Cystic Fibrosis Drugs: Orkambi

Clive Lewis Excerpts

Monday 10th June 2019 Westminster Hall

[Clive Lewis (Norwich South) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Hanson. I add my thanks to the hon. Member for Sutton and Cheam (Paul Scully) for securing this debate.

I will focus on two key things: asking the Minister a series of questions on potential remedies for this situation, but also using my time to speak about Rachael and Ethan, a mother and child in my constituency who are forced to live with the realities of cystic fibrosis every day, and the adverse impact that the actions of the company Vertex are having on their lives. Ethan is 11 years old. He has a big smile and loves pizza, trampolining and spending time with his friends, but sadly that is where the similarity to other 11-year-olds ends, since every day his life and that of his mum Rachael are dominated by the strain of dealing with cystic fibrosis.

To put this in context, because his lung function has declined to just 54%, in the past four weeks alone Ethan has coped with two separate full-day hospital admissions, 14 days of intravenous antibiotics, which are administered by his mum twice a day at home and take 45 minutes each time, and two sessions with a psychologist to help him to overcome needle phobia brought about by years of blood tests. All that is on top of his regular daily cocktail of medication and a physio session of a minimum of 22 minutes every day. Yet none of those treatments are designed to cure Ethan. They are simply designed to treat his symptoms—symptoms that are expected to get worse the older he gets. They attempt to slow down the irreversible lung damage that will slowly cause him to suffocate. He knows that. In 2017, half of all people who died with cystic fibrosis were under the age of 31, as has already been stated. It is a statistic that his mum Rachael is only too aware of as she spends the majority of her time caring for her son.

We know that Vertex drugs could change the lives of cystic fibrosis sufferers and their families, since they fix the underlying genetic mutations that cause the condition, but, as we have heard today, Vertex is more interested in 45% investor returns than in 20%. That seems to be its priority. Although the chronic underfunding of the NHS is a contributing factor in this story, it is by no means the only reason why a deal has not been reached. The unforgivable actions of Vertex Pharmaceuticals, which admittedly does important work in research and development relating to the treatment of cystic fibrosis, mean that it continues to put patients’ lives at risk as it seeks to extract the highest possible price from our NHS. When Alexander Fleming created penicillin, he had it publicly patented so that it was accessible to all, and it became a revolution in modern medicine. Should we not be legislating for pharmaceutical companies to do something similar and put patients, not profits, at the centre of their development?

I have a number of questions for the Minister. How do we approach this matter systematically, so that we are not back here time and time again, as we have heard? The reality is that we have a socialised—dare I say socialist—healthcare system, which treats people’s health on a collective basis, based not on their ability to pay, but on their need. That is quite revolutionary. However, that healthcare system operates in an international pharmaceutical industry based on rapacious profiteering. How do we square that circle? I suggest the answer lies at the European level, not the US level. Ultimately, the EU’s being one of the biggest healthcare markets in the world gives the European Union immense clout in imposing its will on international pharmaceutical companies; that is one of the reasons I want to stay in it.

My other question is a philosophical one: what is a fair price for years of investment and research? Who determines what is a fair price—our collective democracies, which enable these companies to exist, or a handful of corporate executives whose primary motivation is to maximise profit? Who determines that price? At the moment, I do not think that the balance is correct.

Finally, has the Minister considered the use of compulsory licensing, allowing a UK company or other company to make cheap generic copies? That is allowed under World Trade Organisation rules; the definition of an emergency is up to the host country that needs to use it, and from initial research it is something that could be used and has been used before. I know that is not something she would want to do initially, but ultimately, would she consider it if Vertex refuses to move?

I will leave hon. Members with a quote from Ethan, who had his 11th birthday on 5 June. He said:

“I want to live a long life, because then I get to see some things and do things, so please fund The Triple”.

--- Later in debate ---

[Seema Kennedy]

My hon. Friend makes a very good point. Members from across the House have told very moving stories of their constituents, the lives they lead, and the stresses and the strains put on them by the lack of an agreement on this matter. However, other drug companies are developing medications for rare diseases, and agreements have been reached on those. I will turn to them very shortly.

