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POINT OF ORDER
Mr. Alfred Morris (Manchester, Wythenshawe): on a point of order, Madam Speaker, to correct the record. I ask the Leader of the House to accept that he was totally mistaken in saying that my motion on the care and welfare of former service people was discussed early this year. Will he also accept that when what the Royal British Legion is asking for was debated by the House the motion was carried, since when nothing has been done to give effect to that decision. Is the right hon. Gentleman aware that that caused great resentment not only in the Royal British Legion but among former service organisations generally?
Madam Speaker: That is not a point of order for me. I must not extend business questions, but I see that the Leader of the House is willing to reply so I shall allow him to do so.
Mr. Newton: I am grateful, Madam Speakers As I am sure the right hon. Gentleman knows, because he and I have been doing business for a long time, I would not have wanted to convey a misleading impression, and I readily accept that it was not his motion that was discussed. But the issue that he has raised, as he himself acknowledged, was discussed in a debate last year, and the Government's view was made clear at that time.
ESTIMATES DAY
[1st Allotted Day]
VOTE ON ACCOUNT, 1996-97
Class XI, Vote 1
Breast Cancer
Motion made, and Question proposed,
That a sum not exceeding £13,948,653,000 be granted to Her Majesty out of the Consolidated Fund, on account, for or towards defraying the charges for the year ending on 31st March 1997 for expenditure by the Department of Health on or in relation to hospital community health, mental health, family health and family health service administration services, National Health Service trusts and on related services.--[Mr. Horam].
Mrs. Manon Roe (Broxbourne):
I am very grateful to the Select Committee on Liaison for recommending that the House debates this estimate in so far as it relates to the very important topic of breast cancer services. I shall, of course, concentrate on the report published recently by the Select Committee on Health, which I have the honour to chair. The recommendations of the report were unanimous.
I should like to thank all my colleagues on the Committee for the very hard work that they put into the report, and for the very good spirit in which it was discussed. I should also particularly like to thank our specialist advisers, Professor Michael Baum of the Royal Marsden hospital and Professor Roger Blarney of Nottingham City hospital.
I shall begin by outlining the main conclusions and recommendations of the report, and the main points of the Government's response. There are a few questions that I should like to pursue with the Minister, which I hope he will be able to address in his speech.
Although the United Kingdom does not have a particularly high incidence of breast cancer--the disease is more prevalent in the United States of America, New Zealand, Canada and several other European countries, including France, Italy and Denmark--we have almost the highest recorded breast cancer mortality in the world. Breast cancer claims the lives of more than 13,000 women every year in England and Wales alone--more than any other cancer, and more than any disease other than heart attacks and strokes. None of our witnesses was able to offer any explanation of why breast cancer mortality should be so high in this country.
The Government's target, set out in 1990, is
One of the great strengths of the quality assurance programme is that it operates not only in individual screening units but at district and regional health authority level. RHAs are responsible for purchasing quality assurance services and for the operation of the quality assurance reference centres in each region.
In 1992, the chief executive of the NHS management executive told the Public Accounts Committee that the standards laid down centrally for the programme were "non-negotiable", and said:
The national co-ordinator of the NHS breast screening programme also told us that she occasionally had problems with district health authorities which were trying to purchase services that did not meet national standards. That is why the quality assurance programme is so important to the screening programme. It ensures not only that the service provided matches the service for which it is contracted, but that the service for which it is contracted meets the national requirements in the first place. We recommend that the QAP should be preserved in something like its present form after the dissolution of the regional health authorities next April. That could be achieved either by central funding of the programme or by bottom slicing from district health authority allocations.
In their response, the Government said that they had issued guidance to the effect that
The Government have also said, however, that they will move from the present system, under which RHAs are responsible for purchasing quality assurance, to a system of lead district purchasing, which will be funded through the common services levy.
I recognise the steps that the Department is taking to ensure that the QAP continues to operate at all three levels, but I should be grateful if my hon. Friend the Minister were able to assure us that the programme will not become simply a means for purchasers to check on provider units. We must continue to ensure that the service purchased meets the national standard.
The Select Committee on Health recommended, on the strength of the best evidence now available, that the upper age limit for inclusion in the call and recall system for screening should be extended from 65 years to 69, and that the Department of Health must ensure that women over that age are aware of their right to a three-yearly mammogram on request.
Professor Forrest's report, on the strength of which the NHS breast screening programme was originally established, suggested an upper age limit of 64, on the grounds that there was lower acceptance of screening by women of older ages. It is difficult to understand what basis was used for that assertion, as the Swedish two counties study--one of the key pieces of clinical trial evidence on which the Forrest report drew--showed that 80 per cent. of women up to the age of 74 accepted invitations for screening.
