Archive for 23 enero 2011

De como el pueblo estadounidense le hará (nuevamente) el juego a la industria farmacéutica

enero 23, 2011
New York Times, January 22, 2011

Federal Research Center Will Help Develop Medicines

By GARDINER HARRIS

Continuando con su sumisión a la industria farmacéutica el gobierno de USA (o sea el pueblo estadounidense) financiará la investigación inicial que permita desarrollar nuevos medicamentos, hasta que le resulte interesante a la industria que, entonces, se apropiará de la “novedad”.

“The job of the new center, to be called the National Center for Advancing Translational Sciences, is akin to that of a home seller who spruces up properties to attract buyers in a down market. In this case the center will do as much research as it needs to do so that it can attract drug company investment.

That means that in some cases, the center will use one of the institutes’ four new robotic screeners to find chemicals that affect enzymes and might lead to the development of a drug or a cure. In other cases, the center may need to not only discover the right chemicals but also perform animal tests to ensure that they are safe and even start human trials to see if they work. All of that has traditionally been done by drug companies, not the government.”

Esta concepción -nada inocente- de la salud, la vincula a la salida de nuevos medicamentos, e ignora -nada inocentemente- la noción de Social Determinants of Health. Esta última concepcion no es útil al mercado de la salud pues no vende nada, y pone en cabeza de los gobiernos la tarea de solucionar el problema de los SDoH y de la salud pública.

Y después de todo, si los estadounidenses ya financiaron y pagaron la crisis de los bancos ¿porqué no tener la misma gentileza con la industria farmacéutica?

Ver esta increíble noticia en http://www.nytimes.com/2011/01/23/health/policy/23drug.html?ref=us

Salió el Número 2 de la Revista Redbioética/UNESCO

enero 22, 2011

Sumario

Editorial
La bioética y los consensos antropofágicos
Luis Justo
Conferencias
Exclusión en salud en América Latina: tres retos para la justicia sanitaria
Víctor de Currea-Lugo

La Ciencia y la Ética
Daniel Piedra Herrera

Artículos originales
Bioethics, Health, and the Environment: Some ethical concerns in the Caribbean
Bioética, salud y medio ambiente: algunas preocupaciones éticas en el Caribe

Derrick E. Aarons

De la logoterapia a la bioética: herramientas para el abordaje psicológico /
From logotherapy to bioethics: tools for a psychological approach

Olga V. Lehmann Oliveros

Análisis bioético de la investigación de la enfermedad de Huntington
en el estado Zulia, Venezuela /
A bioethical analysis of Huntington’s disease research in Zulia State, Venezuela

Lennie Pineda Bernal

El pensamiento de José Martí al encuentro con la Bioética /
José Martí’s thought toward an encounter with Bioethics

Alina del Pilar Mora Sánchez

Justiça distributiva, critérios de alocação de recursos escassos em saúde e suas críticas /
Distributive justice, criteria for scarce health resources allocation and their critiques

Maria Elisa Villas-Bôas

Teorias científicas ou ciência mítica? Reflexões sobre a ética na ciência a partir
da filosofia de Feyerabend /
Scientific theories or mithical science? Reflections about ethics in science
from the philosophy of Feyerabend

Márcio Rojas da Cruz, Gabriele Cornelli

Bioética, biossegurança e a questâo da interface no controle das práticas da biotecnociencia: uma introduçao
Bioethics, biosafety and the question of control of biotechnoscience practices:
an introduction

Fermin Roland Schramm

Trabajo invitado
El investigador ante lo indecible y lo inenarrable (Una ética de la escucha) – 2008
Juan Pablo Aranguren Romero

Post Scríptum a Una Ética de la Escucha – 2010
Juan Pablo Aranguren Romero

Aportes
Aportes Consenso Latinoamericano en Ética de la Investigación en Seres Humanas
(CONSENSO DE BOGOTÁ)

Alumnos V Curso de Ética en Investigación con Seres Humanos

Recuerdos
Carlos Eroles
Juan Carlos Tealdi

Reseña

Noticias

Carta al Editor

Pares Evaluadores / Pareceristas / Peer reviewers

Instrucciones a los autores

Acceso en http://www.unesco.org.uy/shs/red-bioetica/es/revista/ano-1-no-2-2010.html

Descargar desde acá la revista completa.

