Latest Pandemrix revelations – We need answers from Government, and justice for narcolepsy sufferers
The revelation this week that some individuals received not one, but two, doses of controversial swine flu drug Pandemrix In 2011, is genuinely staggering! Some of these people went on to develop narcolepsy, an horrific incurable condition which results in sufferers falling asleep without warning, which frequently co-occurs with cataplexy, which essentially results in a person’s body being temporarily paralysed, rendering the person unable to speak or move. In April 2017 I highlighted the case of a boy who developed narcolepsy having received the swine flu vaccine in 2010 to Enda Kenny, telling him:
‘I refer to the case of a young man who has narcolepsy, which is a lifelong debilitating disorder. He can fall asleep without warning and has done so. He has smashed his teeth and broken his bones. He experiences terrifying hallucinations in a state of sleep paralysis. He has to be given expensive anaesthetics so that he can get a few hours’ sleep. He has developed joint and muscle pain. He suffers from anxiety and depression to the extent that he has tried to kill himself. He is 14 years of age. This condition, for which there is no cure, limits every aspect of his daily life. While his condition is bad, the worst thing is that he did not always have it. He was not born with it. It is not a genetic disorder. This was an avoidable catastrophe. This young man, like 80 others, developed the condition as a result of receiving the Pandemrix vaccination for swine flu in 2010.’
Narcolepsy is an utterly devastating condition. But what makes it all the more devastating in this context is the realization that they need not have suffered. The problems with Pandemrix were known but criminally ignored by elements within the HSE. This has been going on for years now as 80 cases of mainly young adults have been forced into litigation by a foot dragging establishment, whose modus operandi continues to be deny, delay, circle the wagons, rather than openness and accountability. This weeks revelations are the last straw. Minister for Health Harris & former Minister for Health Leo Varadkar must act. I already warned them of this is in May of this year, (link to my May leaders). Since then they have done nothing. The victims & their families deserve full openness, an agreement to full disclosure & engagement, rather than adversarial litigation, a no fault vaccine compensation scheme as agreed in the program for government.
Here’s what we know…
In September 2009 the Irish Medicines Board(IMB) sent a letter to the Chief Medical Officer of the HSE, Tony Holohan, That letter stated quite clearly that the none of the swine flu vaccines had been fully tested, & that at the point, ‘no safety data’ was available in regard to the vaccines. In other words, clinicians would be prescribing it without knowing what possible side-effects it might have.
It quite clearly stated that ‘the absence of information on dosage in children and use in pregnant women may be a difficulty for national health authorities when making recommendations for the safe use of the vaccines in these patient populations’. Despite this, the HSE released a leaflet a month later, advising pregnant women that they should get the vaccine, and saying: ‘We expect the swine flu vaccine to be as safe as the usual seasonal flu vaccine, which has been used for more than 60 years. Serious side effects are expected to be very rare.’
The HSE had absolutely no evidence on which to base these assertions -in fact the September 2009 letter shows they had evidence to the contrary! Worse still, the leaflet stated: ‘The vaccines are fully licensed and clinically tested, This was patently false as they knew they were not ‘fully clinically tested’. The letter from the IMB stated: ‘While Clinical trials have commenced there are no data yet available from these trials.’ And yet the HSE told the public in October 2009 that the vaccines were ‘fully clinically tested’. This is absolutely outrageous and someone must be held to account.
Tragically, although the World Health Organization declared the swine flu pandemic officially over on 10 September 2010, many of the people who went on to develop narcolepsy having received Pandemrix were given the vaccination after that time.
It is also worth noting that in the September 2009 letter to the HSE, a full year beforehand, the IMB had also pointed out that approval of the vaccines was based on a ‘worst case pandemic scenario’ – in other words, at a very long stretch, the risk-to-benefit ratio of using these untested drugs on the population during a pandemic might come down on the side of it being prudent. But when that pandemic was over – i.e. in early 2011 – the risk-to-benefit pendulum had swung all the way the other way.
Yet, despite this, in May last year Minister Harris confirmed to me that ‘Pandemrix was distributed to GPs in January 2011 with a recommendation that it be used for those in at risk groups for a three week period when there was a temporary shortage of seasonal influenza vaccine.’ We were not told that some people got more than one dose.
The fact that the HSE was instructing doctors to give Pandemrix to patients instead of the winter flu vaccine in early 2011 is truly appalling and devastating for those affected, as the first reports of a link between pandemic influenza vaccination and narcolepsy came in the second half of 2010.
