Commissioner Dalli visits the European Medicines Agency in London‏

Today, Commissioner Dalli visits the European Medicines Agency (EMA) in London. On this occasion Commissioner Dalli will meet the Agency's new Executive Director Guido Rasi who was appointed in October 2011. The mission of Commissioner Dalli to the Agency is meant to contribute to the continued fruitful co-operation between the Commission and its Agency in the best interests of citizens in the EU. The Commission and the Medicines Agency share the great responsibility of ensuring that medicines authorised in the EU are safe and effective.
On the occasion of the Commissioner's visit, the European Commission is launching a video to explain to citizens the system of authorisation for all medicines circulating in the European Union.

Watch the video

More information on the authorisation of medicines More information on the European Medicines Agency

Elementos del vino tinto benefician la aterosclerosis en estadios tempranos

Científicos del Centro de Investigación Biomédica en Red-Fisiopatología de la Obesidad y la Nutrición (CIBERobn) han realizado el primer ensayo clínico que demuestra que, tanto el etanol como los polifenoles presentes en el vino tinto, tienen efectos beneficiosos sobre las moléculas inflamatorias causantes de la ateroesclerosis en sus estadios tempranos.
Estos investigadores, liderados por los doctores Ramón Estruch, Francisco José Tinahones y la doctora Dolores Corella, han descubierto también que la combinación de ambos compuestos es más eficaz en pacientes con alto riesgo cardiovascular.
El trabajo, publicado en 'American Journal of Clinical Nutrition', mostró cambios positivos en el perfil inflamatorio de estos pacientes que indican que su consumo moderado podría ser beneficioso en las primeras etapas de la aterosclerosis contrarrestando su progresión.
La denominada "paradoja francesa" se refiere al hecho de que los habitantes de ese país sufren una incidencia relativamente baja de enfermedad cardíaca, a pesar de tener una dieta rica en grasas saturadas.
Esto llevó a especular con la posibilidad de que se debiese a un mayor consumo de vino tinto, que contiene una elevada concentración de polifenoles, unos compuestos potencialmente beneficiosos para el corazón.
Sin embargo, lo que hasta ahora nunca se había demostrado era que el etanol o contenido alcohólico también contribuyesen a reducir la inflamación arterial y celular.
Según el doctor Estruch, "nuestros resultados sugieren que, tanto el etanol como los compuestos no alcohólicos, contribuyen a los efectos antiinflamatorios del vino tinto".
"Su contenido fenólico puede modular las moléculas de adhesión leucocitaria, mientras que el etanol y los polifenoles que contiene pueden modular los mediadores solubles inflamatorios en pacientes con alto riesgo de enfermedad cardiovascular", asevera.
Para realizar este estudio, el equipo del CIBERobn reclutó a 73 varones de alto riesgo cardiovascular con edades comprendidas entre 55 y 75 años. Se seleccionó a los que eran consumidores moderados de alcohol --entre 1 y 3 bebidas diarias-- y tenían diabetes o tres de los siguientes factores de riesgo cardiovascular: tabaquismo, hipertensión arterial, colesterol, sobrepeso u obesidad y/o antecedentes familiares de enfermedad coronaria prematura. De los 73, un total 67 cumplían con los criterios de inclusión.
El estudio fue abierto, aleatorizado y cruzado y el ensayo clínico controlado. Incluyó tres períodos de cuatro semanas después de uno previo de lavado de dos semanas en el que a los voluntarios se les pidió que no consumieran bebidas alcohólicas.
Todos los sujetos recibieron vino tinto --272 miligramos, 30 gramos de etanol al día--, la misma cantidad de polifenoles pero sin alcohol en forma de vino de color rojo (272 miligramos) y ginebra (que no contiene polifenoles: 100 miligramos, 30 gramos de etanol/día) durante cuatro semanas. Antes y después de cada intervención se analizaron 18 biomarcadores inflamatorios en suero y siete celulares y fueron evaluados.
Los investigadores constataron que la prueba sólo de alcohol (ginebra) ejerció un efecto antiinflamatorio en pacientes de alto riesgo y disminuyó los niveles de algunos marcadores inflamatorios. La intervención sólo con compuestos fenólicos --vino tinto sin alcohol-- mostró la disminución de las concentraciones séricas de otros mediadores de la inflamación.
Otra de las conclusiones obtenidas es que la combinación del etanol y polifenoles que contiene el vino tinto afectan más a los pacientes con alto riesgo cardiovascular, cuyos biomarcadores inflamatorios se vieron reducidos en mayor medida.
El descubrimiento de que los distintos componentes tienen diferentes efectos sobre las moléculas inflamatorias es muy importante porque, según explicó el doctor Ramón Estruch Riba, "el estudio provee una nueva e importante evidencia mecánica de que la reducción del riesgo de enfermedad cardiovascular entre los bebedores de vino tinto observado en la mayoría de los estudios epidemiológicos puede ser consecuencia de una combinación de ambos, el alcohol y los polifenoles del vino, y no sólo de estos últimos como se creía hasta ahora".
A lo que añadió que "alrededor de la mitad de los participantes estaban tomando medicación contra la hipertensión, aspirina o hipoglucemiantes orales, lo que hace que los resultados del ensayo sean relevantes para los pacientes en el mundo real, ya que los efectos positivos constatados no son incompatibles con los tratamientos de estos trastornos".
El profesor Estruch dice que estos hallazgos "abren una nueva vía de investigación encaminada a clarificar la implicación clínica de la modulación de estos biomarcadores y el papel de cada componente de las bebidas alcohólicas y sus correspondientes efectos beneficiosos sobre el sistema cardiovascular".`

