Argentina's government has fined GlaxoSmithKline ($GSK) $93,000 for its management of trials of the vaccine Synflorix in which 14 babies died. This case brings to light questions as to how big drugmakers, looking for lower costs and readily available patients, conduct clinical trials in emerging markets.
Thirteen thousand Argentinian children participated in the Synflorix trial, dubbed Protocol Compas, in 2007 and 2008. GSK found itself mired in controversy when it was reported that 14 babies in the vaccine trial died. Moreover, critics claimed that GSK targeted poor patients at public hospitals, and that some parents were pressured to sign lengthy consent forms that they couldn't understand.
"GSK Argentina set a protocol at the hospital, and recruited several doctors working there. These doctors took advantage of many illiterate parents who take their children for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials," Ana Marchese, a pediatrician who reported one of the cases, told the Buenos Aires Herald.
GSK tells Pharmalot that it respects the ruling but plans to appeal the decision, and stressed that the decision relates to the clinical trial process and not the safety of Synflorix.
The shot has since been approved to protect kids from strains of streptococcus pneumoniae that can cause meningitis, pneumonia and ear infections.
- read the Pharmalot article