• France's news in English
 
app_header_v3
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

 
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)

Your comments about this article

Today's headlines
First driverless minibus goes on trial in Paris
Gilbert Gagnaire, Director General of Easy Mile, poses in front of his driverless EZ10 minibus. Photo: Eric Feferberg/AFP

The French capital's transport authority will carry out its first test of a driverless minibus on Saturday.

Feature
Room for improvement: Paris's matchbox apartments
Receptionist Ivan Lopez in his tiny "chambre de bonne". Photo: Thomas Samson/AFP

Thousands of Parisians round off a hard day's work with a trudge up six flights of stairs to a tiny, stuffy room they resignedly call home.

Former president Chirac still in hospital but wife home
Bernadette Chirac executes a deal at the French Stock Exchange on September 12. Photo: Lionel Bonaventure/AFP

Former French president Jacques Chirac remains in hospital in Paris but his wife Bernadette has now been discharged.

Pope holds multi-faith meeting with Nice victims
Pope Francis kisses a baby on arrival at his weekly audience in St Peter's Square. Photo: Vincenzo Pinto/ AFP

Pope Francis will on Saturday hold a multi-faith meeting of grieving relatives and survivors of an attack in France in July when a jihadist ploughed his truck into a crowd in Nice.

Cameron school pal appointed UK ambassador to France
Ed Llewellyn has spent time in the European Commission. Photo: Gov.uk

Ed Llewellyn attended the Eton College at the same time as former PM David Cameron, and then served as his chief of staff throughout his eleven years as Conservative leader.

UK announces new ambassador to France
Photo: gov.uk

Meet Edward Llewellyn, the UK's new ambassador to France.

How far have you assimilated into French culture?
Photo: Marie/Flickr

Which stage of the assimilation process are you at?

Opinion - Integration
'Stop telling immigrants to be French and help it happen'
Photo: AFP

Demands and laws to force immigrants to live, look, and think like the French are futile and damaging.

France's famous 'rogue trader' must pay €1 million to bank
Photo: AFP

French "rogue trader" Jerome Kerviel was ordered on Friday to pay €1 million to his former employer.

Eleven things you should know before moving to Paris
Photo: Pupkin/Flickr

Moving to Paris or just arrived? Read this first.

Sponsored Article
Why Jordan is the ‘Different’ East
National
France's Marion Cotillard rebuffs rumours of fling with Brad Pitt
National
Eight arrested over links to Nice truck attacker
Features
Why everyone should party in a French chateau at least once
Travel
The Frenchman who hated 'Nazi-Zealand' after four-day hitch-hike fail
Culture
What's on: Ten exciting events across France in September
The 45-million year old underground shells that flavour Champagne
Features
French job speak: All the terms you need to know
'Resilient' Paris now a more appealing city than New York
National
France says it's OK to warn drivers about speed cameras
Meet Honorine, 113, the oldest person in France
Education
Grenoble named France's best city to be a student
Society
New Metro map reveals cheapest pints of beer in Paris
Business & Money
How reliant is the French economy on Paris?
Society
Here's why Parisians want to move to Bordeaux
And the 'best place to spend a weekend in Europe' is… Lyon
Analysis & Opinion
'Muslims in France must be considered ordinary citizens'
Armed guards to ride French trains from October
National
France among Europe's priciest for train travel
National
Paris set to make river bank car-free for six-month trial
Society
Bordeaux hospital ranked as best in France
National
France rolls out 'world's first' driverless buses
Society
15 things a Frenchwoman can do to feel more British
Culture
Every fact you need to know about France's 'départements'
2,729
jobs available