Although a number of media reports have suggested that an experimental cannabis-based painkiller is what caused a “serious accident” during a clinical drug trial this week in France, leaving one person brain-dead and hospitalizing at least five others, the nation’s health ministry has confirmed that the tragedy was not the result of a medication containing cannabinoids.
On Thursday evening, the French media published breaking news about a major calamity in the western city of Rennes in which a number of participants in a research study involving a cannabis-based drug were rushed to the hospital to seek treatment of adverse effects. The report went on to say that the worst of the injuries was brain death in at least one person, while the conditions of the other five victims were unknown. It was later revealed that all of those affected suffered from a “critical neurological condition.”
While some news organizations ran wild with headlines that implied a drug derived from the cannabis plant had destroyed several people’s brains, a spokesperson for France’s health ministry was quick to smash down the claims, saying that the drug responsible had nothing to do with cannabis. The health ministry refused elaborate on what the drug was actually being tested for, only that the drug was a so-called fatty acid amide hydrolase (FAAH) inhibitor. This class of drugs is designed to inhibit the enzyme that degrades natural endocannabinoid, causing an increase in endocannabinoid levels. Many doctors and researchers have displayed interest in using this type of drug to harness the medical potential of cannabis without causing a psychoactive effect. Previous clinical trials indicate that FAAH inhibitors are safe in humans, but this new situation may close the door on this avenue. Currently, Yale University is sponsoring another clinical trial for the use of these potentially dangerous FAAH inhibitors for the treatment of "cannabis withdrawal syndrome."
What we know is that a company called Biotrial was behind the incident. This research center, which has facilities all across the world, including one in New Jersey, was hired by an unknown pharmaceutical company to begin Phase I of the clinical trials on a mystery drug. This portion of the study involves testing on a small group of healthy participants to evaluate the safety and tolerability of the drug. Reports indicate that all of the volunteers were administered the drug orally beginning earlier this week.
"The trial has been conducted in full compliance with the international regulations and Biotrial's procedures were followed at every stage throughout the trial," Biotrial said in a statement. “The priority at Biotrial remains the safety of our subjects.”
Paris prosecutors have reportedly launched a full-blown investigation into the incident.
It is still too early to tell exactly what happened in this case. Hopefully this disaster in France will serve as a wake-up-call for scientists who experiment with our body's endocannabinoid system in unnatural ways, ignoring the obvious solution that grows out of the ground beneath them. HIGH TIMES will continue to monitor the situation, and provide updates as they are made available.