12. A First Class Service set out one of NICE's key objectives as the provision of clear, credible guidance:

"NICE will produce clear guidance for clinicians about which treatments work

 best for which patients"

"The National Institute for Clinical Excellence will ensure authoritative national guidance is available for all health professionals on the latest drugs and technologies"

 "Clear credible guidance and the production of robust audit methodologies are essential"

 [A First Class Service, Department of Health, 1998, 1.15.]

Clarity

13. Clarity is crucial to the success of NICE's guidance, particularly given the complex and broad subject matter falling within its portfolio and the proliferation of guidance of various quality now available to clinicians and patients. Although we received evidence giving examples where NICE guidance could have been worded more clearly, many written memoranda praised the presentational quality of NICE's work.[7] However clarity extends beyond presentation, encompassing consistency of message, lack of ambiguity, and the provision of relevant context. Our evidence suggests that for NICE stakeholders the degree of clarity with which NICE is able to link its evidence to its recommendations is very important, and is also closely linked to its intended function of "ending confusion by providing a single national focus".

Credibility

14. Lord Hunt emphasised the importance of credibility in implementing NICE guidance successfully: "my expectation is that NICE guidance will be credible, that the profession will see it as credible, and will see the merit in following the advice that they give".[8] Establishing credibility with its sponsors, within the policy arena in which it operates, and with its stakeholders is vital for any new organisation. When giving evidence to our predecessor Committee in February 1999, shortly before taking up his position as Chair of NICE, Professor Sir Michael Rawlins highlighted this as his highest priority:

"¼ the most important thing is for us to gain the confidence of the professions, of the public, of Parliament, of ministers, of the Department as a whole. If we can do that, and do that early on, then I think that is the most important thing to do. We will do that by the quality of the technical scientific work we do, by being transparent in so far as is humanly possible, and in making sure that we can consult and disseminate the output as widely as possible."[9]

15. Credibility is clearly a subjective issue. NICE's credibility can only be properly judged by its users, who will inevitably reach their own conclusions about the value and trust they are able to attach to NICE's guidance. Within the evidence we have received about the credibility of NICE's guidance from its stakeholders, the three contributory factors identified by Professor Rawlins have emerged as recurrent themes:

• Clinical credibility is largely determined by the technical quality of the guidance produced. Does it ask and answer the right questions? Is it factually accurate and is it evidence-based? Does its methodology ensure that the evidence it receives is assessed fairly and rigorously?

• Closely linked to quality and rigour is the issue of inclusiveness. Do NICE's processes ensure that the right people, whether they are clinical or academic experts, patient groups or pharmaceutical companies, are appropriately involved in its work? As far as possible, is NICE's guidance sensitive to local concerns and priorities?

• Finally, transparency is needed to enable stakeholders to assess for themselves the rigour and inclusiveness of NICE's decision-making processes.

16. Independence is central to credibility and is linked to each of these areas. Rigorous and well-reported analysis is necessary to reassure stakeholders that decisions are evidence-based and not influenced by outside factors; including the right groups in its processes ensures that NICE's relationships with stakeholders are, and appear to be, measured and proportionate; full transparency about NICE's processes and relationships will add confidence to this. This section gives a brief overview of NICE's performance in these three areas in turn, before exploring the issue of technical quality in greater depth in section IV, and that of independence in section V.

CLINICAL CREDIBILITY

17. NICE's work on zanamivir (also known by the brand name Relenza) provides a useful example of how doubts over independence and technical quality can adversely effect credibility. NICE's initial 'rapid' appraisal of Relenza, a drug marketed for the treatment of influenza, was published in October 1999. NICE recommended the treatment should not be used in the NHS, citing evidence showing that to be effective treatment had to be started within a very stringent timeframe, and even when started early in patients with confirmed influenza it was only likely to reduce the duration of symptoms by one day. NICE also felt that there was insufficient evidence about the drug's effects in 'at risk' groups. The decision was generally supported by clinicians and the NHS, but was opposed by Relenza's manufacturer, Glaxo Wellcome, and by other pharmaceutical companies.[10]

