Staying Awake And Pandemrix - The Swine Flu Scandal

Fourteen-year-old Justin Cooney* was showering when he fell backwards, crashing through the shower glass door, dislodging his two front teeth. His brother David found him on the floor, bleeding and unresponsive.


Later, the hospital consultant told his mother Maeve that Justin was fortunate that his femoral artery had not been severed in the accident. Initially diagnosed as having had a “fainting episode”, Justin underwent extensive medical tests, including a lumbar puncture, before eventually being diagnosed as suffering from narcolepsy: he had fallen asleep in the shower.


Justin’s narcolepsy is not genetic but a serious condition caused by Pandemrix, a swine flu vaccination he received at school in early 2010. Manufactured by pharmaceutical giant Glaxo Smith Kline (GSK), Pandemrix has since been implicated in one of the greatest public health scandals to have emerged in Western Europe in decades. Swine flu vaccinations were administered to over 30 million people across Europe including around 900,000 Irish people in 2009–2010 in response to the World Health Organisation’s declaration of a swine flu “pandemic”http://www.irishtimes.com/news/parents-claim-child-narcolepsy-linked-to-swine-flu-vaccine-1.601851. So far, more than 70 narcolepsy cases have been diagnosed in Ireland alone and the figures are still rising due to delay in diagnosis or confusion with other conditions such as depression and M.E.


Narcolepsy is a profoundly debilitating sleep disorder, usually affecting 1 in 3,000 people (http://www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm). Side effects include cataplexy (complete loss of muscle control), often triggered by intense emotions, particularly laughter, as well as daytime drowsiness and hallucinations, which may be visual, auditory and even tactile. In young people, narcolepsy can result in learning difficulties at school, leading to poor self-esteem, weight gain, diabetes and depression. Once contracted, narcolepsy is a life-long debilitating condition that limits all aspects of daily life, be it driving, keeping a job or engaging in sports activities. There is no cure.


These avoidable catastrophes arose from serious errors by the public authorities in Ireland and elsewhere in Europe, who rushed through a manufacturing licence to GSK for the manufacture and distribution of Pandemrix, in anticipation of a swine flu pandemic. Unfortunately, the usual pre-licence safety checks and protocols were sidestepped by the European Medicines Agency, which used a fast-track procedure to licence the vaccine in the face of mounting global hysteria about swine flu, despite concerns raised by various major paediatric specialists. Consequently, Pandemrix was insufficiently trialled for children/adolescents and young adults prior to the licence being issued. In particular, concerns about the novel use of an adjuvant (an accelerator of the vaccine) in the manufacture of Pandemrix were ignored. Professor Thomas Jefferson, an epidemiologist at the Cochrane Research Collaboration Project in Rome, was one of those who expressed concerns about Pandemrix at an early stage, and http://www.spiegel.de/international/world/interview-with-epidemiologist-tom-jefferson-a-whole-industry-is-waiting-for-a-pandemic-a-637119.html as early as 2007, the World Health Organisation’s expert review group had said, “There may be special safety issues for children e.g. for adjuvanated influenza vaccines”.


Remarkably, despite the inadequate testing and these legitimate safety concerns, no warnings were given to parents of either children or young adults prior to the administration of the vaccine. The Irish health authorities actively promoted a public vaccine campaign, commencing in October 2009 and continuing at a rapid pace into the early summer months of 2010. Children and young adults were the main targets for vaccination from February 2010 onwards. This was despite the consensus within the World Health Organisation and the medical community by January 2010 that the swine flu strain had mutated and was less virulent, having fewer fatalities globally than even the ordinary seasonal flu.http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(09)61792-X.pdf andhttp://assembly.coe.int/CommitteeDocs/2010/20100329_MemorandumPandemie_E.pdf


After the emergence of cases of narcolepsy, families were met with a piecemeal response from healthcare agencies and government, who refused to acknowledge any link between the vaccine and the incidence of narcolepsy. However, in 2012, Dr Darina O’Flanaghan, head of the HSE’s Health Protection Surveillance Centre, published a study that confirmed a 13-fold higher risk of narcolepsy among children, adolescents and young adults vaccinated with Pandemrix than among those unvaccinated (http://www.hpsc.ie/A-Z/Respiratory/Influenza/PandemicInfluenza/PandemicInfluenzaH1N12009/Vaccination/File,13379,en.pdf). Nonetheless, the Irish government still refuses to acknowledge any culpability for the public health disaster.


