Report: Fatal French trial ignored preclinical warning signs

By Ben Adams

French Health Minister Marisol Touraine

A French newspaper is making fresh claims that several dogs were killed in preclinical studies by a drug being tested in France that last month killed one person and left 5 seriously injured.

The publication Le Figaro is reporting that it has seen information suggesting an early-stage animal study of the drug had left "a number" of dogs dead and others suffering with neurological damage.

The newspaper quotes an anonymous source for this information. Daniele Piomelli, a professor of neurobiology and pharmacology at the University of California at Irvine, told the paper that this kind of death in a preclinical study "can be a real warning signal."

The CRO Biotrial was running a Phase I trial in its home base of Rennes, France, on behalf of Portuguese drugmaker Bial, administering a medicine that blocks the enzyme FAAH to treat anxiety.

In all 90 patients had taken the drug, but in January, 6 trial participants took a higher dose form of the treatment, with one becoming brain dead and later dying. Five others were seriously ill but are now slowly improving.

The slowness of the two firms to stop the study came under heavy fire from French Health Minister Marisol Touraine, who said earlier this month that the companies should have been quicker about warning the authorities about the accident. She added however that "the tests were carried out in compliance with current regulations."

François Peaucelle, the director of Biotrial, told the news station BFMTV that 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," he said, as reported by the Guardian.

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

- here's the Figaro story
- read the Guardian's take

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