L’éthique de la recherche et l’usage du placebo: un état de la question au Canada Research ethics and the use of the placebo: the state of the debate

Résumé

Parmi les questions discutées en éthique de la recherche, il en est une qui resurgit de façon récurrente, c’est celle de l’usage du placebo. Cette question était au coeur des discussions précédant l’adoption de la dernière révision de la Déclaration d’Helsinki, en octobre 2000 à Édimbourg. Élaborée par l’Association médicale mondiale, la Déclaration d’Helsinki a pour objectif de fournir des recommandations destinées à guider les médecins et autres participants dans leurs recherches sur l’être humain.

Summary

The question of the use of the placebo is one of the most controversial in the field of the ethics of research today. The use of the placebo remains the standard practice of biomedical research in spite of the fact that various revisions of the Helsinki Declaration have sought to limit its use. In Canada, the Tri-council policy statement: Ethical conduct for research involving humans adopted a very restrictive position with respect to the use of placebos, precisely defining the situations in which its use would meet the demands of ethical research. The positions taken by the various ethical decision-making bodies are, however, hardly shared by regulatory bodies such as the Food and drug administration (FDA), the Council for international organization of medical sciences (CIOMS) or the European agency for the evaluation of medicinal products (EMEA). This divergence of opinions reveals two quite different conceptions of what constitutes the ethical. In the case of decision-making bodies in the ethical field, it is clearly medicine’s Hippocratic Oath which explains their reluctance to use placebos. The first responsibility of the doctor is to «do no harm» to his or her patient. This duty is inherent to the medical profession and as such is not grounded in the view of medicine as a contract for care. In the case of regulatory bodies, it is the vision of «medicine as contract» which is in view; and it is this notion that justifies the use of placebos once free and informed consent has been obtained. It is also worth noting that these regulatory bodies make frequent use of arguments based on utilitarian ends. In an unprecedented move, the World medical association published in October 2001 a clarification note about the use of placebos. An analysis of this text raises the question about its real meaning: clarification or concession?