§ Motion made, and Question proposed, That this House do now adjourn.—[Mrs. McGuire.]
7.23 pm§ Dr. Vincent Cable (Twickenham)I am grateful for the opportunity to speak on this subject. Let me begin by summarising what I want to say before developing my arguments.
The cervical cancer screening programme has performed an enormously valuable service in this country over the years. Tens of thousands of women's lives have been saved by it. However, it is now running up against technical limitations. Advances are being made in the science and the application of testing—especially human papilloma virus testing—that are not yet operating in the United Kingdom. I know that the Government are conducting pilot studies, but my purpose is to bring a sense of urgency to the process, and to ask whether it can be accelerated.
I have a personal and a broader reason for doing this. Earlier in the summer I lost my wife, whom I loved very much, to cancer. As it happens it was breast cancer rather than cervical cancer, but obviously, having been through that experience, I want to ensure that all that can possibly be done will be done to stop women's lives being cut short prematurely. My wife received superb NHS treatment in the Royal Marsden hospital, as many women do. The fact is, however, that lives are being lost, and we must do anything that we can to stop that.
There is a growing campaign to focus attention on the possibilities of human papilloma virus testing. It is now a Europe-wide campaign, and some Ministers, parliamentary colleagues and European colleagues are involved in it. It is sufficiently well developed that, earlier this year, I had 5,000 separate letters from women in my constituency alone, pressing for action on this matter. There is a growing consciousness of the issue, and a growing sense of frustration at the slow progress that is being made.
I shall explain why the issue is important. Cervical cancer is a major cancer in women—the second most important for younger women. The incidence of the disease in the United Kingdom is above average in European terms. Morbidity from the disease has been falling, which clearly reflects the success of the screening programme, but it has, until recently, been rising among younger women, which reflects some growing difficulties.
The key point about this disease, as opposed to many other cancers, is that it is exceptionally amenable to early treatment. I believe that 80 per cent. of women whose cervical cancer is detected early survive, which is a very high rate. That is why the issue of screening is so important.
Smear testing in the United Kingdom has a long history—I think that it was first introduced in the 1940s. It has been well developed in this country, and I think that we are still the only European country with a full national screening programme. It is to the credit of the NHS and the Government that they introduced it and made it work. There have been considerable success stories along the way. As I mentioned, probably tens of thousands of women are alive who would not be if they had not been screened using smear tests.
520 However, it became apparent a few years ago that there have been limitations. This was all brought to a head in the 1998 report by the Public Accounts Committee, which revealed the many limitations of the screening programme that were beginning to pile up. These included human fallibility, lack of staffing, failures in the cytology process, numerous cases of litigation against the NHS—in particular, scandals associated with hospitals such as the Kent and Canterbury hospital—and so on.
The Government have addressed these issues, and I do not want to dwell on them. This is part of the history of the smear test as it has developed, and the limitations are now reasonably well understood, in terms of the lack of training, the lack of staff numbers among cytologists, and the fact that a significant number of women are still being missed by the test, many of whom are on low incomes or in ethnic minority groups.
I do not want to dwell on those issues, however. I want to focus on the particular problems associated with the testing itself. The problem is that the smear test is highly imperfect. Even the most optimistic assessments judge that 20 per cent. of the tests are wrong. There is some argument about whether it is 20 per cent., 30 per cent., or 40 per cent., but substantial numbers of women who are tested and found to be clear none the less develop the disease. That is due to the limitations of the technology.
I believe that about 1,200 women a year die from cervical cancer, despite the screening process. About half those women have been fully tested—in other words, they participated fully in the screening process and there were no failures by the people carrying out the tests. What has happened has been due simply to a deficiency in the technology. That is the issue on which we need to focus.
In recent years, there has been a growing understanding of what causes the disease. Uniquely among cancers, it is caused by a virus, known as the human papilloma virus or HPV. There is also a growing understanding that the virus can be detected. When I started researching this debate, I was surprised at the extent to which that was well known years ago. Professor Jack Cusick, one of the leading practitioners from the Imperial Cancer Research Fund, was publishing on this subject in the British cancer journals in about 1994 and 1995. We are not dealing with entirely new science. We are dealing with science that is well known and well understood.
