ARGENTINA: Glaxo reacciona..."stridently"

GlaxoSmithKline has responded stridently to claims it behaved unethically by failing to get proper consent from the parents of children recruited for a clinical trial in Argentina of its pneumococcal vaccine Synflorix.

The drugs major has been fined 400,000 pesos (about $92,800) by Judge Marcelo Aguinsky following a report issued by the Argentinean National Administration of Medicine, Food and Technology (ANMAT). The judge found GSK responsible for “irregularities” in the recruitment of young children in 2007-8 and also fined two investigators about $70,000 each because consent forms were signed by illiterate parents or people who did not have custody of the children.

GSK says it "respectfully disagrees" with the ruling regarding the administrative conduct of the COMPAS study in Mendoza and will appeal. The firm says it conducts clinical trials "to the same high standards, irrespective of where in the world they are run" and "this includes the requirement to obtain informed consent from participants. That is a fundamental principle of our behaviour and any deviation from this is unacceptable".

With regards to COMPAS, GSK says it identified "some administrative irregularities in the process of obtaining informed consent from a small proportion of patients" and reported these findings to ANMAT. The company "immediately put in place a corrective action plan which involved reconfirming informed consent of patients in the study and retraining doctors conducting the study where necessary".

The safety of patients was not put at risk "and ANMAT agreed that the study could continue as planned", GSK says. COMPAS, which involved close to 24,000 children, was completed in Argentina in June 2011 and is now undergoing its closing phase. (Más)

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GLAXO/ Andrew Witty: "Nobleza" (?) reconocida. (cont.)

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