Debate In The UK Parliament About GSK’s Dodgy ‘Narcolepsy Causing’ Pandemrix Vaccine…


https://www.theyworkforyou.com/whall/?id=2017-03-08a.318.1&p=24853

Joan Ryan Labour, Enfield North 11:00 am, 8th March 2017

Before the next debate begins, I am pleased to say that, on International Women’s Day, we have a woman Member opening her first Westminster Hall debate and a woman Minister to respond, and of course I am in the Chair. On this day, I thought that was worth remarking on. I call Tracy Brabin to move the motion.

Photo of Tracy Brabin Tracy Brabin Labour, Batley and Spen

I beg to move,

That this House
has considered compensation and the Pandemrix vaccine.

It is a pleasure to serve under your chairmanship, Ms Ryan, on the occasion of my first Westminster Hall debate. I thank my hon. Friend Stephen Twigg for his extensive work on this issue on behalf of his constituent Lucas Carleton. I also thank Mr Speaker for allowing this debate to take place. It is vital that Parliament considers this matter and public awareness is raised.

I will set out the effect that Pandemrix has had on several predominantly child patients and their families and discuss the need for the Government to acknowledge and express regret for what has happened to those patients and provide them with support. I will explain the challenges of accessing the necessary medication for affected people, and I will conclude by making recommendations to the Government.

Before I set out the issue at hand, I wish to be clear that, overwhelmingly, vaccines save lives. Thanks to vaccines, we have seen the eradication and near-eradication of diseases such as smallpox and polio, and I have no intention of discouraging parents from ensuring that their children receive tried and tested vaccinations. Quite the opposite—I want the Government to rebuild and maintain trust in our world-class inoculation programme. However, on occasion, certain vaccines have been shown to have damaged patients, sometimes with life-altering consequences. All precautions should be taken to prevent that from happening, and pharmaceutical companies and the Governments that give those companies indemnity should take immediate and full responsibility when that is shown to have happened and, having accepted responsibility, do all they can to support affected people.

I worked to secure this debate because I believe that Parliament and the Government must listen to and support individuals and families who have been affected by narcolepsy and cataplexy as a result of the Pandemrix vaccine. I became aware of this issue when my constituent Di Forbes came to one of my regular advice surgeries. Di has travelled to Parliament to watch these proceedings, and I hope that she will be able to travel home to Batley and Spen having received some assurances from the Government. Di explained to me the damage that the Pandemrix vaccine has caused her son Sam and the unacceptable battle that she has faced while seeking financial support to secure his long-term care and the appropriate medication for his condition.

By way of background, the Pandemrix vaccine was developed by GlaxoSmithKline and given to 6 million people during the global H1N1—swine flu—pandemic in 2009 and 2010. Owing to the nature of that pandemic, the European Commission, on the advice of the European Medicines Agency, fast-tracked the vaccine’s licensing. The UK Government then undertook a vaccination programme, based on advice from the Joint Committee on Vaccination and Immunisation. In short, Pandemrix was licensed for use in the EU, including the UK, without the usual clinical trials having been completed.

Photo of Julian Sturdy Julian Sturdy Conservative, York Outer

I congratulate the hon. Lady on securing this important debate. My constituent Ben Foy suffers from narcolepsy and cataplexy caused by the Pandemrix vaccine. I raised his case in the House in 2014, 2015 and 2016, and I now do so in 2017. The Department for Work and Pensions accepts the causal link between my constituent’s illness and the Pandemrix vaccine that he received, on NHS advice, in 2010. Does she agree that the Government have a moral obligation to quickly resolve the issue of payments to those who have been so badly affected by Pandemrix, not drag the process out with unsuccessful appeal after unsuccessful appeal, which is what seems to be happening at the moment?

Photo of Tracy Brabin Tracy Brabin Labour, Batley and Spen

I will come on to that point, but I totally and utterly agree. As the hon. Gentleman will know, the Government’s foot-dragging is causing unacceptable and upsetting suffering and distress for the families involved.