18. In November 2000, NICE issued new guidance on Relenza, this time recommending the treatment for use in 'at risk' individuals on the basis of new evidence prepared by manufacturers. In February 2001, the Drug and Therapeutics Bulletin, an independent prescribing journal published by the Consumers' Association, published an article offering advice contrary to NICE's guidance. It highlighted what it claimed were weaknesses in NICE's evidence base and analysis, and argued that NICE's recommendation for Relenza to be used in 'at risk' patients seemed at odds with the patient information leaflet supplied with the drug, which in fact offers particular cautions to 'at risk' patients who might take the drug.[11] This dispute was well-publicised.[12]

19. Many witnesses attested to the impact of the new Relenza guidance on NICE's credibility - Dr Martin Duerden, a general practitioner with specialist interest and experience in prescribing and therapeutics, argued that "The real problem that has challenged the credibility of NICE with GPs has been the change in guidance for use of zanamivir (Relenza, the flu drug) without an obvious change in the evidence base to support this approach".[13] Dr Duerden told us that the reversal had "created a perception that maybe NICE had been got at, that it had made a change in response to major political pressure, pressure from the media and the drug industry".[14] Helen Marlow, Pharmaceutical Advisor to Croydon Health Authority, described "incredulity within the NHS when NICE reversed its decision not to recommend zanamivir for the treatment of influenza" and agreed with Dr Duerden that the perception that "external pressure" accounted for this change had "seriously damaged NICE's credibility".[15]

20. As well the relevance of NICE's independence, this emphasises the importance for NHS professionals of what Professor Rawlins termed the "quality of the technical scientific work", about which several witnesses raised concerns. Although we are not qualified to judge the quality and robustness of individual appraisals, and nor is it within the remit of this inquiry to do so, when criticisms are voiced by other respected and established authorities in the field, the potential for damage to NICE's credibility is evident. The North Liverpool Primary Care Trust told us that:

"Unlike the MeReC Bulletin, the Drug and Therapeutics Bulletin and Clinical Evidence [prescribing publications], NICE is widely viewed as pursuing a political agenda at the expense of clinical credibility. This perception became apparent amongst prescribers and advisers after the rapid reversal of guidance on the use of zanamivir."[16]

21. NICE clearly operates in an environment populated by information providers who are already established and respected by clinicians. This means that if NICE is not able to produce guidance which clinicians find credible, then it is likely and reasonable that clinicians will use these other sources of information. Professor David Barnett, Chairman of NICE's Appraisals Committee, implied that NICE's relationships with other information providers should be collaborative rather than competitive, telling us that it was not an "either/or" situation, and that NICE guidance "should be read in conjunction with the BNF [British National Formulary], not instead of or in any other way".[17] However, when NICE and other organisations offer conflicting guidance, as has been the case with Relenza and, for example, guidance on glitazones (drugs used to treat diabetes), clinicians and commissioners of care have to make a choice, or at the very least attempt to grapple with these differences themselves: as Ms Marlow told us, "other authoritative and respected sources, for example the Drug and Therapeutics Bulletin, have drawn conclusions about treatments which are different to NICE and one has to ask why there is that conflict".[18]

22. Evidence from GlaxoSmithKline suggested that NICE has been willing to accept constructive criticism from pharmaceutical companies.[19] However, we are concerned by the reports we have received showing an apparent failure on the part of NICE to engage, either proactively or even reactively, in dialogue with respected prescribing organisations such as the Drug and Therapeutics Bulletin (DTB) and the British National Formulary (BNF) about the content of their work. The DTB told us:

"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."[20]

23. The BNF experienced a similar lack of engagement:

"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."[21]

