Select Committee on Health Minutes of Evidence

Examination of Witnesses (Questions 140 - 159)



  140. In general terms, looking at the way NICE operates, can total independence ever be achieved in this kind of work?
  (Dr Crayford) Probably not. It is very difficult for all members on both sides of the fence, both the evidence NICE listens to and the members of NICE themselves, not to be wholly unbiased. It is almost inevitable when you are dealing with experts in a particular field some of whom will have been working in that field and might hold a partial view; almost certainly not.
  (Dr Walker) Whenever you are looking to appraise evidence, the evidence can never tell you the answer completely, there is always an element of interpretation. One thing the Appraisal Committees do have is a breadth of experience and knowledge which would allow all opinions to be expressed. I do not particularly have concerns.

  141. Do you share Ms Marlow's views on the way in which interests ought to be made much clearer than they are at the present time. Is it an issue which concerns you as well?
  (Dr Walker) It is not an issue which has particularly concerned me. I have not seen any evidence that it has shaped guidance, but it is consistent with the way things are going in medicine generally, in corporate and clinical governance, so yes, I would support the idea.
  (Dr Crayford) It would certainly add weight to the credibility of their guidance if they were to be more explicit about these things.

  142. How do you think this might be done?
  (Dr Crayford) A simple declaration of interests of each of the members, declaration of experience, declaration of interests.

Dr Naysmith

  143. May I pick up what Dr Walker said that this is an indication of the way things are going now in medicine generally? What do you mean by that?
  (Dr Walker) In medical journals now, for example, if you publish a research study and you have a particular interest, you have to declare that interest at the end of the article. That is something which has just come in in the last few years. Corporate governance and clinical governance have been raised in profile over the last few years and that is a good thing and we should encourage it.

  144. Could it also be because there is much more support than there used to be for what used to be called independent research? Do you think that happens? What I mean is that there was a lot more government sponsored research and university research. Is there any evidence now that that has been taken over by pharmaceutical company funded research or not?
  (Dr Walker) I do not know.
  (Dr Crayford) Quite a lot of concern has been expressed about pharmaceutical funding of research, in particular research being funded through contract research organisations which perhaps are not as independent as university-based research which used to be the home of most drug company funded research in the past.

Dr Taylor

  145. Dr Crayford, at the end of paragraph 2.1 in your submission you say "NICE has appointed high-calibre people who have in turn ensured that the membership of the NICE committees is heavyweight and unbiased". Then on the next page in paragraph 2.6 you put what I think you were referring to just now, "There are widespread concerns about NICE's impartiality and bias towards evidence it receives from the pharmaceutical and health technology sector".
  (Dr Crayford) Yes. Two sides of the fence: one about the ears which listen to the advice, which to most of us would seem to be impartial, heavyweight and unbiased; secondly the type of advice which they listen to, which we could consider to be often partial and biased, very industry-dominated and less what we would prefer to see which is systematic reviews of evidence.

  146. That is very interesting. I was approaching it more from the fact that NICE might be influenced from the other side, from the government side.
  (Dr Crayford) That is very likely to be true but we would see that as a political inevitability.
  (Dr Cunningham) No, no; I do not think that is a political inevitability. You asked how independent NICE is and the independence which concerns us particularly, now that we have to fully fund the NICE guidance, is independence from the Department of Health. In a sense NICE was set up to give robust guidance on the basis of evidence and it appears now to be almost being asked to do resource allocation by the Department of Health. It seems sensible to separate these two functions more clearly, particularly the selection of the portfolio which NICE considers and the decisions which are made when NICE has made its pronouncements.


  147. There appears to be general consensus among the witnesses on that point.
  (Ms Marlow) Yes.
  (Dr Crayford) Yes.
  (Dr Walker) Yes.

Sandra Gidley

  148. I want to follow up on the announcement by Alan Milburn last week when he said that he was going to remove himself from the process so that NICE was more independent. Is this a red herring? Do you think that in reality the Department of Health will still have a strong hand on the tiller or be perceived to do so? This was as a result of the Kennedy report; it was slipped into the Government's response.
  (Dr Cunningham) It is not possible to comment on what the Secretary of State intends to do, but you mentioned the Kennedy report. What we should welcome would be if one of the recommendations in the Kennedy report were followed, namely that if the Secretary of State wants all NICE guidance to be binding and health authorities and funders to fund them three months after they are issued, we want a portfolio of guidance relating to needs out in the population. It would be very helpful if programmes were extended to cover major areas of morbidity and mortality which more reflect the priorities we are all facing locally. It would help us to be able to deal more with the affordability issues because the NICE guidance portfolio would be more relevant to the needs we are facing every day.

  Sandra Gidley: That is a change since the submissions were made so I thought it was a question worth asking.


