Drug trial goes wrong, leaves six hospitalized in France
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.
The incident happened as an oral test by a private European laboratory in France’s western city of Rennes, went wrong, Marisol Touraine said on Friday.
According to Touraine, the victims are aged between 28 and 49, with two of them being in a very serious condition.
While evaluating “the safety of its [drug’s] use, tolerance and pharmacological profile … a serious accident took place,” the minister said in her official statement.
The minister added for the time being, the experiment had been halted, and all volunteers taking part in the test were being examined.
She vowed to “shed light on” what happened, calling for an inspection of the research site.
The Paris prosecutor’s office also said an investigation had been opened to probe the incident, which occurred on Thursday.
The total number of volunteers participating in the experiment is unclear.
According to a source close to the case, the volunteers were testing a cannabinoids-based painkiller.
Cannabinoids is an active ingredient found in the cannabis plants.
Cannabis has been used since ancient times for both medicinal and recreational purposes. Banned drugs such as hashish and marijuana are from the Cannabinoids class of medicines.
Clinical tests of drugs
Clinical trials of drugs typically have three phases to assess a new drug or medical innovation for safety and effectiveness before obtaining market authorization.
The study in hand was a Phase I clinical trial, in which healthy volunteers take a prototype medication. This stage entails a small group of volunteers, and focuses only on safety.
Phase II and Phase III are progressively larger trials, typically involving hundreds or thousands of volunteers, to assess the drug’s effectiveness, although safety remains paramount.
Every year thousands of volunteers, often students looking to make extra money, take part in such clinical trials which are seen as safe.
Accidents in these tests are relatively rare, but in 2006 six men were hospitalized in London after taking part in a clinical trial into a drug developed to fight auto-immune disease and leukemia.
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