Friday, August 29, 2014

The deprivation of human rights and the health crisis

The  situation in northern Irak is critical. More than 1.4 million displaced people, severe human rights abuses and violation of international humanitarian laws. Those people are in need of water and basic sanitation services. Health services are overwhelmed by this situation.
Maybe this is the largest tragedy of our days, innocent people taken out from home and left without anything.
The answer by developed countries is becoming too late and too little. Have a look at EU press release (20 m € in 2014 while Saudi Arabia 500m $, Lancet says). This is an additional reason why I feel very far from european policies and citizenship.

PS. Must read (please beware of potential conflicts of interest): Updating Cost-Effectiveness — The Curious Resilience of the $50,000-per-QALY Threshold

PS. FT :  " the right to vote stands above the decisions of a political tribunal.”


Thursday, August 28, 2014

The people's support for public health care

If you want to know what may drive you to participate in a demonstration, just ask the people. This is precisely what CEO report has done with this question:
"Tell me, please, if the following could have driven or push you to participate in a protest or claim" and the options were: tax increase, improving democracy ,corruption, defense of public education, defense of public health care, evictions, budget cuts, the right to vote.
And the winner is? The defense of public health care with 91,1%.
Good to know, if you didn't before. A clear message for any politician that cares about well-being of the population.

PS. If you want to know how many citizens consider that fundamental changes in health care are necessary, CIS has published the figure: 33%, the highest in the period 1995-2013 (p.10), those who think that  some changes are necessary: 45% (p.9). Something should be done.
Support for public provision of primary care: 60%, on hospital care: 50%. Closer data on 2013 by CEO-CatSalut have not been published, my last comment is here.




Wednesday, August 27, 2014

Copayments as deterrents

If you want to know if copayments deter drug consumption just ask the people.This is precisely what CEO has done. In their report p.33 they reflect that 85% of citizens have not decreased their consumption, while 13% say yes, and 2 % dont know (?). The posted question maybe is not the best since the word copayments doesn't appear and there is no adjustment over the former copayment regime (retired vs active population). Anyway, we don't know if this 13% of people that say they have reduced it, is for inappropriate medications or appropriate ones. Still looking for the right assessment, this is only the first glance.

PS. How can we measure media power?

Tuesday, August 26, 2014

The uncertainty over genomics sequencing value in clinical decision making

Assessing Genomic Sequencing Information for Health Care Decision Making: Workshop Summary

"The value of genetic sequence information will depend on how it is used in the clinic", key statement that needs some elaboration. This is precisely what the IOM report does, you'll find in their pages the current situation about how genomics may impact in decision making. In chapter 5 you'll understand how an insurer decides about coverage of such tests according to 5 criteria:
1. The test or treatment must have final approval from appropriate governmental regulatory bodies, where required;
2. scientific evidence must permit conclusions about its effect on medical outcomes;
3. technology must improve net health outcomes;
4. the technology must provide as much health benefit as established alternatives; and
5. the improvement in health must be attainable outside investigational settings.
Unfortunately, if you start from the first one, you'll find a complete lack of references by governmental bodies on the approval of such tests. Therefore, I can't understand from the chapter how successful they are on such process.
While reading the book you'll increase your uncertainty about outcomes and value of genomic tests instead of reducing it. This was my impression. Let's wait for future good news, again.

PS. Summary of the report:
"Clinical use of DNA sequencing relies on identifying linkages between diseases and genetic variants or groups of variants. More than 140,000 germline mutations have been submitted to the Human Gene Mutation Database and almost 12,000 single nucleotide polymorphisms have currently been associated with various diseases, including Alzheimer’s and type 2 diabetes, but the majority of associations have not been rigorously confirmed and may play only a minor role in disease. Because of the lack of evidence available for assessing variants, evaluation bodies have made few recommendations for the use of genetic tests in health care."

