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GSK rebuffs claims of unethical behaviour in Argentine vaccine trial

Takes issue court ruling on clinical study of Synflorix

GlaxoSmithKline has rebuffed claims that it acted unethically by failing to secure proper consent from the parents of children enrolled in a study of its pneumococcal vaccine Synflorix in Argentina.

A statement released by the pharma company yesterday indicated that it "respectfully disagrees" with the ruling of an Argentinian court, which concluded that the company was guilty of unethical conduct in the COMPAS study and fined it 400,000 pesos (around $90,000).

"GSK conducts clinical trials to the same high standards, irrespective of where in the world they are run," the firm said. "This includes the requirement to obtain informed consent from participants."

The court agreed with the contention of the Argentinean National Administration of Medicines, Food and Medical Technology (ANMAT) that consent for the participation of some of the children enrolled in the 24,000-patient study was given by illiterate parents or individuals without rightful guardianship of their welfare.

In its statement, GSK conceded that it had identified some "administrative irregularities" in the process of obtaining informed consent from a small proportion of patients in the study, but said it reported these findings promptly to ANMAT.

The company also said it immediately put in place a corrective plan to reconfirm informed consent for these patients, and also retrained doctors involved in the cases.

Synflorix was registered in Argentina in August 2009 - some five months after it was licensed in Europe. GSK stressed the ruling does not question the safety of the product and it remains on the market to protect children against pneumococcal diseases, which cause more than 800,000 childhood deaths each year.

Meanwhile, the company stressed that the fine is in no way related to the deaths of 14 children enrolled in the study - as has been widely reported in the media - noting that both the independent data monitoring committee for the study and ANMAT concluded that none of the deaths were related to the vaccine.

It also said it was shocked by allegations that a child in the trial had been denied treatment after falling unwell, while others had treatment delayed.

"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," said the company.

13th January 2012

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