French drug trial ‘accident’ leaves one person brain-dead

One clinical-trial volunteer is brain dead and five others have been hospitalized, French officials said Friday.

The six patients who became ill began taking the drug on January 7.

One man was left brain dead, three others face possible permanent brain damage and two are critically ill after volunteering to take part.

The drug was painkiller produced by Portuguese pharmaceutical company, Bial.

The volunteers were men aged 28 to 49, French Health Minister Marisol Touraine told a news conference.

“What’s happened is unprecedented”, Ms. Touraine said.

Health Minister Marisol Touraine said the six had been taking part in a trial of an oral medication being developed by a European laboratory in Rennes, north-west France. By Sunday, one member of the group was rushed to hospital, with a brain condition so bad that doctors thought he was having a stroke. “Those in charge of the trial would have had to have shown they had done everything they could to protect patient safety before the trial was allowed to go ahead”, she added. Bial added that initial testing for the drug started in June following toxicology tests. In its’ statement, BIAL noted that development of the drug “has been conducted since the beginning in accordance with all the good worldwide practices guidelines, with the completion of tests and preclinical trials, particularly in the area of toxicology”.

A total of 90 subjects have taken part in the trial, with some receiving the experimental medication and others receiving placebo.

Testing had already been carried out on animals, including chimpanzees, starting in July, Touraine said. The trial has been stopped and all volunteers have been recalled.

There is no way to reverse the brain damage resulting from the drug trial gone awry, a French neuroscientist said.

Biotrial, which also has offices in London and Newark, New Jersey, says it has over 25 years of experience in clinical trials and uses “state-of-the-art facilities”. In France, adults volunteering for Biotrial tests can earn between $US110 ($160) to $US4920, AP reported. The company has confirmed that it is working in co-ordination with the authorities to detect the reason for the problems that occurred in the case of the six volunteers.

The second investigation could lead to charges of “accidentally causing serious bodily harm”.

The tragedy resembles a similar event in Britain in 2006 in which six men were almost killed by a drug aimed at modifying the immune system.