The new declaration of Helsinki and the use of placebo in brazilian clinical trials: controversy remains

Abstract

In 2000, given the urgency for the ethical guidelines adequacy to the present scientific standards, revision initiatives of the most controversial aspects of the Declaration of Helsinki (DoH). These efforts culminated with the publication of its fifth version statingthat the use of placebo was acceptable when proven treatment does not exist. The US Federal Drug Administration, however, continued demanding the placebo control and adopted the Good Clinical Practice Guidelines. The European regulatory agency also considered such prohibition arbitrary and, amongst other entities, started a campaign against the DoH. In 2002 and 2004, ClarificationNotes published on the DoH promoted extensive controversy worldwide, concluded at its version of 2008. Despite the divergence amongst many groups, especially on placebo use, the current text assumed a more neutral positioning, flexibilising its application. Being an ethical norm, the current DoH re-started the discussions about the necessity of a document of uniform worldwide acceptance. Today, the controversy still remains in a few countries, especially in Brazil, where governmental regulatory agencies – namely the Federal Council of Medicine and the National Commission for Research Ethics – posed a ban on the placebo use in clinical trials nationally, when there is available treatment, corroborating with the ongoing controversy amongst regulatory agencies and researchers in Brazil. Therefore, since Nuremberg, given the warranty of not weakening the protection of research subjects recruited throughout the world constitutes the DoH most desired aim, dialogue must be resumed both nationally and internationally, considering the upcoming revision in 2014, at the DoH 50th anniversary.