1 Brain-dead, 5 Hospitalized as French Drug Trial Goes Wrong
French Health Minister Marisol Touraine said Friday that a "serious accident" during a drugs trial in France left one person brain-dead and five hospitalized.
She further added that the six were taking part in a "trial of an oral medication being developed by a European laboratory" in Rennes, northwest France.
Relatively, media reports mentioned that the drug was a cannabis-based painkiller, which was denied by the health ministry.
"A serious accident took place," the minister said, adding that the study was halted and all volunteers taking part recalled.
In the context, the minister explained that the study was a phase one clinical trial, in which healthy volunteers take the medication to "evaluate the safety of its use, tolerance and pharmacological profile of the molecule."
However, medical trials typically pass in three phases to assess a new drug or device for safety and effectiveness.
Phase I entails a small group of volunteers, and focuses only on safety.
Phase II and Phase III are progressively larger trials to assess the drug's effectiveness, although safety remains paramount.
Accordingly, the Paris prosecutor's office said an investigation had been opened.
In addition, Touraine stressed that she was determined to "shed light on" what happened.
Source: News Agencies, Edited by website team