24. Professor Rawlins told us that "one of our problems in a sense, which will always remain with us, is that we will only please some of the people some of the time. We will never please everybody all the time".[22] We agree that it will not be possible for NICE always to achieve consensus between all of its stakeholders. Indeed, if NICE's work attracted no criticism at all, it would be failing in its task. However, we believe that there is a core group of relevant organisations, including the Scottish Intercollegiate Guidelines Network (SIGN), DTB, the BNF, and the Royal Colleges, that it is essential for NICE to engage with constructively and collaboratively in order to maintain its clinical credibility. This view was endorsed by Lord Hunt, who told us that he was "very anxious to ensure that it [NICE] learns as it goes along and that it does engage in dialogue and that even when organisations disagree fundamentally with a decision none the less there should be constructive dialogue".[23] He went on to agree that "in relation to BNF or the Drug and Therapeutics Bulletin I would certainly want to encourage NICE to sit down with the people who produce these two services to discuss where there may be differences, why there may be differences, and whether that might lead to any modification of NICE's process".[24]

25. This view was also echoed by Professor Rawlins, who, prior to NICE's establishment, expressed a hope that eventually "doctors will go to work with the British National Formulary in one pocket and a copy of NICE guidelines in the other".[25] During our evidence session he seemed surprised to learn that the BNF was not given the opportunity to comment on NICE's draft guidance:

"(Professor Sir Michael Rawlins) The British National Formulary have received many of our forms of guidance in draft form, have they, Mr Dillon?

(Mr Dillon) No. The BNF is not a formal consultee. The definition of 'consultees' is representative patient and professional organisations that have a direct interest in the work that we do, and manufacturers."[26]

26. Since the completion of our evidence sessions, it has been announced that NICE and SIGN will formally collaborate on the production of clinical guidelines, a move we commend. We also note that Royal Colleges are well represented on NICE's six National Collaborating Centres.[27] To neglect the input of respected bodies such as the DTB and the BNF is to miss a key opportunity for quality assuring NICE's work, and risks serious damage to the credibility of its guidance. We recommend that NICE puts in place robust mechanisms to ensure closer and more constructive collaborative working with BNF, DTB, and other similar bodies. Although we recognise that such bodies may not have the capacity to contribute to every piece of guidance that NICE issues, they should be allowed a formal opportunity to contribute to work where they have relevant expertise, and there should be an established mechanism for discussing and resolving technical differences.

INCLUSIVENESS

27. Ensuring that its processes are as inclusive as possible is critical if NICE is to achieve and maintain credibility. If a process is insufficiently inclusive, not only does NICE risk losing valuable input which could improve the quality of its products, as we have seen above, but without representative input from relevant groups there is the potential for bias against those who have not been included.

28. Yet the Health Technology Board for Scotland commended NICE's inclusiveness, and pointed out that "NICE was the first appraisal organisation to take evidence from all stakeholders (few involve manufacturers or patient groups)", suggesting that "such broad consultation" was helpful in creating "credible guidance".[28] However, much of our evidence highlighted perceived shortcomings in the ways in which NICE decides which stakeholders to involve in its work.

29. Dr Andrew Bamji, a consultant rheumatologist, claimed that the involvement of the British Society for Rheumatology in the production of GP referral guidelines occurred "by chance" despite the clear relevance of specialist rheumatology input.[29] The Cancer Research Campaign suggested that in NICE's appraisals of cancer drugs "there are issues in relation to credibility where a lack of expertise in oncology has led to a perception that the appraisals lack specialist 'clinical common sense'".[30] The Alzheimer's Society and the Campaign for Effective and Rational Treatment (CERT), an organisation sponsored by the pharmaceutical industry which campaigns for better treatment in a number of different clinical areas, gave examples of seemingly insufficient stakeholder consultation. The Alzheimer's Society argued that during its appraisal of drugs for Alzheimer's disease, NICE, in error, included the Chartered Society for Physiotherapists but not the Royal College of Psychiatrists.[31] Similarly, CERT maintained that NICE did not contact the two specialist colorectal cancer patient advocacy groups during its appraisal of drugs for colorectal cancer,[32] and suggested that in some cases timing may be an issue:

