Cecil. Medicina Interna. 23 ed.


CECIL. Tratado de Medicina Interna, 2 vols. + Expert Consult Premium, 23e (Spanish Edition)

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Edicion numero 23 de esta prestigiosa obra de referencia que constituye uno de los mejores tratados de Medicina Interna de la literatura medica, en cuanto a su longevidad, su exhaustividad y utilizacion por parte tanto de profesionales como de estudiantes en el entorno internacional.
La obra presenta, de manera definitiva, imparcial y basandose en la evidencia, la evaluacion y gestion de todas las enfermedades, asi como las referencias bibliograficas mas pertinentes y explicaciones acerca de su importancia clinica.
Esta edicion incluye Expert Consult online, que permite acceder a todo su contenido en version inglesa, exportar ilustraciones para usar en presentaciones electronicas y ver videos que explican paso a paso los procedimientos clave.
En cuanto a las novedades de esta edicion, se ha potenciado su rapida consulta y versatilidad. La obra presenta un nuevo formato de capitulo que resalta la informacion clinica mas relevante, con algoritmos que simplifican la toma de decisiones.
El equipo editorial esta formado por autenticos lideres de la medicina y reconocidos profesionales del campo de la Medicina Interna, garantizandose asi el rigor, la experiencia y fiabilidad del contenido.
La obra presenta casos de estudio y mas de 1.000 preguntas y respuestas de revision para evaluar los conocimientos adquiridos. Incluye nuevas recomendaciones practicas, terminos de busqueda y los ultimos avances clinicos vitales se han plasmado regularmente en cada capitulo.

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Fisiologia Humana


Fisiologia Humana 3 Ed
Jesús A F Tresguerres

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Tercera edición del primer tratado de Fisiología Humana escrito por prestigiosos especialistas de habla hispana.
- La obra ha sido totalmente revisada y actualizada.
- Se ha mejorado su nivel didáctico y se ha procurado mantener una homogeneidad entre todos los capítulos que componen la obra.
- Se han modificado totalmente los apartados de neurofisiología, sangre y nutrición.
- Al igual que en la segunda edición, en el apartado del sistema respiratorio se mantienen los antiguos sistemas de unidades junto con sus equivalencias en el S.I.
- El apartado del sistema digestivo se ha reorganizado totalmente.
- Se incluyen nuevos autores de México y de Argentina de reconocido prestigio en los temas que tratan.
- Como en ediciones anteriores mantiene el enfoque de libro de texto adaptado a los programas de la asignatura de fisiología.
- Contiene gran cantidad de esquemas e ilustraciones a dos colores que ayudan al estudiante a entender y clarificar los contenidos.
Medicina -ciencias basicas-FISIOLOGIA

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Gracias P.Cicarelli.

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Bioestadistica para no estadisticos


Bases Para Interpretar Artículos Científicos

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si quieren ver el contenido
http://www.sciencedirect.com/science/book/9788445817827


La obra se presenta como un manual práctico en donde se recogen desde los principios y conceptos básicos de la estadística hasta los diferentes diseños bajo los que se puede llevar a cabo un ensayo clínico, todo ello desde un punto de vista finalista.
Su organización y enfoque es muy didáctico, con una clara jerarquización de contenidos, abundancia de ejemplos y contraejemplos y una serie de ejercicios propuestos con sus correspondientes soluciones para autoevaluación. También se ofrece información acerca de una serie de lecturas recomendadas y webs de interés.
La obra se encuentra organizada en 12 capítulos en donde se aborda progresivamente el papel indispensable de la bioestadística en el campo de las Ciencias de la Salud.
El libro es de interés para todos aquellos estudiantes de Medicina, Odontología y Farmacia, para los médicos en su período de formación y para aquellos especialistas (epidemiólogos, farmacólogos) que precisen una revisión y actualización de sus conocimientos y que encontrarán en él una herramienta práctica para su práctica clínica diaria.

Gracias P.Cicarelli ( Pases Médicos )

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US seeks new review of easier-to-spread bird flu


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WASHINGTON — A scientist who created an easier-to-spread version of the bird flu said his work isn’t as risky as people fear. The U.S. government is asking its biosecurity advisers to reconsider if the research should be made public.

Bird flu only occasionally sickens people, mostly after close contact with infected poultry, but it can be deadly when it does. Scientists have long feared it might mutate to spread more easily and thus spark a pandemic. Researchers in the Netherlands and Wisconsin were studying how that might happen when they created bird flu strains that at least some mammals — ferrets — can spread by coughing or sneezing.

The work triggered international controversy. U.S. health officials urged the details be kept secret so would-be terrorists couldn’t copy the strains, and critics worried that a lab accident might allow deadly viruses to escape.

But contrary to public perceptions, the airborne bird flu didn’t kill the ferrets, Dr. Ron Fouchier of the Netherlands’ Erasmus University told a meeting of U.S. scientists Wednesday. In fact, he said those previously exposed to regular flu were protected from severe disease.

Fouchier said publishing the research would help other scientists monitor the so-called H5N1 bird flu for similar mutations in the wild, and to test vaccines and treatments.

A federal biosecurity panel first sounded the alarm about the research, concerned about the easier mammal-to-mammal spread. The U.S. is asking that panel to conduct another review of the two laboratories’ work, Dr. Anthony Fauci of the National Institutes of Health said Wednesday. He said the board should hear some new data that came to light at a recent closed-door meeting of the World Health Organization, where international flu experts concluded the research eventually should be published.

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CDC: 2011-2012 Flu Season


2011-2012 Flu Season

This page provides information about the 2011-2012 influenza season, including information about the season’s vaccines, vaccination recommendations and disease activity.

This year’s recommendations are issued in a shortened format because there are relatively few changes from the 2010-2011 recommendations.

Questions & Answers

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Check Up: So far, very little flu


CDC Director Gerberding Gives Green Light to G...
CDC Director Gerberding Gives Green Light to Gardasil then Goes to Work for Merck (g1a2d0049c1) (Photo credit: watchingfrogsboil)

Check Up: So far, very little flu

The U.S. Centers for Disease Control and Prevention has confirmed what you already guessed: This has been a remarkably mild flu season.
The influenza virus likes cold weather, so infections normally occur from October through March. But technically, the flu season doesn’t start until labs that test respiratory swabs from sick people find the virus in more than 10 percent of the samples.
This season, that threshold wasn’t reached until the week ended Feb. 11, making this the kindest flu spell in 29 years.
Pennsylvania, for example, had only 80 confirmed cases in all of January – barely more than one achy, feverish, nauseated citizen per county.
What’s going on?
No one really knows.
“With flu, everything is unpredictable,” said immunologist Scott Hensley, a flu expert at the Wistar Institute in Philadelphia. “I don’t think we’re out of the woods; it could just be a delayed season.”
Then again, maybe the flu has been as scarce as snow because snow has been scarce.
“Flu is more easily transmitted in colder temperatures. This has been a mild winter,” Hensley said.
Another theory is that the population has high levels of immunity to the influenza strains now circulating, which include the one that caused the 2009 “swine flu” pandemic. Because the strains have been so stable, people have had time to develop antibodies against them. Vaccination has also boosted immunity.
Although Hensley subscribes to this theory, he adds a caveat: “If that’s true . . . the virus will start mutating” to evade human defenses. “A novel strain might emerge in the next couple of months.”
While there’s no room for complacency, let us celebrate the signs, monitored by the CDC, that the flu has given the nation a respite:
One person per 100,000 has been hospitalized with the flu since October. That’s a 95 percent drop from last season’s rate of 22 people per 100,000.
Only 1 percent to 2 percent of visits to doctors since October have been for flulike illness. The usual rate is 3 percent to 8 percent.
This flu season, there have been three flu-related deaths among children, compared with 122 pediatric deaths last season – and 348 during the 2009 pandemic.
- Marie McCullough

Read more: http://www.philly.com/philly/health/20120227_Check_Up__So_far__very_little_flu.html#ixzz1neP8n4sM Watch sports videos you won’t find anywhere else

Posted in CDC, Conditions and Diseases, diabetes, Diabetes mellitus type 2, Endocrine Disorders, flu, Health, HPV vaccine, Human papillomavirus, Pancreas | Leave a comment

Final Statement Of The International Indigenous Forum At WIPO – IGC 20 – Indigenous Peoples Issues and Resources


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Posted: 24 Feb 2012 07:25 AM PST
Final Statement Of The International Indigenous Forum At WIPO – IGC 20
WORLD INTELLECTUAL PROPERTY ORGANISATION
Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore
Twentieth Session Geneva, February 14 to 22, 2012
We, the Indigenous Peoples and Nations present at the International Indigenous Forum during WIPO IGC 20, have evaluated our participation in all of the proceedings of this Committee, and we note with concern the continued reduction of the amount and level of our participation in this process.
We Indigenous Peoples have participated as experts in the IGC sessions, we have worked in good faith, and we have made efforts over the years to submit to the IGC sessions our collectively developed and sound proposals, which have been ignored or left in brackets in negotiation texts.
The IGC, in its overall procedures, has systematically ignored our rights, as Indigenous Peoples and as Nations with internationally recognized collective rights, to self-determination and full and equitable participation at all levels.
The draft study of the Secretariat on the participation of observers before the IGC does not contain modifications proposed by the Indigenous Peoples to WIPO’s rules of procedure. The States have obligations under their constitutions that have not been observed in the IGC, nor have they submitted proposals that could resolve the existing deficiencies in order to improve our participation.
Distinguished delegates: we, the Indigenous Peoples, are the titleholders, proprietors and ancestral owners of traditional knowledge that is inalienable, nonforfeitable and inherent to the genetic resources that we have conserved and utilized in a sustainable manner within our territories. For this reason, we appeal to the States to acknowledge that the discussion on intellectual property rights and genetic resources should include Indigenous Peoples on equal terms with the States since the work will directly impact our lives, our lands, our territories and resources, and will reach to the very heart of our cultures, which are the inheritance of future generations.
Therefore, the Indigenous Peoples present at IGC 20 have reflected seriously on our role in this process and have decided, unanimously, to withdraw our active participation in the work developed by this Committee until the States change the rules of procedure to permit our full and equitable participation at all levels of the IGC and until the instruments recognize and are consistent with the existing international frameworks for the rights and interests of Indigenous Peoples within the scope of the IGC.
Thank you, Mr. Chairman.
February 21, 2012
vía International: Final Statement Of The International Indigenous Forum At WIPO – IGC 20 – Indigenous Peoples Issues and Resources.

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Se crea un registro de Desensibilización a Medicamentos Oncológicos


Martes, Febrero 14, 2012

Via: Daniel Dosmobian
registro
España se convierte en el primer país europeo en contar con un Registro de Desensibilización a Medicamentos Oncológicos.
Este “primer y único” Registro Europeo de Desensibilización a Medicamentos Oncológicos ha sido puesto en marcha por la Sociedad Española de Alergología e Inmunología Clínica (SEAIC),  y su creación se debe al aumento de las enfermedades oncológicas y la frecuencia de reacciones de hipersensibilidad por fármacosconsiderados arsenal de primera línea.
Con este registro se prentende reunir información sobre todos los protocolos de desensibilización con medicamentos oncológicos que se realizan en España.
Según datos de la SEAIC la alergia a medicamentos oncológicos constituye el tercer motivo de consulta más frecuente, de hecho se calcula que entre el 15% y el 25% de la población puede sufrir alguna reacción a la medicación utilizada que, en la mayoría de las ocasiones, puede derivar en una reacción alérgica.
Para evitar la hipersensibilidad de estos medicamentos se recomienda evitar el contacto con el fármaco causante de la reacción y extender esta precaución al grupo de medicamentos relacionados, mientras se busca alternativas seguras de tratamiento.
Desgracidamente hay alérgicos a fármacos que no pueden ser tratados de manera adecuada con otro producto o una familia alternativa. En estos casos, se puede optar por ladesensibilización al agente terapéutico responsable de la alergia que, según explica María José Torres, coordinadora del Comité de Alergia a Medicamentos de la SEAIC,consiste en “inducir de forma temporal una tolerancia al fármaco causante de la alergia, permitiendo así tratar de forma adecuada a los pacientes con medicamentos a los que previamente habían mostrado una reacción de hipersensibilidad”.

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Un estudio afirma que la OMS exagera la letalidad del virus H5N1


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En pleno debate sobre si una variante del virus aviar H5N1 puede ser tan peligrosa como la bomba atómica, un grupo de científicos de EEUU sugiere hoy que todas las cifras que maneja la Organización Mundial de la Salud (OMS) sobre el virus están equivocadas. Los investigadores, liderados por el jefe de Microbiología del Hospital Monte Sinaí de Nueva York, Peter Palese, sostienen que la inmensa mayoría de las infecciones por H5N1 han sido débiles y han pasado desapercibidas para la OMS, que admite menos de 600 casos en humanos, con una mortalidad de casi el 60%. Palese y los suyos creen que “millones” de personas han sido infectadas por el virus, sin desarrollar síntomas, por lo que la letalidad del virus estaría sobredimensionada por la OMS en varios órdenes de magnitud.
Estos científicos escépticos publican hoy en la revista Science un metaanálisis de 20 estudios previos que buscaron anticuerpos generados contra el H5N1 en la sangre de más de 12.500 personas. El examen muestra que entre el 1% y el 2% de los participantes en los ensayos presentaba evidencias en su suero sanguíneo de haber sufrido una infección por H5N1 en el pasado. Para los autores, estos datos muestran que “los virus aviares H5N1 pueden causar infecciones leves o subclínicas en humanos que ahora mismo no se tienen en cuenta” por los “estrictos” criterios de la OMS. Los estudios que han analizado los investigadores de EEUU se llevaron a cabo en países con presencia del virus, como China, Camboya, Vietnam, Indonesia y Nigeria. En estos países el virus ha saltado de aves a personas, pero todavía no entre humanos.
La OMS admite menos de 600 casos, con una mortalidad de casi el 60%
Palese es uno de los científicos que han defendido con más vehemencia la publicación de dos estudios sobre variantes de la gripe aviar H5N1 contagiosas entre mamíferos, después de que el Gobierno de EEUU ordenara retenerlos ante el miedo a que facilitaran un atentado terrorista con un supervirus. Lleva meses denunciando que las cifras de mortalidad de la OMS están infladas y que las políticas de actuación a partir de estos números son erróneas.
La tesis de Palese, apoyado en esta guerra por su colega Taia Wang, es que las autoridades médicas no se enteran de los casos leves de gripe aviar en humanos que surgen en aldeas remotas de Vietnam o Nigeria. Sólo les llegan casos muy graves.
No todos los investigadores comparten las ideas de Palese, según explica Juan Ortín, uno de los mayores expertos españoles en gripe. Para este científico, del Centro Nacional de Biotecnología, perteneciente al CSIC, “todo depende de cómo se quiera mirar”. El virus aviar H5N1, explica, no se transmite bien a los humanos, pero cuando esto ocurre la letalidad es muy alta. Esta es la tesis de la OMS.
Los infectados sin síntomas en aldeas remotas pasan desapercibidos
Sin embargo, Palese interpreta los anticuerpos contra el virus en la sangre de cientos de las 12.500 personas analizadas como una señal inequívoca de infección por H5N1. “Sin embargo, si la dosis de virus que recibe la persona es muy baja, se puede interpretar que no llega a infectar”, aunque haya anticuerpos. Lo que para Palese es infección, para la OMS no lo es. “Es un debate de interpretaciones más que de datos, porque no sabemos cómo se han infectado los sero-positivos, si del todo o por un pequeño contacto”, opina Ortín. En cualquier caso, según alertan muchos expertos, aunque no sea tan letal como parece, el H5N1 sigue siendo una amenaza, sobre todo si muta para contagiarse entre personas.

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Biological clock’ is linked to heart attacks


‘Biological clock’ is linked to heart attacks

Abnormal heartbeat occurs most frequently in the morning — and to a lesser degree in the evening hours — and causes a high number of deaths.


clock
BIOLOGICAL CLOCK: The discovery opens up intriguing paths of research, in pinpointing individuals at risk of nocturnal death and devising drugs to shield them. (Photo: Mike Warot/flickr)
Scientists on Wednesday said they had uncovered the first molecular proof that the “biological clock” is linked to a type of sudden, fatal heart attack.
Ventricular arrhythmia, or abnormal heartbeat, occurs most frequently after waking in the morning — and also to a lesser degree in the evening hours — and causes a high number of deaths.
Reporting in the journal Nature, researchers in the United States said they had uncovered the first molecular link between this risk and circadian rhythm, the term by which biological processes vary according to a 24-hour period.
The finger points at levels of a protein called Klf15, they said.

Abnormal heartbeat occurs most frequently in the morning — and to a lesser degree in the evening hours — and causes a high number of deaths.


Previous research has found Klf15 to be a circadian controller — and, startlingly, is also lacking among some patients with heart failure.
The team created mice that had been genetically engineered to either lack Klf15 or make the protein excessively.
In both cases, the rodents had a much higher risk of arrythmias compared to normal counterparts.
“It is the first example of a molecular mechanism for the circadian change in susceptibility to cardiac arrhythmias,” said Xander Wehrens of Baylor College School of Medicine in Houston, Texas.
“If there was too much Klf15 or none, the mice were at risk for developing the arrhythmia.”
Klf15 is only one step in a complex molecular cascade, the researchers believe.
It controls another protein, KChIP2, which affects potassium-generated electrical current that flows though heart muscle cells called cardiac myocytes.
When levels of KChIP2 fluctuate, this causes electrical instability in the myocytes.
As a result, the heart muscle’s action becomes impaired and it takes longer (or conversely, less time) to empty the ventricle — the heart’s pumping chamber. The heart loses the regularity of the beat and labours to pump blood efficiently.
Co-author Mukesh Jain of the Case Western Reserve University School of Medicine in Cleveland,Ohio said that further work could well uncover other circadian-related causes.
The discovery opens up intriguing paths of research, in pinpointing individuals at risk of nocturnal death and devising drugs to shield them, Jain added.
Copyright 2012  AFP Global Edition

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When it Comes to Colonoscopies, Recession and Co-Pays Matter


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Source: http://blogs.wsj.com/health/
By Katherine HobsonBy a number of indicators, people have been using fewer medical services during the economic downturn.Screening colonoscopies apparently aren’t immune to that trend, according to a study appearing in the March issue of Clinical Gastroenterology and Hepatology. The study finds that during the recent recession, commercially insured Americans had fewer of the tests to screen for cancer — a test that saves lives, according to research published just this week.According to the analysis, there were about 500,000 fewer screening colonoscopies among commercially-insured people aged 50 to 64 than you’d expect during the most recent recession, which officially lasted from December 2007 to June 2009. (The study used the National Bureau of Economic Research’s official designation for the recession.)The U.S. Preventive Services Task Force recommends colorectal cancer screening using several methods, including colonoscopy, for adults aged 50 to 75. The analysis didn’t find that people forgoing colonoscopy were instead using other, cheaper methods, such as fecal occult blood tests or sigmoidoscopy.Researchers looked at the rates of screening before and after the recession, then applied their findings to population data to come up with an estimate of 516,309 colonoscopies that would have occurred absent the downturn. Data came from 106 health plans and added up to a nationally representative picture of the commercially insured population, the authors say.It doesn’t include people who didn’t have a screening colonoscopy because they lost insurance coverage during the recession, says Spencer Dorn, an author of the study and an assistant professor of medicine in the division of gastroenterology at the University of North Carolina at Chapel Hill. And it doesn’t include Medicare or Medicaid beneficiaries.The analysis also found that when it comes to colonoscopy, cost sharing appears to be a deterrent. No matter the economic climate, people with higher out-of-pocket costs — $300 or more for the procedure — were less likely to be screened than those with lower costs, defined as $50 or less. That gap “widened during the recession,” says Dorn.Under the health-care overhaul law, colonoscopy — and other preventive services — must be covered with no cost sharing by Medicare, Medicaid and new private-insurance plans. (“Grandfathered” plans that haven’t significantly changed their design are exempt.)The drop in utilization seen in the study “could have negative consequences down the line,” says Dorn, in terms of cancers being caught at a later stage. (The screening study out this week suggests it might also lead to deaths from the disease.)The CDC last year reported an increase in screening rates for colorectal cancer from 2002 to 2010, but that estimate included all 50- to 75-year-olds and didn’t break down what happened during the intervening years.

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Posted in Clinical Gastroenterology and Hepatology, Colonoscopy, Colorectal cancer, Insurance, Medicaid, Medicare, National Bureau of Economic Research, University of North Carolina at Chapel Hill | Leave a comment

Internet en la consulta


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Transmissible H5N1 – If they publish, wil we perish ?


BioMed Central Blog 

TUESDAY FEB 21, 2012
Two influenza research papers remain suspended in press since the US government’s request for their redaction, made on the recommendation of the National Science Advisory Board for Biosecurity (NSABB) late last year. Were this to be upheld, it would be an unprecedented example of censorship of the scientific literature, justified as a necessary measure to protect against bioterror. A comment published in BMC Biology by Peter Doherty and Paul Thomas counters this justification, arguing that although the work raises legitimate safety concerns, full publication of these studies would not add significantly to the vanishingly small risk that influenza might be effectively harnessed to nefarious ends.  By contrast, Doherty and Thomas see it as imperative that the research community continue to investigate, without undue impediment, how highly pathogenic avian influenza might adapt to become transmissible in mammals, so that we are better able to monitor and counter the significant risk that this might happen naturally, without any human design or intent.

