Saturday, October 22 2016


Man dies after being left brain-dead in French drug trial

Update: January, 18/2016 - 11:32

RENNES, FranceA man who was left brain-dead after suffering serious side-effects during a drugs trial in France died on Sunday, according to the hospital which had been treating him.

The CEO of the Portuguese pharmaceutical company that was developing the drug said he was "profoundly shocked" by the death and pledged an investigation.

Five other volunteers hospitalised a week ago when the drugs trial went wrong were "in a stable condition," the hospital in the western city of Rennes said in a statement.

The France-based private laboratory Biotrial was testing a new pain and mood disorder medication for Bial on humans for the first time, in what is known as a Phase I trial, to test the drug's 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, aged 28 to 49, were the group which received the highest dose.

Bial CEO Antonio Portela said he was "profoundly shocked by the situation," according to Portuguese news service LUSA.

"On my behalf and the behalf of Bial, I would like to express my deepest apologies to the family of the volunteer who died after participating in the Phase I trial of our experimental molecule," he added.

Portela said Bial staff in France and Portugal were "working tirelessly to understand the causes of this accident."

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 ever to have taken place in France, which has launched three separate probes to determine whether the tragedy was caused by an error in the trial's procedures or in the substance tested.

Bial is cooperating with the investigation and vows it followed "international best practice" in developing the drug.

Biotral said in a statement on Sunday that it planned to work with the international scientific community to develop "changes to the standards governing such trials," without giving further details.

The company, which has been carrying out drug trials on behalf of pharmaceutical companies since 1989, said the situation is "even more upsetting given that there is as yet no explanation."

Previous testing, notably on animals, had not thrown up any unusual results.

France's public body ONIAM, which is responsible for compensating the victims of medical accidents, said it had in its files only around 10 cases of accidents during drugs trials over the past 15 years, and "with consequences infinitely less serious" than the case in Rennes. — AFP


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