Intended for healthcare professionals

Letters

The failings of NICE

BMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7284.489 (Published 24 February 2001) Cite this as: BMJ 2001;322:489

Reply from chairman of NICE

  1. Michael D Rawlins, chairman (anne-toni.rodgers{at}nice.nhs.uk)
  1. National Institute for Clinical Excellence, London WC2N 5HR
  2. Westerhope Medical Group, Westerhope, Newcastle upon Tyne NE5 2LH
  3. Welsh Institute for Health and Social Care, University of Glamorgan, Pontypridd CF37 1DL
  4. North Cumbria Health Authority, Carlisle CA14 1TS
  5. Boathouse Surgery, Pangbourne, Berkshire RG8 7DP
  6. Walsall Community Health Trust, Walsall WS4 2HT
  7. North Staffordshire Royal Infirmary, Stoke on Trent ST4 7LN
  8. Endocrinology and Metabolic Medicine, Imperial College School of Medicine, St Mary's Hospital, London W2 1NY

    EDITOR—Restrictions on space prevent me replying here in full to Smith's editorial1; my complete response is published on the National Institute of Clinical Excellence (NICE) website (http://www.nice.org.uk/).

    The institute's purpose is to offer health professionals guidance on the use of technologies, based on rigorous reviews of the available evidence for clinical and cost effectiveness. In doing so, it takes the following six matters into account:

    • The clinical needs of patients in relation to other available technologies; this is an overriding issue, where the evidence base for clinical effectiveness is crucial

    • NHS priorities; this is a relative, but not an absolute, criterion

    • The broad balance between benefits and costs, incorporating both clinical and cost effectiveness

    • The potential impact on other NHS resources

    • The encouragement of innovation

    • Guidance from ministers on the resources available.

    The last point exists should it be required; the institute has not yet received any such guidance. In the event that a technology meets the institute's appraisal criteria but is unaffordable with the resources available, it is a matter for parliament, not the institute, to decide resource allocations. If the institute were to be given such advice on resources, the transparent process that we follow (see http://www.nice.org.uk/) ensures that it would be apparent.

    Issues about cost effectiveness inform, but are not the sole determinant of, the institute's guidance. The institute seeks evidence from, consults with, and offers the right of appeal to professional and patient organisations while developing its guidance. The appraisal committee's members (who include patient representatives) are entirely independent and could not, as Smith insultingly alleges, be manipulated by “nods and winks.” The NHS Plan indicated that the institute should in addition establish a citizen's council, which will inform value judgments, such as the priority that the NHS should give to future guidelines on in vitro fertilisation.

    Finally, the institute did not recommend the use of zanamivir in at risk patients merely because “the drug would reduce symptoms … from 6 to 5 days.”2 We knew this, and published it as part of our original guidance.3 Following our full appraisal of zanamivir, additional evidence (which is in the public domain; see http://www.nice.org.uk/) in patients for whom the complications of flu can lead to serious illness persuaded the appraisal committee that the use of this product could prevent the development of secondary complications and should be recommended to the NHS.

    References

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    NICE and evidence based medicine are not really compatible

    1. Toby Lipman, general practitioner (toby{at}tobylipm.demon.co.uk)
    1. National Institute for Clinical Excellence, London WC2N 5HR
    2. Westerhope Medical Group, Westerhope, Newcastle upon Tyne NE5 2LH
    3. Welsh Institute for Health and Social Care, University of Glamorgan, Pontypridd CF37 1DL
    4. North Cumbria Health Authority, Carlisle CA14 1TS
    5. Boathouse Surgery, Pangbourne, Berkshire RG8 7DP
    6. Walsall Community Health Trust, Walsall WS4 2HT
    7. North Staffordshire Royal Infirmary, Stoke on Trent ST4 7LN
    8. Endocrinology and Metabolic Medicine, Imperial College School of Medicine, St Mary's Hospital, London W2 1NY

      EDITOR—Smith writes of the “[corruption] of evidence based medicine.”1 This corruption or, more correctly, misrepresentation is not exclusively the preserve of the National Institute for Clinical Excellence (NICE), although that organisation typifies the intellectual sloppiness and lack of imagination in the establishment's response to evidence based medicine.

