3
Research on Conditions with Particular Relevance to Women

This chapter discusses women’s health research of the last 2 decades according to conditions.1 The committee limits its discussion according to its characterization of women’s health in Chapter 1—conditions that are specific to women; that are more common or serious in women; that have distinct causes, manifestations, outcomes, or treatments in women; or that have high morbidity or mortality in women. Appendix B summarizes the incidence, prevalence, and mortality data and trends that, in part, guided committee selections.

Given the impossibility of presenting all research on women’s health, the committee first discusses examples of successful research that contributed to progress in women’s health. The committee assessed progress on the basis of decreases in incidence or mortality or on the basis of scientific innovations that led to major transformations in approaching a condition. The committee then discusses conditions on which some progress has been made and those on which little progress has been made and about which heightened awareness and further research are needed. Although aware of comorbidities and cross-cutting issues, the committee organized the data for this chapter by condition to reflect of predominant models of research funding and publications.

The committee is aware that the conditions do not include all health conditions that are important to women; a number of conditions that affect many women’s quality of life—including arthritis, chronic fatigue syndrome, chronic pain, colorectal cancer, eating disorders, fibromyalgia, incontinence, irritable bowel syndrome, many pregnancy-related issues, melanoma, memory and cognitive changes associated with perimenopause, mental illness other than depression,

1

For brevity, diseases, disorders, and conditions are sometimes referred to here as conditions.



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3 Research on Conditions with Particular Relevance to Women This chapter discusses women’s health research of the last 2 decades ac- cording to conditions.1 The committee limits its discussion according to its characterization of women’s health in Chapter 1—conditions that are specific to women; that are more common or serious in women; that have distinct causes, manifestations, outcomes, or treatments in women; or that have high morbidity or mortality in women. Appendix B summarizes the incidence, prevalence, and mortality data and trends that, in part, guided committee selections. Given the impossibility of presenting all research on women’s health, the committee first discusses examples of successful research that contributed to progress in women’s health. The committee assessed progress on the basis of decreases in incidence or mortality or on the basis of scientific innovations that led to major transformations in approaching a condition. The committee then discusses conditions on which some progress has been made and those on which little progress has been made and about which heightened awareness and further research are needed. Although aware of comorbidities and cross-cutting issues, the committee organized the data for this chapter by condition to reflect of pre - dominant models of research funding and publications. The committee is aware that the conditions do not include all health con - ditions that are important to women; a number of conditions that affect many women’s quality of life—including arthritis, chronic fatigue syndrome, chronic pain, colorectal cancer, eating disorders, fibromyalgia, incontinence, irritable bowel syndrome, many pregnancy-related issues, melanoma, memory and cogni - tive changes associated with perimenopause, mental illness other than depression, 1 For brevity, diseases, disorders, and conditions are sometimes referred to here as conditions. 

