Reuters AlertNet Lite - Russia charges 3 doctors over Glaxo vaccine tests

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Russia charges 3 doctors over Glaxo vaccine tests

02 Apr 2007 15:25:43 GMT
Source: Reuters

MOSCOW, April 2 (Reuters) - Russian prosecutors said on Monday they had charged three doctors with breaching medical procedures in a trial of GlaxoSmithKline Plc <GSK.L> vaccines that investigators said made several young children ill.

The prosecutors said that starting in 2005 a hospital in Volgograd, 1,100 km (675 miles) southeast of Moscow, tested the vaccines on 112 children between one and two years of age without informing their parents first.

The vaccines are against childhood diseases including chickenpox.

Glaxo, Europe's biggest drug maker, said it would not comment at this stage of the investigation. Glaxo had earlier denied any wrongdoing.

"We will comment on the case only once we have received more information and details of the current criminal investigation," a Glaxo spokesman in Moscow said.

According to the prosecutors, Glaxo paid the Volgograd clinic's chief researcher 1.5 million roubles ($57,710) and her deputy around 700,000 roubles ($26,930) to conduct the trials, which made some children ill.

"The criminal case was launched after a local resident lodged a complaint at the (Volgograd) prosecutor's office saying her daughter suffered from complications after a visit to the clinic," the prosecutors said in a statement.

"A forensic study established that the deterioration of the child's health was caused by the vaccine she had received ... The children were sent to the clinic as if they had to undergo some kind of routine, planned inoculation."

The prosecutors said on Monday that the clinic had broken the law by testing the vaccines -- Varilrix and Priorix-Tetra -- on children with weak immunity and those suffering from neurological diseases and other illnesses.

According to the contract, only healthy children had been due to take part in the experiment, the prosecutors had said.

The Glaxo spokesman said neither vaccine is so far licensed for use in Russia.

"Russia still lacks an efficient vaccine against childhood diseases like chickenpox and the trial aimed to test the two vaccines and finally register them in the country," he said.

He said Varilrix has been in widespread use outside Russia since the 1990s. Priorix-Tetra is licensed for use in Australia and Germany and is awaiting licences in more than 20 European Union states, said the Glaxo spokesman.

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Last updated:Mon Apr 2 15:27:23 2007