Drug Regulation

Rosiglitazone: what went wrong?

BMJ 2010; 341 doi: http://dx.doi.org/10.1136/bmj.c4848 (Published 6 September 2010)
Cite this as: BMJ 2010;341:c4848

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  1. Deborah Cohen, features editor, BMJ
  1. Correspondence to: dcohen{at}bmj.com

    Over 10 years after the diabetes drug rosiglitazone was approved by regulators, and despite studies on tens of thousands of people, questions remain about its cardiovascular safety. An investigation by the BMJ looks at why this happened.

    It was, as one Food and Drug Administration (FDA) adviser put it, a “perfect regulatory storm”—a combination of problematic data, uncertain clinical need, politics, and poor drug company behaviour.

    Now, 10 years after its approval by regulators in the United States and Europe, the widely prescribed blockbuster diabetes drug rosiglitazone may be about to fold. Two months ago, in July 2010, the FDA convened a 33 member expert advisory panel to decide whether it should be withdrawn from the market in the light of evidence that it may increase the risk of myocardial infarction. Earlier this year a US Senate finance committee report had detailed concerns about the paucity of evidence to support the use of rosiglitazone and about the way in which the drug was evaluated and licensed.1

    At the advisory meeting, members of the public heard a damning analysis of the RECORD trial, commissioned by the European Medicines Agency (EMA) when it approved the drug in 2000 in order to determine its safety. Millions of prescriptions later and with the drug still on the market around the world, this trial and other post-marketing surveillance have failed to resolve the concerns.

    To date, the FDA and the EMA have decided that the drug is safe enough to stay on the market. But the story reflects badly on almost everyone involved: the regulators, the manufacturer, GlaxoSmithKline, and the clinical community. It has also raised a host of questions. Why did the regulators accept such poor evidence on benefit and safety for rosiglitazone? Did GlaxoSmithKline mislead the regulators? Should the drug have been …

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