5 hospitalized in fatal drug trial recovering, 1 sent home

A MAN died in a French hospital on Sunday after taking part in an experimental drug trial for a painkiller, and five other participants remain hospitalised after one of France’s most troubling medical incidents.

The man was left brain dead after the trial at the Biotrial laboratory in the city of Rennes, and five other people were admitted to hospital on Friday.

French Social Affairs and Health minister Marisol Touraine (L) and professor Gilles Edan at a press conference in Rennes.

Ninety volunteers took the drug, which was manufactured by the Portuguese company Bial, according to the BBC.

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

The other five hospitalised patients have neurological problems of “varying gravity”, according to doctors at the University Hospital of Rennes. One of the six had no symptoms but was being carefully monitored, he said.

Both companies said they are working with French authorities on the case. Brassier said there would be no comments after his brief report.

Testing had already been carried out on animals, including chimpanzees, starting in July, Touraine said.

Medical trials typically have three phases to assess a new drug or device for safety and effectiveness. Authorities have suspended the trial, in which 90 volunteers were given the medication.

Six men aged between 28 and 49 started taking repeated doses at higher levels than other participants on January 7.

Both the drugmaker Bial and Biotrial said they were in full compliance with regulations.

Clinical trials are the key to getting that data – and without volunteers to take part in the trials, there would be no new treatments for serious diseases such as cancer, multiple sclerosis and arthritis. Testing such experimental drugs, at the cutting edge of science, can never be completely risk-free.

Bial commented on Friday that it had followed “international best practice” and that it would cooperate with the investigation underway to “determine in a rigorous and exhaustive manner” what happened. As Dr. Stone points out, “We don’t know what doses this group of… volunteers received, or how that was different from earlier groups…”