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French drug agency was not wrong to allow deadly trial, review says

BMJ 2016; 353 doi: https://doi.org/10.1136/bmj.i2774 (Published 23 May 2016) Cite this as: BMJ 2016;353:i2774
  1. Paul Benkimoun
  1. Paris

The French national drug agency was not wrong to authorise a drug trial that left one volunteer dead and four with severe neurological side effects, concludes the final report of an official review published on 23 May.1 However, the Agence Nationale de Sécurité du Médicament (ANSM) should have asked for more details about the escalation of doses described in the protocol, the report said, and it criticised errors made by the company that conducted the trial.

Media commentators and the barrister representing the family of the volunteer, Guillaume Molinet, who died on 17 January after participating in the first in humans phase I clinical trial of the experimental compound BIA-10-2474, had argued that the agency should not have given the go-ahead to test the drug in humans, because neurological adverse …

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