Painkiller trial
The unidentified man died on Sunday at the hospital at the University of Rennes. The new painkiller compound/drug was being trialled by the Portuguese pharmaceutical firm BIAL.
Ninety people were given the drug in various doses and six, all men between the ages of 28 and 49, including the man who has now died, fell ill. The other five were also hospitalized.
Three of the other five may have life-long brain injuries but the hospital has not yet elaborated on those injuries. The French Health Minister Marisol Touraine called the situation “an accident of exceptional gravity.”
The trial was a Phase 1 drug trial which are not normally associated with high risk for the (paid) volunteers because Phase 1 trials are not trials intended to learn of the effectiveness of the new compound. They are rather to learn of dosage and side effects.
Investigation launched
It’s unclear how this compound could have gotten to this stage and cause such terrible damage that it would kill. Details of the dosage taken by the man who died or the other 5 who are ill, or the other 84 who do not appear to have been harmed, have not been released.
An investigation is underway.
The compound was based upon an active ingredient in marijuana and given orally. It was intended to treat pain and as a treatment for mood disorders and anxiety. It was also being designed to act upon the endocannabinoid system to aid in the treatment of neurodegenerative illnesses.
Ten of the other volunteers who took the drug have been tested and nothing was found to suggest an adverse effect upon them. Arrangements are being made to test the others.
