Allen Shibu, Keighley
A patient, who was left brain dead following a careless drugs trial in France, has died. In total, 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 ICU. The head of the hospital’s neurology department explained that the evidence from MRI scans shows that three of the patients may be suffering from irreversible brain damage. Originally, 90 people were given the unknown drug in the trial, out of a total of 128 participants. The rest were given placebos, a “fake” drug. 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 anything that was based on the illegal substance, but acted on the body’s endocannabinoid system which is involved in a variety of physiological processes including appetite, pain-sensation, mood, and memory, and in moderating the effects of cannabis… Taken through the mouth, 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.