Memorandum submitted by BREAST UK|
BREAST UK was formed in April 1999, its members
being made up largely of the former Research Committee of the
UK Breast Cancer Coalition, who had already been working together
for the previous three years. We bring to the task of consumer
advocacy considerable personal experience of the field of cancer
research, local, national, and international. We therefore feel
we have a useful contribution to make to the Committee's inquiry.
For further details and mission statement please see the press
release attached (Annex 1).
1. CONSUMER PARTICIPATION
1.1 Patients as partners
Research should be done with patients as participants,
not to them, as "subjects" or "objects".
Our experience shows that, at present, this is rarely the case.
We should like to ensure that all proposals
for clinical research show evidence of consultation with consumers
in their design, and that the expenses of doing so should be budgeted
1.3 Informed consent
A much more rigorous standard for consent is
required that is usual at present, if consumers are to have confidence
in the process of research (Annex 2).
2. THE RESEARCH
2.1 Patients priorities
Too much research is done on toxic chemotherapy
treatments for advanced cancer that may prolong life for a very
short time (possibly only a month or two) at the cost of great
suffering on the part of the patient (though with large profits
for pharmaceutical companies). Patients are not told the truth
about such treatments. We know that the pharmaceutical lobby is
very powerful, and that there is motivation to research remedies
for which patents can be sought. This distorts the research agenda,
and adds huge cost to NHS expenditure for little benefit. More
research into effective palliative care (including complementary
therapies) would give a better return than more research into
ever more toxic treatments, may of which are themselves life-threatening.
2.2 Causes and prevention
Research into the causes of cancer and its prevention
should take precedence over treatment. After 50 years of research
in breast cancer in the UK mortality is going down at a far slower
rate than incidence is rising.,
There are similarities here with prostate and other hormonally
modulated cancers: there must therefore be environmental causes
for this rise which have to be investigated. There will be powerful
lobbies trying to prevent this, just as the tobacco industry has
lobbied against smoking prevention campaigns. We should look at
the effects on human health of:
2.2 (a) Synthetic hormones in meat, cattle
feed, cattle medicines, and how they affect the human food chain.
2.2 (b) Hormone-mimicking compounds in fertilizers,
pesticides, plastics etc.
2.2 (c) Synthetic hormones in oral contraceptives,
2.2 (d) Pollution from incinerator fallout,
landfill sites, radiation, traffic, electro-magnetic fields, etc.
2.2 (e) Shift work, prolonged use of mobile
phones, microwave ovens, artificial light at night, etc.
2.2 (f) Possible links between thyroid disease
and breast cancer.
2.3 Conflicts of interest
All these topics must be investigated independently
of any vested interests (agriculture, pharmaceutical companies,
nuclear fuels, etc). This means extra government funding for universities
and research institutions such as the MRC, who should not have
to rely on the pharmaceutical industry (as at present) to co-fund
2.4 Cancer charities
The role of the cancer charities must be closely
examined, and any links with the pharmaceutical industry clarified
and declared openly. The role of the UKCCCR should be reviewed
and reassessed, and genuine public participation ensured, as is
required of charities in law. Those who raise money for these
charities (often people with personal experience of cancer) should
have a say in how the money is spent. As the Charity Commission
states, Trustees "should be selected on the basis of their
relevant experience and skills": it follows that people with
personal experience of the disease must be among those selected.
3. A UK NATIONAL
3.1 The need for an NCI
The need for such an institute is clear. This
must however be absolutely independent of any industrial influence,
and should be set up with lay and consumer membership forming
a substantial element in its committees. We suggest that all committees
should have a lay chairperson and 50 per cent lay membership.
Site-specific committees should always include several people
with personal experience of the cancer in question. All members,
including lay, should declare any interests.
3.2 Duplication of effort
The UK NCI should ensure that work is not unnecessarily
duplicated by keeping in close touch with developments elsewhere
in the world. No unnecessary research should be undertaken in
the UK into topics to which the answer is already known from international
research (an example is the START radiotherapy fractionation Trial
A, which also does not have equipoise between the arms, contrary
to the scientific and ethical requirements for all clinical research).
