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. Last Updated: 07/27/2016

Drug Tests Prompt Inquiry in Volgograd

Clinical trials for a chicken pox, measles and rubella vaccine made by British pharmaceuticals giant GlaxoSmithKline have sparked a criminal investigation in Volgograd.

The trials involved 100 babies between the ages of 1 and 2, many of whom have shown troubling symptoms since receiving the injections.

There is some debate about whether parents were aware that their children were part of a test: Parents insist they did not know, while officials at GlaxoSmithKline and the clinic that administered the tests say they did.

What's more, if it is proven that the babies were subjected to the tests, officials at the clinic, Independent Clinical Hospital, would face jail time. By law, minors cannot take part in vaccine trials in Russia. On top of that, prosecutors say nonstate facilities are barred from running clinical trials.

In light of the criminal investigation, a regional court ordered the trials at the Independent Clinical Hospital halted last week. But it remains unclear whether the ruling has actually been enforced.

The regional court judge, Galina Mishiryakova, said in an interview Thursday that the ruling had not been enforced because the clinic has filed an appeal. No one at the clinic answered multiple phone calls.

Vika Geraskina, who was 1 year old when she was given shots at the clinic in November 2005, has displayed disturbing symptoms that her parents are convinced were caused by the trial vaccine.

"Since getting her shots, Vika and I have been to the hospital on several occasions. She's been frequently sick," said Lyubov Geraskina, Vika's grandmother, who said her granddaughter, now 3, had suffered speech and psychological problems since the test.

Parents have claimed that the clinic's doctors encouraged them to allow their children the course of vaccines without providing sufficient warning of the possible side effects.

Some say a free taxi service was offered to and from the clinic.

"The pediatrician explained that this was a standard, essential procedure," said Olga Romanova, whose son Pavel was vaccinated despite warnings that he had a neurological disorder. "That didn't stop them," Romanova said.

Independent Clinical Hospital is owned by Russian Railways. While Russian Railways is state-controlled, prosecutors contend that the clinic is not a state facility.

GlaxoSmithKline contracted Independent Clinical Hospital to test its new vaccine in early 2005.

That was part of a national battery of tests that involved 1,000 babies in 10 cities, including Moscow and St. Petersburg, GlaxoSmithKline's Moscow-based spokesman Alexei Brevnov said. Fourteen clinics took part in the tests.

GlaxoSmithKline's London headquarters referred all questions to Brevnov.

"There is no way GSK would knowingly break Russian law," Brevnov said when asked about prosecutors' contention that the tests were conducted illegally.

He added: "GlaxoSmithKline has not broken the law until a judge delivers such a verdict."

As for the question of whether parents knew their children were being subjected to clinical trials, Brevnov dismissed any talk of wrongdoing. "The parents knew," he said, "and the prosecutors have confiscated the agreements that they signed."

GSK's Belgian arm, GSK Biologicals, paid the Volgograd clinic $50,000 for its services via Russian subsidiary GSK Trading.

Viktor Kostenko, a St. Petersburg-based doctor who has run clinical trials for large drug companies, said the payment was reasonable. "It all depends how complicated the test procedures were," Kostenko said.

Prosecutors maintain that the money was a bribe paid to the clinic's deputy head doctor, Yelena Natsko, to find children for the tests.

Brevnov says the money was merely payment for services rendered.

Natsko said that neither she nor the clinic had done anything wrong. "We had and still have all the documents for these trials," she said in televised comments Thursday. The documents, Natsko insisted, amounted to "permission from federal authorities" to conduct the trials.

The ongoing criminal investigation notwithstanding, Volgograd prosecutor's office spokeswoman Lidia Sergeyeva said GlaxoSmithKline appeared -- for now -- not to have done anything wrong. "GlaxoSmithKline contracted the clinic, so the clinic is responsible," Sergeyeva said.

But she made it clear that future action against the drug maker was entirely possible.

Ultimately, the blame for the clinical trials may not lie with the drug maker or the clinic. Clinical trials must be cleared with a federal ethics committee.

Prosecutors acknowledge that the committee -- an independent panel comprising doctors, lawyers, priests and others -- approved the trials.

A committee member, speaking on the condition of anonymity, disagreed.

Yulia Bogdanova contributed to this report from Volgograd.