Although I acknowledge the difficult balancing act involved in weighing the risk of a pandemic against the risk of fast-tracking a vaccine’s licensing, that does not excuse the fact that some patients were not made aware of the facts, nor does it excuse the Government from subsequently attempting to avoid responsibility for the damage caused. Making the vaccine available at the time of the pandemic clearly came with a degree of risk. GSK was given an indemnity from any liability by the UK Government. My constituent has made it clear to me that she was not informed that the vaccine had not been fully tested or that GSK had obtained an indemnity. Therefore, as the result of advice given to his mother by the NHS, my young constituent Sam received the vaccine on 27 April 2010. He was four and a half years old.

Four months later, concerns were raised in Finland and Sweden about the association between the vaccine and narcolepsy. Following that, a study by the UK Health Protection Agency and others, which was funded by the Department of Health and the HPA, found that around one in every 52,000 to 52,750 Pandemrix jabs led to narcolepsy. The results of that study were published in The BMJ in 2013 and were consistent with the findings of the aforementioned Finnish and Swedish studies. Pandemrix stopped being given to children in the UK in 2011, but that was too late for Sam and dozens of children like him.

Sam has been affected by 14 severe or chronic neurological issues, including narcolepsy and cataplexy. He suffers from night terrors in which he can see and smell dead people. He suffers from a damaged heat regulation system, automatic behaviour, micro-sleeps, temper issues, joint and muscle pain, anxiety and depression. Sam is now 11 years old and has faced unimaginable strain. In addition to being prohibited from enjoying a normal childhood, he lives in a world in which most people know little about his condition and misunderstand his symptoms. Shockingly, on one occasion while Sam was passed out in the street as a result of his condition, a dog walker allowed her dog to urinate on him. No 11-year-old should be expected to face the indignity and pressures that children such as Sam live with as a result of the Pandemrix vaccine.

Tragically, Sam has tried to commit suicide several times. We know from a coroner’s report that one 23-year-old woman took her own life after telling her family that living with narcolepsy after receiving Pandemrix had become unbearable. This is all too desperately sad.

The link between Pandemrix and narcolepsy has had a profound effect on families. My young constituent’s parents have found themselves under immense pressure, and in October 2016 his mum Di had no choice but to call a liquidator into her engineering business. It was impossible for her to work and ensure that her son’s complex care needs were met. Life is unacceptably hard for Di and Sam. They are very grateful to Narcolepsy UK, which receives no assistance from the Government but has been a source of huge support for them.

The Vaccine Damage Payments Act 1979 was intended to help to ease the burden on individuals for whom a specified vaccine had caused severe and permanent disability.

Photo of Jim Shannon Jim Shannon Shadow DUP Spokesperson (Health), Shadow DUP Spokesperson (Transport), Shadow DUP Spokesperson (Equality)

I congratulate the hon. Lady on bringing forward this important case. The Court of Appeal has ruled very clearly on this matter and issued a telling judgment that opens the door to people who have suffered as a result of this so-called vaccine. I believe that its decision enables those people to get the compensation that they need, both physically and morally. Does she feel that the Government must now follow suit and give the go-ahead for compensation to be released?

Photo of Tracy Brabin Tracy Brabin Labour, Batley and Spen

The hon. Gentleman is right. There have been some one-off payments, but they need to be made across the board. The 1979 Act provides for affected patients to receive one-off tax-free payments of £120,000, which would go some way to securing their long-term care needs.

Prior to September 2013, the Government said there was insufficient evidence to establish a causal link between the Pandemrix vaccination and the development of narcolepsy. However, following the aforementioned study commissioned by the Department of Health that recognised the link between Pandemrix and narcolepsy, the Government have conceded and recognised the link.

In spite of the Government’s acceptance of the link between Pandemrix and narcolepsy, they have delayed the processing of applications by denying them, disputing the severity of the disability. They have even appealed a case in which they were ordered to make a payment to one such affected child. In my view, for the Government to make such appeals through the courts system is a poor use of public money and an insult to those families whose lives have already been turned upside down. I hope that the Minister will disclose how much public money has been spent in the courts to delay making payments to those affected by Pandemrix.

Sam’s parents made an application for a vaccine damage payment, which was unsuccessful on the basis that he is not severely disabled enough. For those vaccinated after 31 August 2010, the reason given for refusal is that the vaccine does not fall within the remit of the Act. All appeals against the decision to decline payments are being held up while the Government battle the family of the aforementioned child through the courts. Most recently, the decision for the child to be awarded the payment was upheld at the Court of Appeal. I sincerely hope that Government will accept that outcome and take the case no further.

