GSK’s Pandemrix Damage: These NHS Staff Were Told The Swine Flu Vaccine Was Safe, And Now They’re Suffering The Consequences


https://www.buzzfeed.com/shaunlintern/these-nhs-staff-were-told-the-swine-flu-vaccine-was-safe?utm_term=.yax9NnNkVk#.mrZzO9OA8A

These NHS Staff Were Told The Swine Flu Vaccine Was Safe, And Now They’re Suffering The Consequences

Dozens of NHS workers are fighting for compensation after developing narcolepsy from a swine flu vaccine that was rushed into service without the usual testing when the disease spread across the globe in 2009. They say it has destroyed their careers and their health.

Posted on

When nurse Meleney Gallagher was told to line up with her colleagues on the renal ward at Sunderland Royal Hospital, for her swine flu vaccination, she had no idea the injection she was about to have had not gone through the usual testing process.

It had been rushed into circulation after the swine flu virus had swept across the globe in 2009, prompting fears thousands of people could die. From the moment the needle broke Gallagher’s skin, her life would never be the same.

“I remember vividly we were all lined up in the corridor and we were told we had to have it. It wasn’t a choice,” she claimed. “I was pressured into it. We were given no information.”

The date was 23 November 2009 and Gallagher was one of thousands of NHS staff vaccinated with Pandemrix, a vaccine made by pharmaceutical giant GlaxoSmithKline (GSK).

Eight years later, her career in the NHS is a memory and she’s living with incurable, debilitating narcolepsy and suffers from cataplexy, a sudden, uncontrollable loss of muscle tone that can cause her to collapse without warning. Because of her condition, she can no longer work or drive.

People with narcolepsy experience chronic fatigue and difficulty sleeping at night. They can have night terrors, hallucinations, and a range of mental health problems.

Gallagher is not alone. More than a dozen frontline NHS staff are among around 1,000 adults and children across Europe who are believed to have developed narcolepsy after being given Pandemrix. Today BuzzFeed News can reveal for the first time their battle to gain acknowledgement for a government decision that they say ruined their careers and has dominated their lives since.

Gallagher and four other NHS professionals – two nurses, a community midwife, and a junior doctor – have told how they felt pressured into receiving the vaccine, were given misleading information, and ultimately lost their careers.

They are all suing GlaxoSmithKline seeking compensation for what they believe was a faulty drug that has left them with lifelong consequences and means they will require medication and support for the rest of their lives.

Meleney Gallagher

Photo by Bethany Clarke / edited by Laura Gallant / BuzzFeed

Meleney Gallagher

They have been forced to take legal action, along with almost a hundred other sufferers, to force the company and the government to accept the consequences of the rushed vaccination programme eight years ago. In contrast to the UK, European countries have already compensated people whose narcolepsy was linked to the swine flu vaccine.

The revelations come the same day that health secretary Jeremy Hunt launched new measures to improve patient safety in the NHS, in response to research conducted by experts at the Universities of Sheffield, Manchester, and York that showed prescription errors cause 1,700 deaths each year, could contribute to as many as 22,000 deaths, and cost the NHS £1.6 billion.

The BuzzFeed News investigation raises serious questions over the advice that was given to NHS staff at the time by the government’s chief medical officer, the chief nurse, and the national flu director that the vaccine had been “thoroughly tested” and was safe to use. That advice was shared in a joint statement by the Department of Health (DH), medical royal colleges, and trade unions, including the British Medical Association and Unison.

Normally vaccines undergo testing to make sure they are safe, and vaccination has been proven to save millions of lives across the globe. But Pandemrix was different. It had not gone through the normal process and was fast-tracked without the usual clinical trials.

Staff were also not told that the government had agreed a unique deal with GSK to indemnify the company for any problems with the vaccine.

The investigation also turns the spotlight on decisions by the UK government to continue using the vaccine even after other European countries suspended its use once evidence of a problem emerged.

Advertisement

Peter Carter, then chief executive of the Royal College of Nursing, told BuzzFeed News it was “a matter of huge concern” that the vaccine had not been properly tested, contrary to what he was told at the time.

Meleney Gallagher was diagnosed in 2013 but only after years of being unable to stay awake and having cataplexy attacks several times a day, sometimes caused simply by laughing.

Meleney Gallagher

Photo by Bethany Clarke / edited by Laura Gallant / BuzzFeed

Meleney Gallagher

She switched jobs to be a district nurse, but the problems got worse. She said: “I was falling asleep in the clinic and driving home. I had cataplexy attacks when I was in the room with patients. I knew I wasn’t safe to practise.”

Although she sought help from occupational health services, her GP employer reported her to the Nursing and Midwifery Council and she was medically retired in April 2017. She received just 12 weeks’ pay for 20 years’ service in the NHS.

She said she had been denied an informed choice over the jab. “They can’t just do what they want with vaccines, otherwise it’s like Russian roulette and you can’t do that. I just want someone to stand up and to say they were wrong and apologise. Someone to be sorry for what they have done. I feel really angry.”

Gallagher’s vaccination was part of a concerted effort by the Department of Health to immunise as many workers as possible. At the time, there was widespread global concern about the spread of the swine flu virus and fears it could replicate the Spanish flu of 1918.

While the concern was to save lives, it is alleged that senior figures in the department, including the chief nurse, chief medical officer, and national flu director, did not give a full picture of the vaccine.

A swine flu leaflet produced by the DH for staff and patients ahead of the nationwide vaccination said: “The European Commission carefully considered all the evidence and recommended that [the vaccine] could be used.”

But it made no mention of the fact the European Medicines Agency had licensed Pandemrix under “exceptional circumstances” based on “mock vaccines” that did not include the actual ingredients that would eventually be injected into people. The EMA confirmed this approach was “unique to pandemic preparedness vaccines”.

Matt O'Neil

Chris Bethell for BuzzFeed

Matt O’Neil

The DH leaflet also made no mention of the government’s agreement to indemnify GSK for any problems with the vaccine. This was not widely known at the time, and the indemnity deal has never been published. In the summer of 2009, Wolf-Dieter Ludwig, chair of the German Medical Association’s drug commission, had warned EU governments not to bear the risk for pharmaceutical companies.

Nationwide vaccinations started in the UK on 21 October 2009, despite the fact that experts at the DH had known since May the flu was milder than first thought. On 22 October, ministers agreed to revise down the worst-case scenario from 19,000 deaths to 1,000.

Ahead of the vaccinations starting, Dame Christine Beasley, then chief nursing officer for England, told Nursing Times: “We’ve gone through exactly the same procedures as we do with seasonal flu vaccine and it’s as safe as a vaccine can be.”

On the day immunisations began, the RCN’s Peter Carter was quoted saying he was “entirely satisfied” the vaccine was safe because it had undergone “rigorous testing”.

Advertisement

Carter told BuzzFeed News: “At the time, Liam Donaldson, the chief medical officer, and Professor David Salisbury, the DH’s director of immunisation, were assuring people this vaccine had been thoroughly and properly tested, so people like me, in good faith, had no reason to disbelieve that and were happy to encourage people to have the swine flu vaccine.

“It is a matter of huge concern that several years later it’s now apparent this was not properly tested, and this will obviously shake the confidence of people for any future pandemic flu immunisation programmes. People have a reasonable expectation that what they are being told is accurate and it is a matter of regret that it clearly wasn’t.”

Matt O'Neil

Chris Bethell for BuzzFeed

Matt O’Neil

Salisbury told BuzzFeed News he believed a normal clinical trial would have been too small to pick up the problems with Pandemrix. “Given its rarity, any excess risk could only be detected after huge population exposure done through post-marketing surveillance,” he said.

He declined to comment on staff saying they felt pressured or on issues around informed consent.

Sir Liam Donaldson did not respond to a request for comment.

NHS trusts received six letters between September and October alone urging them to vaccinate staff.

In November 2009, Ian Dalton, then national director for NHS flu resilience and now chief executive of NHS Improvement, wrote for the Health Service Journal that vaccinating staff was the “highest clinical priority”. He stressed the need for staff to have information about “how it has been tested to ensure safety”.

