Archive for 21 marzo 2008

Más ejemplos de ensayos clínicos antiéticos

marzo 21, 2008

En la misma página holandesa (del Centre for Research on Multinational Corporations, SOMO -en holandés-) hay un listado y análisis de ensayos clínicos antiéticos, incluyendo varios de América Latina.

Examples of unethical trials en:

http://www.wemos.nl/en-GB/Content.aspx?type=news&id=2604

Buscar en las publicaciones del 2008

Y el documento está en http://www.wemos.nl/Documents/examples_of_unethical_trials_feb_2008.pdf

LJ

Las autoridades reguladoras estadounidenses y europeas exigen el uso de placebos y entonces…

marzo 21, 2008

…los ensayos clínicos se terminan haciendo en Europa Oriental, Asia y América Latina.  

Así lo demuestra el detallado estudio holandés “Ethics for Drug Testing in Low and Middle Income Countries”, hecho por Irene Schipper y Francis Weyzig, que resulta de lectura obligatoria para integrantes de comités de ética en investigación latinoamericanos.

Las conclusiones del resumen ejecutivo son:

Two overall conclusions are drawn from this research.
1) European authorities not only grants EU market authorisation based on unethical clinical trials, they actually induce the offshoring of unethical trials to countries outside Western Europe, by requiring trials that are rejected by the ethics committees in Western Europe, resulting in the fact that these trials mainly ends up in low and middle income countries like Central and Eastern Europe, Latin America and Asia (India and China). The research of SOMO shows that this is indeed the case with placebo-controlled studies in which stable patients and acutely ill patients diagnosed with schizophrenia and acute mania; these studies take place outside Western Europe almost exclusively.
2) The degree of transparency about clinical trials in low and middle income countries is low, both with regard to the number of trials covered in public databases and with regard to the amount of information on ethical considerations for each trial. Voluntary initiatives of the pharmaceutical industry to increase transparency about clinical trials
have clearly been insufficient in this respect. Information from national medicines agencies in EU member states is limited too, even though current EU legislation requires that all assessment reports be published without delay.

Se puede bajar de http://www.somo.nl/index_eng.php

LJ

No trataríamos a un animal así…

marzo 20, 2008

…dice Udo Schüklenk en su Ethx Blog

Wednesday, March 19, 2008

We would not treat an animal like that …

French woman Chantal Sebire died at the age of 52 at her home near Dijon. Sebire suffered from a rare form of cancer that disfigured her entire face, eventually robbing her of her eyesight, capacity to smell, and that left her in severe pain.
Sebire campaigned during her last months for her right to died a death with dignity, in other words, she requested that France permit her doctors to help her die. Voluntary euthanasia as well as any other form of euthanasia is illegal in France, hence her request was denied. As the court in Dijon, in rejecting her plea pointed out, ‘Even if the physical degeneration of Madame Sebire merits compassion, this request can only be rejected under French law.’
As Ms Sebire pointed out, ‘One would not allow an animal to go through what I have endured.’ The BBC reports, ‘Legislation adopted in 2005 allows families to request that life-support equipment for terminally ill patients be switched off, but does not allow a doctor to take action to end a patient’s life.’
Yet another example where zealot pro-life legislation trumps the decisions of competent individuals who make a voluntary decision to end their lives when they see fit. Sebire is right, we would not permit an animal to be treated as she was. She mentions that children eventually ran away from her when she walked in the streets of Dijon, while she was still capable of doing so. A truly tragic case.

Posted by Udo Schuklenk’s Ethx Blog at 7:21 PM

Gracias Udo, por la reflexión.

LJ