Disposable income trends

From: EU Statistics and book.

Healthy longevity

Health at a Glance 2015

Every year OECD updates health database. The latest one was released yesterday. Japan, Spain and Switzerland are at the top of life expectancy at birth with 83 years. However,  in healthy life expectancy at 65,Switzerland is in the 9th position, and Spain in the 13th. Why is this so?. The priority on quality of life should increase.

Physicians' quality: incentives and information

In the USA, the Affordable Care Act requires the federal government to post information about physician performance and quality of care on a public website. The recent experience of public and private initiatives has been reviewed in a Health Affairs Brief. If you want to know the implications and details on how to make information accessible for citizens, this is a key document to read.

• By 2019 doctors who treat Medicare beneficiaries must choose between two options—enroll in a program called the merit-based incentive payment system or sign up to be part of an alternative payment model.
• The merit-based incentive payment system will adapt and combine multiple programs —PQRS, the EHR meaningful-use program, and the value-based payment modifier initiative—into one.
• Doctors opting for the merit-based incentive payment system must report quality-of-care measures to CMS. How is to be determined, but CMS likely will use an upgraded PQRS reporting system.
• Physicians will be scored on four components of care: quality (30 percent); resource
use (30 percent); meaningful use of EHRs (25 percent); and practice improvement  activities (15 percent).
• Physicians choosing the alternative payment model path would have to be part of an integrated health system, join an ACO.

Sounds interesting. Incentives and information altogether, a hint for other health insurance markets on what to do about it.

Owners and managers in state owned firms

Governance issues are at the center of current debates in public and private firms. Unfortunately, too often as a cosmetic perspective. The roots of the problem are left for another day. Let me give an example. Recently, a hospital selected its CEO by a unique procedure: asking the physicians about the right candidate (at least this is what has been published in the press).
Selecting the right leadership for a firm is the most relevant issue for any board of directors. However, in this case, they will have only one candidate coming from a proposal of professional employees of the firm. The board will confirm their option, for sure, otherwise it will boost a huge crisis.
The worst approach to selecting leadership is to confound participation with governance. In state owned firms, the governance belongs to elected politicians (of course they delegate to appropriate professionals selected for the board). The ownership is public, and citizens are represented through politicians. That's it.
In this unique case, politicians or their delegates have been supplanted by professional employees. This is a biased way to understand governance functions in state owned firms, and somebody should review it in depth before this approach is converted into a trend for other hospitals. Here you'll find the roadmap.

The Theranos contretemps as a serious scandal

Last Thursday WSJ released a long article on Theranos clinical lab. In this blog you may check my February and July posts on this firm under the title: A closely guarded secret. As you may imagine, such a title was not coincidental. There were some clues that justified it, something unusual was happening. And WSJ has contributed to shed light on the issue. All the details in it. Basically, the summary is that analytic validity and clinical validity is under compromise. This is an exemple:



If you want to read a first person account, you'll find it here and here. Some additional articles: Wired, New Yorker, Clinical Chemistry and Laboratory Medicine (CCLM), Forbes, NYT, WP,...
This is not only a contretemps, it is a serious scandal and a huge problem to credibility for this start-up.
From Wired:

Theranos got a lot of traction by tapping into the frustration—both from consumers and the medical community—that diagnostic testing is too painful, too slow, and too expensive. “Their problem is they tried to do it with existing diagnostic instrumentation, instead of innovating new diagnostic instrumentation,”

Theranos is a black box that has touted results rather than process. “The ability of the lab medicine community to police and correct itself depends on that flow of information,” says Master. Instead, Theranos’ research was internal, and rather than submit their work to peer review the company cited their FDA approvals as evidence that the technology worked.

At least in the USA there is a regulator, the FDA, lab regulation in Europe was enacted in 1998, completely outdated under a third party scheme, not a direct public regulator. Therefore, there is a pressing motive to speed up new and different rules in Europe. Microfluidics and nanotechnologies are calling for and urgent overhaul.


 PS. An statement from WSJ:

In 2005, Ms. Holmes hired Ian Gibbons, a British biochemist who had researched systems to handle and process tiny quantities of fluids. His collaboration with other Theranos scientists produced 23 patents, according to records filed with the U.S. Patent and Trademark Office. Ms. Holmes is listed as a co-inventor on 19 of the patents.

The patents show how Ms. Holmes’s original idea morphed into the company’s business model. But progress was slow. Dr. Gibbons “told me nothing was working,” says his widow, Rochelle. In May 2013, Dr. Gibbons committed suicide. Theranos’s Ms. King says the scientist “was frequently absent from work in the last years of his life, due to health and other problems.” Theranos disputes the claim that its technology was failing.

