clearly needed

 They explain the five standards and give rules and criteria for regulation. It is really welcome.

Berenic Abbot exhibition in Barcelona

Improving health in OECD countries

Health at a Glance 2017

Let me highlight toady one figure: 54% of adults in OECD countries today are overweight, including 19% who are obese. Obesity rates are higher than 30% in Hungary, New Zealand, Mexico and the United States.
Many indicators about current state of health in OECD and partner countries can be found in the report. And the public health message is:

While smoking rates continue to decline, there has been little success in tackling obesity and harmful alcohol use, and air pollution is often neglected

These are the new epidemics and prescriptions are not easy to find to curb the current trend.
The report shows many positive messages and this should be a reason for trust in our future, however the uncertainties regarding new risks and how to tackle remain.

Gramophone All Stars Jazz Band. Maraca Soul album. Iko Iko

Rethinking income inequality and health (once again)

Income Inequality and Health: Strong Theories,Weaker Evidence

The inequality frame is usually flawed, and this is specially clear when the metholodogy and data to support the statements are biased. Let me suggest today this article that summarises perfectly common misunderstandings on this relationship. It would be a great input for a review and remake of recent papers.
The summary:

What is already known about this topic? A large body of research has examined the association between income inequality and average health. A separate body of research has explored income disparities in health. These two traditions should be seen as complementary, because high and rising income inequality is unlikely to affect the health of all socioeconomic groups equally. 

What is added by this report? Although plausible theories suggest that rising income inequality can affect both average health and health disparities, empirical tests provide only modest support for some of these theories. We argue that understanding the effects of income inequality on health requires attention to mechanisms that affect the health of different income groups, thus changing average health, disparities in health, or both. 

What are the implications for public health practice, policy, and research? Progress is likely to require disentangling direct effects of rising income inequality, which operate through changes in an individual’s own income, from indirect effects, which operate through changes in other people’s income. Indirect effects of rising income inequality may change a society’s political and economic institutions, social cohesion, culture, and norms of behavior, all of which can then affect individuals’ health even if their income remains unchanged.

PS. If someone needs an estimate of morbidity, please avoid inconsistent approaches. If someone needs policy guidance don't trust on cross-sectional data on such a difficult issue.

PS. My posts on health inequalities.

Hiding money in a neo-feudal world of concentrated wealth

The Panama Papers: Breaking the Story of How the Rich and Powerful Hide Their Money

There is a fight between State and wealthy people, and the outcome depends on the threshold of the cost-benefit of tax evasion. The Panama papers show that by now this threshold is quite low, benefits are higher than costs. My impression is that lobbys are successful in their effort to suggest rules that allow hiding money with a relatively low cost. After reading the book you'll be convinced about that. Therefore, it's a success of wealthy and a failure of the State. Is there are any alternative?

The more than 2.6 terabytes of data from the servers of the Panamanian law firm Mossack Fonseca provide an insight into the offshore world that is more detailed, immediate and up to date than anyone could have previously imagined. Over the course of many months we have seen with our own eyes how Mossack Fonseca has a tailor-made solution for virtually anyone with something to hide. The right loophole can always be found in one or other of the tax havens: if the company in the Seychelles can’t do it, then the Panamanian trust or the foundation in Bermuda probably can – or alternatively a combination of two, three or four of these elements. In our globalized world it seems there is hardly a single law that cannot be circumvented or have its impact lessened with the help of a few shell companies.

My impression is that Panama papers have increased the tax evading cost, but I'm not sure that this will be enough in our neo-feudal world of concentrated wealth.

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..

Is there room for healthcare in blockchain? (2)

THE BUSINESS BLOCKCHAIN: Promise, Practice and Application of the Next Internet Technology

Last month I was saying that business strategy à la Porter required a new perspective, the platform view. Beyond that, blockchain represents a potential disruption of current business and information and communication technologies as of today.
My suggestion is to have a look at the crucial book by Mougayar on The Business Blockchain. You'll get a clear understanding that a deep transformation is in process.

Some key concepts from the book:

• How to think holistically about the blockchain as a meta technology, a business model disruptor, and legal/regulatory policies challenger.
• The 10 properties exhibited by the blockchain (beyond its most popular one, as a distributed ledger)
• Blockchains as a new Internet layer, comprised of the new breed of decentralized applications.
• The unbundling of trust and how a new form of trust inserts itself between peer-to-peer relationships, and brings a new level of transparency, trust and truth.
• The rise of New Intermediaries. Just as the Internet replaced some intermediaries, now the blockchain is replacing other intermediaries, while simultaneously creating new ones.
• Industry cases in healthcare, energy and government, including an in-depth review of financial services.
• Practical recommendations for implementing the blockchain within the enterprise.
• The blockchain as the operating system that enables decentralization, and its technological, political and societal implications.
• The birth of a crypto economy that creates its own wealth via new business models, and peer-to-peer transactional relationships between producers and consumers.
• A new flow of value, with the blockchain acting as the digital leveler that moves value across a new variety of markets.
• 47 blockchain predictions about a not-so-distant future, when blockchain technology permeates our world and creates new companies and new services.

