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Innovation thérapeutique et accident médicamenteux : socio-genèse du scandale du benfluorex (Mediator®) et conditions de reconnaissance d'une pathologie émergente : les valvulopathies médicamenteuses

Abstract : The withdrawal of Mediator®, a drug sold by Laboratoires Servier between 1976 and 2009, occurred after specific pathologies of cardiac valves were identified: the drug induced valvular heart disease. Since then, the incident has been approached from the angle of health and medical scandal, regulation failure and the influence of an industrial company on decision makers (political figures or prescribers). A legal procedure to establish probable violations of criminal laws is under way. To understand the origins and consequences of the benfluorex affair - beyond the fields of legal and political jurisdiction - this thesis proposes an analysis of the process of non-recognition of a serious adverse side effect of a drug for over 30 years and, above all, the effects of this non-recognition on those directly concerned: the people having taken it. Using data from two separate surveys, one of Mediator® users and the other of French cardiologists, this study establishes six different theoretical and analytical "figures" of people exposed to the molecule at the center of the investigation.
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Solène Lellinger. Innovation thérapeutique et accident médicamenteux : socio-genèse du scandale du benfluorex (Mediator®) et conditions de reconnaissance d'une pathologie émergente : les valvulopathies médicamenteuses. Philosophie. Université de Strasbourg, 2018. Français. ⟨NNT : 2018STRAG054⟩. ⟨tel-02426018⟩

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