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News
17 Jan 2012

GSK Disagrees with Argentine Court Ruling over Vaccine Trials

GSK disagrees with the ruling and confirms the fine does not relate to the deaths of 14 children during the trial.

British pharmaceutical company GlaxoSmithKline will appeal to the Supreme Court of Argentina against a ruling 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."

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