Tuesday 6 December 2016

Deadly French trial drug had already proved fatal on dogs

David Chazan

Published 26/02/2016 | 07:17

Biotrial general director Francois Peaucelle Photo: AFP
Biotrial general director Francois Peaucelle Photo: AFP

A drug that killed one person in a botched clinical trial in France and left four others with suspected brain damage had already caused the deaths of dogs in earlier tests, according to reports.

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The laboratory involved and France’s drug safety agency said details of the previous tests on dogs could not be disclosed because of industrial secrecy.

But the newspaper Le Figaro said it had learned that “a number” of dogs had died and others had suffered neurological damage when it was administered to them in a preclinical trial.

Ninety people were given varying doses of the drug at a clinic in the western French city of Rennes in January. Biotrial, a French drug evaluation company, ran the test for the Portuguese pharmaceutical company, Bial.

Six men in good health aged 28 to 49 took the highest dose and fell ill. One died a few days later, and four others were taken to hospital where doctors discovered they had “unusual” lesions to the “base of the cranium”. These caused brain damage resulting in problems with movement and co-ordination that doctors said could be irreversible.

Several investigations were launched to find out what went wrong. A preliminary report cleared Biotrial, Bial and the French drug safety agency of wrongdoing.

The manufacturer, Bial, has refused to reveal details of the preclinical trials on dogs carried out before it was tested on people by Biotrial.

The director of the drug evaluation company, François Peaucelle, claimed the deaths of the dogs were not significant. “The conclusions of this study (the tests on dogs) were sufficiently plain and clear to rule out any particular ambiguity about proceeding with human tests,” he told BFM TV.

Dominique Martin, the head of the national drug safety agency, Agence Nationale de Sécurité du Médicament (ANSM), told Le Figaro: “We have given all the information we can, but there is an issue of industrial property.”

Telegraph.co.uk

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