One person is brain-dead and three others may have irreversible brain damage after taking part in a clinical trial for the Portuguese pharma firm Bial. It is the worst ever incident in a drug trial in France.
France's Health Minister Marisol Touraine and a neurologist said six men aged between 28 and 49 years were taken to hospital last week after taking part in a Phase1 trial of a new medication for the treatment of mood disorders including anxiety. It was developed by the Portuguese pharmaceutical company Bial. Touraine said the drug molecule had previously been tested on chimpanzees.
One person has been left brain-dead and three others face irreversible brain damage, Touraine said. There is no known antidote. "This is unprecedented" in France, she added.
France's national drug safety body (ANSM) said it was the worst ever incident in a drug trial in France. Clinical trials usually involve three phases to assess a new drug after preliminary tests on animals and human cells.
The trial was being conducted by the privately-owned Biotrial company (photo). Its French headquarters are in Rennes, and the trial began in July 2015.
Group of 90 volunteers
The volunteer patients were part of a group of 90 people who took the drug. Thirty others received a placebo. The drug was given in various doses. The six men who were hospitalized were taking the drug "regularly."
Pierre-Gilles Edan, head of the neurology department at the hospital in Rennes where the trial volunteers were admitted for treatment, said one man was clinically dead. Three others were suffering a "handicap that could be irreversible" and one other had neurological problems. A sixth volunteer had no symptoms but was being monitored, Edan said.
The six patients who became ill began taking the drug on January 7. Then on January 10 the first patient began showing negative symptoms, Touraine said. Bial stopped its trial a day later.
The health minister said, "the shock is even greater given the fact that the people taking part in clinical trials are healthy." Touraine said she would "shed light" on who was responsible.
The drug acted on natural receptors found in the body known as endocannabinoids, which regulate mood and appetite. They are not the compound found in the cannabis plant.
The Paris prosecutor's office said a case to investigate the incident had been started.
jm/jil (AFP, APE)