Rubenich Gustavo Butzge, Heck Stephanie Tomasi, Hellmann Fernando, Schlemper Junior Bruno Rodolfo
Universidade do Oeste de Santa Catarina, Brasil.
Universidade do Sul de Santa Catarina, Brasil.
Salud Colect. 2015 Mar;11(1):99-114. doi: 10.18294/sc.2015.418.
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.gov were 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.
2008年，巴西医学联邦委员会（CFM）——医学伦理实践的监管机构——禁止巴西医生参与针对已有有效治疗方法的疾病开展的安慰剂研究。这一立场与《赫尔辛基宣言》不同，后者允许在方法合理的情况下使用安慰剂。为确定CFM的伦理规定是否改变了巴西III期临床试验中安慰剂的使用情况，研究了ClinicalTrials.gov上2003年至2007年以及2009年至2013年期间记录的特征。得出的结论是：a）CFM在2008年发布的规定无效，《赫尔辛基宣言》所采取的立场仍然有效；b）跨国制药行业对安慰剂试验有大量资助；c）研究主要针对慢性病的新药，对巴西具有重要意义的被忽视疾病的研究很少。
