A volunteer left brain dead by a failed France drug trial has died, according to the hospital where he was being treated. Five other participants in the study who fell ill are currently in stable condition since being admitted last week.
The French Health Ministry is calling the drug trial incident a “serious accident” and is currently investigating.
Bial, a Portuguese pharmaceutical company, was testing an experimental oral painkiller intended to treat mood and anxiety issues, as well as movement coordination disorders linked to neurological problems. The Biotrial clinic, which specializes in performing clinical trials, was conducting the test.
The drug was in a phase one trial, with the intention to test “the safety of its use, tolerance and pharmacological profile of the molecule.” Typically, a phase one trial involves very few volunteers.
A total of 128 healthy people, ages 18 to 55, signed up for the drug trial. For the test, 90 participants were given different level dosages of the medication, while the rest got a placebo.
As previously reported by the Inquisitr, six male patients between the ages of 28 and 49 were in good health prior to taking the drug on January 7. Three days into the trial, one person began feeling ill and quickly sent to the hospital, followed shortly by five others.
During phase one testing, the dose of an experimental drug is slowly increased over time, which might explain why the participants did not get sick immediately.
Hospitalier Universitaire de Rennes, where the drug trial patients are being treated, said four of the patients may be permanently disabled with neurological impairment. One person isn’t displaying symptoms similar to the others, but remains under medical observation, nonetheless. Gilles Edan, the chief neuroscientist at the hospital, does not know of any antidote to the drug.
French health minister, Marisol Touraine, said the drug was an FAAH inhibitor that acts on the body’s endocannabinoid system. A few early reports indicated the drug contained cannabinoids, the active ingredient in cannabis. However, the minister has since clarified that this is not the case.
Founded in 1924, Bial currently has several drugs in various stages of trial. In a recent statement, the company said the drug used in the disastrous trial had already been given to 108 people without any significant adverse reaction.
Since Biotrial was created in 1989, thousands of trials have been conducted without incident. According to the French health ministry, the clinic was inspected two years ago and received satisfactory reviews.
Francois Peaucelle, the head of Biotrial, says the company is doing everything it can to help those hurt by the drug, as well as find out how the tragedy occurred. As the drug was approved by French regulators, both companies are working closely with health authorities to determine the cause of the injuries.
Christophe Henin, an attorney and pharmaceutical law expert with Intuity, says authorities will most likely examine if any mistakes arose during the drug’s development as well as how the France drug trial was planned. Specifically, they will look for any missteps taken by the doctors who administered the trial.
Although previous testing was done on chimpanzees in July, there is always an inherent risk when introducing a new substance into the human body. Testing any new drugs is never completely without risk.
Every year, thousands of volunteers take part in clinical trials and botches like the one in France very rarely happen. However, things can go wrong. CenterWatch, a clinical research information firm, estimates roughly 1 in 30 participants will suffer a serious injury during a trial, while 1 out of 10,000 die.
“Study volunteers go through a rigorous informed consent process that explains at length the risks of participation. Study volunteers understand and generally accept the risks,” CenterWatch founder Kenneth Getz said.
In 2006, six men in London were sent to the hospital with organ failure after participating in a clinical trial for a drug that was supposed to fight auto-immune disease and leukemia. The men did survive, but with some permanent injuries.
The France drug trial was suspended last week, along with all testing at Biotrial, pending the investigation.
[Photo by AP Photo/David Vincent]