Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 80 - 100)



Dr Naysmith

  80. If we could just return to that question on who should decide what is examined by NICE, do you think there should be some sort of independent mechanism other than the Minister deciding what should be taken up and what should be examined? I know there are all sorts of things proposed. At the end of the day it tends to be a political decision of Government.
  (Professor Walley) I think it is probably appropriate that it should be. At the end of the day the Minister has to decide what are NHS priorities, so any decision has to be made by the Minister taking advice from his experts, of course. To some extent that has led to an unfortunate appearance that NICE has been firefighting all the time, that its agenda has been thrown around by new technologies that have come up rather than defining what the NHS priorities should be and sorting that out.

Sandra Gidley

  81. My question has almost been asked but you might like to elaborate on it. I want to pick up on the point of the anti-obesity drugs. You suggested that the focus is too narrow, that we look at the drug in isolation and not at the wider issues around this. Would you like to elaborate a bit more on the problems with this approach and perhaps guide us in the way forward?
  (Professor Walley) I do not know if I can guide you in the way forward but I can certainly elaborate on the problems. The anti-obesity drug is a very good example. Again, my reading of the situation was that NICE was driven into appraising these products by the fact that they were coming onto the market and the NHS were screaming for advice, "What do we do with these products?" Given a longer time run-in the approach should have been that one would develop a guideline which included or did not include the use of these drugs and to look at the condition rather than being forced by what seems sometimes the manufacturer's agenda rather than the NHS agenda. It would be appropriate I think to put more effort into guideline development. It is early days for NICE. Guidelines require a much wider view than a simple technology review and therefore take longer to produce. I think NICE has been firefighting at times. It needs to be able to sit back and take a wider view of managing conditions. It is starting to do that. Its programme of guidelines will start to roll out over the next few years.

  Dr Taylor: I am really rather thinking aloud here. Devolution is the flavour of the year. Certainly, as an Independent, I can say this. It appears to me that the Secretary of State is devolving decision-making to take the heat off himself, certainly with NHS appointments, with re-configurations. Is there any sense in which NICE is being made to carry the can for those sorts of decisions?


  82. Yes or no?
  (Professor Walley) Thank you for the poisoned chalice. Yes, I think there is, in that when a NICE appraisal approves a product the funding seems to follow automatically, whereas to my mind the decision should be made by the Minister as to whether or not funding will appear for that product. Because it is not apparent when the Minister has made a decision that the funding will be available there is a perception, which I do not think is actually true, that at some point the Minister has influenced the process before it has got to the final stage. That leads to problems which cause NICE difficulties with credibility. I think there needs to be a clear distinction between executive roles and the evidence weighing appraisal process. The final decision to my mind should rest with the Minister.

Mr Amess

  83. Do any of you gentlemen feel that there is any truth in the claim that since we have had NICE companies have been put off developing their products in this country and have increasingly gone abroad?
  (Professor Walley) I am not aware of any evidence but then it would take quite a long time to shift one's development programme one way or the other.
  (Dr Duerden) One of the things it may have done is improve the research that is done into drugs in terms of providing better evidence in terms of clinical effectiveness, whereas previously we have been getting evidence of the fact that it worked against a placebo and was relatively safe. We are getting better evidence in terms of how it fits in alongside other drugs.


  84. Mr Moore, we have not forgotten your presence. If you want to respond to that please do.
  (Mr Moore) If I may. I have no evidence that research or the profession or anything is moving off shore. I think that pharmaceutical companies are jolly slow beasts. You think the NHS is slow. Inside the pharmaceutical companies it is really slow. I had a director of a pharmaceutical company seeing me two and a half years ago saying that they were desperate to get a systematic review done on a product because they thought they might have a NICE appraisal and it would not be a problem if they came to us, which was a very nice compliment, and two and a half years later I am still waiting for the data. Part of the difficulty here is that although the British arms of the companies might see the necessity for doing this, the American or German arms of the companies, where often the major decisions are made, do not. I think it is going to be a little time before the pharmaceutical companies really appreciate the benefits that companies will get out of this process as well as the NHS. Certainly one of the things that I would like to see out of NICE is getting together with the pharmaceutical companies maybe to do more in helping to determine who benefits from drugs and not just that drugs are beneficial on average.