To give some context to the UK Government’s position, Sweden, Finland, Norway, Iceland and France have already compensated those who developed narcolepsy as a result of the Pandemrix vaccine. Sam is in receipt of disability living allowance, meaning that the Government recognise he is disabled. Why, therefore, do they not consider him to be disabled enough to qualify for a payment under the Vaccine Damage Payments Act? I say to Ministers: spend one day shadowing Sam or another constituent who is living with narcolepsy caused by Pandemrix, and I assure them that they will consider the disability severe enough for a long overdue payment from Government.

In addition to financial support through the Vaccine Damage Payments Act, children affected by Pandemrix require assurances over the long-term development and supply of the drugs that will alleviate their symptoms. Currently, my young constituent receives the drug Xyrem, which is expensive and not licensed for use in children. Sam receives it through a scheme funded directly by the UK Government and GSK, which has been a godsend to him and his family. However, there is a postcode lottery when it comes to access to Xyrem. Many trusts refuse to prescribe the drug, and until recently Sam’s prescription had to be collected from Sheffield Children’s hospital—a 60-mile round trip.

I am advised that the scheme that Sam and others like him currently benefit from is due to end in a year’s time. Sam’s mum advises me that he could not function without it, and as such I ask that the Government either commit to continuing the scheme in the long term or ideally provide an alternative that is secure and accessible to all. I also encourage them to consider opportunities to support research into medicines to alleviate the symptoms suffered by those affected. Clinical understanding of the condition is limited and there is definitely room for improvement.

I have a handful points on which I would be grateful for a response from the Minister. First, by virtue of GlaxoSmithKline requiring an indemnity, there was recognition that the vaccine carried a risk. Reliable studies now link the vaccine to narcolepsy. I would therefore welcome recognition from the Government of what has happened to those affected by Pandemrix and an apology to those families affected both by the incident and by subsequent refusals to provide support. It may be useful if the Government published the terms of the indemnity provided to GSK so that the public are aware of the acknowledgement of the risk carried by the vaccine.

Moreover, in response to my recent written parliamentary question 64695, the Minister said she has no plans to amend the Vaccine Damage Payments Act. I ask her to think again, particularly when considering support for those affected who received the vaccine after August 2011, because it is clear that when the law fails to work for children like my young constituent, it is time for the law to change.

We know that the Swedish, Finnish, Norwegian, Icelandic and French Governments have already made payments to those affected. The Government should therefore support those who have been affected, and they should be concerned about and apologise for the delay in making payments and its effects. They should also put an end to legal action to prevent payments to those who have been damaged by Pandemrix and they should end the delay in processing claims and appeals. They should also recognise that such delays can and will undermine public confidence in vaccinations, which is something that all those with concern for public health will wish to avoid.

I end with some words from Di, describing how Pandemrix has changed her life. Di said to me:

“Life after the vaccine is totally changed. Our son needs 24/7 care, including getting up several times during the night. He is in almost continuous, intolerable pain, had severe headaches every day. He’s not able to go anywhere without careful planning, needs schedule naps, has several specialist meetings every month, so misses school. Sam is scared for his future and we are frightened for his safety.”

Photo of Nicola Blackwood Nicola Blackwood The Parliamentary Under-Secretary of State for Health 11:16 am, 8th March 2017

It is a pleasure to serve under your chairmanship, Ms Ryan, on International Women’s Day. I congratulate Tracy Brabin on securing this, her first Westminster Hall debate, on an important and sensitive topic. She gave a moving account of her constituent Di and her son Sam’s battles with narcolepsy and cataplexy, as did my hon. Friend Julian Sturdy on behalf of his constituent, Ben Foy. The hon. Lady clearly articulated what she would like to see happen as a result of the debate. I am grateful to her for her opening statement in support of the life-saving effects of vaccinations and her recognition of our world-class immunisation programme. It is important that we remember that as we discuss some of the issues at hand today.

As the hon. Lady has focused the debate on the specific vaccine Pandemrix, it is right that I start by explaining why it came to be used in the UK, although she did outline some of that. Pandemrix was developed for use in a flu pandemic. Flu pandemics pose a challenge for any Government, and they occur when a flu virus emerges and spreads around the world and most people do not have immunity.