We can look at what happened in Spain earlier this year, when Vertex did not accept the terms of Spain’s health outcome-related proposal. The Spanish proposal, which is similar to the recent NHS England offer, is based on the ongoing collection and interpretation of real world data. Why is that not acceptable to Vertex? I also note that dialogue between Spain and Vertex has been ongoing for three years, which is similar to the situation here in England.

We will never walk away, but Vertex must now agree to engage with NICE and we urge it to accept all the flexibilities that NHS England has put on the table. There is nothing unusual about Vertex that means that this is not the right thing for it to do. Recently, we have seen deals reached as part of the NICE appraisal process, including that for ocrelizumab, which is an innovative multiple sclerosis drug, that for Spinraza, which is for people with spinal muscular atrophy, and that for axicabtagene ciloleucel chimeric antigen receptor t cell, or CAR-T, treatments.

Given that Vertex remains an extreme outlier in both pricing and behaviour, it is no wonder that patients and families have been looking at alternative solutions to secure access to this drug, and we have heard about the buyers’ club. Hon. Members have also talked about Crown use licensing, and the hon. Member for Bristol East (Kerry McCarthy) talked about large-scale clinical trials.

Unless Vertex changes its approach and behaves responsibly, I have a moral obligation to look at these other options. Of course NHS England and NICE will carry on the negotiations, because a negotiated outcome is the desired option. However, I have no alternative but to look at these other options on the table.

[Clive Lewis]

I thank the Minister for giving way. I raised the issue of compulsory licensing, which the Government have within their armoury. Of course it would be a measure of last resort, but given that we are dealing with people’s lives, the quality of their lives and a company that is quite simply being intransigent, and greedy, surely that option should be considered. That would send a message to those pharmaceutical companies—that global pharma industry—that if they are going to be greedy and put people’s lives at risk, despite being made fair offers, this option could be used by our Government.

[Seema Kennedy]

I thank the hon. Gentleman for his intervention. As my hon. Friend the Member for Sutton and Cheam said in his opening speech, which was very well made, we recognise the importance of British pharmaceutical companies and that companies invest hugely in developing new drugs. However, as the other examples of drugs for rare diseases that I have given show, it is possible to go through the NICE appraisal process and reach an agreement with NHS England. As one hon. Member who is no longer in their place said, this is an offer for a long-term agreement.

Vertex is an outlier, and I would like to put that on the record.

East of England Ambulance Service NHS Trust

Clive Lewis Excerpts

Friday 2nd February 2018 Commons Chamber

[Norman Lamb]

I am grateful for that intervention, and the hon. Lady is doing exactly the right thing in pursuing that matter on behalf of her constituents. They deserve answers to the concerns that they have expressed over that tragic case.

Beyond the list of 40 cases, I understand that a further 120 incidents of potential patient harm and a potential 81 patient deaths have been associated with delays over this period of time. One case, which is not on the list of 40 that I have seen, concerns a constituent who does not want her family’s name to be mentioned. She has written to me as follows:

“My Mum had been ill from Boxing Day and finally on New Year’s Day she deteriorated to such a level that I had to call an ambulance. When I first logged the call they advised me that as she was still breathing we would have to wait an hour before a team could get to us. Mum’s health deteriorated further to a point that I had to place another call to the ambulance call centre as she had suffered a stroke and then a heart attack and had stopped breathing. My sister and I had to perform CPR whilst waiting for the crew. When they finally arrived, although they tried, they said that there was nothing they could do and she was pronounced dead.”

I should say that my constituent commends the crews that attended for the work that they did.

[Clive Lewis (Norwich South) (Lab)]

I have great respect for the right hon. Gentleman for bringing this debate to the House today. Does he agree that this is due to a systemic crisis, rather than to individual failings? Since publicising this issue in the Chamber some weeks ago, I have been inundated by cases of people from across the country, not just the east of England, who have experienced similar failings in the ambulance service. We must make it clear that this is not just about blaming managers at the East of England Ambulance Service NHS Trust; it is also about accepting that the Chancellor of the Exchequer and the Secretary of State for Health bear responsibility for what is happening to ambulance services across the country.

