France pledges reform after diabetes drug scandal

French Health Minister Xavier Bertrand has promised a complete revamp of the country's medical regulatory system.
He was speaking after an official report said a diabetes drug which caused up to 2,000 deaths should have been banned 10 years earlier.
The drug - known as Mediator - should have been banned as early as 1999, when it began to emerge that it could cause heart disease, the report said.
Several other European countries and the US then withdrew it.'Political connections'
But Mediator remained on sale in France for another 10 years.
Between 500 and 2,000 people in France are believed to have died because of its side effects.
It was developed to treat diabetics but millions of people took it simply to lose weight.
The report by a government agency, the Social Affairs Inspectorate, said it was incomprehensible that the authorities had failed to act sooner.
Mr Bertrand said it was now his duty to rebuild the regulatory system to protect the public.
His statement is being seen as an admission that one of the biggest medical scandals in France in recent years may not be an isolated case.
The affair has become politicised as the pharmaceutical company which manufactured the drug, Servier, reportedly had high-level political connections.
The health minister himself has been implicated by French media reports alleging that two of his advisors had previously worked for the company.

**published in "BBC News Health"

NHS Confederation says health reform 'could shut hospitals' The Department of Health said modernisation was 'a necessity, not an option'.

Hospitals may have to close under reforms to the NHS in England, a report from the NHS Confederation suggests.
The findings, reported in the Observer, criticise ministers for not explaining the need for the reforms, describing some of the process as "extraordinarily risky."
The confederation represents bodies such as foundation hospitals, primary care trusts and doctors' groups.
The Department of Health said the reforms would improve the NHS.
Under the changes, contained in a bill to be published this week, GPs will be given more responsibility for spending much of the budget, hospitals are to be set free from central control and an independent board will oversee services. 'Demotivating' attacks
While the NHS Confederation accepts that reform of health service structures in England is necessary, it appears to be unhappy with the way ministers are going about it, the Observer reports.
The confederation said the government was indulging in "unpleasant" and "demotivating" attacks on managers whom it was purging, while still asking them to drive the reforms through.
It also said that allowing GPs to commission services from what is called "any willing provider", could mean the closure of some hospitals and facilities in order to make way for new private providers.
The Department of Health said that modernisation was "a necessity, not an option", and the Health and Social Care Bill would "increase autonomy and accountability at every level in the NHS." 'Demolition job'
Shadow health secretary John Healey described the report as a "comprehensive demolition job," amounting to a big red light ahead of the legislation.
A Department of Health spokesperson said while the NHS budget had been protected by the government, "it must still simplify its structure and cut bureaucracy, which will release further savings to invest in care for patients".
According to The Observer, the NHS Confederation report will also raise concerns over the new system under which consortia of GPs will be able to send patients to whichever provider they judge will offer the best treatment, warning that this will force the NHS to shrink in order to make space for new healthcare providers.
The policy of "price competition", allowing hospitals to undercut one another to attract patients, poses a risk to standards of care, the report is expected to warn.

**Published in "BBC News Health"

Antipsychotic drug prescriptions triple in the US

PRESCRIPTIONS for antipsychotic drugs have more than doubled in the US over the past 15 years, often given for conditions for which there is scant evidence they work.
Antipsychotic drugs are often given for conditions for which there is scant evidence they work
Expensive antipsychotics were originally approved to treat schizophrenia. They are now also prescribed for conditions including anxiety disorders and dementia, even though the Food and Drug Administration has not approved these off-label uses. The side effects of such drugs can include diabetes, weight gain and an increased risk of heart disease.
Caleb Alexander at the University of Chicago and colleagues analysed the results of a survey of visits to doctors between 1995 and 2008. In the sample population, the prescriptions of antipsychotics went from 6.2 million in 1995 to 16.7 million in 2006 and fell to 14.3 million in 2008. Off-label prescriptions also doubled during this time (Pharmacoepidemiology and Drug Safety, DOI: 10.1002/pds.2082).
Alexander points to ways to combat the trend, such as reducing heavy drug marketing and raising awareness of off-label prescribing.

**Published in "New Scientist"

Puritan Medical Products presenta la nueva tecnología de hisopo pendiente de patente

Puritan Medical Products Company, el fabricante líder de aplicadores e hisopos médicos/de diagnóstico de filtro especializados en Norteamérica, ha anunciado la introducción de una nueva línea de productos de borra de alto rendimiento. Los nuevos hisopos HydraFlock(TM) y UltraFlock(TM) ofrecen capacidades de absorción superior combinadas con un rendimiento de liberación extremadamente rápido.
Ambos productos están pendientes de patente en Europa, donde se han publicado las aplicaciones de ambos - consulte la solicitud #: EP 2 263 548 A2 & EP 2 263 549 A2. Las solicitudes de patentes también se han presentado en China, Japón, Canadá, Australia y Estados Unidos.
El desarrollo de estos productos es un resultado directo del actual esfuerzo de Puritan para cubrir las necesidades en evolución del mercado del diagnóstico, que ha llevado a una rápida expansión de la compañía en los dos últimos años.
"Hemos tenido que evolucionar y diversificarnos", dijo Timothy Templet, vicepresidente ejecutivo de ventas. "Las pruebas de diagnóstico en humanos es un mercado de rápido cambio y estamos adquiriendo el compromiso de estar al frente de este mercado".
El proceso patentado único de Puritan permite una combinación de creación de fibra sofisticada y aplicaciones innovadoras, produciendo un dispositivo de recogida de muestras con una métrica de rendimiento extremadamente alta. Esto se logra sin la incorporación de tratamientos de fibras, lo que produce un dispositivo de recogida de muestras totalmente libre de sustancias de interferencia que pueden afectar negativamente a la integridad del hisopo.

