Codes, identities and pathologies in the construction of tamoxifen as a chemoprophylactic for breast cancer risk reduction in healthy women at high risk.

摘要

The chemical compound, tamoxifen citrate, better known by its tradename, tamoxifen, is the most widely prescribed chemotherapeutic agent for the treatment of breast cancer in the world today. In October 1998, the United States Food and Drug Administration (U.S. FDA) approved its use as a chemoprophylactic agent for healthy women at high risk for breast cancer. Most recently, its clinical application was extended for the treatment of pre-cancerous lesions known as ductal carcinoma in situ (DCIS).;As a chemoprophylactic agent for breast cancer prevention, tamoxifen has been evaluated in several large-scale randomized controlled clinical trials (RCTs), including the U.S. National Surgical Adjuvant Breast and Bowel Project's Breast Cancer Chemoprevention Trial, P-1 (NSABP BCPT P-1). This project explored the contested nature of tamoxifen in terms of its therapeutic efficacy as the standard of care for risk reduction in healthy women at high-risk for breast cancer. The research focused on the construction and development of preventative tamoxifen as a constituent of a standardized package. It suggested how, under specific conditions, tamoxifen became highly destabilized as it crossed social worlds. How did the stabilization and destabilization of tamoxifen policy take place? What role did the scientists, regulators, activists, pharmaceutical companies, and clinical organizations play? Have the beneficial outcomes of the P-1 clinical trial data been given pride of place in the policymaking arena, and have the harmful outcomes been marginalized?;My research showed that a core group of NASBP researchers, the AstraZeneca pharmaceutical company, and National Cancer Institute researchers pushed the approval of “risk-reducing” tamoxifen through, even over the objections of some clinical researchers and breast cancer activists. Scientists debated the interpretive nature of laboratory findings and clinical outcomes. Activists were divided between those who did not think it should be approved and those who favored approval as an additional “choice” for women. The lack of uniformity in clinical recommendations further contributed to the controversial nature of “risk-reducing” tamoxifen. Perhaps tamoxifen is a good “choice” for some women today, but women who take tamoxifen for risk-reduction should know of the uncertainty in the scientific foundation upon which the clinical guidelines are based.