Select Committee on Health Minutes of Evidence

Examination of witnesses (Questions 1 - 19)




  1. Good morning, colleagues, and may I welcome you to this meeting of the Select Committee. Can I begin by welcoming our new Member, Ivan Lewis, who is replacing Ann Keen, so welcome to the Committee. Can I welcome our witnesses and thank you for coming to the Committee today. Perhaps, Professor Rawlins, you could introduce yourself and your colleagues and briefly say a bit about your background because it would be interesting to the Committee.
  (Professor Sir Michael Rawlins) I am Michael Rawlins and I have been a Professor of Clinical Pharmacology in Newcastle for 25 years, so I am an adopted Geordie, not a native Geordie. I have recently been appointed Chairman of the National Institute of Clinical Excellence. On my right is Dr Gina Radford who is in charge of public health development within the NHS and on my left is Dr Tim Riley who is the branch head within the same division.

  2. Can I begin, on behalf of the Committee, by expressing some concern that the discussion paper that was issued yesterday was not sent to the Committee for some reason. I suspect that this may be an error within the Department. It has caused us some difficulties in that clearly we had did manage, by a circuitous route, to obtain copies late last night, but it has caused us the Members some difficulty in obviously preparing ourselves for this session and so we may be asking questions which are covered in fact in that document which we have not yet had a chance to consider. Dr Radford, have you any comment on that because obviously the Department did not send this to the Committee which has caused difficulties?
  (Dr Radford) All I can do is apologise on the Department's behalf and clearly we will hope to give as full answers as we can and cover the ground as well. Clearly we would be very happy to give any written evidence or further follow-up if there are any specific questions which are not able to be taken today as a result of that delay.

  3. But you do not know the reason why we were not supplied with it?
  (Dr Radford) No, I am afraid I do not.

Mr Walter

  4. Chairman, could I just say, and this may not be specifically your responsibility, that in the press release which I received last night, it said, "Mr Dobson also today laid before Parliament the Orders to set up the Special Health Authority from 1st April 1999". Those Orders are not available within the House of Commons. I do not know if you would have any comments to make on that.
  (Dr Radford) Can I refer that to my colleague, Dr Riley?
  (Dr Riley) As far as I understand it, they have been sent to the House of Commons and I will follow through with officials to see exactly what the situation is and we will be able to provide you with written evidence afterwards of any circumstances as to why they are not.


  5. I think it is important that you are aware that we do take this seriously and obviously we raised it with the Secretary of State because it makes it very difficult for a Select Committee to undertake its functions without having information that is in the public arena. We found yesterday that other organisations had received this document, but not the Select Committee Clerk, so it does cause us problems and I think you should probably bear that in mind in the questions that we have this morning. Can I begin by asking you, Professor Rawlins, for your thoughts on the reasons behind the establishment of the new National Institute, particularly in respect of the current problems with the existing appraisal system. Could you give us some background information as to the logic behind moving towards NICE, what are the problems with the current system and what benefits do you expect the new system to bring?
  (Professor Sir Michael Rawlins) Over the past 20 or 30 years, I think it has been obvious to everybody that there has been an explosion in medical knowledge and an explosion in medical literature and the quantity is now so great that no doctor or health professional can begin to be able to assimilate more than a small fraction of the information and assessments that he needs or she needs in daily clinical practice. There are even now large numbers of journals which are devoted to reviews and any single health professional really finds it quite impossible to disembroil what is necessary and what is not necessary for his or her practice. The problem of this huge information explosion is not confined to the United Kingdom, but it is all over the world; North America, the rest of Europe and so on are all struggling to find solutions to how to resolve this. Now, over the past few years with new technologies, new devices, new pharmaceuticals, the sort of appraisal that has been undertaken has largely been undertaken by district health authorities each acting independently with little warning, no horizon-scanning, but suddenly presented with a new technology, no agreed criteria on which to perform, a huge replication of effort right across the country, and frankly many of them not having the scope or the expertise to be able to assimilate and assess and appraise all these individual technologies and actually ultimately reaching different conclusions and that is inevitable when you have this disparate, patchy arrangement across the country. By contrast, in one or two areas there have been national guidelines, national, if you like, appraisals, national screening programmes, for example, or immunisation policies, which have actually been very helpful to help professionals right across the country in giving nationally agreed guidelines, targets and so forth. The second area is that of clinical guidelines, and this is not individual technologies, but individual ways of handling and managing clinical conditions and diseases and there again the guidelines that have been produced across not just Britain, but across the world have been extraordinarily variable in quality and if you read the guidelines, it is not very easy necessarily to find out how robust and rugged they are and how well they have been constructed. In some instances, there are large numbers of guidelines covering a single area. I am told that there are 167 guidelines for treating asthma and if confronted with 167 guidelines, the average doctor, and I would call myself an average clinician, finds it very difficult to know where to begin and where to end. Many of them have been indigestible, thick volumes rather than short summaries. You need the thick volume to back it up, but you do not necessarily need the thick volume at three o'clock in the morning if you are the consultant on reception in a teaching hospital. Finally, they are inaccessible and many of them are very difficult to find; they are in what people often refer to as the "grey literature". So these are the broad problems and the background and I do not wish to ascribe blame to anybody, any professional group, any Civil Service group or political parties, but it is a problem that has arisen gradually over the years that we have been struggling to find some sort of answer to which is confronting healthcare systems right across the world.

