Buenos Aires, Jul 10, 2008 — At least 12 babies who were part of a clinical study to test the effectiveness of a vaccine against pneumonia have died over the past year in Argentina, the local press reported Thursday.
The study was sponsored by global drug giant GlaxoSmithKline and uses children from poor families, who are “pressured and forced into signing consent forms,” the Argentine Federation of Health Professionals, or Fesprosa, said.
“This occurs without any type of state control” and “does not comply with minimum ethical requirements,” Fesprosa said.
The vaccine trial is still ongoing despite the denunciations, and those in charge of the study were cited by the Critica newspaper as saying that the procedures are being carried out in a lawful manner.
Colombian and Panama were also chosen by GSK as staging grounds for trials of the vaccine against the pneumococcal bacteria.
Since 2007, 15,000 children under the age of one from the Argentine provinces of Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve.
“Only 12 have died throughout the country, which is a very low figure if we compare it with the deaths produced by respiratory illnesses caused by the pneumococcal bacteria,” pediatrician Enrique Smith, one of the lead investigators, said.