Portuguese pharmaceutical company Bial has been trying to get approval for a synthetic ‘cannabinoid-based’ medication to treat anxiety. Unfortunately for Bial, it seems that things apparently went very wrong.
Bial’s trial is receiving mainstream media attention, perpetuating a myth that cannabis is dangerous, but there are still huge questions about what actually happened. The molecule used in the drug trial wasn’t even from a natural cannabis plant.
Six volunteers in the drug trial were hospitalized, three face irreversible brain damage, and one participant has been left ‘brain-dead,’ according to ABC news.
Ninety participants in the trial took the drug, and 30 received a placebo. The drug trial was halted after a group who started to take the drug on January 7th fell ill, with the first patient showing negative symptoms on January 10.
The Bial website lists a compound called BIA 10-2474 in Phase I for “neurological and psychological properties” for the drug trial. The drug tested in the study was an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme that breaks down so-called endocannabinoids in the brain. FAAH inhibitors have been proposed as a possible treatment against chronic pain.
An investigation has begun. Pierre-Gilles Edan, head of the neurology department at the hospital in Rennes, France where the drug-trial volunteers were admitted for treatment, said that aside from the man who was clinically dead, three others were suffering a “handicap that could be irreversible.”
The affected patients show evidence (by MRI) of deep cerebral hemorrhage and necrosis.
Experts are saying this is the worst failure of any drug trial in history in the country (France). The results are very rare. Others say that if it is a cannabinoid which caused the damage, and the active ingredient caused the troubles, “that is some extraordinarily bad luck or malpractice, considering the ‘clinical trials’ of millions of people using hundreds of different completely untested synthetic cannabinoids as ‘legal highs’ without major acute health issues under a normal dosing regimen.”