A Phase 1 drugs trial conducted in France using a ‘new molecule’ manufactured by Portuguese drugs company Bial has gone horribly wrong, seeing six people in hospital – one classified as ‘brain dead’ and three, if not four others at risk of permanent brain damage.
In all, 198 people were involved in the test, with 90 taking the ‘strongest doses’, explains Diário de Notícias.
Although manufactured in Portugal, there are no tests being taken on this so-called ‘enzyme inhibitor’ here.
The phase 1 trial was the being undertaken by a private French laboratory, and according to a report this evening by the BBC, there is no known antidote to the drug .
French health minister Marisol Touraine has pledged to “get to the bottom” of what she called “a tragic accident”.
After visiting volunteers who took part in the trial, she told reporters: “I was overwhelmed by their distress. Their lives have been brutally turned upside down”.
As BBC health editor James Gallagher explained: “This is the bitter price of the new medicines we take for granted. Testing such experimental drugs, at the cutting edge of science, can never be completely risk-free.
“The safety and effectiveness of these drugs are rigorously tested in animals. The risks are low but there must still be a leap of faith when they are tried in people for the first time.
“This trial has been taking place since July without such major events being reported. Generally in Phase I trials the dose is increased slowly over time, which could be why the side-effects are appearing now.
“The hospitalised men started taking the drug regularly on 7 January and began showing severe side-effects three days later.
“Three of the volunteers are now facing a lifetime of disability in this “accident of exceptional gravity”.
DN added that the trials began after the drug had been tested on chimpanzees.
According to Touraine, it is designed to “act on the endocannbinoide human system – in simple terms, “a group of receptors in the brain that control changes in humour and relieve pain”.
It is this system that is responsible for the response by humans to cannabis.
Le Monde newspaper has given the Bial molecule its technical name: BIA 10-2474, adding that it was being developed to treat changes in humour related to Parkinson’s disease.
As this story is being picked up by all major news channels, Sky News in UK is suggesting the number of people “seriously ill in hospital” could be as many as five.