El número de mujeres que mueren debido a las complicaciones durante el embarazo y parto ha descendido un 34 por ciento desde una cifra estimada de 546.000 muertes en 1990 hasta 358.000 en 2008, de acuerdo con un nuevo informe conjunto de varias agencias de Naciones Unidas La Organización Mundial de la Salud (OMS) anunció en un nuevo informe que cada día de 2008 murieron 1.000 mujeres por causas relacionadas con el embarazo o el parto, principalmente por hemorragias, infecciones, hipertensión y abortos inseguros.
El riesgo que tiene una mujer en un país en desarrollo de morir de una causa relacionada con el embarazo durante su vida es 36 veces mayor en comparación con una mujer que vive en un país desarrollado. Para conseguir nuestro objetivo global de mejorar la salud materna necesitamos hacer más para poder llegar hasta aquéllas que se encuentran en un riesgo mayor, afirmó el director ejecutivo del Fondo de Naciones Unidas para la Infancia (UNICEF), Anthony Lake. Esto significa llegar hasta las mujeres que viven en las zonas rurales y pobres, las mujeres de minorías étnicas y grupos indígenas y las mujeres seropositivas y en zonas de conflicto, añadió.
El informe, que cubre el período de 1990 a 2008, también indica que diez de 87 países con índices de mortalidad materna igual o superior a 100 en 1990 han logrado un descenso anual de un 5,5 por ciento en este período. En el otro extremo, 30 han hecho progresos nulos o insuficientes desde 1990. El estudio muestra progreso en la región de África subsahariana, donde la mortalidad materna cayó un 26 por ciento. Por otro lado, en Asia, el número de muertes se estima que se ha reducido desde las 315.000 a las 139.000 en este período, un 52 por ciento de descenso. Es vital apoyar el desarrollo de unos sistemas de registro civil que sean completos y fiables y en los que se incluyan los nacimientos, las muertes y sus causas. Cada muerte materna debe contabilizarse, afirmó Chan.
16 September 2010
La FADSP crea un Observatorio de Atención Primaria con el que pretende visualizar las necesidades de esta especialidad médica
La Federación de Asociaciones para la Defensa de la Sanidad Pública (FADSP) presenta un nuevo Observatorio de Atención Primaria, que pretende ser un punto de encuentro y de información, que ayude a hacer visible las necesidades de esta especialidad. Se trata de una ventana en la que, a través de su página web, podrán tender acceso todos los ciudadanos y los profesionales de la salud pública. La presentaba Javier González Medel, portavoz de la FADSP, que matizaba que “el observatorio lo gestiona la FADSP pero está abierto a cualquier otra alternativa progresista”. El portavoz definía los objetivos de este observatorio, citando la “vocación preventiva, de educación para la salud, el diagnóstico precoz y todas esas cosas que tantas veces se han dicho y tan pocas veces se practica, que aquí tendrán un lugar destacado”.
La página web (www.atencionprimaria.org.es/) se estructura en diversos contenidos, que pasan desde noticias y artículos a comunicados de diferentes entidades. Igualmente ofrece la posibilidad de contactar con el observatorio y de contribuir aportando informaciones que sean de interés público. Además, se incluye la publicación de diversos informes, como es el caso del realizado acerca de “Los servicios sanitarios de las Comunidades Autónomas”, del que se espera se realice una actualización antes de finales de año. Igualmente, su intención es ser un portal internacional, por lo que incluye en información en distintos idiomas, fundamentalmente en inglés, para de esta manera poder ampliar los contenido y poder llegar a un mayor número de público.
Es sabido que la Atención Primaria es una especialidad médica que pasa por diversas dificultades a nivel internacional. “La Atención Primaria está siendo seriamente atacada en todo el mundo –declaraba González Medel- a pesar de que la propia OMS dijera que debía ser una clave de bóveda de la asistencia sanitaria de cualquier país”. En España, la sanidad pública siempre ha tenido un lugar destacado, aunque actualmente, también se encuentra en una situación difícil, “la Atención Primaria en España es una joya que estamos perdiendo, pero que es aún envidiada por otros países”. Pese a todo ello, la situación se muestra muy diferente dentro del territorio español, dependiendo de las comunidades.
