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.

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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.

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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”.

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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.”

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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.”

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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.

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“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.”

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Hey Andrew Witty And Emma Walmsley? What Do You Have To Say To This Kid About Your Pandemrix Drug? Was Patient Safety The Number One Priority Or Was It Profits For GSK?


Swine flu jab made me see dead people’: Boy, 11, left with devastating sleeping sickness after jab

http://www.irishmirror.ie/news/swine-flu-jab-made-see-10008955

 

Tragic Sam Forbes needs around 15 naps a day and sees and smells dead people in his nightmares after having the NHS jab in the 2010 epidemic when he was four

Sam Forbes and his mum Di (Photo: Nigel Bennett)

The family of a boy who developed the sleeping sickness narcolepsy after a swine flu injection is hoping for victory after a five-year fight for compensation.

Tragic Sam Forbes needs around 15 naps a day and sees and smells dead people in his nightmares after having the NHS jab in the 2010 epidemic when he was four.

The lad, now 11, was also left with 13 other chronic or severe neurological problems caused by the Pandemrix vaccine given to six million people.

Yet even though a link between the drug and narcolepsy has been established by Public Health England – with just one in 55,000 inoculated affected – the Government has spent five years fighting compensation claims.

Now Sam’s parents Di and Mick are hoping a Court of Appeal decision last month, upholding another narcolepsy victim’s claim, will end her battle for ­justice for her son.

Sam with his dad before he had the jab (Photo: Nigel Bennett)
Di Forbes with her son Sam (Photo: PA)

Di said the family nightmare began shortly after his jab with the vaccine, made by GSK. “It was a friend who first noticed a change in Sam’s behaviour,” Di reveals.

“He said Sam was being naughty and different to his usual self. He’s a bright child, but he started falling behind at school and struggling with basic spelling. And his behaviour got worse.”

Sam’s health deteriorated and he had a string of hospital appointments before doctors discovered his narcolepsy.

Sam has to have around 15 naps a day (Photo: Nigel Bennett)

They also found he has catoplexy – similar to epilepsy but longer lasting.

And his heat regulation system is damaged, meaning that even in warm sunshine he can develop hypothermia.

As well as sometimes falling down asleep in the street, he suffers anxiety and depression – and is plagued by nightmares.

Sam Forbes with his parents Di and Mick (Photo: Nigel Bennett)

Di, 50, said: “In his dreams he can see and smell dead people. One night he came downstairs and told us he could smell rotting meat in his dreams.

“He would wake up terrified and then we would get him back to sleep. But the dreams would start again where they left off.”

Di, of Batley, West Yorks, had to quit her job at an engineering business to become Sam’s full-time carer.

Sam sees dead people in his dreams (Photo: Nigel Bennett)

She said: “We want compensation so Sam can enjoy a better quality of life.” Sweden, Finland, Norway, Iceland and France have already compensated Pandemrix narcolepsy sufferers.

“Our Government refused to acknowledge a link until 2013 – but have always fought claims.

The case upheld by the Court of ­Appeal was of a seven-year-old boy.

Sam Forbes with his parents Di and Mick (Photo: Nigel Bennett)

The DWP acknowledged a ‘causal link’ between his narcolepsy and the vaccine, but the case focused on whether he was disabled enough for compensation.

Fears the Government would go to the Supreme Court were allayed by Di’s local MP Tracy Brabin who called a debate in Parliament that helped open the way for other sufferers to claim.

She said: “In these rare, traumatic cases it’s only right the Government steps up”.

Sam about to have one of his 15 daily naps (Photo: Nigel Bennett)

Experts estimate 100 people in the UK were affected. The pay-out is a one-off £120,000.

A Government spokesman said: “All decisions take into account the specific circumstances of each case.”

GSK said: ­“Patient safety is our No1 priority. It is crucial we learn more about how narcolepsy is triggered.

Di added: “We want to be able to move on. It feels like we have been fighting for so long.”

EU health chief: children suffered ‘terrifying experiences’ from swine flu vaccine side effects


https://inews.co.uk/essentials/news/health/eu-health-commissioner-narcolepsy-swine-flu-vaccine/

EU health chief: children suffered ‘terrifying experiences’ from swine flu vaccine side effects

European Health Commissioner Vytenis Andriukaitis said he wanted to prevent any more children suffering narcolepsy as a result of taking the swine flu vaccine Pandemrix.European Health Commissioner Vytenis Andriukaitis said he wanted to prevent any more children suffering narcolepsy as a result of taking the swine flu vaccine Pandemrix. (AFP PHOTO/Emmmanuel Dunand (Photo credit should read EMMANUEL DUNAND/AFP/Getty Images)

The EU Commissioner for Health and Food Safety has told i how Europe is preparing for another swine flu pandemic he hopes will avoid the previous “terrible outcome” where narcolepsy was triggered in around 100 British children following their vaccination against the disease.

Vytenis Andriukaitis, a heart surgeon, said the European Union, in conjunction with the World Health Organisation (WHO) and other agencies, is drawing up new plans following “lessons learned” on how the 2009/10 swine flu outbreak was handled.

A main goal is to “increase flexibility” by addressing the response needed for pandemics of differing severity, from unknown to mild, moderate or severe.

“More research will be conducted together with other independent and EU-funded research to shed light on the causes of narcolepsy, such as how the vaccine might be able to trigger or unmask the condition.”

Vytenis Andriukaitis, EU Commissioner for Health and Food Safety

Following the last outbreak, there were huge delays in delivering the pandemic vaccine, Pandemrix, to certain countries. Communicating the risk versus benefits of the vaccine was considered extremely difficult and some nations reported a loss of public confidence in vaccination, in general, the EU found.

It has promised to increase transparency of the decision-making process, especially in relation to vaccine procurement. Although millions of people received the swine flu vaccine Pandemrix in 2009 without complications, it was subsequently shown to have devastating side effects in a number of people, especially children.

Around 1,700 adults and children across Europe are now registered in the EU database of adverse drug reactions as suffering from the lifelong neurological condition narcolepsy following their vaccination.

Mr Andriukaitis said he was upset about hearing from some of the children and their families at a recent meeting in Brussels where they called on him to launch a pan-EU wide inquiry into the cases that were triggered by use of the Pandemrix vaccine to treat the 2009/10 swine flu outbreak.

Almost 1,700 adults and children in total across Europe are registered in the EU database of adverse drug reactions who now suffer from the lifelong neurological condition as a result.

Earlier this month, the government lost a five-year legal battle at the Court of Appeal over vaccine injury payments.

The judgment was handed down following the battle between the Department for Work and Pensions (DWP) and the family of an anonymous child known as ‘John’, following his diagnosis of the incurable neurological condition and an application in 2012 to the government’s compensation scheme under the Vaccine Damage Payment Act.

The DWP had appealed against an order ordering it to pay John, now 14, £120,000 compensation. Many other families, whose cases had been put on hold pending the outcome, should now receive the same compensation.

“I was very sorry and sad to hear again of the terrifying experience of the children and their families – and I expressed my personal words of sympathy to them [in Brussels],” Mr Andriukaitis told i.

EU funding

“In the Commission, we are funding research into the sleep disorders, including narcolepsy, with nearly EUR 30 million allocated through the Seventh Framework and Horizon 2020 research programmes.”

Mr Andriukaitis said epidemiological studies relating to Pandemrix vaccination in several European countries had indicated an increased risk of narcolepsy in vaccinated – as compared with unvaccinated – individuals.

“Patient safety is paramount to me – I am a medical doctor. It is also the absolute priority of the Commission.”

Vytenis Andriukaitis

The commissioner said the marketing authorisation holder, responsible for reviewing and assessing data to support a medicinal product, has committed to continue to collect and submit any new data related to narcolepsy to the European Medicines Agency (EMA), including after the expiry of Pandemrix authorisation in 2015.

“Patient safety is paramount to me – I am a medical doctor,” Mr Andriukaitis said. “It is also the absolute priority of the Commission. And I would like to reassure you that a medicine, including a vaccine, can only be placed on the EU market after an authorisation has been granted based on a positive assessment of the benefit-risk balance related to its use.

