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March 24 2010

Setting the RECORD Straight

Author Affiliations

Author Affiliation: Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.

JAMA. 2010;303(12):1194-1195. doi:10.1001/jama.2010.333

The Food and Drug Administration (FDA) recently announced another Advisory Panel scheduled to meet in July 2010 to consider whether or not to remove rosiglitazone from the market. Central to the discussion will be the results of a recently published cardiovascular outcomes trial that randomized patients to receive rosiglitazone or alternative diabetes therapies, the RECORD trial.1 On February 20, 2010, the US Senate Finance Committee released a 334-page investigation of rosiglitazone and drug maker GlaxoSmithKline (GSK).2 The documents released by the Senate include internal company e-mails that provide an extraordinary window into the conduct of an industry-sponsored clinical trial. The implications of these e-mails and other documents released by the Senate have profound consequences for academic oversight of commercially sponsored clinical trials.

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