The arguments against censorship would seem to be gaining momentum. Last week the World Health Organization convened a meeting which brought together a group of influenza researchers and global public health experts with key players: the lead authors of the two papers, representatives of those who funded the work, editors from the journals concerned (Science and Nature), and Paul Keim, chairman of the NSABB. Keim stood by the original recommendation for redaction and the balance of reasoning behind it, but the workability of  making the full data available on a “need to know” basis was questioned, and a consensus reached that it would be better to delay publication of the papers until safety concerns were addressed and they could be published in full.

A second outcome of last week’s meeting is an extension of the voluntary moratorium on research to create and study transmissible strains of avian influenza, pending the further discussion of how safety issues should be dealt with. The virus already created in Ron Fouchier’s laboratory was obtained by serial passage in ferrets, is transmitted through the air between their cages, and is highly pathogenic so biosafety issues are an obvious concern; the study demonstrates that such adaptation can occur, could thus occur in nature, and identifies a specific pathway of mutation by which it can occur. The virus created by Yoshihiro Kawaoka is no more pathogenic in ferrets than the H1N1 2009 pandemic virus from which it was derived, but instead of H1, it bears the H5 haemagglutinin molecule of avian H5NA. Both studies show that H5-bearing viruses can be transmissible in mammals and therefore pose a risk to be monitored, and against which we should prepare.

Penelope Austin

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WONCA: Journals Alerts


Journal Watch

Clinical Reviews

Alerta de Journal en Espanol

Pearls

HelpDesk Answers

Journal Alarme auf Deutsch

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Global storage conditions for medicines (9)


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Global storage conditions for medicines (9)
————————————————

The question of storage instructions is a question of money, it is a question of harmonisation, and it is a question of communication.

When global manufacturers send packages labelled with storage instructions for climate zone II to the markets in climate zones IVa and IVb, it’s because they don’t find it necessary to use money on relevant packaging and on relevant stability studies. And the buyers and regulatory institutions in the countries in these climate zones don’t have the money to pay for necessary quality.

The International Conference on Harmonization, ICH, and the World Health Organisation, WHO have discussed this question for several years, with the ASEAN countries giving their view. But the best they have come up with for climate zone IVb (hot and very humid climate) is accelerated (not long or intermediate term) testing at 40oCelcius at 75% relative humidity.
The recommended storage instruction for medicines filling the requirements for climate zone IVb is ‘Do not store above 30oC’

Pharmacists are customed to get exact information and figures, and the evil of evidence is kind of reinforcing this.

Most of the label elements on the packages are accurate and not interpretable. But now we see that the storage instructions are meant to be interpreted. The public is not aware of that, and not even the pharmacists of the world. The necessary knowledge for interpretation is not widespread. And the manufacturers deny to take economic liability for medicines that has been outside the storage instruction temperature.

Stein Lyftingsmo
Hospital Pharmacy of Elverum, Norway
www.lyftingsmo.no
“Stein Lyftingsmo” <stein@lyftingsmo.no>


In Spanish: 



La cuestión de las instrucciones de almacenamiento es una cuestión de dinero, se trata de una cuestión de la armonización, y es una cuestión de comunicación. 

Cuando los fabricantes mundiales de envío de paquetes etiquetados con las instrucciones de almacenamiento para el clima de la zona II a los mercados en el clima de las zonas IV bis y IV ter, es porque no encuentran necesario el uso de dinero en el embalaje correspondiente y en los estudios de estabilidad pertinentes. Y los compradores y las instituciones reguladoras en los países en estas zonas de clima no tiene el dinero para pagar por la calidad necesaria. 

La Conferencia Internacional de Armonización ICH, y la Organización Mundial de la Salud, la OMS ha discutido esta cuestión durante varios años, con los países de la ASEAN que dan su punto de vista. Pero lo mejor que han llegado a la zona climática IVb (clima caluroso y muy húmedo) se acelera (no largo o mediano plazo) las pruebas en 40oCelcius a 75% de humedad relativa. 
La instrucción de almacenamiento recomendada para los medicamentos que llenan los requisitos para el clima de la zona IVb es ‘No almacenar por encima de 30 º C ” 

Los farmacéuticos son customed para obtener información exacta y figuras, y el mal de las pruebas es una especie de refuerzo de este. 

La mayoría de los elementos de la etiqueta de los paquetes son exactos y no interpretable. Pero ahora vemos que las instrucciones de almacenamiento están diseñados para ser interpretado. El público no es consciente de ello, y ni siquiera los farmacéuticos del mundo. El conocimiento necesario para la interpretación no está muy extendida. Y los fabricantes niegan a asumir la responsabilidad económica de los medicamentos que ha estado fuera de la temperatura de las instrucciones de almacenamiento. 

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Guias ADA 2011


De momento hay que esperar un poco para la versión española, pero para aquellos que quieran estar al tanto de los cambios, desde la web del rincón docente de MFyC nos hacen un resumen de ellos, que por este año son más bien pocos. Os cuelgo el link a continuación:
Coincide el tema con la reciente sesión bibliográfica de hoy mismo, que colgaré a lo largo del fin de semana, pero el tema lo tenía ya preparado. Por completar el tema, me ha gustado la serie de dos artículos que se ha publicado en el blog de Hemos leído acerca del aumento de utilización de los análogos de insulina, correlacionando dicha circunstancia con aspectos económicos y asistenciales. Los enlaces son:
Posted in ADA, Diabetes Care, Diabetes Mellitus, Guias Clinicas, hemos leido, Rincon Docente | Leave a comment

FDA sets draft rules for biotech drug copies


Biogen Idec
Image via Wikipedia

Thu Feb 9, 2012 4:46pm EST

(Reuters) – The Food and Drug Administration’s long-awaited guidelines for the sale of lower-cost versions of biotechnology drugs leave open the possibility that some products might not need to be tested in humans.

The proposed rules, issued on Thursday, require studies showing that the generic copies are “highly similar” to the originals, but there are several ways that might be proven.

Because of their complexity, generic copies of biotech drugs – first introduced in the 1980s – are known as “biosimilars.”

“We’re trying to send the signal that it’s not one-size-fits-all. It’s product-by-product,” Rachel Sherman, director of the FDA’s office of medical policy, said during a conference call with reporters.

The worldwide market for copies of biotech medicines will grow to $3.7 billion by 2015, from just $243 million in 2010, as more than 30 branded biologics with sales of $51 billion lose patent exclusivity, according to market analysis firm Datamonitor.

The FDA rules would set “an abbreviated pathway” to approval that would consider factors including a product’s complexity, formulation and stability, the agency said.

The proposal “reads largely as we expected, although a few points read as slightly more friendly to the generics industry,” ISI Group analyst Mark Schoenebaum said in a note to clients.

The FDA said it would decide on the “extent and scope of animal and clinical studies” needed for approval once it has considered other analytical data. The agency said it has yet to receive an application for a biosimilar drug, but nine applications have been filed for clinical trials.

Manufacturers will have the option of asking the FDA to deem their copies “interchangeable” with a brand-name drug, but the `agency said that would require additional clinical studies.

Makers of branded biotech drugs have argued that full-scale human trials need to be conducted before a rival version of an existing biologic drug should be allowed on the market.

Despite such qualms, biotech drug makers including Amgen Inc, Merck & Co and Biogen Idec are working to produce rival versions of biotech drugs made by competitors.

“While the documents provide a roadmap, they are sufficiently vague as to give FDA leeway for case by case assessments of each proposed biosimilar along their respective development paths,” said Wells Fargo analyst Brian Abrahams.

The Congressional Budget Office has estimated that the United States could save $25 billion from the use of biosimilars over 10 years.

European regulators have already approved cheaper versions of some biotech drugs.

The FDA said advances in science and manufacturing may facilitate fingerprint-like analysis of therapeutic protein products, which may allow for a more selective approach to any animal or human studies.

Unlike conventional, easy-to-replicate, chemical-based drug compounds, biotech drugs are derived from living organisms, such as proteins, and are often produced using recombinant DNA technologies.

Once a traditional pill loses patent protection, there is a quick regulatory pathway for generic drugmakers to sell much cheaper versions of the branded medicine. Similar U.S. guidelines for biotech drugs have been under negotiation for several years.

Biosimilar drugs are expected to sell at discounts of 25 to 45 percent to branded rivals, compared with generic versions of traditional pills that often sell for one-tenth the price of the branded product.

Under the U.S. healthcare reform law passed in 2010, brand-name biotech drugs – ranging from relatively simple molecules like insulin to complex antibodies used to treat cancer – were granted a 12-year period of market exclusivity, after which generic versions can be sold.

Opposing trade groups – the Biotechnology Industry Organization and the Generic Pharmaceutical Association – said they are reviewing the proposed rules.

The generic drugs group said it was pleased with the FDA’s action, which it called “an important step in getting these affordable, lifesaving medicines into the hands of doctors and patients.”

The FDA will require that biosimilar manufacturers provide a post-marketing safety monitoring program, which in some cases may include long-term clinical studies.

The agency is accepting public comment on the draft guidance documents for the next 60 days.

(Reporting by Deena Beasley in Los Angeles, Additional reporting by Bill Berkrot in New York and Anna Yukhananov in Washington; Editing by Gerald E. McCormick, John Wallace and Matthew Lewis)

Posted in Amgen, Biogen Idec, Biotechnology, Brian Abrahams, Congressional Budget Office, FDA, Food and Drug Administration, Wells Fargo | Leave a comment

Webeando en la blogosfera hispana


English: photo of someone wearing a Google NOO...
Image via Wikipedia

Dando una vuelta , visitando blogs amigos, van solo algunos (no es facil elegir), de los post mas interesantes de la blogosfera hispana.

