The pharmaceutical company also confirmed which drug was being tested.
In the recent days, news of a French drug trial gone haywire has taken the world by storm. Now, an unfortunate update on the situation reveals that one man has died, and three others may have permanent brain damage from the pre-clinical research.
The reports of the trial’s tragic turn first first came out on January 15, announcing that six people were in critical condition after receiving an experimental pain-relief drug. At the time, there weren’t many details about what had happened in the trial or what drug the researchers were testing.
Rumors in the French media suggested that the trial was testing a cannabis-based painkiller, but French health minister Marisol Touraine quickly denied the allegations.
The trial was being carried out by a private research company, Biotrial, on behalf of Bial, the Portuguese pharmaceutical firm that developed the new drug. Bial has since confirmed that the novel drug was an inhibitor of an enzyme, called FAAH, that acts on our endocannabinoid system. This system involves a group of receptors and molecules that play a role in a number of physiological functions like pain and appetite.
FAAH does its part by degrading the molecules in the endocannabinoid system and preventing them from functioning at the site of action — therefore, inhibiting FAAH helps boost the levels of chemicals like anandamide, the “bliss molecule,” which is a natural pain-suppressor.
While it’s known that cannabis can activate the endocannabinoid system and reduce pain, the researchers were attempting to find another way to achieve the same outcome — without people having to get high in the process.
The Bial press release states that the development of the experimental molecule was conducted “in accordance with all the good international practices guidelines, with the completion of tests and preclinical trials, particularly in the area of toxicology.”
A total of 108 people had participated in the trial — 90 were given varying doses of the drug while the rest were given a placebo. The six men who were admitted to the hospital, including the one who has since passed away, were in the group that was given the highest dose of the drug.
In the meantime, all trials on the medication have been suspended. Ten other volunteers who took the drug have been examined by doctors, but none showed ill effects. Numerous investigations are underway.
According to the press release, the Phase 1 clinical trial was “approved by the French Regulatory Authorities, as well as by the French Ethics Committee, in accordance with the guidelines of Good Clinical Practices, with the Declaration of Helsinki and according to the laws inherent in clinical trials.”
Like in all other clinical drug trials, the researchers had to conduct vigorous tests on cells in the lab as well as animals before the drug could be given to humans. This tragic case goes to show that, even after intensive research and pre-clinical trials, there can still be unforeseen outcomes in the field of scientific research.
Hopefully those affected by this traumatic mishap will find peace.