Así, el portavoz de la FADSP hacia referencia al informe realizado de la situación de cada una de las CC.AA. en relación a los datos extraídos de fuentes como el Ministerio de Sanidad, en los que se sacaban conclusiones como que “Galicia ha hecho un retroceso, y en el caso de Madrid, el área única supone un desmantelamiento de la Atención Primaria”, según aportaba Javier González Medel. De esta manera valoraba que, según dicho informe, Madrid, Valencia, Galicia y Canarias eran las últimas comunidades en cuanto a valoración, pero que también existían casos destacados como el País Vasco, que habría pasado del tercer al octavo puesto, debido a su apuesta más centrada en la tecnología que en la asistencia. Este problema se incrementaría en el caso de que algún día llegara a implantarse el sistema de copago, ya que en palabras del experto, “es atroz porque es poner una tasa sobre la enfermedad, la gente no va al médico porque quiera, sino porque cree que lo necesita, y muchas veces esas visitas son inducidas por los propios profesionales sanitarios”. Otro de los grandes retos es el perfil actual del estudiantes de medicina, que ha pasado de ser más humanista a ser más técnico, debido al auge de la tecnificación sanitaria. Es por ello, otra de las grandes preocupaciones de la FADSP, sobre lo que su portavoz argumentaba que “el tipo de personas que se admite en las facultades de medicina va a condicionar el tipo de profesión en el futuro, dentro de unos años los médicos estarán muy bien formados, pero no sabrán hablar con la gente, y en Atención Primaria, aparte de ser técnicamente bueno, hay que saber más cosas”.
**Publicado en "El Médico Interactivo"
La exposición a plaguicidas, clave en la calidad del semen
La exposición combinada a plaguicidas organoclorados es uno de los factores determinantes de la baja calidad del semen en jóvenes almerienses, según se desprende de un trabajo realizado en la Universidad de Granada (UGR), en el que se advierte de que presentar un número de espermatozoides en el semen inferior al nivel de referencia establecido por la OMS puede producir un retraso evidente en el tiempo requerido para lograr un embarazo con éxito. Este trabajo, realizado en el Hospital Clínico de Granada por el investigador Clemente Aguilar, se ha basado en una muestra formada por 280 jóvenes voluntarios almeriense, de 18 a 23 años de edad, y reclutados en la Universidad de Almería.
En concreto, la hipótesis de esta investigación parte de la premisa de que una exposición a plaguicidas organoclorados incrementa el riesgo de alteraciones en los parámetros indicadores de la calidad seminal, un hecho que se relaciona con su capacidad de modificar la homeostasis de las hormonas del eje hipotálamo-hipófisis-gónadas masculino. Además, alude al hecho de que el riesgo es mayor con la exposición combinada a varios plaguicidas, aún cuando la misma se produzca a bajas concentraciones. Ahora los resultados de este trabajo de Clemente Aguilar, que ha estado dirigida por los investigadores de la UGR Marieta Fernández, Marina Lacasaña y Nicolás Olea, han demostrado también que la calidad seminal de los jóvenes del sureste peninsular se sitúa en una posición intermedia entre las descritas para otras poblaciones europeas, con cifras cercanas a las más altas reportadas.
Esta evaluación se ha llevado a cabo a través de la estimación del número total de espermatozoides (NTE) y el número total de espermatozoides móviles (NTEM).La calidad seminal estimada en la población joven almeriense ha resultado depender también de múltiples factores, entre ellos, los modos de vida, considerando como tales el nivel de escolarización y trabajo; los parámetros físicos y bioquímicos, obesidad, niveles de hormonas sexuales y de lípidos en sangre; y la exposición ambiental. En cuanto a la principal vía de exposición a plaguicidas en población general, este estudio apunta a los alimentos y otros productos utilizados a nivel doméstico. Además, detalla que, de los 18 plaguicidas analizados en la sangre de los individuos participantes, algunos están prohibidos en España, como el DDT. No obstante, otros como el fungicida vinclozolina (utilizado en cultivos y almacenamiento de vid y cítricos) son actualmente de uso legal en España. Todas las muestras de suero analizadas contenían al menos un plaguicida en concentración cuantificable, siendo el promedio de plaguicidas detectados por muestra de 11 compuestos, con un rango comprendido entre 4 y 17. La mayor parte de jóvenes (62%) mostró tener entre 10 y 14 residuos de plaguicidas distintos analizados.E
Los resultados del estudio mostraron una fuerte asociación entre la exposición a vinclozolina y la frecuencia de espermatozoides malformados. Aunque no hay evidencia previa publicada sobre este potencial efecto de la vinclozolina para humanos, este trabajo aboga por la conveniencia de realizar estudios experimentales para confirmar este hallazgo. De hecho, insiste que la exposición a mezclas complejas de plaguicidas organoclorados emerge como un determinante de la calidad seminal que no debería ser obviado en ningún estudio epidemiológico que trate de averiguar la influencia de factores ambientales.