Rafa Cofiño en Medicina Comunitaria con una Guia de Salud para el medio Penitenciario…..http://goo.gl/2GwsT
En salud con cosas, como no extasiarse con el titulo http://saludconcosas.blogspot.com/2012/02/diez-blogs-de-salud-y-una-cancion.html
Rafa Bravo una breve pero linda publicacion que dio en llamar Google diagnostics ( todavia no entendi el porque, aparte de su mapa ), en su blog por supuesto: http://goo.gl/5Vkyl 

Y da para mas, asi que les dejo este listado para que elijan y vayan leyendo durante el dia. Que tengo un dia pesado de trabajo ;-)

Què és l’atenció de “gran valor” amb consciència dels costos?
L’ocupació excessiva d’algunes proves és causa de l’increment dels costos en l’atenció mèdica. L’American College of Physicians va convocar a un grup d’experts amb l’objectiu d’identificar proves d’ús freqüent que al seu judici es sobreutilitzen….
No son médicos
.Leyre Pajín, ex-Ministra de SanidadHoy los medios, esos que cada mañana parecen fundirse en el clamor de escándalos que con toda probabilidad se habrán olvidado mañana, recogen y hablan del falso título de Medicina de Tomás Burgos Gallego, reci…
José Luis Llisterri es el nuevo presidente de Semergen
La Sociedad Española de Médicos de Atención Primaria (Semergen), que celebró el sábado las elecciones para renovar su junta directiva, ya tiene nuevo presidente: José Luis Llisterri, hasta ahora coordinador del Grupo de Hipertensión Arterial de Semergen y médico de Familia del Centro de Salud Ingeniero Joaquín Benlloch (Valencia). El recuento [...]
Los rurales están a la espera del Consejo Interterritorial
http://www.elglobal.net/articulo.aspx?idart=595892&idcat=784&tipo=2
PFyV integra la sostenibilidad ambiental y humana
Damos las gracias al redactor de Diario Jaén Jesús Vicioso del Hoyo por elaborar con cariño y esmero el perfil de los candidatos a parlamentarios andaluces por la provincia de Jaén. Gracias a este reportaje de Diario Jaén, los ciudadanos acceden a su derecho a la información para que puedan conformar su libre opción [...]
Estadísticas Sanitarias Mundiales 2011
Ya están disponibles las “Estadísticas Sanitarias Mundiales 2011″. El documento contiene la recopilación anual que la OMS prepara a partir de los datos recibidos de sus 193 Estados Miembros e incluye un resumen de los avances realizados hacia la consecución de … Sigue leyendo →
La blogosfera pediátrica se hizo presente
Estos días de febrero se paraliza la pediatría para poder asistir en masa al curso de la Asociación Española de Pediatría de Atención Primaria. Un curso de gran calidad y donde lo que predomina es la ciencia, no es un …Sigue leyendo →
L’estudiant t
The Unreasonable Ineffectiveness of Fisherian ‘Tests’ in Biology, and Especially in Medicine. La solidesa d’alguns raonaments científics, en economia i en medicina, acaba necessitant de… [[ This is a content summary only. Visit my website for full…
¿Cómo debería ser una buena canguro?
Una buena canguro debería: Escuchar atentamente a los niños y observar su comportamiento Establecer unos límites razonables para los niños y hacerlos respetar consistentemente Explicar a los niños por qué ciertas cosas no están permitidas y o…
RCP al ritmo de “Stayin ‘Alive” de los Bee Gees: 103 compresiones por minuto
El nombre de la canción es Stayin ‘Alive, de los Bee Gees. Un estudio realizado en el 2008 por el Dr. David Matlock of the University of Illinois College of Medicine at Peoria  confirma que los participantes que fueron instruidos en hacer comp…

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Drugs: Free Trade Agreement that would prove harmful to access to medicines


NEW YORK, NY - JUNE 08:  Demonstrator Arifa Za...
Image by Getty Images via @daylife

Source: List E-Drugs                                En Castellano 


Dr Unni Karunakara, International President of Medecins Sans Frontieres,
has written an open letter to Indian Prime Minister Dr Manmohan Singh,
setting out MSF’s concerns over remaining provisions in the EU/India Free
Trade Agreement that would prove harmful for access to medicines:

The Honourable Dr. Manmohan Singh
Prime Minister of India
South Block, Raisina Hill
New Delhi -110 011
India
Geneva, 8 February 2012

Honourable Prime Minister,

Ahead  of  the  India-Europe Summit on 10 February 2012, where a roadmap to
conclude  the  EU-India free trade agreement (FTA) is set to be agreed, the
international  medical  humanitarian  organization Medecins Sans Frontieres
(MSF)  would  like to draw your attention to specific harmful provisions in
the  proposed  intellectual  property (IP) and investment chapters, that if
included would have serious implications for access to affordable medicines
in India and throughout the developing world.

MSF  today  relies  overwhelmingly on affordable generic HIV/AIDS medicines
produced  in  India to treat nearly 180,000 people in 20 countries, as well
as  using medicines from India to treat other diseases such as tuberculosis
and  malaria.  India  has  played  a  pivotal  role in supplying affordable
generic  versions  of  drugs  used  throughout the developing world.  It is
vital  therefore  that  further  barriers are not created that threaten the
supply of affordable generic medicines from India.

As  such,  the  March  2011  official  statement  by Minister Anand Sharma,
against  the  introduction  of  ‘data  exclusivity’ was welcomed by MSF and
others  given  the  harmful  effect  it  would have on access to affordable
medicines  produced in India. We urge the Indian government to stand strong
in  this  and  in  future  free trade agreements, such as the one currently
being  negotiated  with  the  European  Free Trade Association countries of
Switzerland, Iceland, Norway and Liechtenstein.

However   the  enforcement  and  investment  provisions  within  the  draft
agreement  are  still  a  matter for serious concern as unchanged they will
have  significant negative implications for generic production critical for
ensuring  access  to  affordable  medicines  in  India  and  throughout the
developing world.

We therefore urge India to take a similarly strong stand in relation to the
remaining harmful provisions, particularly:

Enforcement  provisions:
-  The European Commission’s proposed text is broad
in  scope and goes well beyond what has already been agreed and implemented
by  India  under  the  TRIPS  Agreement.
-  The EC had reproduced some of the enforcement  measures  contained in the Anti-counterfeiting Trade Agreement (ACTA)  over which the Indian government has raised serious concerns at the
WTO,  stating  that  the  agreement will ‘impede legitimate competition and
shift  the  escalated  costs  of  enforcing  private  commercial  rights to
governments, consumers and taxpayers’ [1].

The EU is proposing an ambitious enforcement agenda that:

     Widens the enforcement net so that life-saving legitimate medicines,
     under alleged trademark infringement, could be detained or destroyed
     at the border when being exported, simply because their label appears
     similar to the originator product. Although this is often justified
     on the basis of protecting the public from fake medicines, this issue
     is entirely separate, and will do nothing to improve medicines
     safety.  It would in fact have a negative impact on access to
     treatment, as is evident from the recent seizures of Indian generic
     medicines in EU countries. The impact of any such detentions will be
     felt directly by patients awaiting the arrival of crucial generic
     medicines in the many countries that do not have manufacturing
     capacity to produce medicines, and therefore rely on importing more
     affordable generics from India;

     Substantially increases the penalties for alleged patent and
     trademark infringements.  On a mere allegation – and not proof -
     including allegations brought by a competitor, generic suppliers
     allegedly infringing a patent or a trademark may face a ban on
     production, delay or destruction of goods, disproportionate damages,
     and  potential bankruptcy;

     Limits the Indian courts’ ability to balance commercial and public
     health interests and the Indian Constitution’s guarantee to the right
     to life, by making use of a variety of alternative remedies rather
     than as the EU proposes, routinely granting provisional injunctions;
     and

     Extends liability to third parties, thereby putting at risk of
     injunctions and provisional measures a wide variety of public health
     stakeholders, including: suppliers of active pharmaceutical
     ingredients used for producing generic medicines; distributors and
     retailers who stock generic medicines; NGOs such as MSF who provide
     treatment; funders who support health programmes; and drug regulatory
     authorities who examine medicines. This could act as a significant
     deterrent to anyone involved in the production, sale or distribution
     of affordable generic medicines.

Investment  Chapter:  The European Commission is also pushing for the trade
deal  to  be  expanded  in  scope  so that it covers investments, including
intellectual property, and supports an ‘investor-to-state’ mechanism.

This  would  allow  multinational  drug  companies  to  bypass  the  Indian
judiciary and take the Indian government to private arbitration courts over
investment  disputes in relation to intellectual property, in order to seek
to  reverse  domestic health policies like tobacco warnings and measures to
reduce  prices  of  medicines.  Pharmaceutical  companies  must be given no
additional  avenues  to  pressure  India  on policies and laws that promote
access  to  medicines.  India  is already reeling from multiple litigations
filed  by  companies  like  Novartis  and  Bayer  against health safeguards
enshrined in India’s patent law.

In  order  to  ensure  that  the  EU-India FTA does not undermine access to
medicines,  the  additional threats posed by the enforcement and investment
provisions  must  be  addressed.  At  a  minimum,  we would urge the Indian
Government to request the following safeguards are contained in the roadmap
to ensure that damage caused to people’s access to medicines is minimised:

     The withdrawal of the IP enforcement measures, and as a minimum
     safeguard, the deletion of patents from the entire scope of the
     enforcement section;

     The withdrawal of third party liability from the enforcement
     provisions;

     The withdrawal of specific provisions dealing with injunctions from
     the enforcement provisions in order to preserve the existing
     flexibilities of the Indian judicial system;

     Border enforcement should be limited to the requirements of the TRIPS
     Agreement and as such exclude exports and trademark infringements;
     and

     The withdrawal of IP and the investor-to-state mechanisms from the
     scope of the investment chapter.

India  has  already  shown that it is prepared to stand firm against harmful
demands  from  the  European  Commission.  As the negotiations are reaching
their final stages we urge you to maintain your vigilance and commitment to
preserving  the  space  for  continuation  of  the  generic  production  of
medicines that we and so many in India and beyond rely upon.

Yours sincerely,
Dr Unni Karunakara
International President
Medecins Sans Frontieres

c.c. Honourable Minister of Commerce and Industry of India Shri Anand
Sharma
c.c. Honourable Minister of External Affairs of India Shri S. M. Krishna

[1]
http://arstechnica.com/tech-policy/news/2010/06/india-launches-offensive-against-acta-cites-due-process.ars

Joanna Keenan
Press Officer
Medecins Sans Frontieres – Access Campaign
E: joanna.keenan[at]geneva.msf.org
T: @joanna_keenan


II Part
Reputable manufacturers exporting medicines into countries of high
temperature and/or humidity are clearly testing their medicines and making them fit
for climate zone III and IV in particular when a drug regulatory authority
of the importing country makes it a prerequisite. Appropriate testing
requiremens can be found, for example at the homepage of the World Health
Organization:

http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulato
ry_standards/en/index.html


Unfortunately, on national scale, many countries accept much lower drug
development standards for medicines moving into commerce. For example, in
India, all products are labelled “to be stored below 25 degree Celsius”. Here,
local manufacturers are pushing the responsibility for product stability
downstream into the supply chain, for example to the shop keepers and consumers.
This is nationally accepted standard and done even though knowing that
medicines is frequently sold in drug outlets openly without air conditioning or even
a refrigerator. As India gradually became “the pharmacy of the developing
world” these low standards moved along with them. And you just saw the
consequences.

Yours sincerely

Richard Jähnke, PhD
Project Management

Global Pharma Health Fund e.V. (GPHF)
Otto-Meßmer-Straße 1, 60314 Frankfurt, Germany
Head Office: T +49-69-962387-600, F +49-69-962387-609, info@gphf.org
Project Office: T +49-69-46939-662, F +49-69-46939-852,
richard.jaehnke@gphf.org

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Prevalence and Risk Factors of Morning Headaches in the General Population.


Ohayon MMPrevalence and Risk Factors of Morning Headaches in the General Population. Arch Intern Med 2004; 164: 97-102.    TC (s)   PDF (s)

Introducción

Se ha descrito la asociación de la cefalea matutina con trastornos del sueño, especialmente con el síndrome de apneas obstructivas. Sin embargo, existe poca bibliografía sobre la asociación de la cefalea matutina a trastornos mentales.

Objetivo

Describir la asociación de la cefalea matutina con cinco tipos de factores de riesgo: sociodemográficos, uso de fármacos psicoactivos, enfermedades orgánicas, trastornos del sueño y enfermedades mentales.

