Updated 2.15pm: Six medical volunteers are in hospital – one in a state of brain death – after taking part in a botched drug test at a clinic in western France, the Health Ministry said.
The prosecutor’s office has opened an investigation into what the ministry called a “serious accident during a clinical test” in Rennes.
Health minister Marisol Touraine travelled to the city after ordering an investigation into the lab involved and how it conducts clinical tests. She is holding a news conference later and the Rennes-based lab Biotrial said its chief executive Jean-Marc Gandon will join her.
The ministry statement said those who fell ill had taken an oral medication in the first phase of testing, which studies safe usage, tolerance and other measures on healthy volunteers.
It was not immediately clear whether the six were among a larger group of volunteers involved in the tests or what dose they had been given. The statement did not name the type of medication.
Biotrial, with headquarters in Rennes and offices in London and Newark, New Jersey, says on its website it has over 25 years of experience in clinical trials and uses “state-of-the-art facilities”.
In France, adults volunteering for Biotrial tests can earn between €100 and €4,500.
It is rare for volunteers to fall seriously ill when testing new drugs. Researchers generally start with the lowest possible dose for humans after extensive tests in animals.
There was a similar incident in Britain in 2006, when six previously healthy men were treated for organ failure hours after being given an experimental drug targeting the immune system. That prompted a review of procedures and resulted in the UK regulatory agency imposing new testing standards, including recommendations to use the lowest possible dose and to test new drugs one person at a time.
The six men in Britain now apparently have a higher risk of cancer and autoimmune diseases tied to their exposure to the experimental drug.
A "serious accident" during a French painkiller trial has left one person brain-dead and five in hospital.
The country's health minister Marisol Touraine has said it happened during testing of a cannabis-based treatment at Rennes in north-western France.
The trial has been halted and volunteers taking part have been recalled.
France’s Minister of Health has said a “serious accident” took place.
An investigation has been launched into the trial.