**EUROPA PRESS

Potential new treatment identified for leishmaniasis

Researchers at the College of Life Sciences have identified fexinidazole as a possible, much-needed, new treatment for the parasitic disease visceral leishmaniasis. Leishmaniasis is named after William Leishman, a Glasgwegian doctor serving with the British Army in India, who first identified the parasite in the early 1900s. The disease is the second biggest killer in Africa, Asia and Latin America after malaria, and affects 500,000 people, killing about 50-60,000 patients per year. Current drug treatments for the disease are unsatisfactory for reasons such as high cost, drug resistance or the need for hospitalisation.
Fexinidazole is already in phase 1 clinical trials for a related disease -- African sleeping sickness -- but a research team at Dundee including Dr Susan Wyllie, Professor Alan Fairlamb and colleagues has identified it as having potential in treating leishmaniasis.
Their research has been published by the journal Science Translational Medicine, and was funded by the Wellcome Trust.
Tests in mice showed that the drug has a greater than 98% rate of suppressing infection of leishmaniasis, comparable to current treatments such as miltefosine and Pentostam.
These and other existing treatment options all suffer from disadvantages; they are not always safe, effective or easy to administer. The only oral drug miltefosine cannot be given to women of child-bearing age due to a substantial risk of birth defects; other drugs are costly and have to be given by injection. Thus there is a continuing need for safe and cost-effective drugs suitable for use in resource-poor settings.
Professor Fairlamb said that fexinidazole has the potential to become a safe and effective oral drug therapy for treating the severest form of visceral leishmaniasis.
"Visceral leishmaniasis is a neglected disease of poverty which causes huge problems across Africa, Asia and Latin America, killing tens of thousands of people every year," said Professor Fairlamb.
"The current treatments are far from ideal and we need to find better, cheaper and more easily delivered drugs to tackle the disease. Our research suggests that fexinidazole has strong potential to do that."
Drugs for Neglected Diseases initiative have already established that fexinidazole is safe in early clinical trials for African sleeping sickness, so it is some way along the development path.
"This has been a great team effort and I would like to acknowledge the dedication and enthusiasm of the biologists, chemists and pharmacologists involved in this discovery."
Professor Fairlamb and colleagues are based in the College of Life Sciences at Dundee, which houses the Drug Discovery Unit, formed in 2005 specifically to fill the void of research and development of drug targets for diseases of poverty like African sleeping sickness, leishmaniasis, and Chagas' disease that afflict the developing world.
Professor Fairlamb cited the inspiration of the University's former Chancellor, the Nobel prize-winning pharmacologist Sir James Black, in carrying out the research on fexinidazole.
"Sir James always liked to remind me that `the most fruitful basis for the discovery of a new drug is to start with an old drug'. This adage is particularly apt in the search for effective drugs to treat neglected tropical diseases such as visceral leishmaniasis," said Professor Fairlamb.
"Indeed, two of the existing anti-leishmanial drugs, miltefosine and amphotericin B, are examples of medicines originally developed for other purposes -- anti-cancer and anti-fungal, respectively.
"Our hope is that fexinidazole can follow them and provide relief from a disease that is a major blight across the world."

