House of Lords - Science and Technology

Select Committee on Science and Technology Minutes of Evidence

Memorandum by the National Allergy Strategy Group

INTRODUCTION

1. Allergy is a national health problem. There are no class, and no material regional, differences in its distribution. The burden of need falls equally across the population, and is substantial. It therefore requires a national effort to secure fair access to appropriate services. This has not been forthcoming and there is substantial unmet need.

2. The NHS is now organized to provide its services through regional and, to a greater extent, local structures—Primary Care Trusts (PCTs) hold 85 per cent of budgets. One major problem, therefore, is how to address a national health issue which has not been addressed previously through a devolved NHS.

3. Allergy presents a problem of high need, low provision and hence a substantial service gap.

4. The consequence is that a very large number of people are being treated without a correct diagnosis or in the wrong way (for example treating symptoms rather than diagnosing the allergy and avoiding the allergic trigger).

3. The DH has conceded the problem. But the Department proposes to rely (even more than previously) on local and regional agencies to provide solutions. Yet, as DH has also conceded, PCTs know more or less nothing about allergy and most have no local expertise to call on and no information on the allergy needs of their population. Specialist allergists are needed to lead change, yet these are few in number and there is no investment in training to provide more of them for the future. How in this situation can the NHS be helped to orchestrate a national response?

5. Allergy presents today a clear and present challenge in this respect. But through time other new diseases will also require a national response from a devolved NHS. In this sense, allergy might be seen as presenting a test of how the NHS in the future could face up to future health challenges. At the very least, some way needs to be found to:

(a) get more doctors (and other health care professionals) with the relevant expert training into service quickly; and

(b) set up pilots or demonstration projects, showing what a model new service could deliver, from which the rest of the service can learn.

Effect of lack of service on research

6. Although this is much needed the UK produces little clinical research in allergy. Lack of NHS service results directly in absence of research capacity. Research requires a specialist service with large cohorts of well studied patients and clinicians with expertise in centres where research is a priority. This in turn requires clinical leadership in both adult and paediatric allergy. The UK has a tiny specialist workforce (there are only 26.5 whole time equivalent consultants in allergy)—for a huge burden of disease (allergy affects 20 million people of whom about seven million require specialist help).

7. For the reasons set out above, many answers to the questions posed in the Terms of Reference are going to be equivocal. NHS staffing/expertise/clinics/data systems/ modes of treatment etc do not, for the most part, recognise allergy. And so, the basics are not there for the NHS to be a resource for knowledge generation about allergy. Information does exist, but in small pockets, where there are specialist allergy centres, and bodies such as the British Society for Allergy and Clinical Immunology (BSACI) have collected and analysed the published data.

Consequences for patients

8. People with allergy (or who think they or their child have allergy) are having to make their own judgments about what to do. This in turn has several consequences:

— unregulated and sometimes dangerous private practice; and

— failure to make an accurate allergy diagnosis.

Both false positives (labelling a problem as allergy when it is not) and false negatives (failure to recognize or even consider allergy) are common—this inaccurate diagnosis results in bad management and ongoing disease. The need for diagnosis is central. Across the NHS, allergy diagnosis is not being made, because staff in primary and secondary care are not trained to do this. Investment in expertise in allergy is required to make this possible.

9. Estimates of the numbers of patients where allergy diagnosis is required and where specialist referral is needed are available (see Nature and Extent of Allergy in the UK, BSACI 2006). The current capacity of all NHS allergy clinics is only about 2 per cent of those needing hospital referral (not allowing for the fact that many of the allergy clinics run by consultants in other specialties, deal with limited areas of allergy and do not have the expertise or facilities, to undertake more complex investigation) (An NHS Plan for Allergy: Making a Start, NASG 2003, information prepared for the Health Minister).

10. The most serious problems occur for people with multiple allergy (allergy expressing itself in several different ways eg eczema, asthma, anaphylaxis etc)—and for severe allergy.

RESPONSES TO SPECIFIC QUESTIONS

What is allergy?

