3
Non-BCRP Support for Breast Cancer Research

The USAMRMC requested that the IOM assess the portfolio of grants currently supported by the BCRP and other funding agencies. Non-BCRP support is reviewed in this chapter. Although there are numerous funding agencies and state governments that support research programs in breast cancer, the chapter reviews only the funding agencies that support the majority of work in breast cancer research.

PUBLISHED LITERATURE

A search of the scientific literature was performed for 1994 and 1995 to assess the quantity of breast cancer research in the peer-reviewed published medical literature. The committee obtained from the search a general sense of the topic areas covered by research being published by the scientific community at large. (Since the BCRP is still a very young program, there was little likelihood of any BCRP-funded projects having published results.) The results of the search, broken down into seven broad research categories, are presented in Table 3-1. These research categories are also discussed in the final section of Chapter 5 (''Distribution of Awards Among Research Areas").

The results indicate that 2,084 (approximately 50%) of the 4,216 published reports in breast cancer research for 1994 and 1995 combined had a basic genetic, cellular, and molecular biology component relevant to the origin and progression of breast cancer. Many of these studies are developing diagnostic and preventive strategies from a cellular or molecular approach, and are double-counted in the detection category as well. Approximately 17% and 13% were



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A Review of the Department of Defense's Program for Breast Cancer Research 3 Non-BCRP Support for Breast Cancer Research The USAMRMC requested that the IOM assess the portfolio of grants currently supported by the BCRP and other funding agencies. Non-BCRP support is reviewed in this chapter. Although there are numerous funding agencies and state governments that support research programs in breast cancer, the chapter reviews only the funding agencies that support the majority of work in breast cancer research. PUBLISHED LITERATURE A search of the scientific literature was performed for 1994 and 1995 to assess the quantity of breast cancer research in the peer-reviewed published medical literature. The committee obtained from the search a general sense of the topic areas covered by research being published by the scientific community at large. (Since the BCRP is still a very young program, there was little likelihood of any BCRP-funded projects having published results.) The results of the search, broken down into seven broad research categories, are presented in Table 3-1. These research categories are also discussed in the final section of Chapter 5 (''Distribution of Awards Among Research Areas"). The results indicate that 2,084 (approximately 50%) of the 4,216 published reports in breast cancer research for 1994 and 1995 combined had a basic genetic, cellular, and molecular biology component relevant to the origin and progression of breast cancer. Many of these studies are developing diagnostic and preventive strategies from a cellular or molecular approach, and are double-counted in the detection category as well. Approximately 17% and 13% were

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 3-1. Search Results for Reports of Breast Cancer Research for 1994 and 1995 Content 1994 1995 1994 and 1995 Combined Total number of abstracts searched 2,573 1,643 4,216 B = Basic genetic, cellular, and molecular studies relevant to the origin and progression of breast cancer 1,245 (48%) 839 (51%) 2,084 (49%) R = Risk factors, endogenous and exogenous: studies of their molecular mechanisms 338 (13%) 200 (12%) 538 (13%) E = Epidemiological studies of risk factors, progression, and outcome 463 (18%) 276 (17%) 739 (17%) D = Detection, diagnosis, prevention, treatment: clinical studies (excluding imaging studies) 1,459 (57%) 915 (56%) 2,374 (56%) M = Mammography: studies of effectiveness and innovation in breast imaging technology, including databases 283 (11%) 198 (12%) 481 (11%) P = Psychosocial: studies of psychosocial factors, quality of life, and clinical outcomes 128 (5%) 79 (5%) 207 (5%) H = Health care delivery: studies of effectiveness and innovation in providing diagnosis, treatment, and follow-up care. 3 (0.1%) 0 (0%) 3 (0.07%) NOTE: Search terms (English only) used: "breast cancer" and B=gene* or cell*; R=risk factor*; E=epidemiol*; D=detection or diagnos* or treat* or prevent* (not imaging), M=mammogra* or imaging; P=psychosocial or quality of life or behavior*; and H=health care delivery (* indicates truncation). a There was extensive overlap of the abstracts during categorization. The numbers of abstracts cited in each of the content categories were assessed independently of other categories and will not add to 2,574 and 1,643, respectively (or 100%). SOURCE: Medline SilverPlatter.

