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France: Drugs trial volunteer is left brain dead

By Staff Reporter

One man is brain dead and another five medical volunteers are in hospital after taking part in a botched drug test at a private clinic in western France, the country's Health Ministry said.

The prosecutor's office has opened an investigation into what Health Minister Marisol Touraine called "an accident of exceptional gravity... without precedence" in France at the Biotrial 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, she told a news conference in the city.

The six men in hospital, aged between 28 and 49, were healthy when the trial began on January 7, the minister clarified, adding that one man now classified as brain dead was admitted to Rennes Hospital on Sunday.

The chief neuroscientist at the hospital, Professor Gilles Edan, said there was no known antidote to the experimental drug.

Prof Edan said four of the other men have "neurological problems", of whom three could have "irreversible" brain damage.

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 fell 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, 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 (£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's regulatory agency imposing new testing standards, including recommendations to use the lowest possible dose and to test new drugs in only a single person at a time.

The six men who became ill in England now apparently have a higher risk of developing cancer and auto-immune 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 were "largely the same" throughout Europe.

"However, like any safeguard, these minimise risk rather than abolish it," Dr Whalley added.

"There is an inherent risk in exposing people to any new compound."

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