From the Seattle Times. Drug companies continue to do what ever they please to get their vaccinations to market even if it means testing them unethically in other countries.
Argentina investigates deaths of vaccinated kids
Argentine
authorities are exploring a possible link between the deaths of 14
children and an experimental vaccine they were taking in a clinical
trial run by GlaxoSmithKline.
By DEBORA REY
Associated Press Writer
BUENOS AIRES, Argentina —
Argentine
authorities are exploring a possible link between the deaths of 14
children and an experimental vaccine they were taking in a clinical
trial run by GlaxoSmithKline.
Argentina's food and drug administration is investigating whether
the deaths are tied to the Synflorix vaccine, said an agency official
who spoke on condition of anonymity because he was not authorized to
discuss the case.
The drug, designed to fight pneumonia, ear infections and several
other pneumococcal diseases, was manufactured by the London-based
GlaxoSmithKline PLC, the world's second-largest drug maker.
A U.S. spokeswoman for Glaxo, Sarah Alspach, said the company is not
attributing the deaths to the experimental vaccine, which is being
tested in three Latin American countries and in other countries around
the world.
An independent board monitoring participants' safety recommended
that the Latin American trials be temporarily suspended - which they
were in late June - but then gave its OK for tests to resume, she added.
"We rely on their safety review," Alspach said. "Safety is our
primary concern, always, with the development of any new treatment."
More than 19,000 babies have received at least one dose of
Synflorix, which Glaxo plans to test on a total of 24,000 infants, she
said. The company is still enrolling participants.
But according to the Argentine official, who works at the country's
National Medicine, Food and Medical Technology Administration, the
agency "received complaints about irregularities in the recruitment of
patients" for the drug trial and on July 31 asked that recruitment be
suspended.
Glaxo stopped recruiting the following day, saying it had already
gathered the necessary number of participants, the official said.
Ana Maria Marchesse, who heads one of two groups that notified the
national food and drug administration, told The Associated Press that
she'd witnessed "poor ethical management" of patient recruitment.
"They didn't explain to the parents that this was an experimental
vaccine, and a lot of the parents who signed consent forms were
illiterate," said Marchesse, a pediatrician who heads the Health
Professionals' Labor Association in the northern Argentine province of
Santiago del Estero, where she said seven of the 14 children died.
Read the entire article at the Seattle Times
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