My Lords, with the permission of the House, I will repeat the Statement made yesterday by my right honourable friend the Secretary of State for Health and Social Care on breast cancer screening. The Statement is as follows:
“I wish to inform the House of a serious failure that has come to light in the national breast screening programme in England. The NHS breast screening programme is overseen by Public Health England and is one of the most comprehensive in the world. It screens 2 million people every year, with women between the ages of 50 and 70 receiving a screen every three years up to their 71st birthday. However, earlier this year PHE analysis of trial data from the service found that there was a computer algorithm failure dating back to 2009. The latest estimate I have received from PHE is that as a result of this between 2009 and the start of 2018 an estimated 450,000 women aged between 68 and 71 were not invited to their final breast screening.
At this stage it is unclear whether any delay in diagnosis will have resulted in any avoidable harm or death, and that is one of the reasons I am ordering an independent review to establish the clinical impact. Our current best estimate—which comes with caveats as it is based on statistical modelling rather than patient reviews and because there is currently no clinical consensus about the benefits of screening for this age group—is that there may be between 135 and 270 women who have had their lives shortened as a result. I am advised that it is unlikely to be more than this range and may be considerably less. However, tragically, there are likely to be some people in this group who would be alive today if the failure had not happened.
The issue came to light because an upgrade to the breast screening invitation IT system provided improved data to local services on the actual ages of the women receiving screening invitations. This highlighted that some women on the AgeX trial, set up to examine whether women up to the age of 73 could benefit from screening, were not receiving an invitation to their final screen as a 70 year-old. Further analysis of the data quantified the problem and found a number of linked causes, including issues with the system’s IT and how age parameters are programmed into it. The investigation also found variations in how local services send out invitations to women in different parts of the country.
The existence of a potential issue was brought to the attention of the Department of Health and Social Care by Public Health England in January, although at that stage its advice was that the risk to patients was limited. Following that, an urgent clinical evaluation took place to determine the extent of harm and the remedial measures necessary. Public Health England escalated the matter to Ministers in March, with clear clinical advice that the matter should not be made public. This was to ensure that a plan could be put in place that ensured any remedies did not overwhelm the existing screening programme and was able to offer proper support for affected patients.
I am now taking the earliest opportunity to update the House on all the remedial measures that have been put in place, which are as follows. First, urgent remedial work to stop the failure continuing has now been completed according to the chief executive of Public Health England. This was finished by 1 April and PHE is clear that the issue is not now affecting any women going forward. Of the estimated 450,000 women who missed invitations to a scan, 309,000 are estimated to be still alive. Our intention is to contact all those living within the United Kingdom who are registered with a GP before the end of May, with the first 65,000 letters going out this week. Following independent expert clinical advice, the letters will inform all those under 72 years old that they will automatically be sent an invitation to a catch-up screening. Those aged 72 and over will be given access to a helpline through which they can get clinical advice to help them decide whether or not a screening is appropriate for their particular situation. This is because, for older women, there is significant risk that screening will pick up non-threatening cancers that may lead to unnecessary and harmful tests and treatment. However, this is an individual choice and, in all cases, the wishes of the patients affected will be followed. By sending all the letters to UK residents registered with a GP by the end of May, we hope to reassure anyone who does not receive a letter this month that they are not likely to have been affected.
It is a major priority to do our very best to make sure that the additional scans do not cause any delays in the regular breast screening programme for those under 71, so NHS England has taken major steps to expand the capacity of screening services, and has today confirmed that all women affected who wish to be screened will receive an appointment within the next six months. Of course, we intend the vast majority to be much sooner than that.
We have held helpful discussions with the devolved Administrations to alert them to the issue. Scotland uses a different IT system, and while the systems in Wales and Northern Ireland are similar, neither believes that they are affected. However, we are discussing with them the best way to reach women who have moved to another part of the UK during this period. This is, obviously, more complicated, but we are confident that all those affected will be contacted by the end of May.
