Theory, Method and Conclusions
    Workpackage 1 will integrate workpackage 2, 3, and 4 (see Table 1): In the beginning of the project, it elaborates a common theoretical and methodological framework on which the empirical research in workpackage 2, 3, and 4 will be based. In the end of the project, it will be the responsibility of workpackage 1 to summarize the empirical findings of workpackage 2, 3, and 4, to theorize on them, and to formulate policy recommendations.
    To screen or not to screen? Biomarkers for prostate cancers
    Biomarkers are seen as a key tool to make medical treatments more efficient through the early detection of diseases. Workpackage 2 conducts empirical research on biomarkers for prostate carcinoma, focusing in particular on the measurement of prostate-specific-antigen (PSA) levels, a protein that is normally present in the blood at very low levels but that is elevated in the presence of a tumor in the prostate gland. Since the late 1980s prostate tumor testing operates through the measurement of PSA level, rendering the field of prostate cancer diagnostics an excellent example for the analysis of a diagnostic biomarker in action. However, PSA screening is also controversial (Linn et al. 2007), as it produces a high number of so called “false positives”, and as the majority of men with prostate cancer will die with but not from prostate cancer (Nature Genetics 2008). While some take these as good arguments to drop this biomarker altogether, others see these as reasons to search for new biomarkers that help to stratify aggressive tumors from less aggressive ones (National Cancer Institute 2008). Therewith, the field promises rich empirical material on the development of new biomarkers.
    Workpackage 2 studies biomarkers in this field, focusing in particular on the making and operation of a PSA screening program in Tyrol, a western region in Austria, where a screening program has been operating for almost two decades (Bartsch et al. 2008). This site is explored against the background of Iceland, and the United States, where the measurement of PSA levels takes place in the absence of a centrally organized screening program. Observations and interview data gathered in these sites are enriched through an analysis of the “PSA screening controversies” -- scientific publications that discuss the pros and cons of programs of this kind. Moreover, we engage with the development of new markers in these three sites, and study in particular how existing biomarkers interact with the development of new ones.
  Governing Therapeutics: Targeting Breast Cancers
    Biomarkers are strongly associated with the idea of developing more targeted drugs for disease treatment. Workpackage 3 will look at the field of breast cancer research, diagnostics, and therapeutics, focusing on the way in which thera[g]nostic biomarkers become “useful” devices in clinical medicine and transform clinical therapeutics.
    Today, there are no validated diagnostic biomarkers to detect breast cancer, which continues to be based on mammograms and clinical breast exams. There are, however, genetic tests deployed as “risk markers” to calculate the risk of women to suffer from hereditary forms of breast cancer in the future (King, Marks et al. 2003; Parthasarathy 2005; Parthasarathy 2007) and thera[g]nostic tests that help shape treatment options once a breast cancer is diagnosed. One of the best-known examples of such a thera[g]nostic test is the practice of measuring the number of copies of a gene called HER2: Patients suffering from breast cancer with more than one copy of this gene are known to benefit from treatments with trastuzumab (which is known as Herceptin).
     Applying our overall theoretical and methodological research framework, workpackage 3 focuses on sites of application of thera[g]nostic biomarkers for breast cancer in Austria and Iceland, against the background of insights gained from existing studies located in the UK (Hedgecoe 2004). Furthermore, workpackage 3 also takes a look at new developments in breast cancer biomarker developments, focusing in particular on deCode Genetics in Iceland.
    Workpackage 3 cooperates closely with workpackage 2 in order to learn whether systematic differences exist in the governance of the development, evaluation, and application between “diagnostic markers” and “thera[g]nostic” markers, and whether there are systematic differences in the success of biomarkers between “female” and “male” cancers.
    Translating drugs: The governance of biomarkers in China
    Workpackage 4 focuses on the deployment of markers in drug development in China.
    Workpackage 4 pays particular attention to the importance of cultural differences and the importance of existence of specific health care systems or the lack thereof for the transfer of biomarkers from the bench to the bedside, engaging with the study of a biomarker operating in a country in which a specific health care system is only just emerging.
Updated 24.04.2010