Oliveira M, dos Santos EM, Mello JC. AIDS, ativismo e regulação de ensaios clínicos no Brasil: o Protocolo 028. [ AIDS, activism, and regulation of clinical trials in Brazil: Protocol 029 .] Cadernos de Saúde Pública [Public Health Notebooks] (Río de Janeiro, Brazil) 2001 July-August; 17(4):863-875.
Objectives:To analyze the policy and practice of: medication evaluation in Brazil; identifying the influence that the organized civil society, in this case AIDS activists; and the exercise in the construction of scientific rationality concerning modern clinical trials.
Methodology: Qualitative, analysis of documents, professionals declarations, and articles published about the clinical testing of Indinavir by Merck Pharmaceuticals.
Results: Protocol 028 is the number assigned by the Brazilian government agency in charge of clinical trials for the approval of medications, to a clinical trial by Merck Pharmaceuticals. The trial claimed to show the efficacy of a single drug for the treatment of patients seropositive for HIV. The authors of the present article detected three areas of concern: the nature of testing, the polemic concerning mono- versus multiple-drug treatment, and ethics. Initially, activists, researchers, and corporations promoted the completion of the protocol. Later, the entry of new actors and new discourses broke the provisional equilibrium of the socio-technical network. A clinical controversy arose concerning monotherapy with antiretroviral medications. Eventually a controversy concerning ethics emerged, initially accepting limits of the professional code of ethics but also extending to the regulation of research with human subjects; this viewpoint became the principal concern of activists who at that time changed to demand suspension of the trial. The activists questioned the fragility of ethical regulation in research with human subjects in Brazil. A review of government actions showed for the activists the difficulty of proceeding by this path to halt the trial that they considered in violation of the ethics of trials with human subjects. At that moment, activists opted for informal pressure exercised toward doctors in the centers involved in the investigation as well as interviews and articles published in the national and international press. Finally, these pressures succeeded in halting the trial.
Conclusions:The article demonstrates the importance of organized and informed activism to stop studies that, under the appearance of scientific procedures, conceal grave defects in the ethics of testing with human subjects.
Copyright 2007 University of New Mexico