[Norman Lamb]

I thank the hon. Gentleman for his intervention. Ultimately, the Government are responsible for keeping the people of this country safe, with emergency services that work effectively. That is ultimately what we are debating.

This is not something that just happened over the Christmas and new year period. Just last Friday, the 91-year-old mother-in-law of some close friends of ours in south Norfolk fell on to a cold stone floor. They called 999 at 8.45 pm, but the ambulance did not arrive until 4 am. It left at 4.45 to go to the hospital, but she had to wait in the ambulance until 6 am. She then had to wait on a trolley for two more hours. That is intolerable; she is 91 years old. This could happen to a family member of any of us; we all have a stake in this. We have to recognise that it is intolerable. Another constituent has told me about his 92-year-old mother who broke her leg. She had a nine-hour wait, during which she developed hypothermia. Then a car arrived, rather than an ambulance, and she had to wait another 40 minutes for the ambulance. That is simply intolerable.

I am told that, according to the assessment of many people internally, the service over that period was unsafe, and that no assurances have been given that the trust would be able to provide a safe service in the future, if there were to be a period of very cold weather or a flu epidemic, for example. That is a matter of serious concern to the people of the east of England. On several occasions during the period, there were more than 200 999 calls that could not be responded to at the moment they came in, because no crews or ambulances were available.

The Care Quality Commission told me this morning:

“This is a service that is in crisis”.

It also said:

“Patients are at risk”.

However, the CQC appears to have confidence in the leadership of the trust. I fear that it is being complacent in its attitude, and that it is not taking seriously enough the number of patient harm incidents that I have referred to. I have deep concerns about whether any family member of mine, any constituent, or anyone else across the east of England who has to rely on the service will get a service that will protect and safeguard them in their hour of need. I am told response times in North Norfolk are dire—not just that the trust is not meeting the target but that the long tail beyond the target is deeply concerning. I do not have the assurance that we need.

The concerns appear to have been recognised because a risk summit was convened. According to the official guidance, a risk summit is normally triggered

“if there are significant and serious concerns that there are, or could be, quality failings in a provider or system.”

The guidance further states that a risk summit should be called

“only as a last resort”.

Well, we clearly have a last resort here.

My central plea to the Minister is that we need an independent governance review, and I would like a specific response to that because I genuinely believe it is needed, but I would like to raise the following specific concerns. I understand there was a £2.8 million underspend in the trust in month nine of the financial year. How can that be justified? Is the Minister satisfied with that?

I am told that more than 100 staff have been recruited but are currently on a waiting list to start. Some have been on the list for more than a year. I am told there has been no recruitment in Norfolk, which is where response times are at their worst. Staff have left without being replaced.

There was an independent assessment in August 2016, never published, by Operational Research in Health, which said that hundreds more staff are needed across the region to run a safe service. Why has that never been implemented? The only area where there has been recruitment of late, according to adverts online, is in Bedfordshire and Hertfordshire, the best-performing areas. The impression I am left with is that it is all about hitting the national target, rather than ensuring that all parts of the region are safe.

Interestingly, the online job advert has just been changed to include other counties, but the public board papers say there are no vacancies in those other counties. At the same time, lots of additional management posts have been created. There is a new deputy director of human resources, an associate director of HR, a deputy director of strategy and sustainability and other deputy director posts.

The trust has also doubled its spend on lease cars, which in November 2017 was up from just under £500,000 to nearly £1 million, with directors and deputy directors making no contribution. I am told that directors and deputy directors drive around in Jaguars, Range Rovers, Mercedes and Audi A5s. Is the Minister comfortable with that? The policy allows discretion by the director but, with a service that is under such strain, for me it is a question of judgment and culture in this organisation.

I am told there was a very late sign-off of the plan for the Christmas and new year period following the letter from Professor Keith Willett, so the trust was not better prepared than ever, which is the Government’s mantra. Did meetings take place between the trust’s chief executive and the chief executives of hospitals where the delays were at their worst in the run-up to the Christmas and new year period? We have a right to know.