Each pandemic is different. The nature of the virus, the population groups most likely to be affected and its impact cannot be known in advance. It is impossible to predict the severity of a new virus strain. Large swathes of the population can become infected over a relatively short period of time if transmission spreads rapidly. The potential impact of pandemic flu makes effective measures to limit the spread and morbidity of virus infection a public health priority. Countermeasures are employed in combination, including vaccination when possible.

As the hon. Lady knows, the most recent flu pandemic was H1N1 swine flu in 2009-10. All Governments have a responsibility to protect public health in such a situation. The decision to commence the swine flu vaccination programme, made by previous Ministers in 2009, was based, as she said, on the expert advice of the Joint Committee on Vaccination and Immunisation. Pandemrix was one of two vaccines used in the UK in that pandemic. Thankfully, the H1N1 strain of swine flu turned out to be relatively mild, but we should not forget that it still caused more than 450 deaths in the UK.

The hon. Lady clearly described the consequences and impact that narcolepsy and cataplexy have on Sam’s life. I assure her that I do not underestimate how distressing narcolepsy and cataplexy can be. As someone who lives with a complex chronic illness that causes me to collapse in the street at times, I know how vulnerable that can make both those who live with the condition and their families feel. It is important that anyone who lives with narcolepsy receives the appropriate care and attention to manage their condition.

The hon. Lady set out her understanding that Pandemrix has caused narcolepsy for some individuals, including her constituent, Sam, as did my hon. Friend the Member for York Outer in the case of his constituent, Ben Foy. Causation is currently one of the issues in dispute in the ongoing legal proceedings in which the Department of Health is involved, alongside the claimants and the vaccine manufacturer. Those legal proceedings are much wider than the issue of causation and cover many other areas. Until those proceedings are resolved one way or the other, it is not appropriate for me to comment on that in detail; it is a process that should be allowed to continue without interference from a politician. However, I assure the hon. Lady that I am deeply concerned about this and will keep a close eye on it as Minister.

The hon. Lady wants to ensure that Sam and people like him are adequately compensated for the development of narcolepsy following Pandemrix vaccination, and has set out the changes she would like to see to the vaccine damage payments scheme to address that. It is important to be clear that the VDPS was not designed to be a compensation scheme; there is no assessment of what losses were actually suffered. Someone who wishes to seek compensation needs to pursue a claim against the vaccine’s manufacturer. There are ongoing personal injury claims in this case, and it is important that those proceed without interference as well.

The VDPS was established in 1979 to help ease the burdens of individuals for whom, on very rare occasions, vaccination has caused severe disablement. The extent of that disablement is assessed on the same basis as for the industrial injuries disablement benefit scheme. The VDPS provides a one-off, tax-free lump sum payment of £120,000 for those who are severely disabled as a result of a vaccination against the diseases listed in the 1979 Act and diseases that have been specified since 1979 by various statutory instruments. Those vaccinations are within the childhood vaccination schemes.

The hon. Lady noted that Sam’s mother applied to the VDPS but her claim was rejected. The hon. Lady claims that was because Sam was not severely disabled enough, but my understanding is that, although the DWP agrees that Pandemrix can cause narcolepsy in theory, it did not do so in this particular case; the DWP did not accept causation in this particular case, rather than its not accepting that Sam was severely disabled enough. I have a different understanding from the hon. Lady, so perhaps she would like to write to the DWP for clarification.

I should also clarify that the Department of Health is responsible for policy and legislation for the VDPS, but the DWP is responsible for assessing claims, making payments against successful claims and handling appeals. To qualify for a VDPS payment, a claimant has to meet two legal tests. The first is to establish, on a balance of probabilities, that the disablement was caused by vaccination against a disease covered by the VDPS, and the second is that the resulting disablement is severe—60% or more—assessed on the same basis as for the industrial injuries disablement benefit scheme.

Decisions take into account advice from medical advisers who are fully registered doctors with a licence to practise and who have also undertaken special training in disability assessment. They review each claimant’s medical records and advise the DWP’s decision maker on causation and disablement. It is therefore important that the hon. Lady clarifies what happened in her constituent’s case, as it is for my hon. Friend the Member for York Outer in the case of his constituent.

