La Agencia Europea del Medicamento analizará si una vacuna para la Gripe A causa narcolepsia

La Agencia Europea del Medicamento (EMA, por sus siglas en inglés) ha emitido este viernes un comunicado en el que anuncia que revisará los datos de eficacia y los efectos secundarios de la vacuna 'Pandemrix', desarrollada por la farmacéutica británica GlaxoSmithKline (GSK) frente a la gripe A, tras detectarse varios casos de narcolepsia en pacientes inmunizados.
Según informa esta autoridad europea, un limitado número de casos de narcolepsia han sido registrados en diferentes países de Europa después de que un total de 30,8 millones de ciudadanos recibieran la vacuna frente a la gripe pandémica, aunque la mayoría se han detectado en Finlandia, Suecia y Francia.
No obstante, la alerta la ha dado Finlandia, cuyo Instituto Nacional para la Salud y el Bieniestar recomendó este martes que se paralizara la vacunación con 'Pandemrix' después de la aparición de un total de veinte casos de narcolepsia en personas que habían recibido la vacuna de GSK.
La narcolepsia es un trastorno de origen genético desconocido que se caracteriza por la presencia de accesos de somnolencia irresistibles durante el día. En este sentido, el Comité para Productos Médicos de Uso Humano (CHMP, siglas en inglés) será el encargado de investigar los casos registrados para determinar si la relación entre la vacuna y el trastorno es directa o se trata sólo de una casualidad.
Una vez completados y analizados los datos necesarios para emitir un juicio sobre la seguridad de 'Pandemrix', el CHMP decidirá en su reunión del próximo mes de septiembre las acciones a tomar en Europa con este fármaco por parte de la EMA.
España adquirió un total de 13 millones de vacunas frente a la gripe A de tres laboratorios: 'Focetria' de Novartis, 'Panenza' de Sanofi Pasteur y 'Pandemrix' de GSK. Finalmente, sólo se han utilizado unos tres millones de dosis; cuatro millones se donaron a la Organización Panamericana de la Salud (OPS) y otros dos se han almacenado como medida prevenitva.

Un estudio da al arroz negro chino un poder muy antioxidante

El arroz negro, una variedad de grano conocida en la antigua China como 'el arroz prohibido' porque sus cosechas eran requisadas por los nobles y no estaba permitido su uso entre la gente más pobre, podría ser una alternativa más barata para conseguir las propiedades antioxidantes que se atribuyen a frutas, como los arándanos o las moras, según un grupo de investigadores de la Universidad Estatal de Louisiana, en Baton Rouge (Estados Unidos).
Este descubrimiento, presentado en el 240 Encuentro Nacional de la Sociedad Química Americana (ACS, por sus siglas en inglés), que se celebra en Boston, revela que el arroz negro es rico en antocianinas antioxidantes, sustancias que se han mostrado como promesas en la lucha contra las enfermedades cardíacas o el cáncer, entre otras patologías.
El arroz negro se utiliza sobre todo en Asia, para decorar la comida, en 'noodles', en el 'sushi' y en 'pudding'. Tras este hallazgo, los empresarios podrían comenzar a utilizar salvado de esta variedad de arroz, o su extracto, para disparar el valor en salud de los cereales de desayuno, las bebidas, los pasteles, las galletas y otros tipos de alimentos, según los autores.
En la actualidad, el arroz marrón es la variedad que más se produce en el mundo. Los molineros eliminan sólo la cáscara más externa de cada grano de arroz para conseguir este arroz. Si se procesa más el grano, quitando el salvado rico en nutrientes que está por debajo, se obtiene arroz blanco.
Muchos consumidores creen que el arroz marrón es más nutritivo que el blanco, aseguran estos investigadores, porque el salvado del arroz marrón contienen mayores niveles de tocotrienol-gamma, uno de los compuestos de vitamina E, y del antioxidante gamma-oryzanol.

--PARA COMBATIR LAS ENFERMEDADES CARDÍACAS

Diversos estudios han demostrado que estos antioxidantes pueden reducir los niveles en sangre del denominado colesterol malo, ayudando así a combatir las enfermedades cardíacas. El equipo de investigadores dirigido por Zhimin Xu, profesor del Departamento de Ciencia Alimentaria del Centro de Agricultura de la Universidad Estatal de Louisiana, analizó muestras de salvado de arroz negro de una plantación del sur de Estados Unidos.