By 4 February 2010, it was clear swine flu was not going to be the catastrophe many had feared and ministers agreed not to extend vaccinations to the public. The NHS vaccination campaign went on because staff were considered a priority group.

Dalton wrote to trusts again saying he expected improvement in the uptake rate despite the “predominantly mild illness”. In an update for the Health Service Journal, he warned against complacency and said the programme was a “key governance responsibility” for NHS boards.

Photo by Bethany Clarke / edited by Laura Gallant / BuzzFeed

By April 2010, around 40% of the NHS frontline staff had been vaccinated with Pandemrix, which was more than double the seasonal flu vaccine uptake of 17% in 2008.

Among them were Hayley Best, an intensive care nurse working in Craigavon, Northern Ireland, and Shane Keenan, a senior emergency nurse practitioner in Oxford, who worked for 35 years in the NHS.

Both said they felt pressured to have the vaccine. Keenan said he felt it was “emotional blackmail”, adding: “We weren’t informed it wasn’t properly trialled.” Best agreed: “It wasn’t that you were asked if you wanted it; you were told this was your appointment.”

Keenan told BuzzFeed News that after he got the Pandemrix jab his life “started to fall apart… By early February [2010], I was having nightmares like you wouldn’t believe and visual hallucinations.”

Advertisement

Best said the effect on her was similarly dramatic, with severe suicidal thoughts within weeks.

Both said their symptoms were initially dismissed as depression and fatigue. Keenan was referred to specialists in December 2010. He struggled with work and was put through a capability assessment by his trust and moved down a pay band, decreasing his salary by £500 a month.

Shane Keenan

Laura Gallant / BuzzFeed

Shane Keenan

Eventually he realised he couldn’t continue. “I was a potential danger to patients. I went to occupational health and suggested ill health retirement.”

He said narcolepsy had “completely destroyed my life and my career. I worked damned hard to get to the pinnacle of my career. I lectured at Oxford University; now I can’t even stack shelves. I was injured in the line of duty. NHS staff are collateral damage.”

Best wasn’t diagnosed until October 2014. She switched jobs to become a district nurse but still struggled. “It really came to a head in 2014 when I started falling asleep behind the wheel of my car. I just got to the point where I would have driven to somebody’s house and not be able to remember doing it.” She was medically retired in October 2016, just before her 40th birthday.

She said: “I was given a vaccine that wasn’t properly tested. I am a big advocate for vaccination; my children have every vaccine that is offered.

“I was a good nurse, I know I was a good nurse. So where are my employers now? Where is my NHS? Where is my government? If you are going to encourage your frontline staff to have vaccines then the least you can do is have facilities in place if they happen to react to it. I feel completely betrayed. I have been abandoned. The NHS should have something in place if and when it goes wrong.”

Not everyone had been convinced the vaccine was safe for use. Switzerland’s medicine regulator Swissmedic refused to license it for use on under-18s in October 2009, and Michael Kochen, president of the German College of General Practitioners and Family Physicians, told the BMJ that same year that it had not been sufficiently tested to be declared safe.

The first hard evidence of a problem with Pandemrix emerged in 2010 when doctors in Finland noticed a dramatic increase in children with narcolepsy. Since then a number of studies in Europe and the UK have shown the vaccine is linked to an increased risk of narcolepsy in children and adults.

But even then, the Department of Health was not finished with the vaccine. While other European countries suspended its use in August 2010 due to the concerns, the UK used it to fill gaps in the seasonal flu jab supply in January 2011.

Professor Salisbury said at the time it was not a “second-class vaccine” and patients were “getting an effective vaccine and a safe vaccine”.

According to the EMA, more than 980 people across Europe have been reported as developing narcolepsy because of Pandemrix, with 872 people reported as developing cataplexy, including more than 500 children.

Shane Keenan

Laura Gallant / BuzzFeed

Shane Keenan

More than 120 children and adults are believed to have been affected in the UK – some because of vaccinations that took place in winter 2010-11, after the first studies showing the side-effects had emerged and a year after the swine flu scare.

Around 100 UK families are suing GSK claiming the vaccine was a faulty product. Their law firm, Hodge Jones & Allen, declined to comment but the case has been ongoing since October 2013. It could result in a compensation bill as high as £100 million.

In 2016, judges ruled in favour of Josh Hadfield, who received a maximum £120,000 via the Vaccine Damage Payments Act after the Department of Work and Pensions (DWP), which administers the scheme, admitted Pandemrix caused Josh’s narcolepsy when he was vaccinated aged 4.

His mother, Caroline, described the effect of the vaccine to BuzzFeed News: “He would like to have a bath on his own but he can’t because there is a risk that he is going to fall asleep and drown. He is very introverted and doesn’t like going out on his own because he is scared of what might happen.

“He sleeps two to four hours a day at school and that is when he is fully medicated. He has his own small bedroom at school. He doesn’t have a normal childhood.”

She added: “I am not saying all vaccines are bad and people shouldn’t have them. It’s the fact the government won’t help people after something goes wrong.”

During a parliamentary debate in March last year, Tracy Brabin MP accused the government of “foot dragging”, which was “causing unacceptable and upsetting suffering and distress for the families involved”.

She said in Sweden, Finland, Norway, Iceland, and France people who developed narcolepsy due to Pandemrix have already been compensated.

In 2014, 23-year-old nursery assistant Katie Clack died after jumping from a multi-storey car park. In a note to her family written on the day she died, she described the effects of narcolepsy as unbearable and urged her family to continue her legal action against GSK.

For the NHS staff who have developed narcolepsy, their ordeal has been compounded by being forced to battle with the health service and the government for recognition.

Junior doctor Ruth Tunney was in her third year of medical school on placement at Salford Royal Hospital when she volunteered for the vaccine.

“It was bundled in with the seasonal flu,” she told BuzzFeed News. “I don’t remember reading anywhere that it hadn’t been tested. I didn’t see anything that told me it was a different vaccine. It was a generic consent form.”

She added: “I appreciate at the time they thought people were going to die and they had to act. I am completely pro-vaccination but they should acknowledge what has happened and do something about it rather than just denying it, which it feels is what is happening. It’s changed my life for the worse forever.”

Community midwife Susan Hamilton was formally diagnosed in 2012 after falling asleep while driving with her son. Her career was over, and six years on she faces having to sell her family home.

Hamilton said she tried reaching a compromise with her NHS trust but “was told categorically that they could not make a job for me and didn’t have any obligation to make a job for me”.

She said: “I have been forced out of my job because of a faulty drug and a trust who would not help me work around my condition or wait until I was stabilised on my medication. The NHS has abandoned us. We are damaged goods.”

Like other staff, she said was not given information about the vaccine: “We weren’t given a choice. It wasn’t informed consent.”

In response to this winter’s severe seasonal flu there are increasing calls for NHS staff to face mandatory vaccinations. On Twitter, former NHS England and Department of Health medical director Sir Bruce Keogh responded to such calls by saying: “I think a serious debate around mandatory flu vaccination is inevitable before next winter.”

Advertisement

Speaking to Buzzfeed News, Keogh said: “Every winter flu puts a significant strain on the NHS and a lot of people die. Both can be reduced with sensible vaccination programmes. A debate is emerging on how best to protect both vulnerable patients and staff in the NHS, particularly since there is such a big difference in vaccination rates between NHS organisations and over a third of flu is transmitted by asymptomatic people, meaning staff could unwittingly be spreading flu to their patients. No one wants that.

“Some people are in favour of mandatory vaccination, which could be across the board or only as a prerequisite for working in certain areas. Others are opposed on the basis of freedom of choice. My sense is that staff should have their choice informed by evidence of benefit to themselves, their patients, and their organisation along with any potential personal risks or preferences.

Hayley Best

Photo by Barry Cronin / edited by Laura Gallant / BuzzFeed

Hayley Best

“My view is that the focus on increasing staff vaccination rates should be on ensuring that organisations can demonstrate they have offered every single member of staff the chance to have a vaccine and made it easy for them to do so. This is what organisations with high vaccination rates do.”