In addition, and as soon as possible, we will make our best endeavours to contact the appropriate next of kin of those whom we believe missed a scan and have subsequently died of breast cancer. As well as apologising to the families affected, we would wish to offer any further advice that they might find helpful, including the process by which we can establish whether the missed scan is a likely cause of death and compensation is therefore payable. We recognise that this will be incredibly distressing for some families and we will approach the issue as sensitively as possible.
Irrespective of when the incident started, the fact is that for many years oversight of our screening programme has not been good enough. Many families will be deeply disturbed by these revelations, not least because there will be some people who receive a letter having had a recent diagnosis of breast cancer. We must also recognise that there may be some who receive a letter having had a recent terminal diagnosis. For them and others, it is incredibly upsetting to know that you did not receive an invitation for screening at the correct time, and totally devastating to hear you may have lost or be about to lose a loved one because of administrative incompetence. So on behalf of the Government, Public Health England and the NHS, I apologise wholeheartedly and unreservedly for the suffering caused.
But words alone are not enough. We also need to get to the bottom of precisely how many people were affected, why it actually happened and, most importantly, how we can prevent it ever happening again. Many in this House will also have legitimate questions that need answering: why did the algorithm failure occur in the first place and how can we guarantee it does not happen again? Why did quality assurance processes not pick up the problem over a decade or more? Were there any warnings—written or otherwise—that should have been heeded earlier? Was the issue escalated to Ministers at the appropriate time? What are the broader patient safety lessons for screening IT systems?
I am therefore commissioning an independent review of the NHS breast screening programme to look at these and other issues, including its processes, IT systems and further changes and improvements that can be made to the system to minimise the risk of any repetition of this incident. The review will be chaired by Lynda Thomas, chief executive of Macmillan Cancer Support, and Professor Martin Gore, consultant medical oncologist and professor of cancer medicine at the Royal Marsden, and is expected to report in six months.
The NHS has made huge progress under Governments of both sides of this House in improving cancer survival rates, which are now at their highest ever. Some 7,000 people are alive today who would not have been if mortality rates had remained unchanged from 2010. But this progress makes system failures even more heartbreaking when they happen. Today, everyone in this House will be thinking of families up and down the country worried they may have been affected by this failure. We cannot give all the answers today, but we can commit to take all the necessary steps to give people the information they need as quickly as possible. Most of all, we want to be able to promise that this will not happen again. So, today, the whole House will be united in our resolve to be transparent about what went wrong and to take the necessary actions to learn from the mistakes made.
I commend this Statement to the House”.
My Lords, I thank the noble Lord for repeating that Statement and say to him that, along with millions of other people in this country, I am looking at my older relatives and wondering if any of them were caught by this. I do not think I am alone in that. As a woman of my age, it is important to say that we absolutely depend on the screening process to take care of us, to be invited for the smears and breast cancer screening and to be warned and told. So this is a massive public health failure—I think that we would all agree about that.
The noble Lord is quite right: there are a great many questions that he has mentioned that need to be answered. I appreciate his candour in questioning why this problem was not picked up, because eight years is a long time for an error of this magnitude to go undetected. Did the department receive any warnings in that time? Is there any record of how many women raised concerns that they had not received the appropriate screening? Were there any opportunities to change this mistake that were missed? We on these Benches indeed welcome the establishment of a national inquiry. Will the inquiry be hosted and staffed by the Department of Health or by another department? In the interests of transparency, I hope that Public Health England’s analysis from this year will be put in the Library, so that we can see what was identified as the problem with the algorithm. The noble Lord says that NHS England will take steps to expand capacity of screening services. Can he say a little more about that? Where are those extra resources going to be found and how will they provide extra screening?
The reason that this is so terrible in many ways is that we all know that the screening rates were falling; we have known that for years. The proportion of women aged between 50 and 70 taking up routine breast screening invitations fell to 71% in 2016-17; in London, I understand it is about 64%, so this is very serious indeed. In a way, I hope that the inquiry will address how we can make sure that those warnings are heeded and will allow questioning to take place of the whole process, which should be escalated to the right level in the Department of Health. There is an enormously wide range of variation in screening rates, which I hope the inquiry will also address. It seems that the fact that there is such a wide variation is also connected with things such as kit and staff—yesterday we were discussing the understaffing at various levels in the National Health Service. So beyond the problems identified by the Minister today, what more are the Government doing to make sure that screening rates rise again so that cancer care for patients is the best it can possibly be?
