French clinical drug kills one person, five hospitalised as investigation starts

PARIS: An initial inquiry into a French clinical drug trial that left one person dead and five others hospitalised did not identify the exact cause, though several lab failings were found, Health Minister Marisol Touraine said on Thursday.

She told a news conference that the Biotrial lab that conducted the tests should have halted them right after the first person was hospitalised, 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.

"...Given the gravity of the accident, authorities should have been immediately notified," Touraine said, adding that the first accident was on a Sunday evening and authorities were not alerted until Thursday.

The victims had been participating in a clinical trial of an experimental drug made by Portuguese company Bial.

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.

"It's not possible to identify the direct causes of the accident," Touraine said.

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.

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 private facility in Rennes, northwestern France.

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.