Reactions 1168 - 8 Sep 2007

Lessons to be learnt fromrosiglitazone saga

Following the convening of the US FDA’sEndocrinologic and Metabolic Drugs Advisory and theDrug Safety and Risk Management AdvisoryCommittees to assess the risk associated withrosiglitazone among patients with type 2 diabetesmellitus, "several basic tenets emerged . . . that mightideally be used as guiding principles for improving theprocess of approving new drugs", comments Dr CliffordJ. Rosen from St Joseph Hospital, Maine, US.

Firstly, without fully understanding the pathogenesisof a disease and its associated complications, it may bedifficult to design effective therapies, or even todetermine how current treatments that act at multiplesites may affect clinical outcomes in many differentways, he adds.

Secondly, therapeutic options for diseases should beevaluated through an evidence-based system,comments Dr Rosen. The conflicting evidence that hasarisen regarding the safety of rosiglitazone serves tohighlight the weaknesses of observational studies whenexamining events that are common.

Thirdly, Dr Rosen argues that a "uniform approachshould be used to determine the societal benefits andrisks associated with a given intervention".

"One can only hope that the energy generated by theadvisory committee meeting will be channeled intoimproving the open hearing process to better serve allinterested parties", he concludes.Rosen CJ. The rosiglitazone story - lessons from an FDA advisory committeemeeting. New England Journal of Medicine 357: 844-846, No. 9, 30 Aug2007 801075076

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Reactions 8 Sep 2007 No. 11680114-9954/10/1168-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved