FRAME response to French drug trial incident
The catastrophic adverse effects reported last week in a clinical trial undertaken in France were unexpected and extremely surprising.One of six people treated with repeated doses of a new investigational drug in a Phase I clinical trial was initially left brain dead and then died, four others had severe neurological problems and the fifth has had, as yet, no reported symptoms. Although the full details are yet to become publically available, it has been reported that the drug in question was an inhibitor of an enzyme (fatty acid amide hydrolase) involved in breakdown of naturally