The trust issued a statement that it had not been made aware of any patient safety issues internally, but that is not true. I have a copy of an email from a constituent to the chair of the trust on 9 January specifically referring to the fact that someone in the trust had come forward to raise patient safety concerns. Is that acceptable? It is a wholly misleading statement to the public. Does the Minister feel comfortable with that?

Is it acceptable that neither the chief executive nor the chair of the trust has been prepared to be interviewed publicly since the new year? When there have been so many patient safety incidents, surely they should be being held to account for that service on television and radio.

There has been a big issue about director presence over Christmas and new year, with claims and counter-claims having been made, and we need to get to the bottom of it. Will the Minister ensure that we are told who was actually on duty all the way through the Christmas and new year period? By that, I mean on duty and in the region—not at home in some foreign country—leading the service in this region. It was new year’s eve before REAP 4— Resource Escalation Action Plan 4—was declared. That is the highest level. Many people in the organisation felt it should have happened before that, so that mutual assistance could have been secured from surrounding trusts. Why did that not happen?

A report was commissioned last year from SSG Health—a “phase 2 report”—on how the trust can save money. It has never been published. I have tried to get hold of it under freedom of information but my request has been refused. Will the Minister ensure that it is now put into the public domain? Given the scale of the crisis, which the Care Quality Commission has acknowledged, we have a right to know what that report says and what is being done about it. It cost more than £500,000 for this report on how to save money. That shows the scale of the culture problems that we face.

On late finishes, staff regularly work 14-hour to 15-hour shifts, but no data has been available from the trust to the staff side since February last year. In September, the trust removed the staff support desk, which was there to provide support to staff who were working very long shifts. No data has been made available by the trust to the staff side on “tail breaches”—these very long delays in getting to patients. The trust claims an exemption under FOI. That is symptomatic of a trust that fails to be open with staff representatives and with the public it is supposed to be serving. A constituent of mine who has worked for the trust has been declared “vexatious” for making FOI requests about patient safety issues, for goodness’ sake. How about that for the culture of this organisation! The matter is now with the Information Commissioner.

I believe, and I think the Government believe, that trusts should be entirely open; there should be an open culture, encouraging staff to speak out about patient safety issues. Will the Minister send a clear message to end the embargo on FOI requests, so that we can find out what is going on in this trust, rather than have it being kept from the public gaze? This is an issue of the utmost concern to the people of the east of England. People in this region need reassurance that they will be cared for and that the response will be there when they need it. It is frightening for anyone, but particularly for older people, to wait interminably for an ambulance to arrive when a loved one is very ill and potentially dying. This is intolerable in a civilised society and ultimately it is the Government’s responsibility to ensure that there is a service there to serve the people of this country.

NHS Winter Crisis

Clive Lewis Excerpts

Wednesday 10th January 2018 Commons Chamber

[Dr Whitford]

Attendances at A&E tend to be higher in the summer, when kids are on bikes and trampolines, and up trees. It is admissions that are higher in winter, when A&E is dominated by people who are sick. Of course we want primary care and the 111 system to work, so that people do not use A&E as a first port of call, but the problem comes when that all gets too complicated and patients cannot work out where they should go. That is when they go to A&E. It is important to make it really clear where they should go to address which problems.

Having seen the crisis last year, when there was no flu, snow or ice to blame, I believe that there are underlying structural problems. The target was met comfortably until 2013, when the Health and Social Care Act 2012 changes kicked in and NHS England started to become fragmented and to be based on competition instead of co-operation. I would welcome the establishment of a cross-party group here to work on this, so that we did not always have to have these debates, but it would have to look at the structure and unpick what has been done to NHS England in the past four and a half years. Carrying on breaking it apart will not provide a solution.

[Clive Lewis (Norwich South) (Lab)]

Does the hon. Lady agree that the Government’s plans to establish accountable care organisations, which will exacerbate the fragmentation in the NHS, through secondary legislation are completely wrong and will make the NHS crisis even worse?

