Thank you, Mr. Chairman and members of the Appropriations Subcommittee on Military Quality of Life, for the opportunity to talk to you about a program that has made a significant difference in the lives of women and their families. Your fellow appropriators in the Defense Subcommittee 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. Mr. Walsh, we have appreciated your personal support of this program in the past. I am hopeful that you and your Committee will continue that determination and leadership.
I am Fran Visco, a breast cancer survivor, a wife and mother, a lawyer, and President of the National Breast Cancer Coalition (NBCC). On behalf of NBCC, and the more than 3 million women living with breast cancer, I would like to thank you again for the opportunity to testify.
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 individual states. To support this unprecedented progress moving forward, we ask that you support a separate $150 million appropriation for Fiscal Year (FY) 2007. In order to continue the success of the program, you must ensure that it maintains its integrity and separate identity, in addition to the requested level of funding. This is important not just for breast cancer, but also for all biomedical research that has benefited from this incredible government program. In addition, as an Institute of Medicine (IOM) report concluded in 2004, there continues to be excellent science that goes unfunded, but for 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, rapidly respond to changes and new discoveries in the field and fill the gaps created by traditional funding mechanisms.
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.
As you know, the National Breast Cancer Coalition is a grassroots advocacy organization made up of hundreds of organizations and tens of thousands of individuals and has been working since 1991 toward the eradication of breast cancer through advocacy and action. NBCC supports increased funding for breast cancer research, increased access to quality health care for all women, and increased influence of breast cancer activists at every table where decisions regarding breast cancer are made.
The DOD peer reviewed Breast Cancer Research Program has established itself as model medical research program, respected throughout the cancer and broader medical community for its innovative and accountable approach. The groundbreaking 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 BCRP's success.
This program is both innovative and incredibly streamlined. It continues to be overseen by a group of distinguished scientists and activists, as recommended by the IOM. Because there is little bureaucracy, the program is able to respond quickly to what is currently happening in the scientific 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.
Since its inception, this program has matured from an isolated research program to a broad-reaching influential voice forging new and innovative directions for breast cancer research and science. The flexibility of the program has allowed the Army to administer this groundbreaking research effort with unparalleled efficiency and effectiveness.
In addition, an integral part of this program has been the inclusion of consumer advocates at every level. As a result, 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. Since 1992, over 400 breast cancer survivors have served on the BCRP review panels. Their vital role 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 DOD Integration Panel that designs this program has a plan of 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. This plan coincides with our philosophy that we do not want to restrict scientific freedom, creativity or innovation. While we carefully allocate these resources, we do not want to predetermine the specific research areas to be addressed.
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. The IDEA grants have been instrumental in the development of promising breast cancer research. These grants have allowed scientists to explore beyond the realm of traditional research and have unleashed incredible new ideas and concepts. IDEA grants are uniquely designed to dramatically advance our knowledge in areas that offer the greatest potential.
IDEA 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. Therefore, they complement, and do not duplicate, other federal funding programs. This is true of other DOD award mechanisms as well.
For example, the Innovator awards are structured to invest in world renowned, outstanding individuals, rather than projects, from any field of study by providing funding and freedom to pursue highly creative, potentially breakthrough research that could ultimately accelerate the eradication of breast cancer. The Era of Hope Scholar is intended to support the formation of the next generation of leaders in breast cancer research, by identifying the best and brightest independent scientists early in their careers and giving them the necessary resources to pursue a highly innovative vision toward ending breast cancer.
Also, Historically Black Colleges and Minority Universities/Minority Institutions Partnership Awards are intended to provide assistance at an institutional level. The major goal of this award is to support collaboration between multiple investigators at an applicant Minority Institution and a collaborating institution with an established program in breast cancer research, for the purpose of creating an environment that would foster breast cancer research, and in which Minority Institution faculty would receive training toward establishing successful breast cancer research programs.
These are just a few examples of innovative approaches at the DOD BCRP that are filling gaps in breast cancer research. It is vital that these grants are able to continue to support interest in breast cancer research - $150 million for peer reviewed research will help sustain the program's momentum.
The DOD BCRP also focuses on moving research from the bench to the bedside. A major feature of the awards offered by the BCRP is that they are designed to fill niches that are not offered by other 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 expanded its emphasis on translational research by offering five different types of awards that support work at the critical juncture between laboratory research and bedside applications.
The Centers of Excellence awards 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 major contribution towards the eradication of breast cancer. These Centers put to work the expertise of basic, epidemiology and clinical researchers, as well as consumer advocates to focus on a major question in breast cancer research. Many of these centers are working on questions that will translate into direct clinical applications.
The BCRP research portfolio is comprised of many different types of projects, including support for innovative ideas, infrastructure building to facilitate clinical trials, and training breast cancer researchers.