“But this is not enough. This is why, after the initial authorisation, the safety of a product is followed during its whole life-cycle. The Commission and the Member States work together in the Health Security Committee to strengthen pandemic influenza preparedness and crisis management in the EU by updating national pandemic influenza preparedness plans. To this end, work on a guide for influenza pandemic plan will be finalised in the committee soon.”

Further research needed

Mr Andriukaitis said GSK, the makers of Pandemrix, has carried out further research into the link between its drug and narcolepsy.

“More will be conducted together with other independent and EU-funded research to shed light on the causes of narcolepsy, such as how the vaccine might be able to trigger or unmask the condition. All data will be reviewed by EMA’s Committee for Medicinal Products for Human Use as soon as they become available.

“As European decision-makers, our constant objective is to prevent such terrible situations from occurring again.”

Claire Crisp, whose daughter Mathilda needs round the clock care after she developed narcolepsy following her Pandemrix vaccination, said she could only take comfort in another swine flu vaccination program if various measures were guaranteed.

They include “complete transparency” on behalf of the manufacturers GSK and the EU with respect to the content of the vaccine and potential side effects with the information available to every consenting patient.

“I am not anti-vaccine. I am pro-health, pro-science and pro-choice when it comes to vaccinations,” she said.

“Parents should have access to information pertaining to the content of vaccines and whether or not clinical trials were completed. The lack of transparency and honesty on behalf of GSK and the British government harmed hundreds of children who have been devastated by an incurable neurological disorder that requires round the clock treatment. This must never happen again.”

What is swine flu?

Swine flu is an infection caused by any one of several types of swine influenza viruses, the best known arguably the H1N1 virus. It is a respiratory disease caused by influenza viruses that infect the respiratory tract of pigs and result in a barking cough, decreased appetite, nasal secretions, and listless behavior.

The virus can be transmitted to humans.

Swine flu was initially seen in humans in Mexico in 2009. The virus appeared to be a new strain of H1N1 which resulted when a previous triple reassortment of bird, swine and human flu viruses further combined with a Eurasian pig flu virus, leading to the term “swine flu”.

Unlike most strains of influenza, H1N1 does not disproportionately infect adults older than 60. This was an unusual and characteristic feature of the H1N1 pandemic. Even in the case of previously very healthy people, a small percentage will develop pneumonia or acute respiratory distress syndrome (ARDS).

Glaxo’s Swine Flu Jab Pandemrix..


http://www.standard.co.uk/news/health/sleep-disorder-sufferers-await-ruling-over-role-of-swine-flu-jab-a3447096.html

Sleep disorder sufferers await ruling over role of swine flu jab

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Almost 100 people who claim they developed narcolepsy after receiving the swine flu vaccine hope a landmark case could pave the way to compensation following a seven-year battle.

The Court of Appeal will this week consider a government bid to overturn a 2015 Upper Tribunal ruling that gave £120,000 to a boy damaged by the vaccine Pandemrix when he was seven.

The then-work and pensions secretary, Iain Duncan Smith, had accepted that the trial vaccine caused the incurable daytime sleep disorder in the boy, now 14 and known only as “John”.

However, the Department for Work and Pensions denied his disabilities were severe enough to pass the 60 per cent threshold to trigger a payout under the Vaccine Damage Payments Act. This was rejected by the Upper Tribunal but the Government went on to appeal.

John’s lawyer Peter Todd, of Hodge Jones & Allen, who represents 88 of the 94 UK victims, said: “As narcolepsy is a spectrum disorder, there is a range of severity. John is probably at the most severe end. If he doesn’t qualify then pretty much nobody would.”

25katieclack2301a.jpg

Victim: Katie Clack, who took her own life as a result of the incurable condition

About six million UK residents were given the vaccine during the 2009-10 H1N1 swine flu pandemic.

At the time, no approved vaccine was available so the Government agreed to indemnify drugs giant GSK against future claims in return for the use of Pandemrix, a trial vaccine. At the time, the link with narcolepsy was unknown. More than 1,500 cases of narcolepsy allegedly caused by Pandemrix are registered on an EU database.

