Six previously healthy volunteers have been admitted to hospital, including one man who is now brain dead, after taking part in a drug test at a private clinic in France, the country’s health ministry said yesterday.
The prosecutor’s office has opened an investigation into what the French health minister Marisol Touraine called “an accident of exceptional gravity … without precedence” at the Biotrial lab in Rennes.
The drug trial, which was thought to be testing a new painkiller compound manufactured by Portuguese company Bial, involved 90 volunteers who were given the experimental drug in varying doses, she said yesterday.
All six men in hospital were aged between 28 and 49 and were healthy when the trial began on 7 January, she said.
The man now classified as brain dead was admitted to the Rennes hospital last Sunday.
The chief neuroscientist at the hospital in Rennes, Professor Gilles Edan, said yesterday there is no known antidote to the experimental drug that Biotrial was testing.
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 on animals.
The French ministry statement said those who fell ill had taken an oral medication in the first phase of testing.
Biotrial – which has its headquarters in Rennes and offices in London and Newark, New Jersey – said it has more than 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 (about £76 to £3,449).
In 2006 in the UK, six previously healthy men were treated for organ failure only 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 only on one person at a time.
The six are said to now have a higher risk of cancer and autoimmune diseases, tied to their exposure to the drug.
Dr Ben Whalley, a neuropharmacology professor at the University of Reading, said standardised regulations for clinical trials are “largely the same” throughout Europe.
He added: “However, like any safeguard, these minimise risk rather than abolish it. There is an inherent risk in exposing people to any new compound.”