Select Committee on Health Minutes of Evidence


Examination of Witnesses (Questions 1 - 19)

WEDNESDAY 16 JANUARY 2002

CLARA MACKAY AND DR IKE IHEANACHO

Chairman

  1. Can I welcome you to this first session of our inquiry into NICE and can I particularly welcome our first group of witnesses? Can I thank you for your cooperation with our inquiry and particularly for your very helpful written evidence? Could you briefly introduce yourselves to the Committee?
  (Clara MacKay) My name is Clara MacKay. I am the principal policy adviser with responsibility for health at the Consumers' Association. What I would like to do by way of introduction is to say a few words about the Consumers' Association in general and then turn over to my colleague to say a few words.

  2. Most of my colleagues know about your organisation and perhaps we can expand on that when we ask general questions.
  (Dr Iheanacho) My name is Ike Iheanacho. I am deputy editor of Drug and Therapeutics Bulletin, one of the Consumers' Association's publications.

  3. Can I begin, Ms MacKay, by asking you about the inquiry that your organisation undertook into NICE? What was the background to that and what were the reasons for it?
  (Clara MacKay) The Consumers' Association has followed NICE very closely right from the point that it was established through to the present and the Consumers' Association was one of the first organisations to meet with the newly established institute. We fully support and continue to support the principles behind NICE and had not set out earlier this year to work some campaign and research around it. It is not the case that the CA had identified NICE as something that we would construct a formal campaign around. Occasionally, DTB do some reviews themselves that touch on guidance that NICE has done and we have crossed paths with them. Part of our campaign that we have been running is lobbying against the introduction of legislation to allow the promotion of prescription drugs. We did take a keen interest in the work of something called the Pharmaceutical Industry Competitiveness Task Force and this is a government industry task force that was set up in 1999 with a remit to look at ways to ensure that the United Kingdom pharmaceutical industry retains its competitive edge. This task force was chaired by Lord Hunt. When the task force was first established, we wrote to Lord Hunt and we indicated that we had some concerns about the lack of public and patient input to the task force and we felt there were some issues they would be considering that were very pertinent to the public interest. When the task force reported in March 2001, it did deal with and make recommendations about issues that greatly impact on the NHS patients and the public. Some of those recommendations were very closely linked to work that we were doing on direct consumer advertising but we also noted that the report dealt quite extensively with issues about NICE and about a scheduled review that would take place around NICE. That was scheduled for last summer. It seemed to us at that time, in reading the task force report and in talking to some of the individuals involved, that there was a real need to intervene to ensure that the patient and public interest was considered in the actual review, even though the task force itself was not going to conduct this review. When we had some informal discussions with patient organisations that had an interest in NICE, that reinforced our concern that there was not a lot of knowledge about the review that was going to take place and we all felt generally that, without some formal way of intervening and raising patient concerns, the review would take place without this important input and the patient perspective.

  4. This was the background?
  (Clara MacKay) Yes. Given the very tight time frame, we felt that an inquiry type arrangement would be the best way to flesh out and flag up the issues.

  5. You proceeded to invite witnesses?
  (Clara MacKay) Yes. Not unlike a health select committee, we had a small panel chairing and we invited organisations, including NICE, to provide written evidence as well as to come to an inquiry day where questions would be put to them and issues pursued.

  6. From the work you did in this inquiry, do you feel there are particular areas that we especially need to examine? What were the key concerns that came out of your own work?
  (Clara MacKay) Two key issues struck me from the inquiry. One is the enormous amount of effort and time that patient organisations invest in the NICE process, an incredible drain on resources, particularly for smaller organisations. Linked to that, a real concern across the board of patient organisations not having a sense of the impact that they make on the outcome of guidance and that seems to be a crucial issue. One of our key recommendations is we believe that resources need to be made available to support patient organisations. Linked to that and equally important is what emerged from the inquiry, which is a great deal of confusion about the appraisal process and a lack of transparency and clarity about how individual appraisals are undertaken. That was a very strong theme from the organisations that gave evidence.