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 WOMEN’S HEALTH RESEARCH migraines, sexual dysfunction, stress-related disorders, thyroid disease, and type 2 diabetes—are not discussed here. Because of the volume of literature available, the committee could not discuss the research on all health conditions important to women and on some conditions there was little research to discuss. Absence of discussion does not indicate that the committee thought it unimportant. The committee highlighted conditions to provide examples of successes and examples of less progress on which overarching conclusions and recommendations can be based. The diseases on which there has been substantial progress are breast cancer, cardiovascular disease, and cervical cancer. Conditions on which there has been some progress are depression, human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), and osteoporosis. The committee discusses research on other conditions—unintended pregnancy,2 maternal mortality and morbidity, autoimmune diseases, alcohol and drug addiction, lung cancer, gyne - cologic cancers other than cervical cancer, non-malignant gynecological disor- ders, and dementia of the Alzheimer type (Alzheimer’s disease)—on which little progress has been made. Each condition is discussed with regard to a brief evaluation of advances in research; its relevance to women’s health in terms of current incidence, preva- lence, and mortality rates and trends therein; disparities in current incidence, prevalence, and mortality rates and trends therein among groups of women (see Box 3-1 for explanation of data on disparities); advances in research, particularly in relation to women’s health encompassing research on the understanding of the biology, prevention,3 and diagnosis of, screening, and treatment for it; research gaps; and lessons learned from the research and extent of progress. When discuss- ing treatments, the committee focuses on conventional treatments and does not discuss complementary and alternative medicine (CAM) in detail. As discussed in a previous Institute of Medicine (IOM) report (2005), women are more likely than men to seek CAM therapies and, therefore, those therapies are important to consider when looking at women’s health, from the perspective of potential therapies as well as their potential toxicities and interactions with other medica - tions. The reader is referred to the previous IOM report for further details on CAM research (IOM, 2005). It is important to note that trends in incidence need to be interpreted in the context of changes in diagnostic criteria and technologies, which can result in the appearance of an increased incidence of a condition (see Box 3-2). This chapter addresses questions 2, 3, and 4 from Box 1-4, whether women’s health research is 2The committee considered whether to discuss unintended pregnancy as a health outcome or a determinant of health. It decided to discuss it as an outcome, along with maternal mortality and mor- bidity, and discuss the determinants that increase the rate of unintended pregnancies in Chapter 2. 3 Non-biological determinants of health are mentioned only briefly in this chapter. Details of re - search on them are discussed in Chapter 2.

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 RESEARCH ON CONDITIONS WITH PARTICULAR RELEVANCE TO WOMEN BOX 3-1 Data on Disparities Incidence, prevalence, and trend data across races and ethnicities are pre- sented as available. For some conditions for which there is active surveillance, such as cancer, data are routinely collected and presented by race or ethnicity. For other conditions, data are available from the published literature. BOX 3-2 Interpretation of Changes in Incidence In looking at changes in incidence, it is important to consider whether an increase or a decrease in a rate is due to a real trend in occurrence or to a change in diagnostic criteria, sensitivity of diagnostic tests, screening programs, or another external factor that changes the likelihood of finding a case and might make it appear that incidence is changing (Devesa et al., 1984). For example, some increases seen in breast-cancer incidence have been attributed to more intensive screening programs increasing the ascertainment of cases and not an increase in the secular trend (Seigneurin et al., 2008). focused on the most appropriate and relevant conditions and end points, whether it is studying the most relevant groups of women, and whether the most appropri- ate research methods are being used. CONDITIONS ON WHICH RESEARCH HAS CONTRIBUTED TO MAJOR PROGRESS Breast Cancer The committee considered a large and diverse body of scientific research on breast cancer to have contributed to major progress in understanding the basic biology of breast cancer and the identification of specific risk factors, which led to prevention efforts; in improvements in the detection and treatment of breast cancer; and ultimately in a decrease in mortality rates. Incidence, Prevalence, and Mortality in Women During the last 2 decades, there has been heavy investment in breast-cancer research owing in part to the lobbying efforts of breast-cancer survivors and

