GlaxoSmithKline (GSK) will appeal to the Supreme Court of Argentina against a ruling issued by Judge Marcelo Aguinsky over the inadequate handling of administrative conduct during the firm’s Clinical Otitis Media and Pneumonia study in 2007-08.
The firm “respectfully disagrees” with the ruling and the $93,000 fine it received for failing to obtain parental consent to conduct the trial of its pneumonia vaccine Synflorix on 15,000 Argentine babies and 9,000 babies from Colombia and Panama.
In a statement GSK said, “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. “
GSK said that it identified some administrative irregularities in the process of obtaining informed consent from a small proportion of patients in the study, but it reported these findings to the Argentinian National Administration of Medicines, Food and Medical Technology and immediately put in place a corrective action plan.
The company also confirmed that the fine does not relate to the deaths of 14 children during the trial, as previously reported. “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,” the statement continued.