During a Phase I clinical trial run by French drug evaluation company, Biotrial, six participants became critically ill – one of which has now been declared brain dead. The trial was investigating the safety of an experimental drug used to treat anxiety, motor problems and mood, which was developed by the Portuguese pharmaceutical company, Bial.
Initial reports of the accident by the French media explained that the drug in question was a cannabis-based painkiller; it has since been clarified that the pharmaceutical contained no compounds derived from the plant. The French Health Ministry was notified of the adverse effects of the drug on certain patients on Thursday evening, at which time the trial was officially suspended pending an investigation.
The minister for social affairs, health and women’s rights, Marisol Touraine, called the hospitalization of the six men “unprecedented.” She continued by saying, “I have no knowledge of a comparable event.”
The Phase I clinical trial included 128 healthy male participants between the ages of 28 and 49. According to a statement released by the French Health Ministry, the drug was administered to 90 trial participants, however Bial said that 108 volunteers received the treatment.
According to a short statement released by Biotrial, “The trial has been conducted in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of volunteers to the hospital. We are in close and regular contact with the Health Authorities and Ministry in France.”
According to experts in the clinical trials industry, serious adverse reactions to drugs in Phase I clinical studies are rare because the trials involve only healthy participants. In addition, since early-stage trials involve testing an experimental drug on human subjects for the first time, the dosage for the drug is often quite low.
“Many Phase 1 trial volunteers are poor and unemployed, and they volunteer for trials like this because they are desperate for money,” said Carl Elliott, a bioethicist at the University of Minnesota. Elliott is urging French regulators to investigate if the trial participants provided proper consent to the research, and how much the men were paid.
Portugal-based Bial said, “[The company] is strongly committed to ensuring, first of all, the well-being of the participants in this trial and to determine thoroughly and exhaustively the causes which are at the origin of this situation.” According to Touraine, the drug had previously been tested on chimpanzees and other animals, before moving on to testing in humans.
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