“…The BMJ recently ran an extraordinary article by Peter Doshi, followed by an editorial from Fiona Godlee, that hinged on the fact that GSK’s swine flu vaccine Pandemrix causes narcolepsy. For lots of people this wasn’t new. For the many takers of the vaccine who were tortured by it and left unable to function afterwards, if not actually dismembered, particularly children, there was little doubt as to what had happened….”
Where is the outrage? GlaxoSmithKline suppressed clear danger signals from vaccination with Pandemrix. The result, to begin with, was the suffering of a large number of children and adolescents who developed narcolepsy. Peter Doshi is to be commended for dispassionate reporting of the facts, but I am frustrated by his cool rhetoric in the face of what I believe are acts of greed and cruelty.
The facts reported by Doshi are new, but the pattern of behavior is not. The manufacturers and their professional surrogates are past masters at doing research that shows short-term vaccine efficacy but that does not reveal serious adverse effects. They always end up saying, as in this case, that “there is no proof of a causal association.” Such behavior might be forgiven if influenza vaccines were real lifesavers, but we still do not know if they have done more good than harm in the long run. I am not alone in making this assertion.
Not long ago Gaffney and Lexchin said that US and Canadian pharmaceutical systems, “…are dysfunctional. Costs are exorbitant, commercial goals distort drug development, misleading promotion fosters misuse, and medications are too often unaffordable for patients.” (BMJ 2018;361:k1039) Much the same can be said for the development and promotion of vaccines in the last 10-15 years.
I get frustrated and angry about the promotion of some drugs and vaccines, but I am saved from despair by the efforts of professionals like Doshi and his colleagues who keep plugging away at the facts.
A leading medical journal has warned that serious safety “indicators” were raised over the swine flu vaccine Pandemrix in 2009 – almost two years before the vaccine was finally suspended from use in Ireland.
‘The British Medical Journal’ published a major investigation into the use of the drug across Europe where it is now linked to cases of narcolepsy or severe sleep disorders in children.
Last night, one solicitor acting for Irish children who developed narcolepsy said it was “a scandal” families have been fighting for justice for seven years while the State was aware of such data.
Support group Sufferers of Unique Narcolepsy Disorder (SOUND) said the report was “shocking and utterly appalling.”
The British report relies on multiple European investigations and ongoing legal actions over the drug, manufactured by GlaxoSmithKline (GSK).
Last August, a major Irish Independent investigation revealed some children received a double dose of Pandemrix when stocks of the vaccine were used from January 2011 amid fears there would be a shortfall for the normal winter flu jab.
Thousands of children received a single vaccine dose in 2009/2010 at the height of swine flu scare.
But the 2011 re-issue was almost two years after research data showed indicators that Pandemrix had a far higher rate of adverse incidents than other comparable vaccines.
Pandemrix was re-issued to GPs nationwide in 2011 despite the fact major studies were already under way in Sweden and Finland into potential links with narcolepsy.
Re-issued in Ireland on January 7, 2011, the vaccine was recalled on March 28, 2011 when both studies indicated there was a likely link to narcolepsy.
The new UK study revealed that even in 2009 there were indications Pandemrix had a rate of adverse reactions far higher than other vaccines.
It calculated Pandemrix had a 500pc greater rate of “adverse events” reported than another swine flu vaccine.
In Ireland, Pandemrix was only made available before it had completed its testing protocols because the Government had offered GSK a full indemnity.
Almost 100 families are now suing the Government, Health Service Executive and GSK.
Many of the narcolepsy cases are being handled by solicitors Michael Boylan and Gillian O’Connor.
“The fact that the general public were not made aware by the Minister for Health or the HSE that Pandemrix was untested prior to or even during the vaccination programme as adverse data emerged is one of the reasons why we have now served the State defendants with claims for aggravated and exemplary damages,” Ms O’Connor said.
“It is a scandal and totally unacceptable that our clients have had to fight tooth and nail for accountability and appropriate redress for the dreadful injuries caused for the past seven years given that this information has been within the defendants knowledge all this time.”
GSK declined to comment given ongoing legal action.
SOUND said the group was “shocked and appalled” at the report.
“These revelations now present very serious questions for the State, the HSE and GSK as to what exactly happened with Pandemrix.
“These shocking revelations require immediate answers to who knew what and when. We need accountability now,” SOUND co-founder Tom Matthews warned.
The HSE insisted its vaccine selections in 2009 were on the basis of expert medical advice supported by an external panel of experts.
