Prosecutors target Russian clinic testing British firm's MMR vaccine

http://www.guardian.co.uk/internatio...025519,00.html


Prosecutors target Russian clinic testing British firm's MMR vaccine



Luke Harding in Moscow
Saturday March 3, 2007
The Guardian

Russian prosecutors have opened a criminal investigation into a clinic
after unsubstantiated allegations that a vaccine made by the British drugs
company GlaxoSmithKline has had disturbing side effects in a clinical
trial. Prosecutors in Volgograd are investigating a clinic that tested the
chickenpox, measles, mumps and rubella vaccine on 100 babies between the
ages of one and two.

Prosecutors say at least one of the children developed alarming symptoms
after receiving the vaccine. A regional court last week halted the trial,
by the city's Independent clinical hospital, amid complaints from parents
that they had not been fully informed they were taking part in an
experiment.


It follows complaints by the family of Vika Gerasinka, who was given the
GlaxoSmithKline vaccine in November 2005. Her family claim that before
receiving the shots she was developing normally, and was able to say 10
words. Afterwards, however, they allege that she became fretful and
developed problems.

"Since getting her shots, Vika and I have been to the hospital on several
occasions. She has frequently been sick," her grandmother, Lyubov
Gerasinka, said. Vika, now two and a half, had serious speech and
psychological problems, she added.

Yesterday GlaxoSmithKline, the world's second biggest pharmaceutical
company, said the vaccines in the trial were entirely safe and had been
extensively tested.

The clinical trial involved 5,700 adults and children in 10 European
countries including Russia, a spokeswoman said. All three vaccines -
Varilrix, against chickenpox; Priorix-Tetra, a combined MMR and chickenpox
vaccine; and Priorix, a new MMR vaccine - had been approved by European and
Russian regulators.

"GlaxoSmithKline is extremely concerned about the unsubstantiated and
untrue allegations circulating relating to clinical trials in Russia,"
Michael Crow, the firm's Russia vice-president, told the Guardian. He said
an internal audit had found "no signs of misconduct" by the private
Volgograd clinic. There was also no evidence to link Vika Gerasinka's
problems with the MMR vaccine, he added.

The clinic received $50,000 (£25,500) from the British drugs company to
carry out the trial, prosecutors say. The Rossiskaya Gazeta newspaper cited
local doctors as saying one of the problems with the trial may have been
the fact that so few babies were healthy in the first place.

Yesterday a spokeswoman for the Volgo-grad prosecutor's office said the
criminal case was against the clinic and not GlaxoSmithKline.
"GlaxoSmithKline contracted the clinic, so the clinic was responsible,"
Lidia Sergeyeva said. She made clear, though, that future action against
the drug maker was not impossible.