*Source: University of Dundee

La Fundación 'Mussa' lucha para que la musicoterapia clínica se integre en el tejido sanitario español

Que la música tiene la capacidad de generar respuestas emocionales en el ser humano es un hecho indiscutible. La diferencia entre una actividad musical cualquiera y la musicoterapia es que esta última trabaja a partir de los sonidos del paciente, de su musicalidad y sus vivencias. Así, el ritmo se asimila a lo biológico, la melodía a lo emocional y la armonía al intelecto y a la lógica. Resulta complejo de explicar incluso para Aittor Loroño, médico homeópata y musicoterapeuta que lleva muchos años luchando para que esta disciplina se abra un hueco en el tejido sanitario español.

Aittor Loroño toca piano, acordeón, flauta, percusión y “menos cantar”, lo que le echen. Viene de familia de músicos, estudió Medicina y lleva toda su vida sintetizando los dos conceptos. Desde 1986 dirige el Centro de Investigación Musicoterapeútica de Bilbao (CIM), uno de los primeros en ofrecer postgrados en Musicoterapia, todos ellos títulos propios no homologados. El único máster oficial en España se imparte en la Universidad Católica de Valencia. La Fundación Mussa, de la que Loroño es vicepresidente, nació hace un año precisamente por esa necesidad de contar con una entidad jurídica que gestionase las prácticas y proyectos de los alumnos de Bilbao y de otros centros una vez finalizada su formación.
La presentación oficial de Mussa tuvo lugar el pasado jueves en el Conservatorio Superior de Música de Bilbao con la colaboración del violonchelista de la Orquesta Sinfónica de Euskadi, Asier Polo. Sobre la mesa, dos objetivos claros: conseguir financiación para los dos proyectos que tienen en marcha, Hathos y Euterpe, y avanzar hacia el reconocimiento de la profesión en toda España. Actualmente, solo Cáceres reconoce la figura del musicoterapeuta como una categoría profesional. Uno de los responsables extremeños de Sanidad impulsó la iniciativa después de que su hijo autista recibiese tratamiento con musicoterapia.

-El ritmo es lo biológico, la melodía es lo emocional y la armonía, la lógica
La propia presidenta de Mussa, María Jesús del Olmo, se formó en el CIM y trabajó duro para allanar el camino. Primero introdujo la musicoterapia en la Universidad Autónoma de Madrid, dentro de la facultad de Medicina, y después logró un convenio de colaboración con el madrileño Hospital de la Paz. Su tesis doctoral versó sobre el efecto de la música en los recién nacidos, y demostró ante un tribunal científico que sus constantes vitales, cardiacas, de temperatura y oxigenación mejoraban con la música.
El germen del proyecto Hathos lo explica Carlos, un profesional con 20 años de experiencia en musicoterapia con niños autistas y ancianos con Alzheimer y demencia senil: “La naturaleza no verbal de la música, íntimamente ligada a nuestro subconsciente, facilita la comunicación y estimula la capacidad de evocar”. Diversas investigaciones clínicas también demuestran esta influencia beneficiosa sobre la salud física y psicológica de los pacientes con enfermedades crónicas como la fibromialgia, a quienes va dirigido el proyect o Euterpe, en colaboración con el Hospital de Cruces.
La Fundación Mussa ha presentado estudios que demuestran que la musicoterapia aumenta la tolerancia al dolor, disminuye el estrés y mejora la calidad de vida del paciente”, cuenta Loroño: “Hemos tratado de recabar financiación pública, pero es complicado. La sociedad solo da dinero si quieres demostrar algo a nivel científico y eso deshumaniza la asistencia. Los pacientes están por delante de la ciencia abanderada por la medicina convencional”.

