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Treating Health Risks or Putting Healthy Women at Risk: Controversies around Chemoprevention of Breast Cancer

  • Chapter
Ways of Regulating Drugs in the 19th and 20th Centuries

Part of the book series: Science, Technology and Medicine in Modern History ((STMMH))

Abstract

On April 16, 2006, the National Surgical Adjuvant Breast and Bowel Project (NSABP) of the National Cancer Institute (NCI) called a press conference in order to announce the results of the STAR (Study of Tamoxifen and Raloxifene) project. This randomized clinical trial compared the capacity of two drugs, tamoxifen (Novaldex® AstraZeneca) and raloxifene (Evista®, Eli Lilly) to prevent breast cancer in high-risk women. The STAR project was a direct continuation of an earlier NSABP trial, the Breast Cancer Prevention Trial (BCPT), which tested the capacity of tamoxifen to prevent breast cancer against placebo. Tamoxifen, an estrogen-receptor inhibitor, belongs to the family of SERMs (selective estrogen-receptor modulators), which are molecules that modify the effects of estrogen on cells. Tamoxifen was shown to lower the rate of recurrence in women diagnosed with estrogen-receptor-positive breast malignancies. It was found to be as efficient as standard cytotoxic chemotherapy in keeping breast cancer patients in remission, while avoiding most of the harsh side effects of chemotherapy. From the 1980s on, it therefore became a highly popular anticancer drug. It was not clear, however, whether this molecule could also prevent breast cancer in healthy women. The BCPT attempted to answer this question.

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Bibliography

  • Aronowitz R. (1998) Making Sense of Illness, Cambridge: Cambridge University Press.

    Google Scholar 

  • Aronowitz A. (2001) “Do not delay: Breast cancer and time, 1900–1970,” Milbank Quarterly, 79, 355–86.

    Article  Google Scholar 

  • Aronowitz R. (2006) “Situating health risks: An opportunity for disease prevention policy,” in C. Rosenberg, R. Stevens and L. R. Burns (eds.), History and Health Policy in the United States: Putting the Past Back In, New Brunswick, NJ: Rutgers University Press, pp. 153–65.

    Google Scholar 

  • Blaha P., P. Dubsky, F. Fitzal, et al. (2009) “Breast cancer chemoprevention — a vision not yet realized,” European Journal of Cancer Care, 18(5), 438–46.

    Article  Google Scholar 

  • Brenner B. (1999a) “From the executive director: Rolling the dice,” Newsletter of the Breast Cancer Action, #53, April/May.

    Google Scholar 

  • Brenner B. (1999b), “STARs in their eyes,” BCA Newsletter #55, August/September.

    Google Scholar 

  • Burstein H.J., K. Polyak, J. S. Wong, et al. (2004) “Ductal Carcinoma In Situ of the breast,” New England Journal of Medicine, 350, 1430–41.

    Article  Google Scholar 

  • Cody N. (1999) “New Zeneca Ad campaign misleading to women,” Motion Magazine, May 5.

    Google Scholar 

  • Cordiz G.A. (2007), “Decline in breast cancer incidence due to removal of promoter: Combination estrogen plus progestin,” Breast Cancer Research, 9, 108–10.

    Article  Google Scholar 

  • Cutuli B., A. Lesur, M. Namer et al. (2009) “Breast cancer chemoprevention: Rational, trials results and future,” Bulletin du Cancer, 96(5), 519–30.

    Google Scholar 

  • Editorial (2006a) “A STARring role for raloxifene?” Lancet Oncology, 7, 443.

    Article  Google Scholar 

  • Editorial (2006b) “Raising our voices,” National Breast Cancer Coalition Newsletter, Vol. 14, N°. 1, Spring/Summer 2006.

    Google Scholar 

  • Fisher B., J.P. Constantine, D. L. Wickerham et al., (1998) “Tamoxifen for Prevention of Breast Cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study,” Journal of the National Cancer Institute, 90(18), 1371–88.

    Article  Google Scholar 

  • Fisher E.R. (1996) “Pathobiological considerations relating to the treatment of intraductal carcinoma (ductal carcinoma in situ) of the breast,” CA — Cancer Journal for Clinicians, 47(1), 52–64.

