Of the six men in hospital, three could have permanent brain damage, he added.
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The experimental drug is based on a naturally occurring brain compound that is similar to marijuana’s active ingredient, although the health minister denied that it is based on cannabis itself, as some media outlets have claimed.
One person clinically dead, five others severely ill after medical trial for painkiller in Rennes, health ministry says.
Four of the others show signs of neurological trouble with doctors saying three of them are suffering from “handicaps” that are potentially irreversible. The first symptoms appeared in one man on Sunday; he was quickly hospitalized, and the others followed.
Until taking the oral drug at the Biotral private facility, the six men in ages between 28 and 49 had been in good health, according to the health minister. But before any new drug can be given to patients, it must first undergo extensive testing for both safety and effectiveness.
Touraine said all trials on the drug have been cancelled and all volunteers are being called back.
The French state prosecutor has opened an inquiry.
The drug was produced by Portuguese pharmaceutical company Bial. A spokesman said the trial had been conducted in “full compliance with global regulations” and its own procedures, which included monitoring of the participants’ health.
It’s rare for volunteers to fall seriously ill when testing new drugs.
The study was a Phase I clinical trial, where healthy volunteers take medication to evaluate its safety.
Health Minister Marisol Touraine, pictured, told reporters that she was overwhelmed by the distress of the harmed volunteers. In 2006, a volunteer turned into an “elephant-looking” man after a clinical trial in London sent six of its participants in intensive care. During the trial, 108 volunteers had been given the drug, with no moderate or serious adverse reactions, the company said.
Testing had already been carried out on animals, including chimpanzees, starting in July, Touraine said.
Touraine was set to hold a press conference later today alongside a manager from the Biotrial company which has its French headquarters in Rennes. Testing of the compound began in June.
According to Carl Elliott, a bioethicist at the University of Minnesota numerous phase 1 trial volunteers tend to be poor and unemployed people who are ready to give consent to clinical trials like these for the same of money.
But Ben Whalley, a professor of neuropharmacology at the University of Reading, said these could only minimise risks, not abolish them.
Biotrial is an experienced and well-regarded company that conducts up to 25 clinical trials simultaneously and has a turnover of €35m a year.
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The drug – BIA 10-2474 – has been under trial for the treatment of anxiety and pain among sufferers of Parkinson’s disease.