[Dr Whitford]

I completely agree that establishing accountable care organisations only through secondary legislation is utterly wrong. We have had multiple debates about STPs, and I have said that going back to place-based planning is the right way to integrate and develop a local service, but there should not be a private company at the top making the decisions. There needs to be a publicly accountable body. There is going to be yet another big reorganisation in NHS England, and the proposed structure needs to be debated in this place, not behind closed doors. Yes, money is tight, with the NHS seeing rises of just over 1% a year in the past seven years compared with almost 4% in the past, but it is estimated that between £5 billion and £10 billion is being wasted in the healthcare market itself, through bidding, tendering and profits, and now through this habit of companies suing if they do not win a contract.

It is crucial to move back to developing services for a community. It is also crucial that health and social care should be integrated, and I welcome the combination of both titles in the Secretary of State’s role, if that means that we are going to work towards meaningful integration, but it must be done in a structured, responsible and legalistic way.

Oral Answers to Questions

Clive Lewis Excerpts

Tuesday 14th November 2017 Commons Chamber

[Steve Brine]

I thank the hon. Lady for her question. I am open to offers from any Select Committee. It would be premature to consider issues of liability before considering the strength of the evidence and seeing the report, which we will study carefully. The report will conclude whether there is a causal association between the use of HPDs such as Primodos and adverse outcomes of pregnancy. We look forward to seeing its outcomes and its recommendations.

[Clive Lewis (Norwich South) (Lab)]

13. What the timetable is for sustainability and transformation partnerships to become accountable care systems.

[The Minister of State, Department of Health (Mr Philip Dunne)]

There is no fixed timetable for sustainability and transformation partnerships to become accountable care systems. Evolution from an STP into one or more ACSs is dependent on an STP demonstrating that it is working in a locally integrated health system. Both commissioners and providers, in partnership with local authorities, will need to choose to assume collective responsibility for resource and public health, and the criteria for that were set out in NHS England’s next steps in the “Five Year Forward View”.

[Clive Lewis]

Last week, NHS doctors took out a judicial review against the Secretary of State’s plans to use secondary legislation to enable private companies to run big parts of the accountable care organisations. I think the Government understand that doctors, nurses, patients and the public want an NHS that is run for the public by the public using public funds. Ultimately, will the Minister ensure that we have time in this place for Members to discuss and scrutinise the ACOs, because they are a drastic change to our NHS?

[Mr Dunne]

I can honestly say that the best thing the hon. Gentleman can do to understand what STPs are really all about is talk to the recently appointed chair of the Norfolk and Waveney STP, which covers his local area. He will find that the former Labour Secretary of State, Patricia Hewitt, can give him very good advice.

Mental Health Units (Use of Force) Bill

Clive Lewis Excerpts

2nd reading: House of Commons
Friday 3rd November 2017 Commons Chamber

[Victoria Prentis]

I thank my hon. Friend for his intervention. We have begun to understand and talk about mental health only very recently. As we do so, we learn both from those patients who have suffered tragedies and those who have had better experiences with law enforcement agencies. It is important that we learn and listen as the debate progresses. Issues may well come up in Committee that nobody has given a moment’s thought to. A constituent will have a story to tell and we can learn from it as we go forward.

From my own constituency casework, I know that for those at the point of crisis the use of restraint can be both humiliating and traumatising. I discussed this issue with the Causeway Carers, a great organisation comprised largely of parents and other family members of victims with very severe mental health problems. They meet in Bicester once a month. Many have first-hand experience of sectioning and restraint, which they shared with me. That was a great privilege and I do not feel able to share any of those stories with the House today. From what we have heard about Seni, we can all imagine the sort of stories that are taking place even on the high street in Bicester from time to time, often at night. They are also taking place in all our communities. They are not isolated stories, and none of us can feel that we are untouched by them.

These families are suffering enormously because they are dealing with a very ill family member, often a child, and restraint is added to that dreadful suffering that they already have to cope with. I recognise that the use of police cells in England as places of safety under the Mental Health Act 1983 is declining, and that more cases than ever are now referred to health-based places of safety, which is real progress. We should also welcome the significant reduction in the number of deaths in, or following, police custody since 20 years ago. I imagine that this reflects improved training, guidance and practices in a number of areas, most significantly in suicide prevention. My background is as a lawyer for the Prison Service, and it strikes me that this is in sharp contrast to the dramatic and worrying rise in suicide rates recorded in the last 20 years in prisons.