In August 2010, the Swedish pharmacovigilance authority reported that it was investigating six cases of narcolepsy reported by health care professionals as a possible adverse event following the use of Pandemrix vaccine during the pandemic. This was followed later that month by reports from the Finnish National Institute for Health and Welfare noting there had been a more than expected number of cases of narcolepsy in children and adolescents that year. On 23 September 2010, the Committee on Human Medicinal Products of the European Medicines Agency concluded in its initial review of available data that the available evidence did not confirm a link but that more research was needed.
Even if the HSE didn’t know about the cases of narcolepsy in Sweden, the decision to tell doctors to use a drug whose safety profile was unknown at a time when there was no pandemic was not just imprudent – it was downright dangerous, and it really beggars belief that such a decision was taken.
In any case it is very hard to believe that they did not know of the reported Swedish cases – the September 2009 letter from the IMB said it would be undertaking various measures to monitor the safety profile of swine flu vaccines as things progressed through 2009 and 2010. These included accessing ‘safety information from other Member States and the European Medicines Agency through the use of Eudravigilance (European Safety Database)’. Eudravigilance is the central repository for adverse event reporting – in other words, details of the cases being investigated by the Swedish authorities in August 2010 would have been entered into it, and both the HSE and the IMB should have been aware of them. Despite this, the order was given in early 2011 by the HSE for doctors to give people Pandemrix if they ran out of winter flu vaccine! You couldn’t make it up but it gets worse!
Both the World Health Organisation and the National Institute for Health and Welfare of Finland issued statements indicating increased risk of narcolepsy with Pandemrix in early February 2011. Despite this, it was two months – on 28 March 2011 – before the HSE told doctors to stop giving patients the drug! Again, the WHO and Finnish statements must have been known to the HSE – if they were not, that signals massive negligence on the HSE’s part in terms of pharmacovigilance, and is just as serious.
Clearly, therefore, the HSE has major questions to answer about why the decision was taken to instruct doctors to give people Pandemrix on the basis that there was a ‘shortage’ of the normal winter flu vaccine in early 2011. Was this a decision made on the basis that the HSE had spent in the region of €30 million acquiring swine flu vaccines, and had a large stockpile it needed to get rid of if it was to cut its losses?
I’m open to correction on this, but I can find no evidence of a worldwide shortage of seasonal flu vaccine in the 2010/2011 season. Which rather begs the question: If the Irish authorities thought there might be a shortage of winter flu vaccine that year, why use leftover Pandemrix – a drug whose safety profile was in question – rather than order in more of the vastly cheaper seasonal flu vaccine (which cost only €2.32 million for the 2010/2011 season, compared to the €30 million for the swine flu vaccine across 2009/2010)?
Another question arises: Were patients told that they were receiving Pandemrix, rather than the usual flu vaccine in 2011? Did the HSE instruction to GPs include an instruction to check people’s vaccination record, and to not give them Pandemrix if they’d already had a dose of it? Again, bear in mind that this is all happening at a time when a host of national authorities and EU agencies were talking about links between Pandemrix and narcolepsy – surely it would have been wise to take steps to avoid anyone getting two doses?
Against the backdrop of the cervical cancer smear controversy, the failure of the government to implement a statutory requirement for mandatory open disclosure, the delay in bringing in the Coroners Amendment Bill to require mandatory inquests in cases of maternal deaths, and the failure to implement pre-action protocols, the HSE continues to force victims through the courts for answers and assistance in dealing with the lifelong health problems as a result of their treatment by our health service.
This has to stop….But it hasn’t! The problems are deeply systemic and require a huge cultural change to deliver openness & to stop harming people. There will always be mistakes, and there will always be people who have adverse reactions to vaccination, that is why people need access to all the information beforehand in an honest way, and the safety of a no-fault vaccine scheme where they can access supports afterwards. We have to take the courts out of the health service. Too many lives depend on it.
These issues have to be to the fore when the Dáil returns. Sweet platitudes to victims are not enough. The proof will be in how the practical measures identified to transform the situation are implemented. So far, the Government is looking weak and ineffective in this regard. It has to change.
For more information, please find below videos of two Leaders’ Questions exchanges I have had on the issue of Pandemrix, as well as links to some of the Dáil questions I have submitted on it:
Leaders’ Questions, April 2017
Leaders’ Questions May 2018
HSE litigation and State Claims Agency expenditure on fighting legal claims: