Volunteer dies after troubles with French drug trial

Dr Gilles Edan, chief neuroscientist at the hospital, said in addition to the brain-dead man who has now died, three other men could have “irreversible” brain damage. The investigational drug is a product in development for the treatment of different medical conditions including anxiety, Parkinson’s disease, severe pain of sclerosis, cancer and hypertension.

French health authorities have said three of those still hospitalized face possible brain damage, and an investigation is underway into what French Health Minister Marisol Touraine called “an accident of exceptional gravity”.

The hospital said the other 84 volunteers have been contacted – ten of whom have been examined and found to have suffered none of the “anomalies” seen in those taken to hospital.

The drug was a new painkiller produced by Portuguese pharmaceutical company Bial.

In a statement, Biotrial acknowledged “serious adverse effects” in a trial, adding: “The trial has been conducted in full compliance with the worldwide regulations, and Biotrials procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of subjects to the hospital.

Reports that the drug was a cannabis-based painkiller have been denied by the French health ministry.

The ministry on Friday said the six volunteers in Rennes, Brittany, had been in good health until taking the oral medication, which was developed by “a European laboratory”. Another is suffering from neurological problems and the sixth man is in a less critical condition, the Associated Press reported.

A similar incident occurred in 2006, when six people testing TeGenero’s TGN1412 drug fell ill.

The company pays volunteers between 100 and 4500 euros (NZ$169 and NZ$7628) to participate in trials, a common industry practice.

Bial, in response to the controversy, said they have implemented measures to safeguard the health and wellbeing of the participants.

Biotrial, which also has offices in London and Newark, New Jersey, says it has over 25 years of experience in clinical trials and uses “state-of-the-art facilities”.

The trial, now suspended, was an early stage Phase I trial.

Ms. Touraine said the drug had previously been tested on animals, including chimpanzees, and was administered to 90 people under the trial.

Typically, a drug undergoing a clinical trial goes through three phases. It expressed commitment to ensuring the well-being of its trial participants and working with French authorities to know the cause of the injuries. Phase one entails a small group of volunteers and focuses only on safety. But Ben Whalley, professor of neuropharmacology at the University of Reading, said these could only minimize risks rather than abolishing them.