§ Motion made, and Question proposed,
§ That this House do now adjourn.—[Mr. Hill.]
2.33 pm§ Mr. Richard Page (South-West Hertfordshire)First, I wish to thank the Minister for being here to respond to this Adjournment debate. We all know how precious Fridays are to Members of Parliament for visits to their constituencies. They are all the more so to a busy Minister, to whom I say a double thank you.
My interest in this issue initially came from my membership of the Public Accounts Committee, on which I have served for some 10 years. It reported on the effectiveness, or perhaps lack of effectiveness, of the cervical cancer screening programme. The report criticised the programme, which has been the subject of widespread comment. My parallel concern is that, unless there is improvement in the poor levels of accuracy being achieved, confidence among women will inevitably be eroded. That, to my mind, would be a great shame, because the screening programme has been well organised and its coverage of 85 per cent. of eligible women is unprecedented. As it stands, it saves lives. Let us make no bones about that. However, I hope that what I am proposing might save even more.
Each year, the programme costs £130 million, and an average 4.4 million smear tests are taken. The programme is a jewel in the Department of Health's public health policy crown. However, it could be much better. Over the past two years, the Government have attempted to solve many screening problems produced by the laboratory results and to achieve screening coverage targets. To reinforce that attempt, they created the cervical screening action team.
The National Audit Office report highlights the fact that cervical cancer is the most common cancer among women under 35. The United Kingdom continues to suffer some of the highest incidence rates in the developed world. Around 3,500 women are developing invasive cervical cancer, and about 1,300 dying every year.
I shall not go into the detail of the current test, which was developed 40 years ago. The pap test screens for abnormal cell changes. A sample is taken, scraped on to a slide and examined through a microscope. It seems hardly surprising that screening large numbers of tests each year by the human eye alone leads to missed detection of abnormal cells. The results achieved are, under the circumstances, magnificent, but they are not good enough for today.
A recent study by the United States agency, Health Care Policy and Research, reported that the pap test was only 51 per cent. accurate in detecting abnormalities. Other reports suggest greater accuracy levels, but it is an inescapable fact that detection rates vary between 50 and 70 per cent. For every 10 women undergoing a test, between three and five will have abnormalities that may be missed. Some 50 per cent. of women who develop invasive cervical cancer have clear test histories.
I shall not labour my point about the sensitivity of the current test. The Department of Health is only too well aware of its shortcomings. On 25 March, the chief executive of the national health service litigation authority was quoted as saying that a judgment against the Kent 544 and Canterbury Hospitals NHS Trust had put the whole screening programme at risk, demanding a level of accuracy that the present techniques cannot deliver.
I was disappointed to read in the press at the weekend that plans to introduce computerisation of the smear test programme had been abandoned by the NHS. That is not the health service's fault, but, under the proposed PAPNET system, accuracy levels could have risen to 90 per cent. or more. It was hoped that the system could be introduced nationwide, but those hopes have been dashed by the collapse of the American company making the computerised system.
That system would have enhanced 40-year-old technology, and I hope today to persuade the Minister that all is not lost. We have an opportunity to use an alternative test in conjunction with the existing screening programme, which would increase detection rates for cervical abnormalities to around 97 per cent., a considerable jump from 50 per cent. I am referring to the hybrid capture 11 DNA/HPV test that has recently been approved by the United States Food and Drug Administration as having a 99 per cent. negative predictive value. Despite the clumsy title, the test effectively eliminates false negative results. I rely on expert advice when I say that that is highly significant. If a woman is HPV—human papilloma virus—negative, the chances of her being predisposed to the cancer are negligible. Using a combination of the pap test and the HPV test would raise the detection rate to about 97 per cent., as I said.
The Minister will be only too well aware that about 200,000 of the women who are screened every year show borderline abnormalities and 1,000 women are referred to colposcopy—I hope that the Minister will be able to tell me how to pronounce that word accurately — clinics for examination at a cost to the public of about £35 million. Out of the 200,000, only 4,000 were diagnosed as having invasive cervical cancer in 1996-97. We should not underestimate the worry, concern and stress that every one of those 200,000 women felt, especially as 196,000 of them, on current figures, went through unnecessary worry, and the time and cost implications of the health chain involved: the general practitioners, clinicians, screeners, pathologists and all the other staff who take part in the process.
My submission is simple: the HPV test should, at the very least, be urgently piloted in a number of United Kingdom regions. I would not be doing my job as a Member of Parliament if I did not tell the Minister that I hope that she will agree to that and that if she started such a pilot study in hospitals near my constituency I would be more than delighted—I can give her the names of the hospitals afterwards so that she can immediately get the programme under way.
The Government's position on HPV testing has remained static. The Minister will be aware of a parliamentary question that I tabled a few weeks ago on the trials taking place in the NHS. In her answer, she referred to the TOMBOLA study being conducted by the Medical Research Council. I am not in a position to judge the progress of that study, but I have been given to understand that it was commissioned quite a few years ago, but has never really got under way. If that is the case, progress in examining the causes of and surveying the disease have probably rendered the study past its sell-by date.