Perfil del estudio

Tipo de estudio: Estudio transversal
Área del estudio: Causa
Ámbito del estudio: Comunitario

Métodos

Se entrevistó telefónicamente a 18.980 sujetos de 15 años de edad o más de cinco países europeos (Reino Unido, Alemania, Italia, Portugal y España). La muestra se elaboró de forma representativa a partir del censo electoral.
Los entrevistadores utilizaron el programa informático desarrollado por el autor Sleep-EVAL, específicamente diseñado para llevar a cabo estudios epidemiológicos. Este programa recoge información demográfica, sobre el sueño y el despertar, salud física y mental. Las entrevistas duraron (media ± DE) 20 ± 40 minutos.
Se consideró que los sujetos tenían cefalea matutina si respondían a la pregunta ¿tiene dolores de cabeza cuando se despierta por la mañana? con alguna de las siguientes opciones: siemprefrecuentemente o a veces. Se consideró que no la tenían si respondíanraramente o nunca.

Resultados

La tasa de participación global fue del 80,4%. El 7,6% de los individuos afirmaron tener cefaleas matutinas (1,3% siempre, 4,4% frecuentemente y 1,9% a veces). La tabla 1 recoge el análisis de la relación entre la presencia de cefalea matutina y diferentes factores de riesgo tras el análisis multivariante.
Variable OR (IC 95%) P
Edad (años) <25 1,24 (1,00-1,54) <0,05
25-34 1,00
35-44 1,09 (0,89-1,34) NS
45-54 1,25 (1,02-1,53) <0,05
55-64 1,23 (0,98-1,54) NS
≥65 0,86 (0,65-1,14) NS
Género Varón 1,00
Mujer 1,13 (1,01-1,27) <0,05
Trabajo Trabajador diurno 1,00
Trabajador nocturno 0,89 (0,68-1,16) NS
Desempleado 1,33 (1,05-1,70) <0,05
Estudiante 0,88 (0,67-1,15) NS
Jubilado 1,06 (0,83-1,35) NS
Amo de casa 1,32 (1,13-1,54) <0,01
IMC (kg/m2) <20 1,19 (0,98-1,43) NS
20-25 1,00
25-27 1,02 (0,86-1,21) NS
>27 0,98 (0,84-1,15) NS
Rechazó declarar el peso 1,50 (1,14-1,96) <0,01
Enfermedad musculoesquelética 1,57 (1,32-1,87) <0,01
Hipertensión 1,30 (1,11-1,54) <0,005
Alcohol (vasos/día) 0 1,00
1-2 0,77 (0,58-1,02) NS
3-5 0,87 (0,62-1,21) NS
≥6 1,83 (1,05-3,16) <0,05
Ansiolíticos 1,75 (1,35-2,28) <0,001
Pesadillas Nunca 1,00
<1 noche/mes 1,39 (1,19-1,63) <0,001
1-3 noches/mes 1,38 (1,04-1,83) <0,05
≥1 noche/semana 1,76 (1,30-2,39) <0,001
Trastorno de insomnio (DSM-IV) 2,14 (1,79-2,57) <0,001
Trastorno del ritmo circadiano (DSM-IV) 1,97 (1,31-2,94) <0,001
Trastorno de la respiración relacionado con el sueño (DSM-IV) 1,51 (1,11-2,06) <0,01
Trastorno del sueño no específico (DSM-IV) 2,30 (1,94-2,72) <0,001
Ronquido importante 1,42 (1,15-1,75) <0,001
Trastornos mentales (DSM-IV) No trastorno de ansiedad/depresión 1,00
Ansiedad sólo 1,98 (1,74-2,26) <0,001
Trastorno depresivo mayor 2,70 (2,06-3,54) <0,001
Trastorno de ansiedad y depresión 3,51 (2,66-4,64) <0,001
Estrés No o escaso 1,00
Medio 1,19 (1,04-1,36) <0,01
Elevado 1,31 (1,11-1,55) <0,001
La cefalea matutina fue más frecuente en las mujeres y en las personas de menos de 25 años o de 25-45, en desempleados y amos de casa. Las enfermedades crónicas también se asociaban con una mayor prevalencia de dolor de cabeza (hipertensión y trastornos musculoesqueléticos). Se encontró relación con el consumo de psicotropos y con el abuso de alcohol.
Los trastornos del sueño también se asociaron a un aumento del riesgo de presentar cefalea matutina. Tanto el insomnio, como la alteración del ritmo circadiano, el trastorno inespecífico del sueño como los ronquidos y el síndrome de apneas obstructivas del sueño se asociaron a cefalea matutina.
Los trastornos mentales (ansiedad y depresión) también se asociaron a un mayor riesgo de cefalea matutina.
La coexistencia de varios trastornos en un mismo sujeto fue frecuente (ver figura). En casi el 90% de los casos se encontró un trastorno orgánico, mental o del sueño.

Conclusiones

Las cefaleas matutinas son un problema frecuente. A pesar de que se habían relacionado de forma bastante específica con el síndrome de apneas obstructivas del sueño, se asocian a otros muchos trastornos, especialmente a los síndromes depresivos y ansiosos.

Conflictos de interés

Ningún conflicto declarado. Financiado por una beca del National Heart, Lung and Blood Institute.

Comentario

La principal limitación de este trabajo es que se trata de un estudio transversal y que, por lo tanto, no permite establecer relaciones causales. Por ejemplo, es imposible saber si la relación observada con la ansiedad y la depresión se debe a que estas son la causa de la cefalea o una consecuencia de la misma. En cualquier caso, ante una cefalea de este tipo, es importante investigar la presencia de estos trastornos.
Otra limitación del estudio es que se han estudiado muchas relaciones por lo que es posible que algunas de ellas se deban al azar. Sería conveniente confirmarlas mediante estudios similares.

Bibliografía

  1. Loh NK, Dinner DS, Foldvary N, Skobieranda WWDo patients with obstructive sleep apnea wake up with headaches?. Arch Intern Med 1999; 159: 1765-1768.    TC (s)  PDF (s)

Autor

Manuel Iglesias Rodal. Correo electrónico: mrodal@menta.net.

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Posted in AP al dia, Arch Intern Med, Headache, summary | Leave a comment

New Criteria May Change Alzheimer’s Diagnosis


Recently revised guidelines for diagnosing Alzheimer’s disease would reclassify nearly all patients who are currently diagnosed with mild or very mild Alzheimer’s as having mild cognitive impairment (MCI), a new study finds.

The change may be confusing for doctors and misleading for patients and their families, says Dr. John Morris, a neurologist at Washington University in St. Louis.
Reporting in the journal Archives of Neurology, Morris finds that 99.8% of patients now diagnosed with very mild Alzheimer’s dementia would actually be considered to have MCI, according to the latest guidelines. Among patients with mild Alzheimer’s, 92.7% would be reclassified as having MCI.
Before the latest revisions were written, the diagnosis of MCI was limited only to people who had lapses in memory that were not serious enough to disrupt daily life. But that definition began to expand in recent years to include patients with other cognitive problems, including changes in learning or attention and other deficits in thinking.
That’s why the new guidelines for MCI, adopted last year by the Alzheimer’s Association and the National Institute on Aging now include the criterion of “independent functioning,” and that’s where things get tricky. The definition of a patient’s independent functioning may vary widely depending on the doctor, and people with MCI have a broad range of functional independence: a person who can do daily activities on their own would be considered to have MCI, for example, even if they have mild problems or need assistance with paying bills, doing taxes and cooking.
“I think the proposed new criteria were a somewhat premature,” Morris says of the blurry line between MCI and early Alzheimer’s dementia, especially since researchers haven’t yet come up with a definitive way to distinguish MCI from early Alzheimer’s, with, for example, a blood test or other objective measure.
Why is the distinction — or lack thereof — so important? First, not all patients with MCI go on to develop Alzheimer’s, but almost all cases of Alzheimer’s start with MCI. That means that some people diagnosed with MCI may never progress to the serious cognitive declines that characterize the disease. For those whose impairment is likely due to early Alzheimer’s, however, it may do the patient and the family a disservice to call it MCI instead of dementia.
Part of the problem, Morris says, may have arisen from social and cultural factors as much as medical ones. In the study, Morris says doctors acknowledged being reluctant to diagnose patients with “dementia,” and he suspects that’s because they are afraid of scaring patients and robbing them of hope. MCI serves as a more neutral-sounding alternative, and physicians feel it’s more palatable to their patients.
Second, the MCI diagnosis does not include any consideration of what might be driving it — it’s a broad category that in some cases could include patients with Alzheimer’s-related memory problems, or in other cases, additional causes such as vascular problems. This means that studies looking at the beginnings of Alzheimer’s in people with MCI may include a mixture of true Alzheimer’s patients as well as those with other conditions, which may skew the results of, for instance, new drugs being tested.
That’s a particular concern since Alzheimer’s experts are increasingly focusing on the early stages of the disease. The latest evidence suggests that even drugs that have failed to help more advanced patients may be more effective during the first stages of the condition, before buildup of proteins and breakdown of nerves in the brain become irreversible.
In Morris’s study, he applied the new criteria to 17,535 people with normal cognition, MCI or Alzheimer’s disease and found that nearly all of those who in the past who would have been considered to have the first stages of very mild Alzheimer’s would now have MCI.
Medically, the fuzziness between MCI and early Alzheimer’s may result from the way doctors currently diagnose the conditions. In most cases, the decision is based on results from a single point in time. Doctors testing patients for cognitive impairment will frequently give them a battery of tests during one visit, and rate the patients as having either MCI if they only show problems in memory and don’t report any interference in their every day lives, or early Alzheimer’s if they score low on several cognitive tests. They then compare these results to those of people without cognitive problems who are otherwise similar to the patients. But this one-time snapshot doesn’t reveal much about what might be driving the changes in cognitive function.
Instead, Morris argues that older patients should be monitored for longer periods of time, and doctors should conduct more in-depths interviews with patients’ family members who can report changes in behavior and mental functioning. “It takes time and experience, but it is possible to come up with an accurate assessment of figuring out the underlying cause of MCI in patients,” he says. By faithfully recording any changes reported by people who are familiar with a patient and how his mental abilities have changed, he and his team regularly interpret whether a patient’s memory problems are potentially Alzheimer’s related or not. “It’s possible to make a diagnosis as accurately as if the person were more impaired with more obvious signs of Alzheimer’s dementia,” he says.
The key is to compare a patient to his own results over time, and not to test results from a national sample of adults, however similar they are, says Morris.
Ideally, a definitive test that detects the first signs of Alzheimer’s proteins would be able to distinguish Alzheimer’s-related MCI from MCI that’s due to other causes, and researchers are currently working on such screens, using blood tests and images of the brain.
But until those become available, many patients diagnosed with the type of MCI that progresses to Alzheimer’s may not be able to take advantage of drugs that are generally reserved for more advanced patients. Some doctors are already prescribing such medications for MCI patients, but again, there’s a lot of variability in how strongly doctors feel about dispensing them, since the drugs are only moderately effective, if at all, in slowing down the symptoms of cognitive decline. “I do think that defining MCI related to Alzheimer’s better will allow us to use therapies at an earlier stage of the disease,” says Morris, “but I can’t argue very vociferously because unfortunately current medications provide only modest benefit for patients.” Hopefully, new treatments will emerge along with better ways to distinguish the MCI that progresses to Alzheimer’s, and patients will be able to benefit from both.
Alice Park is a writer at TIME. Find her on Twitter at @aliceparkny. You can also continue the discussion on TIME’s Facebook page and on Twitter at @TIME.