There are two good reasons, I believe, for including older women in the screening programme. First, the risk of breast cancer increases with age. Secondly, the cancer detection rate among older women is much higher than among younger women.
Conversely, we found no evidence that extending screening to women under the age of 50 would be beneficial. None of our witnesses supported that proposal. Professor Martin Vessey of the advisory committee on breast screening explained to us that, apart from the lower incidence of breast cancer in women under the age of 50, it is also difficult to screen for breast cancer in pre-menopausal women, as
The NHS breast screening programme is a model service. It has strong central co-ordination, a set of auditable national performance targets, and a quality assurance programme that has been praised by the National Audit Office. However good the screening programme, however, screening alone will not lead to a reduction in breast cancer mortality.
As we were completing our report, evidence emerged that breast cancer mortality was already beginning to fall in 1989. As I have said, such an effect could not have been generated after only two years of breast screening. It is probable that the welcome reduction in mortality is the result of improvements in the treatment of more advanced breast cancer.
There are ways in which treatment for women with both screen-detected and more advanced breast cancer could be improved. There was a wholehearted welcome for the Government's policy framework for commissioning cancer services. The Government's plan is that cancer services should be arranged into three tiers-- primary care, designated cancer units and designated cancer centres.
The designated cancer unit will normally be a district hospital with a full range of support services for cancer patients. More importantly, however, it will have site-specific clinics for patients with the commoner cancers, led by a consultant specialist. Those will be clinics that deal with only one type of cancer, such as breast cancer or gastro-intestinal cancer.
In practice, that means that, where there are several hospitals in one area, purchasers and providers may agree between themselves that a unit for certain cancers or groups of cancers will be established at one hospital, and a unit for another cancer or group of cancers in another
hospital. Such clinics would also treat patients with related non-malignant conditions--for example, women with non-malignant breast problems, which account for about 90 per cent. of all breast disease, would be seen in a specialist breast unit.
The cancer centre will be part of a large general hospital or a teaching hospital, and will offer the same range of services as the cancer unit. It will also offer specialist clinics for the less common forms of cancer, and a full range of support services for the local cancer units, including
The most important point to make about the policy framework is that it is based on sub-specialisation. It is not acceptable that a woman with a serious life-threatening disease such as breast cancer should be treated by a general surgeon who might spend most of his or her time dealing with a muddle of other surgical conditions. In addition to a specialist breast surgeon, the specialist breast unit should have a multi-disciplinary team of other specialists with specific training in the management of breast disease.
The advantages for patients in such units are manifold and great. Each unit will see enough patients to operate a dedicated clinic for new patients with breast problems each week--a one-stop shop, at which women can have all their diagnostic tests done at the same visit.
Rapid diagnosis is of the utmost importance. It allows women who have breast cancer to receive treatment at the earliest opportunity, and permits the timely reassurance of women who do not have cancer. Patients who have breast cancer will receive a high-quality package of care planned by a multidisciplinary team of specialists, rather than what the British Breast Group report, "Provision of breast services in the UK", described as:
More importantly, there is evidence that patients treated in such units have improved survival rates. A paper in The Lancet last spring showed that women treated by a consultant who sees more than 29 new cases of breast cancer each year have a 30 per cent. better survival rate than those treated by a consultant who sees fewer new patients.
The specialist unit also represents a very efficient way of treating breast cancer. Mr. Hugh Bishop, of the British Association of Surgical Oncology breast surgeons group told us:
That is the Government's vision for the future of breast cancer services in the United Kingdom, and it is a vision shared not only by the Select Committee but by organisations such as the British Breast Group, the British Association of Surgical Oncology breast surgeons group and the Cancer Relief Macmillan Fund.
While the Committee welcomed the Government's new initiative, we believe that it could be improved further. We believe that there must be some mechanism for ensuring that a hospital which is designated as a cancer
unit or a cancer centre is providing the necessary services to the required standard. There is a real danger that every hospital with a consultant surgeon will simply hang out a Sign saying "Specialist Breast Unit", and will designate itself as such, without having suitably trained specialist staff or the necessary critical mass of patients that is so vital to the good running of such a unit.
The British Breast Group recommends that a specialist breast unit should see a minimum of between 75 and 100 new cases of breast cancer each year. That serves to ensure both that the general level of expertise among the team is sustained and that the unit remains cost-effective. By issuing a set of national mandatory standards for specialist breast units, the Department could ensure that all women with breast cancer receive the highest standards of care.
