Thank you, Mr. Chairman and members of the Senate Appropriations Subcommittee on Defense, for the opportunity to submit testimony about a program that has made a significant difference in the lives of women and their families.
I am Fran Visco, a 32-year breast cancer survivor, a wife and mother, a lawyer, and President of the National Breast Cancer Coalition (NBCC). My testimony is on behalf of the hundreds of member organizations and thousands of individual members of NBCC, representing diverse perspectives from across the country. NBCC is a grassroots organization dedicated to ending breast cancer through action and advocacy. Since its founding in 1991, NBCC has been guided by three primary goals: to increase federal funding for meaningful 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.
Chairman Shelby and Ranking Member Durbin, we appreciate your support for the Department of Defense (DOD) peer reviewed Breast Cancer Research Program (BCRP). As you know, this program was born from a powerful grassroots effort led by NBCC and has become a unique partnership among consumers, scientists, Members of Congress and the military. You, your predecessors, and your Committee have shown great determination and leadership in funding the DOD BCRP at a level that has brought us closer to ending this disease. 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, including those currently serving in the military, to the scientific and health care communities and to the Department of Defense. Much of the progress that has been made in the fight against breast cancer is due to the Appropriations Committee’s investment in breast cancer research through the DOD BCRP. To support this progress moving forward, we ask that you support a level funding $150 million appropriation for Fiscal Year (FY) 2021. In order to continue the success of the Program, you must also ensure that it maintains its integrity and separate identity. This is important not just for breast cancer, but for all biomedical research that has benefited from this incredible government program.
Vision and Mission
The vision of the Department of Defense peer reviewed Breast Cancer Research Program is to challenge the scientific community to design research that will address the urgency of ending breast cancer. Specifically, the BCRP seeks to accelerate high-impact research with clinical relevance, encourage innovation and stimulate creativity, and facilitate productive collaborations.
The meaningful and unprecedented partnership of scientists and consumers has been the foundation of this model program from the very beginning. It is important to understand this collaboration: consumers and scientists working side by side, asking the difficult questions, bringing the vision of the program to life, challenging researchers and the public to do what is needed and then overseeing the process every step of the way to make certain it works. This unique collaboration is successful: every year researchers submit proposals that reach the highest level asked of them by the program and every year we make progress for women and men everywhere.
And it owes its success to the dedication of the U.S. Army and their belief and support of this mission. And of course, to you. It is these integrated efforts that help make this program unique.
The Department of the Army must be applauded for overseeing the DOD BCRP which has established itself as a model medical research program, respected throughout the cancer and broader medical community for its innovative, transparent and accountable approach. This program is incredibly streamlined. The flexibility of the program has allowed the Army to administer it with unparalleled efficiency and effectiveness. Because there is little bureaucracy, the program is able to respond quickly to what is currently happening in the research community. Its specific focus on breast cancer allows it 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 pioneering research performed through the program and the unique vision it maintains have the potential to benefit not just breast cancer, but all cancers as well as other diseases. Biomedical research is literally being transformed by the DOD BCRP.
Relevance To Military Health
Breast cancer is the most common non-skin cancer in women, causing the most cancer-related deaths in women under the age of 40. Female active duty Service members have a 20-40% higher incidence rate of breast cancer than the general public. The incident rate of breast cancer for active duty women is seven times higher than the average incident rate of fifteen other cancer types across all Service members. The outcomes of BCRP funded research will ultimately benefit military service members, veterans, military beneficiaries, and the general public.
The DOD funded Dr. Dennis Slamon’s early work on Herceptin and thus benefited me as an active duty Service member and now as a Veteran. It is a full circle, with me giving 25 years of service to the DOD, and the DOD giving back to me as a breast cancer patient.-SMSgt (Ret.) Sheila McGlown (Note: Dr. Slamon received the 2019 Lasker-DeBakey Clinical Medical Research Award for his work on the invention of Herceptin.)
Breast Cancer Landscape
The BCRP has prepared an overview of the Breast Cancer Landscape (http://cdmrp.army.mil/bcrp/pdfs/Breast%20 Cancer%20Landscape.pdf.) covering the topics most pertinent to the program’s mission of ending breast cancer. Some key points from the breast cancer landscape: (1) Worldwide, breast cancer accounts for nearly a quarter of all cancers in women. in 2018, there were over 626,000 breast cancer deaths globally. (2) Evidence attributes the majority of breast cancer not to one single factor, but to various physical, environmental and genetic factors. (3) Most risk factors are not modifiable, including age, family history, BCRP mutation status, and breast density. (4) Potentially modifiable risk factors,
including obesity reduction, avoidance of use of combined estrogen and progestin menopausal hormones, reduced alcohol consumption and smoking, and increased physical inactivity, are only weakly to moderately associated with breast cancer. (5) An estimated 20-30% of women diagnosed with invasive breast cancer will have a recurrence. The rate of metastatic breast cancer at initial diagnosis in the United States has not changed since 1975. (6) Treatments to permanently eradicate metastasis do not exist. There is no cure once metastatic disease has occurred.
