France drug trial: Health minister says drug trials should continue despite death
Following the tragic death of a man during an experimental drug trial in France, French health minister, Marisol Touraine, has called for a renewal of medicine trials, saying stopping drug testing is not justified. Touraine said that while investigations should continue, it makes no sense to completely halt medicine trials.
"There is a major problem -- massive, unprecedented in France -- and we must understand what happened, but there is nothing to justify stopping clinical trials," said Marisol Touraine speaking to the country's RTL radio. "A quicker alert would have been appreciated."
Touraine said part of the problem lies in the fact that health authorities were not informed in time. She was informed of the drug testing accident four days after the affected patient was taken to the hospital.
"Faced with such a serious situation, we would expect the laboratory to approach the health authorities more quickly," said Touraine. Biotrial, a French laboratory approved by the Ministry of Health, was conducting the testing of the new pain killer on behalf of Portuguese pharmaceutical company Bial, reported France24 News: "[It is] even more upsetting given that there is as yet no explanation."
Some 108 participants aged between 28 to 49 were involved in the trial and were given different oral quantities of the drug being tested. A total of six people who were given the highest dose were hospitalised. Five of the trial volunteers have been reported as stable now while one was confirmed brain dead on 17 January. Out of the five confirmed stable, four were said to be suffering from "neurological problems".
Meanwhile, Biotrial observed a minute of silence on 18 January following the death of the volunteer. A tweet from Biotrial's official account read: "Our thoughts are with their families and volunteers. We thank the teams of Rennes University Hospital."
Investigations are ongoing to determine whether the accident was a result of the substance being tested or a procedural error. Initial reports indicated that the drug being tested was a cannabis-based painkiller, however this was later denied by the health ministry.
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