One Dead, Others Hospitalized Following Phase 1 Clinical Trial
Death Results in Manslaughter Investigation
According to Fox News, a man in France died in the hospital after voluntarily taking part in an experimental drug trial for a new painkiller. Five other volunteers remain in the hospital.
A manslaughter investigation has been launched into the Portuguese pharmaceutical company, Bial, which is cooperating with French authorities in the ongoing investigation regarding the “tragic and unfortunate situation,” as reported by FOX News.
The victim was not identified in an announcement from the Rennes University Hospital regarding his death. The only thing that was mentioned by the hospital about the death was that the victim had already been in a state of brain death at the time of his passing.
The victim was one of six volunteers from the ages of 18 through 49 who had been hospitalized in the last week after volunteering for the clinical trial to take the drug, which was administered orally by Biotrial – a drug evaluation organization working on behalf of Bial.
According to French authorities, three of the other volunteers also face possible brain damage.
Details of the Bial Clinical Trial
The trial originally began on January 7 and involved 90 healthy volunteers. Ten of those volunteers have already undergone medical exams this weekend, but no other health anomalies have been found. Another five volunteers are scheduled for exams of their own, but there is no other word on whether or not the rest of the volunteers will be monitored or tested.
The drug is intended to treat pain, ease the mood, and the effects of anxiety and motor problems, according to Health Minister Marisol Touraine, who also said that the drug was not based on marijuana or cannabis, as some have previously reported.
In June of 2015, clinical trials had taken place following toxicology tests. 108 people that had participated had taken part in those trials without experiencing any serious reactions like those that have happened recently.
Other Similar Drugs
The drug in question, code named BIA 10-2474 serves as an “inhibitor of an enzyme called fatty acid amide hydrolase, or FAAH,” writes David Kroll for Forbes.
Forbes also reports that other companies have been developing their own FAAH inhibitors, including:
- Janssen/Johnson & Johnson’s JNJ-421625279 – social anxiety disorder
- Merck’s MK-4409
- Pfizer’s PF-04457845 – insomnia, osteoarthritis, Tourette’s, cannabis withdrawal
- Vernalis’ V15866