Select Committee on Science and Technology Sixth Report


Members visiting Germany were: Baroness Finlay of Llandaff (Chairman), Baroness Perry of Southwark, Lord Rea. In attendance: Miss Sarah Jones (Clerk), Professor A. B. Kay (Specialist Adviser), Dr Cathleen Schulte (Committee Specialist).

Wednesday 24 January

Allergie Centrum, Charité, Berlin

The Charité university hospital was split between three different sites across former East and West Berlin. Allergy patients were treated in the Allergie Centrum which had two different parts: adults were largely treated in the Department of Dermatology and Allergy, whereas children were treated in the Department of Paediatric Pneumology and Immunology. The Committee visited both of these sites.

Department of Dermatology and Allergy, Universitätsmedizin Berlin

Presentation by Professor Torsten Zuberbier, Head of the Department

The Committee was welcomed by Professor Zuberbier who outlined the way in which allergy was treated. Allergology training in Germany was offered as a sub-specialty. Approximately 70 per cent of the allergologists were dermatologists, but the sub-specialty was also practiced by ENT physicians, pneumologists and immunologists. The Department of Dermatology and Allergy treated adults with allergic diseases and employed two doctors trained in internal medicine who could treat patients with multi-organ symptoms. However, the treatment of some allergies required the expertise of other specialists, so patients with severe asthma were referred to the pneumology department and patients with suspected food allergies were referred to the gastroenterology department. Professor Zuberbier did not think there was any need for allergology to be a separate specialty, but felt that it was more important to encourage communication between specialists.

As in the United Kingdom, it was felt that GPs in Germany were not adequately trained to correctly diagnose or treat allergic conditions. But unlike the English system, German patients could usually refer themselves to specialists directly; a cost-effective strategy which did not waste GP appointment time. However, as a university hospital, the Charité dealt with the most complex cases of allergy and only received patients referred by specialists.

Professor Zuberbier noted that allergic diseases were on the increase in Western Europe and often severely impaired patients' quality of life. However, only a small percentage of people who felt they suffered from an allergy truly did, and a paradox existed whereby every medical practitioner knew the term "allergy" but only around 10 per cent of patients were treated correctly. Allergic conditions also had an impact on the economy. The treatment of many allergic diseases was relatively cheap but, if left untreated, the social and economic costs of days lost at work or school could be far greater.

As Head of the European Centre for Allergy Research Foundation, Professor Zuberbier explained how the Foundation aimed to improve the knowledge, research and awareness of allergies throughout Europe, and thereby reduce their burden. The Foundation provided training programmes for physicians, educated patients and established an international platform for research. It also granted "quality seals" to products and services which took the needs of allergy sufferers into account, and thus enabled consumers to choose between products easily. The seal had been granted to products such as cosmetics, cleaning agents and foodstuffs, and also to services such as restaurants and hotels. "Allergy friendly" hotels which had been granted the seal of approval had pet-free levels within the building, clear food warnings on menus, and "allergy free" rooms with wooden floors, dust mite protective bed covers and other features aimed to reduce allergen levels.

Professor Zuberbier also described several other international organisations. The GA2LEN co-ordinated research programmes and produced standardised procedures for allergy diagnosis and treatment. It consisted of 27 clinical and experimental research institutes and two patient organisations (the EAACI and the European Federation of Allergy). The EAACI consisted of 39 national societies, as well as academic researchers and clinicians. Its work included the promotion of basic and clinical research, the provision of training and promotion of good patient care. The European Federation of Allergy was a network of patient organisations which focussed specifically on the needs of allergy patients and their carers.

Tour of the Department

Approximately 100,000 outpatients were seen in the Department each year, of which around 16,000 were allergy cases. The clinic also had the capacity to treat 54 inpatients at any one time, which was important because it was often necessary to observe patients for an extended period of time after treatment. For example, some patients suffered a reaction over four hours after a skin provocation test, so the Department usually kept these patients overnight. As a university hospital, the teaching, clinical and research facilities were all in close proximity which had many benefits. For example, biopsies could be transferred quickly to the laboratory for analysis, and the training young doctors received could be informed by the latest clinical developments.

Obtaining a correct diagnosis was vital, and in many patients it was important to rule out allergy as a possible cause of symptoms. As an example, the Committee observed a consultation with a man who suspected he was allergic to local anaesthetic. He had once suffered pain after receiving local anaesthetic and a patch test several years ago had shown that he was allergic, so therefore his dentist would not treat him using local anaesthetic. Although it was thought very unlikely that this man was allergic to local anaesthetic, patch tests and lung function tests were prescribed in order to rule out the possibility. If these proved to be negative it would then reassure the dentist and allow the patient to live a more normal life.

Presentation by Mr Federico Grego, Director of Laboratorios Leti

Mr Grego explained that allergy training was offered as a monospecialty in Spain; doctors had to undergo four years of specialised training to qualify as allergists, of which there were approximately 1,300 within the state medical system and private clinics. GPs referred serious or "difficult to treat" allergy patients to these specialists. Although allergists in Spain prescribed immunotherapy widely, only around 10 per cent of the allergic population received the treatment because other physicians did not offer it. Mr Grego estimated that around 25 per cent of the immunotherapy treatments offered were sublingual, and expected this figure to increase in the future, although subcutaneous immunotherapy remained the preferred treatment option for the majority of allergists. He conceded that immunotherapy was expensive: a course in Germany could cost €450-1300 per year, and some patients required treatment for three years. However, the effects of immunotherapy lasted for many years, reducing the need for further medication, so it was felt to be a cost-effective strategy in the long term.

Presentation by Professor Margitta Worm, Deputy Head, Allergie Centrum, Charité

Professor Worm described an Anaphylaxis Register which had been established in 2006 to monitor the frequency of anaphylactic cases, increase awareness, and provide educational programmes in how to deal with anaphylaxis. An internet-based surveillance questionnaire for doctors had been validated, and 30 centres across Germany, Austria and Switzerland were involved in reporting cases. By December 2006, the register had received reports of 174 cases of anaphylaxis in patients ranging from two months to 84 years old. 54.2 per cent of these patients were women and the mean age was 39 years. From the initial data collected, the most common causes of anaphylaxis appeared to be insect stings, various foods (including vegetables, fruits, tree nuts and peanuts), and medicines such as painkillers. A large proportion of anaphylaxis incidents appeared to happen in the home.

The Anaphylaxis Register was still in its infancy, but in the future it planned to involve all allergists across Germany, and aimed to develop a national task force for anaphylaxis. The project also aimed to develop educational programmes and wanted to expand its reporting network across the whole of the EU.

Department of Paediatric Pneumology and Immunology, Charité-Virchow-Klinikum, Humboldt University Berlin

Presentation by Professor Ulrich Wahn, Head of the Department

Professor Wahn welcomed the Committee and led a tour of the outpatients unit. Children with allergic conditions were treated by paediatricians with a sub-specialty in allergology. The clinic saw many patients with lung deficiency problems for which a variety of tests were offered, including cold-air challenges, treadmill trials and lung function tests. The clinic also carried out a large range of allergy diagnostic procedures such as allergen challenges, skin prick and patch tests, and various treatments including immunotherapy.

It was estimated that one in four children suffered from an allergic condition of some kind, and the "allergic march" meant that many of those might progress to develop more serious allergic conditions such as chronic asthma. Sensitisation to food was often the first indicator that a child would develop other allergies in later life, so early diagnosis was vital. An atopic allergy at a young age indicated that the allergy was likely to persist, whereas a non-atopic allergy suggested that the allergy symptoms might reduce at around eight to nine years of age.

Compared to the United Kingdom, specific immunotherapy was used to a much greater extent in Europe. Germany prescribed around 700,000 courses a year and France prescribed around 500,000, whereas the United Kingdom only prescribed around 5,000 per year. Professor Wahn commented that in European countries such as France, a high proportion of these treatments were administered sublingually, but sublingual immunotherapy was almost unavailable within the United Kingdom.

Presentation by Professor Kirsten Beyer, Co-ordinator of the European Anaphylaxis Initiative

Professor Beyer introduced two different European initiatives which had been developed to monitor allergy and anaphylaxis: EuroPrevall and the GA2LEN Anaphylaxis Initiative (GAIN).

EuroPrevall was an EU-funded project which had been established to monitor the prevalence, basis and burden of food allergy across Europe, in order to improve the quality of life for food allergic patients. Over the next four years the project aimed to develop methods to improve the diagnosis of food allergies, to investigate the role of diet, environment and infection on the development of food allergy, and to train a new generation of allergists in food allergies.

Professor Beyer noted that food allergies tended to peak in prevalence at around one to two years of age and a trans-European birth cohort had therefore been established in 2005 to examine the patterns and causes of food allergies in infants. The aim was that the cohort would include 9,000 babies born between September 2005 and February 2007 at nine centres in Germany, Greece, Iceland, Italy, Lithuania, the Netherlands, Poland, Spain and the United Kingdom. It was hoped that the results of the cohort study would help to elucidate the mechanisms involved in the development of food allergies, and would allow an analysis of the impact that food allergies have on quality of life and the economy.