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 WOMEN’S HEALTH RESEARCH advocates (IOM, 2004a). One example is the authorization by Congress of a new funding mechanism for breast-cancer research through the Department of Defense, initially focused on pursuing interservice research on breast-cancer screening and diagnosis for military women and dependents of military men (IOM, 2004a). Increased funding was also made available from the National Cancer Institute, other government agencies (such as the Centers for Disease Control and Prevention [CDC] and the Agency for Healthcare Research and Quality [AHRQ]), and individual statewide programs (such as the California Breast Cancer Research Program, funded with tobacco-tax funds). In parallel, the private philanthropic community—such as the Susan G. Komen Foundation, the Breast Cancer Research Foundation, and Avon—raised awareness and money for research to improve treatment and quality of life of the growing number of breast-cancer survivors. After remaining relatively steady from 1975 to 1990, the overall invasive– breast-cancer mortality in women in the United States began a steady fall in 1990 and continued to drop each year between 1998 and 2007 (NCI, 2010a). The age-adjusted mortality4 from invasive breast cancer dropped from 33.1 per 100,000 women in 1990 to 22.8 per 100,000 women in 2007 (NCI, 2010a). A consortium of investigators using 7 statistical models indicated that the portion of the reduction in mortality attributable to improved or increased screening varied from 28 to 65% (median, 46%), and the remainder was attributed to improved adjuvant therapies (Berry et al., 2005). Breast cancer, however, is still the sec- ond-leading cause of cancer deaths in women in the United States (ACS, 2009a; CDC, 2010).5 Despite many gains from research and regardless of the recent drop in mortality, the incidence of breast cancer in women is higher now than in 1975, and breast cancer is the most common non-skin cancer in women in the United States, estimated to account for about 28% of new cancer cases in 2010 (Jemal et al., 2010). The age-adjusted incidence of breast cancer was as high as 141.2 per 100,000 women in 1998 and 1999, and decreased to 124.7 per 100,000 women in 2007, up from about 100–105 per 100,000 women in 1975–1980 (NCI, 2010b). Much of the increase between 1980 and 1998 occurred during the 1980s and re- flected increased detection of localized tumors through increased mammographic screening (Garfinkel et al., 1994; Miller et al., 1991; White et al., 1990). During those years, the incidence increased in every 4-year age group above 45 years. From 1999 to 2003, the age-specific incidence of breast cancer decreased in every age group over 45 years (Jemal et al., 2007). Jemal and colleagues (2007) con - 4 Data are from US Mortality Files, National Center for Health Statistics, Centers for Disease Control and Prevention. Rates are age-adjusted to the 2000 US Standardized Population (19 age groups—Census P25-1130). 5 Lung cancer is the leading cause of cancer death in women; cardiovascular disease is the leading cause of death overall in women (see Appendix B for data).

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 RESEARCH ON CONDITIONS WITH PARTICULAR RELEVANCE TO WOMEN cluded that part of the decrease is “consistent with saturation in screening mam - mography.” The large decreases in invasive estrogen-positive breast cancers seen after July 2002 have been attributed to the identification, through the Women’s Health Initiative (WHI), of an increased risk of breast cancer associated with the use of menopausal hormone therapy and a precipitous decline in the number of hormone prescriptions filled after the rapid dissemination of that finding to women who were on hormone therapy (Chlebowski et al., 2009; Hausauer et al., 2009; Ravdin et al., 2007). Sharp decreases in breast cancer from 2002 to 2003 were seen in estrogen-positive tumors in women 50–69 years old (Jemal et al., 2007) and, in a study of white women, were largest in urban counties and counties that had low poverty rates (Hausauer et al., 2007). Disparities Among Groups Large disparities in breast-cancer incidence and mortality exist among differ- ent demographic groups (see Figure 3-1). Breast cancer is one of the few diseases whose incidence is higher in white women than in other ethnic groups; however, black women have higher mortality. Breast-cancer mortality increased in black women from 1975 to 1995—a period when breast cancer mortality in white women decreased (NCI, 2010b). Mortality in black women leveled off and began to decrease in 1995 (see Figure 3-1), but in 2005 mortality in black women (32.8 per 100,000) was still higher than in white women (23.3 per 100,000). The dispar- ity is particularly high in black women under 50 years old (Baquet et al., 2008; DeSantis et al., 2008; Ghafoor et al., 2003; Grann et al., 2006). Both incidence and mortality are lower in Hispanic, Asian and Pacific Islander, and American Indian and Alaskan Native women than in white or black women (Ghafoor et al., 2003). Recently, Kinsey and colleagues (2008) examined breast-cancer mortal - ity in black and white women in 1993–2001 as related to 4 levels of education. Mortality decreased by 1.4% in white women who had less than 12 years of edu - cation and by 4.3% in white women who had more than 16 years of education. In black women, a decrease (3.8%) was seen only in women who had more than 16 years of education; this shows an association of both race and education with breast-cancer mortality. American Indian and Alaskan Native women are also more likely to receive a diagnosis of late-stage disease than non-Hispanic white women (Wingo et al., 2008). Research has documented that Ashkenazi Jewish women have a genetic susceptibility to breast cancer (Rubinstein, 2004). The high case-fatality rate from breast cancer in black women had been hy- pothesized as being due to differences in biologic factors and in access to timely screening and care (Ademuyiwa and Olopade, 2003; Shavers and Brown, 2002). The Carolina Breast Cancer Study showed that basal-like breast tumors were more prevalent among premenopausal African American women than among postmenopausal African American and non–African American women. That sug- gests a biologic cause of the excess mortality in young black women and leads

