Drug trial tragedy: both Biotrial and Bial were responsible "in many respects"

The death and disability resulting from drug trials in France, contracted by the Portuguese pharmaceutical company Bial, have been blamed on the testing centre and its client.

France’s health minister has agreed that the Rennes based test centre Biotrial, and the Portuguese drug company Bial were responsible for the tragedy, "in many respects."

Bial’s management says the results of the French report into the January tragedy are inconclusive and that the trail was correctly operated with dosage decisions carefully decided on and it regrets that the report does not even clarify the causes of death of one of the volunteers.

The report, published by France's General Inspectorate of Social Affairs, looked into the testing of the BIA10-2474 molecule which was hoped to become part of a new medicine to bring relief to those suffering certain neurological and psychological disorders.

The tests went disastrously wrong with one volunteer dying and several being hospitalised.

Bial says it is hard to comment when it has not been given access to the volunteers’ medical data, but insists that during the clinical trials, "decisions on escalating doses were properly taken."  

But one section of the report points the finger at Bial: the higher dosages, claim the French, were not properly controlled.

Bial say earlier tests showed nothing adverse and the raised dosages were carefully controlled but certain of the French media is claiming that earlier tests of the drug using animals showed dire reactions and that higher dosages should not have been used on humans.

The French Health Minister said that Bial and Biotrial have responsibilities "in many respects" but did not suggest legal remedy or prosecution.

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