There has been a lot of research and testing, particularly in the United States. I do not claim to be a medical scientist, but I have tried to understand as best I can some of the recent literature. In February, a major study was published in "Journal of the National Cancer Institute" in the United States—the ASCUS/LSIL triage study, a summary of a great deal of testing in pilot studies in the United States, which advanced not only the science, but the understanding of how testing can operate and be made to work.
Knowledge is spreading widely in Europe. The European Journal for Infectious and Immunological Diseases in Obstetrics and Gynaecology published a study earlier this year by a group of German scientists, which again advanced knowledge and understanding of the subject. What can now be said categorically is that the cause of the disease is understood: it comes from the virus. That virus can be detected with 100 per cent. certainty, as opposed to the 80 per cent. or less certainty that comes from the smear test.
521 I understand that merely achieving a scientific breakthrough is not a sufficient condition for adoption by the NHS. The NHS rightly has to go through a process of evaluation. The economics are always important. I have on occasions pressed for early introduction, for example, of drugs to deal with Alzheimer's, and the answer comes back from Ministers, "We understand that it will clearly help a lot of people, but it is very costly and we have to look at the costs and benefits."
What is unique about the HPV screening controversy is that it is an example of a new advance that would save, as opposed to cost, large amounts of money. That is not merely my assertion. A lot of technical literature supports that view, with which I am sure the Minister's Department is familiar. Articles were published as early as 1997 by Professor Cusick and his collaborator Sasieni. The British Journal of Cancer published an article in the same year by a Dutch researcher, Van Ballgooijan. Jeremy Holmes of the Economists Advisory Group was also involved. They have all done the sums and come to some careful conclusions about the benefits that the NHS would derive from adopting the HPV testing system. It would be possible to increase the length of time that women need to spend before the screening from three to five years, and there would be fewer inadequate tests: the figure could be cut from 8 per cent. to 1 per cent. That means fewer women being recalled and less need for testing, quite apart from the anxiety that that causes the women concerned.
There would be a considerable reduction in the NHS time and resources involved. Moreover—and perhaps most important—fewer women would attract the disease, and there would be less need for extensive and indeed painful therapies. The research suggests that the NHS would probably save £30 million a year by adopting HPV testing—a quarter of the whole cost of the screening programme. There are probably very few examples in modern medicine where the benefit-cost ratio of a new programme is so clear cut.
That brings us to why testing is not happening. A controversy has run over the years as to why things have not moved more quickly under the Government of the day—primarily this Government, because people became aware of the problem after 1997. One of my colleagues in the House of Lords, Lord Clement-Jones, secured a debate on the issue in the early part of 1999 and raised many of the questions that I raise now, which makes me even more impatient to understand why there has been a hiatus.
I understand that the Government have brought in a series of pilot tests in three regions and that they are due to be finished at the end of 2002. Presumably, there will then be a period of evaluation until early 2003, and a decision will be made roughly two years from now. Perhaps the Minister can clarify whether that would be the timing and what the roll-out time would be to make the programme universal, were it established that it was sound.
First, I have to ask why this is necessary. As someone with scientific training, I understand the importance of pilot studies, but many pilot studies have been carried out in the United States involving not only an enormous amount of laboratory work, but extensive field testing. Beyond that, health practitioners in the United States have already been given guidance on how to administer the 522 test, so they are several years ahead of us. I appreciate that that applies not only to the UK, but to the whole of western Europe.
I am perplexed about why we cannot adopt American best practice. I appreciate that we have a universal programme and that, in that sense, ours is a better system, but given that the technology and the economics have been proved, I cannot understand why we cannot move on more quickly.
My second question relates to the British pilot testing system. I understand that it deals only with borderline cases. As the HPV test has potential for universal screening to be run alongside the smear test, why is it not being undertaken on all women in a particular region of the country? Why is it being carried out in this rather narrow, circumscribed way?
My third question also relates to the British pilot. I understand that the Scottish Executive have recently curtailed funding for various pilot studies in Scotland. I appreciate that it is not the Minister's responsibility; indeed the Scottish Executive are the joint responsibility of our two parties, so this is not a party political point. However, for whatever reason, the Scottish Executive have chosen to curtail research. That merely adds to the feeling of many campaigners and specialists in this field that the United Kingdom is not as committed as it could be to bringing this new testing system on stream.
