Thank you, Mr. Chairman and members of the Appropriations Subcommittee on Defense, for the opportunity to testify today about a Program that has made a significant difference in the lives of women and their families. I am Fran Visco, a 20-year breast cancer survivor, a wife and mother, a lawyer, and President of the National Breast Cancer Coalition (NBCC). I come before you representing the hundreds of member organizations and thousands of individual members of the Coalition. NBCC is a grassroots organization dedicated to ending breast cancer through action and advocacy. The Coalition's main goals are to increase federal funding for breast cancer research and collaborate with the scientific community to implement new models of research; improve access to high quality health care and breast cancer clinical trials for all women; and expand the influence of breast cancer advocates wherever breast cancer decisions are made.
You and your Committee have shown great determination and leadership in funding the Department of Defense (DOD) peer reviewed Breast Cancer Research Program (BCRP) at a level that has brought us closer to eradicating this disease. Chairman Inouye and Ranking Member Stevens, we appreciate your longstanding personal support for this Program. I am hopeful that you and your Committee will continue that determination and leadership.
I know you recognize the importance of this Program to women and their families across the country, to the scientific and health care communities and to the Department of Defense. Much of the progress in the fight against breast cancer has been made possible by the Appropriations Committee's investment in breast cancer research through the DOD BCRP. This Program has launched new models of biomedical research that have benefited other agencies and both public and private institutions. It has changed for the better the way research is performed and has been replicated by programs focused on other diseases, by other countries and states. To support this unprecedented progress moving forward, we ask that you support a separate $150 million appropriation for Fiscal Year (FY) 2009. In order to continue the success of the Program, you must ensure that it maintain its integrity and separate identity, in addition to the requested level of funding. This is important not just for breast cancer, but for all biomedical research that has benefited from this incredible government Program. In addition, as Institute of Medicine (IOM) reports concluded in 1997 and 2004, there continues to be excellent science that would go unfunded without this Program. It is only through a separate appropriation that this Program is able to continue to focus on breast cancer yet impact all other research. The separate appropriation of $150 million will ensure that this Program can rapidly respond to changes and new discoveries in the field and fill the gaps in traditional funding mechanisms.
Since its inception, this Program has matured into a broad-reaching influential voice forging new and innovative directions for breast cancer research and science. Despite the enormous successes and advancements in breast cancer research made through funding from the DOD BCRP, we still do not know what causes breast cancer, how to prevent it, or how to cure it. It is critical that innovative research through this unique Program continues so that we can move forward toward eradicating this disease.
The DOD peer reviewed Breast Cancer Research Program has established itself as a model medical research program, respected throughout the cancer and broader medical community for its innovative, transparent and accountable approach. The pioneering research performed through the Program has the potential to benefit not just breast cancer, but all cancers, as well as other diseases. Biomedical research is being transformed by the DOD BCRP's success.
This Program is both innovative and incredibly streamlined. It continues to be overseen by an Integration Panel including distinguished scientists and advocates, as recommended by the IOM. Because there is little bureaucracy, the Program is able to respond quickly to what is currently happening in the research community. Because of its specific focus on breast cancer, it is able to rapidly support innovative proposals that reflect the most recent discoveries in the field. It is responsive, not just to the scientific community, but also to the public. The flexibility of the Program has allowed the Army to administer it with unparalleled efficiency and effectiveness.
An integral part of this Program has been the inclusion of consumer advocates at every level. Breast cancer is not just a problem of scientists; it is a problem of people. Advocates bring a necessary perspective to the table, ensuring that the science funded by this Program is not only meritorious, but it is also meaningful and will make a difference in people's lives. The consumer advocates bring accountability and transparency to the process. Many of the scientists who have participated in the Program have said that working with the advocates has changed the way they approach research. Let me quote Dr. Michael Diefenbach of Mount Sinai School of Medicine:
"I have served as a reviewer for the Department of Defense's Breast and Prostate Cancer Review programs and I am a member of the behavioral study section for the National Cancer Institute… I find survivors or advocate reviewers as they are sometimes called bring a sense of realism to the review process that is very important to the selection and ultimately funding process of important research…Both sides bring important aspects to the review process and the selected projects are ultimately those that can fulfill scientific rigor and translatability from the research arena to clinical practice. I urge that future review panels include advocate reviewers in the review process."