On the specific issues around Pandemrix and the lack of support for the staff affected by the vaccine, Keogh said: “It would seem both fair and reasonable and in keeping with the values of the NHS that if somebody suffers as a result of trying to do the right thing for others that they would be looked after appropriately.”

Matt O’Neill, chair of Narcolepsy UK, a charity supporting some of the families affected, believes there should be a public inquiry into the use of the vaccines, what was known at the time, and how staff have been treated since.

He said: “NHS staff vaccinated with Pandemrix have been treated pretty disgustingly. Having a vaccination is an act you take on behalf of the community, for the benefit of the herd. When it goes wrong it makes sense that the herd should look after you.”

“More staff would sign up for vaccines if they saw the NHS admit when it went wrong and that it supported staff. At some point, there will be another pandemic and we will need staff to have confidence they will be looked after if something goes wrong.”

In 2010, Andy Burnham, the Labour health secretary at the time, and other ministers contributed to a review of the handling of the pandemic. It said: “[Management] personally would prefer to be criticised for doing too much rather than the alternative, where there could have been unnecessary deaths from doing too little.”

Guy Leschziner, a consultant neurologist at Guy’s and St Thomas’ Foundation Trust, has treated a number of people who developed narcolepsy after having the swine flu vaccine.

On the use of Pandemrix, he told BuzzFeed News: “It’s always easy with the benefit of hindsight. What we have to remember was what was going on at the time, which was that we thought we were going to have an epidemic of a very severe flu. Now today, knowing we didn’t have quite the epidemic we thought we were going to have, you might come to a different conclusion, but at the time we didn’t know that Pandemrix was associated with narcolepsy in comparison to the other vaccine.”

GSK refused to answer questions from BuzzFeed News but issued a statement saying further research was needed to understand what role Pandemrix played in the development of narcolepsy. The company did not renew its licence and the vaccine is no longer authorised by the EMA.

On its website, the EMA said: “Understanding the link between narcolepsy and Pandemrix remains the subject of investigations and may have implications for the future use of similar vaccines.” It said GSK had agreed to continue investigating the vaccine.

Guido Rasi, the executive director of the European Medicines Agency, said: “Immunisation has helped us to bring some major human diseases under control. Worldwide, vaccines are saving the lives of approximately 9 million people every year, more than the whole population of Austria. Today, no child in Europe has to die from formerly common childhood diseases.”

He accepted vaccines were not 100% risk-free but added: “No medicine is. There is a one in a million chance that an adverse event happens. In Europe, we are actively monitoring the safety of medicines, including vaccines, and also looking at all reported side effects. These are recorded in a database and reviewed regularly to identify any potential problem at an early stage.” Around a million reports are made every year.

The Department of Health said its decision to use the vaccine was based on evidence and advice from experts but declined to comment due to the ongoing legal action. Although the DWP has previously admitted causation in the case of Josh Hadfield, it refused to answer questions, saying it would not detail its policy on Pandemrix unless a Freedom of Information Act request was submitted.

Hayley Best

Photo by Barry Cronin / edited by Laura Gallant / BuzzFeed

Hayley Best

Swine flu was a potential health crisis and there are no suggestions ministers, the DH, or GSK acted with anything other than the best of intentions to save lives. But fear of the virus and misplaced confidence in the vaccine’s safety led to staff feeling pressured to have the jab, and not being given all the facts. Eight years on, those staff are still waiting for their sacrifice to be recognised.

Advertisement

“It has been soul-destroying to lose my career,” said Meleney Gallagher. “I used to say if I could go to work and make one patient smile then I’d have done my job, but I couldn’t do that because I couldn’t even risk laughing with a patient in case I collapsed.

“I am angry. I put a lot into my career, I gave a lot. I would have expected a bit of respect for the effort I put into the NHS.”

Advertisements

Irish Politician (Clare Daly) Speaks Out Against GSK’s Dodgy Pandemrix Drug In The Irish Parliament….


 

http://www.irishtimes.com/news/politics/oireachtas/boy-with-narcolepsy-blocked-from-seeking-documents-d%C3%A1il-told-1.3036855

Boy with narcolepsy blocked from seeking documents, Dáil told

Independent TD calls for no-fault vaccine damage payment scheme

Clare Daly said the boy could fall asleep without warning and had smashed his teeth and broken his bones.  Photograph: Gareth Chaney/Collins

Clare Daly said the boy could fall asleep without warning and had smashed his teeth and broken his bones. Photograph: Gareth Chaney/Collins

Independent TD Clare Daly has claimed a 14-year-old boy suffering from narcolepsy has been obstructed from seeking documents under discovery by State agencies.

She said narcolepsy was a lifelong debilitating disorder caused by the Pandemrix vaccination issued for swine flu in 2010.

Ms Daly told the Dáil the Health Service Executive (HSE) and the State Claims Agency (SCA) had gone into the High Court last week, “unnoticed and undocumented’’, to obstruct the boy and other sufferers seeking the documentation.

Ms Daly said the HSE and the SCA had said they would voluntarily disclose the documents in 2015.

“We need to be clear about the fact that the HSE decided to purchase Pandemrix and continued to distribute it even after it knew it was dangerous and untested and before most of the public in Ireland received it,’’ she added.

“It knew there was a sevenfold or eightfold risk of serious adverse effects in comparison with its sister drug and alternative vaccinations for which there were no adverse side effects.’’

Ms Daly said the Government was continuing to deny the requests of victims for discretionary medical cards and other benefits.

“I want to know why Ireland is the only country that does not operate a no-fault vaccine damage payment scheme,’’ she added.

Ms Daly said the boy could fall asleep without warning and had smashed his teeth and broken his bones.

“He experiences terrifying hallucinations in a state of sleep paralysis,’’ she added. “He has to be given expensive anaesthetics so that he can get a few hours’ sleep.’’

He suffered from anxiety and depression to the extent had had tried to kill himself, she said.

Taoiseach Enda Kenny said he did not know why the HSE, having said it would voluntarily disclose the information sought, seemed to have had a sudden change of direction. He would follow the matter up, he added.

Mr Kenny said Minister for Health Simon Harris had met representatives of the support group for people with narcolepsy in recent days and had sanctioned the go-ahead for the centre of excellence for sleep disorder in St James’s hospital.

He said the programme for government included a commitment to examine supports for people who had been harmed by vaccines.

Pandemrix: Another GSK Drug Scandal “As Big As Thalidomide”?


https://inews.co.uk/essentials/news/health/swine-flu-vaccine-pandremix-narcolepsy-victims-campaign-inquiry/

‘The swine flu vaccine triggered my daughter’s narcolepsy – now I want justice’

Clara Crisp with her daughter Mathilda, who began suffering extreme night-time sleep disturbance within two weeks of the vaccine and subsequently developed cataplexy

Clara Crisp with her daughter Mathilda, who began suffering extreme night-time sleep disturbance within two weeks of the vaccine and subsequently developed cataplexy

Campaigners are calling for a Europe-wide public inquiry into how a vaccine triggered devastating health sleep and brain disorders in a scandal they claim is as big as thalidomide.

Almost 1,700 people suffered narcolepsy after being vaccinated for swine flu. They are vowing to continue their fight for justice at the European Union.

The group of Europeans, including nearly 100 Britons, are calling for a public inquiry after suffering the debilitating disease which was triggered by use of the Pandemrix vaccine to treat the 2009/10 swine flu outbreak.

Narcolepsy is a rare neurological condition that affects the brain’s ability to regulate the normal sleep-wake cycle. This can lead to symptoms such as disturbed night-time sleep, excessive daytime sleepiness and cataplexy – the term given to sudden muscular weakness triggered by strong emotions such as laughter, anger and surprise. As a result, narcolepsy is often thought of as a sleep disorder, but its underlying cause means that it is better classified as a disorder of the central nervous system.

Families denied compensation

British families have been denied compensation from the Department of Work and Pensions under its compensation scheme as the Government does not recognise the condition as a “severe disability”.

Representatives of national narcolepsy groups from the UK, Ireland, Sweden, Finland, Denmark and Norway, and parents of affected children, met Vytenis Andriukaiti, EU commissioner for health and food safety, in Brussels in December.

