Information has surfaced that suggests the drug, which caused the death of one person and the hospitalisation of five others, killed five dogs during a pre-clinical test
The Guardian reported that Le Figaro had information suggesting a pre-clinical trial of the drug had left “a number” of dogs dead and others with neurological damage.
In January Bial’s painkiller drug, containing cannabinoids, an active ingredient found in cannabis plants, was being tested in a phase one clinical trial at a Biotrial facility in France.
During the trial one man fell into a coma and was reported dead four days later, whilst five others were taken to hospital suffering from serious brain damage.
Marisol Touraine, the French health minister, said 108 people had taken part in the trial for Portuguese pharmaceutical company Bial at a French clinic. Ninety of them were given varying doses of the drug while the rest took a placebo, The Guardian reported.
However, Bial and France’s drug safety agency say details of earlier testing of the molecule cannot be published because of industrial secrecy.
Dominique Martin, director of Agence Nationale de Sécurité du Médicament (ANSM), told Le Figaro: “We have given all information that we can, but there is an industrial property question here.”
The state prosecutor has opened an inquiry into how the trial was carried out. Yet a preliminary report absolved Biotrial, Bial and the French drug safety agency ANSM, which approved the trial, of wrongdoing, according to The Guardian.
François Peaucelle, director of Biotrial, said the death of the dogs was not significant. “The conclusions of this study were sufficiently clear and clean to rule out any particular ambiguity about proceeding with human tests,” Peaucelle told BFMTV.
Stephen Senn, an expert in statistical methods used in drug testing for the NHS and head of the Clinical and Epidemiological Investigation Center, said to Le Figaro: “The principle behind industrial secrets is relevant but it has to come after the general interest … we cannot accept that it’s more important to keep industrial secrets than to avoid further serious problems for patients taking part in other clinical trials.
“It’s important that results can be discussed by everyone.”