  6. So what are you going to do about it?
  (Professor Sir Michael Rawlins) What we are planning to do is to do three things. We are planning to set up a system of appraisal of new technologies on a national basis, or at least England and Wales. This form of appraisal will provide robust assessment of the clinical and cost-effectiveness of new technologies and should advise on whether they should be in routine use in the NHS or whether for one or reason or another, clinical ineffectiveness or lack of evidence, they should not be in routine use or whether they should still be subject to further research. The second is to produce and disseminate clinical guidelines, disease orientated guidelines, which are robust based on clear scrutiny of the scientific literature and which are disseminated in a form that is practical and useful to health professionals. Thirdly, to develop and promote clinical audit particularly in the areas in which the Institute has produced appraisals and produced clinical guidelines for.

  7. Could you possibly give what might be termed an idiot's guide to the way NICE will encompass the range of other organisations currently attempting to fulfil some of the functions that you have described.
  (Professor Sir Michael Rawlins) Yes. Some of the organisations that are doing some of this work will be brought under the NICE umbrella, for example the National Centre for Clinical Audit. NICE, however, will maintain a sort of arm's length relationship with many other organisations, particularly the Royal Colleges and their audit functions and their confidential inquiries, and will thereby in some senses be a virtual institute rather than just in one large building in the middle of London. It will also need to have very close relationships with the NHS R&D because a lot of what NICE will be doing will be based on the work that the NHS research and development programme has itself instituted. In one sense one can envisage NICE as being a development of the R&D initiative in having determined the best practices and then disseminating them out to health professionals generally.