In conclusion, I should like to quote an extract from what my colleague in the House of Lords said about this two and a half years ago. Almost exactly the same points were being made then, so it is not a novel problem. He said:
The FDA in the United States has already undertaken extensive trials. The test is in use for the US for borderline cases. There are trials in a number of other EU countries. Here in the UK the ICRF has a trial involving 12,000 women due to be completed next year.That was in 2000.It is already in use in Marie Stopes clinics, yet the official trials seem to be destined to take for ever … Yet this is a diagnostic tool to supplement an existing test, not a major new treatment. Why cannot we rely on the ICRF trials when they are complete? That does not seem to be displaying the same sense of urgency as the Dutch Government, for instance, who are pressing for interim results."—[Official Report, House of Lords, 3 March 1999; Vol.597, c.1781–2.]I could repeat the same message today.At first sight, there seems to be little reason for holding back. There are good humane reasons in terms of the health of women as well as economic reasons for progressing fast. Will the Minister explain why it is necessary to go through this rather protracted process? When is the earliest end point to the process of testing that she can envisage? Can she give us an assurance that if—as seems to be the case—knowledge and understanding are advancing rapidly, this process of testing can be short-circuited in order to save hundreds of unnecessary deaths?
§ The Minister of State, Department of Health (Jacqui Smith)I thank the hon. Member for Twickenham (Dr. Cable) for raising this important subject. I am sure that all hon. Members will join me in offering him our condolences. He clearly has a personal commitment to this subject and an understanding of the issues. 523 He outlined the key point, which is to ensure that our programmes are effective and that we do what is necessary to safeguard women from cervical cancer to the best of our ability.
As the hon. Gentleman said, we already have significance evidence that the NHS cervical screening programme is successful. Research has shown that it saves about 1,300 lives per year. It was directly responsible for a 43 per cent. drop in the incidence of cervical cancer between 1988 and 1997, and more than 8,250 lives were saved over the same period. In 2000–01, 83 per cent. of eligible women in England had had a test in the previous five years, 3.6 million women were screened and laboratories reported 4.1 million tests. I pay tribute to the hard work and dedication of cervical screening staff across the country.
Organised screening, as the hon. Gentleman said, is available nationwide only in the United Kingdom, the Netherlands, Denmark, Sweden and Finland. In 1988, the UK was the first country in the now European Union, and one of the first in the world, to launch a nationwide cervical cancer screening programme based on computerised call and recall. The UK programme is among the best in terms of numbers. The Dutch programme is similarly nationwide and organised, but no other country screens as many women per year as the UK, where coverage is highest.
Cervical screening is the most reliable method of detecting changes to the cervix that, if left untreated, may go on to develop into cervical cancer. However, like all screening techniques, it is not perfect. There is a measure of interpretation, as the hon. Gentleman said, based on the expert judgment of the individual cytoscreeners involved in assessing abnormalities in screening samples. In a proportion of cases, the abnormalities will be so slight that different cytoscreeners could reach different decisions as to the correct result. In addition, the test itself is not 100 per cent. sensitive.
Women invited for cervical screening need to understand the potential benefits and limitations, in order to be able to make an informed choice about whether they wish to proceed. Information provided to women must be honest, comprehensive and understandable. That is why the NHS cancer plan said that all women will receive a national information leaflet on cervical screening when they are invited to attend. The new leaflets will be launched at the end of this month, and are based on research, including discussions with a diverse range of women. The development of the national leaflets was overseen by the Advisory Committee on Cervical Screening and the national cancer director.
The new screening leaflets are an important step under the new principle of openness in the NHS to which we are all committed. For the first time, women will be given all the facts about cervical screening and a real informed choice about whether they wish to be screened.
The hon. Gentleman concentrated on the opportunities provided by developments in technology, and I want to follow him in that. New developments may help to address some of the problems surrounding cervical screening. That is why the Government are currently piloting both liquid-based cytology and human papilloma virus testing in the cervical screening programme.
524 The two pilots are related. Liquid-based cytology techniques offer a new way to prepare screening test samples for examination in the laboratory. By offering a new way of storing and preparing cervical samples, liquid-based cytology may improve the quality of the cervical screening test. The National Institute for Clinical Excellence has suggested that introducing liquid-based cytology could increase the sensitivity of slides, reduce the number of unsatisfactory tests and improve the speed with which slides can be read. The LBC arm of the pilot is designed to collect information on the effect, costs and practical implications of introducing LBC technology into the cervical screening programme.
