One dead in French clinical drug trial
January 17, 2016
The Rennes University Hospital announced the mans death in a statement on Sunday, but did not identify the participant, who had already been declared brain dead several days ago.
According to Pierre-Gilles Edan of the hospital's neurology department, five other men remain "in a stable condition," but may be facing "a handicap that could be irreversible." Eighty-four other volunteers exposed to the drug have been contacted. They did not have the "anomalies" seen in the hospital patients, Edan told journalists.
Biotrial, a private laboratory, was testing the drug, developed by Portuguese pharmaceutical company Bial, to treat mood swings and panic attacks. A total of 108 volunteers participated in the trial. Ninety received different doses of the drugs and the rest were administered placebos. The six men who fell ill from the drug received the highest dosage.
Officials from the French police and the French department for medical safety, ANSM, were investigating the incident. The inquiry would seek determine whether there was an error in administering the medicine or whether there was a problem with the medicine itself.
The pharmaceutical company producing the drug, Bial, said it was cooperating with the investigation and followed "international best practice" when developing the drug. "Our principal concern, at the moment, is taking care of participants in the trial," a company statement said.
The incident is the worst of its kind to have taken place in France. Serious incidents like these are rare in the testing of a drug. The medicine goes through several phases before being tested on animals and is tested on human beings in three phases before being available on the market.
France's public body ONIAM, which compensates victims of such trials, says there have been only 10 cases of drug-trial accidents in the last 15 years.
A similar incident occurred in 2006, when six people testing TeGenero's TGN1412 drug fell ill. One suffered from multiple organ failure. All survived, but doctors said their immune systems would be affected for the rest of their lives.
mg/jlw (AFP,dpa)