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00 WOMEN’S HEALTH RESEARCH 150 White Black 125 Asian/ Pacific Islander 100 Rate/100,000 75 Hispanic‡ American Indian/ Alaska Native† 50 25 0 ’75 ’76 ’77 ’78 ’79 ’80 ’81 ’82 ’83 ’84 ’85 ’86 ’87 ’88 ’89 ’90 ’91 ’92 ’93 ’94 ’95 ’96 ’97 ’98 ’99 ’00 ’01 ’02 ’03 ’04 ’05 a) Year of Diagnosis 40 Figure 3-1a.eps Black 35 30 White Rate/100,000 25 American Indian/ Hispanic‡ 20 Alaska Native† 15 Asian/ 10 Pacific Islander 5 0 b) ’75 ’76 ’77 ’78 ’79 ’80 ’81 ’82 ’83 ’84 ’85 ’86 ’87 ’88 ’89 ’90 ’91 ’92 ’93 ’94 ’95 ’96 ’97 ’98 ’99 ’00 ’01 ’02 ’03 ’04 ’05 Year of Death FIGURE 3-1 Annual breast cancer (a) incidence and (b) mortality in the United States by race or ethnicity. Incidence source: Surveillance, Epidemiology, and End Results (SEER) Figure 3-1b.eps Program, National Cancer Institute (NCI)—1975–1991, SEER 9; 1992–2005, SEER 13. Mortality source: US Mortality Files, National Center for Health Statistics, Centers for Disease Control and Prevention. Rates age-adjusted to the 2000 US standard population (19 age groups—Census P25-1130). †Rates for American Indians and Alaska Natives based on Contract Health Service Delivery Area counties. ‡Hispanics are not mutually exclusive from whites, blacks, Asians and Pacific Islanders, and American Indians and Alaskan Natives. Incidence data on Hispanics are based on the North American Association of Central Cancer Registries Hispanic Identification Algo - rithm and exclude cases from the Alaska Native Registry. Mortality data on Hispanics do not include cases from Connecticut, Maine, Maryland, Minnesota, New Hampshire, New York, North Dakota, Oklahoma, and Vermont. SOURCE: http://www.cdc.gov/cancer/breast/statistics/race.htm (accessed May 3, 2010).

