Pharmaceutical giant fined for babies' deaths in clinical trials

Between 2007 and 2008, more than a dozen babies from poor families died in Argentina after they had participated in a clinical trial carried out by the British pharmaceutical company GlaxoSmithKline for a vaccine against bacterial pneumonia and meningitis.

There is no proof that the vaccines caused the deaths of the 14 babies, but investigators found a host of irregularities committed by pharmaceutical officials, including two doctors, in getting consent from the parents to administer the Synflorix vaccine to their children.

Late last month, a judge in the city of Mendoza upheld the 179,000 euros in fines imposed by the Argentinean Health Ministry last April against GlaxoSmithKline. The case has received a great deal of medical attention. The pharmaceutical firm said it will appeal the decision.

Judge Marcelo Aguinsky ruled that some of the consent forms were signed by the babies' fathers who were underage, grandparents who did not have the authority to sign, illiterate parents or, as in one case, a mother who was mentally ill. The judge also found that the directors of the clinical study did not check the past medical histories of the babies to determine whether it was safe to give them the vaccine.

The trials were also being carried out in Panama and Colombia when GlaxoSmithKline canceled them after the 14 deaths.