Sin embargo, Clemente Aguilar puntualiza que la interpretación del efecto final resultante "no es sencilla, fundamentalmente porque estamos expuestos a mezclas de contaminantes ambientales y las interacciones entre los diferentes compuestos determinarán el efecto resultante, lo que hace aparentemente impredecible el efecto final". El investigador de la UGR concluye que, para reducir o retirar la mayor cantidad de residuos de plaguicidas, "es muy importante lavarlos con agua y jabón, ya que este último corta la película grasa de la superficie de esos alimentos que contiene gran parte de residuos de plaguicidas".
FDA panel split on keeping Abbott's Meridia on the market
The chances of Abbott Laboratories' Meridia remaining on the market in the USA have improved slightly after a regulatory advisory panel could not decide whether the controversial obesity drug should be pulled.
The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-8 as to whether Meridia (sibutramine) should be withdrawn. Their review had been prompted by data from the SCOUT study which investigated long-term cardiovascular effects of sibutramine in 10,000 patients, enrolled for up to six years, with high cardiovascular risk.
Those findings demonstrated an increased risk of stroke or heart attack, and the drug was pulled in Europe earlier this year, where it was sold as Reductil, Reduxade and Zelium.
Eight panellists said the potential for heart attacks and stroke outweighed any benefits of minor weight loss and wanted the drug to be pulled, while six recommended restricted sales and a black box warning. Two others said a warning and strict patient monitoring should be sufficient, while no panellists said no changes were necessary.
The vote "highlights the complexity of this scientific debate," said Eugene Sun, head of global pharmaceutical development at Abbott. He added that "we continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine" which is an important option "to treat a serious condition for which there are few treatment options".
He noted that Abbott has proposed "comprehensive risk management tools" to ensure doctors have the most relevant information for the continued appropriate use of the drug. Dr Sun added that sibutramine has been studied in more than 100 trials involving over 20,000 patients, in addition to those involved in SCOUT and the latter "did not directly assess the risk/benefit profile of the medication in patients for whom it is specifically intended".
As such, he argues, "its results cannot be readily extrapolated to the approved patient population, that is, patients who do not have a history of cardiovascular disease."
It is now up to the FDA to decide as to whether to keep Meridia on the market. It is not a big seller for Abbott which no longer promotes the drug in the USA and sales there this year are expected to be in the region of just $30 million.
--Links
www.fda.gov
www.abbott.com
**Published in "Pharma Times"
The US Food and Drug Administration's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-8 as to whether Meridia (sibutramine) should be withdrawn. Their review had been prompted by data from the SCOUT study which investigated long-term cardiovascular effects of sibutramine in 10,000 patients, enrolled for up to six years, with high cardiovascular risk.
Those findings demonstrated an increased risk of stroke or heart attack, and the drug was pulled in Europe earlier this year, where it was sold as Reductil, Reduxade and Zelium.
Eight panellists said the potential for heart attacks and stroke outweighed any benefits of minor weight loss and wanted the drug to be pulled, while six recommended restricted sales and a black box warning. Two others said a warning and strict patient monitoring should be sufficient, while no panellists said no changes were necessary.
The vote "highlights the complexity of this scientific debate," said Eugene Sun, head of global pharmaceutical development at Abbott. He added that "we continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine" which is an important option "to treat a serious condition for which there are few treatment options".
