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France clinical trial: Prosecutors investigating 'accident' as Biotrial defends drug testing safety record

Biotrial said the phase one clinical trial was carried out in 'full compliance with international regulations'

Lizzie Dearden
Friday 15 January 2016 15:53 GMT
Biotrial laboratory building in Rennes where a clinical trial of an oral medication left one person brain-dead and five hospitalised
Biotrial laboratory building in Rennes where a clinical trial of an oral medication left one person brain-dead and five hospitalised (Getty Images)

Prosecutors have opened an investigation into how a volunteer trialling an experimental painkiller was left brain-dead and five more in hospital in France.

All six patients were volunteers in a clinical trial being undertaken by research company Biotrial for the reported drug manufacturers, Bial.

A spokesperson for Biotrial said it was being conducted in “full compliance with international regulations” and its own procedures, which includes health monitoring.

“We are in close and regular contact with the health ministry and authorities in France,” the company said in a statement.

“The priority at Biotrial remains the safety of our subjects.

“We are very grateful for the support we have been receiving from our clients and partners today.”

The French health ministry announced what it called a “serious accident” on Friday, saying the trial had been suspended and all volunteers recalled.

A statement released today did not confirm the name of the drug being tested but French media reports claimed it was a new cannabinoid-based painkiller.

Marisol Touraine, the French health minister, later said that the pill did not contain cannabis or its derivatives but acted on the body's endocannabinoid system.

Taken orally, the drug was undergoing a Phase 1 clinical trial at a licensed private European laboratory that specialises in clinical trials, a spokesperson said.

The trial aimed to evaluate the “safety, tolerance and pharmaceutical properties of the molecule” in healthy volunteers.

The person since declared brain-dead was admitted to Rennes University Hospital on Monday but the first patient in the case had entered the previous day.

Other patients went in on Wednesday and Thursday, while the sixth was taken in this morning as a precaution. Two others were involved in the trial but had taken a placebo,Ouest France reported.

Marisol Touraine, the French health minister, was in Rennes this afternoon to meet the patients’ families and hold a press conference with the CEO of Biotrial, Jean-Marc Gandon, after ordering an investigation.

Biotrial, with headquarters in Rennes and offices in London and Newark, New Jersey, says on its website it has over 25 years of experience in clinical trials and uses “state-of-the-art facilities.” In France, adults volunteering for Biotrial tests can earn between €100 and €4,500 (£76 to £3,400).

France’s medicines agency (ANSM) has launched an investigation into the laboratory.

A spokesperson for the European Medicines Agency in London said it did not have full details of the case but that it was monitoring the situation.

The last drug trial disaster in Europe occurred in 2006, when six healthy volunteers given an experimental drug in London ended up in intensive care.

One of them was described as looking like “the elephant man” after his head swelled up, while another volunteer lost his fingertips and toes.

Additional reporting by agencies

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