Six people critically ill after French drug trial

Six people are critically ill following a clinical drug trial in France.

Health minister Marisol Touraine said there had been a “serious accident” during a trial at a private laboratory in Rennes that led to the hospitalisation of six patients at the Centre Hospitalier Universitaire de Rennes.

The ministry said one of the six patients – all of whom had been in good health before the trial – was brain dead.

French media reports suggested the trial was for a cannabis-based painkiller, but the health ministry denied the reports.

Drug evaluation company Biotrial put out a statement on its website saying that “serious adverse events” related to the test drug occurred in some subjects at its clinical pharmacology unit during a first-in-man study being conducted for a sponsor.

A first-in-man study is a clinical trial during which a medical procedure, previously developed and assessed through in vitro or animal testing, or through mathematical modelling is tested on human subjects for the first time.

“The trial has been conducted in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital,” Biotrial said.

The company said it was in close and regular contact with the health authorities and Ministry in France, adding that its priority was the safety of its subjects.

The trial has now been suspended and all volunteers have been recalled.

France’s medicines agency, ANSM, has launched an investigation into the laboratory.

Incidents of volunteers falling seriously ill during trials are rare as they are usually started off on the lowest possible dose following extensive testing in animals.

However, in 2006, six men in the UK suffered organ failure in what became known as ‘the Elephant Man trial’.

Two became critically ill, with one losing his fingers and toes, and as a result of their exposure to the immunomodulatory drug, the men are now more likely to develop cancers or autoimmune diseases.