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 estimates I have received from PHE is that, as a result, 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 on 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 have been 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 has 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 still be 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 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 a 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 believe they are affected. However, we are discussing with each of 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 those affected will still 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 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 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, which 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. 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 Mardsen, and is expected to report in six months.
The NHS has made huge progress under Governments of both sides of this House on improving cancer survival rates, which are now at their highest ever. Seven thousand 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 who are worried that 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 that 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.
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