"We have heard of occasions when NICE has telephoned experts to ask whether they would be available to advise the Appraisals Committee on a particular date in two or three weeks time. When the experts have said that they were not available on a particular date, NICE have simply advised that they would find someone else ... Medical consultants have said that they find it 'staggering' that treatments are being appraised by clinicians who have no working understanding of the clinical area they are investigating."[33]

30. Similar concerns have been raised about NICE's processes for identifying which patient groups to include as formal consultees: "we welcome the commitment that NICE has given from the start to the user and carer perspective, but perceive that NICE has had difficulty in discovering for itself what the patient perspective is and which organisations properly represent it".[34]

31. Involving such a broad sweep of stakeholders is a complex and time-consuming task, and we welcome NICE's efforts in this area to date. We recommend that NICE should take steps to improve its stakeholder identification methods, to ensure that relevant bodies and individuals are systematically identified for inclusion. If NICE is to gain the full respect of the medical profession, it is essential that it involves clinicians with relevant clinical experience, alongside those capable of taking a broad overview. NICE should consider the possibility of inviting stakeholders in the technology appraisal process to 'self nominate' in the same way as they are permitted to in the clinical guidelines process.

32. Some patient organisations raised wider concerns which went beyond NICE's stakeholder identification processes, and questioned its commitment to patient involvement, as illustrated by the MS Society: "The institute has shown itself consistently unwilling to engage with people who are expert in MS by virtue of having it. Our view is that the Society has a valuable organisational perspective on the appraisal of MS drugs, but that it is complementary to - and not a replacement for - the perspective of people who have MS".[35] We examine the issue of patient evidence alongside our broader consideration of NICE's methodology in section IV.

33. Despite these concerns, the large number of memoranda we received from patient organisations who have been involved in NICE's processes over the past two years clearly demonstrates that NICE has attempted to consider the patient perspective. In marked contrast to this, our evidence from NHS staff suggested that NICE made comparatively little attempt to involve them: Helen Marlow told us that "frontline NHS staff and policy makers are not consulted in the drafting of NICE Technology Appraisals ... there is no opportunity for the NHS to provide practical feedback to NICE about how its guidance is received and implemented in practice".[36] NHS Trusts and Strategic Health Authorities also have no right of appeal against NICE guidance which "does not really help in terms of ownership of the guidance".

34. We were told by the Royal College of General Practitioners that "although NICE has built into its processes a wide stakeholder involvement, including patients, and has introduced a requirement to look at cost effectiveness, NICE does not seem to have processes for considering the impact of guidelines on patterns of service delivery".[37] Following NICE's revised guidance on Relenza, some clinicians voiced concern and disappointment that NICE had not taken into account the practical impact its recommendations could have on general practitioners, who might be inundated with people asking for the drug.[38] Nicola John, Prescribing Adviser to Iechyd Morgannwg Health, argued that "it would be helpful if the guidelines also assessed the service implications of their introduction. For some drugs, the effect on service provision is minimal, but for others, major investment is required in staff recruitment and training".[39] North Derbyshire Health Authority argued that NICE "does not appear to make recommendations that are sensitive to current resourcing problems", and gave the example of NICE's guidance on anti-obesity drugs, claiming that at present "there is simply not the dietetic and nurse time available to provide the level of support likely to make the drugs beneficial, and indeed without such support it might be questionable if they were being prescribed within their Product Licence".[40]

35. NHS representatives also have a further crucial contribution to make, as within NICE's processes they are currently the only advocate for the wider patient population served by the NHS, whose lives may not be directly impacted by NICE's decision on a particular treatment, but may be indirectly impacted if resources, both financial and staffing, are diverted from other NHS services in order to implement NICE recommendations.[41]

