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Testimony on Battle Against Breast Cancer by Susan J. Blumenthal, M.D., M.P.A.
Deputy Assistant Secretary for Health (Women's Health)
Assistant Surgeon General
U.S. Department of Health and Human Services

Before the Senate Committee on Appropriations, Subcommittee on Labor, Health and Human Services and Education
February 5, 1997

Mr. Chairman, members of the Subcommittee, thank you for the opportunity to speak before you today and for your leadership in the battle against breast cancer. I am Dr. Susan Blumenthal, Deputy Assistant Secretary for Women's Health and Assistant Surgeon General in the U.S. Department of Health and Human Services. I direct the U.S. Public Health Service's Office on Women's Health, the focal point for women's health issues in the Department that coordinates women's health research, health care services, policy and public and health care professional education across the Department, collaborating with other government organizations, and consumer and health care professional groups to advance women's health in the United States and internationally.

My remarks will address current Departmental programs to improve breast cancer detection and diagnosis to ensure that today's mammography is of the highest quality and that women have increased access to this lifesaving technology. I then will describe other initiatives underway, some in partnership with other Federal agencies, to bring the field of breast imaging into the 21st century-- to develop more accurate methods to detect and diagnose this disease in all women. I also will provide you with a progress report on Departmental efforts in the fight against breast cancer.

As you know, breast cancer is one of the most complex and devastating public health problems in our country today. It is perhaps the most dreaded and feared disease in women. It has become an epidemic in our country: the number of women affected by this disease has increased from I in 20 over a lifetime in the 1950s to 1 in 8 today. And, while there has been good news in that the overall mortality rate from breast cancer has dropped for the first time in recent history-5% among women nationwide-the death rate continues to increase for women of color, though at a far slower rate than ever before. It is thought that this overall positive trend is related to the increased use of screening mammography by women in this decade, coupled with improvements in treatment.

IMPROVING CONVENTIONAL MAMMOGRAPHY

Since currently there is no cure for breast cancer or method to prevent it from occurring, the key to saving women's lives is the early detection of the disease, when treatment is the most effective and survival rates are best. That is where today's x-ray mammography has proven crucial. Mammography is a life-saving technology that can detect breast cancer more than 1-2 years before a lump can be felt. Experts agree that it can decrease mortality rates by 30% in women over the age of 50. And, when it is detected at its earliest stages, 5 year survival rates are 93 % and 10 year survival is 76%. Early detection also means that breast sparing surgery-lumpectomy--can be performed.

FDA Implementation of the Mammography Quality Standards Act

Until just two years ago, a woman could go to a mammography facility and not know if the machine was 20 years old or whether the person who positioned her for the test or interpreted the x-ray had adequate training. The Food and Drug Administration's implementation of the Mammography Quality Standards Act now ensures that women are guided to the safest and most reliable mammography in their communities. Today, it is illegal for mammography facilities to operate without certification by the FDA.

Mammography Guidelines

Recognizing the importance of the quality of screening mammograms in the early detection of breast cancer, the Agency for Health Care Policy and Research (AHCPR) developed Clinical Practice Guidelines --Quality Determinants of mammography-- with separate versions for mammography providers, health care professionals, and consumers. The guidelines define the areas of responsibility for each member of the health care team delivering mammograms, including women themselves.

CDC Breast and Cervical Cancer Early Detection Program

Additionally, the Centers for Disease Control and Prevention's Breast and Cervical Cancer Early Detection Program is providing mammograms nationwide at low or no cost to women who cannot afford them. To date, over I million low-income, minority and underserved women have been screened for breast or cervical cancer under this important nationwide initiative that includes all 50 states, 3 territories, the District of Columbia and 13 American Indian tribes.

Medicare Initiative

Breast cancer is primarily a disease of older women, with 60% of cases occurring in women over the age of 65. However, nearly 2/3 of older women don't use Medicare's mammography screening benefit. In direct response, two years ago, the Administration launched an educational campaign to encourage the use of mammography by Medicare-eligible older women.