  149. May I move on to NICE "blight"? I assume you are familiar with the term—probably very familiar with the term in some respects. We have had this point mentioned by a number of witnesses and we wonder from your perspective how big a problem it is and whether health authorities should ignore NICE evaluations until they are complete.
  (Dr Cunningham) We cannot really ignore NICE guidance completely: we have to make a decision locally when a drug or an intervention is available for our use. Our examples for blight would be beta-interferon and the blight still goes on. There we had to make a decision. Also, our local trusts are very concerned about Infliximab, which is a drug for rheumatoid arthritis which we assume to be highly effective but cannot necessarily make financial provision for until NICE has made a determination. The problem is whether we should ignore NICE guidance until it is complete. It is difficult. We have to appraise a drug ourselves first of all and make up our mind. We cannot say never. We have sought guidance from the lawyers on whether we can say no to a drug and the answer is no, we cannot. We are putting clinicians and others at risk if we say no. We have to provide some funding. We may provide limited funding and these drugs may be quite expensive so that beta-interferon may cost more than £10,000 per patient per year. The patient we put on it may be on it for several years, maybe up to a decade for some of these long-standing conditions. If NICE guidance then comes out and says they do not recommend the use of something like beta-interferon, it is then unethical to take a patient who feels they are benefiting from a drug off it. We also have a waiting list of people who have been waiting for that drug. It is also unethical not to let the people on the waiting list have that drug. It causes a lot of problems and we end up again with a resource problem and an ethical problem.

Dr Naysmith

  150. What is the difference between saying no, which you said you could not do if a clinician prescribed it, and having only a limited number of patients treated? You are saying no to quite a large number of people.
  (Dr Cunningham) Exactly.

  151. What is the difference?
  (Dr Cunningham) It is a NICE way round a difficult problem. We are unable to say no to any drug, except on the basis of authoritative guidance that it does not work and we have had legal advice on our position and the legal advisers have suggested that we are unable to say no, particularly in the light of previous Secretaries of State's guidance.

  152. I am still genuinely puzzled about what the difference is, because one patient comes along the next day—
  (Dr Cunningham) In effect we have to ration our resources locally. We do not have enough resources to do everything we want. We cannot give an unqualified yes on the basis of an unassessed and unevaluated drug, so we say yes, but this is the amount of money we are allocating to this drug on the basis of the evidence we currently have.

  153. Once that money is used up, then it is no.
  (Dr Cunningham) Different authorities have different ways of dealing with this.
  (Ms Marlow) Legal advice says we cannot have blanket bans, we cannot always say no. We always have to consider individual patients, so even if we feel we do not have the money to fund a particular treatment, if a particular patient or a clinician feels a particular patient has a special case then we will hear those cases under an "exceptional circumstances" policy. We do not have blanket bans, we have general policies but we will always have to consider an individual case.

  154. To look at each case individually would be a more sensible way.
  (Dr Cunningham) It is not necessarily for health authorities to do this. We expect every case to be looked at individually by the clinicians.

  155. What you are saying is that a clinician could come along and say that even though there is no money left, we must insist on this patient being treated.
  (Ms Marlow) Yes, if it is a special reason.
  (Dr Cunningham) Yes and the health authority would be asked to provide special funding for that individual patient.

Jim Dowd

  156. Do you feel that NICE's involvement so far in beta-interferon has advanced the matter or clarified matters at all?
  (Dr Crayford) It has provided and summarised a lot of evidence which probably every health authority in the country has independently had to consider. As a national central evidence collating body, that is undoubtedly very useful. Unfortunately there has been a delay in production of the guidance, this drug has been around for quite a long time anyway, so many health authorities have precedents and policies which are already funding the drug. The intermittent start/go that we have had from NICE, which you may be aware of, has created what we would call NICE blight around this. Now that evidence around beta-interferon has become a bit clearer I suspect that the majority of health authorities probably will not be funding this in most situations at the moment. Unfortunately, because of the delay in NICE's guidance, we are unable to come to that position.
  (Dr Cunningham) We have had to review and reverse our position. Beta-interferon is a special example because other bodies, before the setting up of NICE, had actually considered the evidence and made it available and produced interim guidance. NICE has been asked to consider this particular drug quite a long time after it received its product licence.
  (Ms Marlow) The delay in final guidance coming out is causing problems because the preliminary conclusions are available publicly and there is a lot of patient demand on clinicians to get them on beta-interferon before that becomes guidance. It is a real problem for clinicians.


  157. May I raise with you some evidence we have had from some of the witnesses who will appear in the second session today and that is CERT, Campaign for Effective and Rational Treatment, whose work I am sure you will be familiar with? They talk about what they allege to be inexplicable delays in the appraisals for Herceptin, which they say has been responsible for the premature deaths of women with breast cancer. Is this something you are familiar with? Has it concerned you that delays have resulted in specific problems?
  (Ms Marlow) I am not aware that it has caused us specific problems locally in terms of its delay.
  (Dr Crayford) There is a general issue which we touched on with interferon, about the timing of NICE advice generally and that is that drugs are released at point A and at point B there is some guidance about how to use them. Meanwhile you get this thing called technology creep where in the absence of guidance it works its way into the system and it becomes very difficult to undo precedents which have been set about using drugs. That is a general point which probably affects most of the things NICE is considering. What would be best would be for drug approval to come complete with NICE guidance. Then we would have a managed way of introducing the drug across the NHS.

  158. That would presumably take longer so you would still get the arguments that people were dying because of the lack of appropriate provision of drugs which could save their lives.
  (Dr Crayford) You would, but it would be consistently longer and that would be the issue.

  159. I am not sure if I were dying I would be entirely happy about that.
  (Dr Crayford) No.

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