CHAPTER 8: RESEARCH
An effective infectious disease service should
be underpinned by research and development in order to further
understanding of how organisms survive, spread and interact with
their hosts. This in turn should inform action: how best to react
to and prevent further outbreaks.
We were particularly concerned about reported
difficulties in obtaining support for developing new products
such as tests to diagnose infectious disease and vaccines and
funding for research on delivery of services.
of vaccines and diagnostics
8.1 The development of both vaccines and diagnostics
is a lengthy process with uncertain outcomes and profits. This
makes it a relatively risky venture for industry [Roche Diag,
I p141]. In particular, this means that there are still many unexploited
opportunities for developing and using vaccines [BioIndustry Assoc,
I p25, UK Vaccine Ind Grp, II p234-8].
8.2 We were particularly impressed, when we visited
the National Institutes of Allergy and Infectious Disease in the
US, to hear about their Small Business Initiatives. Small companies
willing to take financial risks inherent in developing a vaccine
could apply for up to $100,000 to cover initial development costs.
If the company then patented the vaccine they were obliged to
make every effort to bring it to market [Chatfield, II p248; USA,
8.3 Pharmaceutical companies invest ten or twenty
times less money in vaccine R&D than in therapeutics. They
regard the public expectation that vaccines should not have any
side-effects as a particular burden. Such public anxiety requires
vaccines to be more thoroughly tested than other pharmaceutical
products in order to reveal any potential side-effect. This informs
companies' risk-analysis of products to decide whether or not
to further develop or to market [Kingston, Q530]. Pharmaceutical
companies desire clearer guidance from Government about levels
of demand [Kingston, Q531]. For example, the Government promised
to include a vaccine for meningitis C in the childhood schedule
(vaccines given to children as routine) and this facilitated its
development [Salisbury, Q42].
8.4 We believe that vaccine development should
be facilitated and recommend that the Government should
develop and maintain clear evidence-based guidelines about vaccine
requirements and should create financial incentives to enable
early research, development and commercialisation of vaccines.
8.5 We heard that academic medical researchers often
do not consider commercial applicability of their research [Borriello,
Logan, Reeders Q476]. However, this is changing somewhat with
an increase in numbers of university technology transfer offices,
which encourage and facilitate moves from research to development
[Logan, Q503]. The MRC also expects to encourage more product
development of research through a Health Implementation Research
Centre which would enable people to "design their projects
so that they can be better implemented and translated into practice"
[Q752]. We applaud this move and hope to hear of its progress
over the next few years.
and Development funders
Department of Healthspecifically
the NHS R&D fund and the Policy Research Programme, which
has historically funded much public health work [Pattison Q617];
funds research into animal infection. It has recently announced
a joint fund with Higher Education Funding Councils of £23
million in veterinary science.
and carry out R&D work. Before the Health Protection Agency
was created on April 1st 2003 the Centre for Applied Microbiology
and Research had research funding, which has transferred to the
HPA. The Public Health Laboratory Service carried out significant
work in development of new diagnostics, vaccines and other lab-based
technologies [Miller, Q523]. The HPA expects to raise further
funds from outside bodies [HPA Qs 735-46; PHLS Q303].
Medical Research Councilany
area of infectious disease work is funded apart from that which
is "needs-driven research" [MRC Q743]. Infectious disease
research applications have an average success rate and antibiotic
resistance is now a priority area. Health services research grant
applications are considered so long as their outcome is generalisable
[Q752]. The MRC hopes to hear to secure a funding stream for health
protection research in conjunction with other funders next year.
The Wellcome Trustfunds
across the board of different types of research with approximately
a thirty percent success rate for applications for research in
infectious disease [Q736-41]. It is currently reviewing its ten-year
Medical Microbiology Fellowship Initiative [Q743].
The Department of Trade
and Industryfunds development work
through its Link Programmes specifically in health technology
devices, applied genomics and genetic and environmental interactions
in health [II, p364]. It is unclear how much spend in infection
disease developmental work these programmes have led to.
Pharmaceutical and biotechnology
industrylarge pharmaceutical companies
such as GlaxoSmithKline and PowderJect Pharmaceuticals invested
£200 and £33 million respectively in vaccine R&D
in 2001-02 in addition to their spend on therapeutics [PowderJect,
I 122; Assoc Brit Pharma Ind, I 3-14; GSK, I 70; UK Vaccine Ind
Grp, Q526-44; II, x]. Smaller venture-capital funded biotechnology
companies, whilst not involved in manufacturing therapeutics or
vaccines, carry out research and development [Dr Chatfield, Q523;
Dr Reeders, Q476].
The European Union and
WHOfund a variety of infectious
disease related research through different streams.
8.6 One of the concerns regarding development work,
particularly related to public health, was that staff in the PHLS
pursued this on a day-to-day basis alongside their other work,
and it is, as of yet, unclear whether this will be able to continue
under the HPA [Duerden, Q303].
8.7 The big funders of medical research such as the
MRC and the Wellcome Trust do not fund research into use and development
of diagnostic technologies [Q757-759]. Apart from the HPA it is
unclear which organisations would prioritise development of diagnostics.
The development of diagnostics is a general concern and we heard
in the United States that no one is taking responsibility for
developing and improving standards of diagnostics [USA, II p384].
8.8 We were pleased to hear from the Government that
they have established a Bioscience Innovation and Growth Team
(BIGT) to examine how policy and investment can encourage innovation
and growth in the UK bioscience industry. One of its particular
aims is to examine how to develop relationships between the NHS
and industry in order to exploit new technologies [Q850]. BIGT
expects to report in July 2003. We look forward to its recommending
a strategy to develop priority areas for investment [DTI, II p364].
8.9 Highlighting priority areas and linking funding
to those priorities could facilitate development of appropriate
technologies [Borriello, II p218; Miller, Q548]. In order to ascertain
that development is properly linked with health care need it may
also be necessary to carry out evidence-based research to assess
efficacy and cost-effectiveness of vaccines and diagnostics. All
of this would require a certain amount of coordination between
relevant funding bodies. Sir William Stewart, Chairman of the
HPA, expressed caution about over-coordination [Q788]. We agree
that it is important not to stifle innovation but we note that
in a stretched health care service with limited R&D funding
it is necessary to prioritise.
8.10 We recommend that the Department of Health,
in conjunction with the HPA, establishes and publishes by the
end of 2003 clear evidence-based priorities for the development
of vaccines and diagnostics.
8.11 We heard that in order to improve infectious
disease services there needs to be more research into how services
are organised and decisions are taken. Better understanding of
human behaviour has a significant part to play in understanding
how organisations are run and s can reveal how organisations could
Understanding organisational issues and behaviour can help to
inform guidelines about treatment, prevention and control measures
and may improve outcomes [CAMR, I p42; Crowcroft, I p45-9]. For
example, research can examine how laboratory testing can be used
to inform GPs' decisions about when and how to treat [PHLS Prim
Care, I p132-3].
8.12 Further research is required into questions
such as the best design of hospital wards for managing infection
and reasons for patients failing to complete courses of treatment.
We heard that there is a disproportionate burden of infection
in certain social groups but the reasons for this, or indeed why
people choose not to take up interventions such as vaccines, are
not fully understood [Calman, Ghosh, Q364-5]. We found that work
is needed to ensure that infection services reach socially disadvantaged
groups if health inequalities are not to be perpetuated [Assoc
Brit Pharma Ind, I p10; Hawker, II p117].
8.13 We are concerned that there is not enough delivery
related research, either that which evaluates methods of diagnosis
(such as near patients tests) or surveillance, or seeks out new
sources of information [see chapter 5]. This type of research
would provide evidence to improve services.
8.14 It is clear that it is, at present, difficult
to fund research that examines social factors, evaluates new techniques
and considers the delivery of services. The PHLS used to carry
out research in this area [AcMedSci, II p36; PHLS, II p139]. The
MRC considers funding applications of this nature, with the caveat
that results should be generalisable across the health service.
However, such research applications are subject to severe scrutiny
and we heard that it is often more difficult to convince MRC research
committees of the quality of service delivery research than of
basic science research [Q754].
8.15 We recommend that the Department of Health
ensures that funding is made available to increase research into
organisation and delivery of infectious disease services and,
in particular, into how human behaviour impacts on outcomes of
diagnostic procedures, treatments and prevention programmes.
17 We discussed this in our report on Antimicrobial
Resistance, 7th report 1997-98 HL81-I Back