French prosecutors have started an involuntary manslaughter investigation into the death of one man in a trial carried out in Rennes earlier this year.
Last month, France's health ministry said that Portuguese drugmaker Bial and its French laboratory partner and CRO Biotrial were at fault "on several counts" on the trial, which also saw 5 participants seriously injured.
The French CRO was running a Phase I trial in its home base of Rennes, France, on behalf of Bial, administering a medicine that blocks the enzyme FAAH to treat anxiety.
The drug's mechanism is well-known to the industry but had not shown safety concerns in previous testing--although French news reports surfaced in March that there had been some unusual deaths and issues in preclinical trials of the drug, which had seemingly not been acted upon.
In all, around 100 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 improving.
According to Reuters, the prosecutors will seek to understand whether the man died through a criminal element, or whether his death was legally acceptable within the boundaries of clinical risk and experimental drug testing.
An initial report found that the first accident with the drug was on a Sunday evening--yet authorities were not alerted until the following Thursday. Several reports have since been published, one blaming the “toxic compound” of the drug, with another from the health ministry saying that both companies were “partly responsible” given the apparent slowness of response--but added that they had been compliant with current legislation.
The death and injuries have already prompted the EMA to tighten up its rules on early-stage trials, with France also pushing to have new rules and laws in place to ensure this cannot happen again.
Biotrial, which has issued a series of releases defending its actions over the past 6 months, has not yet responded to the prosecutor’s investigation.
- see the Reuters story