A clinical trial gone wrong has left one person brain-dead and five others hospitalized in France, confirmed the country’s health ministry last Friday.
The trial – said to be of an experimental medication by Portuguese company Bial – involved 90 people.
At a news conference, French health minister Marisol Touraine said the trial participants had been taking some drug dosage intended to tackle mood and anxiety disorders, as well as movement coordination issues connected with neurological problems.
“This is unprecedented,” proclaimed Touraine at the press conference. “We’ll do everything to understand what happened.”
The six victims were men ages 28 to 49, all said to be in good health until they took the oral drug at a Biotrial private facility in Rennes, western France that specializes in clinical trials.
French prosecutors have launched an investigation on the case, where the six men began taking the drug on Jan. 7 while the brain-dead victim was admitted to a hospital Monday.
All trials on the drug were already suspended and volunteers were recalled following this development, added Touraine.
Neurologist Gilles Edan feared irreversible handicap for three of the five hospitalized men, although he remains hopeful that it would not be the case.
The experimental drug is based on a naturally occurring brain compound that is similar to marijuana’s active ingredient, although the health minister denied that it is based on cannabis itself, as some media outlets have claimed.
Bial confirmed that 108 healthy individuals had already participated in the trials and exhibited no moderate to serious effect, adding that initials were carried out last June after toxicology tests. It expressed commitment to ensuring the well-being of its trial participants and working with French authorities to know the cause of the injuries.
Biotrial, on the other hand, said it uses “state-of-the-art facilities” and claimed more than 25 years of clinical trial experience.
The Phase 1 stage involves giving a small dose of the drug to healthy volunteers or those with a medical condition to check for any side effects. Despite strict regulations, however, risks still remain.
"There is an inherent risk in exposing people to any new compound," said neuropharmacology professor Ben Whalley from the University of Reading.
In Phase 2 trials, the drug is given to those with a medical condition to see if it is helpful. In Phase 3 trials, which includes drugs or medical devices that have already passed the first two stages, the effect of the drug is compared to placebo or existing treatments. This could involve several thousand participants.
In a similar incident in 2006 in Britain, six previously healthy men underwent organ failure hours after being given an experimental drug that targets the immune system.
The case prompted the UK regulatory agency to impose new testing standards, including recommending the lowest dose possible and testing new medicine on one person at a time.
Photo: Till Krech | Flickr
