The active substance of a medicine used in a medical experiment that left one person dead and five seriously injured in France last week was produced by a Hungarian company, according to Bial, the Portuguese firm that commissioned the experiment. Bial refused to disclose the name of the company but said that the medicine was made in Italy using the Hungarian-produced active substance.
One man left brain-damaged during the trial of the new painkiller died on Sunday, while press reports are divided in whether the condition of the other five people is improving or whether some of them are believed to have suffered irreversible brain damage.
The accident is one of the most serious safety failures in a clinical trial since 2006, when six people suffered a life-threatening reaction to an experimental treatment in London.
Like the London accident, the incident in France took place during the first phase of the three-stage trial process involved in assessing the safety and efficacy of new drugs. Volunteers typically receive financial compensation for participating in such experiments.
Bial, based in Porto, Portugal, said on Friday that the trial involved a “FAAH enzyme inhibitor” for relieving pain and had been under way in France since last June. The experimental molecule had been administered to 108 patients in total “without any moderate or serious adverse reaction,” it said.
via index.hu and ft.com
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