**Publicado en "EL PAIS"

Rituximab possible treatment option for patients with primary biliary cirrhosis

An open-label study of rituximab, a monoclonal antibody for human CD20, was shown to be safe in patients with primary biliary cirrhosis (PBC) who had an incomplete response to the standard ursodeoxycholic acid (UDCA) therapy, also known as Ursodiol. Study details available in the February issue of Hepatology, a journal published by Wiley-Blackwell on behalf of the American Association for the Study of Liver Diseases, report that rituximab was successful in reducing the level of alkaline phosphatase (ALP) -- a protein used to measure liver injury. According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), PBC -- an autoimmune liver disease characterized by inflammation of the bile ducts that ultimately causes bile to build up and damage the liver -- typically occurs between the ages of 40 and 60, primarily affecting women. Medical studies have identified the presence of anti-mitochondrial autoantibodies (AMA) to enzymes involved in the production of the body's energy (pyruvate dehydrogenase complex-PDC-E2) in up to 95% of PBC cases.
Currently, the standard therapy for PBC is UDCA or liver transplantation in patients who have progressed to end-stage liver disease. However, previous studies have shown that UDCA may be ineffective in up to 40% of PBC patients and 10% could require transplantation or die from the disease. "Small trials using immunosuppressants have failed to demonstrate significant clinical benefit or carry unacceptable safety profiles," said Dr. Christopher Bowlus with UC Davis Health System in California and lead author of the current study.
Dr. Bowlus added, "Given our previous work implicating B cells to the development of this disease, we hypothesized that a therapy such as rituximab, which depletes B cells, could offer a potentially effective treatment option with acceptable adverse effects." The team enrolled 6 patients between the ages of 18 and 65 years of age who were diagnosed with PBC and had an incomplete response to UDCA despite 6 months of therapy. Participants in this open-label study received an intravenous infusion of 1000 mg of rituximab on day 1 and day 15, with follow-up for 52 weeks. Two patients received one dose of rituximab due to latent varicella (chickenpox) activation in one and viral respiratory infection in the other.
The trial results found that rituximab was safe and well tolerated by PBC patients, with no serious adverse events reported. By 16 weeks post-treatment patients had significantly lower levels of immunoglobulins IgG, IgM, and IgA, which are the antibodies normally present in blood, but in the case of IgM are often elevated in PBC. In addition, the abnormal antibodies directed against mitochondria (AMA), were also reduced after treatment. However, levels returned to baseline by 36 weeks. Further, serum alkaline phosphatase decreased up to 36 weeks post-treatment.
The authors noted that rituximab therapy could clinically improve PBC through multiple pathways that include the reduction of anti-mitochondrial antibodies through depletion of memory B cells, increases in regulatory T cells associated with immune response, and modulation of cytokine production involved with inflammation. "Further investigation of B cell targeting strategies is necessary to develop potentially novel therapeutic options for patients with PBC," concludes Dr. Bowlus.

