Lab Criticized as 'Slow to React' in Bial's Fatal Drug Trial
February 5, 2016
By Alex Keown, BioSpace.com Breaking News Staff
PARIS – A French laboratory has come under scrutiny after clinical trials conducted there left one dead and five others hospitalized, Reuters reported this morning.
The French Health Ministry said officials at the lab were slow to react after the first patient fell ill. However, the ministry said no regulations appear to have been breached during the trial. On Thursday, French Health Minister Marisol Touraine released initial findings of its investigation, which said the lab should have halted trials after the first patient was hospitalized. However, the ministry said the drug was administered to five more patients the next day, Reuters reported. Touraine said authorities were not alerted to the accident for several days after the first patient was hospitalized.
The lab was conducting a Phase I clinical trial studying an experimental fatty acid amide hydrolase inhibitor being developed by Portugal-based Bial-Portela. FAAH inhibitors are designed to break down endocannabinoids, including anandamide, in the brain and are being investigated for use in the treatment of chronic pain. These molecules activate cannabinoid receptors—the same ones that bind THC, the key component of cannabis, a report in Science magazine said. Bial’s BIA 10-2474, the drug tested in the French facility, is designed to inhibit FAAH, and thus slow the breakdown of endogenous cannabinoids, which might help fight pain, the magazine said.
The trial was being conducted by Biotrial, a clinical research organization in Rennes, France. Company officials said that it had “strictly complied to international standards.”
“The trial has been conducted in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of volunteers to the hospital,” the company said in a statement on its website.
In a separate statement on its website, BioTrial said “our thoughts go out to the volunteers and their families. We are working hand in hand with the Health Authorities to understand the cause of this accident.”
There are still numerous unanswered questions, but most specifically, what went wrong with these six patients. The drug was administered to 108 patients in varying doses, but only those six were negatively affected. The patients who were hospitalized had received the highest dose of the drug during the trial, the minister said. The five patients have since left the hospital and returned home and will be given another health check up at the end of February, she said.
Stephen Alexander, a molecular pharmacologist at the University of Nottingham in the United Kingdom, told Science magazine that it’s possible BIA 10-2474 had “unexpected effects because it binds to another target besides FAAH.” It also could have been a dosing accident, another pharmacologist told the magazine.
All trials on Bial’s drug have been suspended.
FAAH inhibitors are being studied by other pharmaceutical companies. Janssen, a division of Johnson & Johnson , is developing a FAAH inhibitor for social anxiety disorder, while Merck and Pfizer are developing FAAH inhibitors for treatment of osteoarthritis pain, insomnia, Tourette syndrome and cannabis withdrawal. However, following the French lab accident, Johnson & Johnson said on Jan. 21 that it was voluntarily suspending its FAAH trials.