DEADLY PHARMA: One man dead and six injured in wake of botched French drug trial
Sunday, April 03, 2016
(NaturalNews) Officials are investigating a French Phase I drug trial that left one man dead and five people hospitalized in January, according to a recent government report.
The victims were participating in a trial for an experimental pain and mood disorder medication known as BIA 10-2474. The government committee released a report in March which confirmed that all six hospitalized participants suffered brain damage to the same part of the brain, after taking the new painkiller. The severity of brain damage varied among the patients.
'Unlike anything we've seen before'
A group of experts summoned by the National Agency for Drug Safety said that the incident was of an "astonishing and unprecedented nature," which triggered a brain reaction, "unlike anything seen before."
The trial consisted of 108 volunteers, and was intended to review the drug's safety and side effects. Only 90 of the participants were given the drug in different doses; the remainder received a placebo. The participants who were hospitalized had been given the highest dose.
The group deemed that neither drug manufacturing issues nor the participants' genetic makeup were to blame for the drug's side effects. However, the team did recognize that the participants were relatively old, aged up to 49, and some shared an increased risk for specific adverse drug reactions, according to Medical Xpress
The pharmaceutical company, Bial, told sources that, "the results obtained in these pre-clinical [trials] didn't raise any issue regarding the toxicity/dangerousness of the molecule."
BIA 10-2474 was created to inhibit an enzyme known as fatty acid amide hydrolase (FAAH), which breaks down a neurotransmitter known as anandamide, a messenger molecule that plays a role in pain, depression, appetite, memory and fertility.
"It is clearly the molecule that is the cause. The common element between the victims is indeed that molecule," said Dominique Martin, director general of the drug safety agency, after the report was published.
The experts noted that, "BIA 10-2474 was administered to the volunteers at a dose 10 times greater than that needed to completely inhibit the FAAH enzyme," but that, "the stimulation, even massive, of the endocannabinoid system... is not known to cause very serious toxic effects in itself."
Irresponsible drug doses
One of the questions the team of experts wants answered, is why the drug had been tested on so many animals prior to the human trial. Animal testing had suggested that FAAH could be completely inhibited at a dosage nearly 40 times lower than doses used in the trial. The number of animal tests conducted implied that the lab may have been suspicious of the drug's toxicity. Furthermore, the team said that the alleviating effects of the drug seen in the animals were "much too superficial" to merit human testing.
The experts are requesting that the company responsible for the trial provide additional information about why these doses were administered in the study. The lowest doses were administered at 2.5 and 5 milligrams respectively, while the highest doses were administered at 20 and 50 milligrams. The gap between these doses is too large to bridge.
It's not yet known why three of the six participants had more severe adverse reactions. One of the participants died, two had less serious reactions and one experienced none at all. No evidence of additional drug or alcohol use was found among the participants.
In the wake of the study, the report has called for new procedures to be implemented that establish appropriate dosage increases for future clinical trials. The committee behind the report were scheduled to present their conclusions on March 24.