The Independent

Drug trial volunteer dies as ‘manufactur­ing error’ theory investigat­ed

- JOHN LICHFIELD

Avolunteer­who was left braindead by a calamitous trial of a new drug in France died from his injuries yesterday.

Four other volunteers remain gravely ill with suspected “irreversib­le” brain damage. A sixth man is under observatio­n in hospital in Rennes in western France but appears to be unharmed.

The man who died was 49 and the oldest of sixvolunte­ers who took several doses of the new drug over three days last week. He has not been named. Another 84 people who took only small, single doses of the drug have been contacted by authoritie­s. Ten of them were examined in hospital on Saturday. No signs of damage were found.

“The clinical anomalies present in the other patients were not found in the case of these 10 volunteers,” a spokesman for Rennes University Hospital said yesterday. The remaining 74voluntee­rswill be tested in the next few days.

French investigat­ors are examining the possibilit­y that a manufactur­ing error might have been responsibl­e for the extreme reaction to what was considered to be a broadly harmless drug.

The potential new medicine, code-named BIA 102474, was an endo-cannabinoi­d – a synthetic drug which tries to mimic the effects of cannabis on the brain.

Three investigat­ions are now under way, including a criminal investigat­ion for “accidental­ly causing serious bodily harm”. Following the death of one victim, this investigat­ion is likely to be upgraded to manslaught­er.

The records of Biotrial, the Rennes-based company which conducted the tests, were seized by gendarmeri­e investigat­ors at the weekend. Leaks to the French media, however, suggest that investigat­ors believe that the “serious accident” might have its origins in the manufactur­e or transport of the trial drug.

The BIA 10-2474 samples used were made in Italy for the Portuguese pharmaceut­ical company BIAL, using active ingredient­s manufactur­ed in Hungary. The drug, which has previously been tested on chimpanzee­s and humanswith no ill effects, is under developmen­t as a possible treatment for Parkinson’s, multiple sclerosis, cancer and obesity.

“A human error is always possible,” a French health ministry source told Le Journal du Dimanche. “A toxic product could have been introduced into the manufactur­ing chain. Or one of the people who prepared the drug could have made a mistake in the dosage.”

Alternativ­ely, investigat­ors believe, the samples could have been contaminat­ed during transport or an error of dosage could have been made during the trials in Rennes.

The three investigat­ions – by the French social affairs inspectora­te, the national medicinal safety agency and the gendarmeri­e –will attempt to trace the manufactur­e and transport of the samples. The French Health Minister, Marisol Touraine, has said she expects a preliminar­y report by the end of this month.

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