Mr Burns

  85. You want independence from the political agenda and Professor Walley has made it clear that as long as resources are involved it is virtually impossible to have that independence. Do you agree with Professor Walley's view or do you think there is some way to achieve independence?
  (Mr Moore) I think this is less of a problem now than perhaps it has been in the past. When NICE came along first of all there was a general fear, and perhaps a genuine fear, that NICE was a mechanism in some way to establish rationing on the NHS. What we have had are a number of decisions which have been broadly positive. They broadly come along and say yes, these interventions work, and that should not surprise us because we are looking at interventions that have gone through a very lengthy process. At the same time as that is happening, there is this general feeling that NICE is a little more benign than people were worried about two or three years ago and the resource is coming into the NHS now. The lack of pressure on prescribing budgets in particular, and perhaps the provision that prescribing budgets may go up in years to come to at least accommodate some of the provisions of NICE has actually changed that perception that NICE is controlled directly from Whitehall. I am less concerned about that than I have been in the past.

  86. What about the saga of beta interferon?
  (Mr Moore) In a funny sort of way I think they may have come up with a reasonable answer. The beta interferon problem was not something that was a surprise to anybody who had looked at it. In fact, you could have said a couple of years previously that this was a difficult one, that on balance this looked like interventions which were effective, but we did not know if it was effective. That made it expensive, combined with the cost of the drug. On balance it would have been difficult for anybody to have looked at the evidence and say unequivocally that this was something that should be done. I think it would be equally difficult for anybody to look at the evidence and say, "This should not be done". It seems to me that by coming up with that answer and finding a way out of it, that is, that you should perhaps go down the route of treating some of the patients as deemed appropriate, but making sure that they go on to some sort of treatment register so that we can look at this, is a sensible way forward.

  87. You do not think that having this kind of trial that has been introduced was bypassing NICE and basically seeking to get the Government off a very difficult political hook?
  (Mr Moore) No, I really do not. It may have been done for that reason. I have no idea what the reason for making that decision was.

  88. That is why I was asking.
  (Mr Moore) I think it is a very sensible thing to do.

  89. But does that not rather invalidate the whole raison d'être of NICE?
  (Mr Moore) No.

  90. Correct me if I am wrong, and I may well be, but I understood that the whole purpose of NICE was to take away from ministers the decision-making process of what drugs would be supplied and paid for by the National Health Service and theGovernment and that in effect you would have this independent organisation that would scientifically evaluate new drugs and whether they were effective for treating patients as their manufacturers claimed. As I understand it, what we now have is that we do not have a final decision yet by NICE on beta interferon but the Government decided to have a trial use of the drug. To my mind what is the point of NICE if the Government are going to step in and bypass it by having this trial, a trial that I think you have half admitted is probably due to political pressure. Surely if you are going to have an independent scientifically based body that is going to evaluate the effectiveness and the usefulness of drugs you wait until NICE has issued its considered opinion before you take a decision. You do not jump the gun by having a trial.
  (Mr Moore) I think that is a reasonable point of view. If you are happy that we know (a) how to evaluate the evidence and (b) you think you know what the evidence is. I am much less certain and certainly much less confident that we know what the basic rules are here. What could NICE have done? On the basis of the trials as done I cannot see a way in which it could have come up with a definitive answer either on efficacy or cost effectiveness. Therefore a trial in the way that has been proposed is a reasonable way forward. What could NICE have done? It is interesting. There are a couple of things. For instance, one of the issues is outcomes in trials. We have been sitting here using the word "evidence" and we are making assumptions here about the statistics and the outcomes. Some of the statistical things that we do are not right. Certainly when we look at outcomes of trials, what the actual result is, very often we do not really appreciate how useful that outcome is. Okay, this is tricky territory. In this particular case what they could have done was to go to all the companies with similar products, ask, for instance, for the individual patient information, and perhaps be able to do a better analysis on that basis for which patients particularly would benefit, especially if you have got blood samples available at the start of the trials. These days with the rapid advances in genetic testing we are getting to the stage where we might be able to say not just that that drug works for everybody but that it works particularly well in some patients and not so well in others.

  91. Thank you. Can I now ask Professor Walley, who has listened to all of that, what he thinks of that answer.
  (Professor Walley) I have not seen the protocols for this trial yet.

  92. On the general principle.
  (Professor Walley) As Chairman of the Health Technology Assessment Panel for Pharmaceuticals in the past, we tried to set up a pragmatic study of this kind and we were unsuccessful because we could not get the neurologists to agree what the protocols for the outcomes were. I am not at all clear that it will be any more successful this time and I wonder what the purpose of the trial is.

  93. I just find it an unusual decision in that it seems to me that it is completely undermining the raison d'être of NICE in that I thought that the whole point of that organisation was in effect to take difficult research and scientific decisions on medicines in particular out of the political arena and left in the hands of the experts, the scientists, etc, to carry out their research and reach a decision. Does it not seem rather pointless to short circuit that by having political interference to set up a trial process two-thirds of the way through?
  (Professor Walley) I think it would be very nice to have the evidence from a properly designed trial but in the short term this may damage the credibility of NICE.

Jim Dowd

  94. The position that Simon sketches there about the role of NICE, and I am not sure if he was saying that that was his preference, as I understood your initial comments some time ago would be the very reverse of what you would like to see. Ultimately all these things are political decisions for ministers and others to make, with guidance, rather than just handing everything over to research.
  (Professor Walley) I agree that the decision should be made by the Minister but I think I would really like to see what the protocol of the trial would be. Is it going to resolve the difficulties we faced four or five years ago when we considered this before?

  95. So you are simply saying to Mr Moore, "Andrew, we will be no further forward"?
  (Professor Walley) It may be so.

Dr Naysmith

  96. Is it not true that the very last disease or condition that you would use to design something that is NICE would be MS? It is so unusual in that there is a small proportion of patients who are assisted by beta interferon and the great majority are not. How are you going to sort that out? Simon is suggesting a model that it is irrelevant really to give beta interferon treatment of MS.
  (Professor Walley) I think it is exceedingly difficult to untangle this one. The disease itself is so variable in its progress, it is difficult in its diagnosis sometimes and there is a very variable response to drugs. It would be exceedingly difficult and a properly designed trial is going to be very expensive to undertake.
  (Mr Moore) And we are uncertain what the outcome of any trial would be. I think that is exactly the point Tom is making and one that I would go along with, which makes it almost impossible for NICE to appraise it if you do not know the benefit of the outcome. Perhaps that is one of the things that we are arguing too much about the difficulties and at this stage that is one of the things that we might like to see NICE doing, turning around and looking at this as a whole issue because there are outcomes of benefit to the patient, outcomes of benefit to professionals and health care systems, and outcomes of benefit to society as a whole. Maybe some agreement on those would allow us to revisit the trials that have been done and also get a greater appreciation of any pragmatic trial that might be ongoing.

  97. What would you do about the situation in MS because you said it is a political decision? If you were a politician what would you do?
  (Professor Walley) I would accept what seems to be NICE advice in this particular case and I would consider asking the companies to reconsider their trials. In an ideal world we would actually have had that input into the trial development of the drugs long before it ever got to launch, so that it is actually looking at outcomes that were irrelevant to the NHS.

