GSK faces fine over Argentina clinical trial
pharmafile | January 6, 2012 | News story | Research and Development, Sales and Marketing | Argentina, GSK, Vaccine, deaths, emerging markets
A court in Argentina says GSK should be fined for irregularities in recruitment during a trial in which children died.
GSK said it “respectfully disagrees” with the ruling in favour of ANMAT (National Administration of Medicines, Food and Medical Technology).
The firm says it will appeal against the ruling to the country’s Supreme Court after a judge upheld the £60,000 penalty against it.
The regulator slapped the fine on GSK after problems emerged in the way GSK carried out the COMPAS (Clinical Otitis Media and PneumoniA Study) trial of its pneumococcal vaccine Synflorix in the province of Mendoza during 2007 and 2008.
GSK has been at pains to point out that the fine was never about the safety of the vaccine, which was licensed in Argentina in 2009
Fourteen children are believed to have died during the study. But a GSK spokesperson said: “We are concerned by inaccuracies in the recent media reports stating that the fine relates to the deaths of children during the COMPAS trial.”
The pharma company said it offered its “full sympathy to their families” but added that “any deaths in the study have been thoroughly and independently investigated, and it has been concluded that none of the deaths were related to the vaccine they were given”.
ANMAT has accepted there was no link between the administration of Synflorix and the deaths – however, GSK admits that it was at fault over the way recruitment for the trial was carried out.
The spokesperson said it identified “some irregularities in the process of selecting, recruiting and obtaining informed consent for a small number of the patients into the study”.
The group says it reported these to ANMAT, along with a plan to correct them which the regulator accepted.
“Unfortunately, ANMAT has since issued a fine to GSK for these irregularities,” the GSK spokesperson added.
COMPAS was completed in Argentina in June last year in Santiago del Estero and San Juan as well as Mendoza.
Adam Hill
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