The French health ministry reports that the six patients, ages 28 to 49, were in good health prior to taking the oral medication, The Guardian reports. They began taking the drug on Jan. 7, and one man started feeling sick on Sunday. The other five men fell ill shortly after.
On Monday, the volunteer who is now brain dead was taken to a hospital in Rennes. The other patients were hospitalized on Wednesday and Thursday. The fifth volunteer has suffered neurological problems, while the sixth is being watched but isn’t in critical shape, said Pierre-Gilles Edan, the chief neuroscientist at the hospital in Rennes said, according to BBC News.
The drug has no known antidote, said Gilles Edan, who is head of the hospital’s neurology department. Three of the men may have permanent brain damage, he noted.
Earlier reports that the drug, a painkiller, is cannabis-based have been denied by the health ministry. The trial, now suspended, involved taking the drug by mouth and was conducted by a private laboratory in Rennes.
BIAL released a statement and said the drug is a pain medication and that it’s specifically an FAAH enzyme inhibitor, but provided few other details, Ars Technica reports. Early media reports say the test drug may be the compound BIA-10-2474, something BIAL said is designed for treating “neurological and psychiatric pathologies.”
Speaking at a Friday press conference, French Health Minister Marisol Touraine described the drug as for treating anxiety, mood disorders, and motor disturbances that can be common with diseases such as Parkinson’s.
The drug had been tested in chimpanzees prior to the human trial, Touraine noted.
In its statement, BIAL noted development of the drug “has been conducted since the beginning in accordance with all the good international practices guidelines, with the completion of tests and preclinical trials, particularly in the area of toxicology.” During the trial, 108 volunteers had been given the drug, with no moderate or serious adverse reactions, the company said.
CNN reports a total of 128 volunteers between the ages of 18 and 55 participated in the drug trial and were considered healthy. Ninety people received different dosages of varying levels, while the rest received a placebo. The French health ministry said it sent agents to the facility immediately, in order to determine if all rules had been followed during the testing and also checked to see if the facility where the patients were staying during the trial had maintained proper sanitary conditions. In 2014 the facility was inspected and the ministry said the inspections were favorable.
The Guardian reported that the men who were so severely affected by the drug now have a higher risk of cancer, as well as autoimmune diseases, and this has been tired to their exposure to the experimental drug.
BIAL said it is committed to the well-being of test participants and is working with authorities to find out what caused the injuries. The company noted the clinical trial had been approved by French regulators.