We are all concerned—this has cast a shadow that will bring fear and anxiety to millions of people. I know that all Members on all sides of the House who want to see cancer prevented will see this as an issue which we will all join in helping to resolve.
My Lords, I am sure that all of us in this House are considerably concerned about those older women who at the moment are suffering acute anxiety because of what happened, and not only them but their families. It would appear that this was a software error. As I understand it, the same situation has not occurred in Wales, although the health service there appears to be on the same system. Can the Minister tell us a little more about that?
The Minister said that past notes will be looked at. How long does it take to get notes from the archive? Not all notes are held with GPs, and hospitals sometimes archive historic records. Are there enough current NHS staff to look at this, or will we need to take on new staff? That leads me on to another point about speed being of the essence. Depending on the uptake, as has already been alluded to, there may be a need to get women in this cohort X-rayed quickly and at scale. I know that we have had a shortage of radiologists; do we have enough to meet this need?
There is a wider issue, already referred to by the noble Baroness, Lady Thornton, of the lowering of the take-up rate. One thing that has come to my notice because of where I live and from talking to other people, is that if you happen to be unable to take up the appointment in the travelling van that comes round, you are often referred to a hospital. Sometimes that works and sometimes it does not—it can be a long way to go. However, when one of my colleagues asked whether she could have it done when she was here in London and have the X-ray emailed to her, she was told that that was not possible. Can the Minister look at that? While on technology, perhaps the problem of not detecting this is connected with the fact that we have become so reliant on technology that we think it is looking after things and so people do not personally ask the questions they need to.
I hope that the Minister will give us a bit more information about other steps that the Government are taking to try to help improve the take-up rate of screening. Unfortunately, this episode will cause some people to lose faith in the system, and we need to do something about that. Can he also say what his department will do to raise awareness, particularly among women over 70, so that they can continue to be checked?
I hope that the House will indulge me if I take this opportunity to thank those in the health service who have served me with my breast cancer. I may or may not have been one of these people; I self-referred when I was 70 because I had been through the screening process and had been looking out for signs that I had been warned of, so that is one very good thing. I had excellent service at the Royal Victoria Infirmary in Newcastle, which has been rated as outstanding after an inspection, and I was fortunate enough to be able to have chemotherapy down the road in my local hospital in Berwick. The two nurses who run that are absolutely fantastic. So I am very fortunate, and I know that that is what happens in my part of the country. I therefore thank the National Health Service for helping me, and I look forward to hearing from the Minister.
First, if I may, I express my thanks to the noble Baronesses, Lady Thornton and Lady Maddock, for their constructive questions and the offer of working together to make sure that we get to the bottom of the situation and put it right. I also thank the noble Baroness, Lady Maddock, for sharing her own experiences with us. I am glad that she got good care, as, of course, the vast majority of people do, and we are indebted to the NHS staff who provide it. She made an incredibly important point about self-referral. One thing we must emphasise throughout this is that screening is one part of a much broader programme for spotting cancer early, and women’s awareness of their own body is absolutely at the front line of those efforts.
I want to add my own apology to those of my right honourable friend and the Government to the women affected, and to express my personal sympathies to them and to their families.
The noble Baronesses asked excellent questions and I will attempt to answer all of them. Key questions included early warnings, whether public concerns were expressed but not picked up on, and whether technology could have looked for trends in uptake in this age group—an example of technology coming to our help rather than being a problem. These are all very good questions that must be and will be the focus of the review. The review will, I am sure, also look at issues around variation. There are attempts to address falling screening rates, including national information campaigns, but whether or not those are adequate is a reasonable question given what we know about uptake.