Precision medicine in an outdated regulation

Specially dedicated to european politicians, this was my op-ed in Diario Médico last week:

La medicina de precisión en una regulación obsoleta

El retraso regulatorio europeo en pruebas diagnósticas y suministros médicos es descomunal

El avance tecnológico coge por sorpresa a gobiernos y parlamentos. El retraso en actualizar la regulación a las nuevas realidades frena a su vez la difusión de las innovaciones e introduce incertidumbres sobre la eficacia y seguridad. Desde hace más de una década sabemos que el impacto en la asistencia sanitaria de los avances en el genoma humano tendría lugar algún día inexorablemente. Sin embargo,a fecha de hoy, estamos a la espera de su regulación.
En 2005 un periódico anunció que llegaba la medicina personalizada pero muy pronto nos dimos cuenta que todo era más complicado de lo que algunos proclamaban. En 2011, Science decía en portada: “Lo mejor está por venir”. A la secuenciación del genoma humano le faltaba todavía mucho trayecto para que se concretara en impacto en la salud poblacional. Y en el mismo año se publicó el informe del National Research Council estadounidense: “Toward Precision Medicine”. En él se mostraba el impacto del conocimiento biomédico en la clasificación de la enfermedad, describía el reto de la redefinición de la enfermedad a partir de la biología molecular, a la vez que popularizaba el nuevo término: Medicina de Precisión.
En marzo de 2012, Cell publica un artículo crucial donde se relata la aparición molecular de una enfermedad. Un profesor de Stanford relata la evolución de su perfil ómico personal, analiza qué ocurre durante dos años, cómo surge la enfermedad y cuál es la reacción molecular del cuerpo. Explica cómo descubre el riesgo de diabetes y cuando se confirma, qué hace a partir de aquel momento.
Del titular del periódico de hace una década nos acercamos, ahora sí, a la medicina de precisión, intensiva en datos. Las inversiones públicas en iniciativas de investigación son tan solo una parte del todo. Lo que llamábamos “medicina estratificada”, la que une pruebas diagnósticas complementarias (companion diagnostics) para determinar el tratamiento farmacológico, ya está entre nosotros. Ahora es un ejemplo más de medicina de precisión. Y resulta que a fecha de hoy, en Europa tenemos una regulación vigente de 1998 (!). Desde 2012 circula un borrador para actualizar la directiva sin éxito. Recientemente, el pasado 23 de septiembre, ha surgido un nuevo borrador que la Comisión quiere elevar al Parlamento para su aprobación. Veremos qué sucede en esta ocasión.
El texto considera las pruebas diagnósticas complementarias esenciales para definir aquellos pacientes que son candidatos a un tratamiento específico con un medicamento, a través de la determinación cuantitativa o cualitativa de marcadores específicos que identifican los sujetos con mayor riesgo de desarrollar reacción adversa al medicamento o la identificación de los pacientes en la población para los que el producto terapéutico se ha estudiado de manera adecuada, y es seguro y efectivo. La forma como se evalúa la seguridad y eficacia queda al margen de los procesos equivalentes en los medicamentos y se mantienen las entidades certificadoras, si bien con cierto control adicional. Y la pregunta es la de siempre: ‘Quis custodiet ipsos custodes?’, ¿quien vigila al vigilante?. Este “cierto” control gubernamental será suficiente? O quizás cada estado lo resolverá a su propio estilo?.
El sistema europeo basado en la autoregulación, en entidades certificadoras privadas, queda lejos del sistema norteamericano donde las pruebas diagnósticas complementarias se regulan públicamente por la FDA. De esta forma, un medicamento que requiere una prueba diagnóstica queda regulado en Europa en dos ámbitos distintos, con requisitos de evaluación desiguales. En definitiva, estamos a las puertas de una regulación que es incapaz de tener en consideración que la validez y utilidad clínica en la medicina de precisión debe ser objeto de regulación pública directa.
El retraso regulatorio europeo en pruebas diagnósticas y suministros médicos es descomunal. A fecha de hoy se sigue un proceso para acceder al mercado que requeriría una revisión profunda de su impacto en términos de validez y utilidad clínica. La credibilidad de la evaluación se confirma siempre que existan criterios objetivos, fiables y homogéneos. Los mecanismos actuales de certificación son insuficientes para los objetivos que se esperan de una regulación avanzada. Del mismo modo que el escándalo de los implantes mamarios PIP recordaron la falta de garantía y control en suministros médicos, las pruebas diagnósticas requieren una regulación fiable que garantice seguridad y calidad, al mismo tiempo que aporte información sobre su efectividad. No hay opción para más demora. La nueva propuesta de regulación de pruebas diagnósticas necesita una mejora inmediata o, de otro modo, se convertirá en obsoleta a corto plazo.

 

Mapfre Foundation. Barcelona exhibition.

Disentangling ageing and health

World report on Ageing and Health

Although it may surprise, there is no clear pattern to indicate that elderly people  always utilise more health services. When one looks at the aggregated indicators, one may reach this conclusion, however taking into account the realities and individual characteristics, there are many remaining factors to explain the situation. This fact is evidenced by the last WHO report on aging and health. (P.90).
Even considering the increased morbidity at older ages, the burden of chronic diseases is diverse in terms of cost. Thus, few users and its distribution in the phase prior to death, it is the main cause of the high cost of chronic disease. Proximity to death and corresponding therapeutic effort confound the ageing factor in increasing health costs.
Furthermore, it has been shown that the compression of morbidity continues to advance. That is, the occurrence of chronic diseases is delayed gradually, the phenomenon of "survival of the fittest" is confirmed. The impact or impairment of chronic disease in human physiology for the very old is attenuated .
It is for these reasons that the report is worth, a new look to a reality that is already upon us and we need to give appropriate response.