They pressed him for recognition of the incident, and a public inquiry into lessons learnt for future pandemics. The group also called for the introduction of vaccine injury compensation standards across the EU, as there is a wide disparity in statutory vaccine injury compensation methods. They also called for clarity surrounding funding for research into treatment.

Unclear how vaccine triggered condition

While the vast majority of Pandemrix recipients had no adverse effects, there are now 1,698 adults and children across Europe registered in the EU database of adverse drug reactions who have developed narcolepsy following use of the H1N1 vaccine. While GlaxoSmithKline (GSK), the maker of Pandemrix, has acknowledged the link, and some patients and their families have been awarded compensation, how the vaccine triggered the condition is unclear.

Peter Todd, a solicitor who represents 88 injured people, compared the situation to the thalidomide scandal of the late 1950s and early 1960s. “Everybody is aware of thalidomide, but I think Pandemrix/narcolepsy is a bigger incident because the EU’s database has 1,698 people registered – and that’s a passive surveillance system,” he told i.

Similar to Thalidomide

“While there were hundreds of cases of birth defects caused by thalidomide, most cases involved shortening of one limb. I know that there were a few cases of multiple limbs shortening, but most cases were one and overall, if you weigh it up, it’s broadly comparable. Yet it doesn’t have the same public recognition.

“It’s now about seven years on from the pandemic and it did take considerable time for the epidemiology of Pandemrix and narcolepsy to become clear – the UK’s study in relation to adults and Pandemrix/narcolepsy was only published earlier this year. While the science is now settled you can’t find any clear acceptance of the incident on any EU or national government website. You can’t point to anything that amounts to official recognition. That’s why recognition from the EU is so important.”

‘Round-the-clock care for my daughter’

img_2684
Mathilda, now 10, needed extreme measures to improve her condition

Narcolepsy is incurable and sufferers have a lifetime of managing the symptoms. Claire Crisp’s daughter Mathilda is one of the children affected following her swine flu vaccination. She began suffering extreme night-time sleep disturbance within two weeks of the vaccine and subsequently developed cataplexy. Within two months Mathilda, now 10, needed round-the-clock care.

“Mathilda was eventually diagnosed with narcolepsy with cataplexy,” Ms Crisp, 46, told i from the family home in California, where they felt compelled to go to seek help. “What followed was a year of battling for effective treatment whilst Mathilda continued to deteriorate.

“My husband looked for a job in California, which was not in our life plan, but we were desperate as carers, as a family, and convinced that if Mathilda didn’t get the treatment she needed, she would lose her childhood.

“Mathilda’s case was extreme, and extreme measure were needed to rescue her. I did everything I could to give her her life back. It was huge risk as we sold our home [to pay for treatment] and left our families and lives back in the UK. But I could never have lived with myself if I didn’t fight for her.”

Ms Crisp has written a book on her family’s trauma called Waking Mathilda – A Memoir of Childhood Narcolepsy, to be released this spring.

Mr Todd said: “We don’t want to undermine the vaccine or do down [its maker] GSK, but … for those that have been affected, it is quite important to have some kind of official recognition of what happened.”

Irish government fights claims by children with narcolepsy after Pandemrix swine flu vaccine


http://www.belfasttelegraph.co.uk/news/republic-of-ireland/irish-government-fights-claims-by-children-with-narcolepsy-after-pandemrix-swine-flu-vaccine-34770780.html

 

Irish government fights claims by children with narcolepsy after Pandemrix swine flu vaccine

 

Irish government fights claims by children with narcolepsy after Pandemrix swine flu vaccine

By Eilish O’Regan

Published 03/06/2016

The Irish government is fighting compensation claims by children who developed an incurable sleeping disorder after getting the Pandemrix swine flu vaccine.

This is despite a Government-commissioned report saying the Pandemrix jab left susceptible children at 14 times greater risk of developing the condition.

It said other “unspecified factors” may also have played a role.

The first legal stage of the cases will come before the High Court next week when an order for discovery of documents from the Department of Health and the vaccine manufacturer GlaxoSmithcline (GSK) will be sought.

Solicitor Michael Boylan of Augustus Cullen Law, who represents 60 of the children, revealed yesterday that he is shocked the State is denying liability and fighting the families.

It is denying it owes a duty of care to the children who received the vaccine.

“They are denying everything and putting us on proof of everything. Denying a duty of care is very radical.”

Mr Boylan said the Irish expert group found a 14-fold increase in the incidence of narcolepsy among children vaccinated, compared to those who did not get the jab.

The untested vaccine was rushed out during global panic over the swine flu pandemic in the winter of 2009 and 2010.

Read more

Swine flu jab linked to narcolepsy

Irish doctors must return flu vaccine over narcolepsy fears  

The pandemic turned out to be much milder than feared but parents were strongly urged by senior medical officers in the Department of Health and public health experts to have children, who were a risk group for the virus, vaccinated.

However, some 80 children who received the vaccine went on to develop the sleeping disorder narcolepsy.

The rare disorder causes people to feel drowsy or to suffer spontaneous ‘sleep attacks’. They can sometimes experience loss of muscle power and fall. This can be triggered by stimulus like laughter.

All of the young people, many of whom are now teenagers or young adults, are on medication to stay awake during the day or sleep at night.

Mr Boylan said the children allege negligence by the State and GSK in the circumstances where they were administered an untested vaccine and/or that the vaccine was a defective product.

Parents were not made aware of the fact that it was untested, he added.

At the time the vaccine was issued, GSK got the then government to grant the drugs giant indemnity from any potential compensation claims.

Mr Boylan said: “Other countries like Switzerland, America, Poland and Australia would not give a licence to the vaccine.

“They were afraid it was not fully tested.”

He said boosters were included in the vaccine, which increase the body’s immune response to the jab.

“It is not clear why the manufacturing process for the vaccine in Quebec in Canada, where no cases of narcolepsy followed, was different to that of the drugs plant in Dresden.”

Children in several other countries have been compensated; some through no-fault vaccine redress schemes.

In the Netherlands, some children have got payouts of nearly €1m and the sums demanded here are likely to be in seven figures, he added.

“If you look at the public health leaflets at the time they state ‘it stops with you.’

“People were made to feel they had a civic duty to get the vaccine to stop the plague.”

He said the health effects are devastating for many of the children.

Most also have cataplexy, in which they “collapse like a puppet” and have suffered accidents like falls down stairs or crashes through glass panes in showers.

Mairead Hilliard, whose son Alex (11) developed narcolepsy after the jab, said yesterday the condition has left the young people on life-long medication and at risk of never meeting their full potential.

The compensation is needed because of the debilitating effect it has on their ability to live a normal life, she said.

They are all growing up now and some are students who find they are fighting the illness all the time, and there is no cure for it, she added.

Irish Independent

Background

Pandemrix, a vaccine used in response to the swine flu pandemic that began in 2009, increased children’s risk of narcolepsy – a chronic disorder which causes excessive daytime sleepiness, research suggests. For every 55,000 doses delivered around one child developed the condition, said health experts.

The research, published in the British Medical Journal, examined 75 children aged between four and 18 who were diagnosed with narcolepsy from January 2008 and who attended sleep centres across England. Researchers from the Health Protection Agency (HPA) and Papworth and Addenbrooke’s hospitals in Cambridge found that 11 of these had received the vaccine before their symptoms began.

After adjusting for clinical conditions, the authors associated the vaccination with a 14-fold increased risk of narcolepsy. In absolute numbers, this means that one in 52,000 to 57,500 doses are associated with narcolepsy, said the authors. Since 2011, the use of the vaccine in people under the age of 20 across Europe has been restricted following reports of increased cases of the sleep disorder – which is characterised by periods of extreme drowsiness, sudden naps, and paralysis attacks.

Are GSK Responsible For This Woman’s Death?…


http://www.mirror.co.uk/news/uk-news/nursery-nurse-killed-herself-after-8610711

Nursery nurse ‘killed herself after developing sleep disorder after she received swine flu vaccine’

Katie Clack, 23, became depressed after developing narcolepsy in 2009 and jumped to her death from a car park five years later

PA Katie Clack as a coroner has concluded it is "most likely" that the nursery nurse developed the sleep disorder narcolepsy as a result of receiving a swine flu vaccination
Katie Clack fell from a car park after developing the sleep disorder narcolepsy

A nursery nurse killed herself after becoming depressed over a sleep disorder which “most likely” developed after she received a swine flu vaccination, an inquest heard.