36. NICE has changed its processes so that now two health authority representatives sit on the Appraisal Committee. However, our evidence suggested that these measures have not been entirely successful in fostering within the NHS a sense of inclusion in NICE's processes. Clearly this is vital to securing the local ownership needed to facilitate the implementation of NICE guidance. We recommend that NICE takes steps to improve current methods of involving the NHS in the development of technology appraisals and clinical guidelines, including arrangements for the NHS to be involved in a timely appeal process. Measures to achieve this might include the extension of membership of the Appraisal Committee to more than two NHS representatives; and the establishment of a network of designated individuals within NHS Trusts and strategic health authorities, through whom NICE can maintain open dialogue with working clinicians and commissioners of care throughout the guidance development process. These individuals would be able to act as intermediary facilitators between NICE and the wider NHS, acting as a local source of reference about NICE's processes and promoting the implementation of its guidance, as well as ensuring the systematic inclusion of NHS representatives in NICE decision-making.

37. We hope that the recommendations we have made will help NICE to improve the inclusiveness of its processes. However, as well as ensuring that it gets the 'theoretical' aspects of inclusiveness and stakeholder relations right through well-designed processes, an organisation with as high a public profile as NICE must also ensure that well-intentioned theory is translated into practice through other perhaps less tangible means, such as maintaining a sufficiently outward facing focus and fostering a general organisational culture of inclusiveness. We note the fact that almost a fifth of the memoranda we received came from people with some financial or professional interest in NICE (including even its publisher). NICE issued a very prompt press release following their evidence to us, and this energetically proactive media relations strategy appears to be emerging as characteristic of NICE, with an equally swift rebuttal issued after criticisms of NICE were raised in evidence to the Science and Technology Committee.[42] We recognise that if this is not done in what will often be a difficult field - particularly with the interests of pharmaceutical companies - other interpretations of events and evidence can get established as the only interpretation available to patients, the public and professionals. However, NICE has to be sure that this strong media presence does not stop the organisation from always listening to and responding to counter claims and criticisms of its work.

38. We welcome NICE's attempts to achieve better relationships and open channels of communication with stakeholders - particularly the NHS and patient groups. The future credibility of NICE rests on it being responsive to criticisms, and to it being willing to study them, and if necessary, learn from them. Wherever possible, any resulting press statements about the resolution of disagreements should be agreed with the other parties involved before release.

TRANSPARENCY

39. As shown by the example of Relenza, clarity and transparency about the basis on which decisions have been made is key to NICE maintaining its credibility with clinicians, with the wider NHS, and with patient groups. It is also vital that NICE is able to establish and publish a consistent and robust framework setting out methodology and evidence weighting, an issue which is discussed more fully in section IV.

40. Sir Iain Chalmers, Director of the UK Cochrane Centre, along with several other witnesses,[43] raised the point that much of the information on which NICE appraisals are based is unpublished, as it is supplied to NICE by manufacturers in confidence. Sir Iain argued that "while this state of affairs persists NICE cannot be expected to achieve the credibility that is essential for it to earn the trust of the public".[44] We recommend that all information which NICE uses in its decision-making process is made available for public scrutiny. If industry or others have previously unpublished data which they want to use to support their case then this should no longer be presented to NICE subject to confidentiality. If pharmaceutical companies insist that unpublished data relating to the indication in question remain confidential, this may mean NICE will be forced to withdraw that treatment from the appraisal process. This carries the risk that guidance on a treatment will be delayed until published information is available. However, we believe that pharmaceutical companies are unlikely to use this as an 'opt-out' clause because their refusal to submit their evidence to public scrutiny would be likely to have a negative impact on commissioners' and clinicians' confidence in their product.

