§ Motion made, and Question proposed, That this House do now adjourn—[Mr. Lightbown]2.56 pm
§ Mr. Jerry Hayes (Harlow)
Last year, 2,500 women died of cervical cancer. All of us in the Conservative party and, I suspect, the vast majority of Opposition Members, greatly respect the commitment of my right hon. Friend the Minister for Health to the eradication of cervical cancer, and fully accept everything that he, his Department and our hon. Friend the Parliamentary Under-Secretary of State for Health and Social Security are trying to do to introduce a recall system as fast and as effectively as possible.
I am sure that my right hon. Friend will accept that, sad to say, it does not look as if we shall get a full recall service by the end of the year, but we are working towards it. I am sure that he will also accept that one of the problems with the present test is that it is not as accurate as we should like. In fact, it could be up to 20 or 30 per cent. inaccurate. Another difficulty that I am sure my right hon. Friend would accept involves speed. The cytologists can deal with only 25 to 30 slides a day and sometimes it takes up to a month for a women who is very worried about whether she has cancer to hear the result.
The debate about an organisation called Quest for a Test for Cancer, which is battling against the problems that are besetting the country. The trouble is that it is also battling against some civil servants in the Department of Health and Social Security. I have no criticism of my right hon. Friend the Minister for Health and my hon. Friend the Under-Secretary of State or of the respective private offices. From my experience on the Select Committee on Social Services, and through day-to-day correspondence, I have nothing but respect for the professionalism of those in the private offices and the conscientious why in which they respond to our letters.
I should like to tell the House a little about the test that has been discovered. Many in the medical profession would call it a breakthrough. The test, which was pioneered by two well-known and distinguished research doctors at the academic department of obstetrics and gynaecology atthe Middlesex hospital, detects pre-cancer in normal-looking cells with a staining technique which causes the nucleus, or control centre, of pre-cancerous cells to appear darker than those of healthy cells. The difference in staining is measured by an instrument called an integrating microdensitometer which shines a beam of light through the nuclei, scanning them and measuring how much light passes through. This value indicates whether the cells are pre-cancerous and how potentially malignant they are. A computer is used to store and analyse the results.
The test has been described as the major breakthrough of the decade in cancer detection. It is fast, reliable and cost effective, and it is the only routine test which detects potential malignancy in normal-looking cells. It replaces a decision based on human observation with measurements of a highly accurate instrument. The present cervical screening involves clinicians examining smears from normal-looking cells. The automatic staining machine can take 180 slides at one cycle, each taking one and a half minutes. That compares with the conventional cervical screening when a single cytologist can process 25 to 30 a 656 day. Furthermore, of the 187 women who have been screened at a field trial, which has been written up in The Lancet and other medical journals, there has been a success and accuracy rate of more than 95 per cent. It goes without saying that the Department was and still is interested in the matter. It made overtures to Dr. Sincock and Mr. Steele who have been pioneering these experiments. I should tell the House of the chronology of events affecting the two doctors.
The DHSS invited Dr. Sincock to apply for funds, and the first discussions were held as long ago as 20 May 1987. It was made clear to the Department that the test had to be put through a final clinical trial before it could be adopted for routine cervical screening. On 17 June 1987 representatives visited the laboratory at the Middlesex hospital to see the test in action. They were highly enthusiastic and encouraged Dr. Sincock to make an application for funds as soon as possible. They promised to process such an application as soon as possible in view of the importance of the work. On 6 July 1987 the DHSS made a further visit to the Middlesex hospital laboratory and brought representatives from a commercial company, the name of which it is not appropriate to mention at this stage. One of them, the research and development manager, explained that his company had ready for production a machine that would quickly and reliably read cervical smear preparations.
In July 1987 a formal application was made to the DHSS procurement directorate. In order to expedite its processing, the DHSS had checked and passed a draft version submitted previously. The decision was promised for 30 November 1987 and I have letters from Ministers confirming that. On 3 August 1987 Dr. Sincock was visited by Dr. Rutovitz of the Medical Research Council unit in Edinburgh. His group had been actively involved in the development of the commercial machine. He confirmed that the machine was nowhere near ready for production and that there were some technical problems. On 9 November 1987 the DHSS visited the Middlesex. Dr. Sincock was informed that the application would have to be amended and that the work was now considered low priority.
