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Faute, accident ou risque iatrogène ? La régulation des événements indésirables du médicament à l'aune des affaires Stalinon et Distilbène

Abstract : This article proposes a socio-historical analysis of two cases, one in France and the other in the United States, both originating in undesirable incidents provoked by the use of therapeutic agents. We intend to test the hypothesis according to which, during the 20th century, the types of drug regulation created three systems for supervising and managing therapeutic dangers: those of errors, accidents and risks. In 1953-1954, Stalinon caused a hundred deaths and is France’s first great health scandal. This case and the resulting trial are one of the main reasons the rules for authorising and controlling drugs were modified. This analysis allows us to discuss the transition of the error system to that of accidents. The diethylstilbestrol (DES) case started when the evidence of dozens of cases of cancer in young women whose mothers were prescribed this molecule while they were pregnant was brought to light in the United States beginning in 1971. The question of identifying and controlling the carcinogenic effects of DES was at the origin of a decade of controversy, debates and court cases characteristic of the transition from the accident system to that of risk and which resulted in the courts acknowledging the responsibility of the industrials and a limited reform of the FDA’s evaluation procedures.
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https://hal-cnrs.archives-ouvertes.fr/hal-03477062
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Submitted on : Monday, December 13, 2021 - 12:02:30 PM
Last modification on : Sunday, June 26, 2022 - 12:17:57 PM

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C Bonah, Jean-Paul Gaudillière. Faute, accident ou risque iatrogène ? La régulation des événements indésirables du médicament à l'aune des affaires Stalinon et Distilbène. Revue française des affaires sociales, 2007, 3-4, pp.123-151. ⟨10.3917/rfas.073.0123⟩. ⟨hal-03477062⟩

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