The other five people have been in hospital since Sunday in the Western city of Rennes, three days after starting the trial, and remain in critical neurological condition.
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French authorities are contacting the other 84 people involved in the trial. A research company called Biotrial had been testing the drug manufactured by a Portuguese company, which is meant to help with anxiety and other mood disorders. They were testing the drugs at an institution specialising in clinical trials for “healthy” volunteers according to the French Health Ministry. Earlier reports suggested that the drug contained cannabinoids, an active ingredient found in cannabis plants, but the minister said it did not contain the drug or any derivatives of it.
Marisol Touraine, France’s minister for social affairs, health and women’s rights, reported that a “serious accident” occurred during a Phase 1 clinical trial of an oral drug made by a European lab. However, the doctor said that he hoped that the fears don’t stand true, one of the admitted volunteers although did not show any symptoms, he was still being closely monitored.
Dr. Gilles Edan, the hospital’s chief neuroscientist, said there is no way that the drug’s damage could be reversed.
French media outlet BFMTV said eight people were believed to have taken part in the trial, with two of those given placebos.
Six male volunteers aged between 28 and 49 are in hospital, including one now classified as brain dead.
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. “We will do everything we can to shed light on what happened”, Touraine told reporters.
That prompted a review of procedures and resulted in the United Kingdom regulatory agency imposing new testing standards, including recommendations to use the lowest possible dose and to test new drugs only on one person at a time. She also noted that such severe adverse reactions in a phase I trial are extremely rare.
The initial Phase I stage of clinical testing consists of a medication that is given to healthy volunteers to see the human’s body response to it and to determine the appropriate dose that patients need.
The Paris prosecutor’s office said the investigation was expanded after the death to include potential manslaughter charges.
Dr Ben Whalley, a neuropharmacology professor at Britain’s University of Reading, said standardised regulations for clinical trials were “largely the same” throughout Europe.
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Biotrial is an experienced and well-regarded company that conducts up to 25 clinical trials simultaneously and has a turnover of €35m a year.
