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ABOUT PATIENTS, "INVENTORS", JOURNALISTS, SCIENTISTS AND IRBs (TO SAY NOTHING OF THE INSTITUTIONS): CCSVI AND MS.
Med Law ; 33(4): 177-87, 2014 Dec.
Article en En | MEDLINE | ID: mdl-27351054
In this article, the Author analyzes her own experience as a member of the IRB that approved a trial to determine the efficacy of a disobstruction procedure of extracranial veins by means of angioplasty in patients with multiple sclerosis (MS). The so-called "liberation therapy" was proposed by an Italian vascular surgeon, who theorized a condition called "chronic cerebrospinal venous insufficiency" (CCSVI) as playing a role in the pathogenesis of MS. This approval, given after an animated discussion amongst IRB members, lacked any solid scientific evidence of a causal relationship between CCSVI and MS, and was accepted despite the concerns about potential risks associated with the proposed therapy. Undoubtedly, considerable pressure was exerted on IRB by MS sufferers, who rushed off to get the surgery from the many clinics who offered liberation therapy.The remaining sense of bitter has raised a reflection on how to prevent similar future cases.
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Insuficiencia Venosa / Encéfalo / Atrofias Musculares Espinales de la Infancia / Personal de Laboratorio Clínico / Angioplastia / Periodismo Médico / Comités de Ética en Investigación / Trasplante de Células Madre / Ensayos de Uso Compasivo / Esclerosis Múltiple Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies Aspecto: Ethics Límite: Adolescent / Adult / Aged / Child / Child, preschool / Female / Humans / Male País/Región como asunto: Europa Idioma: En Revista: Med Law Año: 2014 Tipo del documento: Article Pais de publicación: Estados Unidos
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Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Insuficiencia Venosa / Encéfalo / Atrofias Musculares Espinales de la Infancia / Personal de Laboratorio Clínico / Angioplastia / Periodismo Médico / Comités de Ética en Investigación / Trasplante de Células Madre / Ensayos de Uso Compasivo / Esclerosis Múltiple Tipo de estudio: Clinical_trials / Etiology_studies / Prognostic_studies Aspecto: Ethics Límite: Adolescent / Adult / Aged / Child / Child, preschool / Female / Humans / Male País/Región como asunto: Europa Idioma: En Revista: Med Law Año: 2014 Tipo del documento: Article Pais de publicación: Estados Unidos