The noble Baroness, Lady Thornton, asked specific questions about the analysis from Public Health England on the flaw in the algorithm. Indeed, my right honourable friend the Secretary of State committed to sharing that yesterday, which we will do. Since finding out about this problem, we have been in close conversation with NHS England to make sure that there will be additional resources, such that all women can be seen within six months for an extra screening if they want one. The vast majority would be seen much sooner than that and in a way that does not interrupt the normal screening programme, which is critical. The department and NHS England will provide additional resource to make that happen, including using temporary independent sector resource as necessary.
The noble Baroness, Lady Maddock, asked about case notes taking a long time to be assembled. That can happen, and it is critical for any woman or her family who think that they may have been affected negatively by this, with her cancer not being spotted. We will go through case note reviews for each of the women who may have been affected in that way—and if the NHS is shown to have been at fault, they will be eligible for compensation.
The noble Baroness asked a very good question about the location of screening. Choice is embedded in the system. I believe it was the noble Baroness, Lady Jolly, whom she was talking about and who had that experience. I looked into this: the 2016-17 guidance from NHS England provides flexibility and choice for women to say where they want their screening, which is one of the ways of driving uptake. If that has not happened in this case, and it does not sound like it has, I will be happy to raise that directly with NHS England at the highest levels.
I hope that I have been able to answer the questions from the noble Baronesses. I agree with them that this is a dreadful outcome of administrative incompetence and that we need to make sure, as we are reassured at the moment, that it is not affecting either other screening processes or other countries. One reason for that is that the particular clinical trial—the AgeX trial—applied only in England in its interaction with the screening database. The trial is not taking place in Wales or Northern Ireland, which share the same system—which is why the Welsh case seems to be different.
We will at all times in the process of the review and as we find out more be at great pains to make sure that we are as transparent as possible and to share information with the House.
My Lords, the Minister referred to IT and QA failings, and has recently been answering questions about data security. An independent review into the breast cancer screening programme is clearly important and welcome, but how confident is he that the sorts of failings he has talked about do not exist in other areas of the NHS? Given the fact that the QA process failed in the current instance for eight years to pick this up, how can he have any confidence at all in automated processes elsewhere?
We must be absolutely cautious in our dealings with technology. Of course, technology is part of the health and care service now. It is in everything. Making sure that there is good quality assurance is critical to that. Clearly, we have uncovered a problem but we do not think that the problem is in other screening processes. We have had reassurance from Public Health England that that is the case, but we clearly need to investigate further. We also need to be alive to the fact that these systems are often under attack from other actors, and to provide that cyber resilience. So I am afraid that it is an ongoing process to provide that kind of resilience and quality assurance. It is a job that never ends.
My Lords, I declare an interest as vice-chair of the All-Party Parliamentary Group on Breast Cancer. The Minister may be aware—I hope that he is—of a report, Good Enough?, about capacity issues within the breast cancer screening service. The report expresses very forcefully that there is regional variation. What is the answer to this and how can it be improved so that wherever you are you can get excellent service and screening?
The noble Baroness asks an extremely good question. It is important in this instance to distinguish between the very correct questions that she is asking and the particular problem in this case. In this case the problem is not one of resource but of, unfortunately, an IT flaw in the interaction between the national screening programme database and its AgeX trial. I want to make that clear. But in response to her question, we had an opportunity to debate these issues in the House yesterday in an Oral Question from the noble Baroness, Lady Thornton. We are increasing and have increased the number of specialist cancer nurses, for example, by 1,000. Health Education England, in its cancer workforce strategy, has outlined a plan to recruit more radiologists, radiotherapists and so forth. Having more staff and higher-trained staff with the proper competency frameworks is clearly one way in which we can deal with the variations that she rightly highlights.
My Lords, the Minister mentioned that the Government will be looking at public information campaigns to ensure that women who may not have captured the periodic screening letter that is sent out would be aware that they need to take the initiative themselves and find out if they should have been screened. But, if I understood him correctly, when the Minister gave the figures in the Statement, 270 was the upper limit of deaths that would have been caused. If that is the case, I am slightly perturbed in terms of frightening people. He would probably accept that, whatever the figure, it is impossible to be precise about the number of deaths that “would” have been caused. Perhaps he meant to say “may” have been caused—because screening of itself does not cure breast cancer. That is an important distinction to make.
