12 Babies die during vaccine trials in Argentina

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Buenos Aires, Jul 10, 2008

At least 12 babies who were part of a clinical study to test the

effectiveness of a vaccine against pneumonia have died over the past

year in Argentina, the local press reported Thursday.

The study was sponsored by global drug giant GlaxoKline and uses

children from poor families, who are " pressured and forced into

signing consent forms, " the Argentine Federation of Health

Professionals, or Fesprosa, said.

" This occurs without any type of state control " and " does not comply

with minimum ethical requirements, " Fesprosa said.

The vaccine trial is still ongoing despite the denunciations, and

those in charge of the study were cited by the Critica newspaper as

saying that the procedures are being carried out in a lawful manner.

Colombian and Panama were also chosen by GSK as staging grounds for

trials of the vaccine against the pneumococcal bacteria.

Since 2007, 15,000 children under the age of one from the Argentine

provinces of Mendoza, San and Santiago del Estero have been

included in the research protocol, a statement of what the study is

trying to achieve.

" 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, " pediatrician Enrique , one

of the lead investigators, said.

In Santiago del Estero, one of the country's poorest provinces, the

trials were authorized when Enrique's brother, , was

provincial health minister.

According to pediatrician Ana Marchese, who works at the

children's hospital in the provincial capital where the studies are

being conducted, " because they can't experiment in Europe or the

United States, they come to do it in third-world countries. "

" A lot of people want to leave the protocol but aren't allowed; they

force them to continue under the threat that if they leave they won't

receive any other vaccine, " said ta Ovejero, great aunt of one

of the six babies who died in Santiago del Estero.

Fesprosa's Palomares said that " in most cases these are

underprivileged individuals, many of them unable to read or write,

who are pressured into including their children " in the trials.

According to Fesprosa, " the laboratory pays $8,000 for each child

included in the study, but none (of that money) remains in the

province that lends the public facilities and the health personnel

for the private research. " EFE