Volunteer dies after troubles with French drug trial

The chief neuroscientist at a hospital in Rennes, where a botched drug trial has left six people hospitalized, says there’s no known antidote to the experimental drug they were testing.

At a news conference, French health minister Marisol Touraine said the trial participants had been taking some drug dosage meant to tackle mood and anxiety disorders, as well as movement coordination issues connected with neurological problems.

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. Gilles Edan, doctor, said that there were fears of irreversible handicap for three of the five others, who went in on Wednesday and Thursday.

The French health ministry said it immediately sent agents to the medical facility to determine if all the rules had been followed in the testing and if the facility where the patients were staying during the trial maintained sanitary conditions. Portugal-based Bial lab is the manufacturer of the experimental medicine that sent male volunteers in a trial of the drug to hospital in France.

The study was a Phase I clinical trial, in which a drug is tested on humans for the first time, after likely tests on animals and in the laboratory to ensure its safety.

The company, which has been carrying out drug trials on behalf of pharmaceutical companies since 1989, said the situation is “even more upsetting given that there is as yet no explanation”.

It is rare for volunteers to fall seriously ill when testing new drugs.

The drug had been tested in chimpanzees prior to the human trial, Touraine noted.

Clinical trials are the key to getting that data – and without volunteers to take part in the trials, there would be no new treatments for serious diseases such as cancer, multiple sclerosis and arthritis. He added that one of the six men was being carefully monitored, though he had shown no symptoms.

Both the drugmaker Bial and the research company that carried out the study, Biotrial said they were in full compliance with worldwide guidelines and regulations. One of the victims could have permanent brain damage from the trial.

Based in northern Portugal near the town of Porto, Bial says on its website that it is the country’s largest pharmaceutical company, founded in 1924 with a presence in 58 countries.

All trials on the drug were already suspended and volunteers were recalled following this development, added Touraine.

In 2006, Britain saw a similar incident when six previously healthy men were treated for organ failure hours after being given an experimental drug targeting the immune system.