One person is brain dead and five others are in a serious condition in France after a clinical trial went terribly wrong, the French health minister said on Friday (Jan. 15).
The drug was developed by a Portuguese company, Bial, and was being tested in humans for the first time. The trial took place at a private facility near the western city of Rennes.
Health Minister Marisol Touraine said the drug was designed to treat mood disorders, and did not contain any cannabis as media initially reported. She said the drug was meant to act on the body’s endocannabinoid system, which deals with pain and is also responsible for the human response to cannabis.
“The families are devastated. We will do everything we can to shed light on what happened,” Touraine told reporters.
The minister said the trial disaster was unprecedented in France, but urged caution as investigations get underway.
Volunteers called for checkups
The six volunteers who ended up in hospital are all men, aged between 28 and 49, and were the ones who had been given the highest dose of the drug, she said.
The trial has now been suspended, and all of the 90 people who took part in it are being called in for medical checkups.
Both the drugmaker Bial and the research company that carried out the study, Biotrial said they were in full compliance with international guidelines and regulations.