41. Besides transparency about the evidence base for NICE's recommendations, it is also crucial for stakeholders that transparency is maintained during the appraisal process. The MS Society felt that "people affected by the Institute's decisions should be able to follow an audit trail of decision-making. It is currently impossible for consultees - let alone members of the general public - to do this".[45] Specific barriers identified by the MS Society included the fact that patient organisations are unable to attend the final deliberations of the Appraisal Committee, and the fact that minutes of these meetings are often published late and "include little flavour of how conclusions have been reached".[46]

42. Alongside clarity about decision-making, several witnesses felt that confidence in NICE and credibility in its guidance could be improved by publishing members' declarations of interest more explicitly. Ms Marlow told us that:

"When the NICE guidance comes out about a particular technology a number of parties have been involved in developing that and advising NICE. Some parties have relationships with other organisations, for example, the pharmaceutical industry. It would help the openness and robustness of the process if things were openly declared in the final guidance which comes out because it is not made public in the guidance."[47]

43. While we accept NICE's position that members' declarations of interests are available on its website, they are not particularly obvious or easy to locate. We recommend that NICE should improve the transparency of its processes by striving to make information on how and why its decisions are taken, and on members' declarations of interests as readily and clearly available to lay stakeholders as possible. For the sake of clarity, members should declare all interests at the beginning of each appraisal. The decision-making audit trail could be improved if the NICE website supplemented its sections on individual technology appraisals with links to the minutes of all relevant meetings. It would also be helpful if, instead of listing the full membership of the Appraisal Committee, each guidance document listed those specific members who had taken part in decision-making on that particular treatment, and those who had withdrawn due to competing interests.

APPEALS

44. We were concerned to hear from the MS Society that during the course of an appraisal "straightforward questions ... were turned aside by the Institute and we were told that the only way of finding out how that information had been used was through NICE's formal appeals process, which we did, but we could not actually make any critique of how that information had been used because no explanation was given of how it had been used".[48] Some support for this view can also be drawn from Professor Rawlins' description of an appeal which had proved a useful mediation exercise:

"This was an opportunity to allow the particular organisation, which in one case was actually a patient organisation, to explain what their problem was and we could explain what our problem was and I think they were reasonably satisfied. Although the specific appeal was rejected I think they were satisfied that their point of view had been put and we had explained why we could not meet their demands."[49]

45. Although we welcome this example of constructive dialogue between NICE and its stakeholders, we feel that NICE needs to be able to engage in this type of dialogue within its routine processes, rather than in the costly and potentially adversarial setting of a formal appeal. Improvements in the inclusiveness and transparency of NICE's processes are needed to ensure that the appeals process is not the only means for stakeholders to enter into constructive dialogue with NICE.

46. Many memoranda also expressed wider concern that the Chairman of NICE has sole responsibility for deciding whether or not an appeal is heard, and that he is also Chair of the Appeals Committee.[50] The MS Society argued that "the NICE Appeals Panel has neither the qualities of independence or impartiality that are required of a public body exercising an appeals function", without which it will be unable to maintain the confidence of the public.[51] The Association of the British Pharmaceutical Industry (ABPI) agreed with this: "As much as we fully respect Sir Michael Rawlins's independence, he is the Chairman of the Appeals Commission as well as the Chairman of NICE. That seems to be, for his benefit and the benefit of NICE, something which probably ought to change".[52]

47. NICE gave us assurances that the Chairman maintained full independence by having no involvement at all in the technology appraisal process, and told us that they felt this was an appropriate arrangement.[53] However, a perverse consequence of this is that the Chairman may not be able to keep his finger on the pulse of NICE, and may be prevented from giving it vital strategic direction. Indeed, there were occasions during oral evidence when, in response to questioning, Professor Rawlins excused his lack of knowledge about NICE's processes as being the result of his need to stay out of the deliberations of NICE so that he could remain independent for appeals.[54]

48. In an ideal situation, there should be only very limited recourse to an appeals panel. Professor Rawlins told us that around 40% of NICE decisions on technology appraisals are appealed against, and he said that this rate was comparable to that of the Committee on Safety of Medicines.[55] However, figures published by the Medicines Control Agency indicate that between 1995 and 1999, the proportion of decisions that were the subject of an appeal hearing in fact ranged between 4.6 and 9%, with the proportion subject to independent appeals even smaller.[56] We recognise that NICE was created to take difficult decisions about which there will inevitably be disagreement. However, appeals are meant to resolve any genuine concerns that NICE has not followed its own processes properly, rather than to act as a means for stakeholders to question the validity of those processes, or to enter into dialogue with NICE. There should be the opportunity for this to take place within normal procedures, so that by the time NICE reaches a final determination, stakeholders have sufficient confidence in the technical quality and accuracy of the appraisal work, and are satisfied that their own evidence and views have been taken on board and used properly.

