A clinical drug trial in Rennes, western France has caused brain death to one and sent other 5 people to go under treatment in the hospital. Of the six under treatment, three may face permanent brain damage, another is suffering from neurological problems and the sixth one is in less critical condition. Around 90 volunteers have reportedly taken part in the drug trial.
Biotrial private facility, specialized in clinical trails, has conducted trial of an experimental drug made by Portugese drug company, Bial. The volunteers under trial have taken the drug in different dosage. All other volunteers are being contacted. Meanwhile, the Paris prosecutor's office has started investigating the case and suspended all trials of the drug.
The trial has been aimed at tackling mood and anxiety issues. Movement coordination related neurological issues have also been monitored; reports Reuters while narrating a press conference presided by French Health Minister Marisol Touraine.
The drug trial for the six hospitalized men has begun on January 7. It has been halted on Monday, a day after the first volunteer fall sick. All the six men, aged from 28 to 49, have had good health until taking the oral pain killer medicine, reports Yahoo News.
The painkiller under trial is based on a natural brain compound similar to the active ingredient present in marijuana. Testing of the compound as drug has begun in June. The new drug has already been administered to 108 patients without any report for moderate or serious reaction, reports USA Today referring a Bial statement.
Bial states the number of hospitalized as five including one brain dead without furnishing any explanation for the discrepancy with the French health authority. It also commits to ensure the wellbeing of the trial participants.
Meanwhile it has been working with the authority to unearth the reason for injuries. The statement also adds that the clinical trial has been duly approved by the French regulators.
Volunteering in pain and anxiety drug trials has become a popular mean of earning some extra money for the French people. Biotrial spends in between €100 to €400 ($110 to $4,920) for each adult, volunteering in Biotrial tests.
Phase 1 trials (like that under discussion) studies safe usage, side effects and other measures on healthy volunteers instead of drug effectiveness. Falling sick seriously for the volunteers, while undergoing such trial, is a rare event. Researchers generally start with the lowest possible dose after extensive tests in animals. Previously the Bial made painkilling drug has been tested on chimpanzees and other animals.
Volunteering in drug testing has appeared as a popular job for many French people since it brings some quick easy money. A Portuguese pharmaceutical company, Bial has been conducting trial with due regulatory approval over one of its painkiller in Biotrial Private Facility on 90 volunteers. Of them, six volunteers have fall sick after taking the oral medicine and one of them has suffered brain death, reason of which still remains unknown.
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