EMA, MHRA and GlaxoSmithKline blast BMJ’s ‘flawed’ pandemic flu vaccine safety report
“…European drug regulatory bodies and GlaxoSmithKline have quickly rallied their rebuttals to a BMJ report that questioned the safety profile of GSK’s now-unavailable pandemic flu vaccine Pandemrix, as well as the lack of transparency over drug information.
In a report based on GSK-made internal safety reports, The BMJ found that during the 2009-2010 H1N1 flu pandemic, GSK had received 5,069 serious adverse event reports for Pandemrix in about six months. It represents a rate of 72 cases per million doses—seven times the rate for two other GSK pandemic flu vaccines combined. The report also criticized the drugmaker and health authorities for not making the information public.
By Wednesday, the European Medicines Agency (EMA), the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and GSK had raised their issues with the article, lambasting its “scientifically inappropriate” methodology and what they saw as an “incorrect” accusation regarding transparency….”
Eight years after the pandemic influenza outbreak, a lawsuit alleging that GlaxoSmithKline’s Pandemrix vaccine caused narcolepsy has unearthed internal reports suggesting problems with the vaccine’s safety. Peter Doshi asks what this means for the future of transparency during public health emergencies
In October 2009, the US National Institutes of Health infectious diseases chief, Anthony Fauci, appeared on YouTube to reassure Americans about the safety of the “swine flu” vaccine. “The track record for serious adverse events is very good. It’s very, very, very rare that you ever see anything that’s associated with the vaccine that’s a serious event,”1 he said.
Four months earlier, the World Health Organization had declared H1N1 influenza a pandemic, and by October 2009 the new vaccines were being rolled out across the world. A similar story was playing out in the UK, with prominent organisations, including the Department of Health, British Medical Association, and Royal Colleges of General Practitioners, working hard to convince a reluctant NHS workforce to get vaccinated.2 “We fully support the swine flu vaccination programme … The vaccine has been thoroughly tested,” they declared in a joint statement.3
Except, it hadn’t. Anticipating a severe influenza pandemic, governments around the world had made various logistical and legal arrangements to shorten the time between recognition of a pandemic virus and the production of a vaccine and administration of that vaccine in the population. In Europe, one element of those plans was an agreement to grant licences to pandemic vaccines based on data from pre-pandemic “mock-up” vaccines produced using a different virus (H5N1 influenza). Another element, adopted by countries such as Canada, the US, UK, France, and Germany, was to provide vaccine manufacturers indemnity from liability for wrongdoing, thereby reducing the risk of a lawsuit stemming from vaccine related injury.45
In an interview with The BMJ, Liam Donaldson, England’s chief medical officer at the time, recalled the situation around the October 2009 roll-out: “The UK had worked for several years on its pandemic influenza plans, as part of a globally coordinated approach. This included, well in advance, establishing the process for developing and introducing a vaccine in such a public health emergency.
“Faced with an emerging pandemic of unknown severity, the process was initiated. The national scientific committee for vaccines (the JCVI) and the statutory medicines regulatory authorities were fully engaged in the procedural steps that led to the introduction and use of the vaccine. This was not a policy decision taken in the absence of such expertise,” he said.
Vaccines against influenza are arguably the only vaccines that a notable portion of healthcare professionals decline despite recommendations.6 And in late 2009, vaccines against the H1N1 swine flu—which was turning out to be a far milder pandemic than officials had predicted—were even more controversial than normal.
In Germany, senior physicians expressed doubts about GlaxoSmithKline’s Pandemrix vaccine. They were concerned about potential side effects triggered by the AS03 adjuvant, an oil-in-water emulsion that it contained to boost effectiveness.7 Then controversy erupted when the German newspaper Der Spiegel reported that top politicians and government employees were going to receive Celvapan, Baxter’s unadjuvanted H1N1 vaccine, not Pandemrix.7
The concerns, it seems, were prescient. A year later, signs of a problem with Pandemrix were emerging through postmarket reports of narcolepsy, predominantly among children and adolescents in Sweden and Finland.8 Multiple academic and government led studies subsequently judged that the relation between Pandemrix and narcolepsy was likely to be causal.91011 Over 1300 people are estimated to have been affected among the roughly 30 million vaccinated across Europe,12 including around 100 families in the UK.13
However, GSK and the European Medicines Agency, which licensed Pandemrix, have not accepted that the association with narcolepsy has been proved to be causal, and research on the topic continues.14 GSK told The BMJ that “further research is needed to confirm what role Pandemrix may have played in the development of narcolepsy among those affected.”