Monday, August 25, 2014

Consensus in health policy

Some months ago I posted on the same topic. Now you can read my short article in the annual report of the Col.legi de Metges.(text in catalan)



El consens en la política sanitària: el Pacte Nacional de Salut

La política sanitària i els valors socials. La immediatesa i dinamisme del món en que vivim ens porta massa sovint a considerar la política sanitària com el fruit de la decisió puntual, anecdòtica i controvertida del moment. Ens cal una mirada més panoràmica per comprendre que darrera tota política sanitària hi trobarem uns valors socials que li donen fonament. És a dir judicis de valor sobre allò que és bo per a la societat. En ocasions es referiran als objectius o resultats finals i en d’altres als mitjans per assolir-los. Si bé la seva rellevància és determinant per als objectius, en relació als mitjans cal tenir present a més a més la seva efectivitat, i per tant un judici expert sobre allò que de veritat funciona.
L’objectiu final de tota política sanitària descansa sobre la millora de la salut poblacional però va més enllà. L’any 2006 la Unió Europea va considerar que els sistemes de salut són un pilar de la protecció social, de la cohesió i de la justícia social, i assenyala que la universalitat, l’ accés a l’assistència de qualitat, l’ equitat i solidaritat són els valors europeus compartits[i]. En aquest marc i en el seu desenvolupament és on es fonamenta la política sanitària.

El consens en política sanitària. L’adopció de decisions públiques en relació a aquests valors essencials requereix d’un consens polític. Pertoca al parlament i al govern assenyalar què signifiquen exactament aquests valors compartits (objectiu) i quines decisions cal adoptar per assolir-los (mitjans). L’existència d’un consens social sobre aquestes qüestions esdevé una peça clau de l’engranatge. Més enllà de l’acord polític parlamentari, cal que tots els actors que participen en el sistema de salut remin en la mateixa direcció. Precisament un dels elements que es consideren factor d’èxit d’un sistema sanitari és el consens social[ii]. Ens cal doncs una política sanitària basada en el màxim consens possible per tal de tenir un sistema eficient i equitatiu.

La política sanitària basada en l’evidència. Distingir aquells mitjans que poden ser efectius per assolir objectius d’aquells que no ho són, esdevé una prioritat. Disposar d’evidència per tal de contrastar aquelles decisions que produiran el millor resultat és crucial, però alhora complex. La complexitat prové de les singularitats i del context on es desenvolupa cada política. Allò que ha funcionat en un lloc i moment determinat, pot ser difícil de ser reproduït en un altre. Malgrat aquest atenuant, saber allò que funciona amb un criteri expert i objectiu ha d’ajudar a millorar les decisions. Molts informes d’experts sobre reforma sanitària han tractat d’adoptar aquesta perspectiva, si bé amb impacte força limitat. La falta d’aplicació del consell expert té a veure almenys amb les dificultats d’establir consensos amplis i la comprensió del procés polític[iii].

El pacte nacional de salut i els àmbits de consens. La Comissió de Salut del Parlament de Catalunya va acordar el febrer de 2013 impulsar el treballs per assolir un acord per a la salut a Catalunya en el marc d’un model propi. En aquest acord es defineixen les bases del sistema sanitari català, estables i consensuades per tots els agents implicats. Es va precisar que els membres de la comissió serien els representants dels diversos grups parlamentaris i els agents que formen part del Consell Català de la Salut. Els treballs de la comissió es van desenvolupar en vuit grans àmbits temàtics. Es va prendre com a referent els 6 blocs inicials que segons l’Organització Mundial de la Salut han de constituir un sistema sanitari, i s’hi van afegir dos àmbits identificats com a claus pel sistema (la recerca i innovació, i el compromís ciutadà). Els àmbits han estat doncs: finançament i cobertura, professionals, prestacions i catàleg de serveis, model de serveis, avaluació i transparència, recerca i innovació, compromís ciutadà, i governança.
Entrar en el detall del contingut dels 83 acord va més enllà del que es pretén en aquest article, tant sols es farà una breu referència als 2 primers. En l’àmbit de finançament i cobertura s’assenyala amb claredat l’opció per un accés universal de la ciutadania al Sistema Nacional de Salut i alhora s’estableix un criteri de nivell de finançament públic en salut suficient i sostenible, que es relacioni amb el nivell de riquesa del país i que convergeixi amb la despesa de països amb producte interior brut per càpita equivalent i sistema sanitari similar.
En l’àmbit dels professionals s’ha considerat que la planificació de necessitats de professionals, les competències i capacitats acreditades han de ser objecte reconsideració atenent als canvis sociodemògràfics, econòmics i tecnològics. S’explicita l’èmfasi en el professionalisme com a criteri que guia la relació entre professionals amb la ciutadania, amb el sistema sanitari i els proveïdors, i la necessitat d’establir mecanismes per tal de fer efectiva la participació dels professionals en l’elaboració de polítiques i la gestió.