He noted that Abbott has proposed "comprehensive risk management tools" to ensure doctors have the most relevant information for the continued appropriate use of the drug. Dr Sun added that sibutramine has been studied in more than 100 trials involving over 20,000 patients, in addition to those involved in SCOUT and the latter "did not directly assess the risk/benefit profile of the medication in patients for whom it is specifically intended".
As such, he argues, "its results cannot be readily extrapolated to the approved patient population, that is, patients who do not have a history of cardiovascular disease."
It is now up to the FDA to decide as to whether to keep Meridia on the market. It is not a big seller for Abbott which no longer promotes the drug in the USA and sales there this year are expected to be in the region of just $30 million.
--Links
www.fda.gov
www.abbott.com
**Published in "Pharma Times"
Aspirin 'reduces bowel cancer risk'
Bowel cancer could be warded off by a low daily dose of aspirin, experts have declared.
Even people not at high risk of the disease could benefit from the painkiller, with the positive effects mounting up over time, according to the researchers, who were writing in the journal Gut. The team studied almost 2,800 people with bowel cancer and nearly 3,000 healthy people.
Their intake of non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin or ibuprofen, was taken into account.
Overall, 16% of people with bowel cancer were taking a low dose of aspirin compared with 18% of those in the healthy group.
People also responded to questions about their diet and lifestyle, which are known to have a big impact on the risk of bowel cancer.
The results showed that those who took a daily low dose of 75mg of aspirin had a lower chance of developing the disease.
Taking 75mg of aspirin every day for between one and three years led to a 19% reduction in risk.
For people taking the drug daily for three to five years, there was a 24% reduced risk, rising to 31% for those taking the drug for five to 10 years.
Doubling the dose did not lead to any extra benefit, suggesting “the lowest dose of aspirin is effective” and benefits were apparent even at one year, the experts said.
Even people not at high risk of the disease could benefit from the painkiller, with the positive effects mounting up over time, according to the researchers, who were writing in the journal Gut. The team studied almost 2,800 people with bowel cancer and nearly 3,000 healthy people.
Their intake of non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin or ibuprofen, was taken into account.
Overall, 16% of people with bowel cancer were taking a low dose of aspirin compared with 18% of those in the healthy group.
People also responded to questions about their diet and lifestyle, which are known to have a big impact on the risk of bowel cancer.
The results showed that those who took a daily low dose of 75mg of aspirin had a lower chance of developing the disease.
Taking 75mg of aspirin every day for between one and three years led to a 19% reduction in risk.
For people taking the drug daily for three to five years, there was a 24% reduced risk, rising to 31% for those taking the drug for five to 10 years.
Doubling the dose did not lead to any extra benefit, suggesting “the lowest dose of aspirin is effective” and benefits were apparent even at one year, the experts said.
**Published in "Nursing times"
FDA panel recommends withdrawing Avastin as breast cancer treatment
An FDA panel on Tuesday voted 12-1 to recommend to the agency that Roche's Avastin (bevacizumab) should no longer be approved for use in patients with breast cancer. Analysts noted that if the breast cancer indication for the drug were to be removed, it could reduce annual sales by about $1 billion.
The panel also voted 13-0 that a post-approval study of the drug failed to prove that the risks and adverse effect profile associated with use of Avastin in combination with docetaxel did not outweigh its benefits in this patient cohort and voted 12-1 against the same question in regards to Avastin in combination with other chemotherapy drugs. The recommendations echo those discussed in FDA staff review documents posted to the agency's website last week.
As a condition of its 2008 approval of Avastin, Roche was required to conduct follow-up studies to demonstrate the benefits of the drug when used in combination with conventional chemotherapy. However, two follow-up studies demonstrated that progression-free survival averaged 2.9 months, down from a median of 5.5 months observed in the initial study, and patients also reported significant side effects, including high blood pressure and fatigue.
Commenting on the data, Natalie Compagni Portis, the panel's patient representative, noted that "the study shows there's very little benefit to patients with significant toxicity risks and no clear survival benefit." However, Roche noted that it stands by its data demonstrating that Avastin provides a benefit for patients with advanced breast cancer, noting that "Avastin should be an option for patients with this incurable disease." The FDA will make a decision on the use of the drug in this indication by September 17.