SOUND (Sufferers Of Unique Narcolepsy Disorder), a support group founded by families of sufferers, has lobbied government agencies to provide discretionary medical cards and other state benefits but there has been no commitment by either the state or GSK to compensate the victims.


In contrast to Northern European countries, where victims have already been paid compensation of up to €1 million per case under a no-fault scheme, funded by a levy on the pharmaceutical industry, no such scheme or levy exists in Ireland, despite the prominent role played by major global pharmaceutical companies in the country’s economy. Indeed, GSK, whose pre-tax profits in the first quarter of 2010 increased by 16% to £1.93 billion, much of it accounted for by the increase in flu vaccine sales, http://www.ft.com/intl/cms/s/0/42d64854-531b-11df-813e-00144feab49a.html even secured full indemnity from the Irish state for any harmful side effects from Pandemrix. Thus far, families in Ireland have had their cases contested by both the state and the drug company.


Far from remaining neutral, the Irish government has instructed the State Claims Agency not only to defend all actions taken by the families of swine flu victims and act in accordance with its statutory mandate so as to ensure that the “State’s liability and associated expenses are contained at the lowest achievable level”. (http://stateclaims.ie).


For now, the only recourse left for Irish families is to institute legal proceedings through lawyers prepared to take on their cases on a “no-win-no-fee” basis. However, this does not alleviate the devastating consequences, nor does it mitigate the stress of litigation. What families of narcolepsy victims want is for the Irish government to live up to its responsibilities as Northern European countries have done and to do so quickly. Further delay can only exacerbate the situation.


For Justin, life will never be the same: “Prior to this condition (narcolepsy), I was healthy and fit. Before getting the swine flu vaccine, I could never have imagined how painful it could be to get so tired.”

*name and gender changed for confidentiality purposes


Works Cited


Duncan, P. 2011. “Parents Claim Narcolepsy Linked to Swine Flu Vaccine.” Irish Times, September 17. Accessed athttp://www.irishtimes.com/news/parents-claim-child-narcolepsy-linked-to-swine-flu-vaccine-1.601851 on 13 March 2015.


Jack, Andrew. 2010. “GSK Relies More on Emerging Markets.” Financial Times, April 29. Accessed athttp://www.ft.com/intl/cms/s/0/42d64854-531b-11df-813e-00144feab49a.html on 16 March 2015.

National Institute of Neurological Disorders and Stroke. Narcolepsy Fact Sheet. Accessed athttp://www.ninds.nih.gov/disorders/narcolepsy/detail_narcolepsy.htm on 13 March 2015.

National Narcolepsy Study Steering Committee. 2012. “Investigation of an Increase in the Incidence of Narcolepsy in Children and Adolescents in 2009 and 2010: Final Report of National Narcolepsy Study Steering Committee.” Accessed at http://www.hpsc.ie/A-Z/Respiratory/Influenza/PandemicInfluenza/PandemicInfluenzaH1N12009/Vaccination/File,13379,en.pdf on 22 January 2015.

Social Health and Family Affairs Committee. 2010. “The Handling of the H1N1 Pandemic: More Transparency Needed” 23 March. Accessed at http://assembly.coe.int/CommitteeDocs/2010/20100329_MemorandumPandemie_E.pdf on 7 April 2015 (paragraph 41).

Spiegel Online. 2009. ‘A Whole Industry Is Waiting for a Pandemic’: Interview with Epidemiologist Tom Jefferson. July 21. Accessed at http://www.spiegel.de/international/world/interview-with-epidemiologist-tom-jefferson-a-whole-industry-is-waiting-for-a-pandemic-a-637119.html on 13 March 2015.

State Claims Agency. Irish government website. Accessed at http://www.stateclaims.ie/ on 13 March 2015.

The Lancet. 2010 “InFACT: A Global Critical Care Research Response to H1N1” Accessed athttp://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(09)61792-X.pdf on 7 April 2015

World Health Organisation. 2007. Proposed Guidelines: Regulatory Preparedness for Human Pandemic Influenza Vaccines. Accessed at
http://www.who.int/biologicals/publications/trs/areas/vaccines/influenza/Human_pandemic_Influenza_Vaccines_BS2074_01Feb08.pdf on 12 March 2015.
 

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