5 hospitalized in fatal drug trial recovering, 1 sent home

One volunteer died after taking an experimental painkiller during a drug trial in France.

USA Today reports that 90 volunteers were involved in the French drug trial, but the study was ceased on Monday after six people experienced drastic side effects.

The man was left brain dead after the trial at the Biotrial laboratory in the city of Rennes, and five other people were admitted to hospital on Friday.

In its’ statement, BIAL noted that development of the drug “has been conducted since the beginning in accordance with all the good global practices guidelines, with the completion of tests and preclinical trials, particularly in the area of toxicology”. The painkiller is based on a compound produced naturally by the brain and similar (but not the same) to tetrahydrocannabinol (THC), the active ingredient in marijuana.

French health minister, Marisol Touraine, said the drug was an FAAH inhibitor that acts on the body’s endocannabinoid system. Dr. Edan also said that one of the six volunteers did not show any symptoms of this problem, but is still being supervised carefully.

A formal investigation has been opened in Paris.

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.

Testing had already been carried out on animals, including chimpanzees, starting in July, Touraine said.

The trial was made up of 128 healthy male and female volunteers ranging in age from 18 to 55 years.

According to the press release, the hospitalized volunteers had received the medication in higher doses.

Rarely have clinical drug trials gone so awry in France.

Biotrial, which has headquarters in Rennes and offices in London and Newark, N.J., says it has more than 25 years of experience in clinical trials and uses “state-of-the-art facilities”.

The head of Biotrial said Saturday the lab was cooperating with the investigators. While this drug is listed as being in phase 1 testing – which assesses a drug’s safety – on BIAL’s Pipeline list, the pharmaceutical company and Biotrial have not confirmed this to be true.

The trials were stopped after six people became seriously ill.

New EU regulations to speed up clinical drug trials and streamline testing procedures across the 28-nation bloc are due to take effect in May.