Descubrió que los antioxidantes lípido solubles del salvado de arroz negro poseían mayores niveles de antocianinas antioxidantes, que son antioxidantes solubles en agua. Así, el arroz negro podría ser incluso más saludable que el marrón, sugiere Xu.

Asimismo, demostraron que los pigmentos del extracto de salvado de arroz negro podían producir una variedad de colores diferentes, que iban desde el rosa al negro, y proporcionar una alternativa más saludable que los colorantes artificiales que se añaden a los alimentos y las bebidas y que, según diversos estudios, podrían estar vinculados a problemas de salud como el cáncer o las conductas problemáticas en la infancia, entre otros.

Según Xu, "sólo una cucharada de salvado de arroz negro contiene más antocianinas antioxidantes de las que hay en una cucharada de arándanos, pero con menos azúcar y más fibra y antioxidantes de la vitamina E". "Si las bayas se utilizan para mejorar la salud, por qué no utilizar también el salvado de arroz negro y el de arroz blanco. En especial, el de arroz negro puede ser un producto único y barato para aumentar el consumo de saludables antioxidantes", concluyó

Deaf woman to receive first implant

The electronic device will make it possible for the woman, from the Isle of Wight, to hear sound in both ears by running two stimulator wires from the single implant.
One will go into one inner ear and the other under her scalp from the single implant into her other ear - giving the 44-year-old woman much improved bilateral hearing.
Usually adults only have one implant fitted in one ear which leads to problems in noisy situations or finding where the sound is coming from.
A cochlear implant is an electronic device that can help both adults and children who have a severe to profound hearing loss.
It has two parts: an internal receiver/stimulator package and electrode array, and an external speech processor that looks like a hearing aid.
The device uses small electrical currents to directly stimulate the hearing nerve, which then sends signals to the brain where they are interpreted as sound.
The procedure has been developed at the South of England Cochlear Implant Centre (SOECIC), based at the University of Southampton.
Joint head of the centre Julie Brinton said: “Some adults and children have already received two implants, with one in each ear. The difference with the device being used today is that, although information is delivered to each ear, there is only one implant.”
Although around 40 of these devices have been implanted in patients in Europe, this is the first of its kind in the UK, the centre said.

**Published in Nursing times.net

Brazil: cancer patients to be offered nine new treatments

Under a massive expansion of its oncology services, Brazil’s national health care system (SUS) will offer cancer patients access to nine new treatments and expand coverage for 66 already-covered procedures, including 46 chemotherapy treatments.
The nine treatments which are to be made available for the first time through the SUS include three for liver cancer plus five for breast cancer, leukemia and lymphoma and one new radiotherapy treatment.
Investments in the SUS oncology services, which provide treatment for around 300,000 cancer patients, will increase 25% to 412.7 million reals this year, rising to 2 billion reals in 2011. The widening of value coverage for already-provided treatments will see investments in chemotherapy services increasing from 1.25 billion reals last year to 1.5 billion in 2011, with particularly large increases in spending on treatments for conditions such as chronic lymphocytic leukemia, set to rise 765%.
For 24 chemotherapy treatments, value coverage is to be reduced but this will reflect purely reductions in costs of these treatments, say analysts at IHS Global Insight, who also point out that SUS funding for radiotherapy treatments will be increased 94% over 2009 levels to reach 318 million reals in 2011.
The analysts forecast that the SUS oncology services will continue to give priority to the introduction of new technologies, and that the government will maintain its support for local production facilities, such as the development, in partnership with Argentina, of two reactors for the production of oncology drugs, announced in June.
Cancer is Brazil’s second-biggest killer after cardiovascular disease, and the fact that the SUS guarantees virtually all diagnosed patients have access to treatment makes it an attractive market for drugmakers. For example, last year the country’s breast cancer drug market was worth $424 million, rivaling some major markets such as the UK and Japan and greatly exceeding the other BRIC (Russia, India and China) nations, says market research firm Decision Resources, which forecasts that breast cancer drug sales in Brazil will rise to $611 million by 2014.
Decision Resources is also forecasting good growth for Brazil’s non-small-cell lung (NSCL) cancer drug market, driven by increased uptake of higher-priced brands of chemotherapy, around 21% annual growth for targeted regimens and maintenance treatment (all in the advanced setting) and modest uptake of novel targeted agents. Drugs produced by western manufacturers will increase their share of the market from around 60% last year to 70% in 2014, when the total NSCL cancer drug market will be worth $240 million, it says.
- With annual drug sales of just over $17 billion, Brazil is the world’s 11th-largest pharmaceutical market and is once again the biggest in Latin America. Having fallen behind Mexico in the earlier part of the decade, it has produced consistent double-digit growth in the last five years, reaching a peak of 33% in 2005 and rising 13% in 2009, reports IMS Health.

