France clinical trial: Man left brain-dead following drug test dies

Will Worley
Sunday 17 January 2016 15:30
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Biotrial laboratory building in Rennes where a clinical trial of an oral medication left one person brain-dead and five hospitalised
Biotrial laboratory building in Rennes where a clinical trial of an oral medication left one person brain-dead and five hospitalised

A patient in who was left brain dead following a botched drugs trial in France has died, AFP has reported.

Six people became unwell following experimental trials at a hospital in Brittany.

The patients, all men aged 28 to 49, had been treated in Rennes University Hospital, some in intensive care.

The head of the hospital’s neurology department said that based on evidence from magnetic resonance imaging scans, three of the patients may be suffering from irreversible brain damage, the New York Times reported.

Originally, 90 people were given the unknown drug in the trial, out of a total of 128 participants. The rest were given placebos.

The drug that was being trialled is not known, despite some reports that it was a new cannabinoid-based painkiller.

Marisol Touraine, the French health minister, later confirmed that the pill did not contain cannabis or its derivatives but acted on the body's endocannabinoid system.

Taken orally, the drug was undergoing a Phase 1 clinical trial at a licensed private European laboratory, Biotrial. The company specialises in clinical trials and are based in Rennes.

In a statement Biotrial said: “The trial has been conducted in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital. We are in close and regular contact with the Health Authorities and Ministry in France. The priority at Biotrial remains the safety of our subjects.”

Biotrial were conducting the tests on behalf of Bial, a Portuguese drug manufacturer.

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