Botched French drug trial leaves 1 brain dead, 5 in hospital

French health authorities have begun investigating whether a procedural failure was to blame for a medical drug trial that sent six men to the hospital, one of whom is now brain dead. A total of 90 people took part in the trial, taking some dosage of the drug aimed at tackling mood and anxiety issues, as well as movement coordination disorders linked to neurological issues.

“What has happened is unprecedented in France”, said Marisol Touraine, the health minister, yesterday. After the brain-dead man was admitted to hospital on Monday, three of the five others went in between Wednesday and Thursday. Four days later, the most severely injured man was hospitalized followed by the others.

Six male volunteers aged between 28 and 49 are in hospital, including one now classified as brain dead.

The trial was conducted by Biotrial, a French-based company with an global reputation which has carried out thousands of trials since it was set up in 1989.

Edan said there’s no known way to reverse the effects of the experimental drug that Biotrial was testing.

Three of those in hospital may have a “handicap that could be irreversible”, said doctors in Rennes, where the men are being treated.

France’s national drug safety body confirmed it was the worst ever incident to have taken place in a drugs trial in the country. All of the participants who took the drug are now being recalled to ensure their safety.

All six volunteers had been in good health prior to beginning the trial for the unidentified orally-consumed drug. That prompted a review of procedures and resulted in the United Kingdom regulatory agency imposing new testing standards, including recommendations to use the lowest possible dose and to test new drugs only on one person at a time.

“The shock is all the greater as these people undergoing the clinical trials are healthy, they are not ill and don’t expect such an accident”, said Ms Touraine.

The six patients who became ill began taking the drug on January 7.

The French state prosecutor has opened an inquiry.

“Undertaking Phase I studies is highly specialist work”, said Daniel Hawcutt, a lecturer in clinical pharmacology at the University of Liverpool.

The Biotrial website says it has 25 years of experience with Clinical trials.

For example, phase I clinical trials test new treatments in small groups of people for safety and side effects.

In a statement, Biotrial said there were “serious adverse effects”, but the trial had been fully compliant with worldwide regulations. Ben Whalley, professor of neuropharmacology at the University of Reading, said such risks are only manageable but can not be completely diminished.