Public Education

There are many barriers that keep women from using mammography, such as cost, fear, concern about pain and radiation exposure, and inadequate information about the value of early detection.

In an effort to help break down these barriers, the U.S. Department of Health and Human Services has undertaken educational initiatives, often in partnership with public and private sector organizations, to increase women's use of screening mammography.

The National Cancer Institute (NCI), for example, supports three important leadership initiatives-the National Black Leadership Initiative on Cancer, the National Hispanic Leadership Initiative on Cancer, and the Appalachian Leadership Initiative on Cancer. The first two initiatives address a broad range of cancer control issues. The last program focuses specifically on improving breast and cervical cancer outreach activities.

Moreover, the Centers for Disease Control and Prevention (CDC) has developed educational collaborations at the national level with a broad range of private sector, public sector, and consumer groups, supporting programs of national organizations-from the AARP to the YWCA of the USA, and from the American Indian Healthcare Association to the National Migrant Resource Program-to educate their constituencies about breast and cervical cancer, to increase access to screening programs, and to develop methods to reach underserved and other priority populations.

Further, the Department has made the latest information about breast cancer available to the public and to health care providers free through Federal resources, such as the NCI's information line, 1-800-4-CANCER, by the cancer-fax, and on the Internet. And in November 1996, the Office on Women's Health launched an Internet web-site for the National Action Plan on Breast Cancer (NAPBC) that provides answers to frequently asked questions about breast cancer and serves as a gateway to information on research, organizations, advocacy groups, educational conferences and meetings, publications and other resources about breast cancer. The web-site is found at: www.napbc.org.

New Frontiers in Breast Imaging

Despite these improvements and initiatives to improve the quality and utilization of mammography, it is nonetheless a 40-year-old technology. It misses 15% to 20% of cancers, and 80 percent of lesions found by the technology are benign, resulting in unnecessary medical procedures, including surgical biopsies. This is why the Department has made it a priority to bring a new generation of breast cancer detection technologies to the battle against this disease. A range of studies are now being supported-from basic instrumentation and technology development to preclinical and clinical evaluation that have the potential for revolutionizing breast cancer detection and diagnosis. Let me describe some of these new technologies to you.

Ultrasound

Breast ultrasound, unlike other innovative imaging techniques that I will discuss, already has an established role in the diagnosis and management of breast disease. High-resolution breast ultrasound can determine whether lesions found on clinical examination are benign cysts or solid lesions. The features of solid masses can be further analyzed with high-resolution ultrasound to help differentiate those that are most likely to be benign from those with malignant characteristics. The same technology can be used to guide procedures such as aspiration of cysts and needle biopsies of suspicious solid masses.

Digital Mammography

Digital mammography is among the most promising new technologies for improved detection of breast cancer for large scale grams. In sharp contrast to conventional mammography, digital mammography generates images directly on a computer where the image can be digitally enhanced, improving image quality and allowing radiologists to detect smaller lesions using lower radiation doses. In addition, digital mammography opens up new avenues for improved detection, including computer assisted diagnosis, where the computer serves as a second opinion," enhancing radiologic interpretation and improving the ability to distinguish benign from cancerous lesions and telemammography where, using telemedicine, breast images can be transmitted by computer and satellite from community clinics and remote areas to academic centers or other sites for expert radiologic consultation. As we enter the 21st century, telemammography will bring state-of-the-art academic radiologic expertise to underserved populations in our nation and internationally.

Today, an international multi-disciplinary collaboration of academic centers, and industry, supported by the NCI, is facilitating the development, validation and implementation of digital mammography.

Breast MRI

Magnetic resonance imaging (MRI) involves the creation of images from signals generated by the excitation of nuclear particles in a magnetic field. Breast MRI has emerged as one of the most promising novel technologies for the detection and staging of breast cancer in women, particularly for those with radiodense breast tissue for whom traditional or digital x-ray mammography may not be as effective. Unlike either conventional or digital mammography, MRI does not involve ionizing radiation.

