Developing Technologies for Early Detection of Breast Cancer: Public Workshop Summary #2

IOM Committee on the Early Detection of Breast Cancer:

Second Workshop, June 19–20, 2000

INTRODUCTION

In November 1999, the Institute of Medicine, in consultation with the Commission on Life Sciences, the Commission on Physical Sciences, Mathematics, and Applications, and the Board of Science, Technology and Economic Policy initiated a one-year technology assessment study on emerging technologies for the early detection of breast cancer. The committee's mandate was twofold: (1) to review emerging technologies that could potentially aid in earlier detection of breast cancer and (2) to recommend priorities for bolstering the technology development, evaluation, and adoption process, with the goal that such development could reduce breast cancer burden and deaths. As part of its charge, the committee held two workshops. At the first public workshop, held in February 2000, outside experts were invited to describe a variety of promising emerging early detection technologies. A second workshop, held June 19-20, 2000, examined several factors that influence whether or not a new cancer detection technology is developed, tested, and enters the clinic; how fast the technology development process proceeds; the key players in the technology development process; and the current climate for technology development.

As described at the first workshop, many new and improved technologies are being studied for the early detection of breast cancer, but many barriers must be overcome during the process of development, assessment, and dissemination. The expert presentations at the second



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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 Developing Technologies for Early Detection of Breast Cancer: Public Workshop Summary #2 IOM Committee on the Early Detection of Breast Cancer: Second Workshop, June 19–20, 2000 INTRODUCTION In November 1999, the Institute of Medicine, in consultation with the Commission on Life Sciences, the Commission on Physical Sciences, Mathematics, and Applications, and the Board of Science, Technology and Economic Policy initiated a one-year technology assessment study on emerging technologies for the early detection of breast cancer. The committee's mandate was twofold: (1) to review emerging technologies that could potentially aid in earlier detection of breast cancer and (2) to recommend priorities for bolstering the technology development, evaluation, and adoption process, with the goal that such development could reduce breast cancer burden and deaths. As part of its charge, the committee held two workshops. At the first public workshop, held in February 2000, outside experts were invited to describe a variety of promising emerging early detection technologies. A second workshop, held June 19-20, 2000, examined several factors that influence whether or not a new cancer detection technology is developed, tested, and enters the clinic; how fast the technology development process proceeds; the key players in the technology development process; and the current climate for technology development. As described at the first workshop, many new and improved technologies are being studied for the early detection of breast cancer, but many barriers must be overcome during the process of development, assessment, and dissemination. The expert presentations at the second

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 workshop, as summarized here, described many important influences on the development and adoption process. NIH Support for New Technologies* The National Cancer Institute has been actively developing programs to make the National Institutes of Health peer review system more accessible and friendly to technology development. According to Carol Dahl, “one problem that NCI has been struggling with is that the traditional NIH peer review system has not necessarily been friendly to non-hypothesis driven research.” The National Institutes of Health Center for Scientific Review and Office of External Research has taken a very proactive stance in tutoring the study sections that look at these applications. In addition, NCI established a new Office of Technology and Industrial Relations two years ago to facilitate expedited technology development and transfer activities. Aiming to develop a more streamlined grant application and award process for technology discovery and development, the National Cancer Institute has held several meetings with the research community. These discussions have proved fruitful and have revealed that traditional grant awards for technology development do not mesh well with the uncertain timetable of technology discovery, development, and adoption. In FY 2000, NCI invested $63.7 billion in Small Business Innovative Research (SBIR) awards and another $3.8 million in Small Business Technology Transfer Research (STTR) grants. * Based on a presentation by Carol Dahl, Director, Office of Technologies and Industrial Relations, National Institutes of Health

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 Technology development initiatives Recently launched initiatives allow for more flexibility in timing and dollar allocations. As the initiatives have been better tailored to accommodate the needs of investigators, the quality of recent grant applications has gone up substantially, according to Dahl. More focused initiatives target understanding the fundamental nature of cancer and offer researchers “extraordinary opportunities in FY 2001,” according to Dahl. Areas of focus include genes and the environment, cancer imaging, defining the signatures of cancer tumors, molecular targets of prevention and treatment, tobacco and related cancers, and cancer communications. However, the enhanced flexibility in time and dollar allocations has also made it harder for NCI to meet its commitments. Recognizing that the fundamental nature of cancer is genetic, these NCI initiatives focus on the impact of those genetic changes on the expressed products of the genome, including the RNA, the proteins, and the protein interactions that create the functional networks themselves. Of particular interest to NCI are technologies that will permit evaluating multiple levels of analysis: the in vitro (test tube) level, in situ (cellular) level, and in vivo (whole body) level. The Institute is also backing the development of modeling tools, as well as supporting work on the discovery phase - determining the tumor's molecular signature. As the Institute envisages this work, it hopes that emerging technologies will provide the tools for molecular detection, diagnosis, and also facilitate finding new targets for interventions as well. Phased Innovation Award The Phased Innovation Award is a new mechanism directed at supporting technology research from the evolution of the innovative concept to the research development phase.

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 Compared with the traditional R21 grant application process, which awards funding in a two-step process and has proved cumbersome in furthering technology development, the Phased Innovation Award allows for a single submission of two previously distinct awards (the R21 [proof of concept phase]) and the R33. The Phased Innovation Award couples the two awards into one. To move into the second phase, investigators must achieve measurable milestones. Advantages of the new award are that it can be expedited through an administrative review, it eliminates the resubmission of a grant and forces investigators to think toward the future. In considering awards for detection technologies, drug discovery, the award permits flexible staging for research up to four years. Additionally, there is an ongoing open window for grant awards, with three receipt days yearly. According to Dahl, the molecular analysis community has responded enthusiastically to the program and she predicts considerable program expansion. Annual expenditures for the program approximate $12 million, with an additional $23 million expended in small business awards. Additionally, the Phased Innovation Award is beginning to be used as a funding model across the National Institutes of Health. Technology development on the molecular analysis of cancer The Institute has also created an additional mechanism to bolster study for molecular analysis awards that enables researchers to expedite studying the utility of a novel technology on sample type of interest to the investigator. Under the first phase, the investigator must show proof of concept in a pilot biological application and then can generate the data that would permit continuing on to the next phase. The feasibility stage (formerly the R21) can extend up to two years; the R33 can last between one to three years. This mechanism provides funding for a maximum of four years, enables a parallel solicitation in the business community, and grant

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 applicants can apply on three calendar dates per year. So far, this grant mechanism has proved very popular in the biotechnology community. Cancer imaging The National Cancer Institute is also pursuing enhancing opportunities that bring the molecular world together with the imaging community, with the goal of identifying the fundamental molecular signature of tumors. Several program announcements address this area, including developmental grants for diagnostic cancer imaging and the study of novel imaging modalities. The Institute has also promoted the study of imaging agents and probes, especially those that have the potential to better pinpoint the molecular signature of tumors. In structuring these grants, NCI is hoping to fund them so that they have a good shot of making it through the assessment of the technology's clinical utility. The Phased Innovation Award has been the springboard for some of this work. Grant awards in this area were announced last spring. Another new program at NCI aims to enhance multidisciplinary research and reach out to investigators that have not had access to materials and a research environment available at institutions like the National Institutes of Health. Modeled after the developmental therapeutics program, this new program facilitates better access to chemistries, production resources, scaling of production, and other areas. A new Request for Proposal was released that focuses on the development of clinical imaging agents.

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 Research is focused on several phases of the technology development process, including those that expand discovery. A new Request for Proposal is out on ultrasound research interface, as well as an RFA (request for applications) on small animal imaging resource programs. Looking at breast cancer screening technology development and testing specifically, efforts are underway through Dr. Dahl's office to partner academic institutions with small business and research cooperative groups. Study of digital mammography is a case in point. Information systems development There is a tremendous need for information systems development in the area of high throughput biological analysis, according to Dahl. To optimize technology discovery and development, NCI director Richard Klausner, M.D. has played an active role in promoting database creation and management storage that will permit modeling, manipulation, and hypothesis generation. NCI is actively building a Biomedical Information Science and Technology Implementation (BISTI) plan. In part, through an NIH director forum, recommendations for BISTI's development are emerging. Key recommendations include supporting planning grants in national Centers of Excellence, furthering investigator-initiated research, bolstering the Information Storage, Curation, Analysis and Retrieval (ISCAR) program, coordinating work across NIH, and building a computing infrastructure. Initiatives were slated for announcement in June 2000. Initially, investments will focus on traditional, low risk, evolutionary projects, but BISTI will move towards long term, higher risk investments.

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 Unconventional Innovations Program Under the management of Dr. Dahl's Office of Technology and Industrial Relations, NCI is trying a new nontraditional multidisciplinary program through its new Unconventional Innovations Program. Besides reaching out to recruit new investigators and build multidisciplinary teams, the program is actively engaged in translating technology into other nontraditional domains. The program is modeled after the Defense Advanced Research Projects Agency (DARPA) and emphasizes technology maturation and export. This program solicits contracts for the development of Novel Technologies for Noninvasive Detection, Diagnosis, and Treatment of Cancer. According to the most recent solicitation brochure, the program is “specifically soliciting projects to develop technology systems or systems components that will enable the sensing of defined signatures of different cancerous and precancerous cell types or their associated microenvironment in the body in a way that is highly sensitive and specific, yet non-intrusive. The highest priority is for systems that can either support or provide a seamless interface between sensing/detection and intervention. ” The first five awards totaling $11.3 million were issued in 1999 and Dahl anticipates investments up to $18 million over three years in 2000. Within the next five years, NCI plans to invest $48 million in this program. Taking a new tack, the Unconventional Innovations Program is putting its major focus “on the development of technology that will target quantum improvements in existing technologies or entirely novel approaches, rather than incremental improvements to state of the art,” states an NCI brochure describing the program. Integrating detection and care Through most of these programs, NCI is making a concerted effort to move into a prevention, precancer focus, thus finding disease before masses are palpaple. In addition, the

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 Institute is also working to integrate prevention, detection, diagnosis, and treatment efforts in these programs. The goal is to build a common platform that enables identifying the tumor's molecular signature, interpreting what it means, and enabling early intervention. Such a program must incorporate resources for sensing, communication, data analysis, and judgment into a single platform. Venture capital investment* Investment of venture capital is key in providing start-up monies for developing new screening technology, “but investment trends have not been favorable to healthcare,” according to William McPhee, who heads a venture capital fund that exclusively invests in medical imaging. Venture capital (VC) firms view investment in the healthcare sector as a high-risk proposition. Major hurdles that stand in the way of investing in the screening sector include unfavorable reimbursement and slow adoption rates for new screening technologies. Regulators and others view incremental improvements in screening accuracy and medical imaging skeptically, as adding little value over existing screening techniques. “It's very difficult to rationalize investment in breast cancer detection technologies,” said McPhee. Typically, venture capital firms raise capital, make investments, build a company, and then harvest - or sell the assets. Until the last two years, a venture capitalist' s investment horizon was between four-to-ten years. From investment, the cycle took about five years, with approximately another three-to-four years to harvest. That cycle has changed radically in the last two years, largely driven by the Internet, with astronomical investments and rates of return. The * Based on a presentation by William McPhee, Managing General Partner, Mi3 Venture Capital, a venture capital fund that is focused solely on medical imaging.

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 investment-to-harvest cycle is down to 18 months. “Never before has so much venture capital money been deployed so fast for such high returns, but these rapid investments and high returns are not occurring in healthcare, which is no longer the darling of investors,” according to McPhee. The venture capitalist looks for return on investment (or ROI). The venture capital funds are booming because the ROI is at an all-time high, hitting 143% last year. In the 4th quarter of 1999, venture capital firms pumped $160 million dollars per day into entrepreneurial companies, with many of these returns driven by the Internet. McPhee does not believe that this is a sustainable rate of return, yet even so, he sees screening as a poor contender for making back high returns quickly. Today, the VC industry increasingly looks to score a home run, focusing on the “super deal,” rather than investing in a broader portfolio of assets. To make this happen, venture capitalists look for an industry-dominant company that plans to go public in two years. In the past, approximately 20% of companies that went public didn't turn a profit, but now, roughly 80% that go public don't turn a profit, although the recent downturn in Internet and technology stocks has put a damper on that trend. Still, the VC industry looks for a superstar management team with leaders that can bridge the gap between science and the business world. Venture capitalists look for a proprietary product with an immense market, sales projected at $1 billion or more, clearly identified customers, no dominant competitors, and excellent distribution channels. Other factors that venture capitalists look for before they invest today are a digestible first round and ten times their investment back in five years.

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 Healthcare simply cannot generate these rates of returns in the current environment. Most importantly, in the last few years, device companies have not proven to make money over the long haul for venture capitalists. Other factors make health care, particularly screening technologies, a poor contender for investment. Assessing the competitive landscape of technologies in healthcare is tough because of immense competition on the horizon. Another dilemma facing the VC industry is how to move medical culture to change practices and implement new technology. Not only must VC firms contend with how long it will take them to get approval for their technology, but they must also consider— to what extent— an innovative technology can supplant the gold standard, and the medical community's resistance to using new technology. McPhee believes that the broad use of mammography as a screening standard will make it difficult to introduce other technologies, no matter how powerful they are. Investing in new screening technologies is especially difficult because many novel diagnostic techniques have no immediate therapeutic implications. Reimbursers simply won't pay for the technology if the therapeutic implications are uncertain. McPhee argued further that contemporary low or static reimbursement structures, particularly coming from the Health Care Financing Administration, discourage venture capital investment. Not only does HCFA determine Medicare reimbursement for screening, but HCFA rates also set the pace for managed care, creating strong incentives for inertia in VC investment. Other considerations that the VC industry must take into account include defining the customer and assessing true value for new technologies. Venture capitalists have little confidence in finding strong management teams in the healthcare sector, and perceive healthcare (and breast disease in particular) as a high-risk, low-reward sector. Distribution is also daunting

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 from the venture capitalists' perspective because it is difficult to assess and gain distribution in a highly consolidated industry. Building your own sales force is virtually impossible. Another major barrier is an underlying cottage industry mentality and resistance to standardization in healthcare. Not surprisingly, venture capital investment in healthcare has plunged from about 25% traditionally to about 11% in the last quarter of 1999, with about 3 points of that going into Internet-related healthcare ventures. Thus, the real number going into non-Internet related healthcare has dropped approximately 8%. In evaluating medical imaging, McPhee says that his venture capital firm looks at imaging as an integrated sector, rather than as bits of technology. Looking beyond his firm, he says that medical imaging is misunderstood and undervalued in terms of the size and scope of its implications. He views imaging as “the fulcrum of most decisions in the life sciences,” not unlike genetics. McPhee's venture capital firm works closely with corporate partners, including Kodak and Bracco. The practice plan of Indiana University's Department of Radiology is also a limited partner. His firm also works with a strategy firm to do the market analysis, including assessing the adoption rate and the prospects for reimbursement. In evaluating various market volume scenarios, McPhee believes that unless a technology can do both screening and diagnosis, it will prove very difficult to justify the capital risk. The “special breast ” market has been of considerable interest to venture capitalists. This market would include women with dense breasts, scar tissue, and implants. However, it also suffers from similar limitations.

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 In March 2000, the President's Cancer Panel framed seven questions aimed at helping translate research into practice, particularly aimed at eliminating disparities in cancer care. Those questions are as follows: Who is under-served for cancer prevention, cancer control, and cancer care? What must we better understand to address the critical issues and to implement solutions at the macro and micro levels? What are the social/economic forces that need to be influenced at the national, regional and local levels in order to make a significant difference in the quality and consistency of cancer care? How is institutional/organizational bias on the part of the researcher overcome developing the questions to pose? What must be done to ensure that the fruits of research are incorporated into routine practice? Information dissemination is not enough. How is information consumption stimulated and what do you need to know about your consumers to respond to their needs? What infrastructure, legislative, policy, and organizational/system changes are necessary to implement solutions? Looking at the dissemination and diffusion of diagnostic imaging technologies as a good example of the challenges faced, Kerner described how different types of diagnostic imaging techniques range across a continuum of purposes. For example, some imaging techniques have uses that are “specifically procedure-related, such as laparoscopic surgery,” whereas mammography is used for disease-specific screening purposes, he pointed out. Kerner noted that

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 ultrasound is a general diagnostic method that can be used in specific areas. Finally, some imaging technologies are used as a “general technique with multiple applications,” according to Kerner, noting that computed tomography and magnetic resonance imaging fit this use. In assessing new diagnostic imaging, Kerner said that it involves “technical evaluation, assessment of diagnostic accuracy, diagnostic impact, therapeutic impact, and health impact.” The American College of Radiology Imaging Network (ACRIN) clinical trial, which will test digital mammography vs. conventional film-screen mammography, is “now under final implementation review at the National Cancer Institute,” said Kerner. In planning the design for the trial, digital mammography will be tested on a total of 49,500 women, including 15% who will be age 65 and over. At present, accrual for the trial is expected to take 1.5 years, with another 1.5 years of follow-up. Four digital mammography machines made by four different manufacturers (Fischer, Fuji, GE, and Trex) will be studied in the trial. The population will be divided into four groups, with 12,375 women examined on one of the digital mammography machines and will also receive conventional film-screen mammography. The National Cancer Institute, Health Care Financing Administration, and Food and Drug Administration are ironing out specifics pertaining to study design. In evaluating digital mammography's potential, policy-makers will have to consider several factors, such as “clinical need, technical performance, clinical performance, economic factors, and patient and societal perspectives,” said Kerner. On the clinical end, it will be important to determine whether digital mammography “reduces late-stage incidence and mortality rates for breast cancer, improves positive predictive value, and reduces the number of unnecessary biopsies”. The technical evaluation will require evaluation of “x-ray production and

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 absorption, recording of transmitted x-rays, image development and display,” said Kerner. Economic factors that must be considered include “capital and site costs, operating costs in large vs. small-volume facilities, and follow-up costs,” he said. From the patient and societal perspective, patient acceptance and access to digital technologies should be taken into account. Kerner highlighted some of the potential advantages of digital mammography, such as “near real-time operation with increased image acquisition and speed, enhanced detection efficiency, enhanced image presentation due to post-processing options, separation of detection, display and storage processes with optimization at each step, optimum application of computer-aided detection methods, electronic archival and retrieval of images, automated incorporation of images into electronic medical records, and compatibility with telemammography requirements (improved access to high quality mammography).” As clinical trials of this new technology move forward, technical improvements will need to be weighed against costs and access issues. If new imaging technologies like digital mammography prove to be both effective and cost-effective, equal access will then become the issue. If access to digital mammography is limited to resource-rich health care settings, then many under-served populations may be denied access, and health disparities may actually increase. Whether research discovery becomes translated into program delivery through changes in health policy depends, to some extent, on the relationships between researchers and policy-makers, according to Kerner. He described the importance of investing in new partnerships in cancer control between regulatory sectors of government (e.g. FDA, EPA), research (NIH, NSF), research and application (AHRQ), application and research (CDC), and application sectors (HCFA, HRSA) both in and outside of government. If such partnership investments are made today, then the dissemination and diffusion of new cancer prevention, screening, diagnostic and treatment

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 technologies in the years ahead will be enhanced, and more equal access to new technologies should contribute to reducing health disparities in the future, Kerner concluded. Access to Screening Mammography* Utilization of mammography is not evenly spread across the nation 's population, according to Diane M. Makuc, Dr. P.H., Director of the Division of Health and Utilization Analysis at the National Center for Health Statistics (NCHS). Makuc presented a snapshot of recent trends, including the most recent (through 1998) data on mammography use by family income, race, and age. The information was culled from the National Health Interview Survey (NHIS), an annual nationwide survey of 45,000 households conducted by the National Center for Health Statistics. Mammography utilization data were tracked over six years: 1987, 1990, 1991, 1993, 1994, and 1998. “The dependent variable was whether or not a woman reported having a mammogram within the past two years,” Makuc said. She also presented background epidemiological data on breast cancer incidence and outcomes and she highlighted initiatives that target reaching populations not yet adequately screened and followed for breast cancer. There are important differences in breast cancer incidence and mortality by race, according to Makuc. In 1996, the incidence of breast cancer in white women was 13% higher than for black women. However, black women had lower survival rates (71% vs. 86%) and almost 40% greater breast cancer mortality (25.3 vs. 18.3 deaths per 100,000 in 1998, * Based on a presentation by Diane M. Makuc, Dr.P.H., National Center for Health Statistics, Centers for Disease Control and Prevention. Some of these results appear in Makuc, D.M., N. Breen, and V. Freid. 1999. “Low income, race and the use of mammography”. Health Services Research 34:1 (April 1999, Part II): 229-39.

