Man dies after taking part in experimental drug trial

The French government has started an investigation after a clinical trial of an experimental medicine left one man dead and five other patients desperately ill in hospital.

A “serious accident” during a drugs trial in France left one person brain dead and five hospitalised, Marisol Touraine said today.

Six people were hospitalised after taking part in a Phase I trial for a new pain and mood disorder medication being tested by French laboratory Biotrial on behalf of Portuguese pharmaceutical company Bial.

The hospital said it had already contacted the other 84 volunteers who had taken the drug during its Phase 1 trial stage.

The drug had been manufactured by the Portugal-based pharmaceutical group Bial, and was being tested at a facility in Rennes by the research company Biotrial.

The trial, which has been suspended, was conducted by a private laboratory.

In a press conference on Friday afternoon, French health minister Marisol Touraine said the drug “does not contain cannabis or any derivative of cannabis”.

The remaining five are in a “stable condition” the hospital said.

Hospitalier Universitaire de Rennes, where the drug trial patients are being treated, said four of the patients may be permanently disabled with neurological impairment.

Phase II and Phase III are progressively larger trials to assess the drug’s effectiveness, although safety remains paramount.

Volunteers began taking the drug on January 7 in early testing known in the industry as Phase I, in which it’s determined if the drug is safe for human consumption. The trials often last a year or more, involving several thousand patients. Bial has yet to confirm the drug that was being tested. All six got the same dose, while two additional people who received a harmless placebo drug at the same time were not affected. But the trial has been ongoing since July 2015 “and at least 90 participants completed [it] uneventfully”. Serious incidents like these are rare in the testing of a drug.

One volunteer died after taking an experimental painkiller during a drug trial in France.

The incident is the worst of its kind to have taken place in France, which has launched three separate investigations to determine whether the tragedy was caused by an error in the trial’s procedures or in the substance tested. Testing any new drugs is never completely without risk.