11. Allergy is described in the Royal College of Physicians (RCP) Report "Allergy the unmet need" chapter 1, p 3-6. Allergic diseases are wide ranging and cross the traditional organ based specialties within medicine.

12. It is important also to consider what is allergy practice. What does an allergy clinic deal with? This is not restricted to diseases mediated by allergic antibody (IgE), but depends more on presentations of illness, rather than the mechanism. Allergy services deal with many diseases unrelated to IgE, such as non allergic rhinitis, forms of anaphylaxis, angioedema, tongue swelling, drug "allergy" and food intolerance and have an important role in excluding allergy as a cause of disease.

13. The other aspect is the additional value offered by an allergy service. A particular disease might be appropriately dealt with in other parts of the NHS (eg asthma in primary care or by a respiratory physician where the focus is on drug treatment to control symptoms), but what an allergy service adds is the diagnosis/management of allergy. For the most part this is not taking place in the rest of the NHS. Because allergy commonly has multiple manifestations, the `added value' of an allergy specialist is also in being able to deal with the whole patient in a single service, rather than picking off symptoms one by one and requiring referral to a series of specialists.

What gaps exist in establishing the overall disease burden for all types of allergy and what are the barriers to filling these gaps?

14. An assessment of the burden of allergic disease in the UK was undertaken by BSACI in 2005 for the DH review of Allergy services, 2006 ("Nature and Extent of Allergy in the UK"). This was evidence-based using published data on epidemiology for each disorder where allergy might be involved, and severity, complexity and co-morbidity (several conditions occurring together in an individual).

15. From these data, service implications could be calculated: first, the number which could be treated by self care or in primary care with symptomatic treatment without need for a formal allergy diagnosis and the number where an allergy diagnosis was needed; and second, the number which could be managed in primary care (assuming the conditions required to improve allergy knowledge were met) [13 million people] and the number where referral to an allergy specialist was required [up to seven million].

16. Despite the gaps in information, therefore, a count can be made of the amount of allergy. BSACI data shows that there are >47 million disease episodes or >20 million people who have a disorder where allergy may be involved.

17. Gaps were evident for:

(i) Prevalence of urticaria, angioedema, drug allergy and latex allergy and there was incomplete data for anaphylaxis of any cause.

(ii) It is also not known how many people falsely believe they have allergy and act, or are encouraged to act, as if they do so. Or their doctor takes action without a proper diagnosis. Important areas here are drug and food allergy, with medical and cost implications from incorrect diagnosis. The number wrongly labelled is likely to be in excess of seven million people for food allergy and several million for penicillin allergy alone.

(iii) In a proportion of these, investigation to exclude allergy needs to be undertaken, so that appropriate management can be put in place. No estimate is available.

(iv) There is also insufficient information to suggest estimates of the numbers of people in the country who have an illness with an allergic cause which has been left undiagnosed.

Whilst there is considerable data on aspects of co-morbidity taken from the perspective of a single disorder (especially for rhinitis/asthma/eczema), there was no data in other areas. Documentation of the extent of multiple allergy (the number of diseases in the same patient) is not available.

(vi) There are several newly emerging allergies, and absence of data capture on these, for example, sesame and fruit allergy. There is now data on peanut allergy, the epidemic of the 1990s, but little information on other nut allergies.

(vii) NHS statistics on allergy are lacking.

(a) This is partly due to the failure to "code" allergy work. An allergy code was introduced in 2005 but has only been adopted in the few specialist allergy centres, and even there only applies to day case work.

(b) This is also due to failure to recognise allergy across most of the NHS. And, even when recognised, recording of allergy is not mandatory in GP data systems.

et al

(viii) Effect on Quality of Life. There are data, but most of this is anecdotal although compelling, from the patient organisations, Anaphylaxis Campaign and Allergy UK, who receive thousands of calls to their help lines which reveal effects on quality of life from (i) failure to get medical help and (ii) coping with the disease.