Since 1992, over 585 breast cancer survivors have served on the BCRP peer review panels. As a result of this inclusion of consumers, the Program has created an unprecedented working relationship between the public, scientists, and the military, and ultimately has led to new avenues of research in breast cancer. The vital role of the advocates in the success of the BCRP has led to consumer inclusion in other biomedical research programs at DOD. This Program now serves as an international model.
It is important to note that the Integration Panel that designs this Program has a strategic plan for how best to spend the funds appropriated. This plan is based on the state of the science—both what scientists know now and the gaps in our knowledge—as well as the needs of the public. While this plan is mission driven, and helps ensure that the science keeps that mission—eradicating breast cancer—in mind, it does not restrict scientific freedom, creativity or innovation. The Integration Panel carefully allocates these resources, but it does not predetermine the specific research areas to be addressed.
The DOD BCRP research portfolio includes many different types of projects, including support for innovative ideas, networks to facilitate clinical trials, and training of breast cancer researchers.
Developments in the past few years have begun to offer breast cancer researchers fascinating insights into the biology of breast cancer and have brought into sharp focus the areas of research that hold promise and will build on the knowledge and investment we have made. The Innovative Developmental and Exploratory Awards (IDEA) grants of the DOD Program have been critical in the effort to respond to new discoveries and to encourage and support innovative, risk-taking research. Concept Awards support funding even earlier in the process of discovery. These grants have been instrumental in the development of promising breast cancer research by allowing scientists to explore beyond the realm of traditional research and unleash incredible new ideas. IDEA and Concept grants are uniquely designed to dramatically advance our knowledge in areas that offer the greatest potential. IDEA and Concept grants are precisely the type of grants that rarely receive funding through more traditional programs such as the National Institutes of Health and private research programs. They therefore complement, and do not duplicate, other federal funding programs. This is true of other DOD award mechanisms also.
Innovator awards invest in world renowned, outstanding individuals rather than projects, by providing funding and freedom to pursue highly creative, potentially groundbreaking research that could ultimately accelerate the eradication of breast cancer. The Era of Hope Scholar Award supports the formation of the next generation of leaders in breast cancer research, by identifying the best and brightest scientists early in their careers and giving them the necessary resources to pursue a highly innovative vision of ending breast cancer.
These are just a few examples of innovative funding opportunities at the DOD BCRP that are filling gaps in breast cancer research. Scientists have lauded the Program and the importance of these award mechanisms. In 2005, Zelton Dave Sharp wrote about the importance of the Concept award mechanism:
"Our Concept grant has enabled us to obtain necessary data to recently apply for a larger grant to support this project. We could have never gotten to this stage without the Concept award. Our eventual goal is to use the technology we are developing to identify new compounds that will be effective in preventing and/or treating breast cancer…Equally important, however, the DOD BCRP does an outstanding job of supporting graduate student trainees in breast cancer research, through training grants and pre-doctoral fellowships…The young people supported by these awards are the lifeblood of science, and since they are starting their training on projects relevant to breast cancer, there is a high probability they will devote their entire careers to finding a cure. These young scientists are by far the most important 'products' that the DOD BCRP produces."
- Zelton Dave Sharp, Associate Professor, Interim Director/Chairman, Institute of Biotechnology/Dept. Molecular Medicine, University of Texas Health Science Center (August 2005)
The DOD BCRP also focuses on moving research from the bench to the bedside. DOD BCRP awards are designed to fill niches that are not addressed by other federal agencies. The BCRP considers translational research to be the application of well-founded laboratory or other pre-clinical insight into a clinical trial. To enhance this critical area of research, several research opportunities have been offered. Clinical Translational Research Awards have been awarded for investigator-initiated projects that involve a clinical trial within the lifetime of the award. The BCRP has expanded its emphasis on translational research by also offering five different types of awards that support work at the critical juncture between laboratory research and bedside applications.
