Select Committee on Health Written Evidence


Evidence Submitted by Dr Imogen Evans, Mrs Hazel Thornton and Sir Iain Chalmers (NICE 21)

  We welcome the opportunity to submit comments to the Committee's Inquiry into NICE. [169]Our expertise encompasses medical journalism/ethics (IE), independent patient advocacy (HT), and research and research evidence appraisal (IC). In 2006 we wrote a book for the general public—Testing Treatments: better research for better healthcare—in which we emphasised the need for unbiased research to assess the effects of treatments, and we highlighted the key role of NICE (Evans et al. 2006). We therefore hope that this submission will be helpful to the Committee. In particular, we wish to address the following interlinked issues: NICE's evaluation process; public confidence in NICE; and recent challenges to NICE decisions.

NICE'S EVALUATION PROCESS

  1.  The cost of healthcare weighs heavily on all national economies, and the need to set priorities is inescapable. NICE was established to provide independent guidance on the clinical and cost-effectiveness of health technologies for use in the NHS, partly because the drug licensing system is unable to provide this information. The NICE approach to evaluation has been commended by an external review conducted by the World Health Organisation, has found favour among other European countries, and has even aroused serious interest in the USA.

  2.  In its investigation of NICE in 2002, the Health Committee stressed the importance of transparency as a precondition for credibility of the Institute's appraisals and guidance. Paragraph 40 of the Committee's report read as follows:

    " . . . much of the information on which NICE appraisals are based is unpublished, as it is supplied to NICE by manufacturers in confidence.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." 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 If industry or others have previously unpublished data which they want to use to support their case then this should no longer be presented to NICE subject to confidentiality."

  3.  The Health Committee reiterated the need for greater transparency two years later in the recommendations in its report on the Influence of the Pharmaceutical Industry. Despite this, NICE's transparency was further eroded last year when the Institute switched from independent assessments of scientific evidence to sponsor-produced evaluations of effectiveness and cost-effectiveness. We urge the Committee to continue to press for greater transparency, which we continue to believe is a precondition for public confidence in NICE.

PUBLIC CONFIDENCE IN NICE

  4.  From the outset, the rationale for NICE has been undersold to the public, and NICE's decisions have been undermined by political interference. A passage we wrote in Testing Treatments illustrates the immense difficulties that NICE faces:

    "Because the annual cost of treating each [multiple sclerosis, relapsing and remitting type] patient with an interferon was over £10,000, NICE . . . concluded that using these drugs . . . would not be a responsible use of limited resources. Many patients with this debilitating disease, and especially the organisations lobbying on their behalf, were outraged. They were angry that the NHS could deny patients drugs that appeared to hold out some hope. Yet did they fully realise the extent to which the available evidence was far from convincing? It was based on partial release of the relevant research results, outcome measures of dubious relevance, and follow-up over only two or three years in a disease that usually lasts at least two decades. The government caved in under pressure. ... But this effectively ended the possibility of learning whether [interferons] are helpful to patients."

  5.  It is highly unlikely that the scheme agreed between the Medicines Division at the Department of Health and the companies making interferons to make interferons available to patients will yield reliable information about the impact of these very expensive drugs on important issues such as whether they delay dependence on mobility aids, or the moment when people with multiple sclerosis become bed bound. Provision of interferons in this way means that unbiased assessment of their effectiveness becomes virtually impossible. Moreover, for ostensibly inexplicable reasons, the contract for analysing the data has been moved from the University of Sheffield to Parexel (the contract research organisation associated with the TGN1412 disaster); this does little to promote confidence in the government's reasons for overruling NICE's guidance.

  6.  Uncertainties about the value of the interferons in multiple sclerosis have been handled in a much more responsible way in Italy. The Italians have begun a randomised comparison of interferon with azathioprine, a dramatically cheaper drug, which existing evidence suggests may be just as effective as interferon beta (Sudlow and Counsell 2003). It is worth noting that the costs of the Italian trial are being met from a fund of 35 million Euros derived from a 5% tax on the marketing budgets of pharmaceutical companies to support independent drug research (Chalmers In Press).