Advocates bring a necessary perspective to the table, ensuring that the science funded by this program is not only meritorious, but that it is also meaningful and will make a difference in people’s lives. The consumer advocates bring accountability and transparency to the process. They are trained in science and advocacy and work with scientists willing to challenge the status quo to ensure that the science funded by the program fills important gaps not already being addressed by other funding agencies. Since 1992, nearly 1,000 breast cancer survivors have served on the BCRP review panels.
Twelve years ago, Karin Noss, a retired Air Force Lieutenant Colonel who served almost 21 years on active duty as a missile launch officer and intelligence analyst, chaired the Integration Panel. Lt. Col. Noss was 36 years old when she discovered a lump that was misdiagnosed by mammography and clinical exam; just over one year later, however, she was diagnosed with Stage II breast cancer. Her diagnosis inspired her to become knowledgeable about her disease, and as a trained consumer advocate she began participating as a consumer reviewer on BCRP scientific peer review panels in 1997. Karin was committed to making a difference and ensuring that the voice of consumer advocates was heard by the scientific community, challenging scientists to think differently.
Karin worked tirelessly in support of the BCRP through the pain and fatigue of metastatic breast cancer. She died of the disease in September 2008. Just a few weeks before her passing, Karin served what would be her final role for the BCRP when she chaired the FY08 Vision Setting Meeting, an important milestone at which the program determines which award mechanisms to offer in order to move research forward. She said that:
Consumer involvement in all facets of the BCRP has proven crucial to ensuring not only that the best and most innovative science gets funded, but that the science will really make a difference to those of us living with the disease.
Lt.Col. Noss demonstrated an amazing strength, determination, and commitment to eradicating breast cancer. She was an optimist, determined to make things better for women with breast cancer and her legacy reminds us that breast cancer is not just a scientific issue; it is a disease that affects people. The consumers who sit alongside the scientists at the vision setting, peer review and programmatic review stages of the BCRP are there to ensure that no one forgets the women who have died from this disease and to keep the program focused on its vision.
For members of the military and their families, the consumer participation aspect of the program is particularly meaningful.
Beyond my personal medical care provided by the military, it means so much to me that the DoD is also providing for military families by funding such important research on breast cancer and metastisis. Alexis Rhoads, Military Spouse, Warriors for Warriors (Alexis passed away from metastatic breast cancer on October 29, 2017)
For many consumers, participation in the program is “life changing” because of their ability to be involved in the process of finding answers to this disease. In the words of one advocate:
Participating in the peer review and programmatic review has been an incredible experience. Working side by side with the scientists, challenging the status quo and sharing excitement about new research ideas…it is a breast cancer survivor’s opportunity to make a meaningful difference. I will be forever grateful to the advocates who imagined this novel paradigm for research and continue to develop new approaches to eradicate breast cancer in my granddaughters’ lifetime.–Marlene McCarthy, Rhode Island Breast Cancer Coalition (Marlene passed away from metastatic breast cancer on July 17, 2018)
Scientists who participate in the Program agree that working with the advocates has changed the way they do science. Let me quote Greg Hannon, the FY10 DOD BCRP Integration Panel Chair:
The most important aspect of being a part of the BCRP, for me, has been the interaction with consumer advocates. They have currently affected the way that I think about breast cancer, but they have also impacted the way that I do science more generally. They are a constant reminder that our goal should be to impact people’s lives.–Greg Hannon, PhD, Cold Spring Harbor Laboratory
The DOD BCRP uses a two-tiered review process for proposal evaluation, with both steps including scientists as well as consumers. The first tier is scientific peer review in which proposals are weighed against established criteria for determining scientific merit. The second tier is programmatic review conducted by the Integration Panel (composed of scientists and consumers) that compares submissions across areas and recommends proposals for funding based on scientific merit, portfolio balance and relevance to program goals.
Scientific reviewers and other professionals participating in both the peer review and the programmatic review process are selected for their subject matter expertise. Consumer participants are recommended by an organization and chosen on the basis of their experience, training and recommendations.
The BCRP has the strictest conflict of interest policy of any research funding program or institute. This policy has served it well through the years. Its method for choosing peer and programmatic review panels has produced a model that has been replicated by funding entities around the world.
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 and consumers 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 of 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.
Distinctive Funding Opportunities
The DOD BCRP research portfolio includes many different types of projects with the shared goal of making breakthroughs in understanding breast cancer. These award mechanisms span the scope of the research continuum from research in the earliest stages of idea development to those where near term clinical impact is expected. In addition, they recognize the individuals undertaking this research – from those at the starts of their careers to those already distinguished in their fields.
The intent of the Breakthrough Award is to support promising research that has high potential to lead to or make breakthroughs in breast cancer. The impact may be near-term or long-term, but must be significant and move beyond an incremental advancement. Applications must articulate the pathway to making a clinical impact for individuals with, or at risk for, breast cancer, even if the clinical impact is not an immediate outcome.
