GSK Fined Over Vaccine Trial In Argentina

(c) Sky News 2012

Pharmaceutical giant GlaxoSmithKline (Other OTC: GLAXF.PK - news) has appealed against a fine issued by an Argentine court relating to clinical drug trials involving babies.

The world's second-largest drug manufacturer was fined 400,000 pesos (£60,000), after a report by the National Administration of Medicine, Food and Technology (ANMAT).

The allegations revolved around irregularities in administration.

Since 2007, a total of 15,000 babies - primarily recruited from poorer families around the country - have taken part in clinical trials.

Judge Marcelo Aguinsky found the company responsible for "irregularities" in the recruitment of young children, and also fined two doctors nearly £45,000 each.

A source in Judge Marcelo Aguinsky's office said consent forms were signed by illiterate parents or people who did not have custody of the children.

London-based GlaxoSmithKline PLC said it "respectfully disagrees" with the court's ruling and is appealing to the Supreme Court of Argentina.

The Buenos Aires Herald reported that 14 children died during the study, but GSK said the babies were given placebos and that no links were found between the vaccine and the deaths - a position supported by Argentine health officials.

"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," a GSK said in a statement.

"ANMAT has also concluded that there was no causality between the administration of the vaccine and the deaths that have occurred in the study. We offer our full sympathy to their families."