Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 160 - 179)



Mr Amess

  160. Helen, in your written evidence you made that damning statement that you feel that the credibility of NICE has been damaged. This is big stuff. Could you explain to the Committee why you feel it has been damaged? Given that you have this—some might say; I am not saying it—jaundiced view, how then when they give their guidance do you and your colleagues react to it?
  (Ms Marlow) The first thing to say is that I am not saying NICE is an organisation without credibility. I do think credibility is a perception and the perception around NICE's credibility has been damaged for a number of reasons because some things have happened which have made us lose some confidence in their decision making. Probably the best example is the guidance on Zanamivir. The timing of that was very unfortunate because it was very early on in NICE's life when they were trying to develop a track record. A lot of people thought that decision to recommend Zanamivir seemed rather strange based on the information available in terms of the health technology assessment. That raised a lot of question marks about how on earth they could possibly come to that decision and whether there were other factors at work or other pressure being put on them to come to that decision. That was the first issue around credibility.

  161. You said "other pressure". What might this other pressure be?
  (Ms Marlow) It could be the Department of Health, it could be the pharmaceutical industry, it could be patient groups. I do not know, but it seems a strange decision and it does make you wonder why they made that decision, that is all. I have no material evidence to suggest what that might be, but it just seemed quite strange at the time.

Mr Burns

  162. Do a lot of people in the medical world share your concerns and suspicions on that issue?
  (Ms Marlow) Certainly about Zanamivir, yes.

  Mr Amess: There is nodding going on everywhere.

  163. The Department of Health or the pharmaceutical industry put pressure on NICE.
  (Ms Marlow) I do not know.

  164. I am not saying you know, but that is what is perceived within the health profession.
  (Ms Marlow) Yes.

Mr Amess

  165. So it was a bad start really.
  (Ms Marlow) Yes, and other things have happened since. It is detail really, but issues around quality of some of the health technology assessments which NICE have used. People who look at them in detail feel that the quality of some of them could be better. There are other issues around other authoritative and respected sources, for example the Drug and Therapeutics Bulletin has drawn conclusions about treatments which are different to NICE and one has to ask why there is that conflict. There are other issues around NICE being able to use unpublished data which is not in the public domain and open to scrutiny which the NHS and others have no access to. There are issues around the conflict within the Department of Health to whom NICE are responsible, because of trying to manage the tension between being responsible for the NHS and the pharmaceutical industry. That is a potential conflict. There is the issue of them not being as open as they might be about declarations of interest.

Mr Burns

  166. Briefly on this question of credibility, do you think the saga and delays over-beta-interferon have adversely affected NICE?
  (Ms Marlow) Yes, I think that has added to it; definitely.

  167. Do you think that the pilot scheme of people being able to test it before we get a final decision from NICE has seriously undermined their credibility? It looks as though, for whatever reasons, whether political or whatever, politicians have stepped in. In a way one assumed when NICE was set up that they would be given the task to look into a specific drug and everyone then waited until the report came from NICE on that. For some odd reason we have the situation where not only has there been constant postponement and missing of deadlines on getting NICE's final decision, but we also now have what I think is unique in NICE's history so far: Ministers stepping in with this half-way house to try to relieve the political pressure of a pilot scheme for testing the drug on a cohort of patients.
  (Ms Marlow) That certainly raises the question of whether NICE is being undermined.

Jim Dowd

  168. I should like to revisit the Relenza issue for a moment because there seems to be broad agreement amongst all of you that this was not well handled, for whatever motives. How did that translate for good or ill in terms of patient care? What effect did it actually have on the treatment which was given?
  (Ms Marlow) One of the issues that winter was that we did not have very much flu circulating so there was not a great need for the drug anyway. If you look at the national figures—and certainly in all our health authorities—very little was used.
  (Dr Cunningham) We had a policy of not implementing it the first time the guidance came out on Relenza.

  169. So the effect on patient care of this hiatus in the progress of NICE was zero.
  (Ms Marlow) Very little. One of the issues around Relenza is that there are many practical issues about it having to be started within a certain timing, patients seeing doctors and being able to use the inhaler device. There were many practical barriers to using it as well which meant in reality that it did not get implemented particularly because there were so many other barriers to using it.
  (Dr Crayford) Until very recently, NICE guidance had not been mandatory. We were left to make local decisions and make those according to how Relenza fitted in with our local priority setting process.
  (Dr Walker) We had problems with a number of issues locally. The first one was selection, the prioritisation of Relenza. In our particular population it was much more important to consider non-time-dependent interventions, particularly vaccination with the flu vaccine. We felt we could have spent the time which was used on setting up patient group directions for Relenza on promoting the vaccine. We felt it was inappropriate use of resources, although we did follow the guidance. Secondly, we thought that the recommendations did not appear to be supported by the evidence which was published at the time. Whether there was other evidence which was not published at the time is another matter but that created a lot of difficulty in the medical press, amongst general practitioners locally who felt they were being asked to do something for which there was not a sound evidence base. Finally, there were the practical problems to do with not just the distribution, which was difficult in 36 hours from the onset of symptoms. In a rural population very few people are going to present to their general practitioner with flu within 36 hours of getting symptoms, so this was not going to be available to them. There was the broader issue of whether the evidence was relating to our population.

