One person has died and five others are in a serious condition after taking part in a French drug trial of an experimental painkiller.
(NVO)- One person has been left brain dead and five others are in serious condition after taking part in a clinical trial in France of an experimental painkiller made by Portuguese drug company Bial, the French Health Ministry said on Friday (January 15).
The medicine involved works by targeting the body’s pain-controlling endocannabinoid system, which is also responsible for the human response to cannabis.
The ministry said the six volunteers in Rennes, in western France, had been in good health until taking the oral medication at a private facility that specializes in carrying out clinical trials.
The brain-dead volunteer was admitted to hospital in Rennes on Monday. Other patients went in on Wednesday and Thursday.
“An accident of exceptional gravity happened during a clinical trial in phase 1 in Rennes. Six people have been hospitalized in this university hospital since last Sunday. They’re all men aged between 28 and 49. At the moment I’m speaking to you, the doctors advise that one of them is brain dead,” health minister Marisol Touraine told a news conference.
In total, 90 people have taken part in the trial, taking some dosage of the drug, she said, adding that others took a placebo.
All trials on the drug have been suspended and all volunteers who have taken part in the trial are being called back.
“The families are devastated. We’ll make sure they’re given all the answers, particularly as at the moment I’m talking to you, I am not aware of any comparable case. What has happened is unprecedented and requires the greatest possible vigilance in the coming investigation,” she said.
Cases of early-stage clinical trials going badly wrong are rare but not unheard of. In 2006, six healthy volunteers given an experimental drug in London ended up in intensive care. One was described as looking like “the elephant man” after his head ballooned. Another lost his fingertips and toes.
In the initial Phase I stage of clinical testing, a drug is given to healthy volunteers to see how it is handled by the body and what is the right dose to give to patients.
Medicines then go into larger Phase II and Phase III trials to assess their effectiveness and safety before they are finally approved for sale.