Research suggests that MRI is able to pinpoint suspicious lesions camouflaged behind dense breast tissue that traditional x-ray based mammograms have been unable to penetrate sufficiently to accurately detect. Additionally, MRI appears to be unique in its ability to define the size, shape and potential spread in the breast of the tumor, critical for disease staging and treatment planning. Preliminary data suggest that this technology can detect lesions as small as 1-3 mm and that high resolution MRI can improve the differentiation of benign lumps from cancerous ones.

Positron Emission Tomography (PET)

The ultimate goal of new breast imaging technologies is to detect breast cancer at its earliest stages-ideally when only a few cells are present, and long before conventional mammography can detect a tumor. That's where the field of molecular imaging comes in. Positron Emission Tomography-the PET scan-is a nuclear medicine imaging technology that produces an image of the biochemical and physiological processes in the body. PET makes it possible to detect primary tumors as well as the spread of breast cancer to the lymph nodes and other regions of the body. It is also able to image estrogen receptors and chemotherapeutic agents.

IMPORTANCE OF FEDERAL AGENCY COLLABORATIONS

The Missiles to Mammograms Project

Deeply concerned about the limitations in conventional mammography, the U.S. Public Health Service's Office on Women's Health 2 « years ago developed the "New Frontiers in Breast Imaging: From Missiles to Mammograms" initiative to adapt advanced defense, space, and intelligence imaging technologies from the DOD, CIA and NASA -- capabilities estimated to be about I 0 years ahead of medical imaging -- to the early and more accurate detection of breast cancer.

Medical and intelligence imaging share some common challenges. Both must scan and compare two or more large areas to detect and precisely locate small subtle changes in topography-the tank that has been deployed onto a landscape and is camouflaged behind trees; the small cancerous tumor growing deep in a woman's breast, camouflaged by dense breast tissue. And, in both intelligence and medical applications, an incorrect analysis-a missed cancer or a missed military target-can have tragic consequences.

Using CIA-developed computer algorithms called neural networks (modeled after human brain cells), a computer "learns" the features of the terrain from surveillance photographs and can detect subtle changes in visually matched photographs taken over time, identifying the construction of new buildings or troop movements, for example, and distinguishing them from the context or "normal" landscape. Applying this CIA technology to the detection of breast cancer, a computer can be "trained" to recognize the features of an individual woman's breast-including the regions of cancer deposits, such as microcalcifications, that might not be found on digital mammography. In this way, the computer acts as a "second reader." Preliminary results have found that the CIA's neural network technology improves the accuracy of mammography. This new technology is now being tested in a major multi-site clinical trial conducted by the University of Pennsylvania in collaboration with several other academic and industrial partners, supported by the U.S. Public Health Service's Office on Women's Health.

Another component of this multi-site clinical trial is the application of CIA technology used to simulate 3-dimensional missile launches to improve MRI's diagnostic capabilities, creating 3 -dimensional pictures of the breast where the volume, shape and size of a tumor can be visualized. This technology is providing a new method to determine the extent and spread of cancerous growth, to improve the accuracy of biopsies, and to monitor tumor response to treatment.

Breast Biopsies

Imaging technology is also being used in performing biopsies. Eighty percent of women in the United States who undergo surgical breast biopsies do not have cancer. As an alternative to surgical tissue removal, image-guided needle breast biopsy that uses the optics from the Hubble telescope developed by NASA is being studied for women with non-palpable lesions. Image- guided needle biopsy offers the potential advantages of minimized tissue damage, reduced waiting time until diagnosis, and cost savings. A multi-institutional research program is now testing the efficacy and cost-effectiveness of large-core and fine-needle biopsies compared with more extensive surgical biopsies.

Other research is developing methods to detect products of breast cancer (antigens) in blood, urine, or nipple aspirates, and to detect genetic alterations in women who are at increased risk for breast cancer. Once cancer is diagnosed, studies of these types contribute to characterization of breast tumors and can be useful in treatment planning.

