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.

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.

Bial has published the protocol for the administration of the drug but refuses to divulge more information on pre-clinical trials.

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.



Dominique Martin, director of ANSM, told Le Figaro: “We have given all information that we can, but there is an industrial property question here.”

Touraine has promised complete transparency on the study, which she said was a phase one clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”.

Medical trials typically have three phases to assess a new drug or device for safety and effectiveness. Phase one entails a small group of volunteers and focuses only on safety. Phase two and three are progressively larger trials to assess the drug’s effectiveness, although safety remains paramount.

Testing had already been carried out on animals, including chimpanzees, starting in July, Touraine said in January.

Prof Stephen Senn, an expert in statistical methods used in drug testing for the NHS and head of the Luxembourg-based Clinical and Epidemiological Investigation Center, said the drug trial accident was “extremely worrying”.

He said hiding behind industrial secrets legislation was “not acceptable”.

“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,” Senn told Le Figaro.