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It is hard to overstate the public health fears generated by the threat of swine flu in 2009.

The world had been bracing itself for a flu pandemic for years and the prospect of a flu that ‘jumped species’ seemed to pose a particularly lethal threat.

TV and newspaper reports invariably included references to the dreaded Spanish flu of 1918, a form of the H1N1 virus which struck just as the world was recovering from the carnage of World War I. It infected roughly 500 million people and killed somewhere between 50 million and 70 million, 3pc of the world’s population.

Public and State fears about swine flu were understandable.In 2009, the race was on to develop a vaccine to protect the world against swine flu or a H1N1 virus that jumped species from animals to humans.

GlaxoSmithKline had such a vaccine in the pipeline, Pandemrix. The problem was that it wasn’t fully tested. As it was subsequently offered for use, the Irish public was never told it had not completed the normal exhaustive medical trials.

To fast-track it into service in 2009, Ireland – like many other European countries – granted GSK the full indemnity the firm insisted upon. If there was a future problem or side-effect from Pandemrix, it would be the taxpayer who footed the bill.

The vaccination programme began in autumn 2009 and was stopped in March 2010, when the swine flu pandemic predicted by the World Health Organisation failed to materialise.

Ireland secured roughly eight million doses at a reported cost of €80m. However, as early as 2009, there were concerns about Pandemrix. The then Irish Medicines Board wrote to the Health Service Executive (HSE) querying the lack of data on such swine flu vaccines.

In Germany, where Pandemrix was made, the vaccine was offered to the general public. But members of the German government, civil service and military received a second, different vaccine. ‘Der Spiegel’ revealed this was on the basis the second vaccine was deemed to have a lower risk of side-effects.

Back in Ireland, unused Pandemrix stocks were kept in HSE storage in 2010. Then, in January 2011, when there was a threatened shortfall of the normal winter flu vaccine, the decision was taken to re-issue Pandemrix. From January 7, stocks were sent to two-thirds of all Irish GPs and clinics.

Then, on March 28, 2011, Pandemrix was recalled after the HSE cited studies in Finland and Sweden which highlighted fears the vaccine could be linked to narcolepsy cases being reported in young people.

Pointedly, the Finnish and Swedish studies were launched in August 2010, five months earlier, amid mounting concern over a spike in narcolepsy cases.

To compound the problem in Ireland, not all GP practices – slightly less than half – opted to use the HSE drug disposal system and instead used their own waste disposal services.

That meant it was difficult, if not impossible, for the HSE to later calculate how many doses had been administered over the three-month period.

Despite HSE claims it was likely no one received the Pandemrix jab because winter flu stocks didn’t run short, the Irish Independent discovered the vaccine was, in fact, used in 2011.

One of those who received Pandemrix in January 2011 was Emily (10). The youngster had also received Pandemrix in 2009 at the height of the swine flu fears. She now battles chronic narcolepsy.

“She can fall asleep talking to us, eating her dinner or while studying in school. She can even fall asleep standing up,” explained her mother, Mary.

Emily also has cataplexy, a condition often associated with type one narcolepsy. If she gets excited or emotional, Emily can suffer an effective nervous and physiological shutdown – she can freeze and become immobile. Emily cannot move despite being able to hear everything that goes on around her.

Her problems are exacerbated by disrupted sleep patterns, resulting in terrifying dreams so realistic Emily can believe they are actually occurring.

Emily is just one of around 100 Irish children and young adults who developed narcolepsy having received Pandemrix.

To date, the Government has contested all compensation or support claims, insisting there is no link between the vaccine and narcolepsy. As one legal firm, Augustus Cullen Law, pointed out, this State position is despite multiple international studies – including a medical report by Irish experts in 2012 – which draws a link between Pandemrix and narcolepsy.

Sound (Sufferers of Unique Narcolepsy Disorder) warned the Government has a moral duty to accept its duty of care. “We accept the State acted with the best of intentions in 2009,” Sound co-founder Tom Matthews said. “But the State has a duty of care to these children and young adults – it has an obligation and a moral duty to support them as they try to address these challenges in their lives.”

GSK has declined to comment, given ongoing legal issues.

Taoiseach Leo Varadkar said he needs an update. “Last time I studied that topic and got a briefing, my understanding was there wasn’t sufficient epidemiological evidence to show that vaccine caused the harms that were claimed,” he said in June.

Supporters of narcolepsy sufferers are clear about what should happen next.

Marc MacSharry has demanded the Taoiseach and Health Minister Simon Harris order the State Claims Agency to immediately cease its defence of such vaccine compensation actions. Some €2m has already been spent simply handling legal document disclosures in respect of claimants. The Sligo TD said mediation talks should be offered and, if necessary, a redress scheme considered.

Those in Sound simply want a nine-year nightmare to end – and for the State to fulfil its duty of care to some of its most vulnerable citizens.

Source: Irish Independent, 11th August 2018.

https://www.independent.ie/irish-news/health/narcolepsy-drug-firm-got-indemnity-and-government-refuses-to-step-in-37205393.html

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