Select Committee on Science and Technology Minutes of Evidence

Memorandum by the Immunology SAC, Royal College of Pathologists

  Immunologists and allergists provide specialist clinical allergy services in the UK, and are the only medical specialties with extensive training in the immunological basis of allergy and the clinical care of patients with allergic disorders affecting all organ systems. Allergists devote all their professional time to the management of Allergy, immunologists often have other responsibilities and varied job plans, but most devote substantial parts of their professional time to the provision of allergy services.

  The remit of the House of Lords Sub-Committee is very wide-ranging and will require a thorough review of a vast amount of evidence. The published evidence on conventional practice, and that on complementary therapies will need to be subjected to proper scrutiny for quality, lack of methodological flaws, exclusion of placebo effect and reproducibility before being used as evidence for public policy decision-making.


1.1  What is allergy? What is the difference between allergy and intolerance?

  1.1.1  Allergy—Immunological disease mediated by the Immune system—it has a limited number of stereotypic manifestations which are dictated by the immunological mechanisms underlying Mast cell activation. It has a genetic basis, but the expression of disease is influenced by the environment and reproducible allergen-triggered, IgE antibody-mediated disease mechanisms can be identified and give rise to clinically disease.

  1.1.2  Intolerance is a catch-all term for any adverse effect experienced by an individual which is often mistakenly attributed to allergy but for which there is no reputable evidence to suggest that it is an immunological adverse reaction to foods or medicines. Some "intolerances" such as food-induced migraine are probably pharmacological actions of the food. Intolerance is therefore a state of sensitivity to a specific environmental component which manifests within an individual, objectively or subjectively, as a reproducible unpleasant reaction upon exposure to that component.

  1.1.3  Detailed nomenclature can be found at

  1.1.4  Much information including practice parameters/position statements and expert evidence-based guidelines on the management of allergic disease can be found at the websites of allergy/Immunology professional societies such as;;

1.2  Why is the incidence of allergy and allergic diseases rising? Why does the UK in particular have such high prevalence of allergy?

  1.2.1  The incidence of many forms of allergy is clearly rising and the rise does not appear to be related to better reporting and diagnosis, but the reasons are poorly understood. Epidemiological meta-analysis of the existing data has already been published as an appendix to the DH (Department of Health) report into the provision of allergy services, but caution is needed in comparison of results in different countries. The lack of systematic meta-analysis is hampered by the variable quality of the data and expert large scale epidemiological studies are required—the UK is uniquely well-placed to deliver these studies through the NHS and associated research but the lack of investment in the future training of specialists practicing allergy and immunology and the difficulties pursuing an academic medical career (likely to result from a potential reduction in overall funding associated with the Culyer report) are likely to impair this important work.

  1.2.2  It is not known why the UK or anywhere else has a rising incidence of allergic disease—although there are many hypotheses all of which remain unproven. Despite their plausibility, the link is still speculative for most. The DH review highlighted the gaps in evidence at present.

1.3  What is and what is not known about the origins and progression of allergic disease?

  1.3.1  There is much work still to be done on the genetic and environmental predisposition to the development of allergic disease, and strategies to prevent its development or modify its expression in individuals. In the absence of a national strategy, the failure to support and develop academic and NHS research into allergic disease may seriously impair future understanding of the issues in the UK. There is exciting and preliminary work suggesting that the "Allergic March" in children can be prevented by early immunotherapeutic intervention.

  1.3.2  What is known:

    —  Genetic influences (some of).

    —  Environmental influences (some of).

    —  Immuno(dys)regulatory mechanisms (some of).

    —  Intrauterine and postpartum influences (some).

    —  The existence of the "allergy march".

    —  Age influences on disease presentation.

  1.3.3  What is not known: [Sic]

    —  Why predominance of different clinical presentations at different ages?

    —  Why does some atopy manifest as clinical disease and some remain latent?

    —  What factors determine mild vs. moderate vs. severe allergy.

    —  How to predict the severity of the next reaction in an individual in order to tailor individual treatment plans and risk-assessments.

    —  How to prevent allergy developing or modify its severity.

    —  There are many putative factors with varying levels of supporting evidence.

    —  Genetics.

    —  Hygiene hypothesis (much conflicting evidence).

    —  Pollution (personal and environmental).

    —  Lifestyle effects (homes, pets, diet etc).

    —  Climate—effects on home environment—eg for House dust mite.

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

  1.4.1  Evidence has delineated a substantial and underestimated disease burden in the UK. Further work is needed to develop robust evidence base with validated measures, this is unlikely to occur if the specialities of Allergy and Immunology are not developed as part of a national strategy to improve NHS service and research provision, as well as providing the infrastructure for the proper gathering of such information.

