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| October 12, 2000 | Contact: | HHS Press Office (202) 690-6343 NCI Press Office (301) 496-6641 FDA Press Office (301) 827-6242 |
According to a July 2000 report released by the Centers for Disease Control and Prevention's (CDC) National Center for Health Statistics, nearly 7 out of 10 women aged 50 and over - or 69 percent - received mammograms in the past two years. Additionally, a recent study by the National Cancer Institute (NCI) and the Health Care Financing Administration (HCFA) suggests that the number of women age 65 and older receiving routine mammograms increased to 70 percent in 1998. And a CDC survey of 38 states in 1997 found that approximately 71 percent of all women over age 40 had a mammogram in the previous two years.
The administration's fiscal year 2001 budget encompasses $695 million for breast cancer-related activities, which includes $553 million for breast cancer research at the National Institutes of Health (NIH). The NCI has also launched the Study of Tamoxifen and Raloxifene (STAR) clinical trial testing each drug's effectiveness in reducing the risk of breast cancer in postmenopausal women. In January 1998, NCI and HCFA formed a partnership to raise the importance of regular mammography screening among women ages 65 and older. At the same time, Medicare coverage expanded to help pay for annual mammograms for all Medicare beneficiaries age 40 and over.
This year marks the 10th anniversary of the Centers for Disease Control and Prevention's (CDC) National Breast and Cervical Cancer Early Detection Program. CDC's screening and early detection program has grown from eight states in 1991 to 50 states, six U.S. territories, the District of Columbia, and 12 American Indian/Alaska Native organizations in 2000. The President's fiscal year 2001 budget proposed creating a new Medicaid option for states to cover uninsured women who have been diagnosed with breast or cervical cancer through CDC's early detection program receive the full Medicaid benefits package for the entire time they require treatment. The Congress has recently passed legislation that would provide this important new health coverage option to low-income, uninsured women with breast cancer.
To spread the word about the importance of mammography in early detection of breast cancer, especially in minority communities, Secretary Shalala released two public services announcements in October 2000 featuring David A. Satcher, M.D. Between 1995-1999, President Clinton and/or the First Lady have appeared in televised public service announcements encouraging older women to get mammograms and promoting the use of Medicare coverage for mammography.
Background:
Despite Incidence, More Women Can Survive Breast Cancer--More than 2 million women alive today have had breast cancer. Five-year relative survival rates for breast cancer have increased in recent years -- in the 1990s, 85 percent of women are survivors versus 75 percent of women in the mid 1970s. However, breast cancer still accounts for 30 percent of all cancers among women and 15 percent of cancer deaths. If current rates stay constant, a baby girl born today has a one in eight chance of developing breast cancer in her lifetime.
A woman's chance of getting breast cancer changes with age: by age 40, one in 225 women will face breast cancer; by age 70, one in 13 will be diagnosed with the disease. An estimated 182,800 new cases of breast cancer will be diagnosed among women in the year 2000, and 40,800 will die from the disease. Epidemiologic studies estimate that breast cancer will be diagnosed in 1.5 million American women in this decade, and claim nearly half a million lives. Death rates from the disease are highest among older women and African-American women. During the 1980s, breast cancer incidence for women increased, but in the 1990s, it leveled off.
Age-adjusted death rates from breast cancer for women fell to 19 deaths per 100,000 in 1998, down from 23 in 1990. Between 1990 and 1997, the greatest reduction in death rates were among younger women (2.6 percent per year) and white women (2.4 percent per year), with more modest reductions among African-American women (0.2 percent per year) and women age 65 and older (1.5 percent per year).
From 1990 to 1997, death rates among white women ages 30 to 79 declined and rates also fell among African-American women 30 to 69 years of age. Among both groups, the greatest improvements in mortality were seen in younger age groups. For women ages 30 to 39 years, rates dropped about 3.2 percent per year among whites and 1.2 percent per year among African Americans. For women ages 40 to 49, rates dropped 3.4 percent per year among whites and 0.8 percent per year among African-Americans.
NATIONAL INITIATIVES TO COMBAT BREAST CANCER
HHS has directed a wide array of activities and new initiatives:
HHS National Action Plan on Breast Cancer (NAPBC)-Coordinated by HHS' Office on Women's Health, the National Action Plan on Breast Cancer was initiated under the Clinton administration's direction and Secretary Shalala's leadership. The NAPBC serves as a catalyst for national efforts in six priority areas:
The Center for Disease Control and Prevention's (CDC) National Breast and Cervical Cancer Early Detection Program -- CDC's National Breast and Cervical Cancer Early Detection Program is celebrating 10 years of providing free or low-cost mammography screening to uninsured, low-income, elderly, minority and Native American women nationwide. Established in 1990 by Congress' Breast and Cervical Cancer Mortality Prevention Act, the program has provided more than 2.5 million screening tests -- nearly 1.2 million mammograms and more than 1.3 million Pap tests -- and diagnosed nearly 8,000 breast and cervical cancers. Among women receiving their first CDC-funded mammogram, 7.7 cancers were detected per 1,000 white women; 6.4 cancers per 1,000 African-American women; 6.2 per 1,000 Asian/Pacific Islander women; 4.9 per 1,000 American Indian/Alaska Native women; and 4.9 per 1,000 Hispanic women.
