APPENDIX 8: VISIT TO ODENSE AND COPENHAGEN,
DENMARK
Members visiting Denmark were: Lord Colwyn, Baroness
Finlay of Llandaff (Chairman), Lord Haskel, Baroness Perry of
Southwark. In attendance: Miss Sarah Jones (Clerk), Professor
A. B. Kay (Specialist Adviser), Dr Cathleen Schulte (Committee
Specialist).
Thursday 22 March
Odense University Hospital (OUH)
Presentation by Mr Peter Frandsen, Medical Director
The Committee was welcomed by Mr Frandsen, who explained
that the hospital was organised into four centres containing 31
clinical departments, with around 85 wards, 1,150 beds and an
additional 120 rooms in a "patient hotel." The hotel
was a useful facility with a more relaxed atmosphere than the
main hospital. It could be used for women expecting a normal birth,
all cases of breast surgery, all patients with eye disease and
also for some patients undergoing hip and knee replacements. There
were also rooms available for parents of children who were admitted
as inpatients, and for relatives of patients who had travelled
a long distance to the hospital.
Presentation by Mr Poul-Erik Svendsen, First Deputy
President, Southern Denmark Regional Council
Mr Svendsen outlined how health services were co-ordinated
at a national and local level within Denmark. From 1 January 2007,
the country's 13 traditional counties had been replaced by five
new administrative regions, and the 270 municipalities had merged
to create 98. The aim of this huge reform had been to create a
new Denmark where citizens received better services, and the most
important area of responsibility for the new regions was the organisation
of the national health service.
National health targets were set by the Ministry
of Interior and Health Affairs, whilst preventative strategies,
treatments and health personnel were managed by the National Board
of Health. However, responsibility for the treatment sector and
allocation of the health budget had been devolved down to the
municipalities and regions. The municipalities and regions ran
the hospitals and entered into agreements with GPs, specialists
and dentists about payments. OUH was one of three university hospitals
in Denmark. The hospital was the natural choice for the inhabitants
of Region Southern Denmark, but also received patients from other
regions of Denmark who chose to be treated there. Patient satisfaction
was high and over 80 per cent of medical research in the region
was being carried out at the hospital.
Presentation by Dr Arne Høst, Head of
Department of Paediatrics, OUH
Dr Høst described allergy, atopy and the different
types of hypersensitivity reactions that could be either allergic
or non-allergic. Epidemiological studies had shown that some allergic
reactions peaked in prevalence during childhood and then became
less common. For example, atopic dermatitis peaked around age
one, and food allergies peaked around one to three years of age.
Asthma tended to increase in prevalence until around age 15, and
the prevalence of allergic rhinitis rose dramatically between
the ages of three to 10 years.
A number of long-term birth cohort studies had been
carried out in Denmark where follow-up assessments were needed
many years later. Funding for this had come from the National
Board of Health, the Danish Medical Research Council and local
funding boards. There had also been good co-operation with local
GPs who often referred patients to researchers for these studies.
The 1985 Odense birth cohort study monitored 1,749 infants born
at OUH during the first year of life, and showed that of the children
who displayed cow's milk allergy as infants, 88 per cent of them
had recovered by three years of age, and 97 per cent of them had
recovered by 10 years of age. The children who suffered from non-IgE-mediated
allergic reactions tended to have a good prognosis, whereas the
children with IgE-mediated cow's milk allergy had a higher risk
of the allergy persisting, and a higher risk of developing other
food allergies, inhalant allergies, asthma or rhinoconjunctivitis.
Research facilities at university hospitals, and
sustained levels of funding, were vital for important interventional
studies. The current evidence base led clinicians to recommend
that all infants should be exclusively breastfed until at least
four months old, but otherwise no special diet was recommended
for pregnant or lactating women. For high-risk infants (who had
a family history of allergy), if a milk supplement was needed
during the first four months then a documented hypoallergenic
formula was recommended.
Presentation by Dr Tine Hansen, Consultant, Allergy
Centre, OUH
Dr Hansen explained that hypersensitivity reactions,
which included allergies, placed a huge burden on the patient
as well as the economy and social services. Asthma cases in the
year 2000 cost Denmark approximately DKK1,100 million in medical
treatment, and DKK800 million due to work absences or early retirement.
It was therefore extremely important to prevent hypersensitivity
disorders.
Allergology required the treatment of many different
conditions, often involving multiple organ systems, both in children
and in adults. Different kinds of specialists were therefore needed
and patients were often sent between several different departments.
From 1982 until 2004, Denmark had offered a three-year sub-specialty
training in allergology under the internal medicine specialism.