  1.4.2  There are likely to be significant gaps in robust mechanisms for workload recording/capacity in primary care and secondary/tertiary care. These will be essential for teasing out allergy workloads from workload recording of related/overlap diseases—especially in Immunology centres as opposed to pure Allergy centres. Improved coding necessary to collect this information in a sophisticated and standardised way is essential, as current ICD 10 and Payment by results codes are currently insufficiently detailed. It is hoped that NHS data collection will gradually be improved by these drivers.

  1.4.3  There are many barriers which need to be overcome—recognition at local/commissioning level that allergy is a significant problem for the NHS, improved allocation/prioritisation of resource for allergy research, and successful establishment of the relevant NHS IT infrastructure to support improved data collection which is currently underway.

1.5  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)?

  1.5.1  The assessment of disease burden or socio-economic impact with any reliability is also very difficult, and difficulties in validation of presumed measures of economic impact. It is clear however from the evidence presented to the DH Review, and evidence from patients, patient support organisations, allergists, immunologists, GPs, nurses and other medical specialties, that allergy in all its forms has considerable impact on the lives of patients, disrupting schooling, work, and general quality of life, as well as the risk of death and other morbidity from more serious forms of allergy and asthma.


2.1  What is the effect of current treatments on the natural history of allergic disease?

  2.1.1  There is much published evidence for the effectiveness of interventions by allergists/immunologists (see AAAAI "Consultation and referral guidelines citing the evidence: How the allergist-immunologist can help"—on particularly for allergen avoidance strategies, immunotherapy and treatment of asthma, hay fever and specific food allergies. A review of meta-analysis of effectiveness of treatments has been published as an appendix to the DH report. This highlighted the need for more research and gaps in the evidence. This will require the support and development of national centres of expertise, a network of regional centres of excellence in NHS service provision (primarily through allergists and immunologists and multidisciplinary team working) and improved service provision and data collection in primary care. Much of NHS treatment in all specialties is of necessity based on expert opinion and experience in the absence of randomised double-blind controlled trials in many areas. While we all strive to correct this, and NICE may be given the task of reviewing evidence to identify interventions for which there is evidence of ineffectiveness (in a limited number of interventions, not involving allergy to date). The select committee must remember that lack of evidence of effectiveness is not evidence of lack of effectiveness. The two are often conflated in policy decision-making, often erroneously.

  2.1.2  Pharmacotherapeutic options currently available are unlikely to have significant effects on natural history of disease other than primarily managing symptoms. The same may well be true for allergen avoidance/environmental modification measures.

2.2  The data on complementary interventions

  2.2.1  Research into complementary interventions is inadequate and this is a highly contentious issue. While acknowledging that the evidence base for many conventional treatments is sub-optimal, this should not influence the critical scientific evaluation of the quality of evidence for complementary interventions, which is often regarded as poor by most scientific standards.

  2.2.2  To our knowledge there is only one chair of Complementary Medicine in the UK (at the Peninsular Medical School in Plymouth (

  2.2.3  "Vega" testing has recently been examined as complementary diagnostic technique without demonstrating efficacy (Lewith et al BMJ 2001;322:131-134 ). Interventional studies are often flawed and difficult to interpret due to methodological biases.

  2.2.4  If necessary the committee should consider clearly argued critiques of the evidence for the more esoteric complementary therapies from a "conventional" medical/scientific standpoint, as well as the counter arguments of the proponents of esoteric therapies to gain an insight into the controversial nature of these debates.

  2.2.5  The committee should familiarize themselves with the position statements on complementary therapies of the RCP (Royal College of Physicians), AAAAI, BSACI (including that submitted to the DH review) and other allergy and immunology organisations for the expert consensus view of the evidence for some complementary therapies.

  2.2.6  Most conventional medical practitioners and professional societies have reservations about the quality of evidence for many complimentary investigations and acknowledge the difficulty in producing interventional studies of sufficient power which are not subject to error and biases or the placebo effect (even if the placebo effect is a very important tool in making patients feel better and an important part of patient care, even in conventional medicine).

  2.2.7  There is some recently published data of doubtful validity to suggest that IgG antibodies may predict food intolerances but this is controversial and is not confirmed by other studies. Interventional studies using dietary avoidance may have methodological errors that may lead to biases which make them unreliable.

2.3  Evidence base for Pharmacological and non-pharmacological Management Strategies

  2.3.1  To a certain extent the evidence base has been examined in the appendices to the DH review. This is far too large an area to review in this submission but we would direct the select committee to the evidence submitted to the DH enquiry by the BSACI and others, and to the websites above, for expert consensus opinion.

  2.3.2  The evidence base for most standard pharmacotherapeutic options—corticosteroids, H1blockers etc. have a significant body of evidence underpinning their beneficial use in allergy.

