One person brain-dead, five seriously ill after French drug trial ‘accident’

One person has been left brain dead and five others are in serious condition after taking part in the clinical trial of an experimental painkiller made by Portuguese drug company Bial, the French Health Ministry said on Friday.

She said the drug acted on natural receptors found in the body known as endocannabinoids which regulate mood and appetite, and which are not the compound found in the cannabis plant.

The injured people are being treated at Rennes University Hospital, in northwestern France, and the trial has since been suspended and other volunteers recalled.

The final patient in hospital has not shown any of the symptoms, but is being monitored given what happened to the others taking part in the trial.

The health ministry said Touraine shares her solidarity with the families of patients and is determined to “get to the bottom of…this tragic accident”.

The drug trial for the six hospitalized men began on January 7 and was halted Monday.

Touraine said the drug was not based on marijuana itself, as some media reports had claimed.

French media said the first people to fall ill were taken into hospital earlier this week.

One man is brain dead and four others are likely to suffer “irreversible handicaps” after participating in a drug trial for a French company that specialises in testing new medicines for pharmaceutical firms. Ninety participants in the trial have been asked to contact the hospital.

Phase 1 drug trials test the safety and side effects of new drugs on healthy volunteers.

The French Agency for the Safety of Health Products, the General Inspectorate of Social Affairs, and even the health branch of the Paris prosecutor’s office have chose to investigate the matter seriously. Up to 300,000 clinical tests for medical drugs take place every year and serious mishaps are extremely rare, according to doctors.

Earlier testing of the drug in question involved animals, the health minister said.

The trial of the drug containing an FAAH inhibitor had preliminary tests on chimpanzees in July past year.

The participants in the trial conducted by Biotrial were healthy volunteers, with the drug being taken orally.

Both the drugmaker Bial and the research company that carried out the study, Biotrial said they were in full compliance with worldwide guidelines and regulations.

Medicines then go into larger phase two and phase three trials to assess their effectiveness and safety before they are finally approved for sale.

“However, like any safeguard, these minimise risk rather than abolish it”, Dr Whalley said.