Lab criticised as slow to act in fatal French drug trial

An initial inquiry into a clinical drug trial that left one person dead and 5 others hospitalised in France last month found that the laboratory conducting the tests was slow to react once the primary patient fell unwell.

A full investigation geared toward characteristic the precise causes is anticipated by end-March, French Health Minister Marisol Touraine aforementioned on Thursday.

No rules were broken and it had been not possible at this stage to determine specifically what went wrong, Touraine aforementioned.

"The tests were applied in compliance with current rules," she said.

The victims had been given associate degree experimental drug created by Portuguese company Bial in associate degree initial section one stage.

Biotrial , the laboratory accountable of conducting the tests in a very non-public facility in Rennes, Brittany, aforementioned in a very statement it had strictly complied to international standards. no one at Bial was forthwith accessible for comment.

All trials on the drug, that is meant to treat mood and anxiety problems additionally as movement coordination disorders connected to neurologic problems, have since been suspended.

Touraine aforementioned Biotrial ought to have halted the tests right when the primary person was hospitalised, however instead 5 a lot of individuals got the drugs following day.

The work conjointly ought to have warned authorities promptly concerning the accident and expressly asked different participants whether or not they wished to remain within the take a look at trial, she added, presenting the most findings within the investigators' initial report.

Touraine aforementioned the primary accident was on a Sunday evening, nonetheless authorities weren't alerted till the subsequent Thursday.

Touraine aforementioned investigators had not involved suspension of Biotrial's authorisations to hold out drug trials.

The medicine concerned could be a questionable FAAH matter that works by targeting the body's endocannabinoid system, that is additionally accountable for the human response to cannabis, however isn't a cannabis-derivated drug.

Asked if the person World Health Organization died last month had eaten cannabis before taking the drug, Touraine aforementioned it had been potential.

In total, ninety individuals participated within the trial and therefore the six men World Health Organization fell unwell had been in healthiness till taking the oral medication at the Biotrial facility.

Touraine aforementioned the medical condition of the 5 volunteers still in hospital was rising however that it had been premature to create by mental act their complete recovery.

Cases of early-stage clinical trials going badly wrong square measure rare however not extraordinary. In 2006, six healthy volunteers given associate degree experimental drug in London terminated up in medical care.

On Jan. 21, U.S. Johnson & Johnson aforementioned it had suspended international trials of a drug just like the one experimented by Bial.