  8. You are aware at the present time of the vigorous debate on the issue of "rationing". I am sure you are aware that NICE has been portrayed in some circles as being all about a rationing process. How would you comment on that point? How would you counter that point if you disagree with that?
  (Professor Sir Michael Rawlins) I would not want to get into semantics too much but I am old enough to still have my old ration book which I fondly keep as a memento of the post-war years when I was allowed seven sweeties a week. The coupons are still there and in those days rationing was concerned with a strict allocation, not dependent on need, fat boys and thin boys got exactly the same amount of sweets. My understanding of rationing from those days from personal experience is exactly the same as that in the Oxford Dictionary which points out that it is a fixed allocation of resources. The health service has never done that, it has never had a coupon book where once you have spent your coupons on health care or the NHS has snipped them out of your ration book you have no further health care. I have been practising medicine for over 30 years and never at one moment has that sort of rationing ever occurred. I do not think it has ever occurred at all. What has happened from time immemorial, not just in the health service but since the practice of medicine started with Hippocrates in ancient Greece, is priorities. Doctors and nurses and other health professionals have always had to prioritise-a horrid word, I know, but it has now gained common currency-they have had to prioritise the resources that they have available usually on the basis of need and those who have the greatest need have the first call on the resources. Doctors and nurses and other health professionals have always varied, for example, the amount of time that they spend with patients on the basis of need. Prioritisation in health care is nothing new, it has been going on for centuries and will continue with finite resources. What NICE hopes to be able to do is where circumstances are such that prioritisation is necessary to determine based partly on the scientific evidence but also based on the judgment of clinicians who are involved in these things as to where the needs are greatest and where they are least, where cost-effectiveness, health gain is greatest and where it is least.

  9. If you reject the rationing argument, and I have listened carefully to what you have said, how do you answer the concerns of some doctors who I have spoken to who feel that there are some threats to their clinical freedom in respect of what is being proposed by NICE, that you will be looking over their shoulders and possibly interfering in an area that has been left to their discretion?
  (Professor Sir Michael Rawlins) As a practising doctor myself I have some sympathy with that, but at the same time when you are confronted, as wise old George Godber said many years ago, with the patient in front of you you also have to remember the rest of the patients in the waiting room. You cannot allocate resources to the one individual without taking into account those others who are there also wishing to have a share of the resources. We have finite resources in the health service, we always have had. Every health care system has that sort of problem. However, when it comes to guidelines clinical guidelines never can encompass one hundred per cent of patients, people vary and some people, some patients, do not fit into guidelines so there needs to be a lot of professional judgment in determining which people are appropriate to follow the guidelines and which patients are not.

Mr Walter

  10. I am interested in what you say, whether we are using the word "rationing" or whether we are using the words "priority setting", and you referred to a previous Chief Medical Officer, surely that is when you are talking about financial rationing or financial priority setting? What about a clinician who says "this is the treatment which I think is right for my patient" whereas you might have said as an Institute that in general terms you do not think this is a clinically effective treatment?
  (Professor Sir Michael Rawlins) I think there are two areas there. One is we may believe it is not clinically effective and I think most doctors would accept that judgment. Virtually the entire medical profession commenting on NICE has accepted that the professions as a whole would accept those sorts of judgments. When it comes to cost-effectiveness there comes a limit. I have told this story on many occasions. About three years ago I was rung up by a general practitioner from another part of the north east who said he had a patient who was receiving a particular drug on the advice of a hospital some way away and it was costing a million pounds a year. The patient had recently been for a review and this rather distant hospital had recommended doubling the dose. He asked me what he should do. Two million pounds a year for one patient for a treatment of non-proven effectiveness, irrespective of anyone's clinical judgment, clinical freedom, really does have to be questioned. I know it is a stark example in the extreme.

  11. You are using a rather stark example. Let us say that there is a new therapy which has been developed in the United States on which there is some evidence that it is effective and it is one that you have not as an Institute actually looked at but a particular clinician says "I believe this is right for the rare condition of this patient that I am treating". Are you going to say "No, I am sorry, it does not have our charter mark"?
  (Professor Sir Michael Rawlins) If we had not appraised it then we would not be in a position to make any comments at all. I hope that if it was that sort of episode we would have been asked to appraise it by the Department of Health but if we had not been asked to appraise it we would have no part to play until asked to do so. We would not be in a position to be able to opine on whether it was effective, ineffective, cost-effective or what have you.

  12. If his particular health authority said "I am sorry, you cannot use that treatment because it does not have the NICE seal of approval"
  (Professor Sir Michael Rawlins) We are not going to be appraising every single new incoming technology, the numbers are so great that it would be impractical.