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A Review of the Department of Defense's Program for Breast Cancer Research relevant to epidemiology and the analysis of risk factors, respectively. Breast imaging, including mammography, was specified in approximately 12% of the studies, while psychosocial factors were the topic in only 5%. Health care delivery research was the focus of only 3 of the 4,216 reports that were cited in the search, or less than 0.1% of 1994/1995 published breast cancer research. FUNDING FROM THE FEDERAL GOVERNMENT The U.S. government supports breast cancer research through a variety of agencies and mechanisms. Agencies such as the Department of Agriculture (USDA), the Department of Energy (DOE), the National Science Foundation (NSF), and the Department of Veterans Affairs (DVA) fund research on breast cancer through mostly extramural grant awards, although their programs tend to be small (approximately $15 million in 1994 and approximately $13.3 million in 1995). (The Small Business Administration's [SBA's] "Small Businesses in Research" program also supported breast cancer research, but this was technically in the form of small business loans, and will not be considered part of the federal government's expenditure in breast cancer research.) The research areas supported by these organizations include: basic science, epidemiology, clinical trials, and technical advancement in diagnostics. In addition to the BCRP, the Department of Defense (DOD) also supports breast-cancer-related research throughout its three major service units. Additional federal programs are interagency in nature, and may fall under the aegis of two or more agencies. Non-BCRP Department of Defense Programs DOD supports other breast-cancer-related research in addition to the Army's BCRP. For instance, in FY 1994, the Department of the Air Force funded two intramural projects and one extramural contract related to breast cancer research on studies of environmental hazards such as radiation and fuel propellants. The in-house Air Force projects are ongoing and the extramural award was for $549,000 for 5 years, bringing the average annual funding for breast cancer research over the three projects to $207,633 per year. In FY 1994, the Department of the Army funded 38 breast-cancer-related studies totaling $3,523,400 through extramural grants or interagency transfers. A large percentage of these studies was in the areas of detection and imaging and basic science. Finally, the Office of the Secretary of Defense began a 7-year project for $973,000 in 1991 at the Children's Hospital of Los Angeles that is assessing the effects of infrared radiation on tumor tissue, bringing non-BCRP DOD

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A Review of the Department of Defense's Program for Breast Cancer Research expenditures for breast cancer research to over $3.8 million for FY 1994. In FY 1995, this figure was reduced to under $2 million (CTI/Rand, 1996). All branches of the military service (i.e., Army, Navy, and Air Force) have medical research and development (R&D) programs referred to as clinical investigation units that function under their respective offices of the Surgeon General. Even though breast cancer research is not specifically the charge of these units, they conduct ongoing medical R&D that may be tangentially related to breast cancer. In addition, in FY 1994 DOD established the Defense Women's Health Research Program (DWHRP) with $40 million appropriated that year for a coordinated effort on research into the health and performance of women serving in the armed forces. This program is described in a recent report (IOM, 1995), and a supplemental volume provides listings of military investigators interested in women's health issues (IOM, 1996). A review of studies funded by the Defense Women's Health Program found only three projects related to breast cancer, two involved research with different types of mammography, and one examined prognostic factors. However, the IOM (1995) report on this program did not consider breast cancer as a recommended area of research because of the existence of the BCRP. The TriService Nursing Research Program is a $5 million program funded through the DOD Health Care Program and established at the Uniformed Services University of the Health Sciences. This small competitive grants program supports research by military nurses to improve standards of military nursing practices and improve the health of service members and their beneficiaries. A review of research funded through this program from 1992 to 1995 identified three research projects related to breast cancer totaling $129,212 and addressing prevention and detection, risks, and quality of life issues. Other Federal Entities (Excluding Department of Health and Human Services) As mentioned earlier, there are several government agencies that support breast cancer research. In FY 1994 USDA supported 10 studies (totaling $420,000) on the effect of diet and nutrition in relation to breast cancer risk. These studies on this topic used epidemiological approaches, as well as investigations in tissue culture and animal model systems. In the same year, DOE funded 26 grants (totaling $5,713,000) related to radiogenic neoplasia, digital mammography, and tumor imaging agents, as well as studies of gene expression, cell differentiation, and DNA transcription. The NSF supported 21 grants in FY 1994 (totaling $1,229,000) for breast cancer research, mostly in basic biological sciences, but also in engineering, statistics, and social/behavioral and anthropological research.

