When asking your physician is not enough

23andMe and the FDA

Some weeks ago I explained the FDA "closure" of DTC genetic testing business. NEJM analyses with detail the rationale behind such policy:

The goal of the FDA and 23andMe (as well as all clinical geneticists, testing laboratories, and the entire genetics industry) should be to ensure that genomic information is both accurate and clinically useful. Clinicians will be central to helping consumer–patients use genomic information to make health decisions. Any regulatory regime must recognize this reality by doing more than simply adding the tagline on most consumer ads for prescription drugs: “Ask your physician.” That is insufficient guidance unless your physician has ready access to a clinical geneticist or genetic counselor.

European regulation is 15 years old and the new directive is still being discussed. It will not be applied for at least 3 years. Meanwhile, do you know who is protecting us from inaccurate and clinically useless information?

Let's get fit, not fat

Aportaciones de la economía del comportamiento en política sanitaria: Algunas notas en torno al ejemplo de la obesidad
 The influence of obesity and overweight on medical costs: a panel data perspective

In the EJHE you'll find  a clear message:

The results indicate that obesity is associated with substantial healthcare cost increases and there are large differences in costs by degree of obesity. Specifically, severe obesity raises total direct medical costs by an average of 160 € per patient and year. With total medical costs averaging 600 € for normal-weight individuals, this means that severe obesity is associated with an increase in costs of 26 %. The effect of moderate obesity is more modest: it raises medical costs by 97 € or 16 %. Overweight has an even smaller impact, raising costs by 51 € or 8.5 %.

Therefore, if obesity has an economic and health impact, what next?
The EEA article by A. Garcia-Altés reflects current knowledge on behavioral economics and obesity. However there is a long way to go. As I said in a former post we do need a battery of measures to fight obesity: regulatory, social and individual measures.

Our irrational behaviour

The Behavioral Economics of Health and Health Care
Irrationality in Health Care: What Behavioral Economics Reveals About What We Do and Why

Thomas Rice provides an overview of behavioral economics in health in a recent article in Annual review of public health. More or less the same things we already know with some concrete messages. A good starting point for those that want to take first steps in this discipline. The summary:

People often make decisions in health care that are not in their best interest, ranging from failing to enroll in health insurance to which they are entitled, to engaging in extremely harmful behaviors. Traditional economic theory provides a limited tool kit for improving behavior because it assumes that people make decisions in a rational way, have the mental capacity to deal with huge amounts of information and choice, and have tastes endemic to them and not open to manipulation. Melding economics with psychology, behavioral economics acknowledges that people often do not act rationally in the economic sense. It therefore offers a potentially richer set of tools than provided by traditional economic theory to understand and influence behaviors

Right now behavioral economics is still a promise, let's wait until we can really apply it widely.
Thomas Rice says in this respect:

 With the exception of Kahneman & Tversky’s prospect theory, which was developed more than 30 years ago, there has been little in the way of bringing the various tools and policies of behavioral economics under one umbrella. As a result, most of the applications seem to be ad hoc. More development of an overarching theory could aid those interested in designing new interventions when it is clear that traditional economics remedies are insufficient

Regarding the book on Irrationality in Health Care, I haven't had the opportunity to have a look at it. I leave here the reference and 23 anomalies . Maybe in the book there is the answer to solve them.

PS. For those interested in an introductory course, on March 11th starts at Coursera:  A Beginner's Guide to Irrational Behavior

Hostis populi

A plot written by Ibsen in 1882 could reflect current conflicts nowadays. Whats first: Your money or your health?. I went to the theatre last week. Great "mise en escène".
The summary:

Doctor Thomas Stockmann is a popular citizen of a small coastal town in Norway. The town has invested a large amount of public and private money towards the development of baths, a project led by Stockmann and his brother, Peter, the Mayor. The town is expecting a surge in tourism and prosperity from the new baths, which are said to be of great medicinal value, and as such, a source of great local pride. Just as the baths are proving successful, Stockmann discovers that waste products from the town's tannery are contaminating the waters, causing serious illness amongst the tourists. He expects this important discovery to be his greatest achievement, and promptly sends a detailed report to the Mayor, which includes a proposed solution which would come at a considerable cost to the town.
To his surprise, Stockmann finds it difficult to get through to the authorities. They seem unable to appreciate the seriousness of the issue and unwilling to publicly acknowledge and address the problem because it could mean financial ruin for the town. As the conflict develops, the Mayor warns his brother that he should "acquiesce in subordinating himself to the community." Stockmann refuses to accept this, and holds a town meeting at Captain Horster's house in order to persuade people that the baths must be closed.
The townspeople — eagerly anticipating the prosperity that the baths will bring — refuse to accept Stockmann's claims, and his friends and allies, who had explicitly given support for his campaign, turn against him en masse. He is taunted and denounced as a lunatic, an "Enemy of the People." In a scathing rebuttal of both the Victorian notion of community and the principles of democracy, Stockmann proclaims that, in matters of right and wrong, the individual is superior to the multitude, which is easily led by self-advancing demagogues. Stockmann sums up Ibsen's denunciation of the masses with the memorable quote "...the strongest man in the world is the man who stands most alone." He also says: "A minority may be right; a majority is always wrong.

