GSK fined after over vaccine trials; 14 babies reported dead

Buenos Aires Herald

February 3, 2012

By Javier Cardenal Taján
BuenosAiresHerald.com staff

GlaxoSmithKline Argentina Laboratories Company was fined 400,000 pesos by Judge Marcelo Aguinsky following a report issued by the National Administration of Medicine, Food and Technology (ANMAT in Spanish) for irregularities during lab vaccine trials conducted between 2007 and 2008 that allegedly killed 14 babies.

Likewise, two doctors -Héctor Abate, and Miguel Tregnaghi- were fined with 300,000 pesos each for irregularities during the studies.

The charges included experimenting with human beings as well falsifying parental authorizations so babies could participate in vaccine-trials conducted by the laboratory from 2007 to 2008.

Since 2007, 15,000 children under the age of one from Mendoza, San Juan and Santiago del Estero have been included in the research protocol, a statement of what the study is trying to achieve. Babies were recruited from poor families that attended to public hospitals.

A total of seven babies died in Santiago del Estero; five in Mendoza; and twoo in San Juan.

Pediatrician Ana Marchese, who reported the case through the Argentine Federation of Health Professionals (FESPROSA in Spanish), and was working at the Eva Perón children’s public hospital in Santiago del Estero when the studies were being conducted, said this morning in conversations with Continental AM radio that “GSK Argentina set an protocol at the hospital, and recruited several doctors working there.”

“These doctors took advantage of many illiterate parents whom take their children for treatment by pressuring and forcing them into signing these 28-page consent forms and getting them involved in the trials.”

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.