A closely guarded secret

Stealth Research. Is Biomedical Innovation Happening Outside the Peer-Reviewed Literature?

How can we identify a snake-oil seller?. Not so easy. Have a look  at JAMA, John Ioannidis article shows his concerns about Theranos, a company that is providing lab services with a new propietary technology that has no peer-review article in any scientific publication. Nobody can check tests sensibility and specifity, no external quality controls, and so on.
If this is the path for the future of health care provision, then I am really concerned because it will be a complete disaster. No consumer protection, no regulation, uncertain science and more uncertain outcomes. After all this years, is this what citizens deserve?.
Such style of "laissez-faire, laissez-passer" medicine could represent huge profits for some and a big loss for everyone.
Otherwise some alternative should be proposed to boost publication and transparency. The author's suggestion is the following one:

To solve this conundrum, it may be necessary to find ways to realign the reward system for innovation. One possibility is to make the scientific literature more receptive to innovators. This could include models in which reports of disruptive discoveries that are in dissonance with the mainstream can still be communicated as preprints without prior peer review, perhaps in the same way as the successful example of arXiv in the physical sciences, which has now reached 1 million e-print articles. That there has been no peer review of these initial reports should be transparent to researchers and the public.

Thus, some better regulatory process is needed so that innovative ideas for financially successful applications can be scrutinized by the wider scientific community as to their validity. A company should not be forced to disclose its science secrets in detail, especially while its efforts are still exploratory rial-and error and while creating basic elements for its products and services. However, if a product or service reaches the point at which it generates substantial revenue, the science behind it should then be communicated in detail to ensure adequate review.

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.

Lakoff brilliant analysis

Handbook of Neurosociology

Today I would like to quote a clever analysis of US health reform. Just as an alert for any other country that wants to start a similar process.

Solving a Social Science Puzzle

In 2009, when President Barack Obama chose the policy provisions for his health care plan, polls showed that most provisions (e.g., no preconditions, choice of plans) were supported by 60–80% of Americans. Yet, when the whole plan was polled, fewer than 50% supported it. Why? Why the disparity between the parts and the whole, when the whole literally equals the sum of the parts?
The answer is straightforward from the perspective of real reason. When President Obama came out with the provisions of his health care plan in early 2009, the conservatives decided to attack it not on policy grounds but on moral grounds. They chose two areas of morality: Freedom (“government takeover”) and Life (“death panels”). And they repeated over and over that “Obamacare" (naming matters) was a government takeover that was a threat to individual freedom, with death panels that were a threat to life itself.
Note that the policy provisions were about the everyday details of dealing with one’s HMO. They were in the Practical Health Care Details frame. The conservative attack was in the Morality frame, activating freedom and life. The conservatives understood that all politics is moral, that political lead- ers all say they are doing what is right, not what is wrong.
The policy details and the moral attack were in different frames, located in different parts of the brain. From the perspective of real reason, the whole health care act was, for those with a conservative worldview, not equal to the sum of its policy parts. Conservatives and independents (actually biconceptuals, who are progressive in some respects and conservative in others) had their conservative moral worldview activated by the conservative moral attack. This separated the moral whole from the practical parts.
For progressives, their morality and the practical details fit together; for conservatives and biconceptuals (aka “independents”), they were different subject matters.
Such an explanation is natural when you think in terms of the brain and frame-circuitry. It is not possible when you think in terms of the logic of Enlightenment reason, where the whole is necessarily (logically) the sum of the policy parts

PS. You may find former posts about George Lakoff's work on cognitive science, here and there.
PS. This is the coda of the first chapter of the book. The whole chapter is a must read for those interested in "brain circuitry", language, metaphors and politics.