Fiscal year 2000 appropriations of approximately $167 million enable CDC to increase education and outreach programs for women and health care providers, improve quality assurance measures for screening, and improve access to screening and follow-up services.
Medicare's Annual Mammography Benefit--Since January 1998, Medicare coverage has helped pay for annual mammograms for all Medicare beneficiaries age 40 and over. Under this new benefit, Medicare waives the Part B deductible for screening mammograms. In 1998, NCI and HCFA formed a partnership to raise awareness of the importance of regular mammography screening among women age 65 and older, and of the expanded mammography screening benefit for Medicare beneficiaries. According to a joint HCFA/NCI study, the vast majority (88 percent) of older women have had at least one mammogram in their lifetime, representing a 25 percent increase from a similar survey conducted by American Association of Retired Persons (AARP) in 1992. And 80 percent received their most recent mammogram two years ago or less -- again a substantial increase from 55 percent in 1992.
Still, data from the survey also show that more than one-third of women age 65 and older are not as concerned about getting breast cancer as they were when they were younger. Additionally, only 57 percent of the nationally representative sample of 814 women ages 65 and older know they should have a screening mammogram every one or two years. To spread the word about the importance of mammography in early detection of breast cancer, especially in the minority community, HHS Secretary Shalala released two public service announcements in October featuring singer and actress Whitney Houston and First Lady Hillary Rodham Clinton. Information about the Medicare benefit also is included in the new Medicare & You handbook, mailed to all Medicare beneficiaries and is on the Internet at www.medicare.gov.
Mammography Quality Standards and Technology--The final regulations to implement the Mammography Quality Standards Act (MQSA) of 1992 went into effect April 28, 1999, ensuring universal access to high quality mammography services in this country. Under the final rules, FDA sets high standards for mammography facilities and certifies those that meet the standards. The roughly 10,000 mammography facilities nationwide accredited by the FDA must meet quality standards for equipment and personnel and are inspected annually. These regulations spell out the details for requiring facilities to hire capable technologists, use quality dedicated equipment that produces clear images, and employ skilled interpreting physicians to interpret the results both accurately and efficiently. The rules also require that doctors be fully and quickly informed of results so that any follow-up testing or treatment can begin immediately. In fact, the Mammography Quality Standards Reauthorization Act of 1998 required every U.S. mammography facility to notify patients of their mammogram results promptly and in easy-to-understand language.
The names and locations of FDA-certified mammography facilities are available by calling NCI's Cancer Information Service at 1-800-4-CANCER. In addition, the FDA has included a list of all FDA-certified mammography facilities in the United States on its Internet home page. The address is www.fda.gov/cdrh/mammography/certified.html.
Medicaid Coverage - The President's fiscal year 2001 budget proposed to create a new Medicaid option for states to cover uninsured women who have been diagnosed with breast or cervical cancer through CDC's early detection program. Women covered under this option would receive the full Medicaid benefits package for the entire time they require treatment. The Congress has recently passed legislation that would provide this important new health coverage option to low-income, uninsured women with breast cancer.
HHS PROPELS BREAST CANCER RESEARCH AND PROGRAMS INTO THE 21st CENTURY
National Cancer Institute (NCI) Research Grants--In September 2000, the National Institutes of Health's National Cancer Institute awarded $6.7 million in two-year grants to 31 applicants in support of novel or innovative research in the area of breast cancer. The NCI grants will support a variety of studies focusing on breast cancer biology, etiology, genetics, prevention, detection, diagnosis and prognosis, treatment, control and outcomes. Funding for the grants was raised through an act of Congress in 1997 that allowed contributions to breast cancer funding through the purchase of a first-class stamp for 40 cents. Seventy percent of the proceeds were set aside for breast cancer research by NIH. Approximately $1 million more in stamp sales proceeds is expected to be received by NIH before the end of the year 2000. This installment of funds will be used to award additional grant applications.