The GAIN was established in January 2007 with three main aims: to develop an educational program for patients, relatives and healthcare workers; to raise awareness of anaphylaxis amongst the public; and to co-ordinate a European registry for anaphylactic reactions. It was noted that anaphylaxis could be fatal and often involved more than one organ system including the skin, respiratory, neurological, cardiovascular or gastrointestinal systems. The majority of patients were not correctly treated. Although adrenaline could be life-saving the majority of children were not prescribed this treatment, and the poor quality of patient education meant that this treatment was used incorrectly in the majority of cases.

Presentation by Dr Susanne Lau, Co-ordinator for aspects of paediatric allergology in the GA2LEN network

Dr Lau outlined the work of the European GA2LEN birth cohort co-operation which aimed to examine different birth cohorts within Europe. Birth cohort studies were particularly useful because they were longitudinal and therefore detected cause-effect relationships. They were also the best study design for diseases that began in infancy. The objectives of the co-operation were to describe the different designs and methods used within birth cohorts across Europe and to identify the strengths and weaknesses of each of them.

The project examined 19 birth cohort studies carried out in various centres across Europe. Most of the studies had examined similar factors and tended to suggest that family history, tobacco smoke exposure, pet ownership and nutrition all had an effect on allergy development. However, the practices used to assess these were not standardised so the various methodologies made international comparisons difficult. Therefore the project was trying to standardise methodologies for future studies, and was attempting to harmonize the procedures used for follow-up work to existing birth cohorts.

Friday 26 January

Department of Dermatology and Allergology, Technical University Munich

Presentation by Professor Johannes Ring, Head of the Department

The Committee was welcomed by Professor Ring, who explained that the Department was part of the Technical University Munich and its situation near other university Departments, such as pharmacology, allowed close collaboration between specialists.

The clinical problems surrounding allergies arose because allergic conditions involved multiple organs and often exhibited manifold, subjective symptoms. Allergic conditions could be chronic, of variable intensity, and could alter as the patient matured. Professor Ring thought that over the last 20 years, the number of more complex cases had increased, and many allergic conditions also had a psychosomatic influence.

The prevalence of allergic disease in both children and young adults was on the increase. Possible hypotheses for this included the hygiene hypothesis, altered genetic susceptibilities, changes in allergen exposures and environmental pollution. An increased awareness of allergic conditions, and improved diagnostic tests, may also have been partly responsible for the increase in reported allergy cases over the last 50 years. Although there was an abundance of hypotheses it was not known which, if any, were correct and the true reason for the increase in allergy had still not been determined.

Professor Ring commented that allergic conditions were often incorrectly thought to be minor inconveniences, but there were several types of allergic emergency that could be life threatening. These included angioedema, uterine contractions (a condition suffered by pregnant women which could be fatal for the baby), and anaphylactic shock.

Some of the molecular mechanisms of allergic diseases had been elucidated. For example, the progression of eczema appeared to be linked to the development of the epidermal skin layer, and some of the genetic complexes involved in this had been discovered. Specific IgE antibodies present in the serum of allergic individuals had also been characterised. However, now that the mechanisms were relatively well understood, future research needed to focus on broader issues such as why allergy was on the increase, whether the brain played a role in allergy and what made a substance an allergen. Further preventative work was also needed, and possible strategies for the future included true "vaccination" for children with a family history of allergy, and environmental planning with hypoallergenic plants or animals. Professor Ring emphasised the fact that every patient was different, so individually tailored management plans would need to be used in the future.

Presentation by Professor Markus Ollert, Head of Laboratory

Professor Ollert outlined the procedures used for allergy diagnosis. These ranged from bedside techniques, such as taking a family history, physical examination and skin tests, to laboratory tests such as IgE measurements and provocation tests.

The "component-resolved approach" to diagnosis and treatment was being developed, which tested the reactivity of patients to various components of an allergen. This technique was mostly used to assess allergy to bee and wasp venom. The genetic sequences from the venom were cloned and the appropriate nucleotide sequences characterised. These were then expressed in insect cells to produce recombinant allergens, against which patient serum was tested. It was felt that the component-resolved approach could not only be useful for diagnostic purposes, but recombinant allergens could also be used in specific immunotherapy. In the future, immunotherapy treatment using hypoallergenic "fusion molecules" containing several allergens at once, could prove more cost-effective than the prescription of different treatments for each allergen. However, work was still needed to determine which molecules could be used, how their performance could be improved and how the treatment could be refined.