Julia Drown

  13. I would just like to ask a bit more about who will be involved in NICE and whose opinions should count. Clearly you are looking at all the scientific evidence. Would you take into account the views of healthcare workers, patients, users and carers?
  (Professor Sir Michael Rawlins) Very much so and it is the intention that when appraisals are undertaken, the, as it were, provisional conclusions, draft conclusions will be widely circulated and discussed with health authorities, patients, consumer groups and seek their views on the appropriateness or otherwise of the draft advice. Of course it is the intention of the Institute to involve patients and patient representative groups right the way through the organisation and I think it would be my hope that the Secretary of State would agree to appoint a non-executive director who represented patient groups and patient interest groups and it would be my hope that I could persuade the Secretary of State to ensure that about a quarter of the partners' council represented patients and patient groups because I think they have a very important part to play.

  14. You said you would like the results of your investigations to be widely available to health professionals. Would they be available to the general public as well and are you likely to make that information available on the Internet, for example?
  (Professor Sir Michael Rawlins) Yes, absolutely. I would also like to see us developing guidelines to help carers and patients themselves. There are particular conditions where great problems are posed to carers, and I am thinking of things like schizophrenia and Alzheimer's disease and so on, where guidelines for carers could be very helpful if we can devise a way of making sure they reach the right people at the right time.

  15. You talked earlier about how you would not be able to appraise every medicine and every innovation. I would be interested in knowing how you are going to select the different areas of investigation. I am particularly aware that a similar institution in America set out to do 30 to 50 appraisals a year and did not even succeed in doing that, so how will you succeed where they did not?
  (Professor Sir Michael Rawlins) Well, we will be hoping to do 30 to 50 once the Institute is mature, but our sights are set a little lower for the first year or two while the organisation is getting on stream. The, as it were, shopping list for what NICE is to appraise will ultimately be determined by the Department of Health and I think it might be more appropriate if either Dr Riley or Dr Radford described that because they will, as it were, be sending it on to NICE.
  (Dr Radford) We have proposed a process within a consultation document, so what I am going to describe is purely the thinking behind that proposal; it is not fixed in tablets of stone, but it is genuinely out for consultation and we welcome comments from individuals on that. There are two components. First, the overall process, because what we are trying to describe is a more comprehensive process that recognises the need to be proactive, not just reactive, but also the other thing is to recognise that we are dealing with not only new technologies, but also existing technologies, so slightly different in terms of that. When the process is fully mature, we see that very early on in the life of a product we will be undertaking what we call horizon-scanning, and we do have a contract with the University of Birmingham to undertake that at the moment, as to what are the most significant technologies that might be coming over the horizon over the next few years so that we have some advance intelligence. That will give us a chance to do some provisional selections, have provisional discussions with the industry about their new technologies and to identify what is likely to be coming. We will be giving formal notification about a year from the expected launch, licensing, whatever it may be, within the NHS and then clearly from there on there will be discussions with industry and others in terms of gathering evidence and providing information for NICE to then consider. So that is the overall process in terms of trying to select at a very early stage and having much more advance warning and intelligence. In terms of what we are proposing and asking for comments on in terms of what may then come to NICE to be selected at that year stage, the sorts of criteria we are looking at are those products, technologies, techniques that have an intrinsic significance to the NHS, whether it be measured by cost or potential health gain and health benefit to patients or patient groups. There are a number of other factors which we also consider, such as the other resources or service implications from that technology because it may not be so much the technology, but particularly around a particular device or a surgical intervention what else is going to be required to support that device or intervention which may have quite a degree of significance for the service. We also recognise that those treatments or interventions which are the first either in a disease area and particularly in chronic conditions or life-threatening conditions where there is no other apparent product or technology we will need to take consideration of. Then there is where the evidence for some reason we anticipate being quite hard to interpret, in other words, there are not obvious clinical end points which can be translated usefully at present and where it is going to be difficult to understand what the evidence means and for practitioners to make sense of that. There is also the issue of where we think there may be ethical or scope issues where guidance of some sort would be very beneficial to practitioners. Overarching all of this is the basic question: can NICE and its appraisal mechanism add value to health carers at practice within the NHS and to patients and information to carers? So that really deals primarily with new technologies, but some of those criteria will also apply to existing technologies. The other way we will select existing technologies will be where there is considerable variation in practice and where guidance or guidelines would help in that process and also where there has been research, for instance, on the health technology assessment programme, around existing technologies which would suggest that an appraisal of that technology is appropriate. So the appraisal mechanism will not just be dealing with new technologies, but will be dealing with significant existing ones as well to make sure that there is a fairness and an equity applied to healthcare.

