Volunteer left brain dead as six men fall ill after botched drug test
One man is brain dead and three others are facing possible permanent brain damage after volunteering to take part in a botched drug test in western France.
The prosecutor's office has opened an investigation into what health minister Marisol Touraine called "an accident of exceptional gravity" at the private Biotrial clinical lab in Rennes.
The drug trial, which was testing a new painkiller compound, involved 90 healthy volunteers who were given the experimental drug in varying doses beginning on January 7, she told reporters.
Six male volunteers aged between 28 and 49 have since been taken to hospital, including one now classified as brain dead, she said.
The chief neuroscientist at Rennes Hospital, Professor Gilles Edan, said in addition to the brain dead volunteer, three others could have "irreversible" brain damage.
A fifth man is suffering from neurological problems and a sixth is being kept in the hospital but is in a less critical condition, he said.
Prof Edan said there is no known treatment for the experimental drug Biotrial was testing. It was a based on a natural brain compound similar to the active ingredient in marijuana.
Ms Touraine said the medication was not based on cannabis, as some media reports claimed. She urged calm, saying that no drug on the market was implicated in the failed trial. She said the drug was produced by the Portuguese pharmaceutical company Bial.
All the other volunteers are being contacted, Ms Touraine said.
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. The French ministry statement said those who had fallen ill had taken an oral medication in the first phase of testing, which was studying safe usage, tolerance and other measures on healthy volunteers.
Biotrial, with headquarters in Rennes and offices in London and Newark, New Jersey, says 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 euros (£76 to £3,400).
In 2006, Britain saw a similar incident 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 in 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.
Ben Whalley, a neuropharmacology professor at the University of Reading, said standardised regulations for clinical trials are "largely the same" across Europe.
"However, like any safeguard, these minimise risk rather than abolish it," Dr Whalley said. "There is an inherent risk in exposing people to any new compound."