      When the founding of the institute was announced, along with the inclusion of evidence based practice in clinical governance,2 I imagined that the practice of evidence based medicine would now be encouraged among front line clinicians. This has not happened. What has happened is that the centralised, bureaucratic systems that have hamstrung the NHS for decades, with their traditional panoply of expert committees and top down implementation of guidelines, have claimed extra legitimacy by invoking the mantra of evidence based medicine.

      Far from encouraging clinicians to practise evidence based medicine, the National Institute for Clinical Excellence imposes a “one size fits all” population view. This is undoubtedly more comfortable for the Department of Health and other parts of the NHS's management than the potential anarchy (from their point of view) that could result from empowering clinicians and patients to make their own decisions. These decisions would be informed both by evidence and by patients' values and expectations, a process that follows from the “[application of] epidemiological principles … to the beliefs, judgements and intuitions that comprise the art of medicine,” which is the basis of evidence based medicine.3

      Evidence based medicine challenges the legitimacy, power, and influence of expert groups such as the National Institute for Clinical Excellence to make decisions about management. These decisions are instead taken by individual clinicians and (if the clinicians have thoroughly assimilated both the skills and philosophy of evidence based medicine) shared with their patients.4

      The way that the National Institute for Clinical Excellence functions sits uneasily with the practice of evidence based medicine at an individual level. The lack of skills in evidence based medicine among ordinary clinicians5 means that the institute currently faces no serious challenge to its authority. But it is impossible for a single national committee, or even local implementation initiatives, to tackle more than a fraction of the questions that patients and doctors need to have answered. If subversives such as myself are successful in encouraging others to engage in evidence based medicine, managers and expert groups will sooner or later find that they are consistently behind ordinary clinicians in the understanding and application of evidence in clinical practice. What legitimacy or authority would the National Institute for Clinical Excellence have in those circumstances?

      References

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      Rationing is a respectable word for a disgraceful retreat

      1. Julian Tudor Hart, external professor (crustyhart{at}aol.com)
      1. National Institute for Clinical Excellence, London WC2N 5HR
      2. Westerhope Medical Group, Westerhope, Newcastle upon Tyne NE5 2LH
      3. Welsh Institute for Health and Social Care, University of Glamorgan, Pontypridd CF37 1DL
      4. North Cumbria Health Authority, Carlisle CA14 1TS
      5. Boathouse Surgery, Pangbourne, Berkshire RG8 7DP
      6. Walsall Community Health Trust, Walsall WS4 2HT
      7. North Staffordshire Royal Infirmary, Stoke on Trent ST4 7LN
      8. Endocrinology and Metabolic Medicine, Imperial College School of Medicine, St Mary's Hospital, London W2 1NY

        EDITOR—The central social issue of our era is the yawning gap between what scientific knowledge makes possible for world needs and what is actually done. As Smith said in his editorial about the failings of the National Institute for Clinical Excellence (NICE), doctors have exceptional opportunities and therefore responsibilities for leadership.1 Under Smith's editorship, the BMJ has an excellent record in this regard.

        Unfortunately, Smith's liberal vision has included equally liberal blindness to real social and political context. For almost 20 years he has used the resources of the BMJ to advocate limited professional responsibility, insisting that we all use the term rationing when what we really mean is that the scope of the NHS should be reduced.

        Why is rationing inevitable? The world is awash with money searching for new ways to multiply itself, so why can we not afford to even try to do all that needs to be done? Yes, it's an endless battle for priority against the demands of the rich to get richer, but what else does he expect?

        Encouraged by media entirely dependent on advertising, people's appetites as consumers with cash in their pockets are insatiable—and fortunately so, for if those who already have more than they need were ever satisfied, markets would collapse. As citizens, on the other hand, their expectations for unmarketed, unpromoted, unprofitable, but rational care from public services must somehow be reduced. They must be persuaded that science advances too fast for affordable public services. And who defines what's affordable? It is corporate investors, their politicians, their editors, and that part of the public that has not yet understood the massive shift from taxes on income to taxes on spending.