(ix) Effects on cost to NHS from failure of allergy diagnosis hence appropriate management. Estimate of direct/visible costs of NHS care can be made. The effects on patients and on the cost of failure to diagnose are of an order of magnitude greater. Avoidance of the allergic trigger can ameliorate further acute disease episodes, well documented for food or drug allergy (see BSACI paper, Effectiveness of allergy interventions, 2006).

18. The major reason for these gaps in data is the lack of NHS specialist services in allergy, combined with lack of knowledge and awareness of allergy in primary care. Without a service base—particularly given the way Government research priorities are so closely aligned to clinical emphasis—there is no effective research and data base from which to build.

In addition to the impact on the health service, what is the overall socio-economic impact of allergic diseases (for example, absence from work and schools)?

19. The same issues apply as above: one needs a service to make a diagnosis before impact can be measured scientifically. Some data is available for certain disorders eg nut allergy, venom allergy. Nut allergy causes more stress for families than a diagnosis of diabetes (Avery et al 2003). Bee or wasp venom allergy can cause life threatening anaphylaxis, a common symptom of which is a feeling that the patient is going to die. This fear is reduced by allergen immunotherapy (Oude-Elberink et al 2003), a treatment which is highly effective, "switching off" the allergy, yet it is hardly available to UK patients.

However, Allergy UK and Anaphylaxis Campaign, can give extensive qualitative data on this, from their help lines. Allergy leads to huge stress and anxiety, unnecessary illness and loss of time from work or school, and is exacerbated by the failure of the NHS.

Is the level of UK research into allergy and allergic disease adequate?

Basic and clinical research

20. The major problem with allergy research in the UK is that it lacks a clinical or human resource base. Basic research relies on a few talented individuals. Clinical research requires clinic capacity, excellent clinical practice and clinicians whose main focus is on allergy, enabled to investigate well worked up patients in sufficient volume for expertise in patient management to be built up.

21. Basic research. There is excellent basic research into allergy in UK, where we are world leaders, but this is limited to a few centres, and dependent on a small number of senior academic staff. Its continuation is not guaranteed and the situation is fragile. The loss or retirement of one or two research leaders will greatly diminish our research base.

22. Clinical research. There is a serious lack of clinical research—even fewer centres, than academic centres in allergy related research—and need for substantial expansion here.

23. Examples follow: At what might appear to be a very basic level, information on the value and interpretation of diagnostic tests is needed. Most doctors do not know how to interpret these tests; thinking, incorrectly, that a positive equals an allergy diagnosis. Clinical research is necessary to throw light on this eg in nut allergy, a "grey area" has been identified in the so called "positive" range, where 50 per cent of patients are allergic but 50 per cent are tolerant (Clark & Ewan 2003). Another development is to identify the level in a test result above which nearly all patients will have allergy (Sporik et al 2000; Hill et al 2000). There are other examples eg studies on how best to manage nut allergy with evidence on efficacy (Ewan & Clark 2001; Ewan & Clark 2005). Such evidence can then be rolled out into clinical practice across the NHS.

24. This type of work requires specialist clinics with well studied patients, and clinicians with research facilities. In the UK there are only six such clinical services. The two substantially largest clinics see about 5,000 allergy patients each per year.

25. The role of allergy in asthma deaths. Deaths provide a clear end point. Unfortunately, the recording of asthma and allergy deaths has become compounded and asthma tends to be recorded to the exclusion of allergy (usually because of misdiagnosis) (Pumphrey 2004). Allergic asthma appears to be an important cause of sudden death, yet there has been virtually no study of this. New data is beginning to emerge from the Eastern Region confidential enquiry into asthma deaths—the first such enquiry with any allergy input—but there has been great difficulty obtaining funding for such work. This has important implications—for most of these deaths were in patients on standard asthma medication (ie apparently appropriate management), but the mistake was that allergy had not been considered.