The Centers of Excellence award mechanism brings together the world's most highly qualified individuals and institutions to address a major overarching question in breast cancer research that could make a significant contribution towards the eradication of breast cancer. Many of these Centers are working on questions that will translate into direct clinical applications. These Centers include the expertise of basic, epidemiology and clinical researchers, as well as consumer advocates.
Dr. John Niederhuber, now the Director of the National Cancer Institute (NCI), said the following about the Program when he was Director of the University of Wisconsin Comprehensive Cancer Center in April, 1999:
"Research projects at our institution funded by the Department of Defense are searching for new knowledge in many different fields including: identification of risk factors, investigating new therapies and their mechanism of action, developing new imaging techniques and the development of new models to study [breast cancer]…Continued availability of this money is critical for continued progress in the nation's battle against this deadly disease."
Scientists and consumers agree that it is vital that these grants continue to support breast cancer research. To sustain the Program's momentum, $150 million for peer reviewed research is needed in FY09.
One of the most promising outcomes of research funded by the DOD BCRP was the development of the first monoclonal antibody targeted therapy that prolongs the lives of women with a particularly aggressive type of advanced breast cancer. This drug could not have been developed without first researching and understanding the gene known as HER-2/neu, which is involved in the progression of some breast cancers. Researchers found that over-expression of HER-2/neu in breast cancer cells results in very aggressive biologic behavior. The same researchers demonstrated that an antibody directed against HER-2/neu could slow the growth of the cancer cells that over-expressed the gene. This research, which led to the development of the targeted therapy, was made possible in part by a DOD BCRP-funded infrastructure grant. Other researchers funded by the DOD BCRP are identifying similar kinds of genes that are involved in the initiation and progression of cancer.
Another example of innovation in the Program is in the area of imaging. One DOD BCRP awardee developed a new use for medical hyperspectral imaging (MHSI) technology. This work demonstrated the usefulness of MHSI as a rapid, noninvasive, and cost-effective evaluation of normal and tumor tissue during a real-time operating procedure. Application of MHSI to surgical procedures has the potential to significantly reduce local recurrence of breast tumors and may facilitate early determination of tumor malignancy.
Studies funded by the DOD BCRP are examining the role of estrogen and estrogen signaling in breast cancer. For example, one study examined the effects of the two main pathways that produce estrogen. Estrogen is often processed by one of two pathways; one yields biologically active substances while the other does not. It has been suggested that women who process estrogen via the biologically active pathway may be at higher risk of developing breast cancer. This research will yield insights into the effects of estrogen processing on breast cancer risk in women with and without family histories of breast cancer.
Another example of success from the Program is a study of sentinel lymph nodes (SLNs). This study confirmed that SLNs are indicators of metastatic progression of disease. The resulting knowledge from this study and others has led to a new standard of care for lymph node biopsies. If the first lymph node is negative for cancer cells, then it is unnecessary to remove all the lymph nodes. This helps prevent lymphodema which can be painful and have lasting complications.
The DOD BCRP is as efficient as it is innovative. In fact, 90 percent of funds go directly to research grants. The flexibility of the Program allows the Army to administer it in such a way as to maximize its limited resources. The Program is able to quickly respond to current scientific advances and fulfills an important niche by focusing on research that is traditionally under-funded. This was confirmed and reiterated in two separate IOM reports released in 1997 and 2004. The areas of focus of the DOD BCRP span a broad spectrum and include basic, clinical, behavioral, environmental sciences, and alternative therapy studies, to name a few. The BCRP benefits women and their families by maximizing resources and filling in the gaps in breast cancer research.
The Program is responsive to the scientific community and to the public. This is evidenced by the inclusion of consumer advocates at both the peer and programmatic review levels. The consumer perspective helps the scientists understand how the research will affect the community and allows for funding decisions based on the concerns and needs of patients and the medical community.