Ficciones borgeanas: el consentimiento informado

enero 21, 2011

Esa ficción llamada “consentimiento informado”… que justifica teóricamente la investigación clínica. La enorme mayoría de los trabajos encuentra serias deficiencias, pero todo sigue como si nada.

J Med Ethics 2011;37:74-80 doi:10.1136/jme.2010.035485

What do our patients understand about their trial participation? Assessing patients’ understanding of their informed consent consultation about randomised clinical trials

  1. C Behrendt1,
  2. T Gölz2,
  3. C Roesler3,
  4. H Bertz2,
  5. A Wünsch1

+ Author Affiliations


  1. 1Department of Psychosomatic Medicine and Psychotherapy, University Hospital Freiburg, Freiburg, Germany

  2. 2Department of Internal Medicine I (Hematology and Oncology) Hematology and Oncology, University Hospital Freiburg, Freiburg, Germany

  3. 3Catholic University of Applied Sciences, Freiburg, Germany
  1. Correspondence to Alexander Wünsch, Psychooncological Service of Department of Psychosomatic Medicine and Psychotherapy, University Hospital Freiburg, Hauptstr. 8, D-79104 Freiburg, Germany; alexander.wuensch@uniklinik-freiburg.de

Abstract

Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs.

Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated in a trial and two who declined. The data were analysed on the basis of Mayring’s qualitative analysis.

Results Patients’ understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice.

Conclusion This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients’ understanding of informed consent, to clarify patients’ needs and to develop new ideas to optimise the informed consent.

Cursos Redbioética/UNESCO 2011

enero 21, 2011

PROPUESTA EDUCATIVA 2011

PRIMERA CONVOCATORIA A BECAS Y MATRICULAS 2011

CURSOS TOTALMENTE A DISTANCIA

CERTIFICACIÓN DE LA REDBIOETICA Y EL PROGRAMA REGIONAL
DE BIOÉTICA DE LA UNESCO

“VI CURSO DE INTRODUCCIÓN A LA ÉTICA DE LA INVESTIGACIÓN EN SERES HUMANOS”

“V CURSO DE INTRODUCCIÓN A LA BIOÉTICA CLÍNICA Y SOCIAL”

Con prestigiosos docentes expertos en la temática de toda América Latina y con el auspicio de la
Universidad Nacional de Córdoba (UNC, Argentina), de la Universidad Nacional del Litoral (UNL, Argentina),
de la Universidad de Brasilia (UnB, Brasil) y de la Universidad Alberto Hurtado de Chile.

Inscripciones abiertas desde el 20 de Enero de 2011

Postulaciones a BECAS UNESCO hasta el día 15 de Marzo de 2011

Inscripciones a Matrículas hasta el día 15 de Abril de 2011

Cursos comienzan: 2 de Mayo de 2011

Desde ya agradecemos la difusión de este mail.

Para mayor información visite www.redbioetica-edu.com.ar

O escríbanos a info@redbioetica-edu.com.ar

El colonialista critica a los colonizados por aplicar sus reglas de “justicia”

enero 14, 2011

La revista británica The Lancet publica una fuerte crítica contra el encarcelamiento de un luchador por los DDHH: el médico Binayak Sen. Por supuesto, sin discusión alguna compartimos la condena y exhortamos a participar en las campañas por su liberación (http://www.binayaksen.net/) .

Pero, sin embargo, no puede menos que llamar la atención un párrafo de la nota del Lancet, que refiere lo ocurrido a Sen como “to be convicted under a section of the penal code first introduced by the British to quell political dissent”, y que fue utilizada para condenar a Gandhi, quien manifestó que “the administration of the law had been ‘prostituted consciously or unconsciously for the benefit of the exploiter'”.

Si bien compartimos la fuerte crítica del Lancet ¿no vendria bien un poco de autocritica de parte del país que introdujo la sección del Código Penal para reprimir el disenso politico? Deberían leer a Quijano y su “colonialidad del poder”…

The Lancet, Volume 377, Issue 9760, Page 98, 8 January 2011

Binayak Sen’s conviction: a mockery of justice

vía Binayak Sen’s conviction: a mockery of justice : The Lancet.