 I deeply disagree with this final generalization. The details are important.

Our health and its determinants

Source: UW.

The quality cure into action

The next David Cutler book: "The Quality Cure. How Focusing on Health Care Quality Can Save Your Life and Lower Spending Too" will appear in April. Meanwhile we can read some pages from Google Books. He sets "quality" at the top of the agenda and he explains that Obamacare is trying to solve access. Focusing on quality means effort on greater value, avoiding waste, and therefore cost containment. At the begining it may seem an already heard message, however I agree with him that the quality chasm must be addressed, as well in our country. The book is a must read beyond US borders for any person involved in health care as it is his former book "Your money or your life" . The first statements from the preface:

For decades, health care was like the weather-everybody talked about it, but nobody did anything about it. Talk was easy, politicians and analysts of all stripe agreed that we wanted a health care system focused on preventing disease and treating it appropriately when necessary. In the past half decade, talk has turned into action.

Let's apply his final words,  it's time to turn talk into action.

PS. A former post on this blog about David Cutler.

PS. On conflicts of interest in medicine. The paper on "The burden of disclosure" by Loewenstein et al. And the comment by Alex Fradera.

The hole for genetic testing market entry

Technology Assessment on Genetic Testing or Molecular Pathology Testing of Cancers with Unknown Primary Site to Determine Origin
Update on Emerging Genetic Tests Currently Available for Clinical Use in Common Cancers

AHRQ has just published two reports of interest. The first is devoted  to assess the evidence on the analytical validity, clinical validity, and clinical utility of commercially available genetic tests for identifying the tissue of origin (TOO) of the cancer in patients with cancer of unknown primary (CUP) site. The second describes genetic tests that have applications in the common solid tumors (breast, lung, colorectal, pancreas, etc.) as well as tests that are used in hematologic cancers (leukemia, lymphoma) and are already available in clinical practice.While the first is an assessment, the second is informative.
There is still a third report to be released and meanwhile NRD explains its conclusions. Having selected 11 prognostic tests, only around half had evidence supporting their prognostic accuracy or clinical validity. Therefore the question is always the same: why these tests without evidence are on the market? Why have they been approved by the FDA?. There is a big regulatory hole to fill in.

Conflicts of interest (in medicine)

I would like to attend this seminar:

Professor George Lowenstein
Behavioural Economics and Conflicts of Interest

“A conflict of interest is a clash between an individual’s professional responsibilities and their personal, typically financial, interests. Traditional economics has not shed much light on conflicts of interest, perhaps in part because it has not recognized the importance of professionalism as a motive in human behaviour. In this talk I will present results from a variety of studies that examine the behavioural economics of conflict of interest. Focusing mainly on conflicts of interest in medicine, some of the research shows how people who care deeply about behaving in a professional fashion can be corrupted by economic incentives. Other research shows how disclosing conflicts of interest, far from helping the recipient of information, can backfire, helping the advice-giver and hurting the advice recipient.”

Lecture Theatre 3, Cambridge Judge Business School. Tuesday 25th February 5-6.30pm. No need to register but arrive early in order to get a seat.

Unfortunately, I can't attend. Any info will be appreciated.
You may follow events on Behavioral Economics, here.

PS. Our public expenditure on health on 2012 gave ground, and was close to 5 years before: 2007. Such expenditure over GDP is still at 2008 position: 5,3% , while our GDP per capita (27.442€) is  at levels before 2006 (!). Therefore we are spending on health (more than) proportionally to our GDP historical trend, however our GDP has shrinked a lot. And we maintain distance to OECD average health expenditure (6,69%) although our per capita GDP is 2,7% larger. That's all right now, it's an issue of months.

PS. Interesting post by Josep Maria Via.

The market size of stratified medicine

Defining and quantifying the use of personalized medicines

There is a lot of noise around the message that the personalised-stratified medicine era has arrived. If you split the clamour from the message, the result is close to 34 medicines at the end of 2012, and in market volume accounted for 3% of the global market by the end of 2009. You'll find this details at NRD and this is the key comment:

First, in terms of characteristics, oncology agents dominate personalized medicine utilization, and disproportionately address unmet medical needs as revealed by priority, accelerated, and orphan disease FDA designations. Second, older drugs that have become personalized medicines post-launch have had a significant impact on the growth of small-molecule personalized medicines; however, the translation from label to clinical practice remains uncertain. Third, per capita usage of personalized medicines in the EU5 markets is greater than in the United States, with usage rates in Japan and the rest of the world growing rapidly

 Affair in Cascais

Club des Belugas- the Chin Chin Sessions

Everything is connected

Pla Interdepartamental de Salut Pública

We all know that improving population health is a task that exceeds the healthcare system. The political debate is too focused on healthcare rather than other determinants to improve health. However, today is a different day. A new plan to introduce health in all policies has been approved and this means a change in the agenda. We'll see how this will be managed, since it is a new approach.
Have a look at the document. The authors have been working hard for months on it. Such policy follows EU criteria and represents an innovation in the current health policy landscape. Let's see how effective it is.