Claims for compensation followed, with many still being fought in the courts.15
Now, eight years after the outbreak, new information is emerging from one of the lawsuits that, months before the narcolepsy cases were reported, the manufacturer and public health officials were aware of other serious adverse events logged in relation to Pandemrix.
In documents obtained through the pretrial discovery process (see supplementary data on bmj.com), prosecutors suing the Irish Minister of Health, Health Service Executive, Health Products Regulatory Authority, and GSK have found a string of GSK postmarketing safety reports that show a striking difference in the number and frequency of adverse events reported for three GSK pandemic vaccines approved and used across the world: Pandemrix, Arepanrix, a similar H1N1 vaccine that also contained AS03 adjuvant, and an H1N1 vaccine without adjuvant (no brand name is given).
The BMJ learnt of the reports from my colleague Tom Jefferson, a medically trained epidemiologist who was hired as an expert witness by the solicitors representing Aoife Bennett, an Irish woman who developed narcolepsy after vaccination with Pandemrix in 2009. Jefferson took on the case in 2015, and last year the lawyers received a copy of the GSK safety reports that had been emailed within the company and to at least one regulator (Ireland). Adverse event tables embedded in nine reports spanning the four months between December 2009 and March 2010 offer a glimpse into the vaccines’ safety profiles.
“When I saw those tables, I just fell off the chair. A consumer can figure out what’s going on here,” Jefferson told me (table 1).
Reproduction of table of adverse event reports from internal GSK report dated 2 December 2009*
Jefferson immediately calculated the adverse event rates for each vaccine, which showed large differences between Pandemrix and Arepanrix. Any real differences between the vaccines would be especially alarming because Pandemrix and Arepanrix are, broadly speaking, the same vaccine manufactured in different facilities and used in different countries. Divergent rates of adverse events might implicate a manufacturing problem.
“The odds ratios, the point estimates, are all high. And some of them are significantly high—5.39 [95% confidence interval 3.70 to 7.85] for deaths [for Pandemrix v the other vaccines],” Jefferson said.
“The thing that struck me was not just that the odds ratios were high, but the fact that nobody had tabulated and analysed them,” he said, pointing out that the GSK reports provided numerator and denominator data sufficient to calculate the odds ratios but did not actually contain those calculations.
The BMJ conducted its own analysis of the adverse events, most of which seem to have been reported spontaneously to GSK (figs 1 and 2). For a range of concerning adverse events, reports were coming in for Pandemrix at a consistently higher rate than for the other two GSK pandemic vaccines–four times the rate of facial palsy, eight times the rate of serious adverse events, nine times the rate of convulsions. Overall, Pandemrix had, proportionally, five times more adverse events reported than Arepanrix and the unadjuvanted vaccine.
Adverse event reports (number/million doses) for GSK pandemic influenza vaccines up to 2 December 2009 (GSK reports number of doses for Arepanrix and the non-adjuvant vaccine together)
Adverse event reports (number/million doses) for GSK pandemic influenza vaccines up to 2 December 2009 (GSK reports number of doses for Arepanrix and the non-adjuvant vaccine together)
And the raw numbers of adverse events were not small. Although it is often said that perhaps only up to 10% of adverse events are reported to national reporting systems,16 by late November, GSK had received 1138 serious adverse event reports for Pandemrix—a rate of 76 per million doses administered. By mid-December, there had been 3280 serious adverse event reports (68/million doses). The last report seen by The BMJ, dated 31 March 2010, shows 5069 serious adverse events for Pandemrix (72/million doses), seven times the rate for Arepanrix and the unadjuvanted vaccine combined.
The data are insufficient to draw conclusions about cause and effect, but for Gillian O’Connor, the solicitor representing Bennett, they raise serious questions about transparency. The disparity, she wrote in an affidavit filed in court, was “of such striking difference that any person contemplating taking the Pandemrix vaccine would be likely, if in receipt of this information, not to choose to have the Pandemrix vaccination.”
Alarm bells that never rang
But neither GSK nor the health authorities seem to have made the information public—nor is it clear that the disparity was investigated. This is in contrast to the reaction to narcolepsy, which quickly made news headlines and was the subject of a GSK press release and investigation17 in a matter of weeks after the first reports from Sweden and Finland.
In many of the GSK reports, the company briefly mentions having conducted “safety reviews”—for example, with respect to anaphylaxis, facial palsy, and Guillain-Barré syndrome. The BMJ asked GSK for a copy of those reviews but it did not provide them.