  The Committee suspended from 4.38 pm to 4.48 pm for a division in the House.

  There were practical difficulties in implementing the guidance in those authorities which did. Some authorities chose either not to implement the guidance or not to publicise that the drug was available and therefore not to have to put measures into place. Although we had very little flu, GPs did report to us that they had had a lot of consultations, people asking for the drug. In a larger outbreak of flu, if there were a similar increase in the number of consultations, that would have a knock-on effect of other work in primary care. For that reason, we should like that view, the primary care view, to be reflected in NICE decision making.

Mr Amess

  170. Another question to Helen Marlow. You certainly seemed very keen on the Scottish guideline group SIGN. Could you explain, given that we have already heard how you feel about NICE, why you think that it does work better? In particular do you think that there are things that NICE could perhaps learn from the way the Scottish group works?
  (Ms Marlow) The first point to make is that SIGN, which is the Scottish Intercollegiate Guidelines Network, essentially produces guidelines and does not do technology appraisals of individual therapeutic things. NICE does produce guidelines but it is only part of the work of NICE. There are some key points about SIGN which are interesting to look at: it was developed by health care professionals themselves not government and is based on an academic institution which enhances its credibility and perceived independence; it was started in 1993, so they have an advantage over NICE, in that they have had time to establish themselves and have not had the same spotlight put on them as NICE has had; particularly the robustness of the way they develop their guidelines, the presentation in terms of the clarity of the language—quite often NICE uses quite passive language such as "may consider"; SIGN is very clear and gives very clear practical advice to clinicians, very clear diagrams, summaries of the guidance, they write in a more practical, user-friendly way; they appear to have slightly better involvement from interested parties when developing the guideline as well as the membership of the guideline development group, which is even broader than the NICE membership; they have a national open meeting to which anybody can turn up to discuss the draft guidelines. At the moment NICE only send their guidelines, although they are published on the web, to their consultees, their stakeholders, which is a fairly limited list of people. Their guidelines are also independently reviewed by specialist referees. Just to follow the process through, they have guideline co-ordinators in each trust and health board in Scotland to disseminate and support implementation, which is an example of good practice.

  171. You mentioned that it is really inspired by the professionals rather than the Government. Do you not think it in any sense smacks of self-regulation?
  (Ms Marlow) I do not think so. The ethos of SIGN is very much about improving quality of care and they put a great emphasis on patient involvement. They have strong patient representation, they even have special training programmes and support programmes to allow patients and patient representatives to take an active involvement in the guideline development. That is a very positive thing.

  Mr Amess: Thank you for that. The Committee has heard your evidence. There is a strong Scottish influence within the Government, so perhaps they may act on what you have said.

Dr Naysmith

  172. I must say I am very pleased to hear something good being said about Scotland too, although I represent an English constituency I should quickly say. I should like to pick up something Helen Marlow was saying. You were talking about beta-interferon and you were talking about the debacle—you did not use that word but you were certainly not very happy about what had happened over beta-interferon. You were suggesting that it had destroyed the credibility. We have heard already that quite a lot was known about beta-interferon before we started and that it was going to be a problem even before it went in to the NICE system. What would you do about beta-interferon, given that there are people who want to prescribe the drug and we have questions about its efficacy in a large number of cases. How would you find out whether it is a good thing or not, or would you just prescribe it ad lib?
  (Ms Marlow) We have been looking at it over time already in our health authority and have had a look at the evidence and have agreed how we would use it locally with our local clinicians, which is basically in accordance with the national guidance which came out at the time that beta-interferon was licensed. Our local clinician has a very sensible approach and gives a very balanced view to patients about the pros and cons of Beta-interferon. We do have some patients on it.

  173. Yes, but you have some patients who are not on it. I am quite sure that they are asking why they are not on it. How do you deal with that?
  (Ms Marlow) It is out local clinicians' decision.

  174. I am very much familiar with that, but it is what happens once the clinician has made that decision.
  (Ms Marlow) About not being on it?