The UK NCI should be responsible for maintaining
up-to-date statistics of cancer incidence and mortality. The recent
consultation on cancer referral guidelines, which commendably
did include consumers, quoted out-of-date statistics for breast
3.4 National information service
The NCI should be able to provide an unbiased
national information service for both clinicians and patients,
including information on all current clinical trials. At the moment
such information (even about UK trials) has to be downloaded from
the US NCI information service.
3.5 Setting of national standards in research
In breast cancer, pathology services must be
speedily brought up-to-date throughout the UK so that no further
research is undertaken without ensuring that all the evidence
concerning prognostic factors is available for trials to be conducted
without waste of time and resources: ie hormone receptor assays
and grading of tumours must be performed routinely.
Whereas this standardisation of practice should not have to await
the setting up of an NCI, this is only one example of an area
where the NCI might set national standards.
3.6 Implementation of research
Clinical practice should reflect best research
evidence speedily: there should be some mechanism for ensuring
that this is done and that the funds are available for doing it.
This may be a role for the UK NCI.
4.1 The need for research
Research in complementary medicine must be given
extra resources to bring funding up to an acceptable level. There
is rarely money to be gained from patenting remedies or therapies
in this field, though many cancer patients gain great benefit
from them, especially in alleviating the side effects of orthodox
treatments. This is why the evidence base must be sound, and appropriate
regulatory systems for practitioners must be set in place.
4.2 Integrated healthcare
At a time when NHS money is scarce, exploration
of these low-cost treatments must be taken seriously, and integrated
into a holistic, "joined-up" healthcare system. The
provision of such therapies should not have to depend on the voluntary
sector. But managers will not fund such treatments unless the
evidence for efficacy is there: we need sound research which may
well need to use qualitative as well as quantitative methodology.
5. THE RESEARCH
5.1 Research budgets should reflect disease
Whereas cancer will strike one in two of the
population by the year 2010,8 funding for research does not reflect
this. By comparison the disease burden of HIV and AIDS (for example)
in the UK is tiny and the research funding huge.
5.2 Government must assume responsibility
for research funding
Too great a reliance on industry to fund research
has led us away from patient priorities. As Alessandro Liberati
put it so elegantly: "The quality and relevance of much clinical
research fall short of patients needs. Although there are many
reasons for this, one is that clinical research has been delegated
largely to the pharmaceutical industry, whose main motivation
is its own economic welfare".
BREAST UK will be pleased to offer further evidence
to substantiate the points made in this submission. The main point
we wish to make is that the patients' experience and expertise
must be taken into account in any strategic planning of future
1. Herxheimer A, Goodare H. Who are you,
and who are we? Looking through some key words. Health Expectations
1999; 2: 3-6.
2. Consumers in NHS Research Support Unit.
Involving Consumers in Research & Development in the NHS:
Briefing Notes for Researchers. Help for Health Trust, January
3. Goodare H, Lockwood S. Involving patients
in clinical research. BMJ 1999; 319: 724-5.
4. CERES and BREAST UK. Draft Guidelines
for Ethical Research with Patients. March 2000 [Annex 2].
5. See (for one recent example among many):
Ibrahim NK et al. Colitis associated with docetaxel-based chemotherapy
in patients with metastatic breast cancer. Lancet 2000;
6. Cancer Research Campaign: Factsheets
7. Macmillan Cancer Relief: Report of Cancer
Incidence and Prevalence Projections, June 1997.
8. NHS Executive. Guidance for Purchasers:
Improving outcomes in Breast Cancer. The Manual. Cancer Guidance
sub-group of the Clinical Outcomes Group, July 1996, p. 14.
9. Liberati A. Consumer participation in
research and health care. BMJ 1997; 315: 499.
2 Reference 1. Back
Reference 2. Back
Reference 3. Back
Reference 4 and Annex 2. Back
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