Sandra Gidley

  98. Mr Moore, you provided us with a completely new model for the working of NICE. We have not really got time to go into it but it did strike me as quite expensive and bureaucratic. Does the fact that you have come up with that new model mean that you think that the present arrangements are beyond help?
  (Mr Moore) No, not at all. NICE is essential; if we did not have it we would just invent it. I come from the basis that I spend a lot of time either doing evidence based reviews or reading evidence based reviews and some of them are very difficult indeed. In fact, all of them are quite difficult and some of them are incredibly difficult. There is an assumption that we understand what the rules are to do this. That assumption is often incorrect. What I would be looking for is something which would develop over time to do several things: first of all, yes, provide better evidence from the trials that have been done, but also to input into the trials that are going to be done in the future. The outcomes of trials are not decided by the pharmaceutical companies working alone. They are decided by the pharmaceutical companies working in conjunction with regulatory authorities and the only regulatory authority that really counts is the FDA. We have got to talk to them about getting better in the sense that most of the pharamaceutical companies are in America it is the biggest market for drugs int he world. Almost every other country in the world, apart from Europe and Autralasia and Japan, almost take what the FDA says as gospel. The FDA in a sense is driving part of the agenda. I think we have to get in there and begin to say that there are other issues involved and try and help the companies and the regulatory authorities to think the other way round. There are issues about the evidence, there are issues about cost. There is an assumption that cost effectiveness is a relatively straightforward thing to do. I think it is enormously complicated. Again, whose cost and when? How are we going to fund it, not just in terms of this particular intervention in this particular patient, but in the Health Service as a whole? The one thing that is almost always ignored in all this is how to do it. There is an assumption that anybody anywhere can issue an edict and suddenly it gets done. Actually management issues in the NHS, as the Minister was saying recently, are very complex. He was saying that it is so big, it has a million people in it. A lot of those people are making dozens of management decisions every day and we need to help them in terms of getting good cost effective evidence. That is a big job. Therefore, if you are going to say, "What is clinical excellence", is it just about whether the treatment works or not or about the whole spectrum, then you probably need a reasonably good NICE to do it, and it has got to be excellent. There is no point in being half-hearted about it. It has got to be excellent. That is an incredible name to give any organisation. I would not like to run it with that name. You think about it in parliamentary terms, the Health Committee on Excellence. You immediately start worrying about almost everything you are doing. If one were saying, "Is NICE okay?", no, it is not. No organisation is going to be after three years. Are the people in there doing a reasonable job? Probably, although I think we would all agree with them in some sort of detail. Could they be doing better? Sure they could. Sometimes you have to sit back and not do the British thing and quibble, but look at the vision. We are spending tens of billions of pounds in the NHS. It is a superb treasure. It needs a little bit more help in terms of trying to do a better job with the resources available.


  99. Assuming my colleagues have finished their questions can I throw in one which if any of you want to have a stab at answering I would be very interested. It is back in a sense, Professor Walley, to your comments about affordability being a political question, and the exchange that there was with Richard who was talking about devolution. I have always been very interested in how one devolves these decisions to pleople who are affected by them. Have any of you given any thoughts to how we may devolve the issue of prioritisation to our own localities, the people who the NHS serves? I was very interested some years ago to see the Oregon list system in the States where people have been asked to rank health interventions in the order in which they felt they should be funded. Have any of you ever given any thought at a local level to how this might be addressed?
  (Mr Newdick) Can I start by saying we have done it. Since 1948 we have done it. All these local decisions are delegated to local health authorities.

  100. But they are not made by local people. The point I was really making is that we have a democratic deficit in the Health Service that nobody has addressed. It is not made by the patients. It is made by bureaucrats. Is often is not accountable to the local people. It is accountable to the Secretary of State, not to the people that their decision affects. That is the point I am making. If any of you have any great ways forward in the pursuit of excellence, we are looking at this issue.
  (Mr Moore) One of the things I am interested in is the patient perception of what is a valid outcome. This is an area which we have been pursuing research on, albeit sporadically, because it is not terribly well funded, but if you go and ask patients independent of their doctors in fairly structured circumstances what they think of their treatment, what they think of the adverse events, what their attitude is to risk, what their knowledge is about their treatments and so on, your eyes open very wide very quickly. If we want to go down that sort of route, which is one I strongly advocate doing more of, then the whole way in which you might balance the various components of your health service might change quite dramatically.

  Chairman: This is a bit beyond the terms of reference of our inquiry; I accept that, but if you have any thoughts when you leave the Committee and would care to drop us a line, I would be very interested in them. On behalf of my colleagues thank you for a very helpful session. We are most grateful.

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