Rare Accident in French Drug Trial Has Tragic Consequences

In a phase one clinical drug trial that took place in western France, six volunteers who were taking part in the research have been hospitalized, with one man diagnosed as being clinically brain-dead.

Jan. 17, 2016 Update: The drug test volunteer, the man who first experienced untoward symptoms in the clinical trial and had been declared brain-dead has died. His identity remains unknown at this time.

In what has been termed a “serious accident” during the first human testing of a potential new drug, six of the original 90 healthy, all-male volunteers have been hospitalized after experiencing significant side effects to the tested substance. The first volunteer to become ill has been declared brain-dead, while the other five hospitalized volunteers have “disturbing neurological problems,” with three of those men likely to never recover completely due to likely irreversible damages according to doctors at University Hospital of Rennes, where all those ill from the drug trial were taken for treatment. (Independent.co.uk)

Drug trials taking place in Rennes, France have resulted in serious consequences for six volunteers.

Drug trials being conducted by Biotrial in Rennes, France resulted in “serious accident.”

Professor Gilles Edan, chief neuroscientist at the University Hospital of Rennes, has stated there is no known antidote to the experimental drug BIA-10-2474.

The drug for this trial, BIA-10-2474, acts on natural receptors in the body called endocannibinoids, explained French Social Affairs and Health Minister Marisol Touraine, receptors that regulate mood and appetite, and not the substance found in the cannibis plant. (ABC.net.au) BIA-10-2474 had been tested extensively on animals by the Portuguese company BIAL, creator of the drug. The human drug trial was being conducted by the French government-licensed private company Biotrial.

BIA-10-2474, which early on was falsely reported as being a derivative of cannabis, was being tested for the treatment of anxiety and pain in those with Parkinson’s disease.

This drug trial began on Jan. 7, 2016, with those who have been hospitalized assigned large doses of the experimental drug. On January 10, one of the volunteers became ill. The drug trial was suspended January 11. Thus far, none of the remaining 84 volunteers who had received smaller doses of the trial drug have shown signs of illness.

Three investigations are underway, one by the prosecutor’s office, one by the French health ministry, and one by ANSM, a medical safety watchdog,to determine if all regulations in place for clinical drug trial safety were followed and what exactly might have gone wrong. The investigation by the special prosecutor’s office that deals with medical accidents or failures have the potential to lead to charges of “accidentally causing serious bodily harm .” (Independent.co.uk)

Sources: ABC.net.au

Independent.co.uk

RFI.fr


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