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A Review of the Department of Defense's Program for Breast Cancer Research The largest of the other federal agencies, outside the Department of Health and Human Services (DHHS), sponsoring breast cancer research was the DVA, which funded 327 grants in FY 1994 totaling $7,910,000. The majority of these funds went to DVA medical centers for clinical trials of new chemotherapeutic agents, novel medical/surgical interventions, and prosthetic research. The DVA also supported investigations in the behavioral sciences and patient education (CTI/Rand, 1996). Department of Health and Human Services The Department of Health and Human Services (DHHS) includes the Public Health Service (PHS), which in turn oversees the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH), the last of which, with the Army's BCRP, is the major federal contributor to breast cancer research in the United States. The NIH consists of 21 institutes and centers designed to conduct and support biomedical research, the largest being the National Cancer Institute (NCI) where the majority of NIH's cancer research is based. Of the approximately 1,500 grants related to breast cancer research awarded by NIH in FY 1994, almost 1,200 were supported by the NCI (CTI/RAND, 1996). The National Cancer Institute NCI, the largest component of NIH, coordinates a national research program on cancer cause and prevention, detection and diagnosis, and treatment. These activities are funded by direct appropriations. The NCI's appropriation for FY 1995 was $2.1 billion and the estimated for FY 1996 is $2.2 billion. These funds support research at the institute's intramural laboratories in Bethesda, Maryland, and at research laboratories and medical centers throughout the United States and abroad. Breast cancer research is funded through a variety of mechanisms, including: individual investigator research grants, program project grants, special projects of research emphasis grants, individual or institutional training grants, comprehensive cancer center grants, and clinical trial cooperative group grants, as well as other contractual arrangements. Table 3-2 compares NCI spending in 1995 with 1996 targeted to the four most prevalent types of cancer in the United States.

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 3-2. National Cancer Institute Funding for Research on the Four Most Common Types of Cancer by Site, 1995–1996 Cancer Site 1995 Spending ($ millions) 1996 Spending ($ millions) Breast $308.7 $336.7 Colorectal 96.5 99.3 Lung 113.9 116.9 Prostate 64.3 70.9   SOURCE: NCI, 1997a, 1997b. NCI's breast cancer research goals are to "reduce breast cancer incidence, morbidity, and mortality through the development of new strategies to prevent and cure cancer based on continuously increasing knowledge of the cancer process" (NCI, 1996). To achieve this, NCI endeavors to support high-quality cancer research by funding the development and improvement of the research infrastructure, fostering research training and education, and disseminating information about cancer research. In FY 1995, NCI had a total budget of $1,913,472,000 (exclusive of funding for AIDS research). Of this, $308,730,000 (or roughly 16%) was dedicated to breast cancer research in five categories as indicated in Table 3-3. TABLE 3-3. National Cancer Institute Funding for Breast Cancer Research by Category Research Category Amount Funded ($ thousands) Percentage of Total Basic Research $124,065 40% Treatment/Rehabilitation 82,174 27 Detection 49,205 16 Epidemiology 31,053 10 Prevention 22,233 7 TOTAL 308,730 100   SOURCE: NCI, 1996. Other NIH Institutes Other institutes and centers within NIH that also fund breast cancer research, either directly or indirectly, include the National Center for Human Genome Research, the National Institute of Nursing Research, the National Center for Research Resources, and the Warren Grant Magnuson Clinical Center (see Table 3-4).

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A Review of the Department of Defense's Program for Breast Cancer Research TABLE 3-4. Other National Institutes of Health Institutes Supporting Breast Cancer Researcha Institute/Center Fiscal Year No. of Projects Amount National Center for Research Resources 1995 47 grants $1,114,311   1996 45 grants 1,262,819 National Institute for Nursing Research 1995 14 grants 2,500,944   1996 15 grants 2,835,476 National Institute of Environmental Health Sciences 1996 22 grants 4,411,388 National Institute of General Medical Sciences 1994 32 grants 6,243,121   1995 21 grants 4,265,580 National Institute of Mental Health 1995 6 grants 957,970   1996 7 grants 1,685,876 National Institute on Aging 1996 15 grants 3,253,623 National Institute on Alcohol Abuse and Alcoholism 1996 6 grants 1,110,417 National Library of Medicine 1996 2 grants 1,654,818 a The following institutes may also have dedicated breast cancer research grants in effect, but had not responded to our inquiry at the time of this writing: • National Center for Human Genome Research; • National Heart, Lung, and Blood Institute; • National Institute of Allergy and Infectious Diseases; • National Institute of Child Health and Human Development; and • National Institute of Diabetes, Digestive, and Kidney Diseases. Other DHHS Agencies The CDC also has activities in breast cancer, such as the National Breast and Cervical Cancer Early Detection Program. Not a research program, this was authorized by Congress through the Breast and Cervical Cancer Mortality Prevention Act of 1990 to bring breast and cervical cancer screening to underserved populations, including racially diverse groups, older women, low-income women, and those who are uninsured or underinsured. With this program CDC has been able to give these underserved populations greater access to screening and follow-up services while increasing education and outreach programs. In FY 1997, Congress appropriated $140 million for its continuation (CDC, 1997). The CDC is also funding research in breast cancer through its National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) and its National Center for Environmental Health (NCEH). The NCCDPHP currently has nine breast-cancer-related research projects and the NCEH currently has eight, some in conjunction with the NCI and universities, to assess

