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| France clinical trial: Prosecutors investigating 'accident' as Biotrial defends drug testing safety record | France clinical trial: Prosecutors investigating 'accident' as Biotrial defends drug testing safety record |
| (35 minutes later) | |
| Prosecutors have opened an investigation into how a volunteer trialling a reportedly cannabinoid-based drug 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 manufacturers, Bial. | All six patients were volunteers in a clinical trial being undertaken by research company Biotrial for the reported 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. | “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. | “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.” | “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. | 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. | |
| Taken orally, it was undergoing a Phase 1 clinical trial at a licenced private European laboratory that specialises in clinical trials, a spokesperson said. | Taken orally, it was undergoing a Phase 1 clinical trial at a licenced 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 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. | 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). | 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. | 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. | 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. | 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 | Additional reporting by agencies |