The Pharmaceutical Journal
Vol 273 No 7322 p591
23 October 2004

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Call for all adverse events to be declared before licensing

In the wake of the withdrawal of Vioxx (rofecoxib), an editorial in the BMJ calls for all data on serious adverse events to be made publicly available as soon as clinical trials are completed, in order to allow systematic reviews of such events to be undertaken before a drug is fully licensed (2004;329:867).

Paul Dieppe, director of the MRC Health Services Research Collaboration, and researchers from the University of Bristol and University of Berne, recommend in the editorial that this should help ensure that similar episodes do not occur in the future.

The authors propose that drug companies should register all randomised clinical trials prospectively. They also advocate “the phased introduction of new interventions through randomised trials, which are independent from the pharmaceutical industry and are large enough to study rare outcomes, together with systematic, more robust, and comprehensive approaches to pharmacovigilance”.