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Details of French trial must be released urgently, say UK experts

BMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i319 (Published 18 January 2016) Cite this as: BMJ 2016;352:i319
  1. Nigel Hawkes
  1. 1London

British specialists have called for further information to be made available urgently about a drug trial in France that has claimed one life and left another five volunteers in hospital, three with serious brain damage.

Three separate inquiries have been launched into the disaster, by the French social affairs inspectorate, the national medical safety agency, and the gendarmerie, but details about the product under test and the trial’s protocol and dosing regimen have not been disclosed. Given that 90 people are reported to have been given the experimental treatment in various doses and that drugs with a similar mode of action have been tested by other manufacturers, Carl Heneghan of Oxford University said that an urgent need for transparency transcended any prosecution.

Munir Pirmohamed of the University of Liverpool said that it was possible that the adverse reactions were an off-target effect, in which the drug was interacting with a receptor other than that intended, but that without further information it was impossible to be sure. “It is therefore vitally important that as much information as possible is …

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