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0 RESEARCH ON CONDITIONS WITH PARTICULAR RELEVANCE TO WOMEN to the option of more aggressive therapies for this patient cohort (see below for discussion of treatment options) (Carey et al., 2006). Issues related to access to screening and care are discussed in Chapter 2; more details on the biology of breast cancer are discussed below. Research Advances in Knowledge of Biology Epidemiologic research has identified a variety of factors that are associ - ated with changes in reproductive hormones that are also associated with breast cancer, such as age at first full-term pregnancy, number of full-term pregnancies, breastfeeding, and age at menarche and menopause. Through many types of stud- ies, research has uncovered the role of estrogen in breast-cancer pathogenesis. It is known that estrogen binds to nuclear estrogen receptor α and, with the addition of cofactors, stimulates cell proliferation (Hall and McDonnell, 2005), and it is thus a risk factor for breast cancer. During the last decade, a second estrogen re - ceptor, estrogen receptor β was identified (Kuiper et al., 1996; Mosselman et al., 1996). It is thought that estrogen mediates estrogen–receptor–signaling cross-talk with insulin-like growth-factor receptors to mediate breast-cancer pathogenesis (Clemons and Goss, 2001; Lee et al., 1999). A family history of breast cancer is also a risk factor for breast cancer, and genetic research has provided an understanding of many of the mechanisms that underlie breast cancer (Hua et al., 2008; Olopade et al., 2008). Mutations in two tumor-suppressor genes—BRCA and BRCA—are associated with breast cancer (Antoniou et al., 2008; Claus et al., 1998; Collins et al., 1995; Easton et al., 1993; Hall et al., 1990; Schubert et al., 1997) and responsible for 5–10% of breast cancers (ACS, 2010a). The germ-line BRCA and BRCA mutations are highly penetrant and greatly increase a person’s risk of breast cancer (Easton et al., 1993; Rowell et al., 1994). BRCA breast cancers are typically poorly dif- ferentiated, high-grade, infiltrating ductal carcinomas and are usually estrogen- receptor (ER)–negative, progesterone-receptor–negative, and Human Epidermal Receptor type 2 (HER2)/neu–negative (Bordeleau et al., 2010). BRCA breast cancer is characterized by early age of onset, bilaterality, and association with a risk of ovarian cancer (Frank et al., 1998; Krainer et al., 1997). Later research has identified other gene mutations that are associated with an increased risk of breast cancer, including TP (the human gene that encodes P53), PTEN, CASP, FGFR, MAPK, and LSP (see Garcia-Closas and Chanock, 2008, for review). Most of those mutations are low-penetrance variants, and much of the genetic component of breast cancer is not accounted for by known gene mutations. The understanding of the cellular biology of breast cancer has improved over the past 2 decades, contributing to the development of a number of therapies directed toward interrupting pathways in breast-cancer cells for the prevention and treatment of breast cancer. In particular, the roles of a number of receptors in breast-cancer cells have been identified. Approximately two-thirds of breast cancers express ER. There are two types of estrogen receptors (α and β), but at

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0 WOMEN’S HEALTH RESEARCH present only ERα has any known clinical significance. Withdrawal of estrogen (by oophorectomy) was shown to be an effective treatment for breast cancer in the 1890s (Beatson, 1896). Subsequently developed therapies directed toward interrupting the estrogen/ER pathway have been prime tools in treatment and prevention of breast cancer (see below). HER2, also know as erbB2 and c-neu, is a member of the epidermal growth factor receptor family. Approximately 20–30% of breast cancers have amplified HER2 gene and/or over-express the protein (Cooke et al., 2001; Press et al., 1993; Slamon et al., 1987, 1989; Wolff et al., 2007; Zell et al., 2009). HER2 has been shown to be associated with poorer prognosis in women with newly diagnosed breast cancer, but it is also the target of specifically designed therapeutics directed toward it. In addition to the ER and HER2 systems, several other important biologic pathways have been identified that have been shown or might serve as thera- peutic targets in breast cancer. These include neo-angiogenesis, as mediated by the vascular endothelial growth factor (VEGF). This molecule is the target for bevacizumab, which has activity in the metastatic setting (Miller et al., 2007). Other investigational pathways include, but are not limited to, the insulin-like growth factors (IGFRs), mammalian target of rapamycin (M-TOR), AKT, PI3K, and MEK. Research Advances in Prevention Many factors and exposures that are associated with both increasing and de- creasing risk of breast cancer can be addressed to help to decrease the incidence of breast cancer, including those presented in Box 3-3. A major research finding from the WHI was the confirmation of an increased risk of breast cancer associated with the use of conjugated equine estrogen plus progestin (Prempro™) but not with estrogen alone (Premarin™) (Chlebowski et al., 2003; Writing Group for the Women’s Health Initiative Investigators, 2002). The dissemination of that finding resulted in a rapid decrease in the use of menopausal hormone therapy (Haas et al., 2004; Hersh et al., 2004) and a later decrease in breast cancer incidence (Krieger et al., 2010; Ravdin et al., 2007). That decline, however, was not seen equally across all socioeconomic, racial, and ethnic groups (Krieger et al., 2010). Alcohol, even in moderate amounts, can increase the risk of breast cancer 6 (see Suzuki et al., 2008, for meta-analysis), as can poor diet (see Norman et al., 2007, for review), and more specifically, obesity (Brown and Simpson, 2010; Schapira et al., 1994; Vainio and Bianchini, 2002a). Evidence suggests that the common mechanism whereby alcohol and obesity increase the risk of breast can - 6 Both the adverse and beneficial effects of alcohol consumption are discussed further in Chap - ter 2.

