One man is brain-dead and five others gravely ill after taking heavy and repeated doses of a new drug on trial in France.
The “serious accident” – the worst ever during a clinical trial in France and one of the worst of its kind in the world – baffled officials and health experts.
The new drug had alreadybeen tested nine times in France and 23 times in other countries.
The six men, aged between 28 and 49, all volunteers, and all perfectly healthy before the trials, took heavy doses of the drug on several occasions over the space of four days. A further 84 volunteers, who took lighter doses, have so far shown no signs of illness.
Five of the victims were suffering from “disturbing neurological problems”. Three of them may never recover completely and have probably suffered irreversible damage, a senior doctor said last night.
A sixth man, the first to be taken ill on 10 January, was declared brain-dead.
The drug – BIA 10-2474 – has been under trial for the treatment of anxiety and pain among sufferers of Parkinson’s disease. The trial, which took place in Rennes in western France, was being conducted under government licence by a local company, Biotrial, on behalf of a Portuguese drug company, BIAL. Earlier reports wrongly that suggested the drug was a derivative of cannabis.
The trial began on 7 January. The six stricken volunteers took large doses over the next four days. On 10 January, a first volunteer fell ill. The trial was suspended the next day.
Two investigations were under way last night, one by the French health ministry and one by a special gendarmerie unit that deals with medical accidents or failures. The second investigation could lead to charges of “accidentally causing serious bodily harm”.
The French health minister, Marisol Touraine, said: “The shock is all the greater because these were healthy people, not sick in any way, who had no reason to fear such an accident.”
“This is unprecedented (in France),” she said. “I have no knowledge of any similar event.” She added that no drug currently on the market was implicated in the trial.
Professor Gilles Edan, head of the neuroscience department at Rennes university hospital, said: “All of these men were in the same group and knew each other well. They all took exactly the same doses of the drug.”
All were showing differing degrees of neurological damage or stress, he said. One man was on life support and had been declared brain-dead. Three of the other five victims had probably suffered “irreversible” brain damage, Professor Edan said. He added that there was no known treatment for the experimental drug.
Biotrial is an experienced and well-regarded company that conducts up to 25 clinical trials simultaneously and has a turnover of €35m a year.
In a statement issued via Twitter the company said: “Standard international procedures were followed at every stage of the trial and, in particular, the emergency procedure for referring patients to hospital.”
Pharmaceutical company Bial yesterday said it had followed “international best practice” in the trial.Reuse content