545 A paper by Professor Jack Cuzick, head of epidemiology at the Imperial Cancer Research Fund, has demonstrated that a screening programme using HPV testing could save about £30 million per year, as medical studies show that such testing could safely extend the screening interval from three to five years. The longer interval would also be a tremendous bonus for women and would mean an enormous saving in time and pressure on the medical services.
A little bird has told me—I am not at liberty to go into greater detail—that a further endorsement of the testing process will be forthcoming from the United States in the next few weeks. The Minister is aware that the NHS health technology assessment programme is conducting several studies on primary and secondary research and the roles of HPV testing. I am told that the results will be published shortly. In turn, I sincerely hope and, in fact, expect the programme to endorse the use of HPV testing in borderline cases. It will be interesting to find out its recommendations on the use of such testing on so-called borderline smears.
I am reluctant to discuss finance and cost because I am not qualified to do so with accuracy. I do not have the resources to cite the benefits with authority, but this month a conference of the British Society of Colposcopy and Cervical Pathology held in Sunderland estimated that a policy change to age-restricted cervical screening with a HPV test at 50 would substantially reduce costs. If so, that must generate some enthusiasm for change among the hard-hearted Treasury people who hold some of the purse strings. Various financial models have been run to try to show that the screening would help. They have shown results ranging from savings to maintaining the financial status quo. As the Minister and I know, the only real test of whether it would save money would be a monitored pilot scheme.
I express my appreciation to all the people who have come together to give me the facts and figures to enable me to raise this important issue. They include a professor, a manufacturer, a medical researcher, a woman's health care worker, a specialist journalist and, most importantly, the women taking part in the screening programme. I can safely say that no one has told me, "No, you are on the wrong track. I would not go ahead if I were you." Everyone has said that the test must be introduced by our national health service as soon as possible.
I started by expressing appreciation of the size and coverage of the present screening programme, but technology has moved on. It is time that changes were made to embrace the future. I realise that what I am suggesting will, in the fullness of time, be superseded by better methods, but we cannot afford the luxury of waiting. If the improvements available today are not introduced quickly, the number of medical legal actions descending on the NHS and hospital trusts will mount as night follows day. On Tuesday I heard about the possible consequences of screening failures at Peterborough district hospital.
546 I make my plea to the Minister to agree to the piloting of the use of HPV testing in the national health screening programme on behalf of the women subjected to unnecessary doubt and worry, the women who undergo unnecessary further examination and, perhaps even more importantly, to the women who sadly die unnecessarily every year because of the shortcomings of the testing system.
§ The Minister for Public Health (Ms Tessa Jowell)I congratulate the hon. Member for South-West Hertfordshire (Mr. Page) on securing this debate. I listened carefully to his speech and I think that nothing divides us. I hope that he will take from everything that I say our shared sense of urgency about moving ahead to underpin the screening programme with the quality assurance that is essential and seizing the opportunities of new technology when it is established to the tests of proof that we require: that it is effective and can be disseminated as standard practice.
Having said that, let me recap on the scale of the programme. As the hon. Gentleman said, some 4 million women are screened every year in England. Our experts estimate that the programme prevents about 3,900 cases of cervical cancer each year.
The death rate from cervical cancer has fallen steadily since the programme began in 1988, and mercifully it continues to fall. The number of deaths from cervical cancer in England and Wales has dropped from 1,369 in 1994 to 1,222 in 1997. I think that we should be proud of what has been achieved so far. However, we should be under no illusion—despite the overall success there have been some failures. I shall set out some examples of the price of failure, especially in terms of the confidence of women, to which the hon. Gentleman rightly referred.
Following the failures in Kent and Canterbury Hospitals NHS trust and elsewhere, we believe that as a Government we have taken swift and wide-ranging action to address shortcomings in the cervical screening programme. Since December 1997, the programme has undergone the biggest shake-up in its 10-year history.
I shall run through the steps that we have taken to address the weaknesses that were identified. First, regional directors of public health were required to carry out detailed regional reviews of the cervical screening programmes and draw up action plans to deal with areas of weakness. From this year they will be making formal annual reports to the NHS executive of the performance of the programme in their region, thereby underpinning accountability.
Secondly, improvements have been made in the way in which the programme is managed. Responsibility, particularly for commissioning quality assurance for the cervical screening programme, has been transferred to the regional office and all regions have now appointed a quality assurance director. Let me not for one moment underestimate the extent to which we inherited fragmentation, confused lines of accountability and an absence of any systematic quality assurance, which clearly had a bearing on the poor performance of the screening programme in some areas.
547 The third improvement that we have made is that laboratories that read smear tests are required to apply for accreditation. They were required to apply by June 1998, and all have now done so. This is important because laboratories that read fewer than 15,000 smear tests have been reviewed, and the majority have now stopped reading smears or have merged with other laboratories. That is important because of all the evidence that suggests that it is necessary to have a critical mass of experience to ensure maximum reliability in reading smears.