In the UK, only two sufferers apart from John have had compensation — Josh Hadfield, 10, from Somerset, and nursery nurse Katie Clack, 23, of Peterborough. Her award was posthumous after she took her own life as a result of the condition.

The Government appeal focuses on its belief John’s level of disability should be measured against another child of that age and exclude the impact of the disability on his later life as an adult.

The DWP said the Government did not accept a general causal link between Pandemrix and narcolepsy. It said: “We await the Court of Appeal judgment and it would not be appropriate to comment further.” Defeat for the Government would trigger civil claims against GSK. The drugs giant declined to comment.

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.”

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

Boy, 12, left disabled by his swine flu jab wins £120,000 compensation payout after three-year legal battle by his family


Boy, 12, left disabled by his swine flu jab wins £120,000 compensation payout after three-year legal battle by his family

  • The vaccine triggered debilitating narcolepsy that has ruined the boy’s life
  • Opens the door for 100 more families who believe the jab caused problems
  • Others lost jobs and dropped out of university due to the sleeping disease 

A young boy left severely disabled by the swine flu vaccine has been awarded £120,000 in damages after a three-year legal battle by his family.

Lawyers for the 12-year-old successfully argued that the vaccine had triggered debilitating narcolepsy in the boy.

He has only one friend, struggles in school and may never be able to drive as a result.

Devastating: The impact of the vaccine has ruined the lives of those who suffered narcolepsy as a result

Devastating: The impact of the vaccine has ruined the lives of those who suffered narcolepsy as a result

The Government had insisted the rare sleeping disorder ‘was not serious enough’ for compensation to be paid.

But the illness has left the boy, whose family asked to remain anonymous, unable to get the bus or even shower by himself, according to a report in the Guardian.

The ruling open the doors for compensation claims from 100 other families who believe their children were affected by the jab.

The Pandemrix vaccine was administered to six million people in the UK during the swine flu outbreak of 2009 and 2010. Scientists now believe it triggered narcolepsy – a rare life-long brain disorder which sees the sufferer fall asleep in random locations at inappropriate times – in a handful of cases..

Other alleged victims have lost their jobs and dropped out of university after the disease made daily life unbearable.

Peter Todd, the solicitor for the boy’s family, told The Guardian: ‘They felt quite insulted to have their condition basically dismissed as something quite trivial.

‘They are incredibly needy. Some have lost their jobs, dropped out of university or seen their marriages break down as a result.’

Mr Todd is representing 74 other families who believe they have been affected in the same way.

The upper tribunal heard that the child’s extreme tiredness had made him ‘disruptive’ at school and unable to socialise with his peers.

A similar case is being brought by the family of Mathilda Crisp, who was just three years-old when she got the jab.

Mathilda was the youngest known person in the world to be diagnosed with the sleeping disorder.

Her mother Claire is seeking compensation from the government after the little girl started suffering terrifying nocturnal hallucinations and excruciating pain.

Claire, 44, a former NHS physiotherapist, thought she was playing safe when she had Mathilda vaccinated.

Cure: It was introduced to save children from the impact of swine flu but had an unexpected effect on some

Cure: It was introduced to save children from the impact of swine flu but had an unexpected effect on some

Doctors had suggested her daughter could be at particular risk from respiratory trouble from swine flu because she was born with a minor throat condition, laryngomalacia, which obstructs breathing. Children normally grow out of it by three.

‘We took the swine flu risk seriously since Mathilda had only recently outgrown laryngomalacia,’ says Claire, who also has a son, Elliot, and another daughter, Liberty.

But Mathilda’s first troubling symptoms developed within two weeks of the jab.

Her sleep became disturbed, leaving her exhausted in the day. Then she began to suffer from hallucinations at night, thinking there were demons in her bedroom.

Within six months, Claire and her husband Oliver, a professor of theology, were housebound caring for Mathilda. She was taken to a children’s hospital for what Claire calls ‘a series of failed visits’.

Initially, doctors thought she had a brain tumour, but after tests they ruled that out. ‘The doctors quickly wrote us off as an anxious mother and a pain-in-the-a*** child.’

