The Dahlgren and Whitehead model 30 years after

 The Dahlgren-Whitehead model of health determinants: 30 years on and still chasing rainbows

From the authors review:

Reflection on the past 30 years has helped us identify where to go from here, to develop the model so that it is adapted to the burning issues of the day. First, we need to find ways to better illustrate the vertical links between the social, economic and cultural determinants of health and those of lifestyle. This is needed to reinforce the point that many lifestyles are structurally determined. There is a  common, flawed assumption that the lifestyles of different socio-economic groups are freely chosen, ignoring the reality that lifestyles are shaped in important ways by the social and economic  environments in which people live.

Second, there is a current debate about the importance of the commercial determinants of health and whether they have been neglected by the public health community, including a critique of these not being given sufficient prominence in the Dahlgren and Whitehead model (Maani et al., 202015). By ‘commercial determinants’, Maani and colleagues refer to factors that adversely influence health, which stems from the profit motive; the examples they give concentrate on the strategies of tobacco, alcohol and food and beverage producers to promote their products. While we acknowledge that the impact of commercial interests should always be analysed, we deliberately do not define ‘commercial interests’ as a determinant in its own right to be included in the  rainbow model. In a rebuttal to Maani and colleagues, we explain how we consider profit-driven commercial interests as ‘driving forces’ that are related to almost all determinants of health except genetic factors.

 

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

Inducing methylation

Nutrition, Exercise and Epigenetics: Ageing Interventions

Epigenetics refers to an inheritable but reversible phenomenon that changes gene expression without altering the underlying DNA sequence. Thus, it is a change in phenotype without a change in genotype. The field of epigenetics is quickly growing especially because environmental and lifestyle factors can epigenetically interact with genes and determine an individual’s susceptibility to disease. Interestingly, aging is associated with substantial changes in epigenetic phenomena. Aging induces global DNA hypomethylation and gene-specific DNA hypermethylation due to the altered expression of DNA methyltransferases (DNMTs).

The evidence of the impact of epigenetics on aging is growing. And nutrition plays a key role on epigenetics through the life course. Thus, there are crucial reasons to focus on nutrition early in life.

It is clear that epigenetic alterations caused by aging may provide a milieu that can develop age-associated diseases such as cancer, cardiovascular diseases, neurocognitive diseases and metabolic diseases. Nutrition is one of the most important environmental factors that can modify epigenetic phenomena. Therefore, one might speculate that nutrition may delay the age-associated epigenetic change and possibly reverse the aberrant epigenetic phenomena that can cause age-associated diseases. Indeed, many nutrients and bioactive food components, which can affect one-carbon metabolism that can regulate methylation of DNA and histone or directly inhibit epigenetic modifying enzymes, are showing promising results in delaying the aging process and preventing age-associated diseases through epigenetic mechanisms.

And beyond nutrition, there is exercise. This is what this book explains and it shows the foundations for better health. If it's "only" an issue of regulating methylation...where are the incentives?

Els medicaments que curen el mal dolent

 Addressing Challenges in Access to Oncology Medicines

ESMO-Magnitude of Clinical Benefit Scale version 1.1

La magnitud del benefici clínic dels medicaments és i ha de ser preocupació de tots, principalment dels clínics. En això els oncòlegs fa temps que hi han dedicat temps i esforços. La societat europea, la ESMO ja fa anys que va introduir una metodologia al respecte.

The  ESMO-  MCBS  grading  highlights  those  treatments  which  substantially  improve  the  duration  of  survival  and/or  the  quality  of  life  (QoL)  of  patients  with  cancer  and  aims  to  distinguish  them  from  trials  demonstrating  more  limited  and  sometimes  even  marginal  benefits. The  ESMO-MCBS  assigns categorical benefit scores to European Medicines Agency  (EMA) and US Food and Drugs Administration (since January 2020) approved cancer medicines,  based  on  results  from  ‘positive’ randomised clinical trials:

• superiority trials that have demonstrated a statistically significant result for the primary endpoint of the study, and/ or secondary in case of overall survival and 
• non-inferiority trials, reaching a conclusion of non-inferiority.

La proposta és d'interès però a la pràctica no trascendeix més enllà dels clínics i el motiu entre d'altres és que es basa en una puntuació categòrica d'experts, que desconeixem si els experts fossin uns altres quina puntuació  sortiria. En el fons el que pretén ESMO és arribar a algun consens sobre l'efectivitat relativa dels medicaments aprovats i com a mecanisme de consens professional, res a afegir.