  2.3.3  Adrenaline in anaphylaxis—Expert opinion and extrapolation from retrospective observations, including the UK Rescusitation Council Guidelines agree about the likely benefits, but objective evidence is lacking because of the obvious difficulties which preclude the studying of its efficacy in randomised controlled trials. It would be unethical not to administer adrenaline to a patient with anaphylaxis. There is also the distinction between the end-points of efficacy for prevention of fatalities and efficacy in rapidly terminating an episode and reducing morbidity which must be considered. This is a good example of lack of evidence of efficacy not being equated with evidence of lack of efficacy.

  2.3.4  Anti-IgE—There is evidence of efficacy in severe asthma, and in increasing the dose tolerance of patients with food allergy, and it may have a role in other allergic disorders. Its place in routine practice in the UK is, as yet, unclear although there is much potential in other areas of allergy practice.

  2.3.5  Non-pharmacological: Allergen avoidance: Once again there are difficulties in interpreting the existing evidence. Intuitively this is a "common sense" measure which ought to be highly effective, and there is data to demonstrate this in some food allergies such as peanut sensitivity. Objective evidence of efficacy in most sorts of aeroallergen allergy eg House Dust Mite Sensitivity is difficult to obtain, most likely due to a lack of comparability between different studies because of methods and patient selection.

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

  2.4.1  Clearly not, even though much excellent research is done by a small cadre of specialists—see appendices to DH Review July 2006 and comments above. More importantly, there is reason to believe that the future of such clinically-based applied/translational research is precarious in view of the small number of specialists and lack of training opportunities.

  2.4.2  Both specialties lack manpower and have insufficient training posts, leading to current and future difficulty with recruitment and retention of clinical and academic specialists. A strategy is required to facilitate effective NHS research into the cost-effectiveness of different methods of service delivery and advance the treatment and understanding of allergic disease in general. These two aspects (service provision and research strategy) cannot be easily divorced in a highly specialised clinical service area with a small workforce.

  2.4.3  Answers to UK specific problems will not be forthcoming without support for the retention and development of a cadre of specialist allergists/immunologists, and results from other countries may not always be relevant to a UK population.

2.5  What are the most promising areas of research into preventing or treating allergy?

  2.5.1  There are many promising interventions including:

    —  Conventional allergen desensitization.

    —  New forms of immunotherapy with T cell modulating allergens, modified allergens and use of anti-IgE antibody therapy outside of asthma.

    —  Different routes of administration such as sublingual immunotherapy.

    —  Use of conventional allergen immunotherapy in children to prevent the development of asthma is promising.

    —  Bradykinin- and tryptase-inhibiting drugs and other potentially useful interventions are in development.

    —  Many of these experimental interventions have been championed by UK researchers and clinicians and the continuation of this in the future is in jeopardy without a coherent strategy to secure specialised services and consequent clinical applied research and development.

  2.5.2  There is also a need for research into:

    —  Service delivery/deficiencies/needs/gaps issues.

    —  Efficacy of models of patient/profession education.

    —  The natural history of food allergy is poorly understood although we have some preliminary understanding. We suspect that some people with nut allergy outgrow their sensitivity with time but cannot predict who will do so. We also do not know if these people have a risk of re-sensitisation. There are more questions than answers at the present time.


3.1  How is current knowledge about the causes and management of allergic disease shared within Government?

  3.1.1  We are not aware of effective sharing of knowledge or appropriate input into government policy in these areas other than the DH review and select committee report, although professional societies, patient support groups and Royal Colleges all responded to consultations and reviews when asked. This is a situation that has been of concern to the Royal College of Pathologists for some time in many areas of governmental activity, and it is clear that decision-making will be much improved with effective stakeholder and expert input. A mechanism is needed to facilitate this. There exists a body of experts in the Royal Colleges, willing and able to assist in the formulation of government policy yet often there appears to be no mechanism for ensuring that this resource is effectively and routinely tapped. The Royal College of Pathologists keen to act as a resource for identifying individuals with the appropriate expertise in any given area.

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

  3.2.1  The committee is not aware of any evidence of such action or evidence of its effectiveness. Part of the problem lies in a lack of suitable evidence in relevant areas, for example into allergen avoidance strategies for infants to potentially reduce the incidence of food sensitisation.

  3.2.2  We feel that government policy to date has not been effective in addressing the needs of patients with allergy. The DH concluded that there was a considerable burden of allergic disease, that more specialists were required, and that provision of services was inadequate and geographically unequal and needed to be addressed, perhaps by networking. The report of the DH Select Committee did highlight the need for a network of allergy services throughout the UK, the need for additional training positions and the need for expert review of the effectiveness of interventions perhaps through NICE. Unfortunately to date there is no obvious mechanism or driver to achieve this.

  3.2.3  One key problem in allergy is how to engage local health commissioners to prioritise the establishment of adequate local allergy services in the face of all the other centrally driven demands on their budgets, such as the Quality and Outcomes frameworks for General Practice and Cancer and Heart Diseases National service frameworks, NICE guidance and other drivers. Care and education of patients with allergic disease and continued NHS research and development of new treatments and interventions is unlikely to improve significantly in the absence of such a driver.

