GlaxoSmithKline Argentina Laboratories Company was fined 400,000 pesos for irregularities during lab vaccine trials 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.
The charges in the cases included experimenting with human beings and falsifying parental authorizations in the vaccine-trials conducted by the doctors’ laboratory from 2007 to 2008 for GSK. 15,000 children, under the age of one, from Mendoza, San Juan and Santiago del Estero provinces were included in the research reports Buenos Aires Herald GSK fined over vaccine trials; 14 babies reported dead Tuesday, January 3, 2012 By Javier Cardenal Taján.
Pediatrician Ana Marchese, who reported the case to the Argentine Federation of Health Professionals (FESPROSA), and was working at the Eva Perón children’s public hospital in Santiago del Estero by the time the studies were being conducted, said :
GSK Argentina set a protocol at the hospital, and recruited several doctors working there.”
“These doctors took advantage of the 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.”
“Laboratories can’t experiment in Europe or the United States, so they come to do it in third-world countries.”
“Once a picked patient arrives, it would automatically disappear to be taken somewhere else in order to be treated by those doctors specially recruited by GSK. These sorts of practices are not legal and occurred without any type of state control, plus they don’t comply with the minimum ethical requirements.”
Colombia and Panama were also chosen by GSK as staging grounds for trials of the vaccine against the pneumococcal bacteria.
An ANMAT press statement indicated the irregularities detected during the COMPASS vaccine trial program were related to “failures in the process of obtaining the necessary consent letters from participants, hence violating the patients’ rights; as well the inclusion of patients that did not fully meet the required clinical conditions to be submitted into the program.” but that “none of the deaths mentioned in the media were related to the vaccines given, since all the involved patients received what is called a blind placebo, which is a simile of the vaccine but without any active substance.”
According to Pharmaceutical Technology:
GlaxoSmithKline was also criticised by Judge Marcelo Aguinsky for keeping inadequate records of the children’s ages and medical histories. It is unknown how many babies suffered serious side effects and adverse reactions from the injections, or if 14 is the true number of babies who died during the trials.
Read here for full Buenos Aires Herald story:
Buenos Aires Herald GSK fined over vaccine trials; 14 babies reported dead Tuesday, January 3, 2012 By Javier Cardenal Taján.
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