    Article  Google Scholar 

  • Fletcher S. (1997) “Whither scientific deliberation in health policy recommendations? Alice in the wonderland of breast-cancer screening,” New England Journal of Medicine, 336(16), 1180–83.

    Article  Google Scholar 

  • Foscet J. (2004) “Construction of ‘high-risk women’: The development and standardisation of a breast cancer risk assessment tool,” Science, Technology and Human Values, 29(3), 291–313.

    Article  Google Scholar 

  • Freedman A.N., B. I. Graubard, S. R. Rao et al. (2003) “Estimates of the number of US women who could benefit from tamoxifen for breast cancer chemoprevention,” Journal of the National Cancer Institute, 95(7), 526–32.

    Article  Google Scholar 

  • Gail, M.H., L.A. Brinton, D.P. Byar et al. (1989) “Projecting individual probabilities of developing breast cancer for white females who are being examined annually,” Journal of the National Cancer Institute, 81(24), 1879–86.

    Article  Google Scholar 

  • Gail M., J. Costantino, J. Bryant et al. (1999) “Weighing the risks and benefits of Tamoxifen treatment for preventing breast cancer,” Journal of the National Cancer Institute, 91(21), 1829–46.

    Article  Google Scholar 

  • Gigerenzer G. (2002) Calculated Risks: How to Know When Numbers Deceive You, New York: Simon and Schuster.

    Google Scholar 

  • Goel V. (1998) “Tamoxifen and breast cancer prevention: What should you tell your patients?” Canadian Medical Association Journal, 158(2), 1615–16.

    Google Scholar 

  • Gorman, C. (2006), “A better option?” Time Magazine, April 24.

    Google Scholar 

  • Grady D. (2006), “Sorting out pills to reduce breast cancer risk,” New York Times, May 9.

    Google Scholar 

  • Hampton T. (2007) “Breast cancer prevention trial in limbo,” JAMA, 297, 1968–69.

    Google Scholar 

  • Hogle L. (2001) “Chemoprevention for healthy women: Harbinger of things to come?” Health, 5(3), 311–33.

    Google Scholar 

  • Jordan V. C. and M. Morrow (1999) “Raloxifene as a multifunctional medicine?” British Medical Journal, 319(7206), 331–32.

    Article  Google Scholar 

  • Jordan V. C., S. Gapstur and M. Morrow (2001) “Selective estrogen receptor modulation and reduction in risk of breast cancer, Osteoporosis and Coronary Heart Disease,” Journal of the National Cancer Institute, 83(19), 1449–57.

    Article  Google Scholar 

  • Jordan V. C. (2006) “The science of selective estrogen receptor modulators: Concept to clinical practice,” Clinical Cancer Research, 12(17), 5010–13.

    Article  Google Scholar 

  • Klawiter M. (2002) “Risk, prevention and the breast cancer continuum: The NCI, the FDA, health activism and the pharmaceutical industry,” History and Technology, 18(4): 309–53.

    Article  Google Scholar 

  • Kondro W. (2007) “Decline in breast cancer since HRT study,” Canadian Medical Association Journal, 176(2), 160–61.

    Article  Google Scholar 

  • Krieger N., Löwy I. and the group “Female sex hormones and cancer” (2005), “Hormone replacement therapy, cancer, controversies and women’s health: Historical, epidemiological, biological clinical and advocacy perspectives,” Journal of Epidemiology and Community Health, 59, 740–48.

    Article  Google Scholar 

  • Krieger N. (2008) “Hormone therapy and the rise and perhaps fall of US breast cancer incidence rates,” International Journal of Epidemiology, 37(3), 627–37.

    Article  Google Scholar 

  • Land S.R., D. L. Wickerham, J. P. Costantino et al. (2006) “Patient-reported symptoms and quality of life during treatment with tamoxifen or raloxifene for breast cancer prevention,” Journal of the American Medical Association 295(23), 2742–51.

    Article  Google Scholar 

  • Lerner B. (2001) Breast Cancer Wars: Hope, Fear and Pursuit of a Cure in Twentieth Century America, NY: Oxford University Press,.

    Google Scholar 

  • Li C.I., K. E. Malone, B. B. Saltzman and J. R. Daling (2006) “Risk of invasive breast carcinoma among women diagnosed with ductal carcinoma in situ and lobular carcinoma in situ, 1988–2001,” Cancer, 106(10), 2104–12.

