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Irish MP calls for key documents on Pandemrix to be handed to lawyers representing children with narcolepsy

BMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j1959 (Published 20 April 2017) Cite this as: BMJ 2017;357:j1959
  1. Clare Dyer
  1. The BMJ

A member of Dáil Éireann, the Irish parliament, has accused the Irish state body responsible for buying vaccines of choosing GlaxoSmithKline’s Pandemrix for its swine flu programme when it knew it had a higher risk of side effects than other vaccines.

Clare Daly made the allegation in a debate in the Dáil, when she told the taoiseach, Enda Kenny, “The Health Service Executive (HSE) decided to purchase Pandemrix and continued to distribute it even after they knew it was dangerous and untested, and before most of the public in Ireland received it.” The executive knew that there was a seven to eightfold risk of side effects in comparison with a different vaccine, she said.

Around 80 Irish children and young people who received Pandemrix in 2009-10, when a swine flu epidemic was anticipated, have been diagnosed with narcolepsy. Many are suing the HSE and GlaxoSmithKline, alleging negligence in providing an untested vaccine.

In 2015 a British boy who developed narcolepsy and cataplexy after being vaccinated against swine flu at age 7 was awarded £120 000 (€165 000; $186 000) in compensation, in a ruling that opened the way for dozens of similar awards from the UK’s statutory vaccine damage compensation scheme.1

Daly, an independent deputy, accused the HSE and the State Claims Agency, which represents the Irish government in litigation, of obstructing the handover of key documents.

She cited the case of a 14 year old boy with narcolepsy and added, “The HSE and the State Claims Agency went into the High Court last week, unnoticed and undocumented, to obstruct this boy and people like him who are seeking documents under discovery.”

Daly asked why Ireland, unlike some other countries, decided to use Pandemrix and give GSK full indemnity against legal action over its side effects in what she called an “avoidable catastrophe.”

“In 2009, before 95% of Irish children were vaccinated, the Irish Medicines Board, which is now known as the Health Products Regulatory Authority, was told there was a big difference between the safety profiles of these vaccines. Did the board tell the minister about this, as it had a statutory obligation to do?

“Given that it was in possession of that knowledge, why did it continue to administer the least safe vaccine? Was it cheaper? Did the government have a deal with GSK in return for jobs?”

Why, she asked, did Ireland, unlike other countries including the UK, not operate a no-fault vaccine damage compensation scheme?

Kenny responded: “The deputy has made strong claims about Pandemrix and the company involved. She has said that the authorities continued to use this vaccine even though they were aware of the difficulties it might cause. That is something which deserves immediate analysis and I will ensure it is followed through.”

Daly told The BMJ, “What we want is for them to stop forcing people into expensive and lengthy legal action, to make available all the documents that solicitors representing the families are seeking (and indeed have been granted in discovery orders), and to acknowledge responsibility for not giving accurate information regarding serious adverse effects and for supplying the drug after they were aware of the greater likelihood of such side effects when there were safer choices available.

“We want them to support the health needs of those affected and compensate them accordingly. And for the future, to bring in a scheme, such as exists in other jurisdictions, for people who suffer side effects in relation to vaccines to be supported medically and in any other way necessary.”

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