Investigators in France are still trying to determine why a Phase I clinical trial – conducted last month – left one person dead and five others seriously injured. Now, the lab that conducted the study – called Biotrial – is being criticized for not acting fast enough when the first patient started to experience negative side-effects.
According to France’s Health Minister, Marisol Touraine, the investigation is expected to wrap-up by late March. “No regulations were breached and it was impossible at this stage to establish exactly what went wrong,” said Touraine. “The tests were carried out in compliance with current regulations.”
The drug being investigated in the Phase I clinical trial was manufactured by Portuguese pharmaceutical company, Bial. The drug was designed to treat mood and anxiety disorders, along with movement and coordination disorders stemming from neurological imbalances.
Since the incident, all further clinical trials of the experimental drug have been suspended. According to Touraine, Biotrial failed to stop the study after the first person fell ill and instead, administered the drug to five other participants the next day.
In addition, Touraine criticized the lab for not immediately informing regulatory authorities about the patient hospitalization, and failing to disclose the information to the remaining participants to allow them to make a decision about whether or not to continue their participation in the study. In the initial report compiled by the investigators, the first incident of illness was on a Sunday evening, but Biotrial did not alert authorities about the event until the next Thursday.
Investigators have not recommended that Biotrial lose their license to conduct clinical trials completely. The investigational drug was a FAAH-inhibitor that works on the body’s endocannabinoid system.
While initial reports falsely labeled the drug as a derivative of cannabis, the FAAH-inhibitor does act on the same receptors as cannabis. There were a total of 90 healthy male participants in the trial, six of whom were hospitalized after taking the medication.
“It’s not possible to identify the direct causes of the accident,” said Touraine. She went on to comment on the condition of the five patients still in hospital by saying that they are improving.