Scientist: No known antidote for botched drug test in France

Drugs trial tragedies like that reported in France on Friday which left one person brain dead and three others facing irreversible brain damage are a rarity, experts say.

The study was a phase one clinical trial, in which healthy volunteers take the medication to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule”, French Health Minister Marisol Touraine said in a statement.

One has been declared brain dead and two are in serious condition, in what France’s health minister, Marisol Touraine, has called an unprecedented situation of “exceptional gravity”.

A total of 108 volunteers took part in the trial, 90 of whom received the drug at varying doses while the rest were given placebos. She said she was “overwhelmed by the distress” of the drug trial victims, whose “lives have been brutally turned upside down”.

It is rare for volunteers to fall seriously ill when testing new drugs.

The injured are among a group of otherwise healthy male volunteers participating in a phase I drug trial, which began in June. The drug has since gone back into tests for rheumatoid arthritis and is showing promise when given at a fraction of the original dose.

Because Phase I trials are used to determine a drug’s toxic effects, they “are inherently risky, as unexpected events can – and do – occur”, Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, said in a statement.

Medics rushed six research volunteers to this hospital in western France after they became violently ill while taking part in a drug study. The first volunteer was admitted to the neurology department at the nearby hospital in Rennes three days later.

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. One was described as looking like “the elephant man” after his head ballooned. Wilson experienced the most adverse effects from the medication; he was in pain for months, and even lost parts of his fingers and toes to the effects of the drug. Touraine revealed that the company had already tested the drugs on animals since July 2015.

After Phase I, Phase II and Phase III are progressively larger trials, typically involving hundreds or thousands of volunteers, to assess the drug’s effectiveness. “It is very common for there to be side effects since all medicines (approved or in testing) exert both the desired effect and unwanted effects”, said Dr Ben Whalley, a professor at Britain’s Reading University.

A spokesman for the London branch of Biotrial said that it did not conduct trials in the UK.

He added: “However, like any safeguard, these minimise risk rather than abolish it. There is an inherent risk in exposing people to any new compound”.