http://www.ihsglobalinsight.com/

http://www.decisionresources.com/

http://www.imshealth.com/

**Published in Pharma Times

Boehringer Ingelheim celebrates its 125-year existence and looks to the future with confidence

In its 125th year too, the researchdriven pharmaceutical company Boehringer Ingelheim continues its successful history, researching, developing and marketing innovative medicines for humans and animals.The world’s largest family-owned pharmaceutical company has always stayed true to the values of the company’s founder, Albert Boehringer, and in its jubilee year also confirmed its commitment to its guiding principle “Value through Innovation”. Today, 41,500 employees worldwide work in 142 affiliated companies on all continents. Of these, 11,434 plus 722 apprentices are with Boehringer Ingelheim in Germany. Research and development (R&D) is conducted in seven countries with the largest R&D site located at Biberach, Germany.
“Growth through our own research and development“ has been written large on the company banner. The result of high investment and intensive research: a broad range of prescription-only and over-the-counter products as well as a product pipeline well-filled with therapeutically promising substances in the indications stroke prevention, diabetes and oncology that should be launched within the next few years.
Independence remains the Shareholders’ supreme goalThe Boehringer Ingelheim group of companies, founded in 1885 by Albert Boehringer at the Rhineside town of Ingelheim, has been in family ownership since its foundation. The Shareholders’ declared goal is for Boehringer Ingelheim to remain also in the future as an independent, familyowned company that grows organically.
“With gratitude and respect we look upon what has been created since 1885 by all those people who were involved with the company in this period,“ said Christian Boehringer, Chairman of the Shareholders’ Committee.“Then the Shareholders set, and also set now, a dependable financial framework and provide continuity in the strategic direction for a long-term, successful future as an independent company.”
The jubilee will be marked in September at the company’s three German sites, Ingelheim, Biberach an der Riss and Dortmund with family celebrations for employees and their relatives. “In this way, we wish to thank all our employees most sincerely. They are and will in future remain Boehringer Ingelheim’s greatest asset,“ Christian Boehringer underlined.
The special value that the company attaches to its employees can also be seen in social contributions, some with a long history. Albert Boehringer established a company health insurance scheme as long ago as 1902; from 1910, every employee was given a 14-day paid annual holiday with subsidised travel costs, depending on how long they had been with the company. Today, the company shows its responsibility towards its employees with measures to improve their work-life balance, for example providing crèches at the Ingelheim and Biberach an der Riss locations as well as flexible working hours without core working times. In addition, more than 100 different part time options, and the opportunity to switch to tele-working, support employees in achieving harmony between their careers and families.
In promoting science Boehringer Ingelheim also has a long tradition that the company still maintains, according to Christian Boehringer. Last year, the Boehringer Ingelheim Foundation made EUR 100 million available to the Johannes Gutenberg University in Mainz, Germany, to run an institute for molecular biology. The goal is cutting-edge research in Rhineland-Palatinate (the German state where the company is based) and giving scientists the opportunity to concentrate fully on their research.
Research and development drive the company“All of us at Boehringer Ingelheim will celebrate the jubilee year with joy, as much has been achieved in these 125 years and – of equal importance – we stand at the beginning of a further phase of growth,“ said Professor Andreas Barner, Chairman of the Board of Managing Directors and responsible for the Corporate Board Division Pharma Research, Development and Medicine. “Boehringer Ingelheim the company is like its owner family: it distinguishes itself by long-term thinking and the will to persist as well as by the values of modesty and work ethic, all of which together have contributed to its longevity and shared success.“
Boehringer Ingelheim’s endeavour was and remains to research and develop innovative medicines for the treatment of diseases with an as yet unmet therapeutic need. With Viramune® Boehringer Ingelheim in 1996 brought to the market an HIV medication in a new class of active ingredient, thereby providing a new treatment option. Further examples of innovation are Sifrol®, available since 1997 for the symptomatic therapy of Parkinson’s disease, and Spiriva®, available since 2002 for the treatment of chronic obstructive pulmonary disease (COPD) and today the most frequently prescribed COPD therapy worldwide. The proven blood pressure lowering medicine Micardis® is the only angiotensin receptor blocker in the world that has since 2009 been registered for reducing the risk of serious cardiovascular events, such as heart attacks.
Boehringer Ingelheim has always been a company strongly driven by research, explained Prof. Barner, and, despite difficult conditions, currently invests 21 percent of the net sales of its Prescription Medicines business directly in research and development.
In Hanover the company is currently constructing a European research centre for animal vaccines and thereby establishing a additional location in Germany with the prospect of lasting jobs in research fit for the future.

