Six Hospitalized, One Brain-Dead, After French Drug Trial

Six men were hospitalized and one of them was pronounced brain-dead after a drug trial in northwestern France, the country’s health minister said on Friday.

Marisol Touraine, the minister for social affairs, health and women’s rights, said in a statement that her office was informed Thursday evening about a “serious accident” that resulted in the hospitalization of the six men, at the Centre Hospitalier Universitaire de Rennes, in eastern Brittany.


Calling the incident “unprecedented” at a news conference in Rennes, Ms. Touraine said: “I have no knowledge of a comparable event.”

The patients, all men, were ages 28 to 49, she said. The head of the hospital’s neurology department said that three men may have suffered irreversible brain damage, based on magnetic resonance imaging scans, but cautioned that the scans were not conclusive.

“I was deeply moved by their suffering,” Ms. Touraine said after visiting the patients and their families.

The drug was administered orally to healthy volunteers as part of a Phase 1 clinical trial by Biotrial, a drug evaluation company based in Rennes, on behalf of a Portuguese drug manufacturer, Bial. The drug is intended to help with mood, anxiety and motor problems linked to neurodegenerative diseases by having an effect on the endocannabinoid system, a set of brain receptors. Of 128 participants, 90 were given the drug, and the rest a placebo.

Nytimes