The fourth improvement is that where refresher training has been provided for staff in laboratories, a resource pack for the training of smear takers has also been published. We hope that that will also help to reduce the number of inadequate smears. The NHS cervical screening programme has also provided pump-priming money and expertise for a training course to support the implementation of the training pack. Training and retraining must be a continual aspect of the service.
Finally, work is under way to build better relationships between laboratories and smear takers to ensure that adequate feedback and training systems are in place. Under the new stringent quality assurance arrangements, regional quality assurance teams will be able to identify both those laboratories that report high rates of inadequate smears and individual GP practices which take a high number of such smears, and will work with them to improve their performance in smear taking.
In December 1997, a cervical screening action team was set up to oversee the review process on implementation of the identified action plan. In its report, which was published in August 1998, the team noted the progress made but expressed particular concern about the lack of public confidence in the screening programme. I am extremely concerned about that.
The failure of public confidence is the price that we pay for publicised failures. Whatever the number of women involved, that leads to widespread failure in confidence in the programme. We must always be vigilant about that, but the major task ahead of us is to rebuild confidence among women about the effectiveness of the screening programme. In order to do that, we must be more open and explicit with women about both the benefits and the limitations of cervical screening. We completely understand that when women get a result they want a guarantee that it is correct. However, even with perfect management and 100 per cent. coverage, no screening programme can ever be 100 per cent. accurate. Screening is like wearing a seatbelt; it reduces risk, but does not remove it. We must ensure women throughout the country understand that that is the basis for the terms on which they use the service.
A common, but understandable, misconception is that cervical screening is a test for cancer. It is not. It is a test for abnormalities which, if left undetected and untreated, might lead to cancer. Cervical cancer is a very slow-developing disease. By having smear tests every three to five years, women can reduce their risk of developing cancer by between 80 per cent. and 90 per cent.—a major gain. That is why it is so important for women to have regular smear tests. However, women should always report any abnormal bleeding to their doctors.
548 Beyond the improvements that have already been set in train, we acknowledge that other aspects of the programme need improvement. Regional offices are to improve colposcopy services, building on the action plans drawn up earlier this year.
In order for the screening programme to be successful, it is important to screen as many women as possible—as the PAC report pointed out. We are worried about the range in the level of uptake, especially because those areas where the uptake is lower tend to be poor, deprived areas where general health is also poor. We do not accept the inevitability of that. My right hon. Friend the Secretary of State has made a requirement that all health authorities should achieve 80 per cent. coverage by March 2002. The 13 health authorities that are not currently doing so provided action plans at the end of February setting out the measures they intended to take to achieve that. My right hon. Friend met the chairs of those authorities in March and made it clear—in no uncertain terms—that he expects the chief executives to be held accountable for their health authority's performance on that matter.
The hon. Member for South-West Hertfordshire referred to new developments. We are determined to ensure that-the service provided is the best possible and takes advantage of all the new and available technologies. As the hon. Gentleman pointed out, the current pap test has been in use for about the past 40 years. Although it is not ideal, expert advice is that it is currently the safest and most effective way of screening women for cervical abnormalities. Its estimated failure rate is between 5 per cent. and 15 per cent. New methods of taking smears, such as liquid-based cytology, are currently being piloted in Scotland and we await the results with interest. We are determined that the technology of smear-taking remains at the leading edge. There are also developments in new ways of reading smear tests, such as the semi-automated screening systems.
A great deal of research is under way. Although, unfortunately, Neuro Medical Systems Ltd., the potential PAPNET provider, went into liquidation, other systems are being tested and we shall examine closely their potential benefit to the screening programme. Before any new technology is introduced, it must be safe and effective and meet the high standards that will be required by our newly established National Institute for Clinical Excellence or be approved by the national screening committee.
In respect of new technology, we proceed on the basis of the best available expert advice, and human papilloma virus testing is an example of our adoption of that approach. There is a substantial body of evidence about the relationship between 13 of the 70 HPVs and cervical cancer. It appears to establish a causal link, but the exact nature of the mechanism is not known and it is not yet possible to determine which women with HPV will go on to develop cervical abnormalities and which will not.
Less evidence is available as to the significance of HPV testing: for example, it is possible that HPV testing will help in identifying the vast majority of women who are at low risk of developing cervical cancer. Women with a consistent history of negative smear test results over a period of 15 to 20 years and no evidence of HPV may be suitable for less frequent screening, thereby reshaping screening programme protocols.
549 Another possibility of HPV testing is that it might help to reduce the number of smears and unnecessary intervention in women with low-grade abnormalities of the cervix. Negative HPV status might mean that it is unnecessary to follow the current practice of repeat smears, which should also improve specificity and cost-effectiveness and reduce anxiety. We are closely considering HPV testing and we shall be guided by evidence of its effectiveness.
550 For the Government, there are four key objectives: maximising the number of women who are screened; ensuring quality and reliability; promoting and pursuing the implementation of new technologies; and contributing to our cancer target of reducing the incidence of preventable death by 20 per cent. overall by ensuring that every life that can be saved by screening is saved.
§ Question put and agreed to.
§ Adjourned accordingly at two minutes past Three o'clock.