Healthy Skepticism Library item: 5320

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Publication type: Journal Article

Carpenter D, Ting MM.
Essay: the political logic of regulatory error.
Nat Rev Drug Discov 2005 Oct; 4:(10):819-23
http://www.nature.com/nrd/journal/v4/n10/abs/nrd1850_fs.html;jsessionid=BA9DED6BE100D813C43426D4CE680584

Abstract:

Regulatory error is an issue that has come to the fore following the withdrawal of rofecoxib (Vioxx; Merck) a year ago. Here, we provide a theoretical discussion of the factors that could influence regulatory error, drawing on the Vioxx episode in particular as a possible example of error, and consider the implications for future regulatory policy

Keywords:
Drug Approval/legislation & jurisprudence Drug Approval/methods* Drug Approval/statistics & numerical data Humans Lactones/adverse effects Lactones/therapeutic use Logic* Observer Variation Politics* Research Design/statistics & numerical data* Research Support, Non-U.S. Gov't Research Support, U.S. Gov't, Non-P.H.S. Sulfones/adverse effects Sulfones/therapeutic use