  16. Would there be a different track for an area where NICE has done an appraisal and dismissed something as being ineffective and then new evidence comes through? Would that be a different track or would that go through the same process?
  (Dr Radford) That would go through the same basic process. Clearly the horizon-scanning element would not be required, but it may be that new research is done and either NICE becomes aware of it because NICE itself has suggested that that research might be useful, ie, when it has appraised the original evidence, it said, "More research would be needed", so that research might be forthcoming, or the industry itself may have undertaken further research that would suggest that the original appraisal should be revisited and then the NICE secretariat will take notice of that and decide whether that is of such importance that the appraisal should be reconsidered. Also NICE itself, when it produces the guidance, may itself say, for whatever reason, "This is a time-limited one which we would like to come back on at a later stage because we are aware that there are some other issues on the horizon which we will need to consider".

  17. And what about the first priorities-are you clear what NICE will start off looking at?
  (Dr Radford) No, because we are consulting on the selection criteria at the moment and it would be inappropriate to preempt the results of that.

Audrey Wise

  18. If I can just follow up a little bit on some of Julia's thoughts, you made it clear that patient groups would be involved in this process and there seems to be quite a logic in the description that has been given to us of how the selection of topics for appraisal would work. However, if I can follow the thought through a little bit about patients, that is patient groups involved in the process, but what about patients' views about the end result, patients' views about the effectiveness? This will of course go into what you will think of as meaning that something is effective and there can be differences of view between clinicians and patients as well as clinicians and clinicians. My experience on this Committee is that patients, in dealing with professionals, particularly medical professionals, seem to be regarded as falling into one of two groups: either they are patients and, therefore, they know nothing about it; or they are patients who have taken a considerable interest and read up and, therefore, they have become experts and, therefore, they are disqualified as patients. I wonder how you see the fitting in of patient groups and patients' opinions about effectiveness as well as about the process? I feel happier about the process, I feel suspicious about the views about effectiveness.
  (Professor Sir Michael Rawlins) The point you make is a very important one because doctors, and I am as guilty as anyone, just because the x-rays and the blood tests are all right that is it and if the patient is not feeling any better he or she does not really mind about the x-rays and the blood tests. I do appreciate that. There are a number of approaches to it. The first approach, of course, is in the assessment of effectiveness. Increasingly we are looking for improvements in the quality of life, not the pathological changes or whatever it is but in a quantitative manner how patients are feeling. Quality of life assessment has now become a rather important part of deciding the clinical effectiveness. Nevertheless, I think we do need to engage patients and patient groups. I think one of the important ways will be when we produce our provisional advice and guidelines because we will be going to specific groups and we will be wanting to know what they feel about the criteria of effectiveness that we have used. Maybe we will evolve other approaches. I cannot give a complete answer to you because I think we need to evolve and do a bit of experimentation to find out how we can do that. I do agree that the process being all right is one thing but people have got to feel better as a result of a technology or a guideline and not just be told that they ought to be feeling better.

  19. Or the other way around, if they feel better and they are told "we cannot see why you are feeling better", does that mean they are not feeling better?
  (Professor Sir Michael Rawlins) That is not very encouraging either. No, I accept that. I fully agree.

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