However, in 2004 this sub-specialty was stopped, and since then
allergology had functioned as a sub-specialty within other specialties
such as dermatology, internal medicine, pulmunology or paediatrics.
There was no official training programme or certificate in allergology,
although the scientific societies made guidelines and education
programmes. GPs received no structured education about allergology.
In 2005, the "Allergy Network" was established
on a voluntary basis. The Network included representatives from
different organ specialty groups, and worked towards developing
common clinical guidelines and investigation programmes. It had
developed a training course for specialists which awaited funding,
to standardise allergology training, allow collaboration between
specialties and provide evidence-based, updated education. A training
course for GPs had also been developed to provide a common national
programme for GPs, and had been funded by the Ministry of Interior
and Health Affairs. A standard presentation was used at each course
presented by a standard group of specialists, to provide high
quality education that was identical in each region, although
the GPs could participate to apply the information in a more local
context.
Following the recent reorganisation of the Danish
regions, the Allergy Network saw an opportunity to optimize collaboration
and set out its vision of how allergy services could be improved
in terms of education, use of resources and treatments. The network
aimed to train all medical practitioners in allergology so that
most patients could be dealt with by GPs. It was thought that
GPs should be able to refer patients to specialists in practices
or hospital departments, and close collaboration between these
sectors could form a regional allergy team. The network claimed
that three specialist allergy centres were needed in the country
to treat complicated or rare allergic diseases and carry out research
and education. So far, only one of these specialist services had
been created, at Odense University Hospital. There were plans
to develop a second centre in Copenhagen soon, but the creation
of a third allergy centre at Aarhus awaited the construction of
a new hospital.
Tour of the Department of Dermatology and Allergy
Centre
Professor Carsten Bindslev-Jensen, Head of the Department,
led the Committee on a tour of the facilities at the Allergy Centre.
The importance of challenge tests was noted, as patients who had
not received an appropriate diagnosis often avoided substances
unnecessarily. Confirmation that the patient was not truly allergic
to a substance, or that an allergy had been outgrown, allowed
a significant social burden to be lifted from them. This was also
of economic value. Doctors reported that a high proportion of
patients believed they were allergic to penicillin, but only around
one in six actually were. Alternative antibiotics were a lot more
expensive than penicillin, so investigation of these patients
was therefore extremely worthwhile.
When an allergy was confirmed, it was also important
to establish the severity of the reaction, which could often only
be found using challenge tests. For example, the Committee met
one girl who suffered from peanut allergy, who had a positive
skin prick test and high levels of IgE, so avoided all peanut
products. However, the challenge test had shown that she could
tolerate low levels of peanut, and could therefore consume foods
with peanut traces and peanut oils. There was a danger that other
food products, such as sprouts or hazelnuts, could cross-react
with peanut proteins to produce an allergic reaction, so it was
also important to test the girl for sensitivity to these substances.
These types of detailed studies allowed specific advice to be
issued to different patients and enabled them to live a more normal
life.
The result of every challenge, cross-reaction, skin
test and treatment was recorded within the hospital database and
a blood sample of the patient was kept. This was immensely useful
for further research. It was noted that there was a difference
in attitude regarding research in England and Denmark; in Denmark
it was largely accepted that every patient who presented for treatment
would enter into the clinical trial.
Presentation by Professor Carsten Bindslev-Jensen,
Head, Department of Dermatology and Allergy Centre
Professor Bindslev-Jensen noted that the prevalence
of allergic diseases was still increasing in Denmark, with 40
per cent of the population being skin prick test positive to an
allergen. With increased awareness of allergic diseases, more
people were also reporting to doctors with symptoms of allergic
conditions. Professor Bindslev-Jensen felt that attention should
be focussed on the severe and most complicated cases, such as
peanut, tree nut and occupational allergy and anaphylaxis. Complex
allergies involved a number of organs, so no single specialist
could deliver top class diagnosis and treatment in all of those
fields.
The Allergy Centre had therefore been created in
2001 to deal with multi-organ, complex conditions, whether occupational
or private, in both adults and children. The Centre was formed
in collaboration with the Departments of Dermatology, Paediatrics,
Internal Medicine, Occupational Medicine, Clinical Chemistry and
Clinical Immunology. The number of staff employed by the Centre
included four specialists, two or three registrars, seven nurses
and lab technicians. This allowed specialised treatment of even
the most complex cases, and placed the needs of the patients centrally,
ensuring the best possible utilisation of resources.
