Portuguese pharmaceutical company Bial is taking responsibility for manufacturing an experimental drug that led to one person’s death and the hospitilization of five others during a clinical trial in France.
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 Friday, according to Reuters.
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, quickly followed by the others, and on Jan. 11, officials stopped the trial and recalled all volunteers, Touraine said.
The French Agency for the Safety of Health Products (MSNA) is reportedly conducting an inspection of the clinical trial site.
Those sickened by the drug are being treated in the University Hospital of Rennes. According to Forbes, the hospital’s chief neuroscientist Gilles Edan said that brain scans of the patients reveal bleeding deep in the brain and dead tissue, damage that “could be irreversible.”
According to BioWorld, the drug, known as BIA 10-2474, 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 lincensed 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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