19 Sep (THE GUARDIAN) – The UK government is to reverse its stance on the safety of a swine flu vaccine given to 6 million people in Britain and accept that on rare occasions the jab can trigger the devastating sleep disorder narcolepsy.
The Department for Work and Pensions (DWP) has contacted people turned down for compensation last year to explain that, after a review of fresh evidence, it now accepts the vaccine can cause the condition. The move leaves the government open to compensation claims from around 100 people in Britain, and substantial legal fees if a group action drawn up by solicitors is successful.
Peter Todd, who is preparing the case at the London firm Hodge, Jones and Allen, said that damages could reach £1m for each person.
The Pandemrix vaccine, made by GlaxoSmithKline, was given to high-risk groups, including children and those with asthma, diabetes and heart disease at the height of the 2009-10 swine flu pandemic. Across Europe, around 31 million people received the jab. The vaccine was made specifically to tackle pandemics and is very different to the normal seasonal flu vaccine which has not been linked to narcolepsy.
The condition is a rare but serious neurological disorder that affects about 31,000 people in Britain. The condition can cause massive sleep disruption. The worst hit are often young people who face enormous learning difficulties at school and university. The disorder can destroy self-esteem, and bullying is common. Adults can lose their jobs, their driving licences, and can have difficulties with relationships. Some narcoleptics have another condition called cataplexy, a total loss of muscle control.
The government U-turn follows a major study of four- to 18-year-olds by the Health Protection Agency which found that around one in every 55,000 jabs was associated with narcolepsy. A spokesman for GSK said it had details of around 900 people from 14 countries who had narcolepsy and were vaccinated.
The welfare minister, Iain Duncan Smith, will announce the reversal in October, according to a letter seen by the Guardian. “It has been accepted that, on the balance of probability, vaccination has contributed to … disablement,” the letter says.
The DWP denies that any disability caused by Pandemrix is severe enough to qualify for statutory compensation, a £120,000 tax-free lump sum, but invites people to respond within three weeks.
Todd argues that “in nearly all cases” people who developed narcolepsy from the jab would qualify for compensation. The group action will be brought against GSK, but Todd said the drug company had an indemnity clause in its contract to provide the vaccine which means government will ultimately foot the bill. “Some of these multiparty actions cost endless millions. You can imagine the number of experts involved. We fill up the court when we turn up with these cases,” he said.
The decision was welcomed by Matt O’Neill of Narcolepsy UK. “There are a lot of parents who have been waiting for the right decision on this,” he said. “The problem is that compensation is based on proving that you’re eligible, and that could be very hard for children to articulate.”
In a statement, GSK said: “Patient safety is our number one priority and we are actively researching how narcolepsy is triggered and how this vaccine might have interacted with other risk factors in affected individuals. We hope these ongoing research efforts will enable us to provide more answers.
“Narcolepsy is a complex disease and its causes are not yet fully understood but it is generally considered to be associated with genetic and environmental factors, including infections. We remain committed to pursuing additional research to understand the association between Pandemrix and narcolepsy and continue to support the research of others who are investigating reported cases.”
A Department of Health spokesperson said: “Pandemrix was developed specifically for use in a flu pandemic when the number of lives lost and serious cases could have been enormous.
“The decision to recommend that children got this vaccine during the flu pandemic was based on evidence available at the time, along with the advice from the European Medicines Agency which approved its use.
“We keep all emerging evidence under review and that’s why use of Pandemrix in those less than 20 years old was stopped in the UK in 2011.”
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Tags: cataplexy, GSK, narcolepsy, Pandemrix, Peter Todd, swine flu, vaccine