In a statement, GSK wrote: “After the introduction of Pandemrix, GSK continuously evaluated all available safety data and shared the data with the EMA and other regulatory authorities where the vaccine was licensed so that the authorities could conduct their own independent assessments. EMA made weekly summaries of the data provided by GSK and other manufacturers publicly accessible and they remain accessible through the EMA’s website.”
The BMJ asked GSK whether it ever undertook any investigations to understand the discrepancy in adverse event reporting between Pandemrix and Arepanrix, whether it notified healthcare providers about the discrepancies, whether it considered pulling Pandemrix from the market, or considered recommending Arepanrix or another company’s vaccine. But GSK declined to answer these and all of The BMJ’s questions, citing ongoing litigation.
The BMJ asked the UK Department of Health why it recommended Pandemrix over Baxter’s Celvapan, but the department also declined to comment, calling the question “quite technical” and suggesting we submit a freedom of information request for an answer.
In December 2009 demonstrators in Scotland took to the streets to challenge the government’s swine flu vaccine campaign arguing it was out of step with the mild pandemic.18
The vaccination programme continued in Ireland as well. “The Irish government kept inviting people to get vaccinated,” Jefferson observed. “This was when it was quite clear that the pandemic was on the wane and it was nowhere near the catastrophe portrayed by influenza researchers, governments, industry, and the media.”
Clare Daly, a member of the Irish parliament, called the adverse events after Pandemrix a “completely avoidable catastrophe,” and has been demanding answers for over a year.19 In the Irish National Assembly last year, she told the then prime minister, Enda Kenny, “The Health Service Executive (HSE) decided to purchase Pandemrix and continued to distribute it even after they knew it was dangerous and untested, and before most of the public in Ireland received it.”20 In response, the Taoiseach said that concerns about the safety of Pandemrix and actions by GSK deserve “immediate analysis.” The BMJ requested an update on the investigation from the Irish Department of Health but did not receive a direct answer.
What EMA knew—or could have known—about the comparative safety of GSK’s pandemic vaccines is hard to discern. It told The BMJ that “EMA does not perform comparative benefit and risk evaluations between products approved in the EU, or between EU products and products approved or used outside the EU.”
But, had it wanted to, did the agency have the data to conduct such an analysis? Despite the similarity between the two vaccines, Arepanrix was not authorised in the EU until March 2010, late in the pandemic, and data reporting requirements for the two vaccines differed.
“While it might have been possible to estimate reporting rates based on usage data, which are difficult to obtain during a pandemic, EMA does not have a methodology to compare reporting rates between two products (note that the pandemic influenza pharmacovigilance updates included number of reports, not rates),” an EMA spokesperson said.
Jefferson was uncompelled. “What is the purpose of pharmacovigilance if nobody is acting on the information? This information took eight years to come to light through academic work and litigation. Is this acceptable? If the information at our disposal is partial, that is the direct consequence of secrecy, which should not surround any public health intervention.”
Pandemrix and Arepanrix were designed for a pandemic and were removed from global markets after the pandemic. Whatever adverse events they may have caused, they are vaccines of the past. But the events of 2009-10 raise fundamental questions about the transparency of information. When do public health officials have a duty to warn the public over possible harms of vaccines detected through pharmacovigilance? How much detail should the public be provided with, who should provide it, and should the provision of such information be proactive or passive?
If history were to repeat itself, does the public have a right to know?
This article was amended on 21 September 2018 to correct the date in the legend to figure 1 from 2 October to 2 December.
Competing interests: I have read and understood BMJ policy on declaration of interests and declare I am a colleague of Tom Jefferson, quoted in this story.
Provenance and peer review: Commissioned; externally peer reviewed.
. Increased incidence and clinical picture of childhood narcolepsy following the 2009 H1N1 pandemic vaccination campaign in Finland. PLoS One2012;7:e33723. doi:10.1371/journal.pone.0033723pmid:22470463
Northern Ireland sleep disorder victims sue over claims vaccine was cause
By Brett Campbell
At least three people in Northern Ireland who developed an incurable sleep disorder after receiving a flu vaccine are suing a pharmaceutical giant and the British government.
The UK-wide class action suit is also being taken against a number of companies involved in the production of Pandemrix – including British manufacturer GlaxoSmithKline (GSK) – which remains at the centre of a global narcolepsy controversy.
