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Scientists Retract Narcolepsy Study Linked To GlaxoSmithKline (GSK) Flu Vaccine



8/7/2014 2:57:13 PM

GSK H1N1 Vaccine Link to Narcolepsy Declared Irreproducible GSK H1N1 Vaccine Link to Narcolepsy Declared Irreproducible

August 8, 2014
By Mark Terry, BioSpace.com Breaking News Staff

Emmanuel Mignot, a Stanford University professor of psychiatry and behavioral sciences, asked that a paper linking a GlaxoSmithKline (GSK) H1N1 flu vaccine to narcolepsy in children be retracted. In a statement, Mignot indicated “they were unable to replicate some of the results reported in the paper.”

The vaccine, Pandemrix, was given to approximately 6 million people in Britain at the height of the 2009 – 2010 swine flu pandemic. Approximately 31 million people received the vaccine across Europe. The U.K. government reported claims from about 100 people that the vaccine triggered the sleep disorder narcolepsy.

Narcolepsy is a chronic disorder with excessive daytime sleepiness, sometimes accompanied with a transient loss of muscle tone triggered by strong emotion, i.e., cataplexy. Not particularly common, it is generally found in between 25 and 50 individuals per 100,000, although it varies from population to population.

Mignot’s research into the link between Pandemrix and narcolepsy has been funded by GSK. In a recent statement the company said it believed “the original scientific hypothesis remains a valid one that needs to be further explored.”
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The original article was published in December 2013 in the journal "Science Translational Medicine." Robbert van der Most and colleagues wrote a letter published in the June 2014 issue of the journal (may require registration) that stated that the results should be independently replicated, that they were consistent “with the hypothesis that CD4+ T cell receptors can exhibit cross-reactivity between hypocretin and influenza virus epitopes and that a self-directed CD4+ T cell response against hypocretin can cause disease.” They then went on to say that due to geographic variability, it was clear that other factors were involved, that “the mere presence of the cross-reactive epitope is not sufficient.”

Lawsuit and damages are pending, which could, according to Peter Todd with the London firm Hodge, Jones and Allen, reach £1 million per person. With continuing need for safe and effective vaccines for H1N1 and other pandemics, research into the safety and efficacy of Pandemrix and other vaccines will undoubtedly continue.

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