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Malpractice News: Argentina Investigates Deaths of Children Receiving Experimental Vaccine
Malpractice News: In August 2008, authorities in Argentina’s Food and Drug Administration announced an investigation of the possible link between the deaths of 14 children and an experimental vaccine they received. The children who died included patients in Argentina, Panama and Chile.
The investigation involves Synflorix, a drug designed to fight pneumonia, ear infections and several other pneumococcal diseases. More than 19,000 babies in Argentina received at least one dose of the vaccine.
An official at the Argentine National Medicine, Food and Medical Technology Administration stated they received a number of complaints involving how patients were recruited for the study.
A pediatrician who heads one of the two groups that notified the Argentine FDA expressed concerns about the study. The doctor stated a number of parents were illiterate and not informed that the vaccine treatment was experimental, and that many patients were given the first dose of the vaccine before their parents signed the consent form. The doctor also criticized the 13-page consent form, as she claimed it included complicated information and that she read it several times before she understood the all the information included on the consent form.
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