Volunteer left brain-dead in French drug trial

The trial of the new medication meant to treat mood disorders such as anxiety began last July. It was being conducted by the Biotrial company, which has a research laboratory (above) in Rennes, France.
The trial of the new medication meant to treat mood disorders such as anxiety began last July. It was being conducted by the Biotrial company, which has a research laboratory (above) in Rennes, France.PHOTO: REUTERS

3 others may face irreversible brain damage after taking new medicine for mood disorders

RENNES (France) • French authorities launched three investigations yesterday at a research laboratory in Rennes after a drug trial conducted there left one person brain-dead and three others facing potentially irreversible brain damage.

Late on Friday, judicial police carried out the first searches at the Biotrial lab, which had performed the trial on behalf of Portuguese pharmaceutical company Bial.

Yesterday, they were joined by representatives of France's social affairs inspectorate general and the national drug safety agency.

The probes are seeking to determine if the tragedy was caused by an error in the trial's procedures or in the substance tested - a new drug meant to treat mood disorders such as anxiety.

Six volunteers from a group of 90 were taken to hospital last week after taking part in the Phase 1 trial, French Health Minister Marisol Touraine said on Friday, while about 30 others had received a placebo.

Dr Pierre-Gilles Edan, head of the neurology department at the hospital in Rennes where the volunteers were taken, said on Friday that apart from the man who was clinically dead, three others were suffering a "handicap that could be irreversible" and another also had neurological problems.

The sixth volunteer had no symptoms but was being monitored.

The head of Biotrial said yesterday that the laboratory was cooperating with investigators.

"Our thoughts remain with the victims and their families, but our energy this morning is entirely committed to assisting the investigators and to fully cooperating in the investigations under way," Mr Francois Peaucelle told journalists at a press briefing.

The investigators and inspectors "are trying to understand... what could have happened and how it could have resulted in such an a tragic situation", he said.

Representatives of Bial were also taking part in the probes with "total transparency", according to Mr Peaucelle.

The Portuguese firm had issued a statement on Friday insisting that it had followed "international best practice" in developing the drug and said it would cooperate with the investigation to "determine in a rigorous and exhaustive manner" what had happened.

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

"This type of incident is tragic but very rare in the world of clinical trials," said Professor Jayne Lawrence, chief scientist with Britain's Royal Pharmaceutical Society.

France's national drug safety body confirmed that it was the worst incident to have occurred in a drugs trial in the country.

AGENCE FRANCE-PRESSE

A version of this article appeared in the print edition of The Sunday Times on January 17, 2016, with the headline 'Volunteer left brain-dead in French drug trial'. Print Edition | Subscribe