Capitalism and morality

Market Reasoning as Moral Reasoning: Why Economists Should Re-engage with Political Philosophy

I found this article. Have a look at the abstract:

In my book What Money Can't Buy: The Moral Limits of Markets (2012), I try to show that market values and market reasoning increasingly reach into spheres of life previously governed by nonmarket norms. I argue that this tendency is troubling; putting a price on every human activity erodes certain moral and civic goods worth caring about. We therefore need a public debate about where markets serve the public good and where they don't belong. In this article, I would like to develop a related theme: When it comes to deciding whether these or those goods should be allocated by the market or by nonmarket principles, economics is a poor guide. Deciding which social practices should be governed by market mechanisms requires a form of economic reasoning that is bound up with moral reasoning. But mainstream economic thinking currently asserts its independence from the contested terrain of moral and political philosophy. If economics is to help us decide where markets serve the public good and where they don't belong, it should relinquish the claim to be a value-neutral science and reconnect with its origins in moral and political philosophy.

There are health economics implications, with a little effort you can find them.

Effectiveness, first things first

Homeopathy in Healthcare – Effectiveness, Appropriateness,Safety, CostsAn HTA report on homeopathy as part of the Swiss Complementary Medicine Evaluation Programme

Swiss government requested a report on homeopathy through the Complementary Medicine Evaluation Program, just to understand its cost-effectiveness. You'll find the complete story in this blog.
The key table is here.Such report and this table created controversy due to conflicts of interest of their authors.
Finally the government decided not to include homeopathy in the reimbursed benefit basket.
Is there any reason to regulate when the effectiveness has not been demonstrated?. This is my question today to a regulator that it seems busy on this issue. My answer is clear, it is unnecessary. He has to inform the citizens and incriminate providers in case of false advertising.

PS. I already said this before, here and here .

Competing on biosimilars

One year ago McKinsey released a report on biosimilars. They explained what happened in Europe after 2005 regulation. Now NRD has published an interesting article by Henry Grabowsky et al. that shows wide differences within Europe. In Germany, 42% of the market of Epoetin is biosimilar, while UK remains at 7,9% (!). The article explains the reasons behind such variation. If we have to summarise in one cause, this would be: incentive regulation. And since prices are 25% less than original products, such difference has high opportunity costs for UK citizens (however the price levels in Germany is higher than the UK).
In their words:

One major finding is that the competitive performance of the biosimilars we analysed in Europe is mixed both across countries and products. Although the European Union has a common regulatory system for approving biosimilars, differences in reimbursement practices and incentives as well as variations in medical practices have resulted in  different outcomes across countries.

Does anybody know what's happening here?

PS. IMS presentation.

What is the rule of law?

If we look around us these days we can detect that these conditions have mostly vanished in many public environments:

1. The government and its officials and agents as well as individuals and private entities are accountable under the law.
2. The laws are clear, publicized, stable and just, are applied evenly, and protect fundamental rights, including the security of persons and property.
3. The process by which the laws are enacted, administered and enforced is accessible, fair and efficient.
4. Justice is delivered timely by competent, ethical, and independent representatives and neutrals who are of sufficient number, have adequate resources, and reflect the makeup of the communities they serve.

 How can health policy be implemented in a setting that doesn't conform to such criteria?. Day by day, I'm more convinced that the problem is beyond any policy. Have a look at decree 16/2012, p. 31292, one criteria for public funding of drugs is:

- Social and therapeutic value of the drug and incremental clinical benefit, taking into account its cost-effectiveness relationship

New drugs are being accepted every month, and since June 2012 the Health Ministry hasn't updated the website. Nobody knows its cost-effectiveness. Some weeks ago a transparency law was approved. It's a joke. 
There is one and only option: disconnect asap and forget this nightmare.

PS. I said something similar one year and a half ago. 

PS. Is there any price-cap on publicly funded drugs? In France, the recommendation is to limit any new drug to 50.000€. You'll find it here p.15.  Let's see what really happens here. In UK, confidential discounts apply. Welcome to the transparent world!. Have a look at my previous post on the same topic and the table.

PS. Lewis Mumford dixit:
"For most Americans, progress means accepting what is new because it is new, and discarding what is old because it is old. This may be good for a rapid turnover in business, but it is bad for continuity and stability in life. Progress, in an organic sense, should be cumulative, and though a certain amount of rubbish-clearing is always necessary, we lose part of the gain offered by a new invention if we automatically discard all the still valuable inventions that preceded it.”