CORRECTED: French drug trial suspended after participant left brain dead, five others critically ill
Update: In comments reported by the New York Times, the French health ministry said the drug was not a cannabis-based painkiller, contrary to early French media reports. This post had previously stated the drug was cannabis-based. It has been corrected to reflect the new information.
- Six men in France were hospitalized after participating in a trial for a drug designed to treat mood, anxiety, and motor problems. One was declared brain dead while the other five are seriously ill.
- The phase one trial was suspended following the hospitalizations and the French state prosecutor has opened an inquiry. The study was run by drug evaluation company Biotrial, and the drugmaker has been identified as the Portuguese pharmaceutical company Bial.
- The trial had 128 participants, of which 90 were administered the drug, according to the French health ministry. However, a statement from Bial said 108 people were administered the drug.
The hospitalizations were reported to the French Health Ministry on Thursday night. Biotrial reported the incident to France's drug regulator and halted the trial. Three of the men might have suffered severe brain damage.
In a statement, Biotrial said, "During a FIM study which was being conducted for a sponsor, serious adverse events related to the test drug have occurred in some subjects at our CPU." The company claimed all international regulations had been followed along with its own procedures during the trial.
The French Minister for social affairs, health, and women's rights, Marisol Touraine, on Friday said the drug had been used before on animals, the New York Times reports. The drug was designed to treat mood and anxiety problems associated with neurodegenerative diseases.
Phase 1 trials begin the process of establishing the safety of a drug, and usually do not result in deaths or serious adverse reactions. Typically, drug dosages in phase 1 trials are low.
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