Two further amended applications were submitted to the DHSS, one at the end of November and the other at the end of December. On 14 Decemer 1987, the procurement directorate advised that the application was to be considered by a scientific committee that was scheduled to meet on 25 February 1988. On 28 January Dr. Sincock visited Dr. Rutovitz at the Medical Research Council unit in Edinburgh to give a number of lectures about the test and to inspect the commercial machine. He was alarmed by the number of technical problems with the machine and clearly thought at that stage that it was unable to fulfil the promise of automating the reading of cervical smears, despite many years of development.
On 21 April 1988, Quest for a Test for Cancer received an official rejection of its application from the DHSS. Quest for a Test for Cancer and those at the department of academic obstetrics and gynaecology at the Middlesex hospital—those who pioneered the test—have been horrified by that decision. The DHSS has been dragging its feet for a long time. Even today there has been no scientific explanation of why the test was rejected. I hesitate to say, but nevertheless I shall do so, that there was much unpleasantness between officials and Mr. Steele and Dr. Sincock.
657 On 18 April 1988, Dr. Sincock received a letter from Mr. Kennedy of the supplies technology division about the test. It says:I am writing to you following our telephone conversation of 15 April. First, I regret to have to confirm that the expert panel which met on 26 February did not recommend that your project be funded by the NHS Procurement Directorate. Second, I wish to apologise on behalf of DHSS for the excessive and inexcusable delay in letting you have a written statement of the decision of the meeting and for the fact that during our conversation it took me some time to get to the point that the expert panel had effectively turned down your proposal.At this stage, I should make it clear that all the people who worked to get the project off the ground did everything they could to accede to the requests made by the DHSS and to change specifications. I have been told by those who were involved that they acceded to every request.
We are talking not about an idea but something that has been pioneered, developed, has had clinical trials on 187 women and has proved to have a 95 per cent. success rate. All the funds about which the DHSS initiated the discussions have gone. The chances of getting the test off the ground without £105,000 so that 2,000 or 3,000 women can be tested are remote, unless money is forthcoming from the Department.
A note was sent to Mr. Kennedy by Mr. Steele of the Middlesex hospital in response to the letter of 18 April. He said:I do appreciate your apology but find it quite astounding that we were not informed before now particularly in view of the fact that an application for funds was invited by the department and that we have had to revise our proposal several times since that invitation was issued after we visited the department.As you will know from the papers, we sought a grant in order to validate on a large scale the reliability of this method of screening for cervical neoplasia. Almost daily in clinical practice I meet problems arising from the limitations of cervical cytology and a more reliable method of screening would both save lives and be more cost effective than the present method. I note that you wish to discuss with us the question of commercial exploitation of the assay with the company. As I think Dr. Sincock told you we were not impressed when we met this company last year. They have no particular experience of the type of work which Dr. Sincock is doing and while I am aware that they have been working on the automation of cervical cytology for some years I do not think that this work links in particularly closely with our own nor am I satisfied that they would be the most appropriate people with whom to co-operate. In any case, it seems to us quite illogical to be talking about commercial exploitation before we have a complete appraisal of the method of screening for cervical neoplasia which we have researched. I must say that I find the attitude and response of the Department of Health in this matter very strange.It is with sadness that I received this morning a letter from Dr. Sincock, who pioneered this work. He said:Just a brief note to provide you with an update of information for your …debate on 13th May. Mr. D. Kennedy from the NHS Procurement Directorate has yesterday spoken on the phone with Mr. S. Steele, the Head of this department. He will not speak to me in case any information is passed to Quest for a Test for Cancer. Mr. Kennedy did not succeed in getting Mr. Steele to commit himself to further time wasting meetings and discussions. Indeed, it would be fair to say that at the end of the phone call Mr. Steele was of the impression that nothing was being done to resolve the present serious situation and further the Department seemed to be totally confused about our application frequently making contradictory statements.658I have today offered my resignation. I am forced to do this as a result of the grave damage that has been done to my project by the DHSS. Also, some of their recent comments reflect on my professional credibility as a senior research scientist.Needless to say, Mr. Steele has not accepted that offer of resignation. However, I know that my right hon. Friend the Minister for Health is deeply concerned about this and, probably more than any other Member, is committed to the Health Service and to preventive medicine. I ask my right hon. Friend not simply to give an explanation for what has happened, because what is past is past. I want him to consider that since 15 January, the test has effectively been abandoned.