  7.  Many vested interests contribute to the public's belief that expensive new treatments are better than existing, less expensive treatments. The truth is that new treatments (assessed in randomised trials) are as likely to be inferior as they are to be superior to existing, standard treatments (Kumar et al. 2005).

  8.  Although selling the rationale for and principles of NICE to the public was never going to be easy, this essential public relations challenge appears to have been entirely overlooked by the government when NICE was set up. It is sorely needed now, not least to explain why the criteria for licensing a drug are far less stringent than the criteria for establishing the clinical and cost-effectiveness of the self-same compound.

RECENT CHALLENGES TO NICE DECISIONS

  9.  Pressures from the pharmaceutical industry, and from patient lobby groups often funded by industry challenge a National Health Service such as ours, which is based on the principle of shared risk and equitable distribution of limited resources. Because of the lack of public appreciation and ministerial support for NICE's decisions, it is unsurprising that the Institute's decisions have been contested, and that the public has come to see it as a spiteful rationing organisation. Almost all the media coverage of NICE is negative, and this impression is made even worse when, as with interferons for multiple sclerosis and more recently herceptin for early stage breast cancer, ministers leap in and overturn or pre-empt NICE's recommendations. Most recently, NICE's guidelines on the use of anti-cholinergic drugs for people with dementia have been challenged by a manufacturer of these drugs, and the Institute is currently the subject of a judicial review.

  10.  The current situation with anti-cholinergic drugs for dementia would probably have been avoided had the Institute been making greater use of its option to recommend that a treatment be used only within the context of evaluative research. When there is uncertainty about the effects of a treatment, this is the proper way forward—as an ethicist once commented, in these circumstances "the trial is the treatment". Yet again, the importance of public backing is crucial. And this will only come about when the public is engaged widely in the clinical research process, and when there is general appreciation that patient participation in research is a risk-limiting strategy and not a risky endeavour.

  11.  NICE has used this `only-in-research` approach in only 15 out of its 400 appraisals between 1999 and 2006. When used, however, it has made an important contribution to generating the additional evidence needed, and has led to supportive recommendations when the original guidance was reviewed. The benefit of the "only-in-research" approach is faster accumulation of evidence to inform practice and make shared decisions. It also exposes to the public the need to reduce uncertainties concerning interventions in common use, as well as uncertainties about the effects of new treatments. Importantly, the "only-in-research" approach can reduce the risk of having to reverse previous decisions, as has happened with the anti-cholinergic drugs for dementia.

  12.  We suggest that promoting public partnership in the "only-in-research" approach should become a key role for NICE's Citizens' Council, and that the expertise of Council members be used to promote NICE more widely.

CONCLUSION

  13.  As a 2006 Guardian leader commented, NICE embodies "the least bad way of tackling an impossible job". The Institute should be strengthened, freed from ministerial whims, encouraged to engage more with the general public, and allowed to do its work for the benefit of all who seek treatment in the NHS.

Imogen Evans, Hazel Thornton and Iain Chalmers

March 2007

REFERENCES

  Chalmers I (in press). When does clinical science cease to exist? Science in Parliament.

  Evans I, Thornton H, Chalmers I. Testing treatments: better research for better healthcare. London: British Library, 2006.

  Kumar A, Soares H, Wells R, Clarke M, Hozo I, Bleyer A, Reaman G, Chalmers I, Djulbegovic B (2005). What is the probability that a new treatment for cancer in children will be superior to an established treatment? BMJ 331:1295-8.

  Sudlow C, Counsell C (2003). Problems with UK government's risk sharing scheme for assessing drugs for multiple sclerosis. BMJ 326:388-92.



IC has been a member of NICE's Research and Development Advisory Committee since its inception; addressed NICE's Citizens Council on 26 January 2007 on `Uncertainty and the `Only in Research` Option`; and has contributed a witness statement in connection with the judicial review of NICE's guidance on the use of anti-cholinergic drugs for people with dementia.

HT was invited to attend a meeting of the NICE Citizens Council 26 January 2007 as a Question Time Panel Member on day 2 of their deliberations on "Uncertainty and the `Only in Research' Option".



169   From Dr Imogen Evans (IE), Mrs Hazel Thornton (HT) and Sir Iain Chalmers (IC), co-authors Testing Treatments: better research for better healthcare, British Library 2006. Back


 
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