After a clinical trial in France left one person dead and five others hospitalized last week, there is growing frustration among scientists that little is known about the medicine given to the patients. And under the unusual circumstances, there are calls for the drug maker and French authorities to release some details.
Bial, the Portuguese drug maker whose drug was being tested, has said little publicly about the episode. In its most recent statement, which was released over the weekend, the company would only say that it is “working closely” with French authorities to understand what went wrong. Meanwhile, the French Health Ministry said it is reviewing the trial and expects to issue a report by the end of the month.
At the heart of the mystery is an inhibitor of fatty acid amide hydrolase, or FAAH, an enzyme produced in the brain that breaks down neurotransmitters known as endocannabinoids. The drug reportedly was being developed as a treatment for chronic pain for people with cancer and other ailments. A Phase 1, or early stage trial, began on Jan. 7 in healthy volunteers to gauge drug safety and dosing. About 90 people had been given the tablet at varying doses.
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