El nivell de consens i els propers passos. El procés per arribar a aquest conjunt d’acords ha estat fruit d’una elevada participació. Diversos motius van impedir que la totalitat dels representants confirmessin el seu acord al darrer moment. Cal assenyalar que en l’elaboració del document hi ha contribucions de tots, també d’entitats i grups polítics que no han pogut donar finalment el seu suport. Cal fer efectiu aquest consens que desitja la ciutadania, les bases perquè això sigui possible hi són, només cal teixir-les acuradament i amb generositat. El Parlament de Catalunya va donar l’opció de mostrar el sistema sanitari que desitgem a una àmplia representació social, ara ja hi ha les bases per a que això pugui transformar-se en realitat.


[i] Council Conclusions on common values and principles in European Union  health systems, OJ 2006 No. C146/1.
[ii] Balabanova D, Mills A, Conteh L, et al. Good Health at Low Cost 25 years on: lessons for the future of health systems strengthening. Lancet 2013;381:2118-2133
[iii] Black, Nick. "Evidence based policy: proceed with care." BMJ: British Medical Journal 323.7307 (2001): 275.

Tuesday, August 19, 2014

Statistical life vs. identifiable life

Do We Really Value Identified Lives More Highly Than Statistical Lives?

The recent Ebola evacuated case exemplifies the concept created by Shelling a long time ago, the difference of how a society allocates resources according to 2 different rules:
In 1968, in a paper about valuing ways to reduce the risk of death, Thomas Schelling1 distinguished between “identified lives” and “statistical lives.” Identified lives are the miners trapped in a mine or the child with a terminal disease—specific people who need help now. Statistical lives are those people, unidentifiable before the fact and often after as well, who will be saved by a new safety regulation, public health program, or environmental standard. Schelling observed that people seem to be willing to pay more to save an identified life: “Let a six-year-old girl with brown hair need thousands of dollars for an operation that will prolong her life until Christmas, and the post office will be swamped with nickels and dimes to save her. But let it be reported that without a sales tax the hospital facilities of Massachusetts will deteriorate and cause a barely perceptible increase in preventable deaths—not many will drop a tear or reach for their checkbooks.
Really such a case goes beyond Shelling insight because of uncertainty and unavailability of effective treatment. Bioethics field has argued over what they called "rule of rescue", a different perspective of the same issue. In this respect, NICE statement helps to understand both views:
When there are limited resources for healthcare, applying the ‘rule of rescue’ may mean that other people will not be able to have the care or treatment they need. NICE recognises that when it is making its decisions it should consider the needs of present and future patients of the NHS who are anonymous and who do not necessarily have people to argue their case on their behalf. NICE considers that the principles provided in this document are appropriate to resolve the tension between the needs of an individual patient and the needs of present and future users of the NHS. The Institute has not therefore adopted an additional ‘rule of rescue.
The article by Louise B. Rusell reflects precisely the theoretical and practical controversy and ends with this paragraph:
Adjustments and controversies aside, the evidence provided by VSL estimates suggests that people’s willingness to pay for statistical lives may be consistent with their willingness to pay for identified lives. The apparent existence of 2 different decision rules may have been no more than an artifact of the economic method for valuing statistical lives in use at the time the distinction was proposed. Now that economists’ methods more fully reflect “the interests, preferences and attitudes to risk of those who are likely to be affected by the decisions,” their estimates of the value of a statistical life support the idea that there just may be a single rule: Identified and unidentified lives may be equally valuable. This is good news for decision makers who use cost-benefit and cost-effectiveness analysis to inform decisions.
The theoretical suggestion sounds good, nowadays the political decision making reality goes in the opposite way, at least close.

