Abstract

This article discusses the limitations of clinical trials in determining the safety and efficacy of therapeutic drugs in Latin America. A major limitation is the lack of transparency surrounding the implementation of clinical trials. The data gathered by research ethics committees, regulatory agencies and the pharmaceutical industry is inaccessible to outside parties; this secrecy is not explained by the need to protect industrial secrets but rather by the industry's need to commercialize as quickly as possible the drugs under experimentation. The covering up of ethical violations, errors, and even fraud is a tacit condition imposed by the industry in order to continue future clinical trials. The governments of the region have accepted the industry’s rationalization that clinical trials transfer scientific knowledge, benefit participants, and increase the flow of foreign capital coming in to the country, and in addition the results contribute to improving health in all nations. Based on evidence gathered from several Latin American countries and from independent researchers in other parts of the world, the authors refute the industry's arguments.