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One man brain-dead after French clinical trial

In France adults volunteering for Biotrial tests can earn between €100 and €4,500 (£76 to £3,400).

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In 2006 a leukaemia drug trial in the United Kingdom at Northwick Park Hospital resulted in the hospitalisation of six men, some of whom now have permanent disabilities.

French health authorities have begun investigating whether a procedural failure was to blame for a medical drug trial that sent six men to the hospital, one of whom is now brain dead.

The ministry statement did not name the medication being tested or the laboratory, saying only that it was a private operation that specializes in clinical tests.

French Health Minister Marisol Touraine on Friday said the trial aimed to determine the efficacy and side effects of the drug when administered to patients with mood and movement disorders.

“We haven’t found any such accident for a trial in phase 1 in our records”.

The painkiller compound – manufactured by the Portuguese lab Bial – was being tested by the research company Biotrial, which has offices in London.

Ms Touraine expressed her “deep determination to get to the bottom… of this tragic accident” and denied reports the drug was based on the compound found in cannabis. The brain-dead volunteer was admitted to a hospital in Rennes on January 11, and the other subjects were admitted on January 13 and 14.

It is not yet clear if this trial drug was a synthetic or natural cannabis-based medication.

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

The French newspaper added that the public health division of the Paris prosecutor has immediately opened an investigation.

All trials on the drug were already suspended and volunteers were recalled following this development, added Touraine. The catastrophe happened even though trials in animals suggested the drug was safe.

In the initial Phase 1 stage of clinical testing, a drug is given to healthy volunteers to see how it is handled by the body and what is the right dose to give to patients.

“The shock is all the greater as these people undergoing the clinical trials are healthy, they are not ill and don’t expect such an accident”, said Ms Touraine.

The company conducts its Phase I trials at a 150-bed facility in Rennes and also in Newark, New Jersey, from where it carries out “a large variety of early clinical studies”, according to its website.

“Hundreds of clinical trials involving thousands of people are under way at any time”.

The company insisted that “international regulations and Biotrial’s procedures were followed at every stage”.

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But Ben Whalley, a professor of neuropharmacology at the University of Reading, said these could only minimise risks, not abolish them.

Biotrial general director Francois Peaucelle leaves the Biotrial laboratories today in Rennes western France. A clinical trial of an oral medication conducted by the privately-owned company on behalf of a Portuguese drugmaker left one person brain-dead