Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 60 - 79)



  60. Surely, NICE would have taken the views of cardiologists into account in formulating their advice?
  (Mr Mehta) Indeed. We imagine they should have and would have.

  61. We might have two or three different consultant cardiologists giving different advice?
  (Mr Mehta) Yes. That is perfectly possible.

  62. Why would your advice be preferred to NICE's advice?
  (Mr Mehta) Everybody, whether the BNF, NICE or any other organisation that provides guidance, has to work from the evidence. On the major points of evidence, there was really no huge discrepancy. It was the details where we had some concerns. For example, we know that there are certain drugs which, given after a heart attack, prevent further problems. The BNF advisers have taken the view that those drugs really ought to be started while the patient is still in the hospital, being treated for their heart attack, rather than to suggest that if it is not possible to do it in hospital the GP perhaps might do it. Our advisers took the view that, on this particular point, it was much better to get the patient established on the correct medication before the patient was discharged.

Dr Taylor

  63. We have had some pretty severe criticisms from the Drug and Therapeutics Bulletin about several of the works NICE has done that they have looked into, particularly the use of Relenza, obesity drugs, motor neurone disease drugs and the Alzheimer's drugs. Are you aware of those criticisms that have come from them and do you support those? What are your reactions to those?
  (Dr Taylor) I must say I gave the drug and therapeutics bulletin a plug. The British National Formulary is the second thing junior doctors carry in their pocket after their stethoscope.

Mr Burns

  64. Perhaps you should have declared an interest.
  (Mr Mehta) Going back to Relenza, yes indeed, there were difficulties. We and our advisers saw practical difficulties in implementing NICE advice and therefore the BNF reflected the NICE advice but (in square brackets—it is an editorial comment here) it said, "But see notes above". In the notes above it actually says, "Hang on. There are one or two groups of patients you are recommending this intervention for but it is not actually appropriate because the drug cannot properly be used in these patients, for example, people with respiratory problems". The product literature for the medicine says that you need to take precautions when you are using this drug for people with respiratory problems. However, NICE guidance suggests that it is these very people that should be given Relenza if they have an attack of the `flu.

Dr Taylor

  65. So a pretty significant disagreement?
  (Mr Mehta) Yes.
  (Professor Kendall) The other thing to say is that we do not give the whole lot. We summarise the key points. There are one or two occasions like that where we have chosen to draw attention to the fact that we are concerned and therefore we have given a note saying, for example, that you should not give it to people with asthma.

Dr Naysmith

  66. My final question is to the BNF representatives. Let me make it quite clear that this is asked in a spirit of inquiry and carries no connotations other than that. In this area people are very anxious to attribute bias to people who are getting money from drug companies and being influenced in that situation. The BNF as I understand it, the Editorial Committee, is made up of representatives of the Royal Pharmaceutical Society and the British Medical Association, with representatives from the Department of Health. Both of the first two organisations are a cross between a trade union and a trade association. Is there any suggestion of bias in that? Do you come across lobbying from within your professions to try and make sure that treatments which are felt to be well worthwhile, even though there is no scientific evidence for them, are included?
  (Professor Kendall) I would say firmly and categorically no. The editorial team is one of the most monastic (if I can put it that way) in their views about the pharmaceutical industry. My colleague here would be reticent about saying this but if he found that one of his editorial staff had a biro with a drug name in he would break it in two. He feels lquite strongly about this. I think that we go out of our way to be independent. Our whole reputation depends upon being independent. If doctors felt and pharmacists felt that we were doing anything that showed any kind of bias then our reputation would be lost. I would make the point that all doctors, all pharmacists, all medical students, all pharmacy students have this (the BNF). We come in for quite a lot of close scrutiny.

  67. Thank you for that robust defence. What I really meant to ask was, in this conflict of advice which Richard was eliciting from you between NICE and your publication how is it that you expect your readers to differentiate between the two sets of advice when the Formulary says something and NICE says something else? How would you recommend that practising doctors decide?
  (Professor Kendall) We go out of our way to make it quite clear. I think we have submitted this as a document in evidence (the BNF). What we have done is to pick out all the pages where we have printed NICE advice.

  68. I have it here.
  (Professor Kendall) And so we go out of our way to make it quite clear what we think they should do and if it is not what NICE says we are quite robust about that. I do not think there would be any doubt about it.

  69. How do they choose, is the question.
  (Professor Kendall) The good example is Relenza and asthma. The advice about Relenza is that although NICE recommends that this drug might be used for people with bronchitis and asthma, it is recommended that the drug should not be used in these patients and certainly not without care. We make it quite clear what the doctor should do.

  70. And you expect them to take your advice rather than that of NICE?
  (Professor Kendall) Absolutely.

Jim Dowd

  71. In the notes it says that on rare occasions the Formulary Committee, because of concerns about quality of advice, omits the NICE guidance.
  (Professor Kendall) Yes.

