Experimental French Drug Leaves One Brain Dead, Five in Serious Condition
An experimental drug created by an unnamed drug manufacturer has left one participant brain dead and five others in serious condition, the French health ministry stated on Friday.
Health Minister Marisol Touraine described the situation as a "serious accident," according to the AFP. The French state prosecutor has suspended all of the trials involving the drug and has opened an investigation.
The patient who lost brain function was admitted into a hospital in Rennes this past Monday. The other patients were admitted on Wednesday and Thursday.
The ministry did not disclose what the drug was meant to treat, but it did say that all six participants were healthy before they started the clinical trial. Touraine added that the drug was made in "a European laboratory."
"This test was carried out at a private facility specialized in carrying out clinical trials," the ministry said in a statement.
A source close with the situation claimed that the experimental drug was a cannabis-based painkiller that is administered orally.
Another source claimed that research company Biotrial was conducting trials with the drug for Portuguese company, Bial.
It is unclear how many participants were involved with the trials.
GW Pharma, a company based in Britain, said that it was not involved with the trial. GW Pharma currently has a market-approved cannabis-based drug aimed to treat spasticity caused by multiple sclerosis (MS).
Reactions during phase I of a trial are not rare. The last time that healthy participants ended up with serious medical conditions dates back to 2006.
In Phase 1, a drug is usually given to healthy participants so that researchers can test whether or not the drug is safe.