Tuesday, October 26

One brain dead, five hospitalised after drug trial goes wrong in France


 

One person was left brain-dead and five others hospitalised after participating in a drug trial in France, the country’s Health Minister Marisol Touraine said in a statement on Friday.

Touraine said that the six had been taking part in a trial for an oral medication being developed by a European laboratory in the northwestern city of Rennes when a “serious accident” took place.

The minister did not say what the medicine was intended to be used for, but French media reported that the trial was for a painkiller containing cannabis.

The six volunteers took the medication at a private laboratory, which was “specialised in carrying out clinical trials”, Touraine said.

All tests on the drug have now been suspended and trial participants called back.

The study was a Phase I clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”, Touraine said.

Clinical trials typically have three phases to assess a new drug or device for safety and effectiveness. Human participation in such trials and scrutiny by outside watchdogs are essential for getting market authorisation.

Touraine said that she was determined to “shed light” on what happened in the trial, while the Paris prosecutor’s office said that an investigation had been opened into the incident.

Cases of early-stage clinical trials going badly wrong are rare but not unheard of. The last drug trial disaster in Europe occurred in 2006, when six healthy volunteers given an experimental drug in London ended up in intensive care.