Man Left Brain Dead After French Drug Trial Dies

The study was a Phase I clinical trial, where healthy volunteers take medication to evaluate its safety for wider use. The volunteers were given the experimental drug in varying doses at different times, she told reporters at a news conference in Rennes.

The French health minister, Marisol Touraine, said 90 people in total had taken part in the trial and received some dosage of the drug; others had taken a placebo.

The hospital said the other 84 volunteers have been contacted – ten of whom have been examined and found to have suffered none of the “anomalies” seen in those taken to hospital.

“The families are devastated [and] we will make sure they are given all the answers, particularly as at the moment I am not aware of any comparable events”, continued Touraine. The men who were hospitalized Thursday had taken the highest doses, starting January 7, and the side effects began roughly three days later, the BBC reported.

The company, which has been carrying out drug trials on behalf of pharmaceutical companies since 1989, said the situation is “even more upsetting given that there is as yet no explanation”.

Until taking the oral drug at the Biotral private facility, the six men in ages between 28 and 49 had been in good health, according to the health minister.

On Saturday they were joined by representatives of France’s social affairs inspectorate general (IGAS) and the national drug safety agency (ANSM). The drug is based on a natural brain compound similar to the active ingredient in marijuana.

Touraine said the medication was not based on cannabis, as some media reports had claimed.

Each year, thousands of volunteers participate in clinical drugs trials and experts say that tragic results are rare.

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

In a statement, Bial said it was committed to warranting the wellbeing of test volunteers and was working with authorities to find out the cause of the accidents, remarking that the clinical trial had been authorized by French regulators.

French prosecutors have launched a manslaughter investigation into the unusual case, which shined a spotlight on the practice of testing drugs on paid, healthy human volunteers.

Dr. Ben Whalley, a neuropharmacology professor at the University of Reading, said standardized regulations for clinical trials are “largely the same” across Europe. The risks are low but there must still be a leap of faith when they are tried in people for the first time.