Days after the news broke of six men being hospitalized in France after taking part in a drug trial for a new painkiller medication, one of the patients, who was originally reported as being brain-dead, has been officially declared deceased.
The six patients were reportedly healthy, paid volunteers between the ages of 28 and 49. They were taking part in an experimental drug treatment in a trial that began on Jan. 7.
According to reports, 90 volunteers in total were exposed to the new painkiller developed by Bial, a Portuguese pharmaceutical company. Biotrial was the drug evaluation company handling Phase 1 of the trial for the painkiller which was also expected to help patients with mood and anxiety problems and motor problems caused by neurodegenerative illnesses.
The drug reportedly acts on the endocannabinoid system in the brain – which is also part of the brain that processes chemicals from cannabis. However, Health Minister Marisol Touraine said that the new drug is not marijuana based. Instead, it causes “natural brain compounds act on specific receptors to exert their effects.”
The CEO of Bial, Antonio Portela, has issued a statement via the Portuguese news service LUSA that they are working with authorities in France to understand what caused the accident and death of the unidentified volunteer.
“On my behalf and the behalf of Bial, I would like to express my deepest apologies to the family of the volunteer who died after participating in the Phase I trial of our experimental molecule,” he said.
Reportedly, French prosecutors have launched a manslaughter investigation into the case.
Accidental deaths from Phase 1 of clinical trials are said to be quite rare. This phase of drug trials usually only measures the drug for safe use and side effects and not yet for their effectiveness.
According to reports, the five other volunteers who were hostipalized remain in stable condition, however, the damage to their brains may be “irreversible.”
Reports also show that initial trials on lab animals currently do not offer any clues on what may have caused this accident which is being described as one of the most troubling medical incidents in France.
Photo: Health Gauge | Flickr