26. Clinical guidelines are much needed. The lack of specialist clinical leadership in allergy in the UK (and very little NHS funding for allergy) makes clinical allergy research—and its translation to guidelines for practice etc—vestigial. It is not commensurate with the size of the problem and burden to the NHS. 20 million people have allergy at some time and about seven million need a specialist service (ie could not be expertly and safely diagnosed and managed in primary care). The direct cost for managing allergic problems has been estimated at £1 billion pa (Gupta et al 2004) but the reality is that much of the cost is invisible and incalculable because patients are undiagnosed. More capacity is needed. The essential first step is to increase the number of consultant allergists: there are only 26.5 wte consultants in the UK; and the limiting factor to expansion is the very small number of trainee places—only eight for the UK (not enough even to replace expected retirements—DH workforce data). This is a vital step, identified in previous allergy enquiries.

27. As research priorities are so closely linked to national clinical priorities, it is not easy to obtain research funding for a discipline with no priority. There is therefore a "double whammy".

How effective have existing Government policy and advice been in addressing the rise in allergies?

28. On Policy For Service Development In Allergy Healthcare

(i) The problem allergy presents to government is how to make a start to address a national problem with a devolved health service.

(ii) The Royal College of Physicians gave unequivocal advice on how to do this three years ago: the first step is to get more specialists in allergy into the system. This would begin to create critical mass and improve the geographic distribution of allergy expertise. From these centres, support for other providers of allergy care and enhancement of services across primary and secondary care would flow. Normal processes could then take over.

(iii) The House of Commons Select Health Committee (2004) endorsed the RCP Report and said that there should be an increase of 20 adult and 20 paediatric allergy training posts for doctors, and a commitment to create consultant posts for them to move into.

(iv) The DH has implicitly rejected these recommendations as too centralist (2006).

(v) The DH recognise the need to increase the specialist workforce in allergy but say this is a problem for Strategic Health Authorities and Deaneries to deal with. However the DH advice carries no requirement for action.

(vi) The DH propose to leave the rest of service development to PCT commissioners. But it is known that PCTs lack the input and conditions to do this.

(vii) Policy is needed to enable some action and move forward from this position. One way PCTs might be helped is by example, from a pilot scheme. What are needed are model services, which are working on the ground. These might be studied, used to train more specialists to seed out to new centres, work with primary care and inform on the most efficient way of developing services. DH might be asked to consider a national challenge fund for locally programmed developments, from which others can learn within the devolved NHS. This could provide an engine for major service development outside central priorities.

29. On specific policies—Government advice to tackle rise in allergies: little advice has been forthcoming. But there is a lack of evidence on what to do. For example, the DH advice on prevention of nut allergy (1998) was not evidence based, because of lack of evidence.

What can be done to better educate the public and to improve the quality of information that is available to patients and undiagnosed sufferers?

30. The first problem is inability to get an allergy diagnosis. This is widespread because of serious deficiencies in primary and secondary care allergy services. Education resources will have most impact once the correct diagnosis is made.

31. Some of the advice available direct to patients is of poor quality and highly misleading. Support for the work of the patient support groups, Anaphylaxis Campaign and Allergy UK, is required.

Are current regulatory arrangements, for example, those governing private clinics offering diagnostic and therapeutic services and the sale of over the counter allergy tests, satisfactory?

32. Unorthodox and unsubstantiated practices including methods of diagnosis abound in the private sector (tests of no value are described in the RCP Report p 76-77). This is in part driven by absence of NHS allergy services. Many patients get the wrong diagnosis. This sometimes leads to medical harm; or financial problems for the patient; and wastes NHS funding—unproven private treatment is being paid for by some PCTs.

33. Even the established tests (specific IgE antibody)—without interpretation—can be misleading. Thus sales of these direct to the public eg supermarket, high street or through the media are harmful. Patients are diagnosed allergic when they are not and inappropriate management follows. Furthermore, there is a lack of quality control and tests in these laboratories can be positive when the same test in a CPA accredited laboratory is negative.

DOCUMENTS AND REFERENCES [NOT PRINTED]

PAPERS [NOT PRINTED]

October 2006