HIV Treatment

Debate between Baroness Blackwood of North Oxford and Jim Shannon

Wednesday 29th March 2017 Westminster Hall

[Nicola Blackwood]

I think the right hon. Gentleman slightly misunderstood me on the ring fence. We have kept it because we believe that transparency and accountability measures need to be put in place, so that when local authorities move to business rates retention, their decisions can be made in an appropriately accountable way that can be scrutinised properly. We do not feel as though we have that yet, so we have moved the date back a bit. We want to do that effectively and to have proper consultation on the mandate. On his other point, I think it is a bit early in the process to start discussing that.

Given the time, let me move on to service specifications. During the debate we have heard examples of contracts for sexual health services becoming divorced from the provision of HIV services. A key recommendation from the APPG report was to create a joint service specification for sexual health and HIV services. We recognise that the existing service specification for sexual health needs strengthening, which is why it is now being updated. PHE has committed to building on existing commissioning guidance to provide more focused advice and examples of locally designed systems to support the commissioning of HIV and sexual health services.

NHS England is responsible for the service specification for HIV treatment and care, and we think that that remains a sensible division. However, the development of a new integrated service specification for sexual health services will allow us the opportunity to join up our advice to produce a more integrated offer.

I want to recognise the continuing priority of PrEP, which many colleagues mentioned, and the trial that was announced last year by PHE and NHS England. Up to £10 million has been set aside to fund the trial, which is anticipated to include at least 10,000 participants over the next three years. We expect the trial to be under way this summer. It has the potential to change the lives of thousands of people who are at risk of contracting HIV.

[Jim Shannon]

I asked about where the older generation featured in things, as did the right hon. Member for Exeter (Mr Bradshaw), but the Minister has not touched on that yet. If she is not able to do so now, perhaps she can come back to us in writing.

[Nicola Blackwood]

The whole point of developing a much more systematic process and having a commissioning programme that does not allow the fragmentation of services, but instead is much more integrated, is that it will take into account more ageing people living with HIV. We believe that that will deal with the issue.

The hon. Gentleman also asked how we will tackle the issue of undiagnosed people living with HIV in the community. We believe that the strategy of increasing education and introducing compulsory sex and relationships education will be part of that, as will improving our performance, testing and early diagnosis. The work being done through the innovation fund is a key plank of that. Having clear specifications in commissioning guidelines so that we have coherent services for all who seek them is the strategy. We think that is a coherent response.

Pandemrix Vaccine: Compensation

Debate between Baroness Blackwood of North Oxford and Jim Shannon

Wednesday 8th March 2017 Westminster Hall

[The Parliamentary Under-Secretary of State for Health (Nicola Blackwood)]

It is a pleasure to serve under your chairmanship, Ms Ryan, on International Women’s Day. I congratulate the hon. Member for Batley and Spen (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 the Member for York Outer (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.

The hon. Member for Strangford (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.

[Jim Shannon]

Will the change at the DWP following the Court of Appeal’s decision start immediately?

[Nicola Blackwood]

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.

Oral Answers to Questions

Debate between Baroness Blackwood of North Oxford and Jim Shannon

Tuesday 20th December 2016 Commons Chamber

[Nicola Blackwood]

As my hon. Friend says, we must focus on innovation and better diagnostic tests, particularly bedside tests. The Government are actively reviewing evidence of the benefits of CRP tests. Pilot studies in the United Kingdom are contributing to that, and will be evaluated so that we can see how best to build on what can be shown to be working well.

[Jim Shannon (Strangford) (DUP)]

20. Given that 480,000 people develop multi-drug-resistant tuberculosis each year and that drug resistance is starting to complicate the fight against HIV and malaria, what steps has the Secretary of State taken to increase awareness in GP surgeries and to provide alternative treatments that can be equally effective, and what co-operation has taken place with devolved Assemblies?

[Nicola Blackwood]

I am grateful for that immediate promotion from the hon. Gentleman.

We have made considerable progress in establishing the building blocks of our domestic AMR strategy, including better data, guidance for primary care, and a strengthening of the framework for antimicrobial stewardship, which involves introducing incentives for the NHS to improve the prescribing of antibiotics. That has led, in the last quarter, to the first reduction in such prescribing, which I think we can take as an encouraging sign.

Variant CJD and Surgery

Debate between Baroness Blackwood of North Oxford and Jim Shannon

Tuesday 29th November 2016 Commons Chamber

[Nicola Blackwood]

That is one reason why the Department has continued in difficult financial times to ring-fence £5.5 million a year for CJD-related research. We are keen to see safe, evidence-based, cost-effective measures to reduce the risk of vCJD. At the moment, however, there is no validated diagnostic blood test that can be used before the onset of CJD symptoms to diagnose whether someone is infected or incubating the disease. We will of course take advice from the ACDP and the Advisory Committee on the Safety of Blood, Tissues and Organs on the use of any potential test in any proposed Department of Health-funded research study or deployment by UK blood services, but there are established systems for applying for research funds. We have put such funds out there, and any applications for those funds must go through the standard processes. To do otherwise would be to undermine the reputation for research excellence that the UK scientific community has fought hard to establish.

