One ‘brain dead’, five hospitalized after botched drug trial in France

The participants in the early-stage trial were healthy volunteers and the drug was taken orally, the ministry said.

PARIS (AP) — One man is brain dead and three others are facing possible permanent brain damage after volunteering to take part in a drug test that went awry, France, French authorities said Friday.

In Phase 2 trials, the drug is given to those with a medical condition to see if it is helpful.

Biotrial, a research company for the reported drug manufacturers, Bial, has defended its drug-safety testing record following the incident.

“Serious adverse events related to the test drug” had occurred, Biotrial announced on its website.

The ministry said the six volunteers in Rennes, in western France, had been in good health until taking the oral medication, developed by “a European laboratory”.

Prosecutors in Paris have launched an investigation on the grounds of “causing involuntary injuries”.

The hospitalised men started taking the drug regularly on 7 January and began showing severe side-effects three days later.

French Health Minister Marisol Touraine was en route to Rennes on Friday and pledged to shed light on the circumstances of the tragedy, the statement added. Touraine revealed that the company had already tested the drugs on animals since July 2015.

The trial has now been suspended, and all of the 90 people who took part in it are being called in for medical checkups.

There is no way to reverse the brain damage resulting from the drug trial gone awry, a French neuroscientist said. He added that the other 83 volunteers were being contacted.

Biotrial has been approved by the French health ministry.

The trial drug was aimed at treating “disorders with mood, motor troubles and anxiety problems” said Touraine at the press conference, also attended by The Local. SA, a closely held Portuguese company, led to six patients being hospitalized in France including one person who was put on life support and diagnosed as brain dead.

A person who responded to a phone call at Bial said the firm was planning to issue a statement and declined to elaborate.

The nation’s drug safety agency ANSM plans to inspect the clinical trial site. It insisted that “international regulations and Biotrial’s procedures were followed at every stage”. Dr Ben Whalley, a neuropharmacology professor at the University of Reading, said that while such incidents were incredibly rare, “there is an inherent risk in exposing people to any new compound”. During Phase III, current treatments are compared with the developing ones and often lasts for a year or more and involves thousands of patients.