Government promises to investigate ‘unprecedented’ accident as six volunteers remain in hospital after trial for pharmaceutical company Bial

One man is brain dead and three others could face irreversible neurological damage after they volunteered to take part in a drugs trial in western France.

Six volunteers remain in hospital in Rennes, Brittany, after taking part in the Phase 1 trial for a new experimental medication designed to treat mood disorders such as anxiety, which was under development by the Portuguese pharmaceutical company Bial.

The French government promised to investigate the “tragic circumstances” of what it called an unprecedented and exceptionally serious accident which has sent shockwaves through the pharmaceutical industry.

French drug trial leaves one brain dead and five critically ill Read more

The six men, aged between 28 and 49, had been pronounced fit and healthy when they arrived at the Biotrial private clinic at the start of the drug trial on 4 January.

As paid volunteers , they spent over a week at the approved clinic where they tested the drug by regularly taking increased doses by mouth. Approximately 90 people had taken the drug while about 30 others received a placebo.

The six men who were hospitalised were the group who had taken the drug regularly and had taken the most.

Contrary to earlier reports, the health minister Marisol Touraine stressed that the drug did not contain cannabis or any element derived from cannabis. The minister said the drug was meant to act on the body’s endocannabinoid system. It had an impact on receptors which regulate pain, mood or appetite.

The men began taking the drug on 7 January after being checked for health and fitness. The first volunteer was admitted to the neurology department at the nearby hospital in Rennes three days later.

Pierre-Gilles Edan, head of the neurology department, said the man had come in with acute symptoms similar to a stroke and was now in a brain-dead state. The other volunteers were admitted to hospital shortly after. He said four men were suffering from neurological problems, three of whom might face permanent damage. A sixth volunteer was being monitored in hospital.

He said there was no known antidote to the drug because it had never been used on humans in that dosage. All trials on the drug have been suspended and all volunteers who have taken part in the trial are being called back.

A judicial investigation has been opened by the French state prosecutor as well as two separate state-run inquiries. After visiting the men and their families in hospital, Touraine, promising to shed light on who was responsible, said: “Their distress is immense. Their lives have been brutally turned upside down ... The shock is even greater given the fact that the people taking part in clinical trials are healthy.”

In the initial Phase 1 stage of clinical testing, a drug is given to healthy volunteers to see how it is handled by the body and what is the right dose to give to patients.

Cases of early-stage clinical trials going wrong are rare but not unheard of. There was a similar incident in Britain in 2006, when six previously healthy men were treated for organ failure only hours after being given an experimental drug targeting the immune system.

The six men who received the drug suffered a severe immune reaction which caused swelling and widespread organ failure. One patient was described as looking like the “elephant man” after his head swelled up; another has since required surgery to remove fingers and toes, and all the volunteers have been told they face a heightened risk of cancer and immunological disorders in later life. The catastrophe happened even though trials in animals suggested the drug was safe.

The incident prompted a review of procedures and resulted in the UK regulatory agency imposing new testing standards, including recommendations to use the lowest possible dose and to test new drugs only in one person at a time.

The French health ministry urged calm and said no drug currently on the market was implicated in the failed trial.

