Many worrisome questions remain about the French drug trial that left one person dead and six hospitalized in January, according to a recent government report.
The government committee report released this week found that all six hospitalized participants suffered brain damage in the hippocampus, which plays a role in memory, and the pons, which is part of the brain stem, after taking the experimental pain medication BIA 10-2474. The report says that “the entire picture … [is] completely unusual, with no relatedness to a known disease or toxicity.” The damage in each participant differed in severity.
The panel called the incident caused by the Portuguese drug “astonishing” and “unprecedented.” But obvious answers are so far lacking — there were no manufacturing issues or genetic issues among participants that may have caused the adverse reactions, The Guardian reports.
The drug in question was supposed to relieve pain and treat mood disorders. This trial, which included 90 participants of varying ages, was looking at safety and side effects.
Scientists present some hypotheses in the report — maybe the drug interacted with other substances in the body, produced toxic chemicals, or acted in an unintended manner — which will be reviewed later in March, NPR reports.
But procedural issues are also still being probed, according to the report. For instance, why was the trial not suspended days earlier, when the first patient was hospitalized? And why was the drug first tested in four different species, as opposed to the expected two?
The Food and Drug Administration is also looking into the matter. As of January, they were “collecting and reviewing safety information” relating to this class of drugs.