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 A full investigation aimed at identifying the exact causes is
expected by end-March, French Health Minister Marisol Touraine said
on Thursday.
No regulations were breached and it was impossible at this stage to
establish exactly what went wrong, Touraine said.
"The tests were carried out in compliance with current regulations,"
she said.
The victims had been given an experimental drug made by Portuguese
company Bial in an initial phase 1 stage.
Biotrial , the laboratory in charge of conducting the tests in a
private facility in Rennes, Brittany, said in a statement it had
strictly complied to international standards. Nobody at Bial was
immediately available for comment.
All trials on the drug, which is intended to treat mood and anxiety
issues as well as movement coordination disorders linked to
neurological issues, have since been suspended.
Touraine said Biotrial should have halted the tests right after the
first person was hospitalized, but instead five more people were
given the medicine the next day.
The lab also should have warned authorities promptly about the
accident and explicitly asked other participants whether they wanted
to stay in the test trial, she added, presenting the main findings
in the investigators' initial report.
Touraine said the first accident was on a Sunday evening, yet
authorities were not alerted until the following Thursday.
Touraine said investigators had not called for suspension of
Biotrial's authorizations to carry out drug trials.
The medicine involved is a so-called FAAH inhibitor that works by
targeting the body's endocannabinoid system, which is also
responsible for the human response to cannabis, but is not a
cannabis-derivated drug.
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Asked if the man who died last month had ingested cannabis before
taking the drug, Touraine said it was possible.
In total, 90 people participated in the trial and the six men who
fell ill had been in good health until taking the oral medication at
the Biotrial facility.
Touraine said the medical condition of the five volunteers still in
hospital was improving but that it was premature to envisage their
complete recovery.
Cases of early-stage clinical trials going badly wrong are rare but
not unheard of. In 2006, six healthy volunteers given an
experimental drug in London ended up in intensive care.
On Jan. 21, U.S. Johnson & Johnson said it had suspended
international trials of a drug similar to the one experimented by
Bial.
(Writing by Leigh Thomas and Matthias Blamont; Editing by Michel
Rose and Andrew Callus/Mark Heinrich)
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