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Man Left Brain Dead After French Drug Trial Dies

The other five, aged 28 to 49, were said to be in a stable condition.

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“The 84 other volunteers exposed to the drug” have been contacted, said the hospital.

Clinical trials are typically conducted in three phases.

In all, 90 volunteers were taking part in the trial, which was halted on Monday.

Every year, thousands of volunteers, often students looking to make extra money, take part in such trials. Ninety people received different dosages of varying levels, while the rest received a placebo. Serious incidents like these are rare in the testing of a drug. One of the six had no symptoms but was being carefully monitored, he said. The drug has no known antidote, said Gilles Edan, who is head of the hospital’s neurology department.

Health minister Marisol Touraine said it was a “tragic accident” and the volunteers’ “lives have been brutally turned upside-down”.

Reports have suggested that the drug being trialled was a painkiller and mood disorder medication based on the natural brain compound that has the same function as an active ingredient in cannabis. However, the minister has since clarified that this is not the case. Bial has yet to confirm the drug that was being tested.

“Our principal concern, at the moment, is taking care of participants in the trial”, a company statement said.

Bial and Biotrial are working with French authorities on the case.

According to the health ministry, the adverse effects occurred on Thursday.

The Portuguese firm had issued a statement yesterday insisting it had followed “international best practice” in developing the drug and said it would cooperate with the investigation to “determine in a rigorous and exhaustive manner” what had happened.

Both the drugmaker Bial and Biotrial said they were in full compliance with regulations. Specifically, they will look for any missteps taken by the doctors who administered the trial.

Testing had already been carried out on animals, including chimpanzees, starting in July, Touraine said. Testing any new drugs is never completely without risk.

“Phase one trials often involve young participants who take part in return for payment”.

The big question in France: what went terribly wrong?

One died on Sunday after being rendered brain dead.

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Britain saw an equally horrific accident in 2006 when six men were admitted to hospital in Northwick Park Hospital in London after a clinical trial where they were given a drug meant to fight autoimmune disease and leukaemia. The men did survive, but with some permanent injuries.

Experimental Drugs