5 volunteers are ill, and one is brain-dead after a cannabis painkiller drug trial gone horribly wrong in northwestern France.
The news surfaced on Friday, January 15, in a press release issued by Marisol Touraine, the French minister of Social Affairs, Health and Women’s Rights.
The experiment was being conducted by a research company whose name wasn’t initially revealed to the public, although iTELE speculated correctly that the crisis involves Biotrial, headquartered in Rennes, Brittany.
Apparently, the “cannabinoid painkiller”, which was supposed to be administered orally, as a tablet, was right in its embryonic stages of testing.
This phase 1 of the experiment had the aim of allowing experts to determine if the compound they were developing was indeed well-tolerated by patients, without having noteworthy adverse reactions.
Given the fact that human trials aren’t launched without carrying out animal tests at first and ensuring that risks faced by volunteers are kept at a minimum, it’s unclear what exactly backfired, especially since all the participants had been considered in good health at the beginning.
Up until this moment, officials have remained relatively tight-lipped, simply declaring that “a serious accident” has occurred.
More precisely, a number of 5 volunteers have fallen severely ill after taking part in the clinical trials, while a sixth one is currently comatose and believed to have lost brain function completely.
The six subjects, whose condition has been listed as critical, have been admitted at the University Hospital of Rennes, and efforts are underway so as to ensure their survival.
Now the entire experiment will be halted, and all the study participants which had enrolled in testing the cannabis-based medicine will be discharged, as the laboratory is being thoroughly examined and the incident is being investigated by the French Agency for the Safety of Health Products.
Another inquest will be led by the General Inspectorate of Social Affairs, while a third one will be coordinated by prosecutors at the Paris health branch, as the research company is now being accused of having provoked “involuntary harm” during the course of more than 3 months.
It is hoped that through these combined efforts authorities will gain further knowledge into how this unexpected tragedy could happen.
For now, information regarding the unfolding crisis is relatively sparse. Namely, it’s unclear exactly how many volunteers had participated in the trial, and if there are others who are also exhibiting worrying symptoms.
Also, little is known concerning the reason why experts initially thought the cannabinoid compound would be a viable, safe alternative to countless other painkillers available in drugstores worldwide.
Even the identity of the company conducting the trial was confirmed with delay, as more and more evidence began to point to the fact that Biotrial was indeed at the center of the investigation.
Representatives eventually released a press statement today, in which they admitted that theirs was the laboratory which had been in charge with the experiment.
So far, the manufacturer of the cannabinoid painkiller is yet to be named, but Biotrial insists that during the trial safety procedures were followed painstakingly, and emergency assistance was provided to volunteers as soon as their first adverse symptoms appeared.
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