Almost 350,000 doses of the swine flu vaccine, which included Pandemrix, were issued to protect certain “high risk groups” in NI as part of a mass immunisation campaign in 2009/10.
Six-month-old children and pregnant women were among the recipients, which also included 33,000 healthcare workers and medical students.
At least 119 people in the UK – including dozens of NHS staff – claim they were affected by the vaccine which can trick the human immune system into mistaking the neuropeptide Orexin – a vital regulator of sleep – for the H1N1 virus.
But health officials in England and Northern Ireland deny any link to the vaccine and insist that narcolepsy can occur spontaneously.
The Department of Health in England is involved in the legal action because the UK Government indemnified the company behind Pandemrix in order to expedite production amid fears of a swine flu pandemic. A test case is currently before the High Court in the Republic of Ireland, where dozens of cases have also been reported.
Full clinical trials had not been completed before six million doses were administered in the UK and 30 million across Europe.
The disorder causes sufferers to collapse into a deep sleep without warning, often in the middle of daily tasks such as eating and bathing.
Although there was no known link between Pandemrix and narcolepsy in 2009, campaigners say evidence was beginning to emerge in countries across Europe and as far away as China.
However, the UK Government reissued the vaccine in the 2011 as a seasonal flu jab.
A global spike in narcolepsy prompted the Medicines and Healthcare products Regulatory Agency (MHRA) to conduct a thorough review before EU regulators restricted the licensed use of Pandemrix.
It is no longer licensed at all.
In 2011, Northern Ireland’s chief medical officer Dr Michael McBride said it was typical that new instances of narcolepsy would be reported, but he played down any link to the vaccine.
“The fact that symptoms occur after a vaccination is given does not mean that they have been caused by the vaccine itself, as underlying illnesses and other conditions may be responsible,” he said.
The Department of Health in England and NI continue to assert that view and said narcolepsy can occur “naturally” and “spontaneously”.
A spokesperson for the Department of Health and Social Care in London also said the decision to vaccinate was based on guidance from the Joint Committee on Vaccination and Immunisation and the European Medicines Agency.
They added that it would be “inappropriate” to comment further due to “ongoing personal injury claims”.
A spokesperson for the Department of Health in Stormont said it is only aware of two individuals being affected.
It is feared that others have yet to display the symptoms of narcolepsy – in some cases it manifests itself many years later, such as during puberty.
A GSK spokesperson was unable to comment due to ongoing litigation.
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.
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.
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.
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.
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”.
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”.
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.”
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.
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 , I was having nightmares like you wouldn’t believe and visual hallucinations.”
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.
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.
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.
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.”
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.
“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.
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.
“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.”
An interesting case is brewing in Ireland over GSK’s Narcolepsy inducing vaccine- Pandemrix. It will be interesting to see how the case unfolds, and to what extent the Irish regulator (formerly- IMB- now the HPRA) and GSK, knew (or were aware), of the risks involved with Pandemrix.
Pandemrix was over sold, over-prescribed and over-hyped. There was really no need for these mass vaccinations at the time, but GSK made a tidy profit from it, they hyped it to the max and used every ounce of their power to promote it- and the public were used as guinea pigs.
This is typical GSK behavior, as can be seen from their Seroxat and Avandia debacles of past years, and perhaps also illustrated by their Tafenoquine human guinea pig experiments of the present.
Pandemrix is yet another useless GSK poison that was rushed to market on dodgy ‘evidence’ of effectiveness.
Woman suing State over swine flu jab is one of 70 cases initiated
Kildare woman says she suffered narcolepsey and fainting fits after getting Pandemrix vaccine
Signs posted in Dublin Airport in 2009 warning about swine flu. Photograph: Frank Miller
An action by a woman who claims she suffered narcolepsy after receiving the swine flu vaccine is among 70 cases initiated here over the vaccine.
Aoife Bennett is among those suing the Minister for Health, the HSE and Glaxosmithkline (GSK) Biologicals S.A in the High Court over being given the Pandemrix vaccine against “human swine flu” in the period 2009-2010.
Ms Bennett, from Naas, Co Kildare, claims she suffered injuries including narcolepsey and cataplexy disorder, fainting fits, as a result of being given Pandemrix in 2009.
The application to join the HPRA came after her lawyers discovered information about the vaccine’s safety records furnished by GSK in 2009-10 to the then IMB.
The IMB, which became the HPRA in 2014, is a State body whose role is to protect and enhance public health by regulating medical products.