-Into to future with inquiring minds

Boehringer Ingelheim’s largest research site worldwide is Biberach an der Riss in the Upper Swabia region of Germany with 4,500 employees. There the company runs a large pharmaceutical research centre and one of the most innovative biotechnology centres in the world for researching, developing and producing biopharmaceuticals.
The active ingredient dabigatran etexilate was researched and developed in Biberach. This novel oral thrombin inhibitor has been on the market since 2008 under the brand name Pradaxa® for prevention of thrombo-embolism after knee or hip replacement operations. With Pradaxa®, for the prevention of stroke in patients with atrial fibrillation, a true medical breakthrough can be seen. Securing international market authorisation in this indication is the next goal for dabigatran etexilate.
Boehringer Ingelheim continues to research: study data from large-scale, controlled clinical studies with thousands of patients contribute to improving medical knowledge and the treatment of the three most frequent causes of disease-related death – cardiovascular diseases, stroke and COPD. “Despite the difficult years 2010 and 2011, due to the loss of patents, the foundation for Boehringer Ingelheim’s future has been laid thanks to innovative research”, Prof. Barner emphasised. “Medicines from Boehringer Ingelheim in the therapeutic areas diabetes and oncology will also be available to physicians and patients in the next few years. We are entering new territory with confidence and the knowledge, in keeping with the company’s guiding principles, to serve humankind by researching, developing, producing and marketing new medicines.”

Black Rice Is Cheap Way to Get Antioxidants

Inexpensive black rice contains health-promoting anthocyanin antioxidants, similar to those found in blackberries and blueberries, new research from Louisiana State University indicates.
"Just a spoonful of black rice bran contains more health promoting anthocyanin antioxidants than are found in a spoonful or blueberries, but with less sugar and more fiber and vitamin E antioxidants," Zhimin Xu, PhD, of Louisiana State University Agricultural Center, says in a news release. "If berries are used to boost health, why not black rice and black rice bran?"
Xu and colleagues analyzed samples of black rice bran from rice grown in the Southern U.S.
He says black rice bran would be a unique and inexpensive way to increase people's intake of antioxidants, which promote health.
Black rice is rich in anthocyanin antioxidants, substances that show promise for fighting cancer, heart disease, and other health problems, Xu says.
He adds that food manufacturers could use black rice bran or bran extracts to boost the health value of breakfast cereals, beverages, cakes, cookies, and other foods.

-Black Rice vs. Brown Rice
The most widely produced rice worldwide is brown. Millers of rice remove the chaff, or outer husks, from each grain to make it brown.
White rice is made when rice is milled more than is done for brown rice; the bran is also removed, Xu says.
The bran of brown rice contains high levels of one of the vitamin E compounds known as "gamma-tocotrienol" as well as "gamma-oryzanol" antioxidants.
Many studies have shown that these antioxidants can reduce blood levels of LDL "bad" cholesterol and may fight heart disease.
So black rice bran may be even healthier than brown rice, Xu says.
He and his colleagues also showed that pigments in black rice bran extracts can produce a variety of colors, from pink to black, and may be a healthier alternative to artificial food colorants that manufacturers now add to some foods and beverages.
He writes that several studies have linked some artificial colorants to cancer, behavioral problems in children, and other adverse health effects.
Currently, black rice is used mainly in Asia for food decoration, noodles, sushi, and pudding, and Xu says that he would like to see it eaten by more Americans.
Black rice bran could be used to boost the health value of foods, such as snacks, cakes, and breakfast cereals, Xu and his colleagues suggest.
This study was presented at a medical conference in Boston. The findings should be considered preliminary because they have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal.

