A France-based private laboratory Biotrial starting testing a new pain and mood disorder medication for Bial(Portuguese pharmaceutical company)on humans for the first time, in what is known as a Phase I trial, to test the drug's safety.A total of 108 volunteers took part in the trial, 90 of whom received the drug at varying doses while the rest were given placebos.
Six male volunteers between 28 and 49 who were among the group which received the highest dose from January 7th ,started reacting to it and were hospitalized at the Rennes University Hospital in western France.One of then developed a brain damage and died almost a week later.
According to Rennes hospital,the other five are “in stable condition” as at the time of report.However,in another report,Dr Gilles Edan, chief neuroscientist at the hospital, last Saturday ,said three other men could have "irreversible" brain damage.Meanwhile,one other man is suffering from neurological problems and another is being kept in the hospital but is in less critical condition.
Dr Edan further added that,there is no known way to reverse the effects of the experimental drug, which was given orally to healthy volunteers as part of the Phase 1 trial
However,three separate investigations are under way to try and find out what went wrong.
Meanwhile,Judicial police began their investigation last Friday at the premises of Biotrial in Rennes.They were joined on saturday by officials from IGAS,the National Health audit and evaluation, and the National Agency for Medicine and Health Product Safety(ANSM)
The investigators are trying to determine whether the accident was caused by an error in the testing procedure or by the drug molecule itself.
However,every other person involved in the drugs test have been contacted and none has so far reported anything unusual, according to the hospital in Rennes.
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