During our inquiries, a definition of a specialist breast unit was produced by an ad hoc group consisting of representatives of various organisations involved in the management of breast disease, including several of the royal colleges. The Committee published the definition as an appendix to its minutes of evidence, and it can be found on page 191 of that volume. The same ad hoc group met again recently, and it has further revised the definition.
I have praised the mechanism which the NHS breast screening programme has in place to ensure that all screening and assessment units provide a high-quality level of service through its quality assurance programme. It is a Rolls-Royce among breast cancer services. Unfortunately, many women whose breast cancer is not detected by the screening programme receive a second-hand Trabant service. They might be referred to a general surgeon at a local hospital who has no special training in the management of breast cancer, does not work closely with a team of oncologists, radiologists and cytologists, sees only a few cases of breast cancer each year, and is not subject to any external mechanism of quality control.
In our report, we concluded that the QAP is one of the great strengths of the programme, as it operates at a level; above individual purchasers and providers. We recommend that the remit of the national co-ordinator of the NHS breast screening programme and the regional quality assurance teams should be extended to cover the provision of services for women with symptomatic as well as screen-detected breast cancer.
Such an extension of the quality assurance programme would enable the Department of Health to ensure that all hospitals which were operating specialist breast units met the minimum mandatory standards. My noble Friend Lady Cumberledge and the chief medical officer told the Committee that they were worried that a mandatory service specification might stifle useful innovations at a local level. I fully appreciate their concern, but the mandatory requirements which the Committee proposed F are the minimum requirements. There is no reason why they should prevent units from providing a higher level of service than is specified.
Perhaps I might draw an analogy with the patients charter. The charter lays down the minimum level of service that patients have the right to expect, but does nothing to prevent providing units from exceeding those standards I am pleased that the Department of Health is working to develop service guidance for the common
cancers, but I shall be grateful again if the Minister will assure the House that this will be sufficient to stop hospitals simply hanging out a sign.
Breast cancer is almost unique, in that a quality assurance system operating at national and regional level is already in place within the screening programme. The Select Committee believes that an extension of the functions of the quality assurance programme and the office of the national Coordinator to include services for women with symptomatic breast disease could lead the way for other site-specific specialties. It is perhaps surprising that that proposal was supported by many of the doctors who gave evidence to us. They want their work to be subject to rigorous quality control.
Dr. Mike Richards of the British Breast Group told us that he would favour a national Coordinator for all breast cancer services. Mr. Hugh Bishop of the British Association of Surgical Oncology told us that such a development was "absolutely essential". It is a pity that the Department is proving reluctant to build on the success of the screening programme in that way, but I await the Minister's response on the matter.
During our inquiry, the Committee learned that at least one regional health authority--North Thames--is extending the role of its regional quality assurance manager to encompass the provision of treatment for breast cancer patients. It told us:
The Committee considered ways in which clinical research in breast cancer might be improved. Although our inquiry related primarily to breast cancer services, our recommendations on clinical research will inevitably have benefits for many researchers working in other fields. We heard from researchers and from the Department of Health that one of the obstacles to conducting good clinical research was disputes over who was to provide indemnity for the clinicians and trusts involved in that research. The present system of providing indemnity for clinicians and trusts engaged in research is ambiguous.
The Department of Health told us that NHS indemnity covered all NHS-provided health care professionals for negligent harm resulting from research undertaken as part of their NHS contract, and that the employing NHS body--for example a hospital trust--is expected to meet the entire cost of defending, and if necessary settling, a claim where negligence is alleged.
Ultimately, it is for the employing body to decide whether to allow research to proceed or not, and a trust may decide not to allow its employees to participate in a trial if it does not wish to provide indemnity for them. Mr. Richard Gray of the clinical trials service unit at the university of Oxford told us that many trusts refused to allow their doctors to take part in trials unless they received indemnity cover from the study sponsors.
In some cases, that has led to the absurd situation in which doctors have been permitted to use conventional treatments and new treatments of unproven effectiveness in an ad hoc manner, but have not been allowed randomly to assign patients to control and study groups in a way that would allow them to gain useful information about the effectiveness of the unproven treatment. That clearly militates against the Department's efforts to encourage the practice of evidence-based medicine, of which I am sure the whole House would approve.
Good clinical research is of benefit to the whole NHS, and the Select Committee did not think it fair that the indemnity cost of that research should be provided only by those NHS bodies which participated in it. We therefore recommended that indemnity for NHS bodies and their employees participating in research which is approved by the relevant research bodies--in the case of breast cancer research, the United Kingdom Co-ordinating Committee on Cancer Research--should be provided centrally by the Department of Health. The Committee was pleased to learn from the Department that it will be considering that option in its current review of research indemnity. I hope that the Minister will be able to report the latest progress of the review to the House today.