The family was being referred to a psychiatric unit when a locum doctor from India diagnosed narcolepsy, which normally appears at around the age of 15.

Stanford University in California finally confirmed a diagnoses of narcolepsy based on blood samples sent to them.

Last night the Department of Health declined to comment on the case.

A spokesman for the Department of Work and Pensions said: ‘The Vaccine Damage Payments Scheme provides support in very rare cases where someone has become severely disabled as a result of immunisation against certain diseases. Decisions on claims take into account the individual circumstances of each case and the latest available medical evidence.’

He added that they do not comment on individual cases.

And They Call Us “Conspiracy Theorists”…


From CNN MONEY 2005.

http://money.cnn.com/2005/10/31/news/newsmakers/fortune_rumsfeld/

Rumsfeld’s growing stake in Tamiflu
Defense Secretary, ex-chairman of flu treatment rights holder, sees portfolio value growing.
October 31, 2005: 10:55 AM EST
By Nelson D. Schwartz, Fortune senior writer

NEW YORK (Fortune) – The prospect of a bird flu outbreak may be panicking people around the globe, but it’s proving to be very good news for Defense Secretary Donald Rumsfeld and other politically connected investors in Gilead Sciences, the California biotech company that owns the rights to Tamiflu, the influenza remedy that’s now the most-sought after drug in the world.

Rumsfeld served as Gilead (Research)’s chairman from 1997 until he joined the Bush administration in 2001, and he still holds a Gilead stake valued at between $5 million and $25 million, according to federal financial disclosures filed by Rumsfeld.

The forms don’t reveal the exact number of shares Rumsfeld owns, but in the past six months fears of a pandemic and the ensuing scramble for Tamiflu have sent Gilead’s stock from $35 to $47. That’s made the Pentagon chief, already one of the wealthiest members of the Bush cabinet, at least $1 million richer.

Rumsfeld isn’t the only political heavyweight benefiting from demand for Tamiflu, which is manufactured and marketed by Swiss pharma giant Roche. (Gilead receives a royalty from Roche equaling about 10% of sales.) Former Secretary of State George Shultz, who is on Gilead’s board, has sold more than $7 million worth of Gilead since the beginning of 2005.

Another board member is the wife of former California Gov. Pete Wilson.

“I don’t know of any biotech company that’s so politically well-connected,” says analyst Andrew McDonald of Think Equity Partners in San Francisco.

What’s more, the federal government is emerging as one of the world’s biggest customers for Tamiflu. In July, the Pentagon ordered $58 million worth of the treatment for U.S. troops around the world, and Congress is considering a multi-billion dollar purchase. Roche expects 2005 sales for Tamiflu to be about $1 billion, compared with $258 million in 2004.

Rumsfeld recused himself from any decisions involving Gilead when he left Gilead and became Secretary of Defense in early 2001. And late last month, notes a senior Pentagon official, Rumsfeld went even further and had the Pentagon’s general counsel issue additional instructions outlining what he could and could not be involved in if there were an avian flu pandemic and the Pentagon had to respond.

As the flu issue heated up early this year, according to the Pentagon official, Rumsfeld considered unloading his entire Gilead stake and sought the advice of the Department of Justice, the SEC and the federal Office of Government Ethics.

Those agencies didn’t offer an opinion so Rumsfeld consulted a private securities lawyer, who advised him that it was safer to hold on to the stock and be quite public about his recusal rather than sell and run the risk of being accused of trading on insider information, something Rumsfeld doesn’t believe he possesses. So he’s keeping his shares for the time being.

http://www.smh.com.au/comment/tamiflu-is-the-new-snake-oil-20140416-zqvj8.html

Tamiflu is the new snake oil

Date
April 16, 2014

Dr Joe Kosterich

Millions has been wasted on Tamiflu.Millions has been wasted on Tamiflu. Photo: fairfax

In days of old when the snake oil salesman came to town folks would gather round to hear of miracle cures. Those who were sufficiently impressed would buy some of the salesman’s wares to cure colds, sore toes or a myriad of other ailments. The snake oil salesman would then get back onto his cart and go to the next town.

