Research strategies in the United
Kingdom
7.13.At the beginning of our inquiry, we released
a Call for Evidence which asked, amongst other questions, "why
does the United Kingdom in particular have such high prevalence
of allergy?" The evidence we have received suggests that
the prevalence of allergy in the United Kingdom is on a par with
many other Westernised countries, but is far higher than most
developing countries. The EAACI reported that "if one allows
for international differences in general levels of prosperity,
then it is not so clear that the UK has substantially higher levels
of allergy compared to other European or developed countries"
(p 67).
7.14.The real differences in prevalence could be
seen in countries that were undergoing transition, such as in
Africa. As Professor Custovic noted, "numerous studies have
demonstrated unequivocally that the prevalence of allergic diseases
is markedly higher amongst affluent populations which have adopted
westernised lifestyle compared to populations living in the same
areas but not adopting westernised lifestyle" (Q 461). As
discussed in Chapter 4, it seems likely that multiple environmental
factors have contributed to the increase in allergy prevalence
seen within the United Kingdom and many other parts of the Westernised
world in the last 50 years.
7.15.Although high quality research in the United
Kingdom has significantly advanced our understanding of the molecular
mechanisms of allergy, we were therefore concerned at the relative
paucity of research into these environmental factors. Dr Susan
Leech, Allergy Representative from the Royal College of Paediatrics
and Child Health, noted that "the areas of uncertainty are
around causes of allergies, particularly early life events and
allergen exposure" (Q 357). A lack of research into the development
of the immune system and the establishment of allergy, means that
the scientific community is still unable to answer fundamental
questions such as whether peanut avoidance during pregnancy protects
a child from peanut allergy (see paras 6.47-6.57).
7.16.To answer these types of questions, broader
studies are required which do not necessarily produce simple conclusions,
and which might therefore deter some clinicians and academics.
Dr William Egner, representing the Royal College of Pathologists,
commented that "you are only as good as your last research
grant and the outcome of that. In a competitive research environment,
it is a brave person who goes into a messy area with no clear
outcome" (Q 358). Professor Burney added that it was a "dilemma"
for research funders to choose between good, basic science that
will "find the exact answer" and "a more speculative
bit of work that is going to advance general knowledge but is
not going to give you the same kind of precise answer" (Q
165).
7.17.Professor Sheikh told us that "in terms
of primary prevention, we need long-term follow-up; we need 15-20
year studies" (Q 143). These long-term investigative studies
are expensive, and therefore Dr Diana Dunstan, Director of Research
Management at the MRC, told us that they were usually funded "in
partnership" (Q 223). Collaboration between academia, clinicians,
research councils, charities and pharmaceutical companies is therefore
essential. We visited a striking example of effective collaboration
at the MRC-Asthma UK Centre in Allergic Mechanisms of Asthma (a
collaboration between the MRC, Asthma UK, King's College London,
Imperial College London, and the NHS). The Centre combined their
research strengths into one cohesive strategy, with its research
priorities informed by national consultations on asthma research.
The Centre also provided research training through 10 PhD studentships
and supported NHS trainee allergists in partner hospital trusts,
as well as fostering translational research.[118]
7.18.We also heard that pharmaceutical companies
engage in collaborations with research councils and academic centres.
Mr Allen told us that GSK had "set up a number of long-term
academic collaborations with a number of the Centres of Excellence
supported by the MRC" (Q 225), and Professor John Westwick,
Global Head of Respiratory Diseases at Novartis Institute for
Biomedical Research, added that "most pharmaceutical companies
that are in respiratory medicine have long-term arrangements with
leading academic and clinical centres" (Q 226). Professor
Lee noted that collaborative projects to run large cohort studies
were essential, but added that most collaborations tended to be
within the "asthma" field, and were lacking for other
allergic disorders (QQ 221-222).
7.19.Professor Lee also highlighted the fact that
"the vast majority of funding" focuses on the basic
mechanisms of allergy and that "we need to do more now to
translate those findings into the patient" (Q 241). Several
of our witnesses added that future research needed to focus on
the individual, rather than the majority. Mr Allen pointed out
that "we need to understand the clinical phenotypes within
each of the diseases as well as between the diseases. We can only
do that by good translational medicine work, by long-term clinical
studies, but also by phenotyping these patients very carefully
so that we can start to understand their disease long before we
can start to attempt to cure it or even modify it" (Q 249).
On our visits to Germany and Denmark, we saw the benefit of clinical
services being closely linked to research.[119]
7.20.Mr Allen told us that GSK already take "with
the patient's consent, blood samples from every single patient
who is involved in a GSK research and development organised clinical
trial," with the objective of genotyping patients to "look
at how that genotype has reacted to the treatment and the outcome,
both from a safety and efficacy point of view." Professor
Westwick reported a similar story from Novartis, which identifies
"the phenotype and the genotype" of patients (Q 249).
Professor Lee commented that "to be able to have all the
blood samples genotyped and be able to link that to treatment
responsiveness is very, very powerful" to assess the efficacy
of treatments in various groups of patients (Q 250).
7.21.But epidemiological research in academia was
hindered because access to patient data from general practitioners
was denied. Professor Burney explained that academics had to approach
general practices to invite collaboration, which was expensive
and time-consuming, and some practices refused to collaborate.
Therefore samples were often "unrepresentative" and
studies of a clustered design led to "loss of power, or the
need for larger more costly studies." In addition, the general
practice itself must select and contact the patients for consent,
which required a lot of time and energy; academics could not assist
with this because they "cannot have access to the names and
addresses until the patients have replied to say that they are
willing to participate." Furthermore, academics received
no information on the patients that did not respond. Professor
Burney commented that these types of restrictions in epidemiological
research contributed to "a large scale repeat of the legal
nonsense that held up anonymous testing for HIV and any chance
of understanding the spread of AIDS in the UK for some years"
(p 60).
7.22.In 2006, the DH published its Best Research
for Best Health strategy. In the opinion of Professor Sally
Davies, Director General of Research and Development, this provided
"a lot of funding opportunities" for allergy or other
diseases where clinical research was needed (Q 31) and Mr Lewis
was confident that the strategy would ensure "stability in
terms of research funding" (Q 829). The National Institute
for Health Research, established as part of this strategy, had
been allocated £4.75m over five years specifically to look
at allergy (QQ 828-829). Following the suggestion that a central
disease registry could be established to co-ordinate information
on patients' genotypes and phenotypes, Mr Lewis replied that "investment
in disease research registries is not a good use of central research
and development provision. Such registries are expensive to develop,
and funding their long-term maintenance can create difficulties
in a system that has to be responsive to changing demands and
priorities" (p 320). However, Professor Lee argued that "if
that database was available it would be extremely useful"
(Q 259).
7.23.Sir David Cooksey's Review of UK health research
funding recommended that "greater priority should be
given to supporting medicines and therapies that tackle unmet
health needs in the UK" and suggested the creation of a new
Office for Strategic Coordination of Health Research (OSCHR) to
"set the strategic direction for research into particular
disease areas." The review also recommended that "future
increases in funding should be weighted towards translational
and applied research until a more balanced portfolio is achieved"
and that a Translational Medicine Funding Board should "take
the lead in developing a translational research strategy which
aims to increase translation into health and economic benefit."[120]
7.24.In light of this review, Dr Dunstan commented
that allergy "may well fall into the categories of unmet
need that we shall have to direct more attention to," but
Professor Lee added that there will be "difficulty in capturing"
information about unmet need due to the structure of the health
service (Q 240). An interim oversight group for OSCHR was established
in January, and Mr Lewis hoped that a new OSCHR would result in
"a higher priority being given to allergies," but could
not provide "a tangible commitment on how much additional
resource this may trigger" (Q 827).
7.25.Throughout this report we have drawn attention
to a number of areas which require further research, from maternal
and foetal nutrition to environmental factors such as air quality
or infection, and the way in which these interact with genetic
polymorphisms to contribute to allergy development (paras 4.37,
4.30, 5.16). Important unanswered questions remain regarding possible
preventative strategies such as the use of probiotics and beneficial
weaning practices, how to improve the indoor environment, why
and how the "allergic march" occurs with age, and what
allergy triggers exist in the outdoor environment (paras 4.32,
6.47-6.57, 5.2-5.14, 2.14-2.18, 5.15-5.18). Most important of
all, there is now a need to focus on the broad, fundamental questions
about how the early immune system evolves and how allergies develop,
to investigate appropriate preventative strategies, and to research
novel treatments to manage allergy symptoms in every patient.
KEY RECOMMENDATION
7.26.Although high quality research into cellular
and molecular mechanisms of allergy is advancing, the factors
contributing to allergy development and the "allergy epidemic,"
are poorly understood. It is imperative that further research
should focus on the environmental factors, such as early allergen
exposure, which may contribute to the inception, prevention or
exacerbation, of allergic disorders. Long-term cohort studies
are a vital part of this research, and interventional studies
are key to verifying the role which these factors may play. We
look to the development of the Office for Strategic Coordination
of Health Research to improve the co-ordination and funding for
these types of projects.
KEY RECOMMENDATION
7.27.We are concerned that the knowledge gained
from cellular and molecular research is not being translated into
clinical practice. We therefore regard allergy research directly
related to health care to be an area of unmet need that requires
greater priority. The Translational Medicine Funding Board must
ensure that allergy research is applied to develop novel individualised
treatments. The cost of a central disease registry may be too
high to warrant investment. Therefore, a comprehensive patient
database within each allergy centre (see para 9.40) will be key
to epidemiological and other studies, and is best maintained by
ownership at a local level.
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