Promising contributions to healthcare:

The theory is attractive: publish your medical record safely on the blockchain and be assured that you or an authorized person can access it anywhere in the world. That is what the government of Estonia has done—a good case of blockchain technology in healthcare. Using Guardtime’s large scale keyless data authentication, in combination with a distributed ledger, citizens carry their ID credentials which unlock access to their healthcare records in real-time. From that point forward, the blockchain ensures a clear chain of custody, and it keeps a register of anyone who touches these records, while ensuring that compliance process is maintained.

Other healthcare usages might include:

• Using a combination of multisignature processes and QR codes, we can grant specific access of our medical record or parts of it, to authorized healthcare providers.
• Sharing our patient data in the aggregate, while anonymizing it to ensure privacy is maintained. This is helpful in research, and for comparing similar cases against one another.
• Recording and time-stamping delivery of medical procedures or events, in order to reduce insurance fraud, facilitate compliance and verification of services being rendered.
• Recording the maintenance history of critical pieces of medical equipment, for example, an MRI scanner, providing a permanent audit trail.
• Carrying a secure wallet with our full electronic medical record in it, or our stored DNA, and allowing its access, in case of emergency.
• Verifying provenance on medications, to eliminate illegal drug manufacturing.
• “CaseCoins:” originating specific altcoins that create a cryptocurrency market around solving a particular disease, such as FoldingCoin, a project where participants share their processing power to help cure a disease, and get rewarded with a token asset.

Definitely, this is a key book to understand blockchain and again, there is room for healthcare. Wether the promise will become a reality, it's uncertain today.

Rational emotions

Feeling smart

Game theory is a crucial contribution to science. However it is not that easy to get a clear understanding unless experiments that confirm hypothetical outcomes are well described. And experiments are context dependent.
If you want a good overview of the main insights of Game Theory, have a look at this book "Feeling Smart, why our emotions are more rational than you think" by Eyan Winter. It goes beyond game theory, this is the most fortunate part.You don't need maths to understand it. Mostly it is devoted to applications in a useful way, using behavioral and information views .
Let's take a statement on trust:

Trust is an engine of cooperation between individuals. Cooperation, in turn, is an engine of economic growth and social welfare. Trust cannot be sustained in a society without credibility, the behavioral trait that fosters trust. On the other hand, just as trust cannot survive for long without credibility, credibility is eventually destroyed without trust. If trust is virtually nonexistent in a social setting, then there is no point in trying to develop or sustain credibility; in that situation you are better off adopting selfish and unreliable behavior. Societies and nations can be in one of two equilibria: a “good” equilibrium in which individuals trust each other and behave in a reliable and cooperative manner toward others (justifying the trust), or a “bad” equilibrium in which individuals do not trust each other, with that lack of trust becoming self-justifying as people act without any sense of a need to be trustworthy or reliable. It is easy to guess, even without empirical data, which of these equilibria leads to greater economic growth.

If you are interested in trust games, then go to part II, "On trust and generosity", this is what you should read. I highly recommend it, I've enjoyed reading it.

 

PS. I have a vague feeling these days about what's going on health policy in my country. May be credibility is starting to be undermined? Any health model relies on the credibility and trust of different actors. It is not possible to build a health system without trust among all stakeholders. Instead of creating the conditions for a new health policy based on cooperation, may be the new foundations are departing from conflict?. Is this the way to create a successful health policy?

Physician self-referral: a call for action

Physician Self-referral: Regulation by Exceptions

In 2002 a new agreement was published in internal medicine reviews on Medical Professionalism in the New Millennium: A Physician Charter. Some years ago I posted the same issue. Today, I would like to highlight three points again:

• Commitment to professional responsibilities. As members of a profession, physicians are expected to work collaboratively to maximize patient care, be respectful of one another, and participate in the processes of self-regulation, including remediation and discipline of members who have failed to meet professional standards. The profession should also define and organize the educational and standard-setting process for current and future members. Physicians have both individual and collective obligations to participate in these processes. These obligations include engaging in internal assessment and accepting external scrutiny of all aspects of their professional performance.

• Commitment to maintaining trust by managing conflicts of interest. Medical professionals and their organizations have many opportunities to compromise their professional responsibilities by pursuing private gain or personal advantage. Such compromises are especially threatening in the pursuit of personal or organizational interactions with for-profit industries, including medical equipment manufacturers, insurance companies, and pharmaceutical firms. Physicians have an obligation to recognize, disclose to the general public, and deal with conflicts of interest that arise in the course of their professional duties and activities. Relationships between industry and opinion leaders should be disclosed, especially when the latter determine the criteria for conducting and reporting clinical trials, writing editorials or therapeutic guidelines, or serving as editors of scientific journals

• Commitment to maintaining appropriate relations with patients. Given the inherent vulnerability and dependency of patients, certain relationships between physicians and patients must be avoided. In particular, physicians should never exploit patients for any sexual advantage, personal financial gain, or other private purpose.

