Days after the news broke of six men being hospitalized in France after taking part in a drug trial for a new painkiller medication, one of the patients, who was originally reported as being brain-dead, has been officially declared deceased.
A comparable accident took place 10 years ago in London when six people taking a drug made in Germany which aimed to treat certain types of cancer and immunological disease fell seriously ill, with one suffering multiple organ failure.
The trials of the analgesic drug wre being run by a private laboratory for the Portuguese drug company BIAL.
French TV channel iTele said the trial was for a painkiller containing cannabis, but this was denied by the health ministry. As per French health authorities, three other participants who are now in the hospital could face the brain damage condition.
The hospital said the other 84 volunteers have been contacted - ten of whom have been examined and found to have suffered none of the "anomalies" seen in those taken to hospital. Touraine added that the drug molecule had previously been tested on chimpanzees.
"There is a major problem - massive, unprecedented in France - and we must understand what happened, but there is nothing to justify stopping clinical trials", Touraine told RTL radio today.
In total 128 had taken part in the trial - 90 were given the drug at different dose levels and the others received a placebo.
All trials on the drug have now been suspended and all volunteers who have taken part in the trial are being called back.
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.
The injured are among a group of otherwise healthy male volunteers participating in a phase I drug trial, which began in June.
According to BIAL, the development of the FAAH enzyme inhibitor "has been conducted since the beginning in accordance with all the good global practices guidelines, with the completion of tests and pre-clinical trials, particularly in the area of toxicology". One person isn't displaying symptoms similar to the others, but remains under medical observation, nonetheless.
The accident was during a Phase I clinical trial at a lab in Rennes that specialises in them.
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