[Clive Lewis (Norwich South) (Lab)]

We are being consensual across the House, and I would like to retain that spirit, but would also make the point that one of the linking factors in terms of both prisons and mental health is funding for the institutions. Staff and service users at the Norfolk and Suffolk mental health trust, which is in special measures, are concerned that a reduction in the number of staff—nurses and doctors—over the past five years means they have less ability to watch and monitor patients, so it is more likely that those patients are using medication, and that means restraint is more likely to be used, so we end up with the situation that the Lewis family were in. Will the hon. Lady comment on that?

[Victoria Prentis]

Rather than get too party political, I think it is appropriate to talk about other difficulties that have led to reductions in staffing in real terms in the Prison Service, because we on this side of the House can give lots of facts and figures about how much more is being spent. The difficulty that I know about personally now in my Banbury constituency is in recruiting and retraining staff—not with the money to pay for them, but with finding the right people. I pay tribute to all who choose to work in the very difficult mental health sphere, with patients who suffer from dreadful illnesses; the House should pay tribute to the work they do day in, day out with people who are often very difficult to deal with while they are ill.

One matter on which I am sure we can agree is the importance of reducing further the number of black, Asian and minority ethnic people detained for mental health reasons in police cells. The figures are disproportionately high. It simply cannot be right that black people are four times more likely to be detained under the 1983 Act than white people. The hon. Member for Croydon North mentioned the Angiolini review and the importance of standardised data recording. I apologise for again referring to my Prison Service experience, as the mental health system is completely different from the criminal justice system, but there are themes that run through the way BAME people are treated in both systems which we increasingly find utterly unacceptable.

--- Later in debate ---

[Oliver Dowden]

My hon. Friend is absolutely right. I do not think anyone is suggesting that police officers are actively seeking to treat mental health patients in an incorrect fashion, but there is a need for training so that they understand the correct way to behave.

[Clive Lewis]

We on the Opposition Benches do not think that this is only about the money that is going in now. If we look at the figures, we can see that there has been an increase in recent years, but the fact is that the years of cuts that went before have had an impact on staffing levels. In my trust, the Norfolk and Suffolk mental health trust, we have seen a 20% drop in the number of doctors and nurses on the payroll in the past five years. We can train up a lower number of doctors and nurses in restraint techniques, but the fewer there are, the more risk there will be of a need to restrain. We cannot get away from that fact.

[Oliver Dowden]

I am not sure that I entirely agree with the hon. Gentleman. Of course there have been historical problems with the funding of mental health. I hope that Opposition Members will recognise, as we do on the Government Benches, that over the decades there has not been enough funding going into that area. On the question of the NHS, however, despite this Government inheriting the largest budget deficit in our peacetime history and an appalling fiscal situation in which we were spending £4 for every £3 we earned, we made a decision to prioritise health. Health spending has risen every year under this Government and we are committed to implementing Simon Stevens’ recommendations. He, after all, was a Labour special adviser who advised this Government, and he recommended £8 billion of additional funding. I am very pleased that we have been able to do that.

Oral Answers to Questions

Clive Lewis Excerpts

Tuesday 10th October 2017 Commons Chamber

[Jackie Doyle-Price]

My hon. Friend is right to raise this issue. Certainly, in CQC inspections in the past, the whole issue of “do not resuscitate” orders has been an area of concern. This is something we will very much look at as part of the end of life policy, but I would like to hear more about the case my hon. Friend mentioned, if he would like to write to me.

[Clive Lewis (Norwich South) (Lab)]

T5. Accountable care systems are a systemic change to the way the NHS will be managed and a significant step towards an Americanised care system, so will the Minister explain why NHS England is having a fundamental reorganisation take place under the radar without a national consultation?

[Mr Hunt]

Accountable care systems are supported by such rabid right wingers as Polly Toynbee, writing in The Guardian, because they are about health systems coming together to co-operate to give the best care for patients. That is what is happening across the NHS, and it is already delivering great results.