The organisation of allergy services in the Southern
Denmark Region resembled a pyramid-like model involving three
different levels. At level one, the GP saw 80 to 90 per cent of
allergy patients in primary care. Level two consisted of specialist
practices or county hospital departments which dealt with around
5 to 15 per cent of patients. Then at level three, around 1 to
5 per cent of patients, who had complex or severe allergies, were
referred to the Allergy Centre and other departments in the university
hospital. The aim of the allergy centre was to diagnose and treat
patients, and then refer them back to their GPs or district hospitals
with appropriate advice for both the patient and GP.
Collaboration between the different levels was therefore
essential, and the knowledge passed down from the Allergy Centre
helped to educate the local GP and specialist workforce. The Allergy
Centre made its standard operation procedures available to GPs
which contained basic information about allergic diseases, outlined
the type of samples that should be taken for each condition, and
offered guidance about where to refer cases of allergy. An example
of when inter-level collaboration had been important was in 2004,
when it was discovered that many patients had suffered severe
reactions following grass immunotherapy treatments. The Allergy
Centre alerted all the GPs, specialists and hospital departments
in the Region, established a hotline, and allowed GPs to refer
any cases to the centre which they were uncomfortable treating
themselves.
The work of the allergy centre was varied, and involved
challenges to foods, drugs, and occupational substances, allergy
testing in vivo such as skin prick tests or patch tests,
and in vitro allergy tests such as the measurement of IgE
levels. The treatments offered included allergen avoidance advice,
immunotherapy and pharmacological treatments. In addition the
clinic was involved in several research projects such as the Danish
Allergy Research Cohort and GA2LEN research programmes.
The Allergy Centre also worked with patient organisations
to organise holidays for families in locations completely free
of allergens. Schools in asthma, eczema and food allergy had been
organised in collaboration with other departments and the Asthma
and Allergy Association (a patient organisation), to educate patients
about how to cope with allergy in everyday life.
In discussion, it was debated whether allergy should
be treated by separate specialists in a co-ordinated centre, such
as in Denmark, or by allergy mono-specialists. It was felt that
the appropriate model of service delivery in each country depended
on the individual history of its health system. It was noted that
allergists in Italy received training in many different fields,
including paediatrics, dermatology and respiratory medicine, so
the allergology specialty was justified and allergologists worked
with paediatricians to provide most of the care.
However, it was suggested that in countries where
allergologists did not receive this range of training, allergy
should be treated by organ specialists with an interest in allergy.
In Germany, most allergy expertise was provided by dermatologists
and paediatricians. The system employed by the Allergy Centre
at OUH, where many organ specialists cooperated in allergy treatment,
was a similar model of service delivery to that used in France
and Germany.
It was noted that the Allergy Centre did not detract
from routine allergology performed by organ specialists. Instead,
the role of the Centre was to investigate more complex cases and
avoid multiple referrals between specialists. The staff at the
Allergy Centre often investigated patients' histories and decided
whether immunotherapy should be used, but then referred the patients
back to organ specialists or GPs to administer the treatments.
Friday 23 March
ALK-Abelló
Presentation by Dr Peder Anderson, UK Director
Dr Anderson briefly introduced ALK-Abelló,
a small- to medium- sized pharmaceutical company. It claimed to
be the world leader in specific allergen immunotherapy, holding
around 32 per cent of the market share. Around 50 per cent of
the products it produced were subcutaneous immunotherapy treatments,
25 per cent were sublingual immunotherapy and another 25 per cent
were adrenaline autoinjectors.
Dr Anderson estimated that around five million people
in the United Kingdom were allergic to grass pollen to some extent,
but that due to a lack of service provision many people relied
upon suboptimal treatments over the counter at pharmacies. It
was thought unlikely that allergy services in the United Kingdom
would be improved soon due to the shortage of allergy specialists,
and Dr Anderson thought that subcutaneous immunotherapy would
never be used in primary care due to the need for administration
by specialists. The company had therefore developed sublingual
immunotherapy tablets in the hope that these may eventually enable
GPs in the United Kingdom to treat allergy using immunotherapy.
Presentation by Dr Jørgen Nedergaard Larsen,
Senior Scientist
Dr Larsen outlined the scale of the allergy problem
in Europe. Every allergy patient was different and could potentially
suffer from several allergic diseases at once. Common comorbid
conditions included hayfever, asthma, eczema, food allergy and
urticaria. The mucosa in the airway functioned as one organ, so
similar allergic symptoms often presented in the eyes, lungs and
nose. Although the common view was that allergy presented as several
diseases with overlapping symptoms, Dr Larsen therefore felt it
was more useful to view allergy as one disease, with several different
manifestations.
Immunotherapy was the only treatment which stopped
the symptoms of allergy on a long-term basis. It could not be
viewed as a "cure" because allergy symptoms could still
be provoked following immunotherapy if high doses of allergen
were applied. However, it rendered the patient tolerant enough
of the allergen for everyday life. The efficacy of subcutaneous
immunotherapy was good. There was a clear dose-response efficacy
relationship, but the allergen dose that could be administered
during immunotherapy was limited, due to the increasing risk of
adverse reaction with increased doses.
The company had gained product licenses for subcutaneous
immunotherapy products within several European countries but had
virtually given up seeking product licences in the United Kingdom
because it felt that the MHRA was resisting the approval of this
treatment. However, its products could still be used within the
NHS if they were imported on a named-patient only basis. The company's
focus in the United Kingdom had turned to sublingual immunotherapy
as the safety profile of this treatment was good and it allowed
patients to treat themselves at home. Grazax, a tablet form of
immunotherapy for the treatment of grass pollen allergy, had been
granted a product license in the United Kingdom in 2007.
Tour of the Research Department
The Committee was given a tour of the research facilities
by Dr Michael Spangfort, Director of Research.
Preclinical research data was needed to receive a
product license in the United States and also contributed to applications
for product registrations in Europe. Compared to human studies,
the use of the mouse as a clinical model allowed more parameters
to be investigated, so a rhinitis mouse model had been developed.
Research was being carried out into the mechanisms involved in
sublingual immunotherapy, and adjuvants were being tested for
the next generation of sublingual products.
Presentation by Dr Rowena Holland, Marketing Manager
Dr Holland began by outlining how respiratory allergic
disorders impaired patients' quality of life. Within the United
Kingdom, the shortage of specialist allergy centres meant that
the use of subcutaneous immunotherapy was minimal, and patient
surveys had shown that many patients felt that the treatments
they received had only a partial or poor effect on their symptoms.
Trials of Grazax had shown that the sublingual immunotherapy product
was effective at reducing symptoms and improved sufferers' quality
of life. Dr Holland claimed that when quality adjusted life years
were taken into consideration, the product had been shown to be
cost-effective compared to other treatments and was not associated
with risks of anaphylaxis. After being granted a product license
by the MHRA, it was hoped that this product would be used within
the NHS, but the long-term effects of the product were still under
investigation.
National Board of Health
Presentation by Dr Else Smith, Acting Medical
Director, National Board of Health
Dr Smith welcomed the Committee to the National Board
of Health and outlined the healthcare problems the country faced.
The National Board of Health was a semi-independent agency within
the Ministry of Interior and Health Affairs. It acted as an advisory
body to ministers, parliament and public authorities, but the
Ministry had no instructive authority over the Board, so the political
functions of the Ministry were separated from the health strategies.
Healthcare in Denmark was financed through general
taxes. The National Board of Health co-ordinated national health
policies and regulated personnel in the health services. However,
the allocation of funding towards local prevention work and the
provision of healthcare services was decentralised, managed locally
by the five regions and 98 municipalities. The former Ministry
of Health Affairs, now the Ministry of Interior and Health Affairs,
had recently produced a national strategy, Healthy throughout
Life which set out targets and strategies for improving public
health from 2002-2010. The overall aim of the project was to increase
life expectancy free of illness for everyone at all ages. Included
in this strategy were eight major groups of non-communicable diseases
which the Ministry felt needed to be targeted, and one of these
was hypersensitivity, including asthma and allergy. Although the
Ministry had set strategies, it was the National Board of Health
which would have to issue guidelines in order to tackle the rise
in allergic conditions.
Presentation by Dr Jette Blands, Senior Medical
Officer, National Board of Health
Dr Blands outlined the ways in which the National
Board of Health tried to monitor the prevalence of allergy. The
National Health Interview Surveys from the National Institute
of Public Health showed that there had been a large increase in
the number of self-reported and parent-reported cases of asthma,
wheeze, hayfever and allergic rhinitis over the last decade in
Denmark. It was not clear whether the number of cases was still
on the increase, but it did not look like it was on the decline.
The Danish National Patient Registry contained information about
all patient contact with clinical hospital departments, but GPs
did not register their cases so there was still a great need to
improve data collection on a national level.
As many factors contributed to allergy development
it was difficult to decide how to distribute resources. Possible
targets for prevention strategies included working conditions,
diet, smoking and the indoor and outdoor environment. The Board
provided information and guidance for families, day-care centres
and schools, in addition to producing guidelines for healthcare
professionals. Information was often displayed on the National
Board of Health website[156]
to enable easy access.
The Board also engaged in partnerships, such as the
Food Allergy Project in 2003. This project was a collaboration
between the Danish Veterinary and Food Adminstration, the National
Food Institute, the Asthma and Allergy Association and the National
Board of Health. The outcome of the project was the production
of eight booklets regarding food allergies and hypersensitivities,
and a conference for primary care nurses and doctors about food
hypersensitivity in children. The project had also established
a dedicated website[157]
regarding food allergy which was aimed at the public, but which
was also useful for healthcare personnel. The website contained
information about food allergy, shopping, the pollen season and
possible allergen cross-reactivities.
The reform of the Danish regions and municipalities
had provided the Board with an opportunity to develop guidelines
for allergy care and prevention. The pyramid model of service
provision for patients with chronic diseases stratified them according
to their individual needs. This meant that most allergy patients
should be managed in primary care. For this management to be successful
it was important for healthcare personnel of different disciplines
and levels to work co-operatively.
Presentation by Professor Jeanne Duus Johansen,
Director, National Allergy Research Centre for chemical substances
in consumer products
Professor Johansen described the work of the National
Allergy Research Centre for chemical substances in consumer products.
The Centre had been developed in 2001 by a steering group consisting
of the National Board of Health and the Environmental Protection
Agency, and carried out research purely into contact allergies.
Contact allergens were low-molecular weight chemicals, organic
substances or metals, and were frequently found in consumer products
such as fragrances, preservatives, hair dyes or jewellery, as
well as at work. It was estimated that around 20 per cent of the
population suffered from contact allergy, that the majority of
sufferers were women, and that contact dermatitis was especially
common in younger people.
The staff at the Centre consisted of the Director,
10 researchers and an IT specialist. It was important to maintain
contact with clinicians who dealt with contact allergy on a regular
basis, so the Centre was supported by the Department of Dermatology
and Department of Respiratory Medicine at the Gentofte University
Hospital, and the Department of Dermatology at OUH. The Centre
carried out research into allergens contained within consumer
products, and studied the details of clinical cases in order to
develop prevention strategies. The National Board of Health supported
a clinical database of dermatitis cases. The details of around
4,000 cases were received each year from 10 centres across the
country, including university hospitals and private clinics. This
assisted the surveillance of national targets, monitoring of interventional
strategies, and the development of clinical guidelines and standards
of care.
The Centre was also involved with consumer protection
work and clinical experiments carried out at the Centre had led
to allergenic products being removed from the market.
Research areas at the Centre included:
- work on hair dyes and semi-permanent
tattoos to identify the allergens contained within them, and the
threshold levels at which these substances were safe
- investigation into chromium allergy, as chromium
on the leather of shoes and gloves had been shown to act as a
potent allergen for a small group of individuals. The unit had
measured the gene expression patterns of patients to aid diagnosis
in the future, and also carried out preventative work
- examination of perfumes and fragranced products.
It was noted that perfumes were applied to the skin but were also
inhaled, so for this research it was important to work with both
respiratory and dermatological clinicians.
Presentation by Dr Janne Sommer, Asthma and Allergy
Association Denmark
The Asthma and Allergy Association Denmark was a
patient organisation established in 1971 which aimed to improve
the lives of people affected by asthma and allergies, and helped
them to make informed judgements about treatments. It had 14,000
members and ran activities through 22 local branches, but from
1990 a central office had been established to co-ordinate its
work and initiate major national initiatives. The Association
was funded partly by private organisations and partly by grants
from the National Board of Health which supported activities such
as the patient counselling service.
The Association offered a range of services which
included a free telephone hotline offering professional counselling,
a free weekly newsletter, a members' magazine and a large website
with detailed information for patients, relatives and healthcare
workers. The Association organised patient schools, family days
and seminars which educated children and adults about how to manage
allergic conditions on a day-to-day basis, and also ran a product
evaluation service which worked with industry to improve the quality
of products sold to the public.
The Association was also the only non-governmental,
not-for-profit organisation in the EU which ran a large pollen
monitoring program. The Association worked in collaboration with
the Institute of Environmental Health and aerobiological groups
to trap, identify and count pollen across the country. Daily counts
of the six greatest allergological pollens were communicated to
the public via free emails and the website. Pollen forecasts for
birch, grasses and mugwort were also distributed on the internet
or in leaflets, and enabled allergic patients to plan events avoiding
the peak pollen seasons. As pollen levels in the air were affected
by meteorological conditions on a global level, international
co-operation between governments and meteorological groups would
be needed to improve services in the future.
156 See www.sst.dk. Back
157 See
www.foedevareallergi.dk. Back
| 
