Botched drug trial investigated in France

Days after the news broke of six men being hospitalized in France after taking part in a drug trial for a new painkiller medication, one of the patients, who was originally reported as being brain-dead, has been officially declared deceased.

French authorities launched 3 investigations Saturday, January 16, at a research laboratory in the northwestern city of Rennes into a drug trial that left one person brain-dead and three others facing potentially irreversible brain damage.

The unidentified victims were part of a Phase 1 test, checking the safety of the drug and not its effectiveness, in a licensed clinic in Rennes, for the Portuguese pharmaceutical company Bial.

The company conducting the testing said on its website the trial was administered “in full compliance with the global regulations and Biotrial’s procedures were followed at every stage throughout the trial”.

French TV channel iTele said the trial was for a painkiller containing cannabis, but this was denied by the health ministry. Another is suffering “neurological problems” and the sixth is being monitored, but showing no symptoms.

Eighty-four other volunteers exposed to the drug have been contacted.

According to the press release, the hospitalized volunteers had received the medication in higher doses.

It said another five people in the trial would have medical exams closer to their homes.

All trials on the drug have been suspended and all volunteers who have taken part in the trial are being called back.

A logo of the Biotrial laboratory is displayed outside its building in Rennes, western France, Friday, Jan. 15, 2016. “This accident caused the hospitalisation of six of the volunteers at the University Hospital of Rennes”.

According to Touraine, the drug used in the trials was not based on marijuana, contrary to what early media reports suggested as the news first broke.

Accidental deaths from Phase 1 of clinical trials are said to be quite rare.

The trial was conducted by Biotrial, a French-based company with an worldwide reputation which has carried out thousands of trials since it was set up in 1989.

The drug was in a phase one trial, with the intention to test “the safety of its use, tolerance and pharmacological profile of the molecule”.