L'OCDE per la seva part va fer un document que revisava com es trobava l'accés als medicaments oncològics en diferents països. Allà es mostra amb molt de detall què fan i com ho fan (excepte Espanya que no va contestar el qüestionari).

Aquests són els reptes que l'informe va identificar i que cal tenir en compte com a temes pendents de resoldre:

Hi ha molts més temes dins l'informe, en especial els temes relatius a diferències d'accés estan ben tractats. Els fabricants de medicaments europeus EFPIA també van fer l'abril passat un document al respecte. Fa setmanes parlava de l'elevat preu dels medicaments oncológics, i aquest tema acaba copsant tot l'interès, però n'hi ha d'altres, que convé que siguin resolts.

MABS in history of medicine

The Lock and Key of Medicine Monoclonal Antibodies and the Transformation of Healthcare

While reading FT this summer I came across an article quoting a unique book on history of monoclonal antibodies (MABS). Right now there are more than 30 drugs in the market based on hybridoma technology that was created in 1975.
The birth of MABS is explained with full details, how the creators finally didn't patented it and why, the difficulties for research in an unconnected world, etc... An exciting story that is worth reading. Right now, it would be completely different, commercialization of research and medicine has raised considerably.

That a British company spearheaded the first marketing of Mabs, a technology devised in a British laboratory by an émigré Argentinian scientist with his German colleague, highlights the international nature of biotechnology commercialization. Sera- Lab’s venture to sell Mabs took place in the midst of the excitement generated by the founding of Genentech in 1976. The emergence of Genentech, which had been set up
to market recombinant DNA products, galvanized numerous alliances among academics, entrepreneurs, and venture capitalists to launch new companies to commercialize biotechnology. Most of the early enterprises set up in the wake of Genentech’s birth were dedicated to exploiting recombinant DNA for the mass production of natural products such as interferon and insulin for drugs. But the early germination of the modern biotechnology industry did not rest solely on recombinant DNA. By the 1970s a number of pioneering companies were developing Mab products, including Sera- Lab and two startups: Hybritech in San Diego and Centocor in Philadelphia. Entrepreneurs who risked entry into the field had no guarantee of success and were entering totally uncharted
territory. Such individuals faced major fi nancial, personal, professional, and regulatory challenges as well as a great deal of hostility, pessimism, and litigation.

Milstein with Köhler at the time of their receiving the Nobel Prize in 1984 together with Nils Jerne.

Mabs have had their strongest therapeutic impact in the field of cancer. The first Mab to reach the market for cancer was edrecolomab (Panorex), which was granted German regulatory approval in 1995 for the treatment of postoperative colorectal cancer. Developed by Centocor in partnership with the Wistar Institute, it was withdrawn in 2001 because of its poor effi cacy in comparison with other drugs. Since 1997, however, the U.S. Food and Drug Administration (FDA) has approved twelve Mab drugs for cancer treatment, including rituximab (Rituxan), approved in 1998 for the treatment of non- Hodgkin’s lymphoma. By 2012 there were over 160 candidates in clinical trials for cancer, with seventy of them in phase III trials, the stage before a drug is submitted for regulatory approval.

Mabs have enabled the identification and characterization of cancerous tumors previously difficult to detect and diff erentiate from other tumors, thereby providing a better understanding of cancer. They have also opened a path to more personalized medical treatment. Trastuzumab (Herceptin), for example, was specifically developed to target HER2/neu, a protein overexpressed by tumors found in 25 percent of newly diagnosed breast- cancer patients

The politics of calories

Why Calories Count

Marion Nestle says in her book:

In some ways, the calorie environment could not have been more brilliantly constructed to overcome physiological controls of overeating.

The new labeling initiatives have been really minor up to now. Wether they will have beneficial effects in the long run is still unknown. Calorie labeling should be extended when eating outside home and to alcohol.
The government has not paid enough attention to food regulation and specially to information about calories. In the book there is a guide for improvement. This is the previous step in any nudging effort. To be clear, information disclosure is the very beginning of any consumer protection and health promotion policy in this field.

Opening the door to recreational genetics testing

On February 19th, the US Food and Drug Administration (FDA) authorized 23andMe to market a direct-to-consumer (DTC) carrier test for Bloom syndrome. Such test was classified as a medical device, and exempting it from premarket review. This may pave the way for DTC genetic testing in the US market.
The decision to open door for one test may represent the biggest move towards a recreational genetic testing market. You know that from this blog I have backed a ban on developing such markets and the need for an effective regulatory review different from the flawed medical device system.
The european regulator is still on holiday, I said that some months ago and it is still "out".

PS. Variations in health care in GCS Blog.

The decline of pharma R&D productivity (2)

Science needs to move beyond luck if it is to design better drugs for the brain

The Economist:

Between 2011 and 2020 the likelihood of a drug in psychiatry being approved by the Food and Drug Administration was 7.3%. In neurology it was 5.9%. (The industry average is 7.9%.) As well as being less likely to succeed in trials (see chart), neurology drugs also take much longer, on average, to develop, further decreasing their appeal

According to the Global Burden of Disease project 12 mental-health disorders affect about 970m people. Their prevalence has increased by 48% since 1990 as the population has grown. With more than one in ten people on the planet affected, it is a global problem, although what data are available suggest it is more marked in Western countries (see map).

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

Improving physician compensation

A Guide to Physician-Focused Alternative Payment Models

A fixed flat monthly payment to  physicians is a vulgar method to compensate a professional effort. At some initial stages of the career, it may work. As far as experience and knowledge improves results, than some adjustments are needed. In general the publicly funded health system is not able to change the initial stage and remains with more or less the same approach of low-powered incentives. This may work for some individuals, but not for all of them.
Paying on a fee-for service it creates strong incentives to boost volume, and paves the way to overdiagnosis and overtreatment. Privately funded health care is still using mostly this high-powered approach and it is also not able to reform.
Alternative methods of compensating physicians have been described recently in an interesting report. Forget for a while that it is based on the US health system. These are the seven options:

APM #1: Payment for a High-Value Service 
APM #2: Condition-Based Payment for a Physician’s Services

APM #3: Multi-Physician Bundled Payment

APM #4: Physician-Facility Procedure Bundle

APM #5: Warrantied Payment for Physician Services

APM #6: Episode Payment for a Procedure

APM #7: Condition-Based Payment

Food for thought. Something should done to go beyond fee-for service. And do not forget it, changing incentives without any organizational alignment or reform may drive to surprises and poor performance.

PS. Just the opposite to us, NHS expands private care . A controversial trend.

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 

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.

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.

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..

An ongoing tug-of-war

Understanding Differences Between High- And Low-Price Hospitals: Implications For Efforts To Rein In Costs

Consolidation of private healthcare providers is an increasing trend nowadays. The exact implications for competition and choice are usually unknown. It is worth having a look at other markets. This article in HA explains the impact for the US context:

Prior research shows that private hospital prices vary considerably both within and across markets, even after differences in patient populations and services provided are accounted for. The wide variations in price and the high prices at some hospitals reflect an ongoing tug-of-war between increasingly consolidated buyers (health plans) and increasingly consolidated sellers (hospitals and hospital systems).

Given the intense and growing pressure to rein in the growth in private health insurance premiums, the continuation of current trends appears to be unsustainable. It remains to be seen whether or not health plans will somehow regain the upper hand. If they do not, more radical approaches—such as state-based rate setting or restrictions on contracting arrangements between hospitals and health plans—may gain traction.

PS. HA Blog, a comment.

PS. On limiting bisphenol in food.

PS. Health expenditures NEJM Graphic 

PS.Health Policy Basics: Health Insurance Marketplaces

PS. Are Human Genes Patentable? 

PS. Regulating 23andMe to Death Won’t Stop the New Age of Genetic Testing

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

L'economia del comportament i l'obesitat

Eating Behavior and Obesity Behavioral Economics Strategies for Health Professionals

Sabem que majoritàriament els indicadors de salut dels catalans que empitjoren, tenen relació amb els comportament, amb els hàbits saludables. I que l'obesitat es troba al capdavant.
Entendre què cal fer és crucial. Però malauradament tenim visions i estratègies de curta volada. Ara acaba d'aparèixer un llibre que ofereix noves perspectives tot introduint l'economia del comportament davant el problema de l'obesitat. Diu:

There are two ways of thinking about influencing behavior. The first is based on the standard rational model. That is, infl uencing what people consciously think about by increasing knowledge and awareness (known as the refl ective system ). This aproach assumes that the individual is a rational agent who surveys the situation to see what the various options are and then does a quick cost-benefi t analysis of those options in order to choose. The second approach is to alter the context within which people act (known as the automatic system ). This type of intervention is similar to the “nudge” outlined by Thaler and Sustein (2008), which often involves small changes to the choice environment. For example, one intervention tried to encourage school children to make healthier choices without alienating students by reducing their perceived choices. In a school cafeteria, what kids choose depends on the order in which the items are displayed.

