GSK at centre of Russian vaccine scandal

http://news.independent.co.uk/busine...cle2418483.ece

GSK at centre of Russian vaccine scandal

By Andrew Osborn in Moscow
Published: 04 April 2007

The pharmaceutical giant GlaxoSmithKline has become embroiled in a
vaccine-testing scandal in southern Russia after prosecutors set out
criminal charges against three doctors involved in a trial of the company's
drugs.

Prosecutors claimed that the doctors broke Russian law and ethics, but have
so far stopped short of criticising GSK. The pharma titan has denied any
wrongdoing, calling the allegations "unsubstantiated and untrue".

The dispute centres on a series of trials conducted at Volgograd's
Independent Clinical Hospital on GSK's behalf on 100 babies between the ages
of one and two, starting in 2005. The trials involved GSK-branded vaccines
for chickenpox (Varilrix), measles (Priorix), mumps and rubella (a combined
MMR Priorix Tetra vaccine) and were part of a larger series of trials
involving almost 6,000 adults and children in ten European countries
including Russia. Problems arose after some parents of the babies involved
claimed that they did not give their consent and were not even aware that
their children were taking part in the trials.

Prosecutors said they have found evidence to back up parents' concerns.
"Preliminary investigations showed that the doctors, seeking material
benefits, conducted clinical tests of the vaccines with no regard for the
children's lives and health," they said. "The parents believed these were
routine vaccinations, they were not told that new vaccines were being tested
on their children." The paediatricians received 1.5 million rubles ($57,670)
and 700,000 rubles from GSK, prosecutors added, something they said parents
were also unaware of.

The claims are however robustly rejected by the hospital, which insists it
has the paperwork to prove that the parents knew what was happening and gave
their written consent. Perhaps more seriously, the parents of one baby -
Vika Gerasinka - also alleged that GSK's drugs had caused serious damage to
their child's health, retarding her development. They claimed that Vika was
developing normally before she was given her shots in November of 2005 and
could say 10 words, but that she became disturbed and ill after being
inoculated. Vika, now two and a half, has developed serious speech and
psychological problems.

Prosecutors appeared to back up her parents' allegations. "Medical
examination revealed the girl's health problems occurred as a result of the
vaccination," they said in a statement to which GSK has so far declined to
respond. The scandal has triggered a bout of hand-wringing in local and
national media about how Russia is allegedly being used as a laboratory for
questionable experiments by unscrupulous foreign firms.

This is not the first time GSK's Priorix has been called into question. Last
year a child in Vietnam died from toxic shock syndrome after being
administered a shot and five other infants fell ill.

However, an investigation suggested the side effects were unrelated to the
vaccine which has been tested extensively.

Just to make this clear: This is a problem with the oversight of a vaccine
trial, not a problem with the vaccines, themselves.

nonetheless, if the accusations are true, this is unacceptable.

Jeff

"JOHN" wrote in message
...
http://news.independent.co.uk/busine...cle2418483.ece

GSK at centre of Russian vaccine scandal

By Andrew Osborn in Moscow
Published: 04 April 2007

The pharmaceutical giant GlaxoSmithKline has become embroiled in a
vaccine-testing scandal in southern Russia after prosecutors set out
criminal charges against three doctors involved in a trial of the
company's drugs.

Prosecutors claimed that the doctors broke Russian law and ethics, but
have so far stopped short of criticising GSK. The pharma titan has denied
any wrongdoing, calling the allegations "unsubstantiated and untrue".

The dispute centres on a series of trials conducted at Volgograd's
Independent Clinical Hospital on GSK's behalf on 100 babies between the
ages of one and two, starting in 2005. The trials involved GSK-branded
vaccines for chickenpox (Varilrix), measles (Priorix), mumps and rubella
(a combined MMR Priorix Tetra vaccine) and were part of a larger series of
trials involving almost 6,000 adults and children in ten European
countries including Russia. Problems arose after some parents of the
babies involved claimed that they did not give their consent and were not
even aware that their children were taking part in the trials.

Prosecutors said they have found evidence to back up parents' concerns.
"Preliminary investigations showed that the doctors, seeking material
benefits, conducted clinical tests of the vaccines with no regard for the
children's lives and health," they said. "The parents believed these were
routine vaccinations, they were not told that new vaccines were being
tested on their children." The paediatricians received 1.5 million rubles
($57,670) and 700,000 rubles from GSK, prosecutors added, something they
said parents were also unaware of.

The claims are however robustly rejected by the hospital, which insists it
has the paperwork to prove that the parents knew what was happening and
gave their written consent. Perhaps more seriously, the parents of one
baby - Vika Gerasinka - also alleged that GSK's drugs had caused serious
damage to their child's health, retarding her development. They claimed
that Vika was developing normally before she was given her shots in
November of 2005 and could say 10 words, but that she became disturbed and
ill after being inoculated. Vika, now two and a half, has developed
serious speech and psychological problems.

Prosecutors appeared to back up her parents' allegations. "Medical
examination revealed the girl's health problems occurred as a result of
the vaccination," they said in a statement to which GSK has so far
declined to respond. The scandal has triggered a bout of hand-wringing in
local and national media about how Russia is allegedly being used as a
laboratory for questionable experiments by unscrupulous foreign firms.

This is not the first time GSK's Priorix has been called into question.
Last year a child in Vietnam died from toxic shock syndrome after being
administered a shot and five other infants fell ill.

However, an investigation suggested the side effects were unrelated to the
vaccine which has been tested extensively.