The noble Baroness makes an incredibly important point. To refer back to the Statement, I think that the word used was “may” and that an upper range was given. I want to distinguish between two things. The first is the national campaigns that take place—I think there were 14 in the past eight years—to encourage women to check for their own symptoms and take up opportunities for screening programmes. Those will continue; that is part of the overall programme. In terms of writing to the women who are still alive who may have been affected, that is a separate and discrete process. It will start with a letter. It is easy for us to track down those who are registered with a GP in England and we are working with colleagues in the devolved Administrations, as noble Lords would expect, to make sure that we can write to those who have moved to those countries, and to provide resources to those countries so that they can provide screening. A helpline is also included that has been publicised.
On the point about the number of deaths that may have occurred, it is a difficult issue. On the one hand, we have received advice that that may be the case and we felt that it was wrong not to be honest and transparent about it. At the same time, there is not a clinical consensus about the benefits of breast cancer screening for women aged 70 and over—that came as something of a surprise to me—because of the non-malignancy or low malignancy of some tumours that can be spotted and the harms that can follow from treatment.
So we need to be cautious. What we have projected as a range is based on statistical modelling and not based on scrutiny of actual case note reviews. Of course, we deeply hope that the number will come down as we carry out that inquiry.
My Lords, why is there the magical cut-off point of 72? In the paper the Minister just read, what are the non-threatening cancers in older people and what are the harmful tests and treatment? If they are harmful for older people, what about younger people?
The noble Baroness asks an excellent question. The clinical advice that we received, which is the reason for the extension of screening from up to the age of 70 to up to the age of 73, is part of a clinical trial. There is no evidence that screening necessarily benefits women in general; of course, it will benefit some women in particular. There are breast cancers—I cannot claim to be able to describe them because that is well beyond my clinical knowledge—that women can have at that age and live with, and, indeed, they can die of something else at a later age. The treatment process, whether it is chemotherapy, radiotherapy or surgery, can be very debilitating, harmful and in some cases unnecessary, although, having found a tumour, a woman may well want to progress with that treatment. We have been driven by that age range, with 72 as the cut-off, and the wider description of this lack of clinical consensus. I assure the noble Baroness that we have been informed by a clinical advisory group throughout the process to make sure that we are as accurate and effective as possible.
My Lords, a broadcast on the BBC news last night commented that people should not contact their GPs but use some number instead. A lot of people will want to go to their GP to be reassured about this. Visits to GPs were not mentioned in the Minister’s Statement, nor in the Oral Statement, so it is important to explain this.
The noble Lord makes a good point. We are encouraging people to use the helpline. Indeed, the number will be written in the letter that is sent to women, whether they are offered a screening because they are aged 72 or under or want to refer themselves for a screening. At the same time, many women will be anxious and will want to see their GP, or are seeing them anyway. We recognise that. We have liaised with the Royal College to make sure that GPs are properly briefed on a potential increase in the number of women referring themselves so that they are able to cope with that and provide the necessary signalling.
It is also important to highlight that we are working very closely with the key cancer charities, such as Macmillan, Breast Cancer Care and Breast Cancer Now, and others to make sure that there is a proper, broad approach so that women, whatever their anxieties—mental health issues may have been triggered as well as physical ones—get the support that they need and deserve.
My Lords, I obviously share in the concern about what has happened. I want to emphasise a point that has already been made and make sure that it will be part of the review. It is unimaginable that some women realise that they have not got the recall for their regular breast screening appointment. As a woman, you are sort of aware when it is about to come around; if the letter had not come, some people—though not everybody—would have either contacted the helpline or gone to their GP. I am worried that the response was, “Well, the computer says you’re not ready for a screening yet”, so the person was not listened to. I am seeking some assurance that the inquiry will come back with an answer on what happened when women said, “I think my breast screening appointment is late”.
Secondly, I am not sure about the scope of the inquiry, which I of course welcome. Will it look at all the circumstances surrounding this incident or will it go further, for example by looking at other causes of the drop in the percentage of people taking up such opportunities, as well as the regional disparities, which have already been mentioned?