Katie Clack, 23, became depressed after developing narcolepsy in 2009.

She jumped to her death from the top of a multi-storey car park in Peterborough in September 2014.

Her narcolepsy had led to her sleeping for up to 19 hours per day on occasions and her mental health worsened.

An inquest in Stamford heard that the Peterborough woman did not want the vaccine but was required to take it for her job.

Recording a narrative conclusion, Paul Cooper, acting senior coroner for South Lincolnshire, said studies showed there were “significantly raised odds of narcolepsy after (being given the) Pandemrix” vaccine in those aged 18 and above.

Hoax caller warned if she swears at anyone she could face a jail sentence

“On the available evidence on the association between vaccination with Pandemrix and onset of narcolepsy it seems most likely that receipt of this vaccine in December 2009 caused Miss Clack’s narcolepsy,” said Mr Cooper.

He added that narcolepsy triggers depression, though he noted the case of Ms Clack was “complex and very rare”.

A statement issued on behalf of Ms Clack’s family said: “Katie was an energetic young woman who had just discovered her passion working with children.

“Narcolepsy turned her life into a terrible daily struggle and drastically reduced her quality of life.

“We cannot believe she would have decided to take her own life had the balance of her mind not been disturbed.”

Ms Colvin added: “The Clack family has waited a long time for this inquest.

“It is important that the coroner has recognised the casual link between the vaccine and narcolepsy and the devastating impact this had on Katie’s short life.”

Earlier this year a boy who developed the sleeping disorder caused by the swine flu vaccine was awarded £120,000 in damages.

Josh Hadfield, 10, from Frome in Somerset, developed narcolepsy after receiving the Pandemrix vaccine six years ago.

In 2013, lawyers launched a class action on behalf of 38 Britons – including 19 children – who developed narcolepsy after having the vaccine.

Scientists from the former Health Protection Agency (HPA) said there was evidence of a link between the Pandemrix jab – manufactured by GlaxoSmithKline(GSK) – and narcolepsy in children.

HPA figures suggested one in 55,000 children vaccinated – about 20 in the UK – are thought to have developed narcolepsy.

Josh was awarded the money after an appeal against the Government, which had initially refused to pay as he was not “severely disabled” enough.

Speaking at the time, a spokesman for GlaxoSmithKline said: “We remain committed to carrying out additional research into the potential role of Pandemrix in the development of narcolepsy.”

It was also supporting investigations into reported cases.

Across Europe, about 31 million people are thought to have received the Pandemrix jab.

Narcolepsy is a rare but serious neurological disorder that affects about 31,000 people in Britain.

The condition can cause massive disruption to sleep and daily life.

A Department of Health spokesman said: “Katie’s death was tragic and we offer our sympathies to her family.

“Pandemrix vaccine was used to prevent serious illness and deaths during the swine flu pandemic in 2009/10.

“At the time, the possible association with narcolepsy was not known.”

Narcolepsy Boy Harmed From GSK Vaccine (Pandemrix-H1N1) Wins Damages


http://www.bbc.com/news/uk-england-somerset-35472926

A boy with a rare sleeping illness caused by a swine flu vaccine has won £120,000 in damages.

Josh Hadfield, 10, from Frome in Somerset, developed narcolepsy after receiving the Pandemrix vaccine six years ago.

He was awarded the money after appealing against the government which had initially refused to pay as he was not “severely disabled” enough.

His mother Caroline Hadfield said winning was a “huge relief”.

Families are entitled to £120,000 through the Vaccine Damage Payments Scheme, but only if they can prove “severe” disability.

Josh’s narcolepsy was triggered after he was given the H1N1 2009 influenza vaccine, known as Pandemrix, made by GlaxoSmithKline, in January 2010.

He also suffers from cataplexy, which affects muscle control, but he had shown no symptoms of the illness before being vaccinated.

Image caption In January Josh was “wired up” for a sleep study at St Thomas Hospital in London

Ms Hadfield said: “It will help secure Josh’s future. It’s just a shame we had to jump through this amount of hoops to get this far.”

She said her son was “coping” and had to have “one to two sleeps” during the school day.

“Josh has had to work incredibly hard because he misses lessons due to sleep and medical appointments,” she said.

She added he had also had a large weight gain caused by the condition and his medication.


The Hadfield’s solictor Suzanne Williams said she was “incredibly pleased” for Josh: “To succeed in the appeal, we had to satisfy the tribunal that he had a 60% disablement or more and they, in fact, concluded that he was 72% disabled based upon his present symptoms.

“They were also critical of the medical evidence provided by the secretary of state which they considered had not taken into account the whole picture.”

Pandemrix was most widely used in the UK during the 2009-10 flu pandemic and given to almost a million British children between six months and five years old.

Image copyright Caroline Hadfield
Image caption Josh’s mother Caroline Hadfield said his cataplexy sometimes caused “complete body collapse”

A spokesman for GlaxoSmithKline said: “We remain committed to carrying out additional research into the potential role of Pandemrix in the development of narcolepsy.

“We are also supporting ongoing work from other experts and organisations investigating reported cases of the condition.”

The vaccine, which is no longer used, has also been linked to narcolepsy in children from Finland, Sweden and Ireland.


Matthew Hill, Points West Health Correspondent

The link between Pandemrix and narcolepsy was first suggested by studies in Finland and Sweden where a review of 75 children who developed the disorder had a tenfold increased risk of the condition within six months of having the jab.

This was confirmed by another study in 2012 in Ireland showing a 13-fold increase in youngsters between five and 19 years of age.

There are about 100 other cases in the pipeline, so it seems the awarding of £120,000 to Josh Hadfield is only the start.


Narcolepsy facts

• Narcolepsy is a rare illness, with around 10 new cases per million people every year

• The main symptom is falling asleep suddenly

• The cause of narcolepsy remains unclear

• Some people may be predisposed to the condition by their genetics

• Suggested initial triggers include infections such as measles or mumps, accidents and the hormonal changes that take place in puberty

• It most often begins between the ages of 15 and 30


Josh Hadfield’s story was featured on BBC Radio 4’s File on 4. You can listen online or download the programme here.

GSK bills UK government $92 million to compensate victims who were brain-damaged by its own vaccine for swine flu


GSK bills UK government $92 million to compensate victims who were brain-damaged by its own vaccine for swine flu

(NaturalNews) It looks like there’s more trouble in Vaccineland, as UK-based jab giant GlaxoSmithKline (GSK) has been exposed for peddling a swine flu vaccine that caused brain damage in potentially thousands of children. But rather than be held responsible, GSK is actually billing the UK government the equivalent of about $92 million to pay for damages, which means taxpayers are footing the bill.

Reports indicate that dozens of Pandemrix victims from the UK will be awarded about $1.5 million each in British pounds for permanent health damage caused by GSK’s Pandemrix vaccine. One in 16,000 people who took the vaccine, it turns out, are said to have developed narcolepsy and/or cataplexy, two neurological diseases that disrupt normal sleep patterns and muscle function.

The U.S. Centers for Disease Control and Prevention (CDC) describes narcolepsy as “a chronic neurological disorder caused by the brain’s inability to regulate sleep-wake cycles normally.” The agency also admits that Pandemrix, which was widely administered during the manufactured 2009 swine flu “pandemic,” increases one’s risk of developing narcolepsy.

During the 2009/10 swine flu outbreak, some 60 million people received the Pandemrix jab. Based on a risk of one in 16,000, this suggests that nearly 4,000 people have likely developed one of the neurological diseases, with many more cases expected to emerge in the coming months. If each case is paid out at the roughly $1.5 million rate, taxpayers could be forced to shell out upwards of $5.6 billion in damages.

“There has never been a case like this before,” stated Peter Todd, a lawyer representing many of the claimants, to the Sunday Times (as quoted by the International Business Times). “The victims of this vaccine have an incurable and lifelong condition and will require extensive medication.”