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A Review of the Department of Defense's Program for Breast Cancer Research the association of risk for breast cancer and exposure to exogenous compounds (CDC, 1997). National Action Plan on Breast Cancer The National Action Plan on Breast Cancer (NAPBC) was established in 1993 as a public/private partnership by the Clinton administration to "serve as a catalyst for national efforts in the battle against breast cancer, and coordinate activities of government and non-government organizations, agencies and individuals" (DHHS, 1996b). The NAPBC is co-chaired by the Deputy Assistant Secretary for Health (Women's Health) at DHHS and the president of the National Breast Cancer Coalition and is coordinated by the PHS's Office of Women's Health. The NAPBC awarded 99 grants in FY1995/1996 totaling $14.5 million in six priority areas: clinical trials accessibility, consumer involvement, etiology, hereditary susceptibility, Information Action Council, and the National Biological Resource Bank. Both the peer review panels and second-level review by the NAPBC steering committee included breast cancer survivors affiliated with advocacy groups (NAPBC, 1996). THE CALIFORNIA BREAST CANCER RESEARCH PROGRAM In 1993, California enacted the Breast Cancer Act (AB 2055 and AB 478), establishing the California Breast Cancer Research Program and the Breast Cancer Control Program. These programs are funded with revenue from the state tobacco tax. Breast cancer research is defined in the act as including, but not limited to, research in the fields of biomedical sciences and engineering; social, economic, and behavioral sciences; epidemiology, technology development and translation; and public health. The legislation mandated funding of innovative and creative breast cancer research that complements, rather than duplicates, research funded by the federal government and other agencies. Funding priorities for 1996 include several areas of breast cancer research—etiology, pathogenesis, prevention, early detection, and innovative treatment modalities. The legislation also stipulates that funding decisions should be made "based on the established priorities and the scientific merit of the proposals as determined by peer review panels" (CBCRP, 1997). The enabling legislation stated that the University of California should establish and administer the Breast Cancer Research Program which is administratively housed in the office of the president of health affairs. This office utilizes a peer review process to determine the scientific merit of competitive grants from public, private, or nonprofit organizations or

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A Review of the Department of Defense's Program for Breast Cancer Research individuals. Approximately $20 million has been awarded between the enactment of the 1993 legislation and June 1995. PRIVATE FOUNDATIONS American Cancer Society The American Cancer Society (ACS) is a private funding organization whose mission is to "eliminate cancer as a major health problem" (ACS, 1996a). In 1996, the ACS provided a total of $171 million in grants for cancer research; most of these grants were investigator-initiated research projects. In 1996, the ACS provided over $14 million for breast cancer research and an additional $64.5 million toward basic cancer biology research, which may apply indirectly to breast cancer. Topic areas of 1996 breast cancer research grants awarded are described in Table 3-5. TABLE 3-5. American Cancer Society Support of Breast Cancer Research in 1996a IOM Category Area No. of Awards Amount B Basic genetic, cellular, and molecular studies 36 $4,643,000 R Risk factors, endogenous and exogenous 9 1,522,000 E Epidemiological studies 8 2,785,240 D Detection, diagnosis, prevention, and treatment 23 3,013,766 M Mammography 2 400,000 P Psychosocial 8 1,358,000 H Health care delivery 4 375,500 Total   90 14,097,506 a Grants in effect as of August 16, 1996. SOURCE: ACS, 1996a. The grants noted in Table 3-5 fall into four general categories. Out of the $76 million awarded in national extramural grants in FY 1995, $59.6 million (78%) was given to research and clinical investigation (project) grants. The ACS also awarded $11.7 million (15%) for personnel grants, including postdoctoral fellowships, physicians research training awards, junior faculty research awards, and junior clinical research awards, scholar grants, research professors, and

