Five volunteers have been hospitalized and are in serious condition and another is dead after participating in a clinical trial of an orally-consumed experimental painkiller at the Biotrial laboratory in the French city of Rennes.
Though French officials have not yet released the name of the drug, France’s Minister of Social Affairs and Health Marisol Touraine said at a Friday press conference, seen in the above-embedded video, that the drug “acts on natural systems which fight pain, a system called the endocannabinoid system.”
While cannabis also functions by acting on the endocannabinoid system, she added, “But I must stress, there is no cannabis in this drug.”
Touraine noted that the drug had previously been tested on animals prior to the Phase 1 trial on humans.
Agence France-Presse is reporting that the volunteer who died was first admitted to the hospital in a brain-dead state, but passed away a week later on Sunday.
The drug was developed by the Portuguese pharmaceutical company Bial, which noted that the drug is a fatty acid amide hydrolase (FAAH) inhibitor.
According to The New York Times, volunteers, all of whom are males aged 28 to 49, began taking the drug on Jan. 4, with 90 participants taking the medication itself and 38 participants taking a placebo.
Some of the six participants who fell ill began showing symptoms the following Sunday, and the trial was subsequently halted the next day. Those participants were reportedly healthy prior to consuming the drug.
Following the accident, the six men were admitted to Centre Hospitalier Universitaire de Rennes in Brittany. MRI results, which are not yet conclusive, suggest that three of the men may have suffered permanent brain damage.
France’s General Inspectorate of Social Affairs, its National Agency for Medicines and Health Products, and the Rennes and Paris prosecutors’ offices have sparked investigations into the trial.
A statement by Biotrial read, “During a FIM study which was being conducted for a sponsor, serious adverse events related to the test drug have occurred in some volunteers at our CPU. The trial has been conducted in full compliance with the international regulations and Biotrial’s procedures were followed at every stage throughout the trial, in particular the emergency procedures for the transfer of volunteers to the hospital. We are in close and regular contact with the Health Authorities and Ministry in France. The priority at Biotrial remains the safety of our volunteers. We are very grateful for the support we have been receiving from our clients and partners today.”
Attorney Jean-Christophe Coubris told Vice News, “To my knowledge, this case is a first in France. Whatever contract these patients may have signed, they will be protected by French legislation in the case of proven misconduct.”
“There is a major problem — massive, unprecedented in France — and we must understand what happened, but there is nothing to justify stopping clinical trials,” said Marisol Touraine.
“Faced with such a serious situation, we would expect the laboratory to approach the health authorities more quickly,” she added. Agence France-Presse pointed out the fact that Biotrial waited 4 days after the first volunteer was admitted to the hospital to report the incident.
“On my behalf and the behalf of Bial, I would like to express my deepest apologies to the family of the volunteer who died after participating in the Phase I trial of our experimental molecule,” said Bial CEO Antonio Portela.