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france 24 France

Botched French drug trial claims first fatality

© Damien Meyer, AFP |

Text by FRANCE 24

Latest update : 2016-01-18

A 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.

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.

Professor Pierre-Gilles Edan, head of the neurology department at the hospital where the sick volunteers were taken, said on Friday that there was no known antidote to the drug.

Eden also reported that three of the other victims had suffered symptoms that could lead to a “possibly irreversible handicap” and another had neurological problems. The sixth volunteer had no symptoms but was being monitored.

The six men who were hospitalised were the group which received the highest dose.

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.

All tests on the drug have since been suspended and study participants called back.

Investigation launched

The drug had been manufactured by the Portugal-based pharmaceutical group Bial, and was being tested at a facility in Rennes by the research company Biotrial.

The study was a Phase I clinical trial, in which healthy volunteers take the medication to "evaluate the safety of its use, tolerance and pharmacological profile of the molecule", French Health Minister Marisol Touraine said in a statement on Friday.

Touraine also dismissed earlier media reports that the medication, which was meant to treat mood disorders such as anxiety, contained cannabis. Touraine added that the drug molecule had previously been tested on chimpanzees.

France's national drug safety body (ANSM) has confirmed that it is the worst-ever incident to have taken place in a drug trial in the country.

It was reported on Friday that the Paris prosecutor's office has opened an investigation into the trial.

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.

'Damaged for life'

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

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.

Although a rarity, there have been precedents in other countries.

A comparable accident took place in 2006 in London when six people taking German drug manufacturer TeGenero's 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 had the impression that 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.

(FRANCE 24 with AFP, AP, REUTERS)

Date created : 2016-01-17

  • FRANCE

    Botched drug trial leaves one brain-dead, five hospitalised

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