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French Victim of Bial-Portela Drug Tests Dies, Others Stable
Five other volunteers, hospitalised a week ago when the drug trial went wrong, were in a stable condition, the Rennes hospital said in a statement on Sunday.
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The drug had been manufactured by the Portugal-based pharmaceutical group Bial, and was being tested at a facility in Rennes by the research company Biotrial.
Reports have suggested that the drug being trialled was a painkiller and mood disorder medication based on the natural brain compound that has the same function as an active ingredient in cannabis.
Gilles Edan, chief neuroscientist at Rennes CHU university hospital, said three of the volunteers could have permanent brain damage. Five other patients who took part in the trial for the closely held Portuguese company remain in hospital.
Hospitalier Universitaire de Rennes, where the drug trial patients are being treated, said four of the patients may be permanently disabled with neurological impairment.
According to the statement, the trial was being performed in a lincensed private institution that conducts trials of drug safety, tolerability, and pharmacology, in healthy volunteers.
Reports also show that initial trials on lab animals now do not offer any clues on what may have caused this accident which is being described as one of the most troubling medical incidents in France.
“Our principal concern, at the moment, is taking care of participants in the trial”, Bial said in a statement on Friday.
The drug was in a phase one trial, with the intention to test “the safety of its use, tolerance and pharmacological profile of the molecule”.
The hospital said it has contacted the other volunteers exposed to the new painkiller.
The trials were stopped after six people became seriously ill.
The trial was meant to test for side-effects of the new drug but all trials at the clinic have been suspended and the French state prosecutor has opened an inquiry.
The firm said that a total of 108 people have received the medicine – which acts on the endocannabinoid system to target pain – as part of the study, “without any moderate of serious adverse reaction”.
Trials typically have three phases to assess a new medicine for safety and effectiveness. Serious incidents like these are rare in the testing of a drug.
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After visiting volunteers who took part in the trial, she told reporters: “I was overwhelmed by their distress”.