Decisions by regulatory agencies: are they evidence-based?

Full Abstract

Contradictory statements about the non-steroidal anti-inflammatory drugs from the European Medicines Agency and the United States Food and Drug Administration have raised questions about whether regulatory decisions are evidence-based. For the selective COX-2 inhibitors, there are clear contraindications and warnings in Europe, but only a vaguely worded Black Box warning in the United States. All the non-selective agents are given an almost "clean bill of health" in Europe, while all of them are judged to have a similar risk-benefit ratio as celecoxib in the United States. The regulatory agencies have failed to recognize the clinical trial evidence that the risk of cardiovascular events varies substantially among the non-selective agents, with diclofenac carrying the highest risk of harm.

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Author information

Author/s: Furberg, Curt D (CD);

Affiliation: Division of Public Health Sciences, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, North Carolina 27157-1063, USA. cfurberg(-atsign-)wfubmc.edu

Journal and publication information

Publication Type: Editorial

Journal: Trials (Trials), published in England. (Language: eng)

Reference: 2007-; vol 8 (issue ) : pp 13

Dates: Created 2007/04/18; Completed 2007/08/02; Revised 2008/11/20;

PMID: 17428328, status: PubMed-not-MEDLINE (last retrieval date: 12/26/2008)

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