Thank you, Mr. Chairman and members of the Appropriations Subcommittee on Defense for your exceptional leadership in the effort to increase and improve breast cancer research. You and your Committee have shown great determination and leadership in searching for the answers by 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.
I am Fran Visco, a breast cancer survivor, a wife and mother, a lawyer, and President of the National Breast Cancer Coalition. On behalf of NBCC, and the more than 3 million women living with breast cancer, I would like to thank you for the opportunity to testify today.
The DOD BCRP’s decade of progress in the fight against breast cancer has been made possible by this Committee’s investment in breast cancer research. To continue this unprecedented progress, we ask that you support a $175 million appropriation for fiscal year (FY) 2004. The program was cut back from $175 million to $150 million two years ago as part of an across-the-board cut in Congressionally directed health programs. However, there continues to be excellent science that goes unfunded which is why we believe that the BRCP should be appropriated $175 million for FY 2004.
As you know, the National Breast Cancer Coalition is a grassroots advocacy organization made up of more than 600 organizations and tens of thousands of individuals and has been working since l99l toward the eradication of this disease 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.
Overview of the DoD Breast Cancer Research Program
In the span of only ten years, the DOD Peer-Reviewed Breast Cancer Research Program has established itself as model medical research program, respected throughout the cancer 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 Institute of Medicine (IOM). Because there is no bureaucracy, the program is able to quickly respond to what is currently happening in the scientific community. It is able to fill gaps, with little fuss. 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 skill.
In addition, an inherent part of this program has been the inclusion of consumer advocates at every level, which has created an unprecedented working relationship between advocates and scientists, and ultimately led to new avenues of research in breast cancer. Since 1992, more than 600 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. In addition, 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 and innovation. While we carefully allocate these resources, we do not want to predetermine the specific research areas to be addressed.
Unique Funding Opportunities
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 academic 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 recognize talented individuals, rather than projects, from any field of study by providing funding and freedom to pursue creative, potentially breakthrough research that could ultimately accelerate the eradication of breast cancer. In the area of training, the DOD BCRP has launched innovative programs such as Physician-Scientist Training Awards, which are intended to support the training of new breast cancer clinical research physicians.
Also, Historically Black Colleges and Minority Universities/Minority Institutions Physicians’ Training Awards (“Minority Institution” 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 established investment in breast cancer research, for the purpose of creating an environment that would foster breast cancer research, and in which Minority Institute faculty would receive training toward establishing successful breast cancer research careers.
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 the growing interest in breast cancer research -- $175 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, for investigator-initiated projects that involve a clinical trial within the lifetime of the award, make up the majority of the BCRP’s translational research portfolio. The BCRP expanded its emphasis on translational research by offering 5 different types of awards that support work at the critical juncture between laboratory research and bedside applications.
Scientific Achievements
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.
One of the most promising outcomes 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. This drug could not have been developed without first researching and understanding the gene known as HER2-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 HER2-neu could slow the growth of the cancer cells that over-expressed the gene. This research led to the development of the drug Herceptin. This research 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.
Several studies funded by the BCRP will examine 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 a higher risk of 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.
Another DOD BCRP IDEA award has generated a new vaccine targeted against ductal carcinoma in situ (DCIS), a malignant, non-invasive lesion that can develop into an invasive breast cancer. The vaccine is being tested on mice that develop spontaneous mammary tumors that over express the HER-2/neu protein. Mice treated with the vaccine show a markedly decreased rate of tumor development when compared to that generated for the prevention of tumor formation in women at risk for the development of HER-2/neu expressing tumors.
Investigators funded by the DOD have developed a novel imaging technique that combines two-dimensional and novel 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.
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.
Federal Money Well Spent
The DOD BCRP is as efficient as it is innovative. In fact, 90% 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 is able to fill gaps by focusing on research that is traditionally under-funded. It is also responsive, not just to the scientific community, but also 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 $1.2 billion in appropiations, which has resulted in 2,837 awards for FY92-00. The areas of focus of the DOD BCRP span a 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; the program offers awards that fill existing gaps in breast cancer research. Scientific achievements that are the direct result of the DOD BCRP 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 2300 publications in scientific journals, 1800 abstracts and 30 patents/licensure applications.
The federal government can truly be proud of its investment in the DOD BCRP.
Positive Feedback on 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 two unique assessments of the program. The Institute of Medicine (IOM), which originally recommended the structure for the program, independently re-examined the program in a report published in 1997. Their findings overwhelmingly encourage the continuation of the program and offer 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 recommends continuing the program and establishes a solid direction for the next phase of the program. 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 IOM report has laid the groundwork for effective and efficient implementation of the next phase of this vital research program, now all that it needs is the appropriate funding.
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 2002 Era of Hope meeting, all BCRP award recipients from fiscal years 1998-2000 were invited to report their research findings and many awardees from previous years were asked to present advancements in their research. Scientists reported important advances in the study of cancer development at the molecular and cellular level. Researchers presented the results of research that elucidates several genes and proteins responsible for the spread of breast cancer to other parts of the body, and, more importantly, reveals possible ways to stop this growth. The meeting, which marked the 10th Anniversary of the program, also featured grant recipients who are working towards more effective and less toxic treatments for breast cancer that "target" the unique characteristics of cancer cells and have a limited effect on normal cells.
The DOD Peer-Reviewed Breast Cancer Research Program has attracted scientists with new ideas and has continued to facilitate new thinking in breast cancer research and research in general. 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.
Commitment of the National Breast Cancer Coalition
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 at 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.
In May of 1997, our members presented a petition with over 2.6 million signatures to the Congressional leaders on the steps of the Capitol. The petition called on the President and the U.S. Congress to spend $2.6 billion on breast cancer research between 1997 and the year 2000. Funding for the DOD Peer-Reviewed Breast Cancer Research Program was an essential component of reaching the $2.6 billion goal that so many women and families worked to gain.
Once again, NBCC is bringing its message to Congress. Just last week, many of the women and family members who supported the campaign to gain the 2.6 million signatures came to NBCC’s Annual Advocacy Training Conference here in Washington, D.C. More than 600 breast cancer activists from across the country joined us in continuing to mobilize behind the efforts to eradicate breast cancer. The overwhelming interest in, and dedication to eradicate this disease continues to be evident as people are not only signing petitions, but are willing to come to Washington, D.C. from across the country to deliver their message about our commitment.
Since the very beginning of this program, in 1993, Congress has stood in support of this important investment in the fight against breast cancer. In the years since then, 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 Defense Appropriations Subcommittee, to recognize the importance of what you have initiated. What you have done is set in motion an innovative and highly efficient approach to fighting the breast cancer epidemic. What you must do now is continue to support this effort by funding 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 2.6 million women living with breast cancer.
