A drug that left one person dead and four others with suspected brain damage in a controlled trial had killed several dogs in a previous test, it has been claimed, reports The Guardian.
However, the laboratory involved and France’s drug safety agency say details of earlier testing of the molecule cannot be published because of industrial secrecy.
Le Figaro said it had information suggesting a pre-clinical trial of the drug had left “a number” of dogs dead and others with neurological damage.
When news of the incident was revealed, Marisol Touraine, the French health minister, said 108 people had taken part in the trial for Portuguese pharmaceutical company Bial at a French clinic in January. Ninety of them were given varying doses of the drug while the rest took a placebo.
Six male patients aged 28 to 49, who were in good health, were given the highest dose and fell ill.
One was declared brain-dead and died days after being given the drug. Four others were taken to hospital where neurological specialists discovered they had suffered “unusual” lesions to the “base of the cranium”. These had caused brain damage resulting in coordination and movement problems that specialists suggested could be irreversible.
The state prosecutor has opened an inquiry into how the trial was carried out. A preliminary report absolved Biotrial, Bial and the French drug safety agency Agence Nationale de Sécurité du Médicament (ANSM), which approved the trial, of wrongdoing.