Breakthrough Award Levels 1 and 2 focus on the preliminary stages of the research process. Level 1 Awards are characterized as innovative, high-risk/high-reward research that is in the earliest stages of idea development and which has the potential to yield new avenues of investigation. Siyuan Zhang of the University of Notre Dame received a FY2014 Breakthrough
Award Level 1 to explore the repurposing of clinically available neurological drugs as a novel therapy of treating breast cancer brain metastasis.
Level 2 Awards require research that is already supported by preliminary data and has potential to make significant advances towards clinical translation. A FY2013 Breakthrough Award Level 2 awarded to Ramesh C. Gupta of the University of Louisville hypotheses that a mixture of blueberry anthocyanidins – the colored pigments in the berries – will inhibit the growth of human breast cancer cells, thus resulting in more effective inhibition of breast cancer, and enhance therapeutic response of standard chemotherapeutic drugs.
Breakthrough Award Levels 3 and 4 focus on the more advanced end of the research continuum. Level 3 Awards support advanced translational studies that have the potential for near-term clinical investigation, including small-scale clinical trials. Elizabeth A. Mittendorf of the University of Texas, MD Anderson Cancer Center received a FY2013 Breakthrough Award Level 3 (Clinical Trial) to continue her work on a combination immunotherapy for the treatment of high-risk HER2 positive breast cancer following encouraging preliminary data.
Level 4 Awards are large-scale projects that will transform and revolutionize the clinical management and/or prevention of breast cancer with near-term clinical impact expected. A FY2013 Level 4 Award was granted to Stephen A. Johnston of Arizona State University, Tempe for studies on a system for early detection of breast cancer which could detect cancer before it was diagnosed and distinguish aggressive from indolent cancers. Both Award Levels 3 and 4 require consumer advocate involvement.
The Breakthrough Award is uniquely designed to dramatically, not incrementally, advance our knowledge in areas that offer the greatest impact to those living with, or at risk for, breast cancer. Such grants are precisely the types that rarely receive funding through more traditional programs. They therefore complement, and do not duplicate, other federal funding programs.
As the Breakthrough Award recognizes research which will have the potential for a major impact and accelerate progress toward ending breast cancer, the following awards invest in individuals – whether at the beginning of their careers or those who have already shown the ability to be innovative leaders in their fields.
Era of Hope Scholar Awards support 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. Dr. Mikala Egeblad of the Cold Spring Harbor Laboratory received a FY2013 Era of Hope Scholar Award to determine if the inflammatory microenvironment can eliminate therapy resistance in breast cancer. This project seeks to establish strategies to better treat several groups of breast cancer patients: those with advanced metastatic breast cancer (cancer that has spread to other organs), those whose disease is dormant but are at risk of relapse, and those recommended for adjuvant treatment after surgery (patients at risk of early disseminated disease).
Innovator Awards provide funding and freedom to world renowned, outstanding individuals to pursue highly creative, potentially groundbreaking research that could ultimately accelerate the eradication of breast cancer. Dr. Bert O’Malley of the Baylor College of Medicine was granted an Innovator Award in FY2012 to develop therapies that can prevent and overcome the development of hormone-resistant metastases of primary breast cancer by targeting a specific family of steroid receptor coactivators (SRCs). These therapies would be able to restore the benefits of endocrine therapies such as tamoxifen and the aromatase inhibitors to resistant breast cancers.
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 FY21.
Outcomes and Reviews of the DOD BCRP
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 18,400 publications in scientific journals, over 1,200 patents/licensure applications and more than 6,700 research awards. 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 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 Institute of Medicine (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 has also reported the results of this research to the American people 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 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/.
Commitment of the National Breast Cancer Coalition
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 ending breast cancer. NBCC 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.
Consumer advocates have worked hard over the years to keep this program free of outside influence. Often, specific institutions or disgruntled scientists try to change the program though legislation, pushing for funding for their specific research or institution, or try to change the program in other ways, because they did not receive funding through the process, when that process is fair, transparent and successful. We are grateful that you have helped protect the integrity of the program. The DOD BCRP has been successful for so many years because of the experience and expertise of consumer involvement, and because of the unique peer review and programmatic structure of the program. We urge this Committee to continue to protect the integrity of the important model.
There are over three million women and men living with breast cancer in this country today. This year, more than 42,000 women and more than 500 men will die of the disease. We still do not know how to prevent breast cancer, how to diagnose it in a way to make a real difference or how to end it. It is an incredibly complex disease. We simply cannot afford to walk away from this program.
Since the very beginning of this Program in 1992, Congress has stood with us in support of this important approach in the fight against breast cancer. In the years since, Chairman Visclosky and Ranking Member Calvert, you, your predecessors, 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 fight 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, especially to the over 3 million women in the United States living with breast cancer and all those who share in the mission to end breast cancer.