Reactions 1024 - 23 Oct 2004 New safety measures needed prior to drug licensing The implementation of new safety measures prior to definite licensing of drugs will reduce the number of patients exposed to unknown hazards and "provide robust and unbiased evidence on adverse events", say Drs Paul Dieppe, Shah Ebrahim and Richard Martin from the University of Bristol, England, and Dr Peter J¨ uni from the University of Berne, Switzerland. They raise three concerns following the withdrawal of rofecoxib [Vioxx]: • that it needs to be determined whether rofecoxib’s cardiovascular effects are a class effect and, if so, what degree of cyclo-oxygenase 2 inhibition is needed to produce this adverse effect • that the widespread use of NSAIDs for noninflammatory pain should be reconsidered • that measures to prevent further similar episodes must be found. To address the third concern, Drs Dieppe, Ebrahim, Martin and J¨ uni recommend that pharmaceutical companies be required to prospectively register all randomised controlled trials and that, on completion of the trials, data on serious adverse events should be made available to the public immediately. They also recommend the "phased introduction of new interventions through randomised trials", the use of both published and unpublished data to continuously update systematic reviews of adverse effects, and ‘financial firewalls’ between pharmaceutical companies and the researchers conducting clinical studies or systematic reviews. Dieppe PA, et al. Lessons from the withdrawal of rofecoxib: patients would be safer if drug companies disclosed adverse events before licensing. BMJ 329: 867-868, No. 7471, 16 Oct 2004 800973929 1 Reactions 23 Oct 2004 No. 1024 0114-9954/10/1024-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

New safety measures needed prior to drug licensing

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Reactions 1024 - 23 Oct 2004

New safety measures needed priorto drug licensing

The implementation of new safety measures prior todefinite licensing of drugs will reduce the number ofpatients exposed to unknown hazards and "providerobust and unbiased evidence on adverse events", sayDrs Paul Dieppe, Shah Ebrahim and Richard Martin fromthe University of Bristol, England, and Dr Peter Juni fromthe University of Berne, Switzerland.

They raise three concerns following the withdrawal ofrofecoxib [Vioxx]:• that it needs to be determined whether rofecoxib’s

cardiovascular effects are a class effect and, if so,what degree of cyclo-oxygenase 2 inhibition isneeded to produce this adverse effect

• that the widespread use of NSAIDs fornoninflammatory pain should be reconsidered

• that measures to prevent further similar episodesmust be found.

To address the third concern, Drs Dieppe, Ebrahim,Martin and Juni recommend that pharmaceuticalcompanies be required to prospectively register allrandomised controlled trials and that, on completion ofthe trials, data on serious adverse events should bemade available to the public immediately. They alsorecommend the "phased introduction of newinterventions through randomised trials", the use of bothpublished and unpublished data to continuously updatesystematic reviews of adverse effects, and ‘financialfirewalls’ between pharmaceutical companies and theresearchers conducting clinical studies or systematicreviews.Dieppe PA, et al. Lessons from the withdrawal of rofecoxib: patients would besafer if drug companies disclosed adverse events before licensing. BMJ 329:867-868, No. 7471, 16 Oct 2004 800973929