GSK refused to supply governments with Pandemrix vaccines unless first granted total immunity from liability

Throughout Europe, where Pandemrix was primarily administered — no Pandemrix vaccines were administered in the U.S., as the vaccine was never licensed and approved for use there — there have been about 800 reported cases of injuries from the vaccine in children. Besides inducing sleep randomly, narcolepsy damages mental function and memory, and can lead to hallucinations and mental illness.

Similarly, cataplexy causes sufferers to suddenly lose consciousness during times when they’re experiencing heightened levels of emotion, including when they’re laughing. The condition is said to be incurable, and sufferers are constantly at risk of having “sleep attacks,” including when they’re working, driving, operating heavy machinery or performing other tasks that require one’s full attention.

What many of the people who took the Pandemrix vaccine probably didn’t realize, however, as they lined up like herded sheep to get jabbed is that GSK refused to supply the vaccine to governments without first being indemnified against any damage claims. The $92-or-so million now being shelled out, in other words, isn’t actually coming out of its own profits.

According to the International Business Times, GSK will, in fact, have to pay the bill as required for damages caused by its Pandemrix vaccine. But it will then claim the money back from the government, meaning taxpayers in the various countries where Pandemrix was administered will end up footing the bill for their own injuries.

“There’s no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries – and probably in most countries,” stated Emmanuelle Mignot, a specialist in sleep disorders at Stanford University, to Reuters.

Mignot, it turns out, was actually paid by GSK to investigate the effects of Pandemrix, and even he came to the conclusion that the vaccine is dangerous and can cause permanent neurological damage in some people.

Sources for this article include:

http://www.ibtimes.co.uk

http://www.cdc.gov

Scientists find new evidence on GSK vaccine link to narcolepsy


GSK harming children again…

http://www.reuters.com/article/2015/07/01/us-health-narcolepsy-vaccine-idUSKCN0PB5PN20150701?feedType=RSS&feedName=healthNews

Health | Wed Jul 1, 2015 2:19pm EDT

Scientists find new evidence on GSK vaccine link to narcolepsy

Scientists investigating why a GlaxoSmithKline flu vaccine triggered narcolepsy in some people say they have the first solid evidence the rare sleep disorder may be a so-called “hit-and-run” autoimmune disease.

The researchers were trying to find out why, of two different flu vaccines widely deployed during the 2009/2010 swine flu pandemic, only one — GSK’s Pandemrix — was linked with a spike in cases of narcolepsy.

In a study published in the journal Science Translational Medicine, they said the answer could lie in a protein in the H1N1 flu strain found in high amounts in the GSK shot but at much lower levels in the other vaccine, Novartis’ Focetria.

“It was a really exciting moment,” Lawrence Steinman, a professor of neurology and neurological sciences who led the work at Stanford University, said of the finding.

A spokeswoman for GSK, whose Pandemrix vaccine was withdrawn from the market after the 2009/2010 pandemic, said the company was aware of the study and would “review it carefully”.

“We are actively conducting research into the observed association between Pandemrix and narcolepsy and the interaction this vaccine might have had with other risk factors in those affected,” she said in an emailed comment.

Narcolepsy is an incurable, lifelong brain disorder that disrupts normal sleep-wake cycles and causes severe nightmares and daytime sleep attacks that can strike at any time.

Scientists are not sure exactly what causes it, but the latest research suggests it is a type of auto-immune disease, where the immune system misfires and mistakenly attacks the body’s own functions and organs.

Studies in countries where GSK’s Pandemrix vaccine was used in the 2009/2010 flu pandemic — including Britain, Finland, Sweden and Ireland — have found a significant rise in cases of narcolepsy in children.

Narcolepsy patients have been shown to have a loss of function in “wakefulness” cells called hypocretin cells in one of the brain’s sleep centres.

In their study, Steinman’s team found that H1N1 pandemic flu contains a protein whose structure partly mimics a portion of a hypocretin receptor in the brain. This H1N1 protein was contained in both vaccines studied, but at much higher levels in GSK’s Pandemrix than in Novartis’ Focetria.

The scientists said they now believe the narcolepsy in people vaccinated with Pandemrix was caused by a so-called “hit and run” mechanism, in which high levels of the H1N1 protein stimulated the production of large amounts of antibodies to both the virus and the hypocretin receptor.

(Editing by Larry King)

Apart From Dealing With The GSK Global Bribery Scandal… What Will GSK Do To Help The Narcolepsy Sufferers Damaged From Their Pandemrix H1N1 Swine Flu Vaccine?


Probably nothing…

They usually get away (scot-free) with damaging the public with dodgy, ineffective, defective and dangerous drugs and vaccines..

They’ve been doing it for decades

and they almost always get away with it…

 

http://www.reuters.com/article/2013/01/22/us-narcolepsy-vaccine-pandemrix-idUSBRE90L07H20130122

Insight: Evidence grows for narcolepsy link to GSK swine flu shot

STOCKHOLM Tue Jan 22, 2013 7:26am EST

Emelie Olsson falls asleep as he watches television in her apartment in Stockholm, January 17, 2013. Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunised in 2009 with the Pandemrix H1N1 swine flu vaccine made by British drugmaker GlaxoSmithKline. Picture taken January 17, 2013. REUTERS-Ints Kalnins
Emelie Olsson shows her paintings in Stockholm January 17, 2013. REUTERS-Ints Kalnins

 

 

 

 

 

 

 

1 of 13. Emelie Olsson falls asleep as he watches television in her apartment in Stockholm, January 17, 2013. Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunised in 2009 with the Pandemrix H1N1 swine flu vaccine made by British drugmaker GlaxoSmithKline. Picture taken January 17, 2013.

 

Narcolepsy diagnosis in Sweden and Finland

(Reuters) – Emelie Olsson is plagued by hallucinations and nightmares. When she wakes up, she’s often paralyzed, unable to breathe properly or call for help. During the day she can barely stay awake, and often misses school or having fun with friends. She is only 14, but at times she has wondered if her life is worth living.

Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy, an incurable sleep disorder, after being immunized with the Pandemrix H1N1 swine flu vaccine made by British drugmaker GlaxoSmithKline in 2009.

Finland, Norway, Ireland and France have seen spikes in narcolepsy cases, too, and people familiar with the results of a soon-to-be-published study in Britain have told Reuters it will show a similar pattern in children there.

Their fate, coping with an illness that all but destroys normal life, is developing into what the health official who coordinated Sweden’s vaccination campaign calls a “medical tragedy” that will demand rising scientific and medical attention.

Europe’s drugs regulator has ruled Pandemrix should no longer be used in people aged under 20. The chief medical officer at GSK’s vaccines division, Norman Begg, says his firm views the issue extremely seriously and is “absolutely committed to getting to the bottom of this”, but adds there is not yet enough data or evidence to suggest a causal link.

Others – including Emmanuel Mignot, one of the world’s leading experts on narcolepsy, who is being funded by GSK to investigate further – agree more research is needed but say the evidence is already clearly pointing in one direction.

“There’s no doubt in my mind whatsoever that Pandemrix increased the occurrence of narcolepsy onset in children in some countries – and probably in most countries,” says Mignot, a specialist in the sleep disorder at Stanford University in the United States.

30 MILLION RECEIVED PANDEMRIX

In total, the GSK shot was given to more than 30 million people in 47 countries during the 2009-2010 H1N1 swine flu pandemic. Because it contains an adjuvant, or booster, it was not used in the United States because drug regulators there are wary of adjuvanted vaccines.

GSK says 795 people across Europe have reported developing narcolepsy since the vaccine’s use began in 2009.

Questions about how the narcolepsy cases are linked to Pandemrix, what the triggers and biological mechanisms might have been, and whether there might be a genetic susceptibility are currently the subject of deep scientific investigation.

But experts on all sides are wary. Rare adverse reactions can swiftly develop into “vaccine scares” that spiral out of proportion and cast what one of Europe’s top flu experts calls a “long shadow” over public confidence in vaccines that control potential killers like measles and polio.