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 age-adjusted). NCHS mortality data reveal a breast cancer mortality reduction among white women since 1989, but death rates have remained relatively stable during the same period for black women. Breast cancer mortality for Hispanic, American Indian, and Asian women was one-third to one-half lower than for white women in 1998 (12.1, 10.3, and 9.8 deaths per 100,000 age-adjusted, respectively). Having said that, Makuc limited her presentation to white and black women's use of mammography because these groups have “the highest death rates for breast cancer and the most stable estimates of mammography use” over time, she pointed out. “Substantial outreach efforts have been directed towards increasing mammography use and as a result, recent mammography use (within the past two years) has risen sharply since 1987, with 69% of women age 50 and older reporting that they had a mammogram within the past two years in 1998, compared with 27% in 1987,” said Makuc. A variety of interventions have been used to promote use of mammography. These include media campaigns, system and physician reminders, letters to patients, access-enhancing mobile mammography vans, reimbursement for mammography by Medicare, and outreach by community peer leaders, all of which stress the importance of screening mammography in reducing mortality through early detection and treatment of breast cancer. According to previous research, mammography use is positively correlated with a higher income and education, having health insurance, urban residence, and having a usual source of care. Older women, especially those age 75 and over, are less likely to have mammography. Previous studies differ concerning whether black women are less likely than white women to use mammography.

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 In discussing trends between 1987-1998, Makuc reported on age, race, and income as independent variables. For 1993-1994, education, health insurance coverage, place of usual care, region, and metropolitan status were additional independent variables. Women in the 50-64 age group were analyzed separately from women age 65 and over. The NHIS analysis also examined two distinct income groups: women with family income below twice the poverty level and those with income at least twice the poverty level or higher. Between 1987 and 1991, mammography use rose rapidly among women 50-64 years of age in low- and higher-income groups, but these increases slowed between 1991 and 1994. Between 1994 and 1998, increases in mammography proceeded more rapidly for lower income women than higher income women. “Nevertheless, in 1998, use of recent mammography was about 35 percent greater for higher income- than low income-women, ” said Makuc. In the 50-64-year age group, almost one-fifth of white women had incomes that were below twice the poverty level, while 45 percent of black women were in the lowest income group in 1998. Among low-income women mammography use approximately doubled for both white and black women between 1987 and 1991. Black women increased their use of mammography by more than a third between 1991 and 1994, but similar strides were not achieved during this timeframe for low-income white women. In the next four-year period, between 1994 and 1998, the trends reversed, with low-income white women achieving increased utilization, while rates for low income black women held constant. By 1998, the percent of low-income middle-aged women reporting recent mammography was similar for white women and black women (61% and 57%). In the 65+ age group, recent mammography use “increased rapidly between 1987 and 1991 and then rose at a less rapid rate between 1991 and 1998 for both higher income and low

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 income women,” said Makuc. Higher income older women had a 27 percent greater rate of self-reported recent mammography in 1998 than low-income women. The gap in mammography use between higher income and lower income older women narrowed from a 67% gap in 1987. Seventy percent of older black women and about 40% of older white women had income below twice the poverty level in 1998. NHIS data reveal that in 1987, less than 20% of both older low-income white and black women reported having a recent mammogram examination. However, that percentage approximately doubled among low-income white women by 1991 and tripled for low-income black women by 1991. Between 1991 and 1994, older low-income black women's reported use of mammography expanded at a faster pace than it did for low-income white women. Since 1994, self-report of recent mammography use has increased for low-income white women, while the rates for black women remained stable. By 1998, “there were no significant differences between the two groups,” said Makuc. The remainder of the presentation focussed on exploring reasons why low income black women had higher rates of mammography use than low income white women during 1993 and 1994. Among low-income women 50-64 years of age, NHIS shows that in 1993-94, black women were nearly 30% more likely to report recent mammography than white women (58% vs. 45%) were. By 1998, mammography utilization no longer differed between low-income white and black women. The NHIS analysis examined the potential contribution of factors that might account for different rates of mammography among low income black women and low income white women, such as insurance coverage, residence, and access to usual care. Makuc said that there was no statistically significant difference in the percent uninsured between black and white women during 1993-94. However, low income black women were twice as likely to have

