Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 120 - 134)



  120. To be clear, you would support money for cancer but not within that for cancer drugs?
  (Ms Miles) I think there is a strong argument for ring fencing the modernisation agenda across the NSFs and that is about additional growth monies which you can trya nd spend. There is a strong argument about, "Here is some more money but what have you spent it on? How have you improved it and let us see it done at patient level?". That is a cogent argument. People do not think through the process of, "Let us have some topics". The topic selection in itself will skew the resource allocation in the end. Let us look at the assessment of clinical evidence and do that pretty purely and scientifically, and then let us have a think before we start about the impact, the "what ifs", the actual costs, the pricing and whether it is effective and whether we want to afford it. What do we afford in relation to one thing versus something else?

  121. In your evidence you also talked about the blight issue. Would you recommend that in the interim, while we are waiting for a NICE guidance, the decision should be taken at PCT level or at individual commission level?
  (Ms Miles) It is speed versus time to think and the number of appraisals that NICE is resourced to do and at £10 million a year that it gets per year it is not going tobe able to achieve very much very quickly. Yes, you do need to increase the resourcing in NICE. There are existing processes for making decisions about what is clinically effective at a local level, and it is done by public health consultants, it is done by drug therapeutic clinics; there is a range of organisations and advice that comes through, and they should continue it. I think the DoH has issued guidance, if not instructions, to PCGs, PCTs, that they should do that. In particular, in respect to Glevec(?), the drug for CML, recently, it was very strong. It said, "You will have to pay for this drug irrespective of whether it is being appraised by NICE and we will wait for the outcome of that appraisal".

  122. I was interested in your evidence again on the approach which has been made by the pharmaceutical industry to help some patient groups with producing evidence for NICE. Can you say a bit about how they may have already been compromising patient groups or whether that is a theoretical worry, and whether there is a way round that?
  (Ms Miles) We have talked about the resourcing of patient groups and it is again about why, what we want and what do we define by the patient group and what we want from patient groups. People are very confused about that. Patient involvement is what I am interested in. It can happen at various levels in various ways. It could be that the R&D committees could be commissioning patient groups or research organisations to do patient based quality research. In relation to supporting the input of patient groups, clearly they cannot do this for nothing. Organisations such as mine have not got the resources. We have already spent a lot of time just to prepare for this process today. The industry, I know, because they have phoned me, have offered support and help, one, to share the information or their publicity about their particular product with patients and patient groups, and I know many of them have offered to go to meetings and hear the evidence. That is probably sort of okay as long as we have the ability as an organisation to robustly and critically appraise what they tell us. Of course that is another time resource. When it slips into, "Can we help you prepare your submission to NICE?", which again is something that I have experienced, then it gets into a compromising situation. It could be that that is a very pure process and the organisations are both responsible for that, but my board has chosen not to accept that offer because of the risk of bias.

Siobhan McDonagh

  123. Mr Cayton, do you think the NICE guidance has put inappropriate emphasis on drug treatment compared to other forms of supporting Alzheimer's, and what about more general guidance which puts drug treatment into its therapeutic place?
  (Mr Cayton) This picks up in some ways what Dr Taylor was thinking about in relation to MS and certainly again we would want to say that you should not see drugs as either/or or separate from the care that we provide. The problem that you pick up (quite rightly) in relation to people with Alzheimer's is that these drugs were the first drugs ever and therefore they were being appraised in NICE's context against nothing. They were not being appraised against other technologies because what we have currently is primarily social care and diagnostic and supportive therapies but not the kinds of therapies that NICE appraises. In some ways there is a danger in the question because once we get on tot he cost effectiveness debate we fall into this trap that the Health Service budget is one budget, but all the other care, including voluntary sector care, is not part of that cost base. Who costs how much a carer saves from the person they care for having their health improved? Who costs the savings to the Health Service because the carer is not stressed? The whole system of cost effectiveness and the ability that we have—and by "we" I mean the whole of our research establishment—to make those assessments is flawed. I think one of NICE's biggest problems was being given this second task, which in a sense people have referred to as really a political decision, of doing cost effectiveness as well as clinical effectiveness which has dug NICE into a completely different mire of shortage of adequate information and really not very good techniques for carrying out those assessments.

  124. Why do you feel that NICE should take into account material such as patient views that have not been tested in clinical trials? To what extent do they do so?
  (Mr Cayton) I think this is terribly important, I really do. Let me say first of all that I think that randomised control trials are great. Randomised control trials are one of the best ways we have discovered of objective appraisals of evidence, but randomised control trials by definition always try and ask a very narrow question, always try and have a very clear and focused outcome measure, and always try and eliminate variables. Real clinical life is completely different. Real clinical life is full of variables, it is full of all kinds of odd outcome measures, it is full of adverse events and difficulties. It is full of people having different relationships. In my area diagnosis itself is very difficult. The drugs for Alzheimer's were closely defined by the FDA as being only for Alzheimer's disease. Actually we do not really know how to diagnose Alzheimer's disease accurately prior to death, so you have a drug that is appraised for Alzheimer's disease and we are now being told it is not suitable for other dementias and yet the clinical evidence is that it is particularly good, for instance, for Lewey Body disease. What I would want to argue is that we are now beginning to develop again good qualitative ways of looking at patient perception and patient outcomes and that those should be formally and very clearly part—not all—of the evidence. There is this curious idea that goes around that somehow doctors are always objective and all they do is read the BMJ and look at the manuals and they do exactly what they supposed to do.

  125. I do not think anybody here thinks that.
  (Mr Cayton) I do not know a single doctor who does not prescribe on anecdote.

Dr Naysmith

  126. You said they should be part of the clinical evidence.
  (Mr Cayton) Yes.

  127. Should they not be part of the clinical trial?
  (Mr Cayton) Yes.

  128. Not something separate?
  (Mr Cayton) The point goes back to this patient determined outcomes. One of the faults of clinical trials, and I can only speak particularly in my own area,—

  129. I accept what you are saying about trials, but if you have got other evidence that this drug is doing good things assessed by patients then it should be part of the clinical trial.
  (Mr Cayton) Yes.

  130. It is not assessed by doctors, not assessed by scientists, but if you have some method of measuring this clinical trial which includes what the patients think of it, then that is what you should have.
  (Mr Cayton) Yes, but the problem is that clinical trials tend to be statistical, quantitative measures and we are talking about qualitative measures. That is a research methodology that needs to be enhanced and developed for, if you like, the more subjective patient evidence to become more objective.

  131. But if 100 patients say that it made them feel better, ten patients say it did not make them feel better, then that converts qualitative evidence into statistical evidence and that is what we are looking for.
  (Ms Rule) But it is a question where we would not start from here because the reality is that most of the RCT data is not including these quality of life issues, so we are all filling the gaps.

  132. I agree with the basic thesis that it should be assessed, but not separate from clinical trials.
  (Mr Cayton) We have got to get right downstream and that means getting downstream of the pharmaceutical industry. The pharmaceutical industry do not start with the patient. With respect, they start with two things. They start first with science because they think, "Ooh, is this a way we could get a rational drug treatment and make money?", or they start with the doctors because that is who they talk to and that is who they sell the drugs to.

  133. When I had a proper job I was a scientist, but you could include that in the clinical trials. I agree with you that if the drug companies are not doing that you have to find a way of doing it.
  (Mr Cayton) As has been said, one of the benefits of NICE is that it is beginning to force the pharmaceutical industry to face up to the poor quality of its evidence in these particular areas.

Sandra Gidley

  134. I will play Devil's advocate for a moment. I have the same problem as Doug in a way, that the scientist in me wants to see the factsand the evidence and all signed, sealed and delivered, and it makes the decisions much easier. The politician in me thinks that the patient should have some sort of voice. I accept your point entirely about good qualitative evidence, and I was quite impressed with what you had done in your submission, but the danger is that not all organisations approach matters in quite that sort of way. If we do more work on the quality of life issues which were highlighted earlier we may come to a position where that is the norm. Having said that, is there a role for the wider patient voice? I become alarmed at this stage—I am not going to mention whose submission this is—when I read a submission saying, "allegedly inappropriate differences in approach", "reportedly inadequate quality evidence base", "perceived differences in the handling", "lack of transparency and perhaps honesty", without any real back-up for those statements. That is the scientist in me saying, "Fine, but where is the evidence?" It is down to the patient groups if you like to provide good qualitative evidence, but should the taxpayer fund that? Where you have got health priorities, and we talked about this at length earlier, where you have got a lot of pressures on the health budget, should we be giving huge chunks of money to patient groups so that their perhaps non-qualitative—
  (Mr Cayton) I would absolutely want to say that I am in favour of giving huge chunks of money to patient groups, though not necessarily for that purpose. We have touched on an important issue which is the very varying capacity of patient groups. There is absolutely no doubt about that. We have very different levels of resource, we have very different levels of skills, we have very different depths. Some of us have our own major research arm so that we can come at these things with a team of our own researchers. Others are real family associations struggling, especially with the rarer diseases, to write their submissions on the kitchen table at home. I take your point but I am not sure that in a way we are saying the patient groups have to give NICE the evidence. We are saying that NICE must have high quality evidence of what patients think. If NICE cannot get that from the patient group in a particular appraisal it should be commissioning that research just as we did. We commissioned independent research and so have other patient groups who have been involved. NICE should not say, "Oh, well, there is no patient group here" or, "There is no-one competent to give us the patient perspective". They should commission the research if there is a gap in the essential evidence that they need.
  (Mr McDonald) Could I comment? There are two issues. One is the issue that Harry has been talking about of delivery of patient related information, which need not come from patient organisations but could come from other sources. It could be funded by NICE but not involve giving money to us. However, there is a much lower level of support which is needed. I do not mean to be pejorative but the kitchen table charities are very small organisations which are facing real choices about "Do we do this and stop doing other things that we currently do?" At the moment there is no financial support for those organisations at all. NICE is about to start making very generous grants of £400 to those sorts of groups. What is interesting and what I would like to see developed is that NICE has a patient involvement unit which helps organisations like ours, or small organisations particularly, in their involvement with the development of guidelines on services. I would like to see that extended to offer similar support to small organisations who struggle not to deliver questionnaires to 10,000 people but who struggle to even have any voice in the process at all.

  Chairman: Are there any further questions from colleagues? We could go on but there is a health debate at seven o'clock that some of us want to participate in, so can I thank you for what has been a very helpful session.

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