**Source: Wiley-Blackwell

Understanding how bacteria come back from the dead

Salmonella remains a serious cause of food poisoning in the UK and throughout the EU, in part due to its ability to thrive and quickly adapt to the different environments in which it can grow. New research involving a team of IFR scientists, funded by BBSRC, has taken the first detailed look at what Salmonella does when it enters a new environment, which could provide clues to finding new ways of reducing transmission through the food chain and preventing human illness. Bacteria can multiply rapidly, potentially doubling every 20 minutes in ideal conditions. However, this exponential growth phase is preceded by a period known as lag phase, where no increase in cell number is seen. Lag phase was first described in the 19th Century, and was assumed to be needed by bacteria to prepare to exploit new environmental conditions. Beyond this, surprisingly little was known about lag phase, other than bacteria are metabolically active in this period. But exactly what are bacteria doing physiologically during this period?
To fill in this knowledge gap researchers at IFR, along with colleagues at Campden BRI, a membership-based organisation carrying out research and development for the food and drinks industry, have developed a simple and robust system for studying the biology of Salmonella during lag phase. In this system, lag phase lasts about two hours, but the cells sense their new environment remarkably quickly, and within four minutes switch on a specific set of genes, including some that control the uptake of specific nutrients.
For example, one nutrient accumulated is phosphate which is needed for many cellular processes, and a gene encoding a phosphate transporter was the most upregulated gene during the first four minutes of lag phase. The cellular uptake mechanisms for iron were also activated during lag phase, and are needed for key aspects of bacterial metabolism. This increase in iron leads to a short term sensitivity to oxidative damage. Manganese and calcium are also accumulated in lag phase, but are lost from the cell during exponential growth.
This new understanding of Salmonella metabolism during lag phase show how rapidly Salmonella senses favourable conditions and builds up the materials needed for growth. This study was carried out by two BBSRC-CASE studentships, which were partially funded by Campden BRI.
Future research to work out the regulatory mechanisms behind these processes and the switch from lag phase to exponential growth will tell us more about how Salmonella can flourish in different environments, and could point to new ways of controlling its transmission in the food chain.

**Source: Norwich BioScience Institutes

A zap of cold plasma reduces harmful bacteria on raw chicken in Drexel study

A new study by food safety researchers at Drexel University demonstrates that plasma can be an effective method for killing pathogens on uncooked poultry. The proof-of-concept study was published in the January issue of the Journal of Food Protection. Although recent high-profile outbreaks of foodborne illness have involved contaminated fresh produce, the most common source of harmful bacteria in food is uncooked poultry and other meat products. The bacteria responsible for most foodborne illnesses, Campylobacter and Salmonella, are found on upwards of 70 percent of chicken meat tested.
Treating raw meat products to remove pathogens before they reach a consumer's home can reduce the risk of cross contamination during food preparation, according to senior author Dr. Jennifer Quinlan, an assistant professor in Drexel's College of Nursing and Health Professions. "If you could reduce contamination on the raw chicken, then you wouldn't have it in the kitchen," Quinlan said.
Past studies have shown that plasma could successfully reduce pathogens on the surface of fruits and vegetables without cooking them.
The value of using plasma "is that it is non-thermal, so there is no heat to cook or alter the way the food looks," said lead author Brian Dirks, a graduate student in the College of Arts and Sciences. Dirks and Quinlan worked with researchers from the University's Anthony J. Drexel Plasma Institute to test the use of plasma for poultry.
In the Drexel study, raw chicken samples contaminated with Salmonella enterica and Campylobacter jejuni bacteria were treated with plasma for varying periods of time. Plasma treatment eliminated or nearly eliminated bacteria in low levels from skinless chicken breast and chicken skin, and significantly reduced the level of bacteria when contamination levels were high.
The researchers also tested using plasma to treat samples of bacteria grown on agar, and demonstrated that antibiotic-resistant strains of bacteria were as susceptible to plasma as the wild-type strains.
Plasma, known as the "fourth state of matter" (after solid, liquid and gas), is a high-energy, charged mixture of gaseous atoms, ions and electrons. Plasma has a wide range of potential applications including energy production and control, biomedical treatments and environmental remediation.
Quinlan described the plasma treatment of poultry in this study as "proof of concept." Current plasma technology is expensive relative to the narrow cost margins involved in food production, and the technology is not currently being developed for processing poultry on a large scale.
If plasma technology becomes cost-effective for use in treating poultry, it may be used in conjunction with existing methods to reduce pathogens, Dirks said, and it may also help prolong the shelf-life of raw chicken if it can be honed to remove more microorganisms responsible for spoilage.
"Until these technologies are more fully developed, consumers should assume that raw poultry has pathogens on it and take care to prevent infection," Quinlan said. "That means cooking thoroughly and making sure not to cross contaminate when handling uncooked meat and poultry."
Quinlan holds a a Ph.D. in food microbiology from North Carolina State University and bachelor's and master's degrees in food science from Rutgers University. Her research focuses on the microbiological quality and safety of food. Her ongoing work focuses on safe consumer handling of food.

*Source: Drexel University