By Olesya Dmitracova
MOSCOW (Reuters) March 02 – Russian prosecutors are investigating a local hospital on suspicions it illegally tested vaccines made by GlaxoSmithKline Plc on toddlers, making them ill and hampering their development.
Europe’s biggest drugmaker denied the claims and said there was no evidence of adverse events or misconduct in the way the study had been carried out.
Glaxo vaccines were tested on more than 100 children between one and two years of age at the hospital in Volgograd after Russian health authorities approved the trials in 2005.
But prosecutors claim parents were not properly informed and they thought these were routine vaccinations.
According to the prosecutors, Glaxo paid the clinic in southwestern Russia $50,000 to conduct the trials, which made some children ill.
“According to the contract, only healthy children can take part in this experiment,” said a spokeswoman for the Volgograd region prosecutors, Lydia Sergeyeva.
“In this case all children were sent for trials, healthy or unhealthy, and many of them had been diagnosed with diseases.
“They had no right to put children with health problems through these clinical tests because… it can lead to a deterioration in the child’s condition, as happened with one girl for instance.”
Sergeyeva told Reuters of a 2-1/2-year-old girl whose neurological illness progressed sharply after she was vaccinated. The girl can hardly speak and shows other signs of arrested development, she said.
Glaxo said the tests were part of a wider clinical trial programme involving 5,700 children across Europe, including around 1,000 in Russia.
The project is designed to evaluate the effectiveness of different vaccines against varicella, or chickenpox, and involves Glaxo vaccines that are already approved for use.
A company spokeswoman said its own internal audit showed informed consent had been given by all parents and doctors involved in the trial had reported no signs of adverse effects.
“GlaxoSmithKline is extremely concerned about unsubstantiated and untrue allegations circulating related to the clinical trial in Russia,” she said.
The prosecutors allege the clinic had no right to conduct the tests as it was not a state clinic.
When asked why the tests were nonetheless allowed in the Volgograd hospital, Sergeyeva said it was a question for the authorities who granted the permission.
A regional court ruled last month that the vaccinations should stop but Sergeyeva said the hospital promised to appeal. If no appeal is made, all future tests of the vaccines in the clinic will be banned as of next week.
(Additional reporting by Ben Hirschler in London)