title: [Controversies over the surgical placebo: legal issues and the ethical debate].
abstract: The debate on controlled surgery trials has had some rather "sensational" repercussions, enlivening the placebo issue. In France, there is a consensus on the ethical conditions necessary for proper protection of individual persons. This consensus has taken on a legal form with the promulgation of the Huriet law. For this reason, all studies and research protocols in medicine and surgery are examined by ethics committees (CCPPRB) who assess the inclusion conditions within the framework of biomedical research and in compliance with the concept that individual participants must be give proper protection. These committees are faced with increasingly complex situations, particularly concerning the pertinence of information give to the participant and the modalities of consent. In France, standard measures were established after a parliamentary debate issuing from a wider public debate. The issue has become a social transaction between biomedical research professionals and the society in general. The international debate over the surgery placebo is an interesting illustration of how mediation institutions, working along the principles of ethical committees, play a key role in social awareness of the ethical issues involved before an innovating practice is initiated. But how legitimate are sensational pieces published in the media, which as is clearly demonstrated with the debate over the surgical placebo, are almost always individual points of view? Shouldn't the debate take into account the contributions of ethical committees which integrate representatives of the social community as well as the importance of a legal framework for individual protection as proposed by the French law? Shouldn't personal points of view be counterbalanced by regularly expressed ethical committee opinions formed after appropriate ethics-oriented discussion going beyond the simple question of "should we do it", a question often dismissed by extreme theoretical arguments that leave unanswered the practical question of "how should we do it"?
authors.affiliation: Laboratoire d'Ethique médicale et de Santé publique, Faculté de Médecine Necker, Université Paris René Descartes. hervé@necker.fr
authors.forename: C
authors.initials: C
authors.lastname: Hervé
authors.forename: G
authors.initials: G
authors.lastname: Moutel
authors.forename: J P
authors.initials: JP
authors.lastname: Meningaud
authors.forename: M
authors.initials: M
authors.lastname: Wolf
authors.forename: M
authors.initials: M
authors.lastname: Lopes
mesh_terms: D018849:Controlled Clinical Trials as Topic; D004992:Ethics, Medical; D006801:Humans; D010919:Placebos; D011639:Public Opinion; D012107:Research Design; D013514:Surgical Procedures, Operative
chemical_list: D010919:Placebos