As the hon. Gentleman said, human papilloma viruses are a group of 80 viruses known to be implicated in 99 per cent. of cervical cancers. In most women, the virus is cleared naturally by the immune system, but in some it persists and goes on to cause cervical abnormalities that, if left untreated, may develop into cervical cancer.
The hon. Gentleman's questions about the speed and effectiveness of HPV screening partly come down to whether we are talking about that screening as a primary screening method or as a method of sorting, following a smear test that suggests a mild or borderline case. I wish to address both of those issues.
As yet, there is no evidence to support the use of HPV testing as a primary screening tool. The health technology assessment review of research into HPV testing, published in September 1999, concluded that the evidence might support testing for HPV only in certain situations, such as the management of mild and borderline screening tests. The HPV arm of the pilot is therefore using HPV testing as triage—sorting—for women with mild or borderline test results to provide stronger evidence on which women should return for further screening and how soon.
We are not ignoring the issue of primary screening. St Mary's hospital in Manchester is co-ordinating a study to investigate HPV as a primary screening method. The study began in January 2001 and will take six years, including the following up of the data, and will involve 28,000 samples. The Department of Health is funding equipment for the study, at a cost of £90,000.
§ Mrs. Patsy Calton (Cheadle)I was interested to hear the Minister's comments about the Manchester trial, because I have also been in contact with the people there. Is she aware that a significant part of the trial includes the examination of the stigma associated with cervical cancer, of the resultant depression when women believe that they have contracted cervical cancer, and of the expensive prescribing of anti-depressants that results? Is she also aware that significant bodies of medical research suggest that HPV testing can be used as a predictive measure to identify those women at particular risk of developing cervical cancer and enable follow-up work to be done?
§ Jacqui SmithThe hon. Lady makes important points about the range of the research, the complexity and implications of screening programmes—for diagnosis and the effects on the women involved—and the procedures before and after diagnosis that we need to ensure are in place.
The hon. Member for Twickenham raised the issue of the timing of the pilots. It is beneficial to pilot the HPV testing and the liquid-based cytology together, which is 525 one of the reasons for the timing; HPV testing can be carried out on the original LBC slide, whereas at present a woman would need to be called in for a separate HPV test.
The pilot of HPV testing as triage and of liquid-based cytology began in April 2001 at three sites in Newcastle, Norfolk and Norwich and north Bristol after the selected sites had addressed the issues of training and installation of equipment. Results of the liquid-based cytology arm of the pilot should be available early next year. The HPV arm of the pilot will end in September 2002. Analysis of the data on HPV will begin in October 2002, and the report on the evaluation of the HPV arm of the pilot will be submitted in early 2003. As the hon. Gentleman will know, the NHS cancer plan set out the commitment that, if the pilots prove successful, the Government will fund implementation of the programme across the NHS.
In addition to piloting the new technologies, strict quality assurance operates across the cervical screening programme, at a cost of £3.5 million a year. Quality assurance is an important part of the cervical screening programme. It acts as a safety lever by maintaining standards and continuing improvement in the performance of all aspects of cervical screening in order to ensure that women have access to a high-quality service wherever they live.
The performance of laboratories is kept under close review. They are subject to rigorous external quality assurance procedures. The procedures aim to spot potential problems before they become serious and quickly to identify solutions. This, together with the ever-increasing expertise of screening staff, means that the observed benefit of cervical screening is set to continue to increase.
The improvements in cervical screening would not be achievable without investment in cancer staff. Cervical screening staff are an important group and we will invest 526 to support their continuing development. Arrangements for new ways of working are under development. They will explore the potential for an advanced practitioner grade, which will lead to a more flexible work force. New pay arrangements to support this measure have now been agreed with staff representatives.
In conclusion, I thank the hon. Member for Twickenham for raising this important subject. The NHS cervical screening programme is successful, enabling us to identify and support women. It has enabled us to diagnose early and to save women's lives. However, we need to ensure that as we develop the technology, we introduce it into the screening system effectively and appropriately. We are committed to ensuring that we maintain a high quality of monitoring and staff development.
I hope that the hon. Gentleman will accept that the issue is not only of personal importance to him, but of significant importance to the NHS, and one that we are committed to continue to develop.
§ Question put and agreed to.
§ Adjourned accordingly at eight minutes to Eight o ' clock.
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