Botched Drug Trial Leaves Man Brain Dead

And 2 more are hospitalized in France
By John Johnson,  Newser Staff
Posted Jan 15, 2016 6:53 AM CST
Updated Jan 15, 2016 12:06 PM CST
Volunteer Brain-Dead in Botched Drug Trial
French Health Minister Marisol Touraine, left, and Professor Gilles Edan, the chief neuroscientist at Rennes Hospital, address the media.   (AP Photo/David Vincent)

A drug trial in France has gone horribly wrong, leaving one healthy volunteer brain-dead; three other men may have suffered irreversible brain damage, another has "neurological problems," and a sixth is hospitalized with less severe problems, reports AP. Details on what happened, including what drug was being tested and its manufacturer, remain under wraps. One thing that is known: No treatment is available. Early reports in France suggested it was a cannabis-based painkiller, reports the Guardian, but the health ministry has denied that. The AP describes it as some kind of "painkiller compound." Testing was being conducted by the French company Biotrial, a veteran player in the industry, at a clinic in Rennes.

All 90 volunteers who took the drug were healthy before the trial started, reports the BBC. Those hospitalized range in age from 28 to 49 and began taking the drug on Jan. 7. Health Minister Marisol Touraine promised to "get to the bottom... of this tragic accident" and said she's been "overwhelmed" by the tragic turn for participants. "Their lives have been brutally turned upside down." The study had been in phase one, in which volunteers take the drug orally to evaluate its effectiveness and side effects. A message on Biotrial's website states that "serious adverse events" occurred and says that international regulations "were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital." (More drug trials stories.)

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