  7. You have emphasised the role of patient organisations and you said there needs to be more time for them to consult with the members but you have also raised concerns about delays in the NICE process. How do you square the two areas? How can you have it both ways?
  (Clara MacKay) You are quite right. A number of patient organisations raised issues about very short, very tight time frames that they were expected to respond to. I would repeat that their biggest concern when they did respond was that they were never sure what the real impact of their input was. I would go back to the point I made earlier about the transparency issue. It seemed to me, looking at the evidence, that as the process was not explicit it was often difficult for patient organisations to have a sense of when and what it was they needed to be able to contribute and improving administrative processes could be quite easily dealt with. A more explicit process would help to resolve some of those problems. It is very important that although we would call for any unnecessary delays in the appraisal process to be eliminated patient organisations, in the same way as manufacturers, should have an adequate opportunity to consider the information that is being provided and have a chance to respond to that. It is eliminating unnecessary delays, getting an appraisal through as quickly as possible, but doing it appropriately and that is about giving organisations sufficient time to be able to respond to queries and to the process.

  8. One of the issues about transparency and one of the concerns expressed in some of the evidence is related to commercial confidentiality. Was this an issue you looked at? Do you feel it is possible to square transparency with dealing with those concerns?
  (Clara MacKay) We did not go into a lot of detail in terms of the actual going back to NICE, confirming process and pursuing the issues that were raised in our inquiry. The point was to get these issues on the table and to make sure that the formal review process and this process takes them into account. Commercial confidentiality is important but where an element of information is pivotal to a decision about whether to endorse or not to endorse a treatment, on balance, the information available should point to that conclusion. I think there has been some wide concern that that is not always the case.

Sandra Gidley

  9. Dr Iheanacho, so far NICE has published 31 technology appraisals and you have highlighted six in your submission which there were problems with. I thought the points you raised were very good but could you comment on whether the other 25 were without flaws or you just picked six as an example?
  (Dr Iheanacho) The topics that we looked at were nine in number. There were six major areas of interest, six treatment areas, but in all NICE has issued nine pieces of guidance relating to those areas. In total, we are talking about a third of the 31 technology appraisal guidance documents that you refer to. We came to look at those because they are areas in which DTB had published guidance by the time NICE issued its own, so we were interested to see whether they came to the same conclusion or different conclusions or we published guidance after NICE had given its advice and therefore we wanted to take NICE advice into account when reaching our own conclusions. All the areas which we have reviewed fulfil those criteria. They are not things that we have cherry picked because we are interested in either criticising or praising NICE specifically on those areas. On the second part of your question, if you consider the six areas in which we have found flaws, the kind of flaws that we have found are far ranging, we think. Although it would be comforting to think that the examples that we have highlighted represent a minority, we think it is hard to believe that the other 22 can be assumed to be perfect in every respect. The kind of issues we are raising relate to the scope which the guidance has taken, how narrow or wide the brief for the guidance has been, how the evidence has been collated, how it has been interpreted, how it has been presented, how it has been used in offering guidance, how in some cases there seems to be a lack of evidential basis for some of the recommendations made and no alternative, convincing rationale for following that line of advice. When you consider that scale of problems, it would make us concerned that what we are looking at are fairly fundamental problems, not things which are isolated incidents[1].