Facilitating New Technology Transfer Opportunities

To bring these and other promising new cutting-edge technologies to reality in the diagnosis and treatment of breast cancer, the U.S. Public Health Service's Office on Women's Health established the Federal Multi-Agency Consortium on Imaging Technologies to Improve Women's Health, with diverse membership across Federal agencies, (including the Department of Health and Human Services, FDA, Department of Defense, Central Intelligence Agency, Department of Energy and the Department of Commerce) to foster the identification, evaluation, and transfer of intelligence, space, energy, defense, and other relevant technologies to advance the current state-of-the-art in the early detection and diagnosis of diseases in women, including breast cancer.

DHHS Breast Cancer Initiatives

These new initiatives to improve breast cancer detection and diagnosis are a critical component of the Department of Health and Human Service's all-out assault against breast cancer. Today, real financial muscle has been put behind the Administration's commitment to eradicating this major killer of American women.

HHS Spending on Breast Cancer

HHS funding for breast cancer research, prevention and treatment has increased from approximately $276 million in FY 1993 to an estimated $541 million in FY 1997. The Centers for Disease Control and Prevention (CDC) are working to increase access for all women to mammography screening and follow-up services, with resources devoted to breast cancer services having increased from $42 million in FY 1993, to $81 million in FY 1997. Cancer research is vital to our understanding of how to prevent, detect and treat breast cancer. The Clinton Administration has intensified research efforts on breast cancer at the National Institutes of Health by increasing funding from $229 million in FY 1993, to $430 million in FY 1997. FDA will spend about $26 million in FY 1997 to implement the Mammography Quality Standards Act. HHS also helps provide treatment for breast cancer patients through the Medicare I -- #-and Medicaid programs and through the Indian Health Service.

Federal Breast Cancer Coordinating Committee

Additionally, for the first time, all agencies of government have been mobilized to join in the battle against this disease through the establishment and work of a Federal Interagency Coordinating Committee on Breast Cancer that is fostering new collaborations in the fight against this illness. A Federal inventory of breast cancer-related initiatives has been prepared that will soon be available on the world-wide web homesite of the National Action Plan on Breast Cancer.

National Action Plan on Breast Cancer

In October 1993, the National Breast Cancer Coalition presented President Clinton a petition with 2.6 million signatures urging that there be a new national strategy to fight this disease. DHHS Secretary Donna Shalala convened a conference two months later, in December 1993, followed by the establishment of the National Action Plan on Breast Cancer, an innovative public-private partnership that is catalyzing new action in research, health care service delivery, and education about the disease. The implementation of the Plan is coordinated by the Office on Women's Health.

The Plan involves public/private working groups on a number of high priority action areas, including: (1) increasing research on the causes of breast cancer, particularly the role played by environmental factors; (2) increasing participation of women in clinical trials; (3) developing national biological resource banks; (4) establishing a comprehensive plan for counseling and educating women about the newly-identified breast cancer genes; (5) using new information technologies to improve breast cancer education for consumers and health care providers; and (6) involving consumers in policy and research decisions. Many new cross-cutting initiatives have been implemented in each of these areas.

Breast Cancer Among the Elderly

The Agency for Health Care Policy and Research (AHCPR) is currently funding a five-year Patient Outcomes Research Team study on the care, costs, and outcomes of early stage breast cancer. The study will examine three alternative treatments for early stage breast cancer in the elderly: modified radical mastectomy, breast-conserving surgery with radiotherapy, and breast- conserving surgery without radiotherapy. The project will look at quality and cost-effectiveness in these projects and will develop clear recommendations for treating early stage breast cancer in the elderly.

Office of Cancer Survivorship

Progress is being made in the battle against cancer. Today, we have an entire generation of Americans who can call themselves cancer survivors. On October 27, 1996, President Clinton unveiled the new Office of Cancer Survivorship at the National Cancer Institute. Recent success of cancer prevention, early detection, and treatment efforts has created a new need: research into the physical, psychological, and economic well-being of the growing number of cancer survivors. The Office of Cancer Survivorship will support studies covering the range of issues facing survivors of cancer, including: long term medical and psychological effects; factors that predispose survivors to second malignancies; reproductive problems following cancer treatment; and their unique insurance and employment issues.

Closing