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Meanwhile, the Portuguese pharmaceutical company that sponsored the trial, Bial, confirmed in a statement issued last night that the drug tested in the study was an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme that breaks down so-called endocannabinoids in the brain. FAAH inhibitors have been proposed as a possible treatment against chronic pain.
According to the document, the trial enrolled nonsmoking men and women aged between 18 and 55 who had a body mass index between 19 and 30. The plan was to give patients BIA 10-2474 every day between the third and thirteenth day of their stay at the clinic, while they underwent an extensive battery of tests and sampling—including as many as nine blood collections on some days. On the first and last day of drug administration, patients' heart rates were to be monitored around the clock while all of their urine was collected for analysis. (Between day 3 and 9, however, all they apparently had to do was take BIA 10-2474 and provide a single blood sample.) They were due to be released on 18 January but had to come back for a final check-up and more sampling on 1 February.
The study was halted on Monday, and all six patients who had taken the drug were hospitalized; one is brain dead, four others have neurological symptoms of varying severity, while one is under observation but without symptoms, neurologist Gilles Edan of the University of Rennes Hospital Center said yesterday. MRI imaging has shown "deep, necrotic and hemorrhagic lesions in the brain" of the patients, Edan said.
Touraine said that prosecutors in Rennes have opened an investigation and that ANSM will conduct an investigation as well. Meeting the victims and their families today was "a moment of intense emotion," Touraine said. "The shock is even greater because people who participate [in phase I trials] are healthy, not sick, and obviously they don't expect to be confronted with such accidents."
Phase I studies are designed to test safety and tolerability of a drug, as well as how, and how fast, the chemical is processed by the human body. Most of these studies are carried out by specialized research contract companies; the subjects are usually healthy volunteers who receive modest financial compensation.
originally posted by: LightSpeedDriver
a reply to: charolais
I think that playing with the endocannabinoid system using synthetic drugs instead of what nature provided and making various extracts from that, if necessary is doomed to stupid failure.
I found it interesting they were studying the endocannabinoid system. Goes to show the medical industry might know more than they want to admit about cannabinoids (although most on ATS probably already assume that...)
originally posted by: sycomix
a reply to: FamCore
Any type of "hydro" IS a GMO, cross pollinated strains ARE a GMO, cheap mexican ditch weed is the natural variety. Ya know the seedy stuff??? Those pretty nugs with the hairs, those are man made strains.