  72. Is it not more objective for you to publish that and give your reasons why you find it to be defective rather than pretending it does not exist?
  (Mr Mehta) The BNF is very much a manual for use while the patient is in front of you. It is meant to give you answers very quickly and without sitting on the fence. It does not really often have the room to discuss the pros and cons of particular arguments and for that reason it would be difficult to say, "NICE has given this particular piece of advice; however, the BNF does not agree with this advice, you should do something else and these are the reasons". Instead of that the BNF says, "This is what should be done" which is much clearer and for the busy practitioner it is much easier to follow that advice.
  (Professor Kendall) We have offered to read the NICE guidelines before they come out and come up with these little points before they go public and so far they have not taken up the offer although it still stands. We would like to be able to have the guidelines take notice of our views. We obviously do not want to change those views but the more people who read it the more you pick up things that might go wrong.

  73. You do want to change their views if you think their conclusions are incorrect.
  (Professor Kendall) Absolutely, we do want to change their views. What I mean to say is that I do not want us to be seen as a lobby group. I think they are people who are coming up with their own ideas but sometimes when you have written down your ideas you omit to notice that you have actually recommended something which is not sensible. It does not fit in with the type of patient your are treating or whatever. The BNF has been checking guidelines for the last umpteen years and we still note errors and improve clarity. We have very careful editorial staff and I am sure we can be quite constructive to NICE.

Dr Naysmith

  74. I want to move on to Professor Walley. You indicate in your evidence that NICE can never be entirely independent of Government since "the Government must consider resources to the National Health Service and a possible alternative use of those resources". Does that mean that you believe that NICE is not independent of government as it is set up now and operates now?
  (Professor Walley) I think we need to distinguish which part of NICE's formal activities we are talking about. There are two areas to my mind where NICE cannot be independent of government. The first is in setting which technologies it will embrace, and the second is in deciding what resources will be available to meet the appraisals at the end. At the start and at the end I do not believe NICE can be independent of government. The bit in between where the appraisals are being taken, as far as I know that is independent of government. I know of no government influence during the appraisal or review process.

  75. So you do not believe that NICE should be independent of government? You do not think it can be independent? Not the appraisal part but the referral and the resources.
  (Professor Walley) I think in an ideal world NICE would be independent of government and would be seen as a body giving advice to government. My concern at the moment is that NICE is seen to determine what NHS priorities are and this really should be the minister. NICE should be advising the minister and be seen to be advising the minister. The minister should be seen to either accept or reject NICE advice. I would go along with the argument that NICE can undertake an appraisal of the evidence. Issues of affordability are political issues and not for NICE to decide.

  76. So should there be ring fenced funding for NICE and the part of their series of projects that could be government recommended and they could decide, "This needs looking at and we will do it"? But if they had enough ring fenced money they could do that, could they not?
  (Professor Walley) I would hesitate to dedicate a clear budget for NICE activities only, at least in advance. I think, however, once the Minister has accepted an appraisal from NICE the funding to meet that appraisal should be considered centrally. It is not appropriate in every case that it should be administered centrally. For instance, we might consider in the high volume, medium cost products that would fall into the remit of the average GP that it would be inappropriate that that should be considered for central funding, but areas where NICE appraisals recommend therapies which are really only for use by highly trained specialists in very well defined patient groups, I think it is appropriate that those should be considered for central funding. That has several advantages. One of the current problems when NICE approves a very high cost technology is the effect it has on a health authority in a year. A health authority will have difficulty delivering that technology from its already overstretched budget. As has been said already, the only option for a health authority is that it will divert funding from other areas of its overall care into that technology. The other areas of care are perhaps less visible and not well appraised, but sometimes the postcode rationing is shifted away from the technology under appraisal into the unappraised less visible areas. A clear acknowledgement of central funding for specific areas of administration centrally would avoid that. There are other advantages as well for central funding. It would mean that we could administer the drug according to very fixed protocols in very well defined patients. We could collect data about who had actually received the drug and what the outcomes of that were which at the moment we are very poor at doing in the NHS. There are several advantages of selective central funding to meet NICE appraisals but I would not advise it for all NICE appraisals.

  77. I was talking about the funding of the research process and the whole process of NICE at a national level, but you have answered some other questions. Maybe it was my fault for not making it clearer. The question was really the question of resources for the whole NICE process in terms of producing valid results that people really have confidence in and that the Government can have confidence in. Do you think that needs more resources?
  (Professor Walley) I think it does need more resource. Evidence is very expensive. As one of the units trying to do this work we are conscious that we are constantly working against deadlines, we are working within limited resources, we cannot do everything we would like to do in the time available. However, that is the reality of the National Health Service across the board.

  78. Does that mean you think that just occasionally NICE advice is, if not flawed, not as good as it should be?
  (Professor Walley) There have been occasions when it could have been more robust.

Mr Burns

  79. Can I ask what the occasions were when it could have been more robust?
  (Professor Walley) There are several examples. For instance, I would point to Zanamivir advice which you have already considered this afternoon. I have some hesitations about the advice around anti-obesity agents. My particular point there would be tht they considered the technologies in isolation of the condition. For instance, we have two appraisals on two separate technologies rather than the consideration of how we should manage obesity in the whole of the NHS. It is being driven by the existence of the technology, not the priority of the NHS in managing the condition.

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