Bial – the Portuguese laboratory that hit European headlines in January after one volunteer died, and four others were brain-damaged during a drugs trial – has admitted that pre-clinical tests on animals led to the deaths of three dogs, writes Correio da Manhã newspaper.
The dogs died of what Bial’s press spokesperson Susana Vasconcelos has described as “pulmonary lesions”, said the paper.
But she stressed the damage “had nothing to do with the lesions verified in the volunteers that were interned at Rennes hospital” (click here).
The director of the French company in charge of the trial has also confirmed that the dogs’ deaths “did not invalidate further investigation” of the Bial molecule (BIA 10-2474) at the heart of the controversy.
“Three dogs dead in a study can explain everything or nothing,” François Peaucelle told BFMTV station.
Le Figaro newspaper gives a different viewpoint, says CM, quoting neurobiologist Daniele Piomelli, working at the University of California, saying that the death of animals during drug testing “can be a real sign of alarm”.
CM concludes its story saying “information from Bial reveals pre-clinical tests with the molecule designed as an analgesic did not show signs of toxicity in mice, dogs or monkeys.
“France’s pharmaceutical safety agency has confirmed that the specialised scientific committee knew about the (dogs’) deaths before authorising (the molecule’s) investigation in humans.”
Meantime, the reason for the volunteer death and brain-damage to four others is still being investigated.
Releasing news early February, French authorities said there had been “three major failings” in the way the incident was handled, but that it was still not possible to establish the “direct causes of the accident” described as the “worst of its kind in French medical history”.
In a bid to show support for Bial, health minister Adalberto Campos Fernandes scheduled a visit to the company some weeks later (click here)
Meantime, France’s health minister, Marisol Touraine, has said that in future the selection of volunteers for drugs trials should be “more rigorous” and involve more criteria, such as the level of consumption of “psychoactive substances”, reports TVi 24.
Regular cannabis users, for example, should be excluded from future drugs trials, she said.
Molecule BIA 10-2474 was designed to act on the endocannabinoid human system – in simple terms, a group of receptors in the brain that controls changes in humour and relieve pain. It is the system responsible for the response by humans to cannabis, explained the minister.