By Matthias Blamont
PARIS: An initial report into a drug trial in northwestern France that left one person dead and five others hospitalised last month did not identify the exact cause, French Health Minister Marisol Touraine said on Thursday.
Touraine told a news conference that three major failings had been found although the trial had been conducted in line with regulations. She did immediately say what the failings were.
“It’s not possible to identify the direct causes of the accident,” Touraine said, adding that the condition of the five hospitalised people was improving.
The victims had been participating in a clinical trial of an experimental drug made by Portuguese company Bial.
All trials on the drug, which is intended to treat mood and anxiety issues as well as movement coordination disorders linked to neurological issues, have been suspended.
The medicine involved is a so-called FAAH inhibitor that works by targeting the body’s endocannabinoid system, which is also responsible for the human response to cannabis.
In total, 90 people participated in the trial and the six men who fell ill had been in good health until taking the oral medication at the Biotrial private facility in Rennes northwestern France.
Cases of early-stage clinical trials going badly wrong are rare but not unheard of. In 2006, six healthy volunteers given an experimental drug in London ended up in intensive care.
(Writing by Leigh Thomas; editing by Michel Rose and Andrew Callus)
Reuters
