GlaxoSmithKline respectfully disagrees with the recent court ruling in favour of ANMAT (the Argentinean National Administration of Medicines, Food and Medical Technology) on the fine issued to GSK regarding the administrative conduct of the COMPAS (Clinical Otitis Media and PneumoniA Study) study in Mendoza, Argentina. The fine issued by ANMAT relates to administrative procedures in place for the COMPAS study in 2007 and 2008. It does not question the safety of the study vaccine, Synflorix. GSK is initiating an appeal against this ruling to the Supreme Court of Argentina.
GSK conducts clinical trials to the same high standards, irrespective of where in the world they are run. 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.
We conduct regular monitoring of studies at 6-weekly intervals. During the regular monitoring of the COMPAS study in 2007 and 2008, GSK identified some administrative irregularities in the process of obtaining informed consent from a small proportion of patients in the study. The company proactively reported these findings to ANMAT and 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 participating in the study was not put at risk and ANMAT agreed that the study could continue as planned. ANMAT accepts that the study protocol was properly evaluated and authorised.
The COMPAS trial, which involved close to 24,000 children, was completed in Argentina in June 2011 in three provinces and the study is now undergoing its closing phase. Synflorix was licensed in Europe in March 2009 and in Argentina by ANMAT in August 2009 and remains available to help protect babies worldwide against pneumococcal diseases. The World Health Organization (WHO) has estimated that pneumococcal disease killed over 800,000 children under five worldwide in 2000 with 90 percent of these deaths occurring in developing countries. More than 50 million doses of Synflorix have been distributed for use in children in over 100 countries since 2009.
On the specific allegation on deaths in the study and that a child participating in the study was refused treatment:
We are concerned by inaccuracies in recent media reports stating that the fine relates to the deaths of children during the COMPAS trial. We offer our full sympathy to their families. Any deaths in the study have been thoroughly and independently investigated, and it has been concluded by both the independent data monitoring committee and ANMAT that none of the deaths were related to the vaccine they were given.
We are also concerned by allegations that treatment was delayed for some children in the trial if they were unwell and, if true, these events are shocking. Under the guidelines of the trial, and in an emergency case like this, the child should have been treated immediately by any emergency doctor available. GSK insists on the same standards of care for our trial participants irrespective of where they are in the world, and we will be looking into this further.
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