http://news.independent.co.uk/business/news/article2418483.ece

GSK at centre of Russian vaccine scandal

By Andrew Osborn in Moscow
Published: 04 April 2007

The pharmaceutical giant GlaxoSmithKline has become embroiled in a vaccine-testing scandal in southern Russia after prosecutors set out criminal charges against three doctors involved in a trial of the company's drugs.

Prosecutors claimed that the doctors broke Russian law and ethics, but have so far stopped short of criticising GSK. The pharma titan has denied any wrongdoing, calling the allegations "unsubstantiated and untrue".

The dispute centres on a series of trials conducted at Volgograd's Independent Clinical Hospital on GSK's behalf on 100 babies between the ages of one and two, starting in 2005. The trials involved GSK-branded vaccines for chickenpox (Varilrix), measles (Priorix), mumps and rubella (a combined MMR Priorix Tetra vaccine) and were part of a larger series of trials involving almost 6,000 adults and children in ten European countries including Russia. Problems arose after some parents of the babies involved claimed that they did not give their consent and were not even aware that their children were taking part in the trials.

Prosecutors said they have found evidence to back up parents' concerns. "Preliminary investigations showed that the doctors, seeking material benefits, conducted clinical tests of the vaccines with no regard for the children's lives and health," they said. "The parents believed these were routine vaccinations, they were not told that new vaccines were being tested on their children." The paediatricians received 1.5 million rubles ($57,670) and 700,000 rubles from GSK, prosecutors added, something they said parents were also unaware of.

The claims are however robustly rejected by the hospital, which insists it has the paperwork to prove that the parents knew what was happening and gave their written consent. Perhaps more seriously, the parents of one baby - Vika Gerasinka - also alleged that GSK's drugs had caused serious damage to their child's health, retarding her development. They claimed that Vika was developing normally before she was given her shots in November of 2005 and could say 10 words, but that she became disturbed and ill after being inoculated. Vika, now two and a half, has developed serious speech and psychological problems.

Prosecutors appeared to back up her parents' allegations. "Medical examination revealed the girl's health problems occurred as a result of the vaccination," they said in a statement to which GSK has so far declined to respond. The scandal has triggered a bout of hand-wringing in local and national media about how Russia is allegedly being used as a laboratory for questionable experiments by unscrupulous foreign firms.

This is not the first time GSK's Priorix has been called into question. Last year a child in Vietnam died from toxic shock syndrome after being administered a shot and five other infants fell ill.

However, an investigation suggested the side effects were unrelated to the vaccine which has been tested extensively.