Trial of a painkiller containing cannabis caused six people to fall seriously ill and left a person in coma
Paris: A 'serious accident' during a drugs trial in France has left one person brain-dead and six hospitalised, Health Minister Marisol Touraine said yesterday. She said the six had been taking part in a 'trial of an oral medication being developed by a European laboratory' in the northwestern city of Rennes. The drug was a painkiller containing annabinoids, an active ingredient found in cannabis plants.
"A serious accident took place," the minister said, adding that the study had been halted and all volunteers taking part recalled. The incident occurred on Thursday.
The study was a Phase I clinical trial, in which healthy volunteers take a prototype medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule," the minister said.
The Paris prosecutor's office said an investigation had been opened.
Every year thousands of volunteers, often students looking to make extra money, take part in such clinical trials, which are seen as safe.
>> In 2006, six men were hospitalised in London after taking part in a clinical trial into a drug developed to fight auto-immune disease and leukaemia.
>> In gene therapy, setbacks have included the death of an 18-year-old US volunteer, Jesse Gelsinger, in 1999, and the development of cancer among two French children treated for “bubble baby” syndrome, a chronic lack of immune defences.
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