“No-one wants to be the next Wakefield,” said Mignot, referring to the now discredited British doctor Andrew Wakefield who sparked a decades-long backlash against the measles, mumps and rubella (MMR) shot with false claims of links to autism.

With the narcolepsy studies, there is no suggestion that the findings are the work of one rogue doctor.

Independent teams of scientists have published peer-reviewed studies from Sweden, Finland and Ireland showing the risk of developing narcolepsy after the 2009-2010 immunization campaign was between seven and 13 times higher for children who had Pandemrix than for their unvaccinated peers.

“We really do want to get to the bottom of this. It’s not in anyone’s interests if there is a safety issue that needs to be addressed,” said GSK’s Begg.

LIFE CHANGED

Emelie’s parents, Charles and Marie Olsson, say she was a top student who loved playing the piano, taking tennis lessons, creating art and having fun with friends. But her life started to change in early 2010, a few months after she had Pandemrix. In the spring of 2010, they noticed she was often tired, needing to sleep when she came home from school.

But it wasn’t until May, when she began collapsing at school, that it became clear something serious was happening.

As well as the life-limiting bouts of daytime sleepiness, narcolepsy brings nightmares, hallucinations, sleep paralysis and episodes of cataplexy – when strong emotions trigger a sudden and dramatic loss of muscle strength.

In Emelie’s case, having fun is the emotional trigger. “I can’t laugh or joke about with my friends any more, because when I do I get cataplexies and collapse,” she said in an interview at her home in the Swedish capital.

Narcolepsy is estimated to affect between 200 and 500 people per million and is a lifelong condition. It has no known cure and scientists don’t really know what causes it. But they do know patients have a deficit of a brain neurotransmitter called orexin, also known as hypocretin, which regulates wakefulness.

Research has found that some people are born with a variant in a gene known as HLA that means they have low hypocretin, making them more susceptible to narcolepsy. Around 25 percent of Europeans are thought to have this genetic vulnerability.

When results of Emelie’s hypocretin test came back in November last year, it showed she had 15 percent of the normal amount, typical of heavy narcolepsy with cataplexy.

The seriousness of her strange new illness has forced her to contemplate life far more than many other young teens: “In the beginning I didn’t really want to live any more, but now I have learned to handle things better,” she said.

TRIGGERS?

Scientists investigating these cases are looking in detail at Pandemrix’s adjuvant, called AS03, for clues.

Some suggest AS03, or maybe its boosting effect, or even the H1N1 flu itself, may have triggered the onset of narcolepsy in those who have the susceptible HLA gene variant.

Angus Nicoll, a flu expert at the European Centre for Disease Prevention and Control (ECDC), says genes may well play a part, but don’t tell the whole story.

“Yes, there’s a genetic predisposition to this condition, but that alone cannot explain these cases,” he said. “There was also something to do with receiving this specific vaccination. Whether it was the vaccine plus the genetic disposition alone or a third factor as well – like another infection – we simply do not know yet.”

GSK is funding a study in Canada, where its adjuvanted vaccine Arepanrix, similar to Pandemrix, was used during the 2009-2010 pandemic. The study won’t be completed until 2014, and some experts fear it may not shed much light since the vaccines were similar but not precisely the same.

It all leaves this investigation with far more questions than answers, and a lot more research ahead.

WAS IT WORTH IT?

In his glass-topped office building overlooking the Maria Magdalena church in Stockholm, Goran Stiernstedt, a doctor turned public health official, has spent many difficult hours going over what happened in his country during the swine flu pandemic, wondering if things should have been different.

“The big question is was it worth it? And retrospectively I have to say it was not,” he told Reuters in an interview.

Being a wealthy country, Sweden was at the front of the queue for pandemic vaccines. It got Pandemrix from GSK almost as soon as it was available, and a nationwide campaign got uptake of the vaccine to 59 percent, meaning around 5 million people got the shot.

Stiernstedt, director for health and social care at the Swedish Association of Local Authorities and Regions, helped coordinate the vaccination campaign across Sweden’s 21 regions.

The World Health Organisation (WHO) says the 2009-2010 pandemic killed 18,500 people, although a study last year said that total might be up to 15 times higher.

While estimates vary, Stiernstedt says Sweden’s mass vaccination saved between 30 and 60 people from swine flu death. Yet since the pandemic ended, more than 200 cases of narcolepsy have been reported in Sweden.

With hindsight, this risk-benefit balance is unacceptable. “This is a medical tragedy,” he said. “Hundreds of young people have had their lives almost destroyed.”

PANDEMICS ARE EMERGENCIES

Yet the problem with risk-benefit analyses is that they often look radically different when the world is facing a pandemic with the potential to wipe out millions than they do when it has emerged relatively unscathed from one, like H1N1, which turned out to be much milder than first feared.

David Salisbury, the British government’s director of immunization, says “therein lies the risk, and the difficulty, of working in public health” when a viral emergency hits.

“In the event of a severe pandemic, the risk of death is far higher than the risk of narcolepsy,” he told Reuters. “If we spent longer developing and testing the vaccine on very large numbers of people and waited to see whether any of them developed narcolepsy, much of the population might be dead.”

Pandemrix was authorized by European drug regulators using a so-called “mock-up procedure” that allows a vaccine to be authorized ahead of a possible pandemic using another flu strain. In Pandemrix’s case, the substitute was H5N1 bird flu.

When the WHO declared a pandemic, GSK replaced the mock-up’s strain with the pandemic-causing H1N1 strain to form Pandemrix.

GSK says the final H1N1 version was tested in trials involving around 3,600 patients, including children, adolescents, adults and the elderly, before it was rolled out.

The ECDC’s Nicoll says early warning systems that give a more accurate analysis of a flu strain’s threat are the best way to minimize risks of this kind of tragedy happening in future.

Salisbury agrees, and says progress towards a universal flu vaccine – one that wouldn’t need last-minute changes made when a new strain emerged – would cuts risks further.

“Ideally, we would have a better vaccine that would work against all strains of influenza and we wouldn’t need to worry about this ever again,” he said. “But that’s a long way off.”

With scientists facing years of investigation and research, Emelie just wants to make the best of her life.

She reluctantly accepts that to do so, she needs a cocktail of drugs to try to control the narcolepsy symptoms. The stimulant Ritalin and the sleeping pill Sobril are prescribed for Emelie’s daytime sleepiness and night terrors. Then there’s Prozac to try to stabilize her and limit her cataplexies.

“That’s one of the things that makes me feel most uncomfortable,” she explains. “Before I got this condition I didn’t take any pills, and now I have to take lots – maybe for the rest of my life. It’s not good to take so many medicines, especially when you know they have side effects.”

(This story has been corrected to insert full name in first paragraph)

http://www.independent.ie/lifestyle/health/learning-to-live-with-the-nightmares-of-narcolepsy-30179896.html

Alex Lawless, who developed narcolepsy after taking Pandemrix, with his mum Mairead. Picture: Ronan Lang

Terrifying hallucinations, aggressive behaviour, and threats of self-harm – the nightmare of narcolepsy has devastated the life of Dublin schoolboy Alexander Donovan.

The nine-year-old must take a 20-minute nap in school each morning at 10am, and another 30-minute doze in the afternoon when he returns to the family home in Rathgar.

This is despite the strong medication which his mother, Mairead Lawless, says, is actually licensed for use by adults, but which is crucial to keep Alex alert in the mornings, and provide the deep night-sleep denied him by his debilitating condition.

“It’s a struggle to keep him awake enough to do his homework.He struggles to concentrate and focus, and finds it difficult to pay attention in school. He can be very bad-tempered when he’s tired and he’s a very different child to what he was.”

Her son, she says, can no longer find the energy for the sports he once adored – while other boys of his age are out kicking footballs and getting into mischief, his mother says all Alex wants to do is sit on the sofa.

Once an active, outgoing child, who was full of energy and had lots of friends, Alexander has become quiet, lacking in energy and unable to participate in activities with his pals.

He pushes himself to do Cub Scouts and plays hockey once a week at school, says his mum, but it’s a major effort.

“He cannot go on public transport on his own – he has to be with someone or he will fall asleep,” she reveals.

