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A Failed Drugs Trial in France Left One Dead And Five Hospitalized

Update Date: Jan 20, 2016 08:52 AM EST
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A Portuguese pharmaceutical firm is currently in hot water after a tragic botched drugs trial in Rennes, France left one volunteer dead and five others hospitalized in an 'unprecedented case' of failed drugs experiment involving human lab participants.

"I have no knowledge of a comparable event. I was deeply moved by their suffering," remarked French minister for social affairs, health, and women's rights Marisol Touraine after being informed of the tragedy as mentioned in a report by New York Times.

The volunteer who recently died at a French hospital was initially deemed 'brain-dead' after succumbing to severe multiple side effects in a clinical drugs trial conducted by Biotrial, a private laboratory, for Portuguese drug company Bial in Phase I of the experiment.

The other five previously healthy participants are currently receiving serious medical attention due to severe neurologic conditions that developed after the drug trial. The trial volunteers are reportedly stable.

"Four patients are showing neurological disorders and the fifth patient, who has no symptoms, is under observation. Three patients are in a very serious condition, raising fears of irreversible disability. The MRI revealed necrotic and hemorrhagic brain lesions," said neurology professor Dr. Pierre-Gilles Edan of Rennes University Hospital as quoted by Medscape.

According to ABC Australia, 90 of the 108 individuals who volunteered to take part in the experiment were administered with a newly developed painkiller in varying doses. Others were simply given placebos. The six affected patients were reportedly those who received the highest dose of medication.

Because of the public outcry over the incident, French law enforcement authorities were forced into action and launched a criminal investigation into the case. It also brought into public light the ethical debate on testing new drugs on human, albeit paid, volunteers.

"On my behalf and the behalf of Bial, I would like to express my deepest apologies to the family of the volunteer who died after participating in the Phase I trial of our experimental molecule," Bial CEO Antonio Portela said as he expressed his profound shock after the situation was made public as quoted saying by Yahoo News.

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