The Committee also recommended that the Department consider ways to streamline the system of ethics committees. Ethical review is an essential part of clinical research, but representatives of the UKCCCR told us that the present unwieldy structure of that committee system puts people off entering patients into trials. For a large multi-centre trial, the approval of as many as 40 local research ethics committees might have to be obtained.
There are a few good reasons why a research proposal might be allowed to go ahead in one area and not in another. The provision of information leaflets in ethnic minority languages for patients is liable to be an essential part of a trial conducted in some parts of the country, but not others. Likewise, some hospitals may have the appropriate facilities to participate in a trial and others may not.
The fundamental ethical considerations surrounding a research proposal, however, will not vary from one region to another. Breast cancer research is changing--moving towards the examination of smaller and smaller sub-groups of patients of different tumour types. It is therefore becoming necessary to involve more and more research centres in clinical trials.
I know that the Minister shares the Committee's concern about the unwieldy system of local ethics committees, and that the chief medical officer is considering ways of streamlining the system. Perhaps the Minister might be able to give the House a little more detail about that review this afternoon.
Finally, I should like to say a few words about the United Kingdom Co-ordinating Committee on Cancer Research and, in particular, its breast cancer trials and cancer screening sub-committee.
The UKCCCR consists of the Cancer Research Campaign, the Imperial Cancer Research Fund, the Medical Research Council and several other cancer research charities. It was originally chaired by Professor Sir Patrick Forrest, who was instrumental in establishing the NHS breast screening programme. The Department of Health and the Scottish Office Home and Health Department have observer status on the committee. The UKCCCR provides a forum for the exchange of information on the policies and plans of member bodies, recommends proposals for the co-ordination of policies, and offers advice to the member bodies on any matters that might come before it.
Although the breast cancer trials co-ordinating sub-committee of the UKCCCR runs some trials of its own--such as those that are being conducted to examine
the treatment of ductal carcinoma in situ and the use of tamoxifen--and endorses and co-ordinates large, multi-centre trials, it does not distribute the funds for such trials. After researchers have obtained approval from the UKCCCR, they must scrape around trying to hind out where they can fund the research, going to committee after committee, at the mercy of the weakest of those committees, and all before they have to go through the system of local research ethics committees, which I have just described.
The UKCCCR breast cancer trials co-ordinating sub-committee can be seen as the parent body for breast cancer research, representing most of the main sources of research funding. The Select Committee believes that it would be a step forward if the UKCCCR were to have its own budget for funding trials, so that it could act as a one-stop shop for researchers wishing to undertake a trial.
We recommend that the Department of Health and the Medical Research Council identify their budgets for breast cancer research, and distribute the money through the UKCCCR in the expectation that that will provide an incentive for other research funding bodies to do likewise.
I understand that neither the Department nor the MRC has a specific budget for breast cancer research, but I cannot see why it would not be possible for them to identify the amount which they currently spend on breast cancer research, and devolve that amount to UKCCCR. The whole Committee agrees that that would be a welcome development, which would make it easier for researchers to gather vital information about the effectiveness of new treatments at the earliest possible opportunity .
"to reduce the number of breast cancer deaths among women invited for Screening by at least 25 per cent. by the year 2000."
It is clear from the very wording of that target that the national health service breast screening programme is at the centre of the Government's plans to reduce breast cancer mortality
No reduction in breast cancer mortality from the programme is expected to be observed until around 1997, as there is a "lead time", which means that the full benefits of the programme will not be observed until those women who have benefited from the early detection of their breast cancer begin to enjoy additional life years. None the less, we were impressed by the fact that the programme has met or exceeded all its interim quality indicators so far, largely as a result of its excellent quality assurance programme, and especially the efforts of its national co-ordinator.
"If there are purchasers that want to try to step out of line"--
that is, to try to purchase a service that does not meet national specifications--
"they must be brought back into line by the regions. That is the role of the region and we have made that extremely clear".
"it is vital that quality assurance systems should continue to be funded and operated in the future to the same high standards as at present."
"the hormonal environment in the breast is different"
and the breast is much denser, making it more difficult to obtain accurate readable mammograms. The Committee was pleased to note the Government's response, which is to conduct clinical trials in screening older women.
"those treatment regimens which are too specialised, technically demanding or capital intensive to be provided by the cancer unit"
That could include radiotherapy, for example.
"ad hoc therapy being carried out by an individual acting without interaction with other members of a team"
"a specialist breast unit is actually more efficient it does fewer benign breast operations, it does fewer unnecessary investigations . . . and processes people more efficiently and in a more undly way."
"Women should be offered the same standard of care from the breast service in both screening and symptomatic investigation and treatment."
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