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January 18, 2016.
News broke on Friday of a disastrous outcome to a Phase 1 clinical trial run in Rennes, France, by French CRO Biotrial on behalf of Portuguese pharma company Bial. One healthy male volunteer was pronounced brain-dead and it was reported that the five others had suffered serious neurological damage. The male volunteer has since died; the others are described as being in a stable condition, although for three of them the neurological damage "could be irreversible", according to Dr. Pierre-Gilles Edan, who is now treating the patients. In Saturday's Forbes, Dr. Judy Stone posed some of the questions that need to be answered. The volunteers received a novel compound to target pain relief by acting on cannabinoid receptors on January 7; three days later, five of the volunteers fell ill. But the trial has been ongoing since July 2015 "and at least 90 participants completed [it] uneventfully". As Dr. Stone points out, "We don’t know what doses this group of ... volunteers received, or how that was different from earlier groups... We don’t know if or how food affected the drug’s metabolism. Could there have been a contaminant causing disaster in one batch of drug? ...Did these patients all receive the drug at the same time (in parallel) or sequentially?" Bial commented on Friday that it had followed "international best practice" and that it would cooperate with the investigation underway to "determine in a rigorous and exhaustive manner" what happened. While we wait for a clearer picture to emerge, Forbes's Dr. Stone concluded: "What is imperative is that we conduct trials transparently and ethically, follow safety procedures rigorously, provide a clear and thorough consent process, and minimize the coercion of financial incentives. We still have a lot to learn."