The news of the French drug trial gone wrong has been seen by many people, but since the initial story broke there have been some corrections made. The French Health Ministry has announced that this “cannabis-based” drug that was being tested actually contained no cannabinoids.
Bial is the pharmaceutical firm that was developing this experimental oral medication. Last July they began testing with a biotrial on chimpanzees. For the human trials, they had 90 healthy participants involved to “evaluate the safety of its use, tolerance and pharmacological profile of the molecule.” This was still in Phase one, which usually made up of a small group of volunteers with an emphasis on safety.
January 10th, 2016 was when the first patient first felt ill. After that, five more were taken to a hospital in Rennes, France. The Health Ministry said that all six patients were healthy before they began taking this medication. One patient is irreversibly brain dead while three others had effects that are possibly irreversible. All of these people are facing potential auto-immune complications. The operations at Bial have been stopped while the French state operator does an investigation.
The French Health Minister, Marisol Touraine, said that this drug was an FAAH inhibitor, that is meant to act on the endocannabinoid system in the body. He also said that the drug had no cannabis or cannabis derivatives at all.
Bial attempted to defend themselves by saying that this trial had been approved by French regulators. French attorney Jean-Christophe Coubris says that “Whatever contract these patients may have signed, they will be protected by French legislation in the case of proven misconduct. It seems absurd, since this was only Phase I, i.e. the first introduction [of the drug] into the human body.”
There is an inherent risk anytime that people volunteer for trials like this. Every year there are many thousands of students and other people who financially struggling that look to trials like these to earn some extra money. Dr. Ben Whalley, neuropharmacology professor at Britain’s University of Reading, notes that “However, like any safeguard, these minimize risk rather than abolish it. There is an inherent risk in exposing people to any new compound.”
This story was an opportunity for the prohibitionists to declare victory on the idea that cannabis is dangerous and should not be legalized. However, the truth of the matter is that the natural medicine is still as safe as ever. This experience just shows the danger of pharmaceutical synthetics, not of cannabis itself.