INTRODUCTION

  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".[2] Our experience shows that, at present, this is rarely the case.

1.2  Consultation

  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 for.[3][4]

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).[5]

2.  THE RESEARCH AGENDA

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. [6]

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.[7],[8] 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, HRT etc.

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 important work.

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 CANCER INSTITUTE

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).

3.3  Statistics

  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 cancer.

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.[9] 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.  COMPLEMENTARY MEDICINE

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 BUDGET

5.1  Research budgets should reflect disease burden

  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".[10]

6.  CONCLUSION

  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 research.

REFERENCES

  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 2000.

  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; 355: 281-3.

  6.  Cancer Research Campaign: Factsheets 6.1-6.6 (1996).

  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.

3   Reference 2. Back

4   Reference 3. Back

5   Reference 4 and Annex 2. Back

6   Reference 5. Back

7   Reference 6. Back

8   Reference 7. Back

9   Reference 8. Back

10   Reference 9. Back