  10. What have you done as a result of highlighting the difficulties? Have you communicated those to NICE and, if so, what has the feedback been?
  (Dr Iheanacho) The first time we ran into this kind of problem related to evidence and advice NICE offered on a drug called Relenza. It is an anti-flu drug. When NICE issued its revised guidance as it then was in November 2000, we looked at the evidential basis. They had changed their minds. They were now recommending Relenza having previously said that it should not be used in the NHS. There were a large number of issues of concern which were obvious to us, so much so that we felt that we really should communicate this to NICE to see whether we were missing the point somewhere or whether there were areas of genuine debate or whether there were flaws in the advice. We compiled a fairly detailed report listing all of our concerns and sent that to NICE. That was in February last year, 11 months ago. To date, we have not received an official response to that report. We have not received a rebuttal. NICE has not formally accepted our invitation to debate the issues we raised. Subsequently, perhaps slightly chastened by the experience, we have not prepared anything like the same systematic reports relating to the other areas of guidance, but we do not see that as our role. It is not our role to criticise what NICE does. We have submitted drafts of our advice in preparation for NICE to comment. In the compilation of that advice, we have been very careful to say that this is the conclusion NICE has reached and to make it clear if we take a different view, so they have had an opportunity to come back to us and say, "No, you have got it wrong. You have misinterpreted the concerns" or, "You are looking at the wrong piece of guidance or evidence", or whatever. In general, we have received little or no response to those submissions.

  11. Is that from NICE?
  (Dr Iheanacho) Yes.

  12. What about the wider medical community? Surely the specialists who prescribe any of these drugs will have an opinion, I suspect. In highlighting those discrepancies, have you had any feedback from health professionals?
  (Dr Iheanacho) In giving our advice in terms of publication, we have not majored differences between us and NICE. We do not see that as our role. Our role is to come to an independent view about a treatment or an intervention and to reflect that to our readers. We have pointed out where there are differences between us and NICE so that people can at least, if they want to, look at the basis on which we have reached our judgments and also look at the basis on which NICE has offered its advice. We have not said, "We do not agree with them because of this, this and this" and invited comments on those issues because in a way, for us, that would be a slight distraction. We see our role as offering an independent view based on the evidence as we read it, and that is what we have done.

  13. You have argued that the slimming drug, Sibutramine, should not be given because of the safety risks associated with its use. NICE have argued that it is wrong to reject a drug on safety grounds as the risk benefit analysis had already been done at the time of licensing. In the light of NICE's comments, would you revise your position or would you like to comment on what NICE are saying?
  (Dr Iheanacho) Our reasons for coming to a negative opinion about Sibutramine were not related specifically to safety issues. Having reviewed not only the limited evidence of efficacy but also the safety concerns about the drug and the practical issues of using the drug in the NHS, which are as crucial sometimes as safety and efficacy issues—for instance, contra-indications which are numberous with this particular drug; interactions with other medication, again a potentially problematic thing for prescribers and patients to deal with—we felt that in the round we could not justify recommending this drug. I would like to take up the point you mentioned about safety issues. I think you are reflecting NICE's view that the drug should not not be recommended because there are safety concerns about it, if it has a licence. I can see where that argument comes from but I think it has to be tempered slightly. If you have a drug which has expensive safety concerns of any kind, it is inevitable that those concerns should feed into any evaluation of the cost effectiveness of that drug because if the safety issues necessitate special treatment, special monitoring, or if a drug is prone to produce unwanted effects which consume a lot of health resources, inevitably, if you are performing a detailed cost effectiveness analysis of the benefits of that drug, safety will be an issue. I would temper any view that says, because a drug has a licence we can be reassured totally on safety issues or that we can concentrate on this slightly nebulous term "cost effectiveness" and completely ignore any safety concerns.

  14. Would you go as far as to say that some of NICE's advice has been bordering on the dangerous?
  (Dr Iheanacho) I would not put it in those terms. Sometimes, when you look at guidance, you do not see references to safety concerns. Sometimes you do. Where it is missing, it is not clear why it is missing. Sometimes it could have an influence on prescribers or indeed a patient's wish to use that drug. It is an unsettling feeling because you do not know whether the issue has been taken into account and just not reflected in the guidance or whether it has not been taken into account when assessing whether the drug should be recommended or not. That is the difficulty. It may well have been taken into account but if there is a serious safety concern people should be able to share NICE's, or indeed anyone else's, thinking as to why that does or does not lead to a decision for or against use of a drug in the NHS.