49. NICE is currently undertaking a public consultation into its appeals process, the key proposals of which are that all hearings will be held in public, and that NHS organisations who are formal consultees will be given the right to appeal. However, the current role of the Chair in the appeals system seems to us to be flawed. We recommend that the Government gives careful consideration to reforming the appeals system, as it has at least the appearance of lacking impartiality. We are also concerned that the distance that this creates between the Chair and the everyday business of NICE may be to the detriment of the organisation as a whole.

8   Q501. Back

9   Health Committee, Minutes of Evidence, 4 February 1999, Session 1998-99 (HC222-i), Q52. Back

10  

For example, Too little action, too much uncertainty says GPs' leader, BMA press notice 8 October 1999; Relenza: Drug companies join flu protest, BBC online 6 October 1999, http://news.bbc.co.uk/hi/english/business/newsid_466000/466563.stm; note: Glaxo Wellcome is now part of GlaxoSmithKline.  Back

11   Why not zanamivir? DTB 2001; 39: 9-10. Back

12   Guidance over anti-flu drug 'wrong', BBC online 15 February 2001

http://news.bbc.co.uk/hi/english/health/newsid_1170000/1170376.stm. Back

13   Ev 18. Back

14   Q33. Back

15   Ev 68. Back

16   Ev 240. Back

17   Q378. Back

18   Ev 5 (Consumers' Association); Q165. Back

19   Q261: "An example would be in a diabetes treatment where the original assessment included commentary about use of the product on its own with patients, not in combination with any other products. That is actually outside of the licence indication. We were able to point that out and it was changed" (GlaxoSmithKline). Back

20   Q9. Back

21   Q72. Back

22   Q431. Back

23   Q451. Back

24   Q489. Back

25   Coulson J. NICE work. (Interview with Sir Michael Rawlins.) BMA News Review 1999, 13 Mar, pp. 20-23. Back

26   Q376.  Back

27   http://www.nice.org. Back

28   Ev 208. Back

29   Ev 194. Back

30   Ev 255. Back

31   Ev 55. Back

32   Ev 105. Back

33   Ev 106. Back

34   Ev 54 (Consumers' Association). Back

35   Ev 44. Back

36   Ev 69. Back

37   Ev 231. Back

38   Flu Drug available on NHS, BBC News Online, 21 November 2000 (http://news.bbc.co.uk/hi/english/health/newsid_1026000/1026481.stm). Back

39   Ev 255. Back

40   Ev 228. Back

41   The issues of mandatory funding and diversion of resources are explored more fully in section V. Back

42   NICE press notice 2002/002, NICE responds to comments made by Director of the Cancer Research Campaign (http://www.nice.org.uk/article.asp?a=26605).  Back

43   See, for example, Ev 213 (Mid Devon Doctors' Group). Back

44   Ev 199; The UK Cochrane Centre forms part of the Cochrane Collaboration, an international organisation which prepares, maintains and makes accessible systematic reviews of evidence on the effects of health care interventions.  Back

45   Ev 43. Back

46   Ev 43. Back

47   Q136. Back

48   Q106. Back

49   Q409. Back

50   For a full description of the Appeals process see Annex Back

51   Ev 43-44. Back

52   Q287. Back

53   Q309; Q363; Q426. Back

54   Q309; Q363. Back

55   Q411. Back

56   Official Report, 19 March 2002, col. 289w. Additional information supplied by Medicines Control Agency. Back