    Article  Google Scholar 

  • Löwy I. (1996) Between Bench and Bedside: Science, Healing and Interelukin-2 in a Cancer Ward, Cambridge, MA: Harvard University Press, pp. 39–63.

    Google Scholar 

  • Löwy I. (2005), “Le féminisme a-t-il change la recherche biomédicale? Le Women’s Health Movement et les transformations de la médecine aux États-Unis,” Travail, Genre et Sociétés, 14, 89–108.

    Article  Google Scholar 

  • Löwy, I. (2009) Preventive Strikes: Women, Precancer and Prophylactic Surgery, Baltimore: Johns Hopkins University Press, 2009, pp. 184–89.

    Google Scholar 

  • Löwy I. and Gaudillière J.P., (2006) “Médicalisation de la ménopause, mouvements pour la santé des femmes et controverses sur les thérapies hormonales,” Nouvelles Questions Féministes, 25(2), 48–65.

    Article  Google Scholar 

  • Martin A.R. (2000) “Activist perspective: The dark side of the STAR trial”, The Ribbon, Newsletter of the Program on Breast Cancer and Environmental Risk Factors, Cornell University, Vol. 5 N°. 4. (accessed August 2010).

    Google Scholar 

  • Marshall E. (2007) “Budget pressure puts high-profile study in doubt,” Science, 315, 1477.

    Article  Google Scholar 

  • McNeil C. (2007) “Breast cancer decline mirrors fall in hormone use, spurs both debate and research,” Journal of the National Cancer Institute, 99(4), 226–67.

    Article  Google Scholar 

  • Million Women Study Collaborators (2003) “Breast cancer and hormone-replacement therapy in the Million Women Study,” T he Lancet, 362, 419–27.

    Article  Google Scholar 

  • Mokhiber R (2005). “Lilly’s second disappointment,” Multinational Monitor, 26(11–12), November/December, pp. 49–50.

    Google Scholar 

  • NHBC (2006), “Raising our voices,” NHBC Newsletter, 14(1), Spring/Summer.

    Google Scholar 

  • Page D.L. (2004) “Breast lesions, pathology and cancer risk,” Breast Journal, 10, Suppl. 1, S3–S4.

    Article  Google Scholar 

  • Petitti D.B. (2002) “Hormone replacement therapy for prevention: More evidence, more pessimism”, Journal of the American Medical Association, 288, 99–101.

    Article  Google Scholar 

  • Port E.R., L. L. Montgomery, A. S. Heerdt and P. I. Borgen (2001) “Patient reluctance toward tamoxifen use for breast cancer primary prevention,” Annals of Surgical Oncology, 8(7), 580–85.

    Article  Google Scholar 

  • Powell T.J. (2002) “Breast cancer prevention,” Oncologist, 2002, 7: 60–64.

    Google Scholar 

  • Powles T. J., R. Eeles, S. Ashley, et al. (1998) “Interim analysis of the incidence of breast cancer in the Royal Mardsen Hospital Tamoxifen Randomised Chemoprevention Trial”, Lancet, 352, 98–101.

    Article  Google Scholar 

  • Press N. and W. Burke (2000) “If you care about women’s health, perhaps you should care about the risks of direct marketing of tamoxifen to consumers,” Effective Clinical Practice, July/August, 202–04.

    Google Scholar 

  • Ruber F. (2006) La Vie est là, simplement, Paris: Albin Michel, pp. 153–04.

    Google Scholar 

  • Schwartz L. and Woloshin S. (2002) “News media coverage of screening mammography for women in their 40s and tamoxifen for primary prevention of breast cancer,” Journal of the American Medical Association, 287(23), 3136–42.

    Article  Google Scholar 

  • Taylor R. and K. Taguchi (2005), “Tamoxifen for breast cancer prevention: Low uptake by high risk women after nevaluation of a breast lu mp,” Ann als of Family Medic ine, 3(3), 242–45.

    Article  Google Scholar 

  • Tchou J., N. Hou, A. Rademaker, et al (2004) “Acceptance of tamoxifen chemoprevention by physicians and women at risk,” Cancer, 100(9), 1800–06.

    Article  Google Scholar 

  • US Preventive Task Force (2002) “Chemoprevention of breast cancer: Recommendation and rationale,” Annals of Internal Medicine, 137(1): 56–58.