Thresholds' controversies

Guidance on priority setting in health care (GPS-Health): the inclusion of equity criteria not captured by cost-effectiveness analysis

The threshold for cost-effectiveness is under controversy again. This is not new. FT explains a new York University paper that has created great concern. Is it NICE cost-effectiveness way of implementation really "cost-effective"?. From their point of view, thresholds are higher than they should be to guarantee access.
Thresholds are only one side of the coin. The other one is the introduction of equity criteria in cost-effectiveness analysis. Three years ago, I explained this topic in a post commenting on Tony Culyer''s article. He says that there are two "dragons" in dealing with cost-effective analysis: equity and our ignorance about how to introduce it. I then quoted this statement:

‘Arguably the biggest threat to our public health care system is not our ability to pay for the increasing cost of care, but rather a loss of public confidence.’’

An older post on Eddy's work explains similar concerns over thresholds and equity. We have to convene that there is not only one method to do it. However, some well known academics have published an interesting proposal: criteria for access to be considered jointly with cost-effectiveness.

The GPS-Health incorporates criteria related to the disease an intervention targets (severity of disease, capacity to benefit, and past health loss); characteristics of social groups an intervention targets (socioeconomic status, area of living, gender; race, ethnicity, religion and sexual orientation); and non-health consequences of an intervention (financial protection, economic productivity, and care for others).

Basically, these criteria are well known. The difficulty of its measurement has yet to be overcome.

PS. My former post on the same topic and authors in York. 

Medicine as a data science

THE PATIENT WILL SEE YOU NOW
The Future of Medicine Is in Your Hands

Maybe the title is the most confounding factor of the new great book written by Eric Topol.  Once you have finished reading it, you'll be convinced that he set the expectations to high, ordinary people should develop certain skills beyond their capabilities to apply such concept. I would say that a greater part of the medicine is in your hands, not medicine at all. The rationale behind the book is that medicine digitization allows patients to know more about their disease and how to "manage" it in certain cases. The most important thesis is that future medicine has to be considered a data science. And this is exactly the impact of the digitization of diagnostic and treatment: pervasive application of Bayes theorem in clinical practice, using big data and analytics.(Remember my archimedes posts, surprisingly Topol forgot it).
The book includes many topics that those that follow this blog it would sound familiar, i.e. ch. 4 about Angelina Jolie and BRCA genetic tests, a must read. And chapter 5 is a journey on the new omics of the medicine, a topic that I have also covered in the blog.
Nowadays, Eric Topol is the writer that is able to capture what's going on in medicine and its impact on society. That's why this book is a key reference of our time and I strongly recommend it.

PS. If you don't believe me, check Forbes, NYT, WP, WSJ.
PS. The book is also an invitation to change the current academic programmes for life sciences universities. Better now than later.

Less volume, more value

From 2009 to 2013, the number of primary care visits has fallen by 12.5%, from 51.1 million to 44.7 million, 6.4 million visits less. This is a lot!.
Sometime ago I posted on the same topic. The number of professionals has shrunk slightly, 2.5%. The result is that there is more time for the same patients because the population is closely the same. Therefore, we have to confirm that the impact of electronic prescription and other organizational strategies have a larger effect than anybody could guess, compared to the copayment mantra. However, a deeper analysis of the causal factors and its relationship with health outcomes is needed. We know that there is less volume and we have some clues about more value, though not enough for a sound conclusion.

Health policy extremism and radicalisation

Going to Extremes: How Like Minds Unite and Divide

After reading this accurate article by Guillem López-Casasnovas, I thought that it was worth to quote Sunstein book. His key messages are:

• When groups polarize and separate from mainstream society – either psychologically or physically – they can become extremist.
• People change their attitudes when they want a group to accept them.
• People will abdicate moral decisions to a recognized authority.
• Collective behavior, or “groupthink,” provides a means of identifying decision-making processes that lead to extremism and mistakes.
• Information moves and amplifies among groups via “social cascades.”
• Investment clubs making decisions by unanimous votes produce the worst investment returns.
• Group deliberation produces sounder decisions than individuals acting alone.
• Techniques to blunt extremism include traditionalism, consequentialism, and checks and balances.
• Informational cascades can affect markets and mass behavior.
• In a democracy, information, criticism and skepticism combine to improve an institution’s performance.

Take care, we are right now on a social and informational cascade. Have you noticed?

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.