Man dies in Rennes hospital after drug trial left him brain dead

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Five other volunteers in stable condition after testing pain and mood disorder drug for Portuguese company Bial

A man who was left brain dead after suffering serious side effects during a drug trial in north-west France has died, according to the hospital that had been treating him.

Five other volunteers, hospitalised a week ago when the drug trial went wrong, were in a stable condition, the Rennes hospital said in a statement on Sunday.

The private laboratory Biotrial was testing a pain and mood disorder medication for the Portuguese pharmaceutical company Bial on humans for the first time, in a phase 1 trial to test the drugs safety.

A total of 108 volunteers took part in the trial, 90 of whom received the drug at varying doses, while the rest were given placebos. The six men who were hospitalised were in the group that received the highest dose.

Pierre-Gilles Edan, head of the neurology department at the Rennes hospital said on Friday that three of the men were suffering a handicap that could be irreversible and another also had neurological problems. The sixth volunteer had no symptoms but was being monitored.

The 84 other volunteers exposed to the drug have been contacted, said the hospital. Ten of them came in to be examined and did not have the anomalies seen in the hospitalised patients.

The incident is the worst of its kind to have taken place in France, which has launched three separate investigations to determine whether the tragedy was caused by an error in the trials procedures or in the substance tested.

Bial is cooperating with the investigation and vows it followed international best practice in developing the drug. Our principal concern at the moment is taking care of participants in the trial, Bial said in a statement on Friday.

Such serious mishaps are rare during the development of a drug, which begins in the laboratory, before being tested on animals and then in three phases of human trials before it can be brought to market.

Frances public body Oniam, responsible for compensating the victims of medical accidents, said it had in its files only about 10 cases of accidents during drug trials over the past 15 years, and with consequences infinitely less serious than the case in Rennes.

Although a rarity, there have been precedents in other countries. A comparable accident took place in London in 2006 when six people taking the German drug manufacturer TeGeneros TGN1412 which it was developing to treat certain types of cancer and other immunological diseases fell seriously ill, with one suffering from multiple organ failure.

Two of the volunteers were in a critical condition and one lost all his fingers and toes. The victims said they felt as if their brains were on fire and that their eyes were coming out of their sockets.

Although they all survived, experts said at the time that their immune systems would be damaged for life.

Read more: www.theguardian.com

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