Healthy Skepticism Library item: 17437

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Nissen SE
Setting the RECORD Straight
JAMA 2010 Mar 24; 303:(12):1194-1195
http://jama.ama-assn.org/cgi/content/extract/303/12/1194

Abstract:

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.

On May 1, 2007, Wolski and I submitted for publication a meta-analysis of 42 randomized rosiglitazone clinical trials, showing a hazard ratio (HR) for . . .