Tuesday, April 30, 2013

The stratified approach

How Health Systems Could Avert 'Triple Fail' Events That Are Harmful, Are Costly,And Result In Poor Patient Satisfaction 

While reading the latest HA, I've picked this article that intends to focus on implementation issues: how to improve health. A short statement:
 The stratified approach to the Triple Aim described in this article includes three phases. A planning phase would involve conducting an opportunity analysis, developing predictive models and impactibility (also known as intervenability) models.
More details in the article. Formerly in this blog, I've explained more or less the same. For instance, have a look at a post of last year on risk prediction in a population . We do need to focus on the basics using the most appropriate tools. This is what the article does, and what we have to do.

Thursday, April 25, 2013

Aprés tout (3)

Publicly funded health expenditure reached 9,162m € in 2012, although the initial budget was 8,756m €. Therefore, the size of the budget deviation was  406m €(10% of total public deficit, health care is 38% of total public budget), and we have to remember that in 2011 the deviation was 582m€ .
Let's say it differently, in 2012 we have roughly accomplished the budget of 2011 (!) , or being more precise we have reduced the 2011 budget in 26 million .
The most interesting figure is always the per capita expenditure, in 2012 the final number is 1,205 € per inhabitant. A reduction of 2 € if we compare to 2011 budget (p. 45), or 77€ per capita of cutbacks in current terms.
The level of expenditure is right now close to what we were spending 5 years ago. Surprisingly, the size of population also went back to the figure of 5 years ago.(!)
Meanwhile, citizens wonder if there is a limit in the shrinking trend. The rumor these days is that the 2013 budget may be reduced by 9%. I can't imagine that this is possible to accomplish in 6 months, given that we have reduced 12% in two years(!!!).
And finally, don't forget that we are in a country that only 43% of our taxes come back, the remaining amount we'll retrieve it the day that we all agree in the creation of a new state. Then we'll not discuss again about cutbacks in the health budget, because we'll decide how much to devote to health services with our taxes.

PS. Video: Our politicians in the Parliament, a review of health policy in 2012.

PS. Today at 19:30 h. free broadcast of GET2013:  Genomics in the Practice of Medicine

PS. Otherwise at 22:00 h you may be interested in:  Genetics in Hollywood: Inspiring Writers and Producers to Create Storylines that Improve Health Worldwide 

PS. Recovery room from cutbacks: Must listen to Ben l'Oncle

Tuesday, April 23, 2013

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.

Saturday, April 20, 2013

Full overhaul needed

A full-fledged overhaul is needed for a risk and value-based regulation of medical devices in Europe

This is exacty what medical devices regulation in EU needs: a full overhaul. The weaknesess of current process have been on the press for the case of breast implants. But this is only an extreme case that has shown the failures and conflicts of interest.
Carlos Campillo article in Health Policy shows clearly the details and examples of the current mess.
In Europe, the first step should be to understand thefull extent of the problem and bring it to public attention.Comprehensive, reliable and constantly updated registriescould play an important role in this endeavor. Secondly,all the improvement measures described in connectionwith both sides of the problem (assessment, appraisal andapproval, on the one hand, and postmarketing on the other)should be urgently implemented. The fact that we already know what these measures are would delegitimize any delay in implementation.
A clear alert for any politician with eyes to read.

PS. On non-profit boards

Friday, April 19, 2013

Paving the way

Default Options In Advance Directives Influence How Patients Set Goals For End-Of-Life Care

The end of life is obviously a difficult period. In such context, health care decisions have to be taken and our brain may not be able to perform as it should.
Most seriously ill patients value comfort and dignity over life extension, but routine care often leads to treatment oriented toward extending life. Deviating from this life-extending norm requires that someone actively request or suggest doing so.Specifying one’s goals of care in the living will component of an advance directive provides patients with an opportunity to counter this tendency. However, the text and structure of commonly used advance directives carry some of the same implicit biases that tend to favor life extension in the absence of advance directives.
Halpern et al. show that people are strongly influenced by default options in advanced directives. Without default, 66% prefer confort over life extension. With a default option, 77%  prefer not to extend life, even after reconsideration and being informed over the default.
Food for thought. Behavioral economics is paving the way for new understanding of choices that involve large amount of resources.

Friday, April 5, 2013

Evergreening (2)

The case of Tecfidera deserves a short comment. Imagine a drug for psoriasis, its active ingredient -dimethyl fumarate- modulates the immune system. The drug has been on the german market since the 90's. Right now you can buy this active ingredient at a reasonable price: $56.20 per 1000 grams. Imagine a company that "buys a license" to extend the indication of this active ingredient into multiple sclerosis. The result is a drug recently approved by FDA and sold at a "fair"  price of $54,900 per patient per year (!). With this amount of money we can buy roughly a tonne of dimethyl fumarate per patient per year. Does this make any sense? Is there anybody stopping this madness?

PS. Don't forget my previous post on the same topic.

PS. Why is this information false?. The answer in this post.

Wednesday, April 3, 2013


I'm strongly convinced that strong patent rights spur innovation. In the case of genetics and biomarkers, the impact is even stronger. The Supreme Court has to decide over the Myriad case next April 15th and it is really crucial to follow what will be the definite resolution about genetic patents (at least in US). You'll find a good summary at FT.
The verdict is relevant for society as a whole. The access to new biotech benefits will be cheaper if resolution is finally against patenting. Of course, biotech industry has great concerns about it. But the problem is not on biotech, is on expectations that Wall Street has created. It is again, Wall Street vs. Society, a well known fight. Don't forget, the issue is not about patents. It is about ownership rights that spureously create and distort the economy.

PS. You'll find more previous posts on the same topic, here, there and everywhere.

PS. Uwe Reinhardt on healthcare prices, must read, as usual.

Tuesday, April 2, 2013


To evergreen or not to evergreen, that is the question. The lawsuit in India against Novartis has ended with a verdict that imatinib failed in the tests of invention and patentability.  A serious verdict, because it is an alert for any potential company interested in evergreening as strategy for patent extension.In this specific case, the costs of evergreening have outweighted the benefits.
I'll avoid any discussion about  the ruling, I'll take it as given. I would only suggest to have a look at the remarkable history of gleevec. Unfortunately, the size of public funds involved in the research doesn't appear. It would be great to know it.
Right now I am not able to disentangle the rationale about the threats of the pharmaceutical firm about cancelling the supply of new drugs into this market. It's a mistake, in my opinion. I'll check how they explain it as a CSR strategy.in the next annual report.