  15. The safety issue does concern me. It has been highlighted somewhere—I cannot remember where, unfortunately—that NICE have been enthusiastically endorsing products which are subject to the black triangle and the medical reporting scheme. There was a thought that that might be slightly irresponsible, that they were actually advocating a greater use than was good while that was still undergoing heavy surveillance. Could you comment on that?
  (Dr Iheanacho) I cannot think of a specific example.

  16. The notes which I scribbled on I left behind in my office.
  (Dr Iheanacho) If you look at the interventions on which NICE has issued guidance, a lot of them are new drugs and therefore will be, by definition, black triangle drugs—ie, drugs which are under intense monitoring because they are new, so there would be nothing surprising about that. What would be worrying would be if there were recommendations which go beyond the licensed indication, the indications for which the drug has been specifically licensed, without a clear explanation as to why NICE, or indeed anyone else, feels there is a compelling reason to go beyond licensed indications. If guidance recommends unlicensed indications, if anything, the evidential basis for that recommendation has to be at least as strong as for the licence indications.

  17. Like the new anti-diabetic drugs you highlight in your evidence?
  (Dr Iheanacho) Yes. If that relates to your example, the issue there is that in its recommendations NICE is suggesting use of these new drugs outside the terms of the licence. Prescribing outside the terms of the licence is part of medical practice. There are certain circumstances in which doctors and other prescribers will use drugs outside the licensed indications. That in itself is not necessarily a problem. The problem comes when you do it with new drugs, because there is not the experience necessary to justify doing that; or you do it for drugs where there is no evidence to back up that unlicensed indication. You could be leaping in the dark because you do not have the solid, background knowledge that you would have for a drug which has been licensed specifically for that indication or for a drug which has been used for years and years and where people are familiar with the way it behaves. If guidance is going to say that "this is what the licensed indication is but we feel that it can be used in this other way", the rationale for using it in this other way has to be absolutely clear because, if it is not, people are entitled to say, "There is no evidence to back this up. There is no wealth of experience that says this is a safe or useful thing to do. Why are we being asked to do it?"

Dr Taylor

  18. I would like to thank you for the submission because to my mind this is one of the best submissions that we have had and I think it is incredibly helpful and points the way that the whole of this inquiry of ours can go. As far as the Drug and Therapeutics Bulletin is concerned, as a relatively recently practising doctor, I regarded that without doubt as one of the two or three most essential bits of reading for practising doctors so I am a bit biased in that I am very much in favour of you. I would like to explore your views of the independence of NICE because that is one thing that we will be looking at. Turning to Relenza itself, have you any idea why they changed their mind? Was it really the evidence? Was it pressure from the industry? Was it pressure from the government?
  (Dr Iheanacho) I cannot answer that question. I can only go on the basis of their stated reasons, which was their reading of the evidence. Fundamentally, that is where the Drug and Therapeutics Bulletin and the Institute disagree.

  19. You actually went back to them and had no reply?
  (Dr Iheanacho) We went back to them not just to say that we were publishing an article; we went back with a 10 page report listing everything that we thought was an issue of concern and inviting them to debate those privately if they wished or to come back to us and say, "No, you are wrong because you have misinterpreted what we said or the data." We know, I suppose, what their view of our recommendation is: that it is different from theirs and therefore not sustainable, but we do not know what they think of our detailed comments. That is unsettling for us because we would like to know how they reached their decision; do they think their decision is still justified in the light of what we have said? If they think we are wrong, they should tell us. We would very much like to know, but we do not have, the answers to those questions.

  Dr Taylor: This would strike me as being one of the very obvious questions we have to ask. I was almost horrified by the extent of criticism that you have in all these areas.


1   Note by Witness: While I cannot say for sure that the 22 pieces of guidance we have not looked at in as much detail have flaws, I would be hesitant in assuming otherwise. Back


 
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