 After reading JAMA article on physician self-referrals in US, definitely I have to say that this principles are far to be applied. The size of the resources coming from self-referrals is continously increasing despite the existing regulation for decades. The article puts a lot of expectations on changing the payment system, from fee-for-service towards value-based payments to curb the situation. I'm not so confident on this tool, because its implementation is far from optimal.
Anyway this is a difficult issue, and the same happens to dual practice in general. Some weeks ago a new resolution on how to handle conflicts of interest between public and private care was released. Two different concerns appear on my mind. The first is when any patient that decides to start a private treatment, then there is no option to go back to the public sector. He rejects explicitly public coverage. This statement may be appropriate for those patients on public waiting lists, but its application to other situations may be fuzzy. The second relates to information by the healthcare faciliy to patients about benefits and rights. I'm uncertain about how this can be applied without biases, without interference of physicians. My suggestion would be to use more transparent and centralised ways to inform patients through internet.
Unfortunately what I missed is precisely any regulation on physician self-referrals, the core of the problem. This affects publicly funded -in case of dual practice- and private care. Somebody should have a clear position on that. In my opinion, it should start by physicians associations. Self-regulation is a better starting point than any ban on this practice. As you may deduct easily, the general application of the former physician charter would solve this issue.

The tragedy of commonsense morality

Moral Tribes: Emotion, Reason, and the Gap Between Us and Them

The suggestion by Joshua Green in his book "Moral Tribes" is to put our gut reactions aside, and rely on our utilitarian moral compass for direction. There are two fundamental moral problems. Me versus Us is the basic problem of cooperation. Our brains solve this problem primarily with emotion and thanks to these automatic settings, we succeed in this controversy. However complex moral problems are about the latter, Us versus Them,-between tribes, not within tribes-.

The morality concept:

 Morality is a set of psychological adaptations that allow otherwise selfish individuals to reap the benefits of cooperation

The fact:

Two moral tragedies threaten human well-being. The original tragedy is the Tragedy of the Commons. This is a tragedy of selfishness, a failure of individuals to put Us ahead of Me. Morality is nature’s solution to this problem. The new tragedy, the modern tragedy, is the Tragedy of Commonsense Morality, the problem of life on the new pastures. Here morality is undoubtedly part of the solution, but it’s also part of the problem. In the modern tragedy, the very same moral thinking that enables cooperation within groups undermines cooperation between groups. Within each tribe, the herders of the new pastures are bound together by their moral ideals. But the tribes themselves are divided by their moral ideals. This is unfortunate, but it should come as no surprise, given the conclusion of the last section: Morality did not evolve to promote universal cooperation. On the contrary, it evolved as a device for successful intergroup competition. In other words, morality evolved to avert the Tragedy of the Commons, but it did not evolve to avert the Tragedy of Commonsense Morality.

This is a very interesting and intricate book that requires rereading. There are strong implications for health economics. His recommendations, to be discussed (some day), are the following ones:

The six rules for modern herders:

• 1. In the face of moral controversy, consult but do not trust, your instincts.
• 2. Rights are not for making arguments; they are for ending arguments
• 3. Focus on the facts and make others do the same
• 4. Beware of biased fairness
• 5. Use common currency
• 6. Give

PS. You may apply his arguments to the current political nightmare, and it fits perfectly.

Genetic testing: a knotty problem

Food and Drug Administration. Optimizing FDA's regulatory oversight of next generation sequencing diagnostic tests — preliminary discussion paper

Cutting the Gordian Helix — Regulating Genomic Testing in the Era of Precision Medicine

"Scientific progress alone won't guarantee that the public reaps the full benefits of precision medicine, an achievement that will also require advancing the nation's regulatory frameworks"

This strong statement reflects a wider concern on the implementation of precision medicine or stratified medicine. I have commented before on this issue, the NEJM article of this week clarifies the last attempt by FDA to shed some light and a specific approach to disentangle the current challenges. FDA has submitted a document for comments just to start a new era of regulation in health, a "collaborative framework" for creating reliable databases of genes and genetic variants underlying disease, and provide a "safe harbor" for the interpretation of genomic tests.
This is exactly the right direction. As long as, information is a public good, genetic testing -clinical validity and utility- should be provided only by the regulator.  Professionals and citizens need to trust in precision medicine and avoid snake-oil sellers.
Having said that, today I'm more concerned than yesterday on how our government is delaying to start such effort. Today is one more day lost.

Dufy at Thyssen Museum right now

PS. Somebody should think twice about the style of health policy debates in public TV.

Fines, settlements and reputation

Reputation Capital: Building and Maintaining Trust in the 21st Century

In the last decade there has been a proliferation of cases of fraudulent marketing practices and bribery in pharmaceutical industry. In the case of US you may check the details at Propublica. In EU we don't have a similar summary (as far as I know). The latest case in EU involves 6 companies and fines of €427m . In China, the latest case is about $500m fines for bribery. This case was started by an anonymous whistleblower.
While it is no surprise that pharmaceutical industry reputation is weak, corporate social responsibility is still supported by the firms. I can't understand why. In the page 347 of this book you'll find a chapter on this issue: "Is there no prescription? Reputation in the pharmaceutical industry". It says:

If the pharmaceutical industry does not present itself in an active and self-confident way, it cannot expect the situation to improve. For, apart from itself, it has no other advocates