Otro ejemplo de bullying de las farmacéuticas

enero 14, 2011

La revista Prescrire demandada

La revista francesa independiente Prescrire ha sido demandada por el laboratorio fabricante de tacrólimo tópico (Protopic) por criticar la ampliación de sus indicaciones aprobadas (BMJ 2011;342:d158).

En 2005 varias agencias reguladoras alertaron sobre un posible riesgo de cáncer asociado al uso de tacrólimo y pimecrólimo en aplicación tópica para el tratamiento de la dermatitis atópica (Butll Groc 2005;18:5-6). En el número de septiembre de 2009, después de que el tacrólimo se aprobara también en la prevención del eccema atópico, Prescrire concluyó que su relación beneficio-riesgo es desfavorable y que se debería evitar (Rev Prescrire 2009;29(311):653).

El tribunal se reunió el 5 de enero y dictará sentencia el 16 de febrero. Desafortunadamente, estas demandas dedican mucho tiempo y distraen de las actividades regulares. Nuevamente nos encontramos con otro boletín independiente demandado. El debate científico debería quedar al margen de las presiones. De aquí la necesidad de la libertad de expresión para el progreso de la ciencia y de la atención médica.

vía Noticias Butlletí Groc.

Un vergonzoso escándalo que debe ser fuertemente sancionado a nivel internacional

enero 13, 2011

Reproducimos el editorial del BMJ del número BMJ 2011;342:d212

Editor’s Choice

Goodbye PubMed, hello raw data

Fiona Godlee, editor, BMJ

This time last year the H1N1 influenza pandemic was burning itself out, having caused, thankfully, far less sickness and death than predicted. Now this year’s seasonal flu epidemic is doing its rounds in the northern hemisphere (doi:10.1136/bmj.d203, doi:10.1136/bmj.d190). The UK’s problems with uptake and availability of the flu vaccine seem to have been sorted out, but what interests me is this year’s low key approach to antivirals.

You will remember that neuraminidase inhibitors were promoted by WHO as a key part of influenza prevention and treatment, and that oseltamivir was stockpiled at vast expense by most governments around the world. The drug was made widely and easily available, but even so, huge amounts were left unused. You may also remember that serious doubts were raised about its effectiveness.

At the end of 2009 we published an update of the Cochrane review of antivirals as treatment for flu in otherwise healthy adults (BMJ 2009;339:b5106). As reported in a BMJ/Channel 4 investigation, the reviewers had found that, despite repeated requests to the drug company, Roche, they were unable to obtain the trial data necessary to validate their earlier conclusion that oseltamivir reduced complications (BMJ 2009;339:b5374).

This week the Cochrane team explains why their experience with Roche blows a hole in the systematic review enterprise (doi:10.1136/bmj.c7258). The incomplete information they obtained from Roche merely proved how inadequate the published record on oseltamivir was. The two main published trials don’t mention any adverse events, but the partial study reports from Roche listed 10 serious events, three of which were classified as possibly due to oseltamivir. By laboriously compiling a full list of industry and non-industry trials, they found one large trial by Roche Shanghai that Roche headquarters in Basel hadn’t got on their list. By looking at the regulatory documents, they found that the largest phase III trial of oseltamivir (unpublished) is hardly mentioned in regulatory documents.

From now on, they say, reviewers must have access to all unpublished data, not only from unpublished trials—the usual focus of concern about publication bias—but also from those that have been published in peer reviewed journals. Reviewers must assess entire trial programmes, and so new tools and methods are needed. If the trial reports are incomplete, reviewers should turn to reports from the drug regulators. As Tom Jefferson, the lead author for the Cochrane review, told me, “it’s goodbye PubMed, goodbye Embase.”

The reviewers have posted their new style protocol for this review on the Cochrane site and, recognising the enormity of the task, they are recording how much work is involved. But it must be clear to everyone that such a heroic approach is unsustainable across the whole of healthcare, given the resource constraints on academics and regulators. Which brings us back to what seems to be the only real solution—that the raw data from trials must be made freely available. Journals clearly have a role to play in making this happen, as An-Wen Chan agrees in his editorial (doi:10.1136/bmj.d80). The International Committee of Medical Journal Editors meets in a few months’ time. This will be on the agenda.