The outcomes of the BCRP-funded research can be gauged, in part, by the number of publications, abstracts/presentations, and patents/licensures reported by awardees. To date, there have been more than 11,700 publications in scientific journals, more than 12,000 abstracts and nearly 550 patents/licensure applications. The American public can truly be proud of its investment in the DOD BCRP. Scientific achievements that are the direct result of the DOD BCRP grants are undoubtedly moving us closer to eradicating breast cancer.
The success of the DOD peer reviewed Breast Cancer Research Program has been illustrated by several unique assessments of the Program. The IOM, which originally recommended the structure for the Program, independently re-examined the Program in a report published in 1997. They published another report on the Program in 2004. Their findings overwhelmingly encouraged the continuation of the Program and offered guidance for program implementation improvements.
The 1997 IOM review of the DOD peer reviewed Breast Cancer Research Program commended the Program, stating, "the Program fills a unique niche among public and private funding sources for cancer research. It is not duplicative of other programs and is a promising vehicle for forging new ideas and scientific breakthroughs in the nation's fight against breast cancer." The 2004 report spoke to the importance of the program and the need for its continuation.
The DOD peer reviewed Breast Cancer Research Program not only provides a funding mechanism for high-risk, high-return research, but also reports the results of this research to the American people every two to three years at a public meeting called the Era of Hope. The 1997 meeting was the first time a federally-funded program reported back to the public in detail not only on the funds used, but also on the research undertaken, the knowledge gained from that research and future directions to be pursued. The fifth Era of Hope meeting will be held in Baltimore, Maryland, June 25-28, 2008.
The DOD peer reviewed Breast Cancer Research Program has attracted scientists across a broad spectrum of disciplines, launched new mechanisms for research and facilitated new thinking in breast cancer research and research in general. A report on all research that has been funded through the DOD BCRP is available to the public. Individuals can go to the Department of Defense website and look at the abstracts for each proposal at http://cdmrp.army.mil/bcrp/.
The National Breast Cancer Coalition is strongly committed to the DOD BCRP in every aspect, as we truly believe it is one of our best chances for finding cures for and ways to prevent breast cancer. The Coalition and its members are dedicated to working with you to ensure the continuation of funding for this Program at a level that allows this research to forge ahead. From 1992, with the launch of our "300 Million More Campaign" that formed the basis of this Program, until now, NBCC advocates have appreciated your support.
Over the years, our members have shown their continuing support for this Program through petition campaigns, collecting more than 2.6 million signatures, and through their advocacy on an almost daily basis around the country asking for support of the DOD BCRP.
There are three million women living with breast cancer in this country today. This year, more than 40,000 will die of the disease and more than 240,000 will be diagnosed. We still do not know how to prevent breast cancer, how to diagnose it truly early or how to cure it. It is an incredibly complex disease. We simply cannot afford to walk away from this program.
This April many of the women and family members who support this program came to NBCCF's Annual Advocacy Training Conference here in Washington, D.C. More than 600 breast cancer activists from across the country, representing groups in their communities and speaking on behalf of tens of thousands of others, were here as part of our efforts to end breast cancer. The overwhelming interest in and dedication to eradicating this disease continues to be evident as people not only are signing petitions, but are willing to come to Washington, D.C. from across the country to tell their Members of Congress about the vital importance of continuing the DOD BCRP.
Since the very beginning of this Program in 1992, Congress has stood with us in support of this important investment in the fight against breast cancer. In the years since, Chairman Inouye and Ranking Member Stevens, you and this entire Committee have been leaders in the effort to continue this innovative investment in breast cancer research.
NBCC asks you, the Defense Appropriations Subcommittee, to recognize the importance of what has been initiated by the Appropriations Committee. You have set in motion an innovative and highly efficient approach to fighting the breast cancer epidemic. We ask you now to continue your leadership and fund the Program at $150 million and maintain its integrity. This is research that will help us win this very real and devastating war against a cruel enemy.
Thank you again for the opportunity to submit testimony and for giving hope to all women and their families, and especially to the 3 million women in the United States living with breast cancer.