RESUMO
The experimentation on human beings of one or several therapeutic molecules discovered in laboratory is necessary and important because it helps to find new treatments or new diagnostic methods. But, it presents serious ethical problems. In this article we are analysing the example of the HIV infection. We are succinctly describing the research methods in laboratory for therapeutic molecules, first the experimentation on animals and then on human being in clinical trials. We will then try to show, with several examples, how during these last 25 years of HIV infection, the research of new molecules has not always respected the ethical rules set out in Helsinki declaration, "Code de la santé publique" or "Guide de bonnes pratiques cliniques-ICH" etc. We are discussing here the way to avoid these irregularities.
Assuntos
Síndrome da Imunodeficiência Adquirida/tratamento farmacológico , Fármacos Anti-HIV/uso terapêutico , Ensaios Clínicos como Assunto/ética , Experimentação Humana/ética , Adenina/efeitos adversos , Adenina/análogos & derivados , Adenina/uso terapêutico , Animais , Fármacos Anti-HIV/efeitos adversos , Azatioprina/administração & dosagem , Azatioprina/efeitos adversos , Azatioprina/uso terapêutico , Ensaios Clínicos como Assunto/métodos , Ensaios Clínicos como Assunto/normas , Congressos como Assunto , Ciclosporina/efeitos adversos , Ciclosporina/uso terapêutico , Países em Desenvolvimento , Ditiocarb/efeitos adversos , Ditiocarb/uso terapêutico , Método Duplo-Cego , Avaliação Pré-Clínica de Medicamentos , Quimioterapia Combinada , Comitês de Ética em Pesquisa , Experimentação Humana/normas , Humanos , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Meios de Comunicação de Massa , Oligodesoxirribonucleotídeos Antissenso/efeitos adversos , Oligodesoxirribonucleotídeos Antissenso/uso terapêutico , Organofosfonatos/efeitos adversos , Organofosfonatos/uso terapêutico , Guias de Prática Clínica como Assunto , Estavudina/efeitos adversos , Estavudina/uso terapêutico , Tenofovir , Tionucleotídeos/efeitos adversos , Tionucleotídeos/uso terapêuticoRESUMO
The UK Medical Research Council, in order to further its mission of maintaining and improving human health, supports a substantial number of clinical trials on a wide variety of medical questions; some of these trials involve the use of placebos as controls or to maintain blinding. Before providing support, proposed trials are carefully reviewed to assess scientific quality, and to determine whether a placebo is required and is ethical in addition to ethics review by independent Research Ethics Committees. Some questions such as the choice of placebos in trials in developing countries, in surgical trials and those involving alternative medicine require consideration of additional, specific issues. Involvement of consumers in MRC work has been increasing and includes the establishment of a Consumer Liaison Group; members of this group comment on patient information leaflets for clinical trials, helping to improve patient understanding of trials and ensuring topics like placebo use are explained clearly. Views differ on the value of placebos in clinical care and on their mechanism of' action; continuing research is helping to clarify the issues.