It is alleged the safety reports show a “particularly striking” difference between the number of adverse effects in those given Pandemrix and a similar vaccine also made by GSK.
Had parents been aware of the “vast difference” in the numbers of people who had adverse effects from the respective vaccines, they would not have given their consent to the administration of Pandemrix to their children, it is claimed.
As a result of the documents, Ms Bennett claims the HPRA owes a duty of care to persons given Pandemrix, including relating to how the safety and appropriateness of the vaccine was monitored.
‘Breach of duties’
She alleges that the manner in which the HPRA performed its functions breached those duties.
William Binchy BL, instructed by solicitor Gillian O’Connor, for Ms Bennett secured permission from Master Edmund Honohan to add the HPRA as a defendant.
In a sworn statement seeking to have the authority joined, Ms O’Connor said the application followed examination of 4,500 documents discovered to the plaintiff by GSK.
The HPRA was not represented at Thursday’s hearing but, in her sworn statement, Ms O’Connor said it has said in correspondence the board would not be admitting any culpability in the matter.
Ms O’Connor said the discovery process had revealed the IMB had data concerning the safety records of Pandemrix which is made in Dresden, Germany and a very similar vaccine also used to treat swine flu made in Quebec, Canada, called Arepanrix.
There are some differences in the manufacturing processes between Quebec and Dresden, Ms O’Connor said.
The safety records show the level of adverse effects in those administered Pandemrix ranged between 10 and 7 times higher than the Canadian made product, she said.
One report from late 2009 stated, of the tens of millions of vaccines administered, there was a serious adverse effect rate of 75.9 per million for Pandemrix compared to 7.9 per million for Arepanrix. The type of adverse effects listed in the reports range from conditions such as convulsions, facial palsy, to stillbirth and fatal outcomes in those who got the vaccines, she said.
Ms O’Connor said the discovered material did not indicate the IMB made the information it had received available to the Minister or the HSE immediately after it was received, or at all.
A representative of the IMB attended all meetings of the National Public Health Emergency Team, which was set up by the Department of Health to oversee the administration of pandemic vaccines, she said.
While discovery is awaited on those meetings, no minutes were recorded regarding adverse effects of Pandemrix at meetings to monitor and oversee the swine flue virus, she said.
A HSE brochure issued to the public in 2009 about swine flu contained information to the effect it was safe to use Pandemrix, it had been appropriately tested and side effects were rare.
Mrs O’Connor said the reality, which she said was known to the Irish Medicines Board, was not all the conclusions contained in the brochure were warranted. Pandemrix was not adequately tested on children and young people before it was licensed, she said.
How many kids were harmed from GSK’s over-hyped and over-sold Flu Vaccine – Pandemrix?
Do you think GSK’s former CEO Andrew Witty gives a second thought to the suffering of these children? or do you think the current CEO -Emma Walmsely- loses a single nights sleep over the suffering of these kids?
“…Andrew Witty, the former long-serving chief executive of UK drugmaker GlaxoSmithKline, has jumped into the biotech venture-capital sector and been hired by a former industry mentor to join Hatteras Venture Partners. Sir Andrew becomes a venture partner at US-based Hatteras. Separately, GSK’s ex-research and development head Moncef Slaoui has joined European venture firm Medicxi. “We are thrilled to welcome Andrew to Hatteras Venture Partners. He brings unparalleled strategic insights and extensive industry experience to the firm and to our portfolio of emerging companies,” said Bob Ingram, general partner of Hatteras….”
Lawyers acting for families who say their children suffered significant health problems following a controversial swine flu vaccine are due in court next month as part an effort to force the State to release crucial documents.
The Health Service Executive (HSE) has now identified 300,000 documents relevant to the case and the Department of Health has 465,000 which need to be examined.
The vaccine, called Pandemrix, has been linked to the sleep disorder narcolepsy. Lawyers for both sides will appear in the High Court on October 5.
The State indemnified the vaccine’s manufacturer, GlaxoSmithKline (GSK), against potential lawsuits. Other European countries did likewise, amid global fears of a swine flu pandemic in 2009.
However, some countries, including Poland and Switzerland, refused to licence it, saying it was insufficiently tested.
More than 60 children may have had their auto-immune system compromised by the vaccine rolled out by as part of a public health campaign in early 2010, according to families.
Irish authorities are fighting the families “tooth and nail” over accepting liability, according to solicitor Michael Boylan, a medical negligence expert with law firm Augustus Cullen, which represents more than 60 children.
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.