Y un “actual” trabajo del maestro F. Engels

enero 4, 2011

When one individual inflicts bodily injury upon another such injury that death results, we call the deed manslaughter; when the assailant knew in advance that the injury would be fatal, we call his deed murder. But when society places hundreds of proletarians in such a position that they inevitably meet a too early and an unnatural death, one which is quite as much a death by violence as that by the sword or bullet; when it deprives thousands of the necessaries of life, places them under conditions in which they cannot live – forces them, through the strong arm of the law, to remain in such conditions until that death ensues which is the inevitable consequence – knows that these thousands of victims must perish, and yet permits these conditions to remain, its deed is murder just as surely as the deed of the single individual; disguised, malicious murder, murder against which none can defend himself, which does not seem what it is, because no man sees the murderer, because the death of the victim seems a natural one, since the offence is more one of omission than of commission. But murder it remains.

Condition of the Working Class in England, by Engels, 1845

http://marx.org/archive/marx/works/1845/condition-working-class/ch07.htm

vía Results.

Un “viejo” trabajo del maestro Pellegrino

enero 4, 2011

Este es un trabajo para leer y releer, y también para enviar a los “especialistas en economía de la salud”…

The Commodification of Medical and Health Care: The Moral Consequences of a Paradigm Shift from a Professional to a Market Ethic
Edmund D. Pellegrino

ABSTRACT
Commodification of health care is a central tenet of managed care as it functions in the United States. As a result, price, cost, quality, availability, and distribution of health care are increasingly left to the workings of the competitive marketplace. This essay examines the conceptual, ethical, and practical implications of commodification, particularly as it affects  the  healing  relationship  between  health  professionals  and  their  patients.  It  concludes that health care is not a commodity, that treating it as such is deleterious to the ethics of patient care, and that health is a human good that a good society has an obligation to protect from the market ethos.

Entre otras cosas, Pellegrino dice:

… health, or at least freedom from acute or chronic pain, disability, or disease, is a condition of human flourishing. Human beings cannot attain their fullest potential without some significant measure of health. A good society is one in which each citizen is enabled to flourish, grow, and develop as a human being. A society becomes good if it provides those goods which are most closely linked to being human. Health care is surely one of the first of these goods. It is, to be sure, not the only human  good  (Aristotle,  Nicomachean  Ethics,  1178b30–34).  But  other goods,  like  happiness,  wealth,  friends,  career,  etc.,  are  compromised  or even impossible without health.”

Y termina:

“This is not the place to design a total system of health care, nor to fill in the content of precisely what services constitute a fair share of the common good of health care, nor to speak of the costs, modes of payment, and choices  among  other  societal  goods.  Obviously,  those  are  the  questions most often at issue in policy debates. But, in the end, those are second order questions. They can be answered properly only in light of the first-order questions: What is health care? What kind of good is it? What moral claim  do  members  of  a  society  have  on  this  good?  What  are  society’s obligations, and what are the obligations of the health professional with reference to that good?
Understanding health care to be a commodity takes one down one arm of a bifurcating pathway to the ethic of the marketplace and instrumental resolution of injustices. Taking health care as a human good takes us down a divergent pathway to the resolution of injustice through a moral ordering of societal and individual priorities.
One thing is certain: if health care is a commodity, it is for sale, and the physician is, indeed, a money-maker; if it is a human good, it cannot be for sale  and  the  physician  is  a  healer. Plato’s  question  admits  of  only  one ethically defensible answer.
Can we deny, then, said I, that neither does any physician, insofar as he is a physician, seek to enjoin the advantage of the physician but that of the patient?
(Plato, Republic 342c)”

Journal of Medicine and Philosophy, 1999, Vol. 24, No. 3, pp. 243–266

Accesible en http://jmp.oxfordjournals.org/content/24/3/243.full.pdf+html

Special Report: Ten Stories That Mattered in Access to Medicines in 2010 | Doctors Without Borders

enero 1, 2011

Bioética Latinoamericana les desea a tod@s un mejor 2011, en el que los intereses económicos sean frenados por la acción colectiva.

Special Report: Ten Stories That Mattered in Access to Medicines in 2010 | Doctors Without Borders.

Un impresionante informe de MSF. Quienes estén interesados en el tema del doble standard traten de ver el video que acompaña  el informe en el punto 4.