BUENOS AIRES, Argentina (AP) – GlaxoSmithKline said it will appeal a fine in Argentina involving its development of a vaccine against pneumonia and earaches in small children.
The world’s second-largest drugmaker was fined $93,000 for protocol problems involving the company’s recruitment of children under 5 for clinical trials in several Argentine provinces.
Judge Marcelo Aguinsky found the company responsible for “irregularities” in the recruitment of young children.
The investigative judge also fined two investigators nearly $70,000 each because consent forms were signed by illiterate parents or people who didn’t have custody, according to a source in Aguinsky’s office, who spoke on condition of anonymity because the ruling is being challenged.
“GlaxoSmithKline respects the justice system, but would like to express its disagreement with the fine against the laboratory and investigators who participated in the clinical studies,” the company said Tuesday.
Both Argentine health officials and London-based GlaxoSmithKline PLC said there are no links between the drug and the deaths of 14 babies who participated in the trials. Argentina’s drug regulator, ANMAT, said in a statement Tuesday that “all of these patients had been given a placebo – that’s to say, something that appeared to be the vaccine but that had no active ingredients. The vaccine is safe.”
“The doctors involved, investigators, health authorities and a committee of independent international experts have studied and analyzed each death and it was demonstrated that none of the deaths is related to the vaccine,” the company statement said.
The studies were successfully completed in 2011 and the vaccine is now preventing infections in 80 countries, the company said.
Date: January 3, 2012
Source: Associated Press