Presentation by Professor Ulf Darsow, Clinician

Professor Darsow outlined the various ways in which allergic diseases could be managed in Germany. It was vital to correctly diagnose the allergic disease, as the type and severity of the condition determined the type of treatment that was required. Where possible, allergen avoidance was the most basic approach to manage allergies. Basic medication such as nasal sprays, corticosteroids and antihistamines were also needed to manage symptoms in many cases.

For some patients, allergen avoidance and medication did not adequately control their disease, so specific immunotherapy was prescribed. This treatment was widely used in Germany for the treatment of allergic rhinoconjunctivitis, insect venom anaphylaxis and bronchial asthma. Professor Darsow noted that the WHO placed great value by specific immunotherapy as it was the only treatment which could influence the natural course of allergic disease. Of all the patients that presented to the clinic with allergy to insect venom, approximately 90 per cent would receive immunotherapy, and around 90 per cent of those people would be successfully desensitised. However, there was a small proportion of patients that were refractive to immunotherapy treatment.

Presentation by Professor Heidrun Behrendt, Head, Centre for Allergy and Environment

Professor Behrendt introduced the Centre for Allergy and Environment (the ZAUM), which was a research unit within the Technical University Munich, founded by the Bavarian government in 1999. The purpose of the centre was to investigate the impact of biogenic and anthropogenic environmental factors on the development, maintenance and aggravation of allergic diseases, in order to provide evidence for preventative or regulatory interventional strategies. The centre had access to patients and clinical expertise through its affiliation with the Department of Dermatology and Allergology. Access to environmental measurements was provided by its association with the National Research Centre for Environment and Health. The centre ran an environmental medicine outpatient clinic and also had four laboratory research groups.

Professor Behrendt outlined current research into two types of environmental substances—biogenic compounds, such as pollen associated lipid mediators (PALMs), and anthropogenic adjuvants:

Under natural conditions, pollen grains functioned as allergen carriers that released allergens when they came into contact with aqueous mucosal membranes such as the airway. Recent research had shown that pollen grains also contained lipid mediators which were released upon contact with the membranes. It was thought that these mediators recruited and activated complexes within the body which contributed to allergic inflammation, so the PALMs might therefore contribute to the elicitation phase of allergic reactions. Further research was therefore being carried out into the role of these PALMs in allergy development.

The centre was also carrying out research into the role of anthropogenic adjuvants such as PAHs and VOCs. These adjuvants had a carbonaceous core to which other compounds could be absorbed. It was thought that substances such as diesel exhaust particles, which were allergic sensitizers, could be absorbed into these particles and in this way they could act as mediators in allergy development. The role of pollution in the development of allergy could therefore be extremely important.

Tour of the ZAUM and the Department of Dermatology and Allergology

Professor Behrendt led a tour of the clinical and experimental research facilities of the ZAUM. The Committee viewed the pollen trap and cascade impactor used to measure pollen and allergen levels, and Members were given the opportunity to talk with researchers about their work.

The Committee viewed the facilities at the allergy clinic and observed patients receiving skin tests and provocation tests. Patients who received immunotherapy at the clinic often received a concentrated course of treatment over several days. The risk of adverse reaction following immunotherapy treatment meant that it was important to keep patients overnight so that their response could be monitored.

Presentation by Professor Erika von Mutius, Head of Asthma and Allergy Outpatient Clinic, University Children's Hospital, Ludwig Maximilians University Munich

Professor von Mutius described the results of various studies which had examined the environmental causes of allergy. Some studies had suggested that early exposure to low levels of microbial compounds could protect against the development of allergic conditions, an idea which had been developed in the "hygiene hypothesis." For example, children brought up on farms in rural Germany, Austria and Switzerland had been shown to have a lower prevalence of atopy, hayfever and asthma compared to other children. This was thought to be due to the close proximity of animals and consumption of dairy milk during pregnancy and infancy on these farms.

To analyse these ideas further, Professor von Mutius was co-leading the Gabriel study with Professor Cookson (Imperial College London). This was an EU-funded project involving 150 scientists from 14 European countries, which aimed to examine how genetic and environmental interactions contributed to the development of allergic diseases in over 40,000 individuals. It was noted that the analysis of large and complicated datasets had previously been extremely difficult, but recent developments in genomics and bioinformatics had made analysis of such interactions much simpler. It was hoped that by elucidating the genetic and environmental interactions, preventative advice regarding the environment could be developed in the future.

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