**Published in Web MD

España "campeona del mundo" en el número de trasplantes de órganos

España con 34,4 donantes por millón de personas y más de 4.000 trasplantes efectuados en 2009 mantienen su liderazgo mundial en este campo, según la publicación oficial 'Newsletter Trasplant', de la Comisión de Trasplantes del Consejo de Europa, editada por la Organización Nacional de Trasplantes (ONT), dependiente del Ministerio de Sanidad y Política Social. Europa registra por segundo año consecutivo un ligero aumento en la tasa de donación de órganos, alcanzado los 18,3 donantes por millón de población (p.m.p), frente a los 18,2 del pasado año. De éstas el 17,5 por ciento se efectuaron en España.

Así, en cifras totales la ONT contabiliza en 9.152 los donantes registrados en la UE de los 27 el pasado año --139 más que en 2008--, lo que supone un aumento del 2,2 por ciento. Este ligero incremento ha permitido elevar en un 3,8 por ciento el total de trasplantes efectuados, hasta alcanzar los 28.875. Del total de trasplantes efectuados en Europa los de riñón son los más numerosos con 17.886 frente a los 17.198 del pasado año; le sigue los de hígado con 6.687 (6.551 en 2008), corazón con 2.090 (2.011), pulmón con 1.418 (1.293), páncreas con 779 (756), e intestino que con 15 intervenciones son los únicos que bajan teniendo en cuenta los 44 realizados en 2008. Asimismo se contabilizaron un total de 44 trasplantes multiorgánico con 44, 28 intervenciones más que en 2008. Según el Ministerio de Sanidad esta cifra es "insuficiente", sobre todo si se tiene en cuenta el número de pacientes europeos en lista de espera para recibir un trasplante que, a 31 de diciembre de 2009, incluía a 64.726 personas --1.619 más que en 2008--. "Estos datos ponen de manifiesto la necesidad urgente de incrementar las donaciones de órganos en toda Europa", añade Sanidad, que recuerda que en 2009 estas donaciones cubrieron únicamente el 44,6 por ciento de las necesidades de órganos de los pacientes europeos.

--EN EL RESTO DEL MUNDO

En todo el mundo el Registro Mundial de Trasplantes, que gestiona la ONT desde hace 4 años en colaboración con la Organización Mundial de la Salud, cifra en 100.528 los trasplantes de órganos sólidos efectuados, aunque en muchos países de África y Asia estas cifras tiene que considerarse como aproximadas. Según recoge la publicación, estas cifras suponen un incremento del 1,2 por ciento respecto al año anterior. De ellos, 69.214 son de riñón, 20.280 de hígado, 5.327 de corazón, 3.329 de pulmón y 2.378 de páncreas.

El 'Newsletter Trasplant' recoge asimismo los datos de Estados Unidos, Canadá, América Latina y Australia. En ellos destaca el descenso que por tercer año consecutivo registra en Estados Unidos en su tasa de donación, que se sitúa en 25,5 p.m.p (frente al 26,3 en 2008) con un total de 8.021 donantes en el pasado año y 28.254 trasplantes. En Canadá con 14,5 donantes p.m.p las donaciones también han disminuido ligeramente por segundo año, al igual que en Australia (11.3 p.m.p), que ha experimentado una reducción de casi 1 punto en su tasa de donación.

Por su parte, América Latina es el área geográfica que registra un mayor crecimiento en cuanto al número total de donaciones. El pasado año se registraron un total de 3.410 donantes de órganos, con un incremento de un 8 por ciento. Estas donaciones han permitido realizar 12.249 trasplantes, lo que supone un aumento del 9,3 por ciento del total respecto al año anterior. El Registro Mundial de Trasplantes reflejan que al menos diez europeos mueren cada día a la espera de recibir un trasplante. Se estima que esta cifra -- que sitúa en 3.791 el número de personas fallecidas en 2009 a la espera de un órgano-- está "infravalorada" si se considera que en muchos países no todos los enfermos acceden a la lista de espera.