Times change. Today we have scientific channels, advisory panels and rigorous process to make sure that whatever claims are made are verifiable.

So surely governments around the world could not spend billions of dollars stockpiling a drug which does not actually do anything?

Tamiflu has been a big waste of money.Tamiflu has been a big waste of money.

Could doctors, advisory panels, and health departments have been sold modern day snake oil?

Unfortunately, the answer is yes!

The anti viral drugs Tamiflu (oseltamvir) and Relenza (zanamivir) have been promoted as a treatment for influenza. But most specifically, they have been claimed to reduce transmission of influenza and reduce complications such as pneumonia. Governments have bought them so that they can be released in the event of an epidemic.

But recent research has found that these drugs are little more than today’s snake oil potions. A review of 46 studies on more than 24,000 people has shown that they do not prevent people catching the flu. They do not reduce the rate of complications or hospitalisations. At best, they might reduce the length of the illness by about half a day.

Let me repeat that- it shortens the course of influenza by half a day, at best!

How could so much money get spent on something of so little value? That is because the drug manufacturers refused to release most of the data that is now available.  Only information from drug trials, which showed a positive effect from the drug, was previously published.

The British Medical Journal and independent Cochrane Collaboration had been fighting for four years to get hold of all the data so that it could be independently examined and to answer the very basic question – does it work?

Obviously the manufacturers are keen to put the best spin on their products. But they are not the only ones culpable here. There are numerous problems to fix.

Between 48% and 89% of researchers involved in clinical trials of new treatments have been found to have undeclared conflicts of interest. This occurs  where the company that has a new drug being studied may pay them directly or indirectly.

Medical research needs to be cleaned up.

Governments look to advisory panels for independent advice. Some 75% of doctors on panels, which make recommendations about disease definitions and management, have ties to the pharmaceutical industry.

Any advisory board must have totally independent members.

 The facts show that every influenza “epidemic” since 1918 has had fewer deaths than the one before.  Predictions about millions of deaths from, Avian flu, SARS and Swine flu all turned out to be completely wrong.

Each year in Australia there are around 2500 deaths associated with influenza. Some 98% of these are due to secondary pneumonia in people of an average age of 87(which is older that the average life expectancy).

The annual “killer flu” hype needs to be toned down.

Is the flu really so fearsome? For the vast majority of people it will be up to a week of feeling unwell followed by a full recovery. There are exceptions and whilst tragic, they are very rare and are not always understood or preventable.

Governments like to be seen to be doing something. Wendy Barclay from Imperial College London best summed this up telling Reuters: “If another pandemic came tomorrow, and the government had no drug to treat thousands of influenza infected patients, I imagine there would be public outcry”.

She sums the situation up very well – the public expects the government to provide a medication, which does not work for an illness, which will go away by itself.

Maybe deep down we still want to buy the snake oil and the salesman is still ready to assist us.

Read more: http://www.smh.com.au/comment/tamiflu-is-the-new-snake-oil-20140416-zqvj8.html#ixzz2z76m6aXj

Ben Goldacre Slams Roche For Tamiflu Scam, Yet No Mention of GSK for Relenza?..


roche_logo

The UK government has spent £473 million on Tamiflu and £136 million on Relenza since 2006, and other countries have stockpiled it too.

When the government made the decision to stockpile the medications its medicines regulator MHRA had not seen all of the evidence” 

(From AllTrials : http://www.alltrials.net/2014/we-need-all-information-from-clinical-trials-to-make-decisions-about-medicines-tamiflu-relenza-study-shows/)

_________________________________________________________

In a recent post I drew attention to how Roche and GSK basically defrauded the UK Government/Tax Payer out of almost half a billion pounds by stockpiling the practically useless drugs, Tamiflu ( by Roche) and Relenza (by GSK).

The post was basically an article I pasted by Sarah Boseley, of the Guardian, in it she mentions how the UK wasted money on both flu drugs. See Here:

Britain had stockpiled these flu drugs in case of an outbreak and after the (media induced) hysteria about Swine Flu died down, subsequent inquiries in recent times, found that not only was the supposed epidemic merely media hype, but the supposed effectiveness of both the drugs in question were also vastly over hyped too.