The drug has global sales of $5.9 billion.
Reference Articles
Roche’s Avastin fails to win FDA panel backing in breast cancer - (Bloomberg)
US panel rejects Roche's Avastin for breast cancer - (Forexpros)
Genentech provides update from Avastin FDA Advisory Committee meeting - (Genentech)
Genentech disappointed with FDA panel on Avastin - (MarketWatch)
FDA panel: Avastin adds no benefit to chemotherapy for breast cancer - (SmartMoney)
Panel urges FDA to revoke approval of drug for breast cancer treatment - (The New York Times)
FDA panel urges Avastin be disallowed as breast cancer treatment - (USA Today)
FDA panel: Study did not show benefit with Avastin - (Yahoo!News)
**Published in "First Word"
The panel also voted 13-0 that a post-approval study of the drug failed to prove that the risks and adverse effect profile associated with use of Avastin in combination with docetaxel did not outweigh its benefits in this patient cohort and voted 12-1 against the same question in regards to Avastin in combination with other chemotherapy drugs. The recommendations echo those discussed in FDA staff review documents posted to the agency's website last week.
As a condition of its 2008 approval of Avastin, Roche was required to conduct follow-up studies to demonstrate the benefits of the drug when used in combination with conventional chemotherapy. However, two follow-up studies demonstrated that progression-free survival averaged 2.9 months, down from a median of 5.5 months observed in the initial study, and patients also reported significant side effects, including high blood pressure and fatigue.
Commenting on the data, Natalie Compagni Portis, the panel's patient representative, noted that "the study shows there's very little benefit to patients with significant toxicity risks and no clear survival benefit." However, Roche noted that it stands by its data demonstrating that Avastin provides a benefit for patients with advanced breast cancer, noting that "Avastin should be an option for patients with this incurable disease." The FDA will make a decision on the use of the drug in this indication by September 17.
The drug has global sales of $5.9 billion.
Reference Articles
Roche’s Avastin fails to win FDA panel backing in breast cancer - (Bloomberg)
US panel rejects Roche's Avastin for breast cancer - (Forexpros)
Genentech provides update from Avastin FDA Advisory Committee meeting - (Genentech)
Genentech disappointed with FDA panel on Avastin - (MarketWatch)
FDA panel: Avastin adds no benefit to chemotherapy for breast cancer - (SmartMoney)
Panel urges FDA to revoke approval of drug for breast cancer treatment - (The New York Times)
FDA panel urges Avastin be disallowed as breast cancer treatment - (USA Today)
FDA panel: Study did not show benefit with Avastin - (Yahoo!News)
**Published in "First Word"
Glaxo and Genmab drop IV version of immune drug
GlaxoSmithKline PLC and Genmab A/S will end the development of an intravenous form of a drug intended to treat autoimmune diseases like lupus and multiple sclerosis, and focus on an injectable version.
The companies said an injectable version of Arzerra should be more convenient for patients and have fewer side effects. The drug can also be used to treat rheumatoid arthritis.
Based on from a recent study of Arzerra in multiple sclerosis, GlaxoSmithKline will start a new trial of the drug in 2011. The results from that study were announced Friday. GlaxoSmithKline is solely responsible for developing the drug as a treatment for autoimmune disorders. The companies are codeveloping the drug as a treatment for cancer.
Arzerra is approved as a treatment for chronic lymphocytic leukemia in patients who have received at least one previous therapy. The companies are also testing it as a treatment for newly diagnosed chronic lymphocytic leukemia, and lymphoma.
**Published by "AP"
The companies said an injectable version of Arzerra should be more convenient for patients and have fewer side effects. The drug can also be used to treat rheumatoid arthritis.
Based on from a recent study of Arzerra in multiple sclerosis, GlaxoSmithKline will start a new trial of the drug in 2011. The results from that study were announced Friday. GlaxoSmithKline is solely responsible for developing the drug as a treatment for autoimmune disorders. The companies are codeveloping the drug as a treatment for cancer.
Arzerra is approved as a treatment for chronic lymphocytic leukemia in patients who have received at least one previous therapy. The companies are also testing it as a treatment for newly diagnosed chronic lymphocytic leukemia, and lymphoma.
**Published by "AP"
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