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Healthy Skepticism Library item: 19995

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.


Publication type: news

Cardenal Taján J
GSK fined after over vaccine trials; 14 babies reported dead
Buenos Aires Herald 2012 Jan 3

Full text:

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 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.”
Colombian and Panama were also chosen by GSK as staging grounds for trials of the vaccine against the pneumococcal bacteria.
Likewise, Marchese, explained the modus operandi: “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.”
Meanwhile, a press communiqué was released by the ANMAT indicating that the irregularities detected during the COMPASS vaccine trial programme were related to “failures in the process of obtaining informed consent for participation, hence violating patients’ rights, and the inclusion of patients that did not fully meet the required clinical conditions to be submitted to the programme.”
Furthermore, the release states that “We [ANMAT] expressly remark that none of the deaths mentioned in the news stories were related to the vaccines given as part of the COMPASS programme, since all the involved patients had received blind placebo, which is a simile of the vaccine but without any active substance. The vaccine is safe.”
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 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’s massive 28,333 square-metre manufacturing plant is located in Northern Greater Buenos Aires town of San Fernando.


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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909