Botched French drug trial leaves 1 brain-dead, 5 others hospitalized

One man is brain-dead and five others are hospitalized after receiving an experimental drug in France, health officials announced Friday.

In all, 90 volunteers were taking part in the trial, which was halted Monday. Of those in the hospital, three could have permanent brain damage. Another is suffering from neurological problems and the sixth man is in less critical condition, the Associated Press reported.

The drug was a new painkiller produced by Portuguese pharmaceutical company Bial.

"This is unprecedented," French Health Minister Marisol Touraine said at a news conference Friday, according to Reuters. "We'll do everything to understand what happened."

The six men, ages 28 to 49, had been in good health before they started taking the drug Jan. 7 at a private Biotrial testing facility in Rennes, western France, Reuters reported. The brain-dead volunteer came to the hospital Monday. Most of the others arrived Wednesday or Thursday.

All other volunteers are being contacted, and the Paris prosecutor's office is investigating the case. All trials of the drug are suspended.

Gilles Edan, chief neuroscientist at the hospital in Rennes, said there's no known treatment to reverse the effects, according to AP. The French health ministry said those who had fallen ill had taken an oral medication in the first phase of testing, AP reported.

The new drug, a molecule that treats pain, had already been administered to 108 patients without any moderate or serious reaction, Bial said in a statement. Testing of the compound began in June.

The company "is strongly committed to ensuring, first of all, the well-being of all participants in this trial and to determine thoroughly and exhaustively the causes which are at the origin of this situation," Bial added.

Biotrial said in a statement that the trial was conducted in compliance with international regulations and its own procedures. The company, which has more than 25 years of experience in the field, is headquartered in Rennes with offices in London and New Jersey. In France, adults volunteering for Biotrial tests can earn between $110 to $4,920, AP reported.

Both companies said they are working with French authorities on the case.

Cases of drug trials causing serious harm are rare. In 2006, six men in Britain were treated for organ failure hours after being given an experimental drug that targeted the immune system, AP reported. The case prompted new testing standards in the U.K.