• France's news in English
Volunteer left brain-dead as French drug trial goes wrong
Photo: AFP

Volunteer left brain-dead as French drug trial goes wrong

The Local/AFP · 15 Jan 2016, 16:04

Published: 15 Jan 2016 16:04 GMT+01:00
Updated: 15 Jan 2016 16:04 GMT+01:00

Facebook Twitter Google+ reddit
An investigation has been launched after the drugs trial being carried out in the western city of Rennes went tragically wrong.

Some media reports in France claimed the drug was a cannabis-based painkiller and AFP quoted a source "close to the case" who said the drug contained cannabinoids - an ingredient found in cannabis plants.

However a spokesperson for France's health ministry has told The Local this information is false.

"This medication did not contain cannabis and was not a cannabis-based drug," said Health Minister Marisol Touraine.

According to France's Minister of Health Marisol Touraine the trial has been called off after one person was left brain-dead and five others hospitalised after taking the drugs.

However some reports suggest the victim has been left in a coma, which would mean the brain damage may not be permanent. 

It is believed eight people were taking part in the trial, but of two of them had been given a placebo.

"A serious accident took place," the minister said, adding the study had been halted and all volunteers taking part recalled.

"This trial was performed in a licensed private institution specializing in the conduct of clinical trials (...) in healthy volunteers. This accident caused the hospitalization of six of the volunteers at the University Hospital of Rennes. One of them in intensive care, is brain dead," said the minister in a statement.

READ ALSO: How does drug approval work?

French drug trial goes wrong: How does drug approval work?

The Paris prosecutor's office said an investigation had been opened by police as well as health authorities.

Touraine, who was informed of the accident on Thursday evening, was on her way to Rennes on Friday morning, where she is expected to hold a press conference along with a representative from the company Biotrial which was leading the trial.

The study was a phase one clinical trial, in which healthy volunteers take the medication to "evaluate the safety of its use, tolerance and pharmacological profile of the molecule", the minister added in a statement.

Touraine gave no further details on the type of drug being trialed or what it would eventually be used for.

She simply said it was a medication "taken orally and in the process of being developed by a European laboratory".

Medical trials typically have three phases to assess a new drug or device for safety and effectiveness.

Phase I entails a small group of volunteers, and focuses only on safety.

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

Touraine said she was determined to "shed light on" what happened.

The trial was being carried out by the private laboratory named Biotrial, that was accredited and approved by the Ministry of Health. 

Story continues below…

The firm released a statement via Twitter in which it insisted that all the necessary rules were followed.

Biotrial is a French company that employs 300 people worldwide, including 200 in France. It also has labs in Paris and in London and New Jersey, from where it carries out "a large variety of early clinical studies," according to its website.

On its website Biotrial boasts of having 25 years experience in clinical drug trials. 

Every year thousands of volunteers, often students looking to make extra money, take part in such clinical trials which are seen as safe.



The Local/AFP (news.france@thelocal.com)

Facebook Twitter Google+ reddit

Your comments about this article

Today's headlines
Calais migrants given mixed reception in French towns
Photo: AFP

Some in France have shown solidarity with their new guests, while others have made it clear they are not welcome.

Lonely Planet says Bordeaux is world's best city to visit
The fantastic new Bordeaux wine museum. Photo: AFP

After The Local France, the Lonely Planet has followed suit by urging everyone to head to Bordeaux in 2017.

Jungle shacks set ablaze and torn down as camp razed
All photos: AFP

IN PICTURES: The razing of the Jungle has finally begun.

Frenchwoman finds WW1 grenade among her spuds
Photo: AFP

It could have been a very explosive family dinner.

Refugee crisis
What rights to a future in France for Calais migrants?
Photo: AFP

What does the future hold for the migrants of the Jungle? Can they work or claim social benefits or travel freely inside Europe?

Pampers nappies 'contain carcinogenics': French study
Photo: Robert Valencia/Flick

The substances in the nappies are meant to prevent skin irritation but are cancerous, the study concludes.

France to scrap special prison wings for dangerous jihadists
Photo: AFP

The experiment has been ditched.

Myth busting: Half of French adults are now overweight
A model at the Pulp Fiction fashion show in Paris that represents society's diverse spectrum . Photo: AFP

Hold on, aren't the French all meant to be finely toned specimens with not an ounce of fat on them?

France poised to send bulldozers into Calais Jungle
Photo: AFP

As hundreds of migrants leave, the bulldozers are set to tear down the sprawling Calais shanty town on Tuesday.

UK to spend €40 million on securing Calais border
Photo: AFP

Britain spending big on security in Calais.

The annoying questions only a half French, half Brit can answer
Sponsored Article
Last chance to vote absentee in the US elections
Forget Brangelina's chateau - here are nine others you've got to see
The must-see French films of the millennium - Part One
How life for expats in France has changed over the years
Why Toulouse is THE place to be in France right now
Video: New homage to Paris shows the 'real side' of city
The 'most dangerous' animals you can find in France
Swap London fogs for Paris frogs: France woos the Brits
Anger after presenter kisses woman's breasts on live TV
Is France finally set for a cold winter this year?
IN PICS: The story of the 'ghost Metro stations' of Paris
How to make France's 'most-loved' dish: Magret de Canard
Welcome to the flipside: 'I'm not living the dream in France'
Do the French really still eat frogs' legs?
French 'delicacies' foreigners really find hard to stomach
French are the 'world's most pessimistic' about the future
Why the French should not be gloomy about the future
This is the most useful French lesson you will ever have. How to get angry
Why is there a giant clitoris in a field in southern France?
French pastry wars: Pain au chocolat versus chocolatine
Countdown: The ten dishes the French love the most
Expats or immigrants in France: Is there a difference?
How the French reinvented dozens of English words
jobs available