[Transparency in biomedical research: about the risks associated with the use of 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 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.
Escuela de Medicina, Universidad Diego Portales, Chile. sofia.salad@udp.cl
Sofía P
SP
Salas
Moisés
M
Russo
D035843:Biomedical Research / Q000941:ethics*; D002318:Cardiovascular Diseases / Q000139:chemically induced*; D002677:Chile; D016265:Conflict of Interest; D004345:Drug Industry / Q000941:ethics*; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects*; D012108:Research Personnel / Q000941:ethics; D012307:Risk Factors; D000077154:Rosiglitazone; D045162:Thiazolidinediones / Q000009:adverse effects*
D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone