French authorities pins blame on Bial and Biotrial for fatal drug trial
pharmafile | May 24, 2016 | News story | Manufacturing and Production, Research and Development | Bial, Biotrial, France, blame, clinical trial, death, disaster, minister for health, report
Authorities in France have criticised the pharmaceutical company and the clinical research organisation at the centre of the Rennes clinical trial tragedy which left one dead and several injured.
The clinical trial was taking place to assess the efficacy of an FAAH enzyme inhibitor, but very quickly turned sour with one man dying in hospital, and five more hospitalised with neurological issues.
Portuguese pharma company, Bial, and the research firm, Biotrial, were said to have been responsible for many of the adverse events that took place, with Biotrial failing to immediately quit administering the drug after the first hospitalisation as well failing to confirm patient consent before running the trial.
The report commissioned by French authorities states that Biotrial “failed to implement the optimal level of protection for volunteers”, and that both Bial and Biotrial took far too long to inform the relevant bodies of the serious adverse events. The National Agency of Drug Safety, however, was cleared of any wrongdoing in the matter.
French health minister, Marisol Touraine, says: “A final investigation report confirms that conditions under which the test was approved did not breach existing legislation. Inspectors consider, however, that Bial and Biotrial are responsible on several counts; regarding the dosage prescribed […] and the time taken to alert authorities.”
While there was no immediate comment from Bial, Biotrial mounted a robust defence of its role in the event. They released a statement saying: “Biotrial deplores this situation, especially since it has always strictly respected the test protocol validates by the ANSM (French national agency for the safety of medicines and health products), and that it has been shown that it is the Portuguese laboratory Bial’s compound, by its unexpected and unpredictable toxicity, which is at fault for the accident.”
Sean Murray
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