A painkiller that left one person dead and four others with brain damage during a disastrous clinical trial in France last month had already proved fatal to dogs during previous tests, according to French newspaper Le Figaro. It's unknown how many dogs there were, although the information appears to suggest they suffered neurological damage.
In response, the drug evaluation company that ran the trial has said that these deaths were not significant to its evaluation of the compound’s safety, although it is unable to provide any details about these preclinical trials until permission is given by the drug’s manufacturer.
Varying doses of the drug – which is made by Portuguese firm Bial – were given to 90 people at a laboratory in the city of Rennes, causing complications in the six participants who had received the highest doses. Both Bial and Biotrial, which conducted the trial, have been cleared of wrongdoing in a preliminary report by state prosecutors, as has the French drug safety agency, Agence Nationale de Sécurité du Médicament (ANSM).
But ANSM director Dominique Martin later told Le Figaro that, while the agency had complied with the investigation as much as possible, “industrial property” issues have prevented it from divulging certain information.
Contractual arrangements forbid Biotrial from disclosing any details of preclinical trials without Bial’s permission, and the manufacturer has so far refused to allow this. However, Biotrial general director Francois Peaucelle told French news agency BFM TV: “The conclusions of this study were sufficiently clear and clean to rule out any particular ambiguity about proceeding with human tests.”
The trial was a phase one study, which is the first round of human testing in which drugs are evaluated for safety of use, before progressing to phases two and three if deemed to be widely tolerable. These latter stages assess the efficacy of a compound.
With investigations ongoing into what went wrong during the trial and who should be held accountable, scientists are divided over whether rights to industrial secrecy should be overruled in the interest of public safety.
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