June 2005 BMJ Editorial Calls for Fundamental Changes to Drug Regulation

Current Drug-safety Methods Used by Regulators are Out-dated

The July 2, 2005 edition of BMJ, a British medical journal, contains a thoughtful editorial entitled "Drug safety and regulation: New powers and resources are needed".

This BMJ editorial comes from several researchers who have been involved with drug regulation in the UK.  They start with mention of the recent drug-safety controversies involving Vioxx and Paxil, then trace the roots of the current drug regulatory system back to the "thalidomide disaster" in the 1960’s. 

The case made by these UK researchers about the need for fundamental change as regards how regulatory agencies go their drug-safety monitoring clearly has universal application.  As such, I recommend this editorial to all people with an interest in how the FDA, as well as other drug-safety oversight agencies around the world, can improve their efforts directed toward protecting patients from serious side effects.

(Posted by: Tom Lamb)

 

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