COMPASS vaccine trial program (Argentina. 2007 and 2008) Glaxo
GlaxoSmithKline fined less than $100,000 for killing 14 babies during vaccine trials
Wednesday, March 02, 2016 by: David Gutierrez, staff writer
Tags: GlaxoSmithKline, vaccine
trials, infant
deaths
(NaturalNews) In reacting to recent news that
pharmaceutical giant GlaxoSmithKline accidentally dumped 12 gallons of live,
concentrated polio virus into a Belgian river, it is important to remember that
the company has a long history of safety violations in its vaccine business. In
2012, for example, an Argentinean judge found the company guilty of conducting
illegal vaccine trials that led to the deaths of 14 babies.
Yet the company was fined only 400,000 pesos, at the time the equivalent of
about $93,000. Two doctors involved in the trial were fined another 300,000
pesos each.
The company was found guilty of conducting trials on human beings (which is
prohibited in Argentina) and of falsifying parental authorizations allowing the
company to experiment on babies.
Illegal human experimentation
The judge handed down the ruling following a report by the
National Administration of Medicine, Food and Technology (ANMAT) which concluded
that the COMPASS trial conducted between 2007 and 2008 demonstrated "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."
A total of 15,000 children under the age of one were recruited into the study
from poor families attending public hospitals in three separate Argentinean
provinces.
The scandal was broken by pediatrician Ana Marchese, who learned of the COMPASS
study while working at one of the public hospitals involved. She reported the
violations to the Argentine Federation of Health Professionals (FESPROSA), which
later took the complaints to the government.
"GSK Argentina set a protocol at the hospital, and recruited several doctors
working there," Marchese said. "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."
"[Drug companies] can't experiment in Europe or the United States, so they come
to do it in third-world countries," she said.
The COMPASS trial was conducted to test a new pneumococcal vaccine.
Similar trials were conducted in Colombia and Panama.
Marchese noted that the new vaccine is not significantly different from existing
pneumococcal vaccines.
"There already exist very good vaccines for the same diseases, but we all know
how laboratories work, they only care for their own business," she said.
Corruption and intimidation
Many of the complaints against GSK centered around its
treatment of the children involved in the study.
"Once a picked patient [arrived], [he or she] would automatically disappear to
be taken somewhere else in order to be treated by those doctors specially
recruited by GSK," Marchese said. "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."
"In various particular cases, the doctors who had conducted the trials avoided
to answer the many phone calls made by worried parents after witnessing their
babies' first reactions to the vaccines," she added.
"A lot of people wanted to leave the protocol but they were not allowed," said
Julieta Ovejero, the great aunt of one of the babies who
died. "They forced them to continue under the threat that if they leave they
wouldn't get any other vaccines for their children."
In 2008, when FESPROSA first broke the story that 12 children had died, local
GSK researcher Enrique Smith dismissed the deaths, calling it "a very low figure
if we compare it with the deaths produced by the respiratory illnesses that the
pneumococcal bacteria causes."
In the Santiago del Estero province, the COMPASS trial was approved by the
provincial health minister -- who also happened to be Enrique Smith's brother.
Sources for this article include:
http://www.buenosairesherald.com
http://www.digitaljournal.com
http://science.naturalnews.com
Learn more: http://www.naturalnews.com/053160_GlaxoSmithKline_vaccine_trials_infant_deaths.html#ixzz45geyyF3C