Millions of women may be suffering from cervical cancer and we know that thousands die every year. The test may provide hope for those women and it will also save the Health Service a great deal of money. I ask my right hon. Friend to give an undertaking that the Department will reconsider the request for very modest financing of £105,000.
§ The Minister for Health (Mr. Tony Newton)
I thank my hon. Friend the Member for Harlow (Mr. Hayes) for raising this matter and I shall say a word about the overall background of screening for cancer. I want to make it clear, especially in relation to what my hon. Friend said about it being later this year before cervical cancer screening systems will be in operation throughout the country, that my colleagues and I in the Department, about whom my hon. Friend made some kind and generous remarks, are proud that, as a result of our efforts, we are the first and only country in the European Community with a comprehensive national cervical cancer screening service based on computerised call and recall.
The entire family practitioner system has now been computerised. That has been a massive exercise for which everyone involved deserves thanks. In addition to its application to cervical cancer screening, that new system offers many possibilities for the prevention of other types of disease.
Incidentally, we are also the first country in the world to launch a nationwide breast cancer screening service and my hon. Friend the Member for Harlow is aware of that, as the West Essex health authority covers the site of one of the first elements of that system. Already the family practitioner computers are being applied to inviting women for mammography and every region in England now has at least one breast cancer screening service with the whole country due to be covered by 1990.
Those two developments—the cervical cancer screening system and the developing breast cancer screening system—provide a record of which my right hon. Friend the Secretary of State and I can be rightly proud.
I move on to the specific issue my hon. Friend has brought before the House. What I have said is not to suggest in any way that we might not do even better if we could overcome some of the problems of cervical cancer screening. One of them is the quality of the smears that are taken. It is important that my hon. Friend should understand that quality problems are the biggest cause of false negatives. I shall say more about that later, if there is time.
Another problem, to which my hon. Friend's remarks have been principally directed, is the misinterpretation in 659 the laboratory of the smears which have been taken. We would he anxious to adopt any system that could be proved to make a significant reliable contribution, against the criteria we must use, to the improvement of laboratory testing. The requirements of a diagnostic test suitable for routine use in NHS laboratories are that it should be robust—that is, it should be capable of being performed in different types of laboratories and by operators with varied levels of skill; it should use readily-available reagents and instruments; it should be reproducible; and it should have a high sensitivity and specificity.
Similarly, any new method for identifying pre-cancer of the cervix must offer advantages over the existing technique. It should be more accurate, faster, require fewer trained technicians, and have an objective end-point. Ideally—or at least it would be an advantage-it would cost no more than the present test.
In considering the test developed by Dr. Sincock, the research director of Quest, we have been applying the criteria I have just outlined. His hydrolysed DNA—or HDA—test still uses a routinely collected smear, which is why I emphasised earlier that the principal cause of false negatives is inadequately collected smears. The difference is that with Dr. Sincock's test the smear is treated with acid to remove everything but the cell nuclei, which are then stained by a special technique. The intensity of that staining, which indicates whether there is a pre-cancerous condition, is measured objectively in a semi-automatic machine. There is the added potential for full automation of density measurement. Doctor Sincock claims that even normal-looking nuclei from an abnormal area of the cervix are positive in his tests. If that is so, it may be an earlier predictor of pre-cancerous changes than the current smear test.
At the end of 1987, as my hon. Friend has said, Dr. Sincock published preliminary results from 187 smears. His measurements showed good discrimination between normal smears and those with pre-cancer on that small sample of specimens. In the past few years, discussion of the problem of diagnosis of cervical cancer has stimulated a great deal of interest in the scientific community. By the end of last year, in addition to the application of Dr. Sincock, the Department had received 12 others—some for the automation of the current screening technique and some for new methods of diagnosis. On 26 February this year, an independent group of experts was called together, chaired by the Department's chief scientist, to review all the applications. That expert group thought that Dr. Sincock's test required greater precision than was likely to be sustainable in routine NHS laboratory use, and they found the technique very exacting. They thought that the method of measuring the staining intensity was still fairly slow, and that alternative instrumentation would be preferable.
The application as submitted was not supported for funding but it was recommended that a study should be undertaken in another laboratory to assess whether the method could be reproduced elsewhere. As my hon. Friend's closing remarks indicated, Department officials have been involved in discussions with Dr. Sincock and with a commercial company to explore the possibility of a joint funding venture aimed at securing an independent valuation of the test in another laboratory. If that proves successful, there would be a possibility that the test could be commercialised.