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 Medicaid coverage (33% vs. 15%), while white women were far more likely to have private health coverage (61% vs. 36%). The percentage of low income women without a usual source of care was the same for black and white women (13-14%), but black women reported using a public clinic or hospital outpatient clinic four times as often as did whites (20% vs. 5%). Place of residence also varied with race. Low income black women were nearly three times as likely as low income white women to live in the central city of a metropolitan area (58% vs. 21%) and black women were also more likely to live in the South than white women (54% vs. 40%). Using a logistic regression model, Makuc's group was able to show that “insurance coverage, place of usual source of care, and place of residence did not account for the higher screening levels reported by low-income black women compared with low-income white women in 1993-94,” she said. The analysis also shows that “the odds of having recent mammography for low-income women who have private health insurance or public health insurance was greater than 2 compared with uninsured women, ” she said. “Odds ratios for low-income women with either a doctor's office visit or clinic as a usual source of care are greater than 3 compared with women who have no usual source of care. Finally, low-income women who reside in a central city have an odds ratio of 1.5 compared with those who reside elsewhere.” Makuc discussed some key factors that have bolstered mammography use among low income and black women since 1991, crediting the National Breast and Cervical Cancer Early Detection Program of the CDC (Centers for Disease Control and Prevention) as “by far, the largest single effort to increase screening” in these groups. This program provides grants to State Health Departments in 35 states and 9 American Indian tribes to screen low-income, uninsured, and underinsured women. “The program targets minority women and older women, providing 284,503 mammograms between 1991 and 1995.”

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 State and community-based clinics also provide mammograms to low-income women and community grassroots outreach programs encourage women to get screened. Yet despite outreach efforts targeting low-income, uninsured, and minority women, access remains a problem for low-income women, who continue to be less likely to report having a recent mammogram than higher income women. In some areas, disparities in screening have been reduced, suggesting that stepped-up efforts to reach these groups have contributed to higher screening levels. Nonetheless, “black women continue to have higher breast cancer death rates than white women,” said Makuc. One possible explanation is that decreases in breast cancer death rates lag behind increases in screening, she suggested. Another concern is that screening does not necessarily ensure follow-up and treatment needed to prevent breast cancer-related deaths. The NCI and NCHS have developed expanded questions on mammography that are being asked in the 2000 NHIS as part of a cancer module. These questions will help in understanding the continuing disparities in screening. In addition to asking about time since the most recent mammogram, the 2000 NHIS mammography questions include information on follow-up and treatment of identified cases, she said. Additionally, the survey will ask about age at first mammogram and total mammograms taken to determine whether women are getting regular mammograms. The context for the mammogram will also be examined more thoroughly, with attention to the type of place where the mammogram was received, the payment source of the last mammogram, whether the mammogram was provided as part of a special low-cost program, the main reason for the mammogram, the main reason for never having a mammogram, or not having one within the past two years, and whether or not a physician advised having a

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 mammogram. Women will also be asked if they ever had an abnormal mammogram; if so, what follow-up tests or surgery were done, and the results of those tests. To collect more reliable information about the Hispanic population, beginning in 1995, the NHIS design over-sampled Hispanic persons. Upcoming analysis of NHIS data will include information about mammography use among Hispanic women. By incorporating new variables into the most recent survey and over-sampling understudied groups, NHIS researchers hope to have a more complete understanding of breast cancer screening and follow-up among low-income and minority women, concluded Makuc.

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Developing Technologies for Early Detection of Breast Cancer: Summary of Public Workshop #2 WORKSHOP SPEAKERS Bruce J. Hillman, MD Professor & Chairman, Department of Medicine-Radiology University of Virginia School of Medicine Susan B Foote, J.D. Associate Professor & Division Head University of Minnesota Harold C. Sox Jr., M.D. Chairman, Dartmouth Hitchcock Medical Center Lebanon, NH Rachel Ballard-Barbash, M.D. Associate Director Applied Research Program National Cancer Institute Alicia Toledano, Sc.D., Assistant Professor Center for Stat Sciences Brown University Lee Newcomer, M.D. EVP and Chief Medical Officer Vivius, Inc. Norman Boyd, M.D. Princess Margaret Hospital Charles Turkelson, Ph.D. Chief Research Analyst Health Technology Assessment Group ECRI John Neugebauer Vice President of Marketing Transcan Medical Bill McPhee Mi3 Venture Capitol Carol Dahl, Ph.D. Director, Office of Technologies and Industrial Relations National Institutes of Health Diane Makuc, Ph.D. Director, Division of Health and Utilization Analysis National Center for Health Statistics Jon Kerner, Ph.D. Assistant Deputy Director for Research Dissemination and Diffusion National Cancer Institute Steven Gutman, M.D., MBA Division Director Food and Drug Administration Clinical Laboratory Devices