Read more: http://healthland.time.com/2012/02/08/why-a-new-definition-of-cognitive-impairment-may-confuse-patients/#ixzz1lqpZlfTs

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Caffeine to inhale hits market


Source: Newsmap


CAMBRIDGE —  Move over, coffee and Red Bull. A Harvard professor thinks the next big thing will be people inhaling their caffeine from a lipstick-sized tube. Critics say the novel product is not without its risks. 

The product, called AeroShot, went on the market late last month in Massachusetts and New York, and is also available in France. A single unit costs $2.99 at convenience, mom-and-pop, liquor and online stores. 

Biomedical engineering professor David Edwards said AeroShot is safe and does not contain common additives, like taurine, used to amplify the caffeine effect in common energy drinks. Each grey-and-yellow plastic canister contains 100 milligrams of caffeine powder, about the amount in a large cup of coffee, plus B vitamins. 

But Democratic U.S. Sen. Charles Schumer of New York wants the U.S. Food and Drug Administration to review AeroShot, saying he fears it will be used as a club drug so that young people can drink until they drop. Schumer’s national press secretary did not immediately respond to calls for comment. 

FDA spokeswoman Siobhan DeLancey declined to comment, saying the agency will respond directly to Schumer on the matter. 

Edwards said Schumer’s comments are understandable in the context of developments over the last few years, when students looking for a quick and cheap buzz began consuming caffeine-packed alcoholic drinks they dubbed “blackout in a can” because of their potency. But he said AeroShot is not targeting anyone under 18 and it safely delivers caffeine into the mouth, just like coffee. 

“Even with coffee — if you look at the reaction in Europe to coffee when it first appeared — there was quite a bit of hysteria,” he said. “So anything new, there’s always some knee-jerk reaction that makes us believe ‘Well, maybe it’s not safe.’ ” 

Once a user shoots a puff of calorie-free AeroShot into his or her mouth, the lemon-lime powder begins dissolving almost instantly. Each single-use container has up to six puffs. 

“The act of putting it in your mouth is the act of breathing — so it’s sort of surprising and often people the first time they take the AeroShot, they laugh … that it’s kind of a funny way of putting food in your mouth,” said Edwards, who also came up with a breathable chocolate product a few years back. 

Dr. Lisa Ganjhu, a gastroenterologist and internal medicine doctor at New York-based St. Luke‘s-Roosevelt Hospital, said people need to be aware of how much caffeine they are ingesting. 

“You want those 10 cups of coffee, it will probably take you a couple hours to get through all that coffee with all that volume that you are drinking,” Ganjhu said. “With these inhale caffeine canisters you can get that in 10 of those little canisters — so you just puff away and you could be getting all of that within the hour.” 

Even the product packaging warns people not to consume more than three AeroShots per day. 

Northeastern University students who sampled the product recently gave it mixed reviews. 

“This tastes really good and I think it rocks,” student Zack Huang said after puffing onto a free sample before rushing to join a group of friends who were walking away from campus. 

Still, one student was not happy with the taste, echoing sentiment expressed online by some consumers. 

People elsewhere vowed they would never give up their morning coffee. 
“I want to brew it, I want to stir it and I want to drink it slowly as I absorb the caffeine,” said longtime coffee fan Mark Alexander. 

The makers of AeroShot appear to be aware of that sentiment, declaring that the product isn’t about switching away from coffee, but rather making it easier for people with active lifestyles to get their caffeine fix. 

“AeroShot can be used in a variety of settings inconvenient for liquids, such as when you study in the library, board an airplane or get into the car for a long drive,” they say in the section dedicated to frequently asked questions on their website. “It’s easy to take AeroShot with you when you go biking, skiing, curling, or any other activity that consumes energy.” 

AeroShot, manufactured in France and the flagship product of Cambridge-based Breathable Foods Inc., is the product of a conversation that Edwards had with celebrity French chef Thierry Marks over lunch in the summer of 2007. 

“We were discussing what interesting culinary art experiments we might do together and I had the idea that we might breathe foods since I’ve done a lot of work over the last 10 or 15 years on medical aerosols,” Edwards said. 

The first venture Edwards worked on with Harvard students was the breathable chocolate, called Le Whif. Now he’s preparing to promote a product called Le Whaf, which involves putting food and drinks in futuristic-looking glass bowls and turning them into low-calorie clouds of flavor. 

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Ola de frio en Europa


Agence France-Presse
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La ola de frío ya dejó más de 480 muertos en Europa



Un frío glacial acompañado de fuertes nevascas y ráfagas de viento persistía este miércoles en Europa, donde causó más de 480 muertos en apenas dos semanas, la mayoría en el Este del continente, aunque también afectaba duramente a Italia y a la región de los Balcanes.
En Polonia, el número de muertos por hipotermia se eleva ya a 74, con cinco más en apenas 24 horas, informó la policía. Y hay que sumarles unas 50 personas muertas a causa de chimeneas defectuosas, que provocaron asfixia por monóxido de carbono y varios incendios.
El frío ya provocó 24 muertos en la República Checa, 23 en Lituania, 10 en Letonia, tres en Eslovaquia y uno en Estonia.
En la madrugada del miércoles las temperaturas habían caído en Moscú a 22 grados centígrados bajo cero, aunque en la región de Iakutie, en la Siberia oriental, los termómetros indicaban 34 grados negativos.
En lo que va de año el frío provocó la muerte de por lo menos 110 adultos, de acuerdo con el Ministerio de Salud.
Los servicios de previsión meteorológica indicaron que “las temperaturas permanecerán muy bajas en la región del centro de la Rusia europea, y el frío se acentuará más en el fin de semana”.
Pese a que el país está acostumbrado a los inviernos crudos, el clima de los últimos días es difícil de soportar.
“Es difícil enfrentar este frío”, dijo Katya, de 24 años, protegida con un enorme sombrero de lana roja. Según Pavel Sterlikov, de 27 años, “un frío como éste sólo lo tenemos cada cinco años”.
Bulgaria era el miércoles uno de los países más afectados, con enormes tempestades de nieve que paralizaron literalmente todos los transportes en el nordeste y el este del país, mientras que en el sur el tránsito continuaba suspendido a raíz de las inundaciones del lunes, que dejaron ocho muertos.
En diversas localidades del país la situación era caótica, con testimonios de automovilistas varados en la nieve sin combustible ni información y aldeas enteras aisladas sin comida ni electricidad.
Puestos fronterizos de Bulgaria con Turquía y con Rumania tuvieron que ser cerrados, así como los grandes puertos búlgaros sobre el mar Negro, en Varna y Burgas. Las autoridades decidieron que las escuelas permanecerán cerradas hasta nuevo aviso, ante la previsión de nuevas nevadas.
En la parte más occidental, Italia es el país con nevadas más espectaculares, y desde el 1 de febrero el número de muertos asciende a 40.
En Venecia, una estatua de 9 metros de altura del artista Guerrino Lovato, símbolo del célebre carnaval de este año, fue derribada por violentas ráfagas de viento de hasta 80 km por hora.
A su vez, en Turín el hielo provocó la ruptura de caños que inundaron cuatro estaciones del metropolitano.
La situación era muy difícil incluso en el sur del país, a raíz de un manto de nieve que llegó a casi tres metros de espesor en la región de Basilicata. Toda la región italiana próxima al mar Adriático sufrirá nevascas en los próximos días.
En Serbia, Croacia, Bosnia, Macedonia y Montenegro por lo menos 70.000 personas llevan días aisladas en aldeas recónditas a causa del cierre de rutas por el exceso de nieve.
Sera el cambio climatico ?
El cierre del tráfico fluvial por el río Danubio el miércoles, ante congelamiento de centenas de kilómetros, también provocó enormes trastornos en la región.
En Bosnia, donde las temperaturas cayeron a 20 grados centígrados bajo cero, más de 15.000 personas en la región de Mostar (en el sur del país) se encontraban el miércoles sin energía eléctrica.
Tres personas murieron por hipotermia en Rumania en las últimas 24 horas, elevando a 41 el total desde el 24 de enero. Todo el sur de Rumania se mantiene en estado de alerta ante la previsión de nuevas nevascas.
En tanto, en Hungría, el saldo de víctimas por hipotermia se elevó a 16 con la muerte de tres personas el martes, de acuerdo con los servicios de socorro.
En los otros países de la región se vivía el miércoles un escenario similar. En Austria, la muerte de un jubilado de 70 años elevó el saldo de víctimas fatales a cinco desde la llegada de la ola de frío.
El saldo de muertos en Alemania se mantiene en cuatro, pero las autoridades alertaron a la población ante la previsión de nuevas tempestades de nieve. El tráfico fluvial en el río Meno fue suspendido.
Las autoridades francesas informaron que el número de muertos se elevó a cinco, con la muerte de cuatro personas por intoxicación con monóxido de carbono.
Ginebra, en Suiza, seguía tratando de resolver el caos de tráfico provocado por la ruptura de un enorme caño de desagüe a causa del exceso de hielo.
bur-pm/jls/ahg/erl

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Difference in clinical trials according to funding source


Journal of the American Medical Association
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Difference in clinical trials according to funding source