660 In answer to one of my hon. Friend's points, commercialisation of the test is needed so that it can be made available as a complete package of reagents and instruments ready for use by NHS screening laboratories. Only if that is done can the benefits of the new test be brought to the women who use the screening service.
I realise—and I have firmly registered what my hon. Friend has said—that the Department appears to have taken a long time, especially from the point of view of Dr. Sincock and his supporters, to consider a proposal whose advocates believe that it provides a solution to the problem of accurate smear analysis. I hope that my hon. Friend will agree, however, that it would be wrong to embrace such an idea without being fully satisfied both that it is an improvement and that it is suitable for use in the NHS. The Department has sought, with the help of its independent advisers, to help Dr. Sincock to formulate his proposals and to give them a fair hearing. It is still seeking to work with him and Mr. Steele to see whether a way can be found of taking forward the evaluation of the test.
When I heard that the debate was to take place. I asked for a detailed history of the contacts between the Department and Quest for a Test and Dr. Sincock. I can find only one occasion on which it can be said that things really went wrong. Officials had told Quest that a final decision would be received on the request for funds to evaluate the test by the end of March, but it was not notified formally until 18 April. That notification was in the end conveyed in the letter, part of which my hon. Friend read out. The notification, from Mr. Kennedy, contained a clear and ample apology. It is also fair to note that the delay was due in part to the efforts that my officials had been making to find an alternative way of having the test evaluated along the lines suggested by the expert panel.
It has been suggested that Dr. Sincock's application for support was rejected on scientific grounds, and that he was not told what those grounds were. I have already explained why the expert panel felt that it could not support his proposals. Perhaps my officials could have been more explicit; however, confidential commercial matters were involved, and they were at the time seeking to meet Dr. Sincock to explain the position face to face.
I also ackowledge that Dr. Sincock was originally told that his application would be considered at a meeting in November, as that was the intention at the time. However, as I have explained, 12 other applications were received, and it seems to me that it was more sensible in those circumstances to look at them all together. The panel of independent experts was set up, and that caused a delay in responding to Dr. Sincock's application. That was perhaps unfortunate, but as the total applications amounted to some £5 million and the available funds were limited, it was obviously important to select those likely to produce the best results. That could not be done on a piecemeal basis.
I should perhaps make it clear that our officials strongly dispute the suggestion that Dr. Sincock was told that his work was of low priority. He was, I understand, told that the external referees to whom his original application was referred had some reservations about his proposal, which had received only cautious support, and he was asked to amend it in the light of their comments. He has been assured—I re-emphasise this—that the whole subject of cervical cancer is of high priority within the Department, 661 and that any new methods that could improve the laboratory diagnosis are, and will continue to be, carefully and seriously considered.
My hon. Friend suggested that we might, even at this stage, finance Quest for a Test's work, despite the background which he has covered from his perspective, and which I have covered from the perspective available to me from the Department. I hope that I have explained that we have considered the application very carefully, as has the independent expert panel convened specially for the purpose, and given the reasons why funding has not been provided. With regret, I do not see that what my hon. Friend has said provides a basis for changing that decision. I do not wish to raise false hopes, although in view of my hon. Friend's final remarks I am willing to say that I will have a further look at the matter. That is said with no commitment, and without seeking to raise expectations, which might prove false, of finding any alternative way round the difficult position that he has described.
The House may be interested to know something about the projects that the chief scientist's expert group considerd as suitable for funding by the DHSS. One was 662 a monolayering machine. The Department had already helped to fund the development of a prototype of that machine, which is now ready for field trials. It prepares a single layer of cells from cervical smear material that can then be screened by an automatic image analyser. That machine is crucial to the development of the other project that has been regarded as suitable for DHSS support. That machine is called "Cytoscan", which is being developed for automatic pre-screening of cervical smears and is intended to scan the single layer slides.
I mention that, even at the expense of including some scientific jargon, to make it clear to my hon. Friend the Member for Harlow and to Quest For a Test for Cancer that there is no question of the Department not being willing, when the advice suggests that it is the right course, to find support for particular proposals designed to improve cervical cancer screening. We are firmly committed to that. We are not, at present, pursuaded that we should act in the way in which my hon. Friend urged in the latter part of his remarks. However, I shall have a further look at the matter in the spirit in which I have sought to respond to my hon. Friend.
§ Question put and agreed to.
§ Adjourned accordingly at twenty-five minutes past Three o'clock.