clínicos no Brasil : o Protocolo 028 AIDS , activism , and the regulation of clinical trials in Brazil

This paper examines the politics and practices of drug evaluation in Bra z i l . It tra c e s the history of AIDS activists’ influence on the organization of modern clinical trials and their scientific ra t i o n a l e . Using the Me rck indinavir trial as a case study, the authors discuss how org a n i zed civil society has developed strategies to intervene in the course of drug evaluation trials, shaping them according to its own intere s t s . Adopting translation sociology as the theore t i c a l f ra m ew o rk , the paper describes and analyzes the strategies used by activists from “ Gr u p o Pe l a Vi d d a / S P ” (an AIDS NGO) to build a consensus concerning indinavir monothera p y’s lack of e f f i c a c y. The study considers the seve ral re g u l a t o ry forums invo l ved in dealing with the controversy during the trial period.