To that end, we recently launched an open competition, inviting proposals for research to further inform our risk-management and health-protection measures, including our understanding of vCJD infection in the UK population, the development of a test able to detect pre-clinical levels of infection in blood, and the development of decontamination technologies for reusable medical instruments. I understand that Professor Collinge’s RelyOn is one application that is currently going though that process, so it would be inappropriate for me to intervene.

I assure the House that the Department recognises the fatal consequences of all forms of clinical CJD and the devastating cost to individual patients, their families and carers, which my hon. Friend described movingly. That is why we set up the vCJD Trust in 2001 in recognition of their wholly exceptional situation and the fact that the Government are their last resort for help. The trust provides a no-fault compensation scheme for vCJD patients and their families, providing payments to be made in respect of 250 cases from a trust fund of £67.5 million. Over £41 million has been paid out by the trust to date.

[Jim Shannon]

In my intervention on the hon. Member for Mole Valley (Sir Paul Beresford), I asked whether compensation should be increased because of the number of years since the agreement was first made. With great respect and humbleness, I ask the Minister whether the Government would consider that.

[Nicola Blackwood]

The scheme is considered to be particularly effective. I shall look at it in the light of the hon. Gentleman’s comments, but it seems to be meeting current concerns. It is also important not to overstate the risks of CJD compared with other disease threats we face. The incidence is now low, with only two new cases in the UK since 2012. While every death is an individual tragedy and we must be alert, we need to ensure that finite resources—research funding, policy development or committee activities—are applied proportionately and are appropriately evidence based.

The ACDP continues to provide independent risk assessment advice on prion disease, informing both research priorities and public health measures to mitigate against risks from healthcare interventions, including the surgical, medical and dental procedures issues that were raised today. The ACDP is clear that risk to both patients and the general public is extremely low. Nevertheless, the current robust systems of active surveillance for CJD continue, and our experts maintain a close watch on new evidence, reviewing it as it becomes available. I assure the House that neither the Government nor the NHS has drawn back from our responsibilities to ensure that precautionary and proportionate measures are in place to protect patients from the risk of acquiring infection with prion agents during their healthcare. We have put in place robust research investment to ensure that the situation can only improve.

Question put and agreed to.

Childhood Cancers

Debate between Baroness Blackwood of North Oxford and Jim Shannon

Wednesday 25th February 2015 Commons Chamber

[Nicola Blackwood (Oxford West and Abingdon) (Con)]

Skye was born on 5 November 2008. He was a happy, healthy young boy with a wonderful sense of humour who loved his younger brother, Jesse. In July 2013, he became unwell with nausea and vomiting and after many visits to the GP and the failure of medication to help, he was referred to the John Radcliffe in Oxford where he had a CT scan and was diagnosed with a brain tumour. That was 27 August 2013.

Skye was operated on less than a week later and tissue analysis identified the tumour as a grade IV metastatic medulloblastoma, the most commonly occurring paediatric brain tumour. It is an aggressive form of primitive neuroectodermal tumour, which originates in the cerebellum, the part of the brain which controls movement and co-ordination. Although Skye’s tumour had been caught early, it had already metastasised throughout the brain and spinal cord. Surgery was quickly followed by what is known as the Milan protocol: four cycles of chemotherapy over 11 weeks, and a further five weeks of hyper-fractionated radiotherapy. After a four-week period of recovery, Skye had high-dose chemotherapy that confined him to hospital for seven and a half weeks.

He then had four weeks rest at home, and was due to head back to hospital on 14 May 2014 for another round of high-dose thiotepa, but a urinary tract infection delayed the treatment until 28 May, which in hindsight was fortunate. Instead of getting stronger, it became apparent that Skye was getting weaker and an emergency MRI scan on 20 May revealed widespread white matter lesions within his brain and spinal cord, which caused a flurry of correspondence between consultants across the UK and abroad. He was quickly started on high-dose steroids to combat the inflammation.

It was initially diagnosed as radionecrosis, which had been brought on by the combination of therapies that he had had to endure. It was later confirmed as radio-chemo neurotoxicity. His parents were told that that was highly unusual and very rare. We now know that a number of other children have also developed severe neurological side effects and the Milan protocol was quickly withdrawn from use in the UK. He was in a state of paraplegia, with double incontinence, and very poor use of his upper limbs and hands. Skye sadly died at home on 29 August 2014.

I did not meet Skye and I only met his parents some time after his death. They are in the Gallery tonight and have demonstrated to me the most extraordinary bravery in the face of losing their child in this most distressing of ways. They have set up Blue Skye Thinking, a charity that supports research so that all children diagnosed with brain tumours will have a better chance of survival and a better quality of life post-treatment. They continue to support many other parents whose children are suffering from cancer today.

