Disir
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- Sep 30, 2011
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A day after news broke about a clinical research tragedy in France, more details are beginning to emerge about what happened at Biotrial, the private research company in Rennes where the Phase I study took place. An information sheet for prospective trial participants, posted yesterday at the French regional news site Breizh-info.com, provides an overview of the study's goal and procedures, while also offering a glimpse of what it's like to partake in a lengthy drug safety study.
According to the document, which is in French, participants in this particular study group were to receive €1900, including travel expenses; in return, they agreed to stay at Biotrial's facility in Rennes for 2 weeks, swallow a drug on 10 consecutive days, undergo extensive medical tests, and provide at least 40 blood samples.
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.
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.
http://www.sciencemag.org/news/2016/01/more-details-emerge-fateful-french-drug-trial
That's a fiasco.
According to the document, which is in French, participants in this particular study group were to receive €1900, including travel expenses; in return, they agreed to stay at Biotrial's facility in Rennes for 2 weeks, swallow a drug on 10 consecutive days, undergo extensive medical tests, and provide at least 40 blood samples.
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.
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.
http://www.sciencemag.org/news/2016/01/more-details-emerge-fateful-french-drug-trial
That's a fiasco.
