Man Dies After Medical Trial Goes Wrong

The French health minister says a failed clinical trial on a cannabis-based drug has left a medical volunteer brain-dead and five others hospitalized, all of them in a serious condition.

Six people have been hospitalized and one person is brain-dead in a trial of a new drug in France, the country’s health minister said in a statement.

Of the six men in hospital, three could have permanent brain damage, he added.

Ninety volunteers took the drug, which was manufactured by the Portuguese company Bial, according to the BBC.

Inspectors from France’s health audit and evaluation office, IGAS, were at the laboratory of clinical trial company Biotrial in the north-western city of Rennes on Saturday, broadcaster BFM-TV reported.

According to the Associated Press, French Health Minister Marisol Touraine said the medication at the center of the clinical trial is not based on cannabis, as some media reports have claimed.

Three days later on Sunday, one patient reportedly fell ill and arrived at the hospital, five more following just days later.

Edan said there’s no known way to reverse the effects of the experimental drug that Biotrial was testing.

Six men aged between 28 and 49 were admitted to hospital, including the brain dead man, after taking the experimental drug. He added that the other 83 volunteers were being contacted.

Prosecutors launched an investigation into the botched clinical trial at the private Biotrial clinic in Rennes.

France’s public body ONIAM, which is responsible for compensating the victims of medical accidents, said it had in its files only around 10 cases of accidents during drugs trials over the past 15 years, and “with consequences infinitely less serious” than the case in Rennes. A total of 128 participants between the ages of 18 to 55 took part in the study – 90 were given the drug at varying dosage levels and the rest received a placebo. The trial has been stopped and all volunteers have been recalled. It was a “phase one” trial, in which a new drug that has been tested in animals is tested for the first time in humans. They started taking the drug on January 7 and started feeling ill shortly afterwards. She also noted that such severe adverse reactions in a phase I trial are extremely rare.

Ben Whalley, a neuropharmacology professor at the University of Reading, said standardised regulations for clinical trials are “largely the same” across Europe.

In a similar incident in 2006 in Britain, six previously healthy men underwent organ failure hours after being given an experimental drug that targets the immune system.

Medicines then go into larger Phase II and Phase III trials to assess their effectiveness and safety before they are approved for sale. “There is an inherent risk in exposing people to any new compound”.