A bit worse before it gets better

Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease

A new mental frame was created some weeks ago when President Obama gave a speach on the creation of the initiative on Precision Medicine. To be honest, the term was in the title of a 2011 report by IOM.
In my opinion, it is a bundle: stratified medicine+big data+regulatory science+... This is the bundle of the new buzzword, and unless new details arise, nothing specially new.
Now the New Yorker speaks abouts the problems of precision medicine, and focuses on the risks. The final paragraph illustrates the issue:

For Solomon, genetics is simply a new tool with a learning curve, the same as any other. “When the electrocardiogram was first developed, about a hundred years ago, most physicians thought it was voodoo,” Solomon said. “Now, if you don’t understand it, then you shouldn’t be practicing medicine.” But Mary Norton sees that analogy as too simplistic. The pace of genetics research, the variability of test methods and results, and the aura of infallibility with which the tests are marketed, she told me, make this advance a more complicated one than the EKG. Norton believes that, as genetics becomes increasingly integrated into medical care, “over time everyone will come to have a better understanding of genetics.” But, as the demand for DNA testing increases, she says, “it will probably be a bit worse before it gets better.”

Could we avoid the initial bit worse of  "imprecision of stratified medicine"? . I'm full convinced that appropriate regulatory efforts could mitigate such impact. Unfortunately, governments are on vacation.

Dancing to public accountants' tune

I would have never imagined that the health policy could have been distorted and dictated to by public accountants. Yes, you have heard correctly. European Union and its statistical arm, Eurostat, has decided what is a public firm. And the decision is so anomalous that it deserves a short comment.
We all know and agree that public accountants need to define with accuracy the size of government deficit. They consider what is public administration according to several criteria (p.25), this is their responsibility. However, the collateral damage of doing it in a weird manner, puts a severe strain on the health system as we know it today.
Management autonomy has been introduced in the last decades within the publicly financed system under a myriad of different organizations. Today, the application of ESA 2010 -the accounting rules in place since last September 1st- represents that all of them have to follow the same path and autonomy will be jeopardized. We will be dancing to public acountants' tune.
Management autonomy helps to boost efficiency, even in public systems where incentives are low-powered. Hence, when somebody complains in the near future about inefficiency, we'll have to remember that european public accountants and its politicians have contributed to worsen health systems. Thank you so much, accountants.

PS. Please save this post for the future. It will have strong implications.

PS. This is the end.

The hype over genetic tests

Implementation of a companion diagnostic in the clinical laboratory:The BRAF example in melanoma

Analytical validity is one of the three steps for any assessment of genetic tests, combined with clinical validity and clinical utility. Understanding how this process affects specific tests is not that easy.Fortunately you can find a detailed explanation of one of them:the BRAF genotype analysis in tumor tissue samples for identification of melanoma patients that can benefit treatment with BRAF inhibitors.
Once you begin to read the article you'll understand the complexity of being precise in a test. This is the reason why if specificity and sensibility is uncertain, different methodologies are needed (check Figure 1).
But how to do it?. How to set up external controls of quality?. All these issues are covered in this article, that explains what's going on in practical terms. I'm concerned if due to such complexity, all "genetic test talent" is not concentrated in one site of the organization-hospital, and many departments and services -oncology or cardiology- are developing their own genetic tests. Somebody should block this option before it is too late.

The size of the health budget

In 2015 the per capita expenditure (1,120€) will be the same as in 2006, nine years earlier (p.46). The economy follows exactly the same pattern. GDP per capita in 2014 was less than in 2006. Therefore, those that are concerned about stagnation and cutbacks, should look at statistics. The health budget is set according to political criteria, and what this amount reflects is exactly the same social effort to cover health risks as before the crisis.
Unfortunately I haven't seen this argument in any debate, up to now. It's really annoying that ideology overpowers evidence.

PS. James Buchanan blog in BMJ

PS. Robbed by the Kremlin in the WSJ.

Mandatory complementary private insurance

Compulsory private complementary health insurance offered by employers in France: Implications and current debate

It looks strange at a first glance. Why a country with statutory Social Health Insurance (SHI) has to set up a mandate to employers to buy private health insurance for their employees?. In France by 2016 all employers will have to do it, and this complementary insurance covers basically copayments in the SHI system. It is really strange, because copayments are created to reduce moral hazard, hence if somebody insures copayments, then its impact on utilization is the same as if it were no copayments in the SHI but with a high and avoidable loading fee. And, as far as this insurance is mandatory and private, then it makes no sense at all.
Each country decides politically according to the context, nothing to add, though this is a very weird case. You'll find more details in this article.

Is this the end my friend? (2)

Once upon a time there was a country with seven Schools of Medicine for 7,5m inhabitants. The needs for future physicians were estimated 8 years ago and the time goes by but somebody seems he is not aware of that. Some months ago I said that the organization of health care system as we have known it, was at their final days, now I can confirm that medical profession structure is also in the same situation.
A big and unnoticed change has occurred. In 2006, only 1,8% of resident physicians were foreigners, in 2013 this figure has jumped to 32,3% (!). Does this makes any sense?.
How is it possible that our citizens can't study medicine and we are able to open the system to foreigners without the right level of qualifications?. Who is boosting this?. I explained it in this post some years ago, here and there.
The time to disconnect is coming. Enough is enough!

The Dunning Funnel criteria for the health basket

The basic benefit package: Composition and exceptions to the rules. A case study

In the Netherlands there are four criteria to assess any benefit to be included in the health basket:

1. Care should be essential: Does the illness, disability or the care needed justify a claim on solidarity within the existing cultural context?
2. Effectiveness: Does the intervention do what it is expected to do? In other words: it is proven to be effective and evidence based.
3. Cost-effectiveness: Is the ratio between the cost of the intervention and the outcome
acceptable?
4. Feasibility: Is it feasible to include the intervention in the basic package, now and in the future?

This is known as the funnel originated by a commission report chaired by Mr. Dunning in 1991. The application of such criteria has been evolving and a recent article says that some benefits have followed a yo-yo effect, being in and out of the package for unspecified reasons. I think that it is better to have some clear principles and justify its application, than not having any.
Here we have some principles, sometimes we change them, sometimes we assess them, sometimes not and nobody knows why.

PS. The Irish  have made a recent effort of definition in this report.