French authorities launched three investigations yesterday 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.
Judicial police carried out late on Friday 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 (IGAS) and the national drug safety agency (ANSM).
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.
A total of 90 volunteers – healthy men aged between 28 and 48 – were given the experimental drug in the Phase I trial.
Six of them were taken to hospital last week.
Pierre-Gilles Edan, head of the neurology department at the hospital in Rennes where the volunteers were taken, said on Friday that aside from the man who was brain-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 CHU university hospital in Rennes, where the six are being treated, said yesterday that they remained in a stable condition, adding that its staff were “fully and constantly mobilised” to attend to the victims and their families.
“Social and psychological care has also been put in place,” the hospital added in a statement, noting that legal support has also been offered to the victims and their relatives.
“All of the volunteers are being contacted,” it said.
The head of Biotrial said yesterday that the lab was co-operating with the 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,” Francois Peaucelle told journalists at a press briefing at the site.
The investigators and inspectors “are trying to understand ... what could have happened and how it could have resulted in such a tragic situation”, he said.
Representatives from Bial were also on site and taking part in the probes with “total transparency”, according to Peaucelle.
The Portuguese firm issued a statement on Friday insisting that it had followed “international best practice” in developing the drug and said it would co-operate with the investigation to “determine in a rigorous and exhaustive manner” what had happened.
France’s national drug safety body confirmed it was the worst incident to have taken place in a drugs trial in the country.
Each year thousands of volunteers participate in clinical drugs trials and experts point out that tragic results are rare.
But the incident in Rennes has raised concerns about such experiments.
A teacher in Rennes who has participated in such trials told AFP he would not do it again.
“I will not do it any more and I’m going to advise against it,” said the 33-year-old, who requested anonymity.
He admitted to being attracted by the “easy money” that participants received.
A picture taken yesterday shows the logo of the Biotrial laboratory on its building in Rennes, western France, where a clinical trial of an oral medication left one person brain-dead and five hospitalised.