        Rather than join patients to fight for resources, those who ration care seek to amputate the rights of citizens to comprehensive care. Some redundant, less necessary, or less popular part of the service must be removed so that there will be sufficient resources for what remains. Advances outside the rationing limits would then go to our wealthiest or most desperate consumers through a legal black market, and private practice would resume its prewar command of professional innovation. Advocates of “fair” rationing systems abdicate responsibility for leadership toward humane priorities. Their policy of appeasement will fail, because those who thrive from chopping bits off the NHS will never be satisfied.

        References

        1. 1.

        “Spinning” is not nice

        1. Robert Walker, director of primary care (Robert.Walker4{at}btinternet.com)
        1. National Institute for Clinical Excellence, London WC2N 5HR
        2. Westerhope Medical Group, Westerhope, Newcastle upon Tyne NE5 2LH
        3. Welsh Institute for Health and Social Care, University of Glamorgan, Pontypridd CF37 1DL
        4. North Cumbria Health Authority, Carlisle CA14 1TS
        5. Boathouse Surgery, Pangbourne, Berkshire RG8 7DP
        6. Walsall Community Health Trust, Walsall WS4 2HT
        7. North Staffordshire Royal Infirmary, Stoke on Trent ST4 7LN
        8. Endocrinology and Metabolic Medicine, Imperial College School of Medicine, St Mary's Hospital, London W2 1NY

          EDITOR—Smith has expressed a lot of the unease that some of us are developing about the usefulness of recommendations by the National Institute for Clinical Excellence (NICE).1 I initially felt positive towards the notion that a national body would be carrying out independent appraisals of therapeutic techniques, including treatment with new and not so new drugs. Why then do I now feel angry and let down after the recent decision concerning zanamivir (Relenza)?2

          The appraisal is fair. It gives a factual account of the evidence for zanamivir and states it clearly. So far so good. What really caused my anger, however, was the “spin” that followed the publication of the guidance. Ministers and civil servants fell over themselves to greet the guidance as if zanamivir was the wonder drug to beat the winter crisis and issued instructions to health authorities that it was to be used regardless of its marginal benefit. They had no concept of the practicalities of dealing with a patient population with flu-like illness and suggested that pharmacists be empowered to give zanamivir by using patient group directions.

          My anger has also been fuelled by an article in the Observer, in which Sir Michael Rawlins, the chairman of the National Institute for Clinical Excellence, is quoted as saying “How will they feel if one or two of their patients dies of flu?” in response to a question about general practitioners who do not wish to prescribe zanamivir.3 If it is a true quote it contradicts the institute's guidance (no impact on mortality has been proved), and it gives a perception that Sir Michael agrees with the spin doctors.

          To my mind, the problem is not so much with the National Institute for Clinical Excellence as with the manipulation of its work by politicians. We should take a lesson from Scotland. The SIGN network (Scottish intercollegiate guidelines network) is producing evidence based guidance at arm's length from the government, and its work is almost universally respected. The zanamivir episode could be a turning point for the institute, but not for the better.

          References

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          Latest decision on zanamivir will not end postcode prescribing

          1. Mike Powell, general practitioner (powellmp{at}compuserve.com)
          1. National Institute for Clinical Excellence, London WC2N 5HR
          2. Westerhope Medical Group, Westerhope, Newcastle upon Tyne NE5 2LH
          3. Welsh Institute for Health and Social Care, University of Glamorgan, Pontypridd CF37 1DL
          4. North Cumbria Health Authority, Carlisle CA14 1TS
          5. Boathouse Surgery, Pangbourne, Berkshire RG8 7DP
          6. Walsall Community Health Trust, Walsall WS4 2HT
          7. North Staffordshire Royal Infirmary, Stoke on Trent ST4 7LN
          8. Endocrinology and Metabolic Medicine, Imperial College School of Medicine, St Mary's Hospital, London W2 1NY

            EDITOR—I agree with the opinions expressed in Smith's editorial on the National Institute for Clinical Excellence (NICE).1 As the prescribing lead general practitioner for our primary care group I am faced with an estimated 7% overspend on our current budget. The institute's guidance on zanamivir (Relenza) is going to compound our problems.2 This might be bearable if the decision had been made with proper regard to evidence based medicine. The scientific review is sloppy and acknowledges that the institute has no idea of the workload implications for primary care stemming from its recommendations.

