AIDS, ativismo e regulação de ensaios clínicos no Brasil: o Protocolo 028

Cadernos de Saúde Pública

Maria Auxiliadora Oliveira²  Elizabeth Moreira Dos Santos¹  José Manoel Carvalho Mello¹ 

[1] ,Fundação Oswaldo Cruz Escola Nacional de Saúde Pública Núcleo de Assistência FarmacêuticaRio de Janeiro RJ ,Brasil

关键词: Acquired Immunodeficiency Syndrome;    Ethics;    Clinical Trials;    Síndrome de Imunodeficiência Adquirida;    Ética;    Ensaios Clínicos;   

DOI  :  10.1590/S0102-311X2001000400020

来源: SciELO

【 摘 要 】

This paper examines the politics and practices of drug evaluation in Brazil. It traces the history of AIDS activists' influence on the organization of modern clinical trials and their scientific rationale. Using the Merck indinavir trial as a case study, the authors discuss how organized civil society has developed strategies to intervene in the course of drug evaluation trials, shaping them according to its own interests. Adopting translation sociology as the theoretical framework, the paper describes and analyzes the strategies used by activists from "Grupo PelaVidda/SP" (an AIDS NGO) to build a consensus concerning indinavir monotherapy's lack of efficacy. The study considers the several regulatory forums involved in dealing with the controversy during the trial period.

【 授权许可】

CC BY   
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