I have taken some time to explain Skye’s story in detail this evening because it illustrates only too well some of the things that are working in childhood cancer treatment at the moment and some of the things that need improvement. The overall story of childhood cancer treatment over the past 30 years is a positive one. Eight in 10 children with cancer survive five years or more, compared with just three in 10 in the 1960s. Short-term survival is also high: fewer than 10% of children die within a year of diagnosis and only 2% die within 30 days.

I congratulate the Government on that. Ministers have demonstrated a clear commitment to fighting cancer and the work and money that has been put into the system to improve cancer survival rates are bearing fruit and proving that the money is being well spent. However, we should not allow these headline statistics, encouraging though they are, to blind us to the fact that, rare though childhood cancer is, it remains the leading cause of death in children and teenagers in the United Kingdom. Childhood cancers account for just 1% of cancer diagnoses in the UK. For research purposes that is a small cohort, but 700 children and young people are diagnosed with a brain tumour every year.

[Jim Shannon (Strangford) (DUP)]

I thank the hon. Lady for bringing this matter to the House today, and for allowing me to intervene. Cancer Research UK has given me some figures today showing that 60 people are diagnosed with cancer each day in Northern Ireland. When Josh Martin, a young boy at secondary school, went into hospital to have his appendix removed, he was found to have progressive cancer. His family started the Pray for Josh campaign, which is being supported by his family and by the Churches. It has not only given great comfort to the family but helped to highlight the scourge of cancer and the fact that funding for drugs and help for families are very important. One of the organisations that can help is Macmillan Cancer Support. Does the hon. Lady agree that the support of such organisations can be important for families at times like these?

[Nicola Blackwood]

The hon. Gentleman is absolutely right to say that this is about not just Government funding but the way in which funds are given, and charities in particular play an important part. The fundraising that they do through individuals is vital.

As I was saying, 700 children and young people are diagnosed with a brain tumour every year, and that makes it the most common form of cancer affecting children and young people. It is also the most lethal. Brain tumours kill more children and young people than any other cancer—around 160 children a year—but despite being responsible for more than a third of childhood cancer deaths, brain tumours receive only 6% of childhood cancer funding. That funding matters because children’s cancers are biologically very different from adult cancers and treating them effectively requires specifically tailored research and targeted treatment regimes. At the moment, only about 50% of childhood cancers are part of a clinical trial; the remainder are treated using standard treatment guidelines. As Sally and Andrew Hall discovered, that can have serious consequences.

Cancer treatment is harsh at the best of times, and recent studies show that while many survivors of children’s cancers go on to live healthy lives, others face long-term disability and reduced immunity. Radiotherapy, the gold standard in terms of its efficacy in treating cancer, can also have damaging long-term consequences for the developing child. This is particularly true of childhood brain tumour survivors, 60% of whom are left with a life-altering disability. In a few cases, the side effects can be so severe as to be fatal. That is what happened in Skye’s case.

The Milan protocol, under which Skye was treated, was a standard treatment guideline, because as with about 50% of other childhood cancers there is no clinical trial available. It has become clear that there is currently no formal infrastructure in place to collect, record and share data, particularly on adverse effects of treatment, about standard treatment guidelines. I understand that before 2008 the responsibility for collecting and sharing data for clinical trials and for standard treatments fell under the remit of the Children’s Cancer and Leukaemia Group. Subsequently, clinical trials monitoring was tightened, and the CCLG’s “Guide to Clinical Trials” states:

“Clinical trials are very closely monitored by a number of different individuals and organisations. This will include the Chief Investigator…the working group…and relevant staff within the clinical trials unit. An Independent Data Monitoring Committee may also be established to oversee the conduct of the trial. At a national level, there will be an ethics committee and the national regulatory body. If there are any concerns about the conduct of the trial or the results, a trial may be stopped early.”

By contrast, in a letter responding to my concerns about the issue, the National Cancer Intelligence Network, told me that

“all of us in the field accept that (adverse effects in Standard Treatments) is something that should, under ideal circumstances, be a part of the data that we routinely collect. Such data are, however very much more difficult to collect than might be imagined and adverse effects were never part of what the CCRG (Childhood Cancer Research Group) or the CCLG themselves collected outside of a clinical trial. There are no nationally agreed datasets relating to adverse effects and few clinicians systematically collect and collate data of this sort...but it is clearly something that we in the NCIN should be considering.”

I am grateful that the NCIN has recognised that these data should be collected and collated, but I do not think that considering doing it is a sufficiently robust or urgent response to the problem, given the gravity of the consequences if a standard treatment goes wrong.

Clearly, in an ideal world all childhood cancers would be the subject of a full clinical trial and new targeted therapies being developed to reduce the long-term risks, but all of us know the challenges associated with research into childhood cancers, where cohorts of rarer cancers can be incredibly small and the ethical issues are more complex, making recruiting participants more difficult. Obviously, I am going to urge the Government to do whatever they can to fund and encourage more research into childhood cancers. I am going to ask the Minister to consider whether having only 6% of childhood cancer funding going to the biggest killer in childhood cancer represents getting the balance right, and I am going to ask her to maintain investment in the Health Research Authority programme to streamline the regulation and governance processes for clinical research in the NHS.