    Article  Google Scholar 

  • Veronesi U., P. Maisonneuve, A. Costa, et al., (1998) “Prevention of breast cancer with tamoxifen: Preliminary findings from the Italian randomised trial among hysterctomised women,” Lancet, 352, 93–97.

    Article  Google Scholar 

  • Veronesi U, P. Maisonneuve and A. Decensi (2007) “Editorial: Tamoxifen: An enduring star,” Journal of the National Cancer Institute, 99, 258–59.

    Article  Google Scholar 

  • Vogel V. (19 9 8) “ Breast cancer prevention: a review of current evidence.” CA001ECancer Journal, 50,156001E170.

    Google Scholar 

  • Vogel V (1999) “Tools for evaluating a patient’s 5001 year and lifetime probabilities.” Postgraduate Medicine, 105(6), 782–86.

    Google Scholar 

  • Vogel V. G. (2000) “Breast cancer prevention: a review of current evidence,” CA Cancer Journal for Clinicians, 50(3), 156–70.

    Article  Google Scholar 

  • Vogel V. G., J. P. Costantino, D. L. Wickham and W. M. Cronin (2002) “Re: Tamoxifen for prevention of breast cancer,” Journal of the National Cancer Institute, 94(19), 1504.

    Article  Google Scholar 

  • Vogel V. G., J. P. Costantino, D. L. Wickerham et al. (2006) “Effects of Tamoxifen vs Raloxifene on the risk of developing invasive breast cancer and other disease outcomes: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial,” Journal of the American Medical Association, 295(23), 2727–41.

    Article  Google Scholar 

  • Waters EA, K.A. Cronin, B.I. Graubard et al., (2010) “Prevalence of tamoxifen use for breast cancer chemoprevention among US women,” Cancer Epidemiology, Biomarkers and Prevention 19(2), 443–46.

    Article  Google Scholar 

  • Welch H.G. (2004), Should I be Tested for Cancer? Maybe Not and Here’s Why, Berkeley: The University of California Press.

    Google Scholar 

  • Wilkinson K. (2006). “Lies about designer Estrogens and breast cancer,” Curve Magazine, (accessed August 2010).

    Google Scholar 

  • Winchester, D.P. J. M. Jeske and R. A. Goldschmidt (2000) “The diagnosis and management of ductal carcinoma in-situ of the breast,” CA — Cancer Journal for Clinicians, 50(3), 184–200.

    Article  Google Scholar 

  • Writing Group for the Women’s Health Initiative Investigators (2002) “Risk and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the women’s health initiative randomized controlled trial,” Journal of the American Medical Association, 288, 321–33.

    Article  Google Scholar 

  • Zones J.S. (2006) “Pushing Raloxifene — Reports of the STAR trial,” BCA Newsletter, #92, August/September.

    Google Scholar 

  • Zubrod G. C., S.A. Schepartz and S.K. Carter (1977) “Historical background of the National Cancer Institute’s drug development thrust,” National Cancer Institute Monographs, 45, 7–11.

    Google Scholar 

  • Zubrod G.C. (1984) “Origins and development of chemotherapy research at the National Cancer Institute,” Cancer Treatment Reports, 68(1), 9–19.

    Google Scholar 

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Authors
  1. Ilana Löwy
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Editors and Affiliations

  1. CERMES3, CNRS, Paris, France

    Jean-Paul Gaudillière (Director) (Director)

  2. Institute for the History of Medicine, Charité University Medicine Berlin, Germany

    Volker Hess (Chair) (Chair)

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© 2013 Ilana Löwy

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Löwy, I. (2013). Treating Health Risks or Putting Healthy Women at Risk: Controversies around Chemoprevention of Breast Cancer. In: Gaudillière, JP., Hess, V. (eds) Ways of Regulating Drugs in the 19th and 20th Centuries. Science, Technology and Medicine in Modern History. Palgrave Macmillan, London. https://doi.org/10.1057/9781137291523_9

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  • DOI: https://doi.org/10.1057/9781137291523_9

  • Publisher Name: Palgrave Macmillan, London

  • Print ISBN: 978-1-349-33742-2

  • Online ISBN: 978-1-137-29152-3

  • eBook Packages: Palgrave History CollectionHistory (R0)

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