Argentina investigates deaths of vaccinated kids
JOHN
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
http://seattletimes.nwsource.com/html/health/2008115287_apargentinachildrensdeaths.html?syndication=rss
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.
"In some cases, they first gave them the vaccine and then gave them a
13-page consent form to sign that I had to read three times to understand,"
she added.
Marchesse said her group and a provincial doctors' association reported what
they saw to the food and drug administration.
Glaxo's trial includes thousands of babies in Argentina, where Alspach said
12 children died; in Panama, where another two died; and in Chile. The
natural infant death rate in those countries from pneumonia is 4 to 5 of
every 1,000 live births - more than four times the rate seen in the study,
Alspach said.
Pneumonia is the world's top killer among infectious diseases, causing more
than 2 million deaths a year in children under five, mostly in developing
countries, she said.
The company is testing the vaccine in more than 40 clinical studies around
the world, she added. Data from other studies show the vaccine is about as
safe and tolerable as competitor Wyeth's blockbuster Prevnar, a vaccine
widely used against pneumococcal disease, she said.
Still, the Argentine province of Santiago del Estero is conducting a
separate inquiry into the deaths of the seven children there, local Health
Minister Franklin Moyano told state news media.
"While legal authorities investigate, we're in an observation phase to see
if everything happened as expected, or if there were deviations that caused
damage, in this case the death of seven kids," he said.
----
D. C. Sessions
> Glaxo's trial includes thousands of babies in Argentina, where Alspach
> said 12 children died; in Panama, where another two died; and in Chile.
> The natural infant death rate in those countries from pneumonia is 4 to 5
> of every 1,000 live births - more than four times the rate seen in the
> study, Alspach said.
Thanks for pointing this out, John. I would, however, challenge
the term "natural infant death rate." It may be technically
appropriate, but the way so many people equate "natural" with
"good" it certainly makes it sound as though that's how many
babies *should* be dying.
--
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+- D. C. Sessions <d...@lumbercartel.com> -+