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0 RESEARCH ON CONDITIONS WITH PARTICULAR RELEVANCE TO WOMEN BOX 3-3 Factors Associated with Breast Cancer Factors Associated with Increased Risk of Breast Cancer Hormone therapy Ionizing radiation Obesity Alcohol Genetic factors Factors Associated with Decreased Risk of Breast Cancer Exercise Early pregnancy Breastfeeding Treatments Associated with Risk of Breast Cancer Selective estrogen-receptor modulators Aromatase inhibitors or inactivators Prophylactic mastectomy SOURCE: National Cancer Institute. http://www.cancer.gov/cancertopics/pdq/prevention/ breast/HealthProfessional (accessed August 3, 2010). cer is an increase in estrogen, which stimulates the proliferation of breast tissue (Brown and Simpson, 2010; Cleary et al., 2010; Ginsburg et al., 1996). The rela - tionship between smoking and breast cancer is not clear. As reviewed by Coyle (2009), although data on deoxyribonucleic acid (DNA) adducts provide biological plausibility for an association between smoking and breast cancer, epidemiology studies have either shown no association or an inverse association. There is some evidence, however, that smoking during a first pregnancy (Innes and Byers, 2001) and secondhand-smoke exposure are associated with an increased risk of breast cancer (Cal EPA, 2005). The research on relevant behavioral factors is discussed in more detail in Chapter 2. Exposure to ionizing radiation can increase the risk of breast cancer, espe- cially if it occurs before the age of 20 years (Ronckers et al., 2005). Most studies that showed an increased risk of breast cancer in association with exposure to ionizing radiation looked at radiation levels higher than occur in mammography (Nelson et al., 2009a). However, exercise, early pregnancy, and number of pregnancies predict a decrease in breast cancer, again with some evidence of a role of estrogen in the altered risk (Bernstein, 2008; Britt et al., 2007; Monninkhof et al., 2007; Pines, 2009). Preventive measures apart from modifying risk factors have been developed for people at high risk for breast cancer. Recommendations for preventive options for breast cancer depend on a person’s risk (Guarneri and Conte, 2009; Sparano

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0 WOMEN’S HEALTH RESEARCH et al., 2009). In very high-risk people—those who have a germ-line mutation in BRCA or BRCA with lobular carcinoma in situ and a strong family history of breast cancer—prophylactic mastectomy is an option to consider to reduce the risk of breast cancer (Bermejo-Pérez et al., 2007; Kaas et al., 2010; Nusbaum and Isaacs, 2007; Zakaria and Degnim, 2007), as is prophylactic oophorectomy (Metcalfe, 2009; Rebbeck et al., 2009). For people who have a high risk because of family history, chemoprevention is available. During the last 2 decades, 2 large sequential breast-cancer-prevention trials of healthy women at high risk for breast cancer demonstrated that treatment with tamoxifen (a selective estrogen recep - tor modulator) for 5 years could reduce the risk of invasive breast cancer by at least 50% (Fisher et al., 1998; Veronesi et al., 2007). Tamoxifen also reduced the risk of recurrent breast cancer after treatment in both younger and older women (Cuzick et al., 2003; Lewis, 2007; Schrag et al., 2000). In a study of postmeno - pausal women with a mean age of 58.5 years, tamoxifen and raloxifene (a selec - tive estrogen receptor modulator approved for prevention of osteoporosis) had similar efficacy in reducing the risk of invasive breast cancer (Vogel et al., 2006). As a result of that research, older women at high risk for breast cancer now have two US Food and Drug Administration (FDA)–approved medications that reduce the risk of breast cancer and of osteoporosis. Side effects, however, contribute to low acceptance and use of tamoxifen (Fallowfield, 2005). In addition, identifying at-risk people can pose a problem. Research Advances in Diagnosis A number of diagnostic and screening methods—screen-film mammography, digital mammography, ultrasonography, magnetic resonance imaging (MRI), and biopsy—can identify breast cancer at earlier stages and facilitate early treatment. The most widely used imaging technology for breast-cancer screening is mammography. Eight randomized trials evaluated the effectiveness of screening mammography in the United States (Shapiro, 1988; Shapiro et al., 1988), Sweden (Andersson and Janzon, 1997; Bjurstam et al., 2003; Frisell and Lidbrink, 1997; Nystrom et al., 2002; Tabar et al., 1995), Canada (Miller et al., 2000, 2002), and the United Kingdom (Alexander et al., 1999). Although criticisms of those trials have been published (Gotzsche and Olsen, 2000; Olsen and Gotzsche, 2001), independent review concluded that there was strong evidence of the effective- ness of mammography for women over 50 years old (Fletcher and Elmore, 2003; Health Council of the Netherlands, 2002; US Preventive Services Task Force, 2002; Vainio and Bianchini, 2002b). According to a meta-analysis that included all the trials, 15-year mortality from breast cancer in women 50–69 years old was decreased by 20–35%, and the reduction was statistically significant; it was reduced in women between 40–49 years old by about 20% (Fletcher and Elmore, 2003). Results of individual trials and another meta-analysis suggest statistically