            The evidence for reconsidering zanamivir is derived from the manufacturer's trial, which is hardly unbiased; it might have been more compelling if there was a comparative trial of zanamivir and amantadine. The institute admits that it was not asked to look at alternative treatments. In at risk patients the duration of symptoms is reduced by 1.2 days, from six to five days, and complications requiring antibiotics are reduced by 6%. Neither of these outcomes is a reliable measure as symptoms are subjective and the decision to prescribe antibiotics in viral infections is not usually scientific or rational. For the important outcomes such as mortality and admission to hospital there are no data. None of the outcomes justifies the decision to recommend prescription of this drug.

            The institute estimates the quality adjusted life year cost of its recommendations as lying between £9 300 and £31 500 (over a threefold variation); the workload is estimated at between an extra 3 and 17 patients per general practitioner per week (over a fivefold variation); and the cost is estimated at between £2.3m and £11.7m in drug costs alone.

            The decision to make the recommendation is extraordinary given the minimal benefits and huge uncertainty about the financial and workload implications. The National Institute for Clinical Excellence has power but no responsibility, as the cost implications are borne by general practitioners and primary care groups. This will lead—as has already started to happen—to local decisions being made about the affordability of its decisions. This is postcode prescribing, which setting up the institute was meant to avoid. The only solution would be for the government to fund the extra costs of its recommendations. This would be welcome but, given that the institute has not the remotest clue about costs, rather difficult to implement.

            I look forward to the replacement of NICE by CHOR (the Committee of Honest and Open Rationing) as Smith suggests.

            References

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            Editor's choice of acronym for new NICE is Punjabi for thief

            1. Jagdeesh S Dhaliwal, director of primary care development (dhaliwal{at}tinyworld.co.uk)
            1. National Institute for Clinical Excellence, London WC2N 5HR
            2. Westerhope Medical Group, Westerhope, Newcastle upon Tyne NE5 2LH
            3. Welsh Institute for Health and Social Care, University of Glamorgan, Pontypridd CF37 1DL
            4. North Cumbria Health Authority, Carlisle CA14 1TS
            5. Boathouse Surgery, Pangbourne, Berkshire RG8 7DP
            6. Walsall Community Health Trust, Walsall WS4 2HT
            7. North Staffordshire Royal Infirmary, Stoke on Trent ST4 7LN
            8. Endocrinology and Metabolic Medicine, Imperial College School of Medicine, St Mary's Hospital, London W2 1NY

              EDITOR—Although the BMJ is always informative and frequently entertaining, I had never thought that it would provide occasion for hilarity. But the last sentence of Smith's editorial on the National Institute for Clinical Excellence (NICE) had me—and, I'm sure, many other readers of North Indian or Pakistani origin—laughing out loud.1

              I enjoyed and agreed with the editorial. It's just that the acronym that Smith suggests for NICE version 2—CHOR (Committee for Honest and Open Rationing)—is the Punjabi word for “thief” or “crook.” Might this be an Indo-Germanic rebuttal of Orwellian Newspeak?

              References

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              Doctors treating patients with multiple sclerosis will lose confidence in NICE

              1. Simon J Ellis, consultant neurologist (Simon{at}northesk.demon.co.uk)
              1. National Institute for Clinical Excellence, London WC2N 5HR
              2. Westerhope Medical Group, Westerhope, Newcastle upon Tyne NE5 2LH
              3. Welsh Institute for Health and Social Care, University of Glamorgan, Pontypridd CF37 1DL
              4. North Cumbria Health Authority, Carlisle CA14 1TS
              5. Boathouse Surgery, Pangbourne, Berkshire RG8 7DP
              6. Walsall Community Health Trust, Walsall WS4 2HT
              7. North Staffordshire Royal Infirmary, Stoke on Trent ST4 7LN
              8. Endocrinology and Metabolic Medicine, Imperial College School of Medicine, St Mary's Hospital, London W2 1NY

                EDITOR—It is time the profession signalled its lack of confidence in the National Institute for Clinical Excellence (NICE). I hoped I was wrong when in 1999 I wrote, “I can only conclude that [the institute's] true purpose is to deprive patients of treatment by delay,”1 but events, at least for patients with multiple sclerosis, have proved me correct.

                The fourth of the institute's stated aims was to “Avoid significant delays.” Let us look at the facts.

                • In 1993 interferon beta was found to be an efficacious treatment for relapsing-remitting multiple sclerosis.2

                • In 1995 the NHS Executive asked purchasers and providers to develop and implement a prescribing approach to interferon beta.3

                • In 1999 the institute announced that it would start evaluating interferon beta in August 1999 and that guidance to the NHS would be issued in August 2000 (NICE press release, 1999: “NICE technology appraisals: programme of results announced” (1999/012)).

                • On 22 December 2000 the chief executive of the institute, Andrew Dillon, announced that a decision on the use of interferon beta would not be considered again until the appraisal committee meets in July 2001 (NICE press release: “NICE to commission further research on MS drugs” (2000/052)).

                • In 2001, patients in the United Kingdom with clear indications for interferon beta are being deprived of treatment more than seven years after it was shown to be safe and effective.

                Peter Cardy, chief executive of the MS Society, has branded the institute as inept. I think he is being too kind. There is nothing inept about this delay. It is a deliberate attempt to delay a potentially embarrassing decision until after the general election.

                Most of us in the medical profession would welcome a rational and efficient rationing system. We would expect it to be “ethical, explicit, transparent, fair, flexible, consistent, and capable of timely response to development.”1 The National Institute for Clinical Excellence is none of these. Most of us would consider it unethical to enter a conspiracy to deprive patients of proved treatment without good reason. Those members of our profession involved in the institute should examine their consciences.

                It is time for the medical profession to signal its lack of confidence in the National Institute for Clinical Excellence. To do otherwise would be to betray the trust that our patients place in us as advocates on their behalf.

                References

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                NICE's guidance suggests using rosiglitazone in type 2 diabetes later than is ideal

                1. Stephen Robinson, consultant physician,
                2. Jonathan Valabhji, lecturer,
                3. Mike Schachter, senior lecturer (stephen.robinson{at}ic.ac.uk)
                1. National Institute for Clinical Excellence, London WC2N 5HR
                2. Westerhope Medical Group, Westerhope, Newcastle upon Tyne NE5 2LH
                3. Welsh Institute for Health and Social Care, University of Glamorgan, Pontypridd CF37 1DL
                4. North Cumbria Health Authority, Carlisle CA14 1TS
                5. Boathouse Surgery, Pangbourne, Berkshire RG8 7DP
                6. Walsall Community Health Trust, Walsall WS4 2HT
                7. North Staffordshire Royal Infirmary, Stoke on Trent ST4 7LN
                8. Endocrinology and Metabolic Medicine, Imperial College School of Medicine, St Mary's Hospital, London W2 1NY

                  EDITOR—The National Institute for Clinical Excellence (NICE) has offered guidance on the use of rosiglitazone for type 2 diabetes mellitus.1 In paragraph 1.2 this states that “patients with inadequate blood glucose control on oral monotherapy (metformin or sulphonylurea) should first be offered metformin and sulphonylurea combination therapy, unless there are contraindications or tolerability problems.”

                  The United Kingdom prospective diabetes study investigated aggregate end points for patients treated with metformin and a sulphonylurea.2 In those taking combination treatment compared with those taking sulphonylurea alone, diabetes related deaths were increased with a relative risk of 1.96 (P=0.039) and all cause mortality was increased with a relative risk of 1.60 (P=0.041). Caution was advised in interpreting these data as there were relatively few events, but the differences were significant. Nevertheless, the National Institute for Clinical Excellence has suggested a drug combination which may delay insulin treatment and is used by many clinicians but is not supported by the evidence.

                  The evidence for the use of rosiglitazone is based on its addition to metformin or a sulphonylurea rather than its substitution for metformin or a sulphonylurea. 1 3 Many patients with type 2 diabetes mellitus who have come to combination sulphonylurea and metformin and have suboptimal glycaemic control will be developing β cell failure and could require insulin treatment. The prescription of rosiglitazone at a late stage of type 2 diabetes mellitus means that it will be used for a relatively short period, if at all, before insulin is required. Does the National Institute for Clinical Excellence's guidance suggesting the use of rosiglitazone later than is ideal, unsupported by evidence based medicine, amount to rationing?

                  References

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                  View Abstract