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A Review of the Department of Defense's Program for Breast Cancer Research clinical research professors. Institutional research grants, providing seed money block grants to academic institutions, accounted for $3.6 million (5%), while the research development program (similar to IDEA [Innovative Developmental and Exploratory Awards] grants) made up the remaining $1.1 million (2%) of the research expenditures (ACS, 1996a). In FY 1995, the ACS also funded an additional $10 million for divisional extramural grants, health professional training grants, intramural epidemiology/surveillance research, and an intramural behavioral research center (ACS, 1996a). The ACS convened a "blue ribbon panel" in 1996 charged with reviewing the current state of cancer research and the role of the ACS in that research effort. The panel recommended substantial changes in the overall research program to be initiated in FY 1997. According to the panel's report, "The most profound change will be a focus on beginning investigators—those researchers who have completed their postdoctoral training and accepted their first faculty position, but who have not yet amassed sufficient preliminary data to compete effectively for grants with more established investigators" (ACS, 1996b). In fact, the report continued, the ACS "will concentrate almost exclusively on investigators at the beginning of their careers" (ACS, 1996b). Other recommendations of the panel include: ensuring that all grant proposals with a research component are reviewed through a peer review mechanism of the research department and are subject to the same classification and tracking as research grants; investigator-initiated, peer reviewed research remaining the basis of the ACS's extramural research program; and allotting up to 10% of the research expenditures to targeted areas of research (e.g., breast cancer), plus another 5% specifically for psychosocial and behavioral research. Susan G. Komen Foundation The Susan G. Komen Breast Cancer Foundation is one of the nation's largest private funding sources for breast cancer research. This national grant program supports research on the causes, treatment, and prevention of breast cancer. Applications are reviewed on individual merit determined by a peer review committee. The efficacy of this review process is evaluated on a periodic basis. Consumer involvement in the peer review process is not directly solicited. However, volunteer consumers are integrated into the funding process on many levels—that is, policy setting, compliance review, budget making, and final approval of the grantees.

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A Review of the Department of Defense's Program for Breast Cancer Research Currently the Komen Foundation funds basic and clinical research projects (up to $150,000 each), postdoctoral fellowships ($105,000 each), and education/screening/treatment projects (up to $50,000 each). In 1996 the Komen Foundation funded 20 basic and clinical research awards for a total of $2,832,718. These awards are almost exclusively for basic science research such as the role of mutations in the BRCA1 and BRCA2, ATM, and erB2/neu/HER2 genes in breast cancer, metalloprotease inhibitors of breast cancer progression, studies of phytoestrogens, and cell surface antigens (Komen Foundation, 1996). In 1996 the Komen Foundation funded 11 education/treatment/screening grants for a total of $526,385, and had 27 three-year postdoctoral fellowships in effect ($2,835,000) for a grand total of $6,194,103 (Komen Foundation, 1996). The research supported includes basic science, treatment, detection, diagnosis and prevention, psychosocial, health care delivery, and mammography. The Komen Foundation maintains an open and very broad-based approach to funding priorities and does not target specific areas of research. A unique aspect of its program is its focus on identifying and supporting opportunities involving education and health care delivery. Projects involving breast cancer screening, patient education, and psychosocial support to patients and their families share a special priority among the grants awarded by the Komen Foundation. Other Philanthropic Organizations Philanthropic foundations such as the Jewish Healthcare Foundation of Pittsburgh, the Elsa U. Pardee Foundation, the New York Community Trust, and the Whitaker Foundation are important additional sources of funding for breast cancer research. Such private philanthropic organizations provide funding for basic, clinical, and behavioral research, as well as prevention studies. The range of funding for individual projects is between $10,000 and $200,000 annually. NATIONAL PROFESSIONAL ORGANIZATIONS AND SOCIETIES Several national professional organizations which are not specifically grantmaking agencies participate in breast cancer research by sponsoring, through fellowship programs, grantees who obtain funding from federal agencies, pharmaceutical companies, or philanthropic societies. An examples of such an organization is the American Society of Clinical Oncology (ASCO), a national medical society that promotes patient-oriented clinical research through fellowship programs.

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A Review of the Department of Defense's Program for Breast Cancer Research PHARMACEUTICAL INDUSTRY A 1995 survey by the Pharmaceutical Research and Manufacturers of America found that approximately 215 new medications are currently undergoing phase I and phase II cancer therapy trials sponsored by approximately 98 research-based pharmaceutical companies and the NCI (PhRMA, 1995). (These are very small trials, usually involving fewer than 100 people, that test the toxicity and preliminary efficacy of a trial drug or biological. Phase III trials are usually large trials [involving several hundred to several thousand people] and run for several years. Phase II trials are used to determine if a new drug entity is both safe and effective for a large population.) These novel cancer therapies include approximately 48 drugs specifically targeted for breast cancer. All but 2 of these drugs are being developed by private companies (NCI is sponsoring the other two). Nearly 70% of these 48 drugs are also being evaluated as therapeutic agents for other cancers. Several of these studies utilize monoclonal antibodies or tumor vaccines.