A cannabis drug trial in France led to serious adverse effects in several subjects.
Collected via e-mail, January 2016
On 16 January 2016, Britain’s Sky News was one of many outlets reporting on significant adverse events during a French drug trial:
Five volunteers are seriously ill in hospital after a medical trial at a private clinic in France.
One of the five is described as “brain dead” while the other four are critically ill, according to the newspaper Ouest France.
A sixth person has been taken to hospital, but is not thought to be seriously affected.
The trial is related to a cannabis-based painkiller, according to reports – research led by the UK-based laboratory Biotrial.
On 15 January 2016, Biotrial tweeted a brief statement about the event. However, the research lab made no mention of cannabis:
— Biotrial (@Biotrial) January 15, 2016
On 15 January 2016 the English-language French news source TheLocal published an article titled “Botched drugs trial leaves volunteer brain-dead in France.” That local reporting included comments from French health authorities who denied the drug in question was cannabis-based, noting that the rumor began in France. Moreover, the outlet stated that the patient reported “brain dead” may actually be in a coma, with a chance for recovery:
Some media reports in France claimed the drug was a cannabis-based painkiller and AFP quoted a source “close to the case” who said the drug contained cannabinoids – an ingredient found in cannabis plants.
However a spokesperson for France’s health ministry has told The Local this information is false.
“This medication did not contain cannabis and was not a cannabis-based drug,” said Health Minister Marisol Touraine.
According to France’s Minister of Health Marisol Touraine the trial has been called off after one person was left brain-dead and five others hospitalised after taking the drugs.
However some reports suggest the victim has been left in a coma, which would mean the brain damage may not be permanent.
Both the BBC and New York Times covered the event; the former included Touraine’s remarks, and the latter described the adverse event as an “accident”:
Six patients were hospitalized — one of them brain-dead — after a drug trial in northwestern France, the country’s health minister said on Friday.
Marisol Touraine, the minister for social affairs, health and women’s rights, said in a statement that her office was informed on Thursday evening about a “serious accident” that resulted in the hospitalization of six patients at the Centre Hospitalier Universitaire de Rennes, in eastern Brittany.
So while a January 2016 adverse event occurred during a drug trial in France, that event remains under investigation. Moreover, French health authorities have confirmed that the medication in question was not cannabis-based.