The company in charge of the trial of an experimental drug that left one person dead and others possibly brain damaged has been found to be at fault, the French Health Ministry said.
A preliminary report found that the laboratory Biotrial failed to suspend the trial on Jan. 10 when one volunteer was hospitalized, and continued to inject other volunteers a day later. Four of those others were later hospitalized with brain disorders, Dow Jones Business News reports.
Biotrial will still be allowed to carry out drug trials, however, the health ministry said.
A total of 90 people were involved in the trial of the drug, which was designed to treat mood and movement disorders, French health minister Marisol Touraine said in a news conference, according to Reuters.
One of the volunteers later died, the company reported on its website. Five others were hospitalized after taking the drug.
The six volunteers who became ill were all healthy men aged 28 to 49. They began taking the drug on Jan. 7, and by Jan. 10, the first volunteer was hospitalized with a headache and blurry vision. The following day, five more volunteers were given the same dosage of the drug. An hour later, the hospitalized patient’s condition worsened, and by the end of the day, he had been declared brain dead, and the trial was suspended on Jan. 11. On Jan. 13, the other volunteers were hospitalized.
The cause of the death is still unknown, and a full report will not be published until late March, Dow Jones Business News reports. The other volunteers are now home and their health is improving, but it’s too soon to know if they will recover fully, the French health minister said.
According to BioWorld, the drug, known as Bial, was intended to act on the brain’s cannabinoid receptors, which are involved in a variety of mental functions, including pain relief. A copy of documents sent to the French media by a prospective volunteer describes the drug as a “product in development for the treatment of different medical conditions from anxiety to Parkinson’s disease, but also for the treatment of chronic pain of sclerosis, cancer, hypertension, or the treatment of obesity.”
The trial participants were reportedly paid €1,900 ($2,080).
Clinical trials are typically conducted in three phases. Phase 1 trials focus primarily on the drug’s safety and side effects, while Phases 2 and 3 are larger trials that focus on its efficacy, though safety is still important.
The trial was conducted by French-based company Biotrial, a licensed private institution that conducts trials of drug safety, tolerability, and pharmacology in healthy volunteers.
Such adverse events during a Phase I clinical trial are rare.
The European Union has very strict standards for performing clinical trials, Jayne Lawrence, chief scientist at the Royal Pharmaceutical Society, said in a statement. “Those in charge of the trial would have had to have shown they had done everything they could to protect patient safety before the trial was allowed to go ahead,” she added.
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. “Phase 1 trials, therefore, pose significant practical and ethical issues.”
The New York Times reported a similar event in March 2006, when six previously healthy young men in England were seriously sickened after being injected with an immune-system stimulant known as TGN1412 in a Phase 1 trial.
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