 Els que llegiu aquest blog ja sabeu que m'hi he referit anteriorment en termes genèrics. Però aquest llibre esdevé més interessant perquè mostra amb molta precisió un canvi de perspectiva. Destaco una conclusió del primer capítol:

Rational food decisions often involve trade-off between short-term gains of sensory pleasure and longer term gains of health and wellness. Findings from behavioral economics research suggest that even when people are motivated to make healthy choices, external constraints in the decision-making process can prevent them from choosing optimally. Most of us prefer immediately gratifying short-term pleasure over our long-term goal of eating healthy. Errors in choices arise from systemic decision biases, emotion, and the limits of cognitive capacity.

Atesa la importància de "l'epidèmia" potser caldria que més d'un hi fes una ullada. Encara que també vull anunciar que el capítol d'implicacions per a la política (el 12) és molt fluix. Us caldrà doncs una mica d'imaginació i reescriu-re'l vosaltres mateixos.

 No us perdeu les friky-fotos de Diane Arbus al Jeu de Paume

(suggerit per un lector del blog i que em plau compartir amb valtros)

PS. Les retallades són notícia a la CNN, (confonen Catalunya amb Espanya, treball periodístic de nivell...)

Against patents

The case against patents

Some months ago, a WP blog hightlighted a paper by Boldrin and Levine with a straightforward title. Now you can read it at the Journal of Economic Perspectives. The summary is in the first paragraph:

The case against patents can be summarized briefly: there is no empirical evidence that they serve to increase innovation and productivity, unless productivity is identified with the number of patents awarded—which, as evidence shows, has no correlation with measured productivity. This disconnect is at the root of what is called the “patent puzzle”: in spite of the enormous increase in the number of patents and in the strength of their legal protection, the US economy has seen neither a dramatic acceleration in the rate of technological progress nor a major increase in the levels of research and development expenditure.

A risky statement unless there is a clear support from research. However, once you continue reading you'll have arguments to be convinced about it. The impact on pharmaceutical industry is analysed in detail:

There are four things that should be born in mind in thinking about the role of patents in the pharmaceutical industry. First, patents are just one piece of a set of complicated regulations that include requirements for clinical testing and disclosure, along with grants of market exclusivity that function alongside patents. Second, it is widely believed that in the absence of legal protections, generics would hit the market side by side with the originals. This  assumption is presumably based on the observation that when patents expire, generics enter immediately. However, this overlooks the fact that the generic manufacturers have had more  than a decade to reverse-engineer the product, study the market, and set up production lines. Lanjouw’s (1998) study of India prior to the recent introduction of pharmaceutical patents there indicates that it takes closer to four years to bring a product to market after the original is introduced—in other words, the fifi rst-mover advantage in  pharmaceuticals is larger than is ordinarily imagined. Third, much development of pharmaceutical products is done outside the private sector; in Boldrin and Levine (2008b), we provide some details. Finally, the current system is not working well: as Grootendorst, Hollis, Levine, Pogge, and Edwards (2011) point out, the most notable current feature of pharmaceutical innovation is the huge “drought” in the development of new products.

And the proposal is a controversial one:

we could either treat Stage II and III clinical trials as public goods (where the task would be financed by National Institutes of Health, who would accept bids from firms to carry out this work) or by allowing the commercialization of new drugs—at regulated prices equal to the economic costs of drugs—if they satisfy the Food and Drug Administration requirements for safety even if they do not yet satisfy the current (overly demanding) requisites for proving efficacy.

The last sentence sounds far from what should be a "fair" regulatory process in pharmaceuticals. Anyway, it seems that we have entered in a new perspective on patents and more scholars will be supporting it in the future.  I'm close to this perspective, but the details are important, as usual.

Behavioural economic-informed regulation

From Nudging to Budging: Using Behavioural Economics to Inform Public Sector Policy

Is it possible to design a regulatory mechanism to budge the private sector away from socially harmful acts?. Adam Oliver, from LSE offers his view at the Journal of Social Policy:

The role of government is not, for the most part, to interfere with personal lifestyle choices unless those choices present harms – or negative externalities – to others, although the government may be warranted in enforcing some behaviours designed to protect people principally from themselves if the intervention is considered openly and explicitly and supported widely, such as seatbelt legislation. The most effective way of preventing people or organisations harming others is to regulate their activities. Nudge is anti-regulation, but behavioural economics is not.

An awareness of the main behavioural economic findings – for example, present bias, reference points, loss aversion and nonlinear probability weighting – can help to inform decisions on where and how to regulate (for instance, traffic light food labelling), and may also ensure that public officials gain a better understanding of their own decision making limitations.

As I have said before, the idea sounds appealing, its implementation remains uncertain.

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!