The use of placebos in phase III clinical trials in Brazil

Gustavo Butzge Rubenich; Stephanie Tomasi Heck; Fernando Hellmann; Bruno Rodolfo Schlemper Junior

doi:10.18294/sc.2015.418

The use of placebos in phase III clinical trials in Brazil

https://doi.org/10.18294/sc.2015.418

Published 4 March 2015

Gustavo Butzge Rubenich Medicine Student, Universidade do Oeste de Santa Catarina, Brazil. , Stephanie Tomasi Heck Medicine Student, Universidade do Oeste de Santa Catarina, Brazil. , Fernando Hellmann Naturologist. Master Degree in Public Health. Professor, Universidade do Sul de Santa Catarina, Brazil. , Bruno Rodolfo Schlemper Junior Physician. Doctor in Medicine. Professor, Universidade do Oeste de Santa Catarina, Brazil.

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Keywords:

Ethics, Research, Medical, Clinical Trial, Placebos, Helsinki Declaration

Abstract

In 2008, Brazil’s Federal Council of Medicine [Conselho Federal de Medicina] (CFM) – regulatory and supervisory agency on the ethical practice of medicine – banned the participation of Brazilian doctors in studies using placebos for diseases with efficient and effective treatment. This position differs with the Helsinki Declaration, which allows the use of placebos in methodologically justified conditions. To ascertain whether the CMF’s ethical regulation modified the use of placebos in phase III clinical trials in Brazil, characteristics of the records in ClinicalTrials.govwere researched in the periods from 2003 to 2007 and from 2009 to 2013. The conclusions reached were: a) the regulations issued by the CFM in 2008 were ineffective and the position adopted by the Helsinki Declaration prevails; b) there was significant sponsorship by the multinational pharmaceutical industry of trials with placebos; c) the research was predominantly on new drugs for chronic diseases, with little study done of the neglected diseases which are of great importance to Brazil.

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