Each claim is decided upon its own evidence. If a claimant disagrees with the outcome, they have the right to request a reversal of the Secretary of State’s decision. There is then an opportunity to provide further information to support that request, and the case will be reconsidered. They can also challenge the decision to reject the claim through a first-tier tribunal.

The hon. Lady also raised more general questions about how the VDPS operates and has suggested changes that she thinks are needed. I will address as many of those questions as I can in turn; if I do not get to some of them, I will write to her. She suggested that anyone who has had a Pandemrix vaccination should be eligible for a VDPS payment if they have developed narcolepsy following a vaccination. The Vaccine Damage Payments Act is based on diseases, not specific vaccines, so it is not possible to include Pandemrix in that legislation. However, the list of specified diseases covered by the Act already includes pandemic influenza A—swine flu—for which vaccination was administered from 10 October 2009 to 31 August 2010. That was a temporary addition considered appropriate by the Ministers at the time. Pandemrix-related claims are therefore already eligible under the VDPS, so long as other eligibility criteria are also met. I am aware that some individuals received a Pandemrix vaccination outside the timescale covered by the Act, and that that was the subject of a debate in the House; perhaps the hon. Lady would like to look at that, and if she has any further questions for me, I will be very happy to answer them for her and her constituent.

The hon. Lady also made the case that the level of the VDPS payment is not adequate to meet the needs of someone with narcolepsy. As I mentioned earlier, that is because the VDPS is not a compensation scheme and the sum paid is not based on an assessment of losses; it is a one-off, tax-free lump sum payment to help ease the burden. It must be seen in the context of wider help and support for the severely disabled within our benefits system, but payments through the scheme cannot meet all of their needs. There are no plans at the moment to increase the value of the payment, but as I mentioned earlier, it is open to individuals to pursue personal injury claims for compensation, in addition to applying to the VDPS.

Jim Shannon raised the recent Court of Appeal judgment on how disablement is assessed. I can confirm that the Government will not appeal that decision. DWP medical advisers will now consider future prognosis in addition to the current level of disablement when assessing claims. Previous cases in which causation has been accepted will be reconsidered in accordance with the Court of Appeal judgment where claimants consent to a further investigation of their medical history.

Photo of Nicola Blackwood Nicola Blackwood The Parliamentary Under-Secretary of State for Health

It will start as soon as it can be implemented.

I will also follow up on the point that the hon. Member for Batley and Spen made about Xyrem. The scheme for its supply is due to continue until the personal injury claims are settled, at which point it will be reviewed. I hope that reassures her. I will be happy to look into the issue that she raised about a postcode lottery to try to understand how that situation can be eased.

We do not have a huge amount of time left, so I will bring my remarks to a close. I assure the hon. Lady that I have every sympathy for Sam and others affected by narcolepsy; I have a small amount of understanding about quite how distressing that can be. The hon. Lady should not consider the VDPS in isolation as a means of supporting Sam and others like him. It is part of a much wider package of care and support that is available to people with disabilities, including the NHS, social care and the benefits system. It is important not to leave the debate with the impression that vaccines are dangerous. Vaccine safety is of paramount importance, and with modern technology and stringent manufacturing and control processes, vaccines are the safest they have ever been. I hope that, by the end of the debate, hon. Members will know that the Medicines and Healthcare Products Regulatory Agency and the Government’s independent expert advisory Commission on Human Medicines keep the safety of all vaccines under review. Serious side effects are, thankfully, very rare.

While it is important to have a scheme such as the VDPS in place—I am grateful to have had the opportunity to hear the views on it of the hon. Lady and of my hon. Friend the Member for York Outer, who is no longer in his place—it is also important to acknowledge that we have a world-class immunisation programme that is the envy of many other countries that are not able to prevent the diseases we do in the UK. Immunisation is a vital way of protecting individuals and the community as a whole from serious diseases. Uptake for UK immunisation programmes is more than 90% of the target population for most childhood vaccinations. Vaccinations save lives, and I strongly encourage families to take them up when offered. I assure the hon. Lady that I have listened to everything she has said and will consider it going forward as the Pandemrix case continues.

Question put and agreed to.

Sitting suspended.

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