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13 Jul, 2007 09:29

Medical testing on children stirs debate in Russia

A heated debate has erupted in Russia over legalising medical testing on children. In the United States and the EU laws have already been introduced, making tests compulsory, but Russian lawmakers are still battling with the ethics.

Until he was 2.5 years old, Pasha Mitin was perfectly healthy. Now he can hardly walk or hear, his liver is twice the normal size and he his heart struggles to keep beating. He has Hunter’s syndrome which is the total failure of the body’s genetic system as toxins are no longer eliminated but left to poison the body from within.
There is a drug that can help Pasha – it appeared in Europe last year. But is illegal in Russia, as is testing on children
“We can bring the drug into the country, but what then?  If a doctor agrees to give it to a child – on the one hand he is saving his life, and on the other he is breaking the law,” said Snezhana Mitina, Pasha’s mother.

The government has discussed loopholes in the legislation, raising a heated debate.
But the problem remains, as tested on adults, the drugs may not produce the same effect.

“We cut the dose by half, give it to a child and see how it works.  A child’s organism is very specific, his system of eliminating toxins is not fully formed. His kidneys, liver – they all work differently,” explained Vitaly Omelyanovsky, a professor at the Russian State Medical University.

In the Russian city of Volgograd a criminal case was filed earlier this year after it was discovered local doctors had been testing a Belgian flu vaccine on children since 2005. Several children ended up in hospital.
“She suffers from numbness in the legs and has been diagnosed with lots of other illnesses.  Everything is inflamed – the pancreas, the gall bladder, the liver,” claimed Lyubov Geraskina, grandmother of a victim.
Prosecutors said the deputy director of the hospital had been paid $US 50,000 to participate.
In January, new EU rules came into effect and now all European pharmaceutical companies are required to prove their drugs are suitable for children. In the U.S. the law came in 2003.

In Russia, there is no legal basis yet and in the light of previous incidents, fear of what to do in case of side effects is widespread.
Abroad it is the drug companies who are liable.

“In terms of whether there have been adverse reactions to products used in trials, then that of course is another responsibility of the sponsor,” says Elaine Godfrey from the Medicines Regulatory Agency, an expert in clinical tests on children.

Children in 27 countries are already being treated with the drug Pasha Mitin needs.
The hope still remains, that if there are no bureaucratic hurdles, the drug should have its Russian licence by autumn.