The six male patients were taking part in a clinical drug trial for for Portuguese pharmaceutical firm Bial at a clinic in Rennes, in the north-west of France.
Local media are reporting the drug in question was a cannabinoid painkiller, according to news.com.au. However, The French Health Minister, Marisol Touraine, said on Friday the drug did not contain cannabis or any derivatives of it, reports the Guardian.
The health ministry said the clinical trial being carried out was to test side-effects of the new drug. The clinic in Rennes “specialised in carrying out clinical trials.” All trials at the clinic have been suspended now that the state prosecutor has opened a formal inquiry.
Gizmodo is reporting a company called Biotrial is involved in getting volunteers for clinical trials, and according to their website, are also asking for volunteers for drug trials in Newark, New Jersey and Montreal, Quebec, Canada.
The study itself was a stage one clinical trial. Healthy individuals are given the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”, Touraine said. Typically, clinical trials have three phases. The first phase usually involves a small number of volunteers, focusing primarily on safety.
Phase two and three involve larger numbers of volunteers, but safety always remains the primary concern. Every year, thousands of people take part in clinical trials and mishaps are relatively rare.
Dr Ben Whalley, a neuropharmacology professor at Britain’s University of Reading, said there are standardized regulations for clinical trials, and they are about the same all across Europe.
“However, like any safeguard, these minimize risk rather than abolish it,” Whalley said in a statement, according to the Guardian. “There is an inherent risk in exposing people to any new compound.”