Eisai opens for business in the Netherlands

Eisai Europe Limited, a subsidiary of Eisai Co., Ltd announces the establishment of its sales and marketing operation in its wholly owned subsidiary in the Netherlands based in Amsterdam. The first Eisai product on the Dutch market is the epilepsy treatment Zonegran (zonisamide).

Commenting on the opening of the new subsidiary, Eisai Netherlands Managing Director, Mr Gert-Jan Kouseband said: "Eisai's entry into the Netherlands is aligned with the company's wider strategy of establishing a solid foundation in Europe. We currently have one product on the market and hope to have five products available in the coming months, boosting our presence in the market. This will allow Dutch patients access to treatments not previously available to them and further supports Eisai's human health care (hhc) mission to satisfy unmet medical needs and contribute to the health and well being of people worldwide."

The Dutch company's initial area of focus is epilepsy and a dedicated Eisai team has already been established. Zonegran, an adjunctive treatment for adult patients with partial seizures, with or without secondary generalisation, is now available. It is estimated that 100,000 Dutch people suffer from epilepsy[1] and the availability of Zonegran in the Netherlands will provide an additional treatment option to help manage their condition. Epilepsy is a key strategic area for Eisai in Europe and the company is committed to developing and delivering highly beneficial new treatments to help improve the lives of people with epilepsy.

Eisai's commitment to establish a strong European presence is further seen by a GBP100m investment in the state-of-the art European headquartered in Hatfield, UK, which opened in 2009. The European Knowledge Centre acts as the hub for all of Eisai's European operations.

Los antibióticos son el tratamiento de elección para la otitis infantil

Los antibióticos son los más eficaces para aliviar las infecciones del oído medio, u otitis aguda media, en niños pequeños, según un estudio del Centro Médico de la Universidad de Pittsburgh en Estados Unidos que se publica en la revista New England Journal of Medicine. En muchos países europeos y en Estados Unidos, se sigue una estrategia de espera con vigilancia en casi todos los casos de otitis infantiles. Los autores del trabajo actual señalan que los ensayos previos que comparan las dos estrategias plantean resultados conflictivos, dadas las diferencias entre los ensayos en la definición de infecciones del oído medio.

En su estudio, los investigadores asignaron de forma aleatoria a 291 niños de entre 6 y 23 meses de edad con infecciones agudas del oído medio y diagnosticados mediante criterios estrictos a recibir amoxicilina-clavulánico o un placebo durante 10 días. Descubrieron que los niños del grupo de tratamiento tenían una reducción significativa tanto en la gravedad y duración de sus síntomas en comparación con los del grupo placebo. Los autores advierten que estos resultados deberían ser sopesados en relación con los efectos secundarios de los antibióticos y la posible aparición de resistencia.

La vacunación reduce en más de la mitad el riesgo de herpes en mayores

El estudio mostró que la vacunación entre un grupo de mayores se asoció con un una reducción de hasta el 55 por ciento del riesgo de padecerlo, con independencia de la edad, la raza o la presencia de enfermedades crónicas, según un estudio de la institución Kaiser Permanente de California del Sur en Pasadena (Estados Unidos) que se publica en la revista Journal of the American Medical Association (JAMA). Los investigadores, dirigidos por Hung Fu Tseng, evaluaron el riesgo de herpes zoster después de la vacunación en centros de medicina general. En el estudio participaron mayores de 60 años, un total de 75.761 en el grupo de vacunación y 227.283 en el de no vacunados.

Los individuos vacunados tendían a ser mujeres blancas con menor prevalencia de enfermedades crónicas y que acudían a más visitas médicas. Se identificaron 5.434 casos de herpes zoster durante el estudio, 6,4 casos por 1.000 personas entre los vacunados y 13 casos por 1.000 personas entre los no vacunados. La vacunación se asoció con un menor riesgo de herpes zoster que no varió por edad, sexo, raza o presencia de enfermedades crónicas. Aquellos que recibieron la vacuna tenían menor riesgo de herpes ocular y hospitalizaciones por herpes. De forma global, la vacuna se asoció con un 55 por ciento de reducción en la incidencia del herpes zoster. Los autores señalan que hasta el momento, la recepción de la vacuna del herpes zoster en Estados Unidos ha sido baja debido a la escasez de infraestructura de la vacunación adulta y también a las graves barreras entre médicos y pacientes.

**Publicado en "El Médico Interactivo"