It is estimated that over half a billion pounds was wasted on these drugs, with Roche’s Tamiflu costing the lions share at over 400 million while Glaxo’s Relenza cost the country almost 136 million pounds.

The vast majority of media reports about the Swine Flu Scam have included the names of both companies and both drugs, apart from,
it seems Ben Goldacre’s reporting, also, in the Guardian

I think Mr Goldacre should explain why he consistently berates Roche for Tamiflu, yet rarely challenges (or focuses his attention on) GSK about their misdeeds.(see here)

Is there a little favoritism here towards GSK on the part
of Mr Ben Goldacre perhaps?…

I have written before about his strange admiration for GSK’s Andrew Witty…

See the link-

https://truthman30.wordpress.com/2013/11/19/ben-goldacre-bad-pharma/

Here is the headline from Ben Goldacre’s spin on the
Swine flu scam:

http://www.theguardian.com/business/2014/apr/10/tamiflu-saga-drug-trials-big-pharma

“What the Tamiflu saga tells us about drug trials and big pharma

“We now know the government’s Tamiflu stockpile wouldn’t have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there’s a lot we don’t know about other medicines we take”

I have read through the whole article, and although it is extremely lengthy, there is not one mention of GSK’s flu drug Relenza, or the fact that, according to the other reports (including from Ben’s Alltrials website) Relenza cost the UK almost one hundred and thirty six million pounds…

Ben does mention GSK in his report, but he mentions them in a positive context (however there is no mention of the Relenza scam, GSK’s behavior in the Swine Flu swindle, or the 136 million of their wasted stockpile).

It’s almost as if Goldacre has chosen to omit GSK’s large part in this scandal

Ben Says:

“While the battle for access to Tamiflu trials has gone on, the world of medicine has begun to shift, albeit at a painful pace, with the European Ombudsman and several British select committees joining the push for transparency.

“The AllTrials campaign, which I co-founded last year, now has the support of almost all medical and academic professional bodies in the UK, and many more worldwide, as well as more than 100 patient groups, and the drug company GSK.”

Goldacre also mentions the amount of ‘half a million’ wasted pounds, but he only mentions it in relation to Tamiflu, which gives the distinct impression than it was only Roche with Tamiflu (and not, in part, also GSK with Relenza) that defrauded the UK people and the UK government out of this money…

Make from that what you will…

Ben goes on to say:

“Should we have spent half a billion on this drug?

That’s a tricky question. If you picture yourself in a bunker, watching a catastrophic pandemic unfold, confronting the end of human civilisation, you could probably persuade yourself that Tamiflu might be worth buying anyway, even knowing the risks and benefits”.

And in any case, that £500m is the tip of the iceberg. Tamiflu is a side show, the one place where a single team of dogged academics said “enough” and the company caved in.

For a comparison  with Ben’s reporting, see some of the other headlines and articles below:

_________________________________________________________
From Alltrials:
“The UK government has spent £473 million on Tamiflu and £136 million on Relenza since 2006, and other countries have stockpiled it too. When the government made the decision to stockpile the medications its medicines regulator MHRA had not seen all of the evidence”.
“Full access has allowed us, for the first time, to quantify the harms and the lack of benefits of Tamiflu and Relenza, which have been extensively stockpiled around the world. What we need to do now, is have the courage to make all clinical study reports available for treatments that are currently available and used.”
______________________________________
“Dr Ben Goldacre, author and co-founder of AllTrials:
This is a pivotal moment. Tamiflu has become the poster child for clinical trials transparency”

Whereas, presumably, now GSK have become the poster-child for ethics?..

The mind boggles…

Ben Says:
“there’s a lot we don’t know about other medicines we take”…
There certainly is a lot we don’t know about medicines  Ben.. but there’s also a lot we don’t know about the pharmaceutical companies who make them.. considering what we do know is dreadful, appalling, disturbing and sinister… then what we don’t know would likely be utterly horrifying…
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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.

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