  175. Yes.
  (Ms Marlow) Because it may not be the best treatment for them.
  (Dr Cunningham) Beta-interferon is an example where a lot of health authorities have taken a decision, based on the evidence as they assessed it and the previous interim guidance which had come out, not to fund it very much. We put in our evidence that we did a study involving about 40 people with multiple sclerosis and the Multiple Sclerosis Society and professionals in our health authority at the time. We asked them where the gaps in the service were, what they wanted us to invest in, whether it was beta-interferon. They said no, that beta-interferon was not their top priority. We shared the evidence with them. They actually wanted other things which we could do, which would make more difference to their lives, such as the only way they could access specialist multiple sclerosis nurses at that time was through the nurses who were funded by the pharmaceutical companies which provided the beta-interferon. What they wanted us to do was fund the nurses so they did not necessarily have to have beta-interferon, but they could have nursing. They wanted better information and a lot of other interventions which we put in our evidence. If you consider the whole package of care, the care pathway that the patient needs, the drug is not necessarily always the most important aspect of that. Unfortunately the way we are told to fund the drug at the moment, the drug is what we are told to fund and sometimes in some of the national priorities at the moment, like coronary heart disease, cancer and mental health, if we really fully funded the drug and fully implemented the guidance, we would use up almost all of the growth money that we have to fund that complete area. That is the problem.
  (Dr Crayford) I would support that entirely. The problem is that NICE is often looking at just a bit of the picture. As health authorities we have all sorts of other pressures on us for things which we have to fund and NICE does not take those things into account by virtue of the way in which it is set up, whereas we have to. It does not seem rational to prioritise health care unless you can consider all of your priorities at once, which by virtue of its design NICE cannot do.
  (Dr Walker) I would agree with the last two comments. That is absolutely right. Also, there is another effect which this delay has and that is to create a conflict and to lose support in all of the different groups which are contributing to this process. Instead of everybody working together for a total package of care which is most appropriate, it becomes a big issue which divides people and that is really unhelpful.

  176. So to go back to my initial question, would you not have recommended that-Beta-interferon be looked at by NICE? I wrote two years ago to my local Avon Health Authority urging them to institute proper nursing facilities for MS patients aside of the Beta-interferon. What you are saying is that you can treat most MS patients perfectly well without widespread prescription of Beta-interferon, but some who are told they need it by consultants get it and this is not what NICE was asked to look at it, was it? It was asked to look at the effectiveness of beta-interferon in that disease. It was not asked about the other things which can make a huge difference to most patients.
  (Ms Marlow) That is one of the problems of looking at an individual drug, individual intervention: you are not looking at the bigger picture and taking the whole context. A drug can distort the whole picture.

  177. Was there anything which should have been referred to NICE as far as treatment of MS was concerned?
  (Dr Cunningham) The problem with Beta-interferon is that so many people have looked at it before. It was very long after it had received its product licence. At the time NICE appeared to have been set up to look at new products coming onto the market, but this was almost an old chestnut. If NICE is looking at new products, this was not new enough and the practice had diffused into the system really. If NICE is now asked to have a slightly wider remit, to look at main causes of morbidity and mortality, it will have to look at existing treatments as well as new treatments.
  (Dr Crayford) That is a really important point because until NICE has looked at things such as the additional half dozen nurses which we really ought to have in our accident and emergency department at Mayday in Croydon, it is very difficult for us to see the sense of giving priority to one of the new technologies that NICE has evaluated when we have pressures like these that we really have to fund. There are national directives through all sorts of other areas of policy which dictate that we should be spending our money on these things and this is one of the real tensions that we face.

Sandra Gidley

  178. A broad consensus appears to be emerging about looking at the broader picture but I want to come back to an area where there seems to be a bit of disagreement among the people I have in front of me and that is the credibility of NICE guidance. Last week we heard from the Drug and Therapeutics Bulletin who were quite scathing and highlighted half a dozen instances where they did not think NICE guidance was very credible. I notice that Dr Cunningham really excused herself from this question but she can answer it if she likes. Helen Marlow questioned the credibility of NICE guidance. Dr Crayford and Mr Walker seemed to think that the guidance was credible. I have to say—and I do not mean this to be disrespectful—I notice you are both public health doctors who have a huge range of skills but would not necessarily be best placed to comment critically on each of the pharmaceutical appraisals. Bearing that in mind, is that not a concern that people in your position are taking the NICE guidance, it sounds plausible, it is fine, but people whose day job is examining pharmaceuticals in detail seem to be questioning some of it.
  (Dr Crayford) Taking those two points about our professional expertise, I am sure you are quite right. Speaking personally I am not an expert in everything that NICE has adjudicated on but I have looked at a few pieces of evidence which NICE has prepared, in particular in relation to implantable cardiac defibrillators, which is why I came to the conclusion in my evidence that NICE was listening to a biased view. Yes, I would agree. We struggle with a broad range of issues. What we would hope for from NICE would be that it could act as an honest broker and appraise evidence equally and do essentially what we have attempted to do, often re-inventing the wheel many times over in each health authority by appraising the body of evidence systematically ourselves. Yes, you are right, we do need to take NICE's evidence on trust and it does need to be credible. We have also read the concerns in the literature about NICE's impartiality and it has to a degree dented its credibility with us in public health.

  179. So you would say from that that more openness about the process and more consistency in the appraisal teams is a must.
  (Dr Crayford) Yes; essential.
  (Dr Walker) I would agree with some of that. Although we are not experts in all the things NICE will look at, we are involved in a lot of areas like commissioning and development of services, where we work with a wide range of specialists. For example, when a cancer drug is being introduced or is proposed, a whole cancer network in my area will get together and discuss this guidance and will critically view the evidence which is presented and it will not just be one individual, it will be many people looking at it from different perspectives. We get the information back and we are part of that group and we can represent that information without necessarily being expert in it.

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2002
Prepared 8 July 2002