Transparencia en la investigación biomédica: A propósito de los riesgos asociados al uso de Avandia

The question of how and when to communicate potential risks associated with new drugs has remained an important focus of tension between the pharmaceutical industry and regulatory entities, such as the American Food and Drug Administration. Recently there has been widespread concern related to the c...

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Autores principales: SALAS,SOFÍA P, RUSSO,MOISÉS
Lenguaje:Spanish / Castilian
Publicado: Sociedad Médica de Santiago 2010
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Acceso en línea:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872010000900017
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spelling oai:scielo:S0034-988720100009000172010-11-09Transparencia en la investigación biomédica: A propósito de los riesgos asociados al uso de AvandiaSALAS,SOFÍA PRUSSO,MOISÉS Biomedical research Conflicts of interest Rosiglitazone The question of how and when to communicate potential risks associated with new drugs has remained an important focus of tension between the pharmaceutical industry and regulatory entities, such as the American Food and Drug Administration. Recently there has been widespread concern related to the cardiovascular risks associated with the use of Avandia, a rosiglitazone produced by Glaxo Smith Kline. In fact, several metaanalyses involving rosiglitazone provided a relatively consistent message that rosiglitazone increases the risk of myocardial ischemic events. In the present article, we review the controversy regarding the way the pharmaceutical company handled this issue, and we describe examples of inappropriate conduct regarding an industry-sponsored clinical trial with this drug. We raise several important ethical questions related to the way researchers handle conflicts of interest when they are employees of the pharmaceutical industry. Finally, we discuss the requirements to conduct biomedical research funded by the pharmaceutical industry in Chile.info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.138 n.9 20102010-09-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872010000900017es10.4067/S0034-98872010000900017
institution Scielo Chile
collection Scielo Chile
language Spanish / Castilian
topic Biomedical research
Conflicts of interest
Rosiglitazone
spellingShingle Biomedical research
Conflicts of interest
Rosiglitazone
SALAS,SOFÍA P
RUSSO,MOISÉS
Transparencia en la investigación biomédica: A propósito de los riesgos asociados al uso de Avandia
description The question of how and when to communicate potential risks associated with new drugs has remained an important focus of tension between the pharmaceutical industry and regulatory entities, such as the American Food and Drug Administration. Recently there has been widespread concern related to the cardiovascular risks associated with the use of Avandia, a rosiglitazone produced by Glaxo Smith Kline. In fact, several metaanalyses involving rosiglitazone provided a relatively consistent message that rosiglitazone increases the risk of myocardial ischemic events. In the present article, we review the controversy regarding the way the pharmaceutical company handled this issue, and we describe examples of inappropriate conduct regarding an industry-sponsored clinical trial with this drug. We raise several important ethical questions related to the way researchers handle conflicts of interest when they are employees of the pharmaceutical industry. Finally, we discuss the requirements to conduct biomedical research funded by the pharmaceutical industry in Chile.
author SALAS,SOFÍA P
RUSSO,MOISÉS
author_facet SALAS,SOFÍA P
RUSSO,MOISÉS
author_sort SALAS,SOFÍA P
title Transparencia en la investigación biomédica: A propósito de los riesgos asociados al uso de Avandia
title_short Transparencia en la investigación biomédica: A propósito de los riesgos asociados al uso de Avandia
title_full Transparencia en la investigación biomédica: A propósito de los riesgos asociados al uso de Avandia
title_fullStr Transparencia en la investigación biomédica: A propósito de los riesgos asociados al uso de Avandia
title_full_unstemmed Transparencia en la investigación biomédica: A propósito de los riesgos asociados al uso de Avandia
title_sort transparencia en la investigación biomédica: a propósito de los riesgos asociados al uso de avandia
publisher Sociedad Médica de Santiago
publishDate 2010
url http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872010000900017
work_keys_str_mv AT salassofiap transparenciaenlainvestigacionbiomedicaapropositodelosriesgosasociadosalusodeavandia
AT russomoises transparenciaenlainvestigacionbiomedicaapropositodelosriesgosasociadosalusodeavandia
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