A groundbreaking outcome of research funded by the BCRP was the development of Herceptin, a drug that prolongs the lives of women with a particularly aggressive type of advanced breast cancer; and has been shown in recent studies to decrease relapses in women with this type of breast cancer, which constitute about 25% of those diagnosed. 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. Most importantly, 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 drug Herceptin, was made possible in part by a DOD BCRP-funded infrastructure grant. Other researchers funded by the BCRP are currently working to identify similar kinds of genes that are involved in the initiation and progression of cancer. They hope to develop new drugs like Herceptin that can fight the growth of breast cancer cells.
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 lead to a standard of care that includes 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.
Several studies funded by the 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. It is anticipated that work from this funding effort will yield insights into the effects of estrogen processing on breast cancer risk in women with and without family histories of breast cancer.
One DOD IDEA award success has supported the development of new technology that may be used to identify changes in DNA. This technology uses a dye to label DNA adducts, compounds that are important because they may play a role in initiating breast cancer. Early results from this technique are promising and may eventually result in a new marker/method to screen breast cancer specimens.
Investigators funded by the DOD have developed a novel imaging technique that combines two-dimensional and three-dimensional digital mammographic images for analysis of breast calcifications. Compared to conventional film screen mammography, this technique has greater resolution. Ultimately, this technique may help reduce the number of unnecessary breast biopsies.
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 an IOM report released in 2004. It 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.
Since 1992, the BCRP has been responsible for managing $1.81 billion in appropiations. From its inception through FY04, 4,293 awards at over 420 institutions throughout the United States and the District of Columbia have been awarded. Approximately 150 awards will be granted for FY05. The areas of focus of the DOD BCRP span a broad spectrum and include basic, clinical, behavioral, epidemiology, 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. Scientific achievements that are the direct result of the DOD BCRP grants are undoubtedly moving us closer to eradicating breast cancer.
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 9,500 publications in scientific journals, more than 9,600 abstracts and more than 300 patents/licensure applications. The federal government can truly be proud of its investment in the DOD BCRP.
The National Breast Cancer Coalition has been the driving force behind this program for many years. 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 review Breast Cancer Research Program commended the program and stated that, "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 IOM report recommended continuing the program and established a solid direction for the next phase of the program. The 2004 report reiterated these same statements and indicated that is important for the program to continue. It is imperative that Congress recognizes the independent evaluations of the DOD Breast Cancer Research Program, as well as reiterates its own commitment to the program by appropriating the funding needed to ensure its success.
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 at a biennial 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 transparency of the BCRP allows scientists, consumers and the American public to see the exceptional progress made in breast cancer research.
At the 2005 Era of Hope meeting, all BCRP award recipients from the past two years were invited to report their research findings, and many awardees from previous years were asked to present advancements in their research. Themes for the 2005 meeting included: Understanding Risk - A Different Perspective; Understanding Who Needs Intervention and Understanding Treatments - Effectively Treating Primary and Metastatic Disease. The meeting also featured grant recipients who have delved into the topic of breast cancer heterogeneity. For example, gene expression profiling technologies have allowed researchers to identify several breast cancer "types." Recognition of the heterogeneous character of breast cancer will allow for better selection of patient subgroups for clinical trials testing targeted therapies. Other researchers presented their research on a many important topics ranging from the usage of nanotechnology to find and treat breast cancer to identifying and destroying progenitor breast cancer cells to developing better clinical trials that still ensure patient safety and make sure that treatments are safe.
The DOD peer reviewed Breast Cancer Research Program has attracted scientists across a broad spectrum of disciplines, launched new mechanisms for research and has continued to facilitate 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 program in every aspect, as we truly believe it is one of our best chances for finding cures and preventions for 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.
Over the years, our members have showed 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 through the country asking for support of the DOD BCRP.
As you know, 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 nearly 220,000 will be diagnosed. We still do not know how to prevent breast cancer, how to diagnose it truly early or how to cure it. While the mortality rate seems to be decreasing, it is not by much and it is not for all groups of women. The incidence of breast cancer continues to rise. It is an incredibly complex disease. We simply cannot afford to walk away from these facts, we cannot go back to the traditional, tried and not so true ways of dealing with breast cancer. We must, we simply must, continue the innovative, rapid, hopeful approach that is the DOD BCRP.
Just over one month from now, many of the women and family members who supported the campaign to gather the 2.6 million signatures will come 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, will join us in continuing to mobilize our efforts to end breast cancer. The overwhelming interest in, and dedication to eradicate 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, Mr. Chairman, you and this entire Committee have been leaders in the effort to continue this innovative investment in breast cancer research.
NBCC asks you, the Military Quality of Life 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. What you must do now is support this effort by continuing to 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 the 3 million women in the United States living with breast cancer.