PS. A must read post on GCS blog about the same topic.

PS. Ebolanomics, the economics of ebola at the New Yorker. Nothing new, prizes instead of patents to promote R&D, a good idea with difficult implementation.

PS. How much would you pay for a quality adjusted life year?



Monday, August 18, 2014

Inconvenient reasons

International statistics provide useful information on trends and allow to compare between countries. This is only true if all countries do their homework. In the last edition of  OECD health data, Australia, Japan, New Zealand, Spain and Turkey have "forgotten" to send 2012 expenditure  data. Maybe there are some inconvenient reasons behind that. Anyway, somebody should ask in Parliament about the delay and why they are not delivering the statistics..
Beyond that, I suggest a look at internal 2012 data, coming from Ministry. You'll find that there are some countries with 9.4% public health expenditure over GDP, while others like Catalonia spend 4.9%. Again, somebody should ask in Parliament if there is anybody in charge of the situation. I stop here to avoid any misinterpretation. Disconnecting is the right option, goodbye.

PS. By the way, today you can find in ARA a flawed op-ed. Check the current and right figures and the argument vanishes.



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Sunday, August 17, 2014

Health as a shared responsibility

During our lifetime we are exposed to risks, some of them are preventable while others not.
Prevention is a shared responsibility, individuals and society may affect the course of such potential health events. Today, while reading in the press about Ebola controls in the flight Conakry-Casablanca-Madrid I was really concerned about how governments are dealing with such an outbreak. If this is true and only three controls were really made, somebody should request explanations in Parliament. Individual opportunism may avoid to declare "yes" when they were asked if they felt bad.
Sounds naive. A responsible individual should say yes if he really feels bad, but he may also ask himself about cost and benefit of such answer...
On September 24th we are helding a roundtable on such issues: "Individual and collective responsibility on health". It may be of interest for the readers of this blog. If you finally come we may meet at the end of the session, Minorca deserves a yearly visit at least.

PS. Full programme, here

Thursday, August 14, 2014

Enough is enough

If there is a grey area in medical devices and services regulation, this is the Laboratory Developed Tests one. Up to now, FDA has refused to define the rules of the game for 11,000 diagnostic tests performed at 2,000 labs in USA. This means that no official or external reviewer has analysed the clinical validity and clinical utility as it is done in any reagent and instrument. I can't understand why we have arrived at such a situation.
Fortunately NYT reports that on July 31st, FDA announced that this will change.
The agency said on Thursday that such discretion must end because circumstances had changed. Lab-developed tests once were fairly simple, often developed by a hospital for tests on its own patients. Now the tests can be complex and are being developed by  companies and marketed widely.
Some widely used commercial tests have never had to be reviewed by the agency. These include Myriad Genetics’ breast cancer risk test, the subject of a Supreme Court patent decision last year; the Oncotype DX test from Genomic Health, which is used to determine if women with early-stage breast cancer need chemotherapy; and noninvasive prenatal tests for Down syndrome that are rapidly catching on.
In this blog I have supported several times for a clear regulation of these tests . Just the other day when looking at the statements of FDA commissioner, I was astonished:
Just as drugs need to be safe and effective for treating diseases, medical devices used to help diagnose disease and direct therapy also need to be safe and effective, Faulty test results could lead patients to seek unnecessary treatment or to delay or to forgo treatment altogether.
These statement raise more concerns about what US regulator has done after all these years. And european regulation is still worse in this sense. I have explained such disaster previously and up to now there is no news. Some times I wonder why do we pay taxes, why do we have to be part of Europe. Enough is enough.