3.3  Do housing policy and regulations governing the indoor environment pay enough attention to allergy?

  3.3.1  We are not aware of evidence that housing policy can impact on allergy development or treatment unless it is proven that a patient is sensitive to a controllable environmental allergen such as mould spores or dust-mite. This may be of more relevance to work environments where we believe that protection against the development of occupational allergy is often covered by Health and Safety legislation.

3.4  How effectively are food policy and food labelling regulations responding to the rise in food allergies?

  3.4.1  Food labelling is very important—some clear steps have been taken to make labelling mandatory including FSA documents but much more action needed (see The FSA 2002 report "Adverse reactions to food and food ingredients" has already examined some of the issues on this topic). One major difficulty is knowing what the minimum threshold for labelling should be, and how to risk-assess this—a few individuals could potentially be sensitive to trace amounts of rare allergens, others may not. This is a difficult issue requiring much careful thought. The role or risks/benefits of genetically modified foods is essentially unknown.

  3.4.2  While food allergy must be taken seriously, some express concerns that an inappropriately low threshold for use of hazard warnings may be problematic. This problem impacts on patients who regularly report difficulties with selecting allergen-free foods and complicates the interpretation of supermarket labelling—where foods which are apparently very unlikely to contain an allergen are labelled as a risk, but the assessment of the level of risk is unclear. Some evidence based consistency and guidance is required.


4.1  What impact do allergies have on the quality of life of those experiencing allergic disease and their families?

  4.1.1  There is much supporting evidence demonstrating that quality of life is impaired by every type of allergy from rhinitis to food-related anaphylaxis, and that allergy impacts adversely on many aspects of daily living. This may be addressed by better services support and advice in primary care, probably best supported by specialist hospital centres with extensive and up-to-date expertise. Much of this work is provided by patients support agencies and charities in the absence of easy access to expert consultations with allergist or immunologists.

  4.1.2  There is preliminary evidence that management by an expert team is of benefit and improves patient outcomes but more work is required.

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

  4.2.1  A lot could be done to improve availability of information and advice from professional as well as informed lay organisations, but much allergy advice requires to be individualized and the construction of appropriate local information is dependent on local medical expertise in allergy which is scarce.

  4.2.2  Allergy and immunology centres provide extensive patient support. This includes information, training in the use of rescue medication and expert assessment of the patients' individual needs. A recent publication in the BMJ suggested that EpipensTM were oversubscribed such that the putative cost of each putative life saved was 20 million pounds, however this point of view is flawed because it ignores the benefits of proper treatment plan in managing anxiety, preventing morbidity and reducing symptoms. Expert risk-assessment and research into improved prognostic markers by expert units is required in order to minimise this cost to the NHS and ensure that rescue medications and therapy are administered in a cost-effective and clinically appropriate manner. It is unlikely that we can rely on non-expert assessment in primary care without clear national evidence-based guidelines which will need to be supported through a local expert allergist/immunologist.

  4.2.3  Nationally, a lead needs to be taken by allergist/immunologists, to create national service standards, create a workable network of NHS allergy services with clear referral patterns and community outreach—including support for education and training in primary care.

  4.2.4  Web-based guidance and information—often including that of some patient support groups—is not quality-assured and often mix complementary approaches and conventional advice, which can lead to confusion.

4.3  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?

  4.3.1  Regulation of non-NHS clinics and over-the-counter treatments for allergy is not adequate—extensive evidence that it leads to direct harm to individuals is lacking, but there is clearly a legitimate concern that ineffective or misleading advice may be harmful, costly and may divert patients from effective evidence-based interventions. High street stores or private centers may offer complementary diagnostic testing with unproven techniques.

  4.3.2  POCT (point-of-care-testing or near-patient testing) is a major potential problem even with conventional evidence-based assays when offered in a context of inadequate quality assurance procedures, and by staff who do not have the clinical training or expertise to properly interpret their significance. A specific IgE test which is offered without evidence-based expert assessment of the pre-test probability of allergic disease is worthless and potentially misleading. This is potentially as great a problem as that of the use of un-validated complementary tests of doubtful value. A positive test is not the same as the presence of a clinically important allergy or vice versa. We do not feel that a policy of "caveat emptor" is appropriate in health policy where there is an effective evidence-based conventional intervention, or where it may lead to harm, and feel that a proper regulatory framework is required.

  4.3.3  Hospital laboratories offering diagnostic allergy tests are required to submit to a regime of inspection against quality standards in order to be able to offer NHS diagnostic services. The same must apply to other providers and the government should assemble an equivalent policy on the basis of an expert review of the evidence.

9 October 2006

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