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

…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

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