An interesting article appears  in JAMA, and shows how the source funding of clinical trials on cardiovascular differs between those entities that are funded by non-profit from those so.
It took all editions published by JAMA, The Lancet and the NEJM between 2000 and 2005, and analyzed if the trend corresponded to previous studies that showed that year was so.
Of 324 articles, 21 not cite the source. Of the 104 trials funded exclusively by nonprofit entities (ESFN or NFPO), 51 (49%) reported significant evidence for vs. new treatments. standard treatment, while 53 (51%) did not (p = 0.8).
In contrast 92 (67.2%) of 137 clinical trials funded by for-profit entities, clearly favored the new vs treatments. treatment standards (p =;0.001).
Among the remaining 62 trials were funded 35 Overall, a favorable intermediate percentage (56.5%) compared to
standard treatments.
For 205 randomized trials evaluating drugs, the ratio in favor of new treatments was 39.5% for studies funded by nonprofit organizations, 54.4% when funding was set, and 65.5% when the Funding was exclusively for-profit entities. The statistical significance trend across groups was 0.002).
For 39 randomized clinical trials evaluating other types of technologies (devices), the proportion in favor of new treatments was 50% in those funded by nonprofit organizations profit, 69.2% in those funded overall, and 82.4 in
funded exclusively by for-profit organizations. The probability trend across groups was 7%, is ie the probability that these results are at random is only 7%.
Regardless of funding source, most of the work used as the final results quantitative results on angiography, intravascular ultrasound, markers biologicicos plasma, and functional measures were more likely be reported positively (67%) than trials using as clinical aspects results. This means that 67% of the jobs are directed to what is known as DOE studies (disease oriented evidence), vv. other studies known as POEMS (Problem Oriented Evidence that Matters), which were reported in just the 54.1% of the studies (p = 0.02).
As we see is not enough to invent diseases, but also the source of funding is clearly relevant, although
there may be publication bias (the magazines usually publish more studies are often positive), it is also true that
financing bias also exists, meaning that it tends to fund over that which can provide more revenue, and it is unknown jobs with few adverse outcomes, were never subjected to medical journals.
This brings us back to the theme that science is not neutral, the same nature of clinical studies is more concerned to validate hypotheses and certainly never to refute them. Induction work even small samples is widespread, and magical way, then becomes widespread, regardless of the particularities of time, space and
individuals. Nothing new to not know, but we are in trouble with this science, apart from all this, taken as the gold standard placebo, which has an average efficiency of 35%.
This would not appear strange that “studies based on evidence “, where diets do not work well, or change
of habits of life. Or the coffee before we caused gastritis Chronic is now that it is exclusively the Helicobacter
pylori.
Too many factors for a science that attempts mathematize complexity of man, and populations. Hypothesis using monocausal not even exist in physics. Which becomes probabilistic and deterministic from these types of tests more Experimental studies about what happens every day. And that insists on fragmenting and assign us the role of living alone biological, hardly know the complexity that it biology brings together, and wherein the linear models do not exist.
An interesting article from a magazine that occasionally have these fits of editorial clarity and decides to publish this data.

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Atlheltes with marked ECG repolarizacion abnormalities


Pelliccia A, Di Paolo FM, Quattrini FM, Basso C, Culasso F, Popoli G et alOutcomes in Athletes with Marked ECG Repolarization Abnormalities. N Engl J Med 2008; 358: 152-161.   TC   PDF

Introducción

Los deportistas presentan alteraciones ECG parecidas a las de la HVI. Estas consisten habitualmente en ondas R o S pronunciadas, pero en ocasiones también presentan T invertidas y profundas. Se desconoce si estas alteraciones de la repolarización son indicativas de alguna cardiomiopatía subyacente.

Objetivo

Evaluar los resultados clínicos asociados a la presencia de trastornos de la repolarización en atletas jóvenes.

Perfil del estudio

Tipo de estudio: Estudio de cohortes
Área del estudio: Pronóstico
Ámbito del estudio: Comunitario

Métodos

En Italia es obligatorio desde hace 25 años que todos los participantes en competiciones oficiales pasen un examen médico y un ECG previo a las mismas. Los deportistas que forman parte de las selecciones nacionales y aquellos a los que se les detectan anomalías electrocardiográficas son atendidos en el Instituto de Ciencia y Medicina de los Deportes, donde se lleva a cabo un estudio que incluye un ECG convencional, una prueba de esfuerzo y un ecocardiograma.
Se revisó la base de datos de los deportistas atendidos en este Instituto entre 1979 y 2001 y se identificaron los que presentaban trastornos de la repolarización importantes (ondas T negativas ≥2 mm en ≥3 derivaciones excepto en DIII y predominantemente en las derivaciones V2-V6). Se excuyó a los que tenían evidencia de lesiones estructurales en el ecocardiograma inicial. Como controles se seleccionaron deportistas entre los 20 siguientes a cada uno de los casos con ECG normal apareados por edad, sexo y duración del seguimiento.

Resultados

Se incluyeron en el grupo de casos 81 deportistas (fig. 1). Para ellos se seleccionaron 229 controles que fueron seguidos durante el mismo periodo de tiempo. En el 67% de los casos se detectaron más alteraciones ECG, entre las que destacaban incrementos de los voltajes de las R o las S (52%) y Q profundas (10%). No se apreciaron diferencias entre los casos y los controles. La edad media de los participantes era de 22 años y el 71% eran varones. Los deportes en los que participaban más frecuentemente eran remo, fútbol y waterpolo. El seguimiento medio fue de 9 años. Al final del periodo de seguimiento, el 78% seguían haciendo deporte regularmente, un 21% habían abandonado la práctica deportiva y 1 de los individuos había muerto.
Durante el seguimiento, las alteraciones de la repolarización se mantuvieron inalteradas en el 67% de los individuos, mejoraron en el 18% (menos derivaciones o menor profundidad de las ondas T) y se normalizaron en el 15% restante. En ninguno de los deportistas se apreciaron cambios en el volumen ventricular.
En 11 deportistas con alteraciones de la repolarización se detectaron cardiopatías en el seguimiento (14%). Uno murió a los 24 años un año después de la valoración inicial por una cardiomiopatía ventricular derecha arritmogénica que no se había detectado. En 3 se detectó una cardiomiopatía hipertrófica y en uno una cardiomiopatía dilatada. Uno de los individuos con cardiomiopatía hipertrófica sufrió un paro cardiorrespiratorio del que se recuperó. Otros 6 pacientes del grupo con alteraciones de la repolarización desarrollaron enfermedades cardiovasculares (3 HTA , 1 cardiopatía isquémica que requirió revascularización, 1 miocarditis y 1 taquicardia supraventricular paroxística que requirió ablación). En todos los deportistas que presentaron cardiomiopatías las anomalías ECG se mantuvieron a lo largo de todo el seguimiento.
Ninguno de los controles desarrolló una cardiomiopatía y sólo 4 desarrollaron algún trastorno cardiovascular: 2 taquicardia supraventricular, 1 miocarditis y 1 pericarditis.

Conclusiones

Los autores concluyen que las alteraciones ECG en deportistas jóvenes y aparentemente sanos pueden ser un indicio de cardiomiopatías subyacentes que pueden no hacerse evidentes hasta años más tarde, por lo que deben ser objeto de vigilancia clínica.

Conflictos de interés

Ninguno declarado. Financiado por el Comité Olímpico Italiano.

Comentario

La práctica habitual de deporte (no deporte de élite) tiene consecuencias cardiovasculares beneficiosas. Sin embargo, no es excepcional que en el deporte de élite se den casos de muerte súbita en el transcurso de una prueba deportiva. Se ha demostrado que un programa de cribado preparticipación disminuye el riesgo de estos accidentes.
En el corazón de las personas entrenadas se desarrollan unos cambios que se conocen como el corazón del deportista. Entre ellos destacan el aumento del tamaño y del volumen de las cavidades cardíacas, en especial del ventrículo izquierdo. Fruto de estos cambios, un 40% de los deportistas presentan alteraciones en el ECG, entre las que las más frecuentes son repolarizaciones precoces, incremento del voltaje del QRS, inversiones más o menos difusas de las ondas T y Q profundas, así como alteraciones de la conducción cardíaca (bradicardias, bloqueos AV tipo Wenkeback y ritmos nodales), así como arritmias ventriculares (extrasístoles e incluso salvas de taquicardia ventricular). Estas alteraciones pueden simular y dificulatar el diagnóstico de determinadas enfermedades cardíacas como las cardiomiopatias hipertrófica, dilatada o la cardioimiopatía ventricular derecha arritmogénica, que es la principal causa de muerte súbita en personas jóvenes.
De los resultados de este estudio se desprende que los deportistas que presentan alteraciones de la repolarización importantes (aproximadamente un 1%) tienen un mayor riesgo de presentar una cardiomiopatía que los que tienen un ECG normal, incluso aunque en la valoración inicial el resto de las exploraciones sean normales (valor predictivo positivo 6%). Estas cardiomiopatías pueden incluso poner en riesgo la vida de la persona (2 sufrieron cuadros de paro cardiorrespiratorio), por lo que parece prudente la recomendación de los autores de hacer un seguimiento clínico.

Bibliografía

  1. Corrado D, Basso C, Pavei A, Michieli P, Schiavon M, Thiene GTrends in Sudden Cardiovascular Death in Young Competitive Athletes After Implementation of a Preparticipation Screening Program. JAMA 2006; 296: 1593-1601.    TC   PDF  RC
  2. Maron BJ, Pelliccia AThe Heart of Trained Athletes: Cardiac Remodeling and the Risks of Sports, Including Sudden Death. Circulation 2006; 114: 1633-1644.   TC (s)   PDF (s)
  3. Pelliccia A, Maron BJ, Culasso F, et alClinical significance of abnormal electrocardiographic patterns in trained athletes. Circulation 2000; 102: 278-284.    TC  PDF

Autor

Manuel Iglesias Rodal. Correo electrónico: mrodal@menta.net.

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Posted in Angina pectoris, BMJ, здоровье, медицина, ECG, Electrocardiography, 衛生,醫藥, Heart disease, Missouri, National Institute for Health and Clinical Excellence, NEJM, nice, United States | Leave a comment

La prescripcion de THS en EEUU disminuyo rapidamente despues de la publicacion de trabajos que cuestionaban su eficacia


Cover of the first issue of Journal of the Ame...
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La prescripcion de THS en EEUU disminuyo rapidamente despues de la publicacion de trabajos que cuestionaban su eficacia

Hersh AL, Stefanick ML, Stafford RS. National Use of Postmenopausal Hormone Therapy. JAMA 2004; 291: 47-53.  TC (s) PDF (s)

Introducción

La prescripción de tratamiento hormonal sustitutivo (THS) ha aumentado de forma importante en las últimas dos décadas a medida que se iban publicando los trabajos observacionales que indicaban que podía tener un efecto beneficioso sobre la prevención de determinadas patologías, como la osteoporosis y la cardiopatía isquémica. En 1998 se publicaron los resultados del estudio HERS, el primer ensayo clínico sobre los efectos a largo plazo del THS, que demostró que el THS no era eficaz en la prevención secundaria de la cardiopatía isquémica. En 2002 se publicaron el estudio WHI, que demostró que el balance entre riesgos y beneficios del THS en prevención primaria no eran favorables al THS y el estudio HERSII.

Objetivo

Conocer si la publicación de los primeros estudios experimentales sobre los efectos del THS han modificado la prescripción de THS y las visitas relacionadas con el tema en los EEUU.

Perfil del estudio

Área del estudio: Tratamiento
Ámbito del estudio: Comunitario

Métodos

Las fuentes de datos fueron las siguientes:
  • Prescripciones: National Prescription Audit Plus (NPA). Incluye una muestra aleatoria de 20.000 farmacias. Los datos de las prescripciones se recogen diariamente y se vuelcan cada mes. Se tomaron los datos sobre el total de prescripciones y, a partir de éstos, se estimó el número de mujeres que estaban tomando THS.
  • Visitas: National Disease and Therapeutic Index (NDTI). Se trata de una base de datos que incluye una muestra representativa de 3.500 médicos que recogen los diagnósticos y los tratamientos de las visitas que realizan. Se recogieron los datos sobre las visitas en las que se había prescrito algún tipo de THS.

