French drug trial disaster: one man brain dead, five in hospital

The study was run by drug evaluation company Biotrial, and the drugmaker has been identified as the Portuguese pharmaceutical company Bial.

PARIS (AP) — One man is brain dead and three others are facing possible permanent brain damage after volunteering to take part in a drug test that went awry, France, French authorities said Friday.

The health ministry has ordered suspension of all the further trial sessions of the so-called FAAH inhibitor that cures by causing improvements in the body’s endocannabinoid system that is in charge of the body’s response to cannabis. She also urged calm, saying no drug on the market was implicated in the failed trial.

Four of the patients may be permanently disabled with neurological damage, doctors in the northwestern city of Rennes said. It was not the case that the drug was being tested for the first time on humans, testing has already been performed on animals, including chimpanzees, starting in July.

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.

A logo of the Biotrial laboratory is displayed outside its building in Rennes, western France, Friday, Jan. 15, 2016.

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.

A total of 90 healthy volunteers were involved in the trial.

‘Unprecedented’ The French health minister Marisol Touraine, who rushed to Rennes to assess what she called an “unprecedented” event, promised to “get to the bottom of this tragic accident”. It did not name the clinic where the trial took place.

In the trial, run by the private research company Biotrial, the 6 men starting taking the investigational drug January 7, in varying doses.

The Paris prosecutor’s office said a case to investigate the incident had been started. The Portuguese company declared five participants had been hospitalized and did not explain why the official French figures had said there were six volunteers being monitored at the hospital.

“Undertaking phase one studies is highly specialist work”, said Daniel Hawcutt, a lecturer in clinical pharmacology at Britain’s University of Liverpool. Wilson experienced the most adverse effects from the medication; he was in pain for months, and even lost parts of his fingers and toes to the effects of the drug.

“However, like any safeguard, these minimise risk rather than abolish it”, Dr Whalley added.