Drug trial volunteer dies as ‘manufacturing error’ theory investigated
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.