Resultados

Se pueden distinguir tres fases en la evolución de las prescripciones de THS (fugura): las prescripciones aumentaron desde 1995 a 1999 (el porcentaje de mujeres de 50-74 años en THS pasó del 33 al 42%), después permanecieron estables hasta el final del primer semestre de 2002 y después disminuyeron a partir de julio de 2002 (el porcentaje de mujeres en tratamiento pasó al 28%). El descenso fue más acusado para los medicamentos que combinaban un estrógeno y un gestágeno.
Figura. Número total de prescripciones de tratamiento hormonal sustitutivo (1995-2003)
En el número de visitas en las que se llevó a cabo alguna prescripción se apreció una evolución paralela. Aumentaron entre 1995 y junio de 2002 del 5% al 28%, para caer al 21% durante la primera mitad de 2003.

Conclusiones

Las prescripciones de THS en EEUU respondieron rápidamente a la publicación de los primeros ensayos clínicos en los que se cuestionó la eficacia del THS y el número de mujeres en tratamiento se redujo de forma significativa.

Conflictos de interés

Ninguno declarado.

Comentario

Los resultados de este estudio demuestran una rápida respuesta del sistema sanitario a la aparición de evidencias científicas relativas a un tratamiento de eficacia dudosa. Sin embargo, la historia del THS es un ejemplo de cómo no se deben incorporar prácticas científicas con un nivel de evidencia bajo, sobre todo en el campo de la prevención. Antes de la publicación de los estudios referenciados las recomendaciones de grupos de trabajo prestigiosos, como el US Preventive Services Task Force o el PAPPS eran muy cautas a la hora de recomendar la incorporación del THS. Es probable que esta prescripción inadecuada de THS haya sido responsable de un número considerable de episodios de cardiopatía isquémica y de cáncer de mama.
Afortunadamente en nuestro país (España) la prescripción de THS fue muy inferior a la de EEUU.

Bibliografía

  1. Hulley S, Grady D, Bush T, Furberg C, Herrington D Riggs B et al. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. JAMA 1998; 280: 605-613.  TC (s) PDF (s)
  2. Grady D. Herrington D, Bittner V, Blumenthal R, Davidson M, Hlatky M, et al. Cardiovascular diseaseoutcomes during 6.8 years of hormone therapy. JAMA 2002; 288: 49-57.  TC (s) PDF (s)
  3. Writing Group for the Women. Risk and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women. JAMA 2002; 288: 321-333.  TC (s) PDF (s)

Autor

Manuel Iglesias Rodal. Correo electrónico: mrodal@menta.net.

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De la prevención a la eugenesia


Ramón Sánchez Ocaña

Un articulo con algunos años ya, pero que que nos invita a pensar.

Ramón Sánchez Ocaña

Reflexiones sobre la actualidad sociosanitaria de un periodista especializado.

De la prevención a la eugenesia

Los avances técnicos de la medicina bordean en muchas ocasiones las fronteras éticas. Nadie duda, sin embargo, que cuando se trata de salvar una vida o librar de una enfermedad grave todas las tentativas que tengan probabilidades de éxito son plausibles. Sin embargo, tras el escaparate de las nuevas posibilidades se esconden medias verdades que sólo sirven, de momento, para alimentar esperanzas que –¡ojalá!– puedan convertirse en realidad.

No hablamos ya de las ofertas poco menos que escandalosas y abusivas de tratamientos a base de células madre que se han denunciado desde distintas instancias. Son ofertas para paliar dolencias serias, graves o crónicas en las que unas hipotéticas células madre podrían aportar algún beneficio. Es, evidentemente, una estafa aprovechando la buena fe de los enfermos y sus familias.

Otro problema más serio es la oferta de la selección embrionaria para evitar el riesgo de cáncer. Inicialmente, una pareja catalana solicitó a la Generalitat la autorización para seleccionar sus embriones y evitar así la posibilidad de que sus hijas sufrieran un cáncer de mama hereditario. Tratan, según la información recibida, de que sus vástagos femeninos no porten el gen BRCA-1, que podría desencadenar la enfermedad.

Poco después, otras familias han seguido el mismo camino y, al parecer, las autoridades correspondientes han autorizado ya algunos casos. La situación se presta a varias reflexiones.

La primera es que se pasa por alto una realidad demoledora: el cáncer no se debe a un único gen. Por lo pronto, y para el de mama, se conocen el BRCA 1 y el 2. Y se les achacan sólo el 5% de los tumores. Es decir, tras esa selección, los sujetos nacidos sin esos genes seguirán expuestos al 95% de posibilidades de un cáncer espontáneo. O debido a otros genes que se desconocen. ¿Alguien podrá asegurar que sin portar el gen se está libre de cáncer de mama cuando la realidad demuestra que el 95% de estas enfermas no tienen esos genes?

No se trata, como afirman desde fuentes oficiales, de que un sector de la población esté en contra de los avances científicos sólo porque se manipulan los embriones. Se trata de que haya una información veraz y de que, después, cada uno pueda tomar la decisión que crea más conveniente. Pero no parece ético que se oferte la posibilidad de seleccionar embriones para evitar el riesgo de cáncer, cuando ese riesgo permanece en la gran mayoría de los casos.

El problema añadido, además, es que al descubrir cada vez más enfermedades ligadas, al menos en parte, a determinados genes, se podrá ampliar la oferta de manera que, con la disculpa de tener hijos sanos, estamos bordeando, sin paliativos, la eugenesia.

¿Y qué? Se preguntarán algunos. Nada: que poco a poco estamos haciendo que el hecho biológico de procrear se convierta en un hecho mecánico. No hace mucho, cuando el Prof. Watson, que entonces era director del Proyecto Genoma, estuvo en España resumió este conflicto de una manera sumamente gráfica: “El problema –dijo– estriba en si estamos obligados a hacer el bebé perfecto”. La definición de lo que es perfecto es tema para otro día.

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Pharmalot: A Paroxetine study and retractation


Brown University, A Paxil Study And Retractions

For the past few years, an effort has been under way by a pair of academics to retract a study about the Paxil antidepressant in the Journal of the American Academy of Child and Adolescent Psychiatry that concluded the GlaxoSmithKline pill was “generally well tolerated and effective for major depression in adolescents.” Why? Since then, the 2001 paper has been discredited amid charges that primary and secondary outcomes were conflated, selective results were reported and ghostwriting was involved (see this).
The details became known more three years ago as documents emerged from investigations (look here) and lawsuits charging Glaxo hid various risks. By then, the FDA required Glaxo to place a Black Box warning about suicidality in youngsters and UK regulators recommended the drug not be given to those under 18 years of age. But by 2010, the paper had been cited in more than 200 other articles, many of which continued to point to the study as evidence that Paxil is effective in treating adolescent depression, according to BMJ.
The listed lead author of the paper, which was also known as study 329, was Martin Keller, a psychiatrist at Brown University (pictured to the right; background here). He was also among more than two dozen academics who were investigated by the Senate Finance Committee over alleged failures to properly disclose of federal grants to research drugs at the same time these professors had accepted payments from drugmakers (look here). Consequently, a pair of academics asked the JACAAP to issue a retraction, but were rebuffed. The editor told BMJ the paper does not contain any inaccuracies and negative findings are included in a results table and, as a result, there are no grounds for withdrawal (read here).
martin-kellerAnd so last October, the same two academics – Jon Jureidini, associate professor of psychiatry at the University of Adelaide, and Leemon McHenry, a lecturer in philosophy at California State University – were joined by two dozen others and wrote to Brown University officials to request that they seek a retraction (read the letter), but they were again rebuffed.
Last month, they received a letter from Ed Wing, who is the dean of the medical school, to say the university would not write the JACAAP to seek a retraction (here is the Wing letter). No explanation was given and he did not respond to a request for comment or The Brown Daily Herald, which first reported the official rejection (see here).
The controversy raised questions about if and when a journal article should be retracted. As BMJ noted in its coverage last year, the Committee on Publication Ethics expanded its own view and recommended retraction if journals “have clear evidence that the findings are unreliable.” The point is to “correct the literature and ensure its integrity” rather than to punish authors (here are the guidlines). And the International Committee of Medical Journal Editors urge retraction in the event of scientific fraud or if an error is “so serious as to vitiate the entire body of work (read here).
The Paxil study also underscored the ongoing dispute over ghostwriting, which has embroiled several drugmakers in scandal. The issue has become so contentious that, several months ago, a pair of University of Toronto academics suggested two legal remedies – pursuing class action lawsuits based on the Racketeer Influenced and Corrupt Organizations Act, or RICO, and filing claims of ‘fraud on the court’ against a drugmaker that uses ghostwritten articles in litigation (read here). And two other academics recently published a paper in which they suggested that all authors should be required to sign a statement guaranteeing that no ghostwriters participated in writing a submitted paper and that all medical writers should be listed as authors on the byline (see this).
However, the failure of universities to investigate instances where their professors may have engaged in ghostwriting has also generated criticism. Last year, Dalhouse University declined to examine allegations of ghostwriting and the involvement of psychiatry professor Stan Kutcher, who was listed as a co-author on Paxil study 329 (read here). “I find it very disturbing that a university that is suppose to be standing up for the highest academic values is unwilling to take any action when its faculty members violate those values,” Joel Lexchin, a professor of health policy at York University in Toronto and one of the academics who signed the letter to Brown University concerning a retraction, writes us.
The Department of Health & Human Services, by the way, was also reluctant to pursue the matter. In a letter last November to Jureidini, John Dahlberg, the director of the Division of Investigation Oversight in the Office of Research Integrity at the HHS, noted that Paxil effectiveness was “apparently exaggerated.” But he went on to say that his office was unable to pursue an investigation due to the statute of limitations.
Due to the statute, “…allegations of falsification, fabrication or plagiarism must be made within six years of the alleged misconduct… Further, given the significant lapse of time between the time the study was conducted and concerns raised, the likelihood of being able to conduct a fair and objective review, given the inevitable difficulties in locating records and relying on memories of events well over 10 years ago, seems remote” (here is the letter). Say Jureidini: “We are a bit stuck about where to take it from here.”

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Posted in Brown University, Education, Malcolm X, Nation of Islam, Paroxetine, Rhode Island, Richard Holbrooke, United States | Leave a comment

La mujer como victima singular de la medicalizacion


Fuente: Acta Sanitaria

Via: Lista DISMOG. Juan Gervas

La mujer como víctima singular de la medicalización

Roberto Sánchez, médico de Atención Primaria, ha elaborado un análisis en donde pone en evidencia las prácticas que, promovidas por grupos diversos, desde médicos a farmacéuticos, están convirtiendo a la mujer en uno de los objetivos del proceso de medicalización que vive la sociedad.

http://www.box.com/embed/qppt3x9um9gxut0.swf

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Vacunacion en embarazadas


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