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 the killing of 14 babies during illegal lab vaccine trials conducted between 2007 and 2008.
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, 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 7 babies died in Santiago del Estero; 5 in Mendoza; and 2 in San JuanPediatrician 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 wee 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.”
“Laboratories can't experiment in Europe or the United States, so they come to do it in third-world countries."
Once a picked patient arrived, it would automatically disappear to be taken somewhere else in order to be treated by those doctors specially recruited by GSK. These kind of practices are not legal and occurred without any type of state control, plus they don’t comply with minimum ethical requirements.”
Marchese also remembered that “laboratory trials on human beings are not legalized in Argentina.”
Furthermore, the pediatrician explained that “it is also known that in various particular cases, the doctors who had conducted the trials did not answer the calls made by the worried parents after witnessing their babies’ reactions to the vaccines.”
According to Marchese, “there already exist very good vaccines for the same diseases, but we all know how laboratories work, they only care for their own business.”
To end, Doctor Marchese aimed to Santiago del Estero Governor, Gerardo Zamora, who “never ever came out to stage to comment on the case, and same happened with national deputies and senators that didn’t even bother into discussing a hot topic that was echoed worldwide. I’m also ashamed of the scientific community that also kept its mouth shut.”
Julieta Ovejero, great aunt of one of the six babies who died in Santiago del Estero, said that “A lot of people wanted to leave the protocol but they weren’t allowed; they forced them to continue under the threat that if they leave they won't receive any other vaccine.”
During 2008, the vaccine trial was still ongoing despite the reports issued by FESPROSA, and those in charge of the study told reporters that the procedures were being carried out in a lawful manner.
On the contrary, the ruling states that the laboratory as well the involved doctors broke all legal requirements for conducting clinical tests on babies.
Surprisingly, during same year pediatrician Enrique Smith, one of the lead investigators told reporters: “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.”
In Santiago del Estero, one of the country's poorest provinces, the trials were authorized when Enrique's brother, Juan Carlos Smith, was provincial health minister.
According to Fesprosa, “the laboratory paid $8,000 pesos for each child included in the study, but none (of that money) remained in the province that lends the public facilities and the health personnel for the private research.”
GlaxoSmithKline is a global pharmaceutical, biologics, vaccines and consumer healthcare company headquartered in London, United Kingdom. It is the world's third-largest pharmaceutical company measured by revenues after Johnson & Johnson and Pfizer.
Ironically, if one visits GlaxoSmithKline Argentina web site it welcomes the reader with a company disclosure that says: “We have a challenging and inspiring mission to improve the quality of human life by enabling people to do more, feel better and live longer."
According to www.GSK.com site, Glaxo was originally a baby food manufacturer processing local milk into a baby food by the same name, and founded in Bunnythorpe, New Zealand in 1904. The product was sold in the 1930s under the slogan "Glaxo builds bonny babies".
GlaxoSmithKline Argentina manufacturing 28,333 m2 centre is located in Northern Greater Buenos Aires town of San Fernando.
Both Argentine health officials and London-based GlaxoSmithKline PLC said there are no links between the drug and the deaths of 14 babies who participated in the trials. Argentina’s drug regulator, ANMAT, said in a statement Tuesday that “all of these patients had been given a placebo
Glaxo and two researchers working on the trial were fined 1 million pesos ($232,200) by the Argentinean National Administration of Medicine, Food and Technology, the newspaper La Nacion reported today. The agency cited the drugmaker for a lack of documentation of patient records and administration of medicines, breaches of security controls and irregularities in authorization for the children to participate, La Nacion said.
The agency cited the drugmaker for a lack of documentation of patient records and administration of medicines, breaches of security controls and irregularities in authorization for the children to participate
Argentina’s drug regulator, ANMAT, said in a statement Tuesday that “all of these patients had been given a placebo
"ANMAT has also concluded that there was no causality between the administration of the vaccine and the deaths that have occurred in the study. We offer our full sympathy to their families."
You're going to have to research a bit more.
Dear Mr xxxxxxx
Thank you for your enquiry. GSK sponsored clinical studies are conducted to the same ethical standards irrespective of where they take place in the world. The studies meet international and national regulatory and legislative requirements and follow the research methodologies outlined in the International Conference on Harmonisation (ICH) Good Clinical Practice guidelines. Moreover, GSK-sponsored clinical studies are conducted in compliance with the principles contained in the World Medical Association Declaration of Helsinki on the Ethical Principles for Medical Research Involving Human Subjects.
More information about how we conduct clinical studies is available in our Corporate Responsibility report. You can find the relevant pages here: www.gsk.com...
We respectfully disagree with the recent court ruling in favour of ANMAT (the Argentinean National Administration of Medicines, Food and Medical Technology) on the fine issued to GSK regarding the administrative conduct of the COMPAS (Clinical Otitis Media and PneumoniA Study) study in Mendoza, Argentina. The fine issued by ANMAT relates to procedures in place for the COMPAS study in 2007 and 2008. It does not in any way question the safety of the study vaccine, Synflorix™. GSK is initiating an appeal against this ruling to the Supreme Court of Argentina.
We are also very concerned by inaccuracies in the recent media reports stating that the fine relates to the deaths of children during the COMPAS study, which is not the case. We offer our full sympathy to their families. Each of these deaths have been thoroughly and independently investigated, and it has been determined that none of the deaths was related to the vaccine administered during the COMPAS study. ANMAT also has concluded that the deaths were not related to the vaccines administered during the study.
Once again thank you for your enquiry. For more information please visit www.gsk.com.
Kind regards xxxxxxx
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
y concluye que los resultados "serán publicados durante 2012".
A double blind trial is when the doctor nor the patient knows who is taking the drug. Only after all the data have been recorded (and in some cases, analysed) do the researchers learn which individuals are which. Performing an experiment in double-blind fashion is a way to lessen the influence of the prejudices and unintentional physical cues on the results (the placebo effect, observer bias, and experimenter's bias). Random assignment of the subject to the experimental or control group is a critical part of double-blind research design. The key that identifies the subjects and which group they belonged to is kept by a third party and not given to the researchers until the study is over.