Biotrial, a medical research center in Rennes, France, has released a statement expressing shock over Health Minister Marisol Touraine’s statements regarding a recent trial that caused the death of a patient.
Biotrial received the General Inspectorate of Social Affairs’ (IGAS) final report at the same time the press conference—which Biotrial was not invited to attend—was ending. This report had, however, been previously provided to the media on Sunday evening.
Regarding the plan of action required by the Social Affairs and Health Minister, Biotrial had already begun to put one into place following exchanges with the French National Agency for the Safety of Medicines and Health Products (ANSM). In addition, the ANSM and the Regional Health Agency’s (ARS) recommendations were immediately put into place after the accident in January 2016.
According to Biotrial, the clinical research center did not wait for the IGAS report and the Health Minister recommendations to make volunteer care improvement its utmost priority.
Regarding the General Inspectorate of Social Affairs’ report, Biotrial contests the conclusions from the IGAS final report which, in order to stay consistent with the report that was hastily published in February, would not allow itself to include the input provided by Biotrial. The center deplores the methods, which it considers contrary to legal procedures that were used to put together the report. Biotech believes this has “remove[d] all of its credibility.”
Biotrial will submit to the Health and Social Affairs Minister its plan of action, which is already in place.
Biotrial stated the Portuguese Laboratory Bial’s compound, by it unexpected and unpredictable toxicity, was at fault for the accident.