Alex was just five years old when he received the Pandemrix vaccine (for swine flu) in January 2010. His mother, father Ray and older sister Eleanor were also vaccinated.

About three months later, at the beginning of April, Lawless, a bank manager, started to notice that Alex was falling asleep at odd times – even on very short car journeys.

She brought him to the family GP. Blood tests showed only a slightly lowered iron and white blood cell count.

By mid-May there was no improvement.

Still falling asleep at peculiar times, Alex was now also enduring horrifying nightmares. “He became very scared of the dark and said he was seeing things – and it started to get a bit scary.

“He was sleeping for up to three hours in the afternoon after coming home from school. He’d become very aggressive and irrational after waking up. Sometimes he’d start screaming while sleeping – but his eyes would be open,” she recalls.

Alex, she says, repeatedly asked her why she couldn’t see the terrifying things he was seeing.

“I became afraid that he had psychological issues,” Lawless recalls. “He was seeing things that I could not see and became angry when I couldn’t see them.”

She later discovered that her child was having what are called hypnogogic hallucinations which is a symptom of narcolepsy.

“You’re effectively awake, but still dreaming and not distinguishing between dream and reality,” Lawless explains.

More consultations and tests followed, but by February 2011 Alex put on a lot of weight – another symptom of narcolepsy as Lawless was to discover.

A formerly slim child, Alex, now aged nearly six, was wearing trousers for a nine-year-old.

At one point Lawless did suggest the possibility that Alex had narcolepsy but was told that this was extremely rare in children and that she should rule it out.

The tests continued, but nothing showed up.

Then, in February 2011 Alex started to talk about self-harm. “I was finding red marks down his arm, where he’d been scratching his nails along the inside of his arms.”

One day after he had misbehaved, she put him on ‘time-out’ and instructed him to sit on the bottom step of the stairs:

“He said he didn’t want to be alive anymore and was very distressed – he said that he wanted to strangle himself.”

His energy levels plummeted. “He had to give up the Gaelic football, because he was too tired and emotional for it – and he was not able to play games with his friends. It was an horrific time,” she says.

“Alex was acting so out of character that we knew there was something going on. At times he’d have been behaving like somebody possessed; he was so aggressive, argumentative and irrational in the afternoons.

“This was a complete change from the gentle, placid and happy child he used to be.”

Then, in March 2011 the breakthrough came – another mother showed Lawless a newspaper article about a girl who seemed to be displaying similar symptoms.

“My hair stood up on end,” she recalls. “The article was about a girl who had all of the same symptoms as Alex – falling asleep, nightmares and so on.”

Things moved very quickly after that – following more tests Alex was officially diagnosed with narcolepsy in August 2011.

“Soon afterwards we got in touch with other children who had had the vaccine, and they all had symptoms like Alex and they were getting a diagnosis of narcolepsy.”

In 2011, Lawless joined other parents in establishing the organisation SOUND, (Sufferers of Unique Narcolepsy Disorder) which supports families affected by narcolepsy and also received the Pandemrix vaccine. There are currently more than 60 such families in the group.

It’s now believed more than 70 children in Ireland developed narcolepsy after receiving the swine flu vaccine.

Sound has four members who were adults when vaccinated, says Lawless. “Adults have also been affected although so far the numbers making themselves known to Sound are small in comparison with the number of children to date.”

The group successfully campaigned for supports to be put in place for the affected children, though Lawless emphasises, these are on a temporary basis.

“We got a number of supports put in place for the children and adults – these include discretionary medical cards which can be reviewed annually, as well as expenses for narcolepsy-related medical expenses.”

The medication is very expensive – the night-time medication alone can cost up to €25,000 a year, she says.

“In addition to that, we organised for the children attending to be assessed for education needs – there is now an allowance for extra tuition,” she says.

“Our children have a life-long condition which not only affects their childhood but will affect their work and study for the rest of their lives.”

Health Minister James Reilly recently detailed the services being provided to people with narcolepsy following pandemic vaccination, but Lawless says these have not yet been confirmed to SOUND as permanent supports: “These are not permanent and there is a concern that they could be withdrawn at any time,” she says.

She also questions the minister’s interpretation of research carried out by renowned US narcolepsy expert Dr Emmanuel Mignot.

Referring to a paper by Dr Mignot, which was published online in October 2012, Mr Reilly said that in the majority of narcolepsy cases, appropriate medication and lifestyle modifications could see functioning restored to about 80pc of normal.

According to Dr Mignot, a return to close to normal functioning was possible in about 80pc of cases through a combination of lifestyle changes and pharmaceutical treatment tailored to each individual.

His study advised that many patients with narcolepsy benefited best from combined drug therapy and behavioural modifications – scheduled napping one to three times a day, for example, while certain drug treatments had found to be of benefit to patients.

However, Ms Lawless points out, the treatments alluded to by the minister when quoting from Dr Mignot’s research are actually not deemed suitable for children

“The issues we have with the minister’s interpretation is that the therapeutic treatments that are referred to by Mignot are not licensed/recommended for use by children,” she says.

Referring to another piece of research published in December 2012 by experts at Stanford Medical Centre, with which Dr Mignot was also very closely associated, Dr Reilly said it indicated that narcolepsy was an autoimmune disorder, and that it was now possible to explore new therapies which may have more beneficial effects.

However, Ms Lawless said SOUND believed that the fruits of the research referred to by the minister were “so far in the future” that the children would be grown up by the time such therapies were available.

As a result, she believed they would be disadvantaged both educationally and career-wise.

“As our children go through education, they face huge difficulty maintaining focus and concentration which in turn will impact on exam results.

“We fear they will be discriminated against in job applications and employment due to their requirement to take naps and a propensity to lose focus/attention.

“They will likely be limited in operation of machinery including driving a car which curtails independence in itself, let alone ruling out many types of employment.”

Lawless also pointed out that although the research indicated that the majority could reach up to 80pc of normal function, that still left a sizeable number who would not reach that level of functioning.

“Furthermore,” she asks, “should we be happy about our children functioning at 80pc of normal capacity?”

GlaxoSmithKline, the makers of Pandemrix said: “Patient safety is our number one priority and we are actively conducting research on the observed association between Pandemrix and narcolepsy and on the interaction this vaccine might have had with other risk factors in affected individuals.

“Whilst people vaccinated with Pandemrix have been shown in several published studies to be more likely to develop narcolepsy than those who were not, further research is needed to confirm what role Pandemrix may have played in the development of narcolepsy among those affected.

“Narcolepsy is a complex disease and has a number of different potential contributory factors.

“The causes of narcolepsy are not yet fully understood but it is generally considered to be associated with genetic and environmental factors, including infections.

“It is crucial that we learn more about how narcolepsy is triggered.

“We remain committed to carrying out additional research into the potential role of Pandemrix in the development of narcolepsy.

“We are also supporting ongoing work from other experts and organisations investigating reported cases of the condition.”

(Reporting by Kate Kelland; Editing by Will Waterman)

 

dralisonbarrett

the ecosystem approach to obgyn

My Life in my 60's

Finding joy in my 60's

The Vile Mint

Poetry, Short Stories and Violent Ideas

POSITIVELY HERE

"HAVE NO FEAR OF PERFECTION, YOU'LL NEVER REACH IT" - Salvador Dali

Rebel City Writers

A radical perspective on local, national and international issues from the pens of a few disgruntled agitators!

Critical Dispatches

Reports from my somewhat unusual life

~ L to the Aura ~

sustainability. compassion. inspiration.

In the Wake of Suicide....trying to understand

....I love You beyond words. Save me Lord. I will not let go of You. Hear me O' Lord. In Christ's Powerful Name Amen ~ Brandon Heath

Heroes Not Zombies

becoming not being.......

DES Daughter Network

Because Social Media increases Awareness and brings the DES Community Together

recovery network: Toronto

people can and do recover from what is sometimes called "mental illness"

Deidra Alexander's Blog

I have people to kill, lives to ruin, plagues to bring, and worlds to destroy. I am not the Angel of Death. I'm a fiction writer.

%d bloggers like this: