Brussels, 22 Mar 2004
Delegates at the fourth European breast cancer conference in Hamburg, Germany, issued a declaration on 20 March warning of the negative effects that the new EU clinical trials directive could have on breast cancer research in Europe.
The 'Hamburg Statement' was adopted on behalf of the 3,557 clinicians, scientists and healthcare consumers at the conference following a computerised plenary vote. It outlined four areas that delegates felt should be made priorities: academic research, individual risk assessment, age limits and care after breast cancer.
The statement begins by acknowledging that, while breast cancer incidence is increasing: 'Research is fuelling progress, and clinical trials and transnational research must be supported.'
Yet the key warning was clear: 'Excessively rigid legislation, unjustifiable administrative restrictions and government budget cuts are threatening cancer research in general, and breast cancer research in particular.'
The statement continued: '[T]he new European directive on clinical trials might contribute to leaving breast cancer research almost entirely to the initiative of the pharmaceutical industry.'
While participants recognised the contribution of pharmaceutical companies in developing new drugs, they expressed their concern at the potential decline in non-pharmacological research, in areas such as surgery, imaging and radiation therapy. 'This negative effect on independent academic research will also encourage even more gifted European researchers to emigrate to the United States to complete their studies and projects,' the statement adds.
According to delegates, the answer is more determined financial and structural support for academic research, the facilitation of the free circulation of tissue and blood samples in the EU for research purposes, and greater involvement of patients and consumers in research planning and monitoring.
Finally, the Hamburg Statement argues that 'funds originating from the EU central budget (e.g. a percentage of the current annual tobacco subsidy) are allocated to transnational research on breast cancer,' and that private donations for breast cancer research be encouraged by raising the tax deductibility level on such contributions in all Member States.
Earlier in the conference, Dr Martine Piccart, chair of the Breast International Group, announced that TRANS-BIG, a transnational research network involving 40 partners from across Europe and Latin America, is in the later stages of negotiation with the European Commission on funding for a Network of Excellence under the Sixth Framework Programme.
A key part of the network would be the first large scale independent trial to study the role of molecular tumour signatures in breast cancer. 'The traditional approach to clinical research in cancer has been the comparison of treatments through randomised clinical trials, with the extrapolation of an average benefit in a patient to each individual,' explained Dr Piccart. 'This often means that many patients are over-treated, while only a few derive a considerable benefit.'
'If the trial outcome is as expected, it will mean that it will be possible to spare patients at low risk of relapse from over-treatment with chemotherapy. This will result in reduced side-effects and will also save health services from unnecessary costs,' Dr Piccart concluded.
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