After taking part in a drug trial for a painkiller, a man died while 5 other people are still in the hospital.
A manslaughter investigation has been carried out by the French prosecutors, shining a spotlight on the practice of testing drugs on paid, healthy human volunteers.
The company which tested the drug was Bial – a Portuguese pharmatical company. It stated that the company was working with the health’s authorities in order to determine the reasons for that “tragic and unfortunate” condition. The purpose of the drug was to ease pain mood, anxiety troubles and also motor problems which are associated with neurodegenerative illnesses.
The death of that man was officially announced by The Rennes University Hospital, a hospital in the west of France, but the name of the patient was not identified. Few days ago, this man was stated to be left brain-dead.
The dead man was among 6 men between 28 and 49 volunteering to take the high level of doses. He was the 1st one to be taken to the hospital, facing possible brain damage. Few days later, he died. Two other men of the six were also hospitalized due to the same condition.
There were 90 people from the Brittany region volunteering to take part in the trial. Apart from the 6 participants above, 84 other ones was contacted and reported exposed to the new painkiller. According to the official statement from the hospital, ten of those volunteers underwent medical exams but no anomalies was found. The hospital said other 5 participants would have medical check closer to their homes, but did not say whether the rest of the team are being tested or not.
The investigators are working to determine whether that situation was caused by the drug itselft or by an error in the testing process.
The drug, which based on a natural brain compound similar to the active ingredient in marijuana, was given directly to the participants as a part of the project Phase 1 trial. Biotrial, a Renes-based drug evaluation company on behalf on Bial.
Bial stated that the Painkiller Drug Trial started following toxicology tests last June and no moderate or serious reactions was identified among 108 healthy people participating in the test.