As always, the noble Baroness makes a very incisive point. The inquiry must look at whether there were signals and whether they were missed. That may be at the macro level or the micro level, with individual women saying to their GP, “Hang on, this is odd, I haven’t got this”. The problem has arisen because of the interaction between the screening process, which is due to run until a woman’s 71st birthday, and the extension, which was meant to run from a woman’s 71st birthday to the end of her 73rd year but was taking women into this clinical trial prematurely and randomising them. Hence, women in their 70th year did not get anything. It was the interaction of the two. It is technically quite devilish. A 70 year-old woman might or might not have known that she was due to have another one. This is one of things we have to get to the bottom of because, as the noble Baroness said, although this is about technology and computers, ultimately humans are at the centre of this problem.
The inquiry is primarily focused on the incident itself, but I imagine that if, during the course of its work, it finds out or establishes that other issues need to be pursued, such as increasing screening rates variation and so on, it will have the freedom to make those recommendations.
My Lords, this is very close to home for me—I am probably not the only one in the Chamber. It was probably the breast screening programme that saved my life. I had no symptoms and if it had not been for regular mammograms, I would not have known. I am grateful to the health service, just as the noble Baroness, Lady Maddock, is.
The worry I have is that although I had a regular mammogram directly resulting from treatment every year for eight years, I was then told last summer at the age of 73 that the following year I would not be able to have a mammogram unless I went private. This seems to rely too much on people taking individual responsibility for their own health, which I support, but does not provide sufficient back-up for those who are perhaps fearful of having a mammogram. It is extremely painful for some women. The fear of it is still there. That explains why some of the take-up is quite poor. We have a duty of care for those in that position. Those of us who are vocal will do our best to look after ourselves.
My final point is that the cut-off is arbitrary and has a sniff of age discrimination about it. I agree with the noble Baroness, Lady Masham: there is sometimes an element in hospitals whereby perhaps you are not worth it any more. I feel obliged to say that I am still very active and working, just to make sure people think I am worth saving. That should not be the case and it ought to be reviewed. There is age discrimination. It might be just a clinical thing, but I cannot help thinking that there is some self-limitation when some of these clinical groups get together and decide what is appropriate for a woman, without consulting them as individuals.
I know that the whole House will join me in saying that the noble Baroness is definitely worth it. Indeed, I am pleased to hear that her care was successful and that she is with us today. It is a very interesting question about age discrimination. We have again to separate it from the clinical advice, which I am reassured, having spent time with those involved in putting it together, is based on a proper weighing of costs and benefits—of course, that is inevitably in aggregate because we are talking about whole populations. Clinicians have autonomy to do things differently. Indeed, the offer we have given to women aged over 72 is that they can refer themselves and they will have an appointment if they want one. I can provide that reassurance to the noble Baroness.
There is perhaps a separate issue. There are sometimes problems of age discrimination in society and in the national health system itself. Could that be an issue regarding why signs were missed? We know that in some instances, the National Health Service has not been very good at listening to women on some of the issues we have debated in this House and that my noble friend Baroness Cumberlege is looking at in her review. This is a very good point that needs to be investigated properly: are there cultural reasons why signs that might otherwise have been picked up during these nine years were not? I can reassure her that the inquiry will look at this.
My Lords, reverting to the point about the role of the GP, does the Minister agree that it raises wider questions about the operation of the health service? Surely, if we are taking a holistic approach to the well-being of patients and people, the GP has a vital role which increases in importance the more technology comes into play. There should be a proactive role for the GP in helping people to meet the challenges that arise from the inevitably rather more impersonal operation of more technological services. There is a significant issue. Frankly, I sometimes wonder what the role of the GP really is. In a lot of surgeries, it is a pretty meaningless term, because one goes not to a general practitioner but to a surgery. This issue needs attention as we consider the future of the health service.
The noble Lord makes a good point, in the sense that technology is an enabler and supporter of clinical practice done by highly skilled professionals, not a replacement for it. That interaction between reliance on technology and the human face of the service is an issue that the inquiry should investigate.
House adjourned at 1.50 pm.