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0 RESEARCH ON CONDITIONS WITH PARTICULAR RELEVANCE TO WOMEN significant reductions of 29–44% in the population 40–49 years old (Andersson and Janzon, 1997; Bjurstam et al., 2003; Hendrick et al., 1997). Some research - ers have noted that screening mammography is associated with a high rate of false positives and overdiagnosis (that is, diagnosis of and treatment for some cancers that might not progress and cause morbidity or death) (Esserman et al., 2009). Such overdiagnosis results in patients being subjected to adverse effects of breast-cancer treatments and being labeled as having a “preexisting condition,” which can affect insurance coverage7 and raise emotional issues (Esserman et al., 2009). This points to the need to be able to differentiate between tumors that will progress and metastasize from those that will not. Recently, the US Preventive Services Task Force (2009) recommended “against routine screening mammog- raphy in women aged 40 to 49 years.” Instead, the task force said the decision to have mammography before the age of 50 years should be an individual choice and take into account individual risks and “the patient’s values regarding specific benefits and harms.” Those guidelines, however, are very controversial, “have had a polarizing effect in the breast-cancer community,” and have led to “confu - sion, fear, and anger on the part of patients with breast cancer, their families, and women’s health advocates” (Partridge and Winer, 2009). The communication of those guidelines is discussed further in Chapter 5. The technology associated with mammography has improved substantially since the first studies of its efficacy. Major developments included more-sensitive high-resolution image intensifiers and film, low-absorption cassettes, and dedi - cated film processors, all of which contributed to radiation-dose reductions for women (Price and Butler, 1970). Changes in mammography tubes (for example, the use of molybdenum targets and filters with beryllium windows and smaller focal spots and the use of moving grids) improved image quality (Haus, 1990; Muntz and Logan, 1979). Digital mammography was developed to overcome the limitations of screen- film mammography, such as difficulty visualizing low-contrast objects against dense backgrounds (Pisano and Yaffe, 2005; Shtern, 1992). Clinical trials (with - out death as an end point) have demonstrated that its diagnostic accuracy is equivalent to that of film mammography for the general population (Lewin et al., 2002; Pisano et al., 2005; Skaane et al., 2007; Vinnicombe et al., 2009), but that digital mammography has better accuracy than film in premenopausal and perimenopausal women, women who have dense breasts, and women less than 50 years old (Pisano et al., 2005). As of August 2010, 68.5% of accredited US mammography units were digital (FDA, 2010)—up from 36% in January 2008 7 Under the Patient Protection and Affordable Care Act (Public Law 111-148) insurers will be pro - hibited from denying or charging more because of preexisting illnesses.

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