Breast Cancer Prevention Trials--As part of a large North American study conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) with support from NCI, more than 13,000 women volunteered to take tamoxifen or an inactive pill to see if the drug would help prevent new cases of breast cancer. In 1998, the Breast Cancer Prevention Trial showed 49 percent fewer cases of breast cancer reported in the high-risk women in the trial who took the drug versus those on the inactive pill. The study highlighted the fact that while a reduction in new cases is significant, there are risks associated with tamoxifen that must be carefully weighed against the benefits of breast cancer reduction. NSABP and NCI developed a Web-based tool for individual decision-making that will help women at increased risk of breast cancer consult with their health care providers about whether or not to begin tamoxifen therapy. The tool can be found at cancernet.nci.nih.gov/bcra_tool.html.
In an analysis of NSABP data released in May 2000, NCI scientists found that tamoxifen is as effective for black women as it is for white women in reducing the occurrence of "contralateral" breast cancer, cancer that develops in the healthy breast after cancer in the opposite breast has been treated.
Building on the success of the Breast Cancer Prevention Trial, NCI funded the Study of Tamoxifen and Raloxifene, or STAR, the largest-ever breast cancer prevention trial. STAR will determine whether raloxifene, a drug similar to tamoxifen, is also effective in preventing breast cancer but with fewer side effects than tamoxifen. Announced by Secretary Shalala in October 1998, STAR began recruiting participants in July 1999, and more than 7,150 postmenopausal women at increased risk of breast cancer are participating in the trial thus far. More than 500 sites across the United States, Puerto Rico and Canada are enrolling women in the trial, which will ultimately include 22,000 women.
Breast Cancer Genetic Discoveries--Breast cancer research and discovery has expanded rapidly at the NIH. Promising news first came in 1994 when a team of investigators at the University of Utah, Myriad Genetics and the National Institute of Environmental Health Sciences (NIEHS) identified a breast cancer susceptibility gene (BRCA1) that may account for 5-10 percent of the breast cancers diagnosed each year. The discovery of a second, entirely different breast cancer susceptibility gene, BRCA2, has helped us understand even more about the genetics of breast cancer. Researchers more recently discovered a particular variant of the BRCA1 susceptibility gene in Jewish women of eastern European descent (Ashkenazi Jews). While only 5-10 percent of all breast cancers are the result of an inherited anomaly, these findings hold promise for the development of new prevention and treatment strategies.
On October 27, 1996, the administration announced $30 million in new funding for research into the genetic basis of breast cancer through a collaborative initiative between the Department of Defense and NIH. A recent initiative under NCI's Cancer Genome Anatomy Project, the Tumor Gene Index, a partnership with academic centers and private companies to compile on the Internet the first comprehensive record of genes involved in human cancer, is identifying and cataloguing genes in the breast that are active in cancer.
Privacy of Genetic Information and Breast Cancer--President Clinton has supported bipartisan legislation to prohibit health plans from inappropriately disclosing genetic screening information or using it to deny insurance coverage or set premiums. In many diseases, such as breast cancer, we are beginning to identify genetic alterations that may place a woman at increased risk. Women who test positive may increase cancer detection efforts, may choose to have preventive surgery or may join a cancer prevention research study. However, insurance companies and others also can misuse genetic testing to discriminate and stigmatize individuals and groups of people. In fact, studies show that women often do not get genetic testing for breast cancer because they fear the information will be used to discriminate against them.
New Frontiers In Breast Cancer Early Detection--HHS has been working with the Department of Defense, the Central Intelligence Agency, National Aeronautics and Space Administration, and other public and private entities to explore ways in which imaging technologies from other fields may be applied to the early detection of breast cancer. In particular, the computer technologies that have been used to improve imaging satellites may help improve breast cancer detection as well. In October 1996, HHS awarded $1.98 million to the University of Pennsylvania to conduct a series of clinical trials of imaging technology from the intelligence community -- originally used for missile guidance and target recognition -- to improve the early detection of breast cancer.
HHS AGENCIES SUPPORT INNOVATIVE BREAST CANCER PROGRAMS
Agency for Healthcare Research and Quality (AHRQ)--is currently funding a five-year Patient Outcomes Research Team study on the care, costs and outcomes of early stage breast cancer specifically for the elderly. 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 October 1994, AHRQ developed a Clinical Practice Guideline--Quality Determinants of Mammography--with separate versions for mammography providers, health care professionals and consumers. The guidelines detail the roles and responsibilities of each health care professional involved in mammography services, and include information and recommendations for women. AHRQ has also funded research of the outcomes, effectiveness, and cost-effectiveness of the diagnosis and treatment for breast cancer.
National Cancer Institute (NCI)-NCI completed a progress review of research on breast cancer in 1998. Recommendations from this review have helped establish research priorities for the NCI. Researchers can view breast cancer funding opportunities at www.cancer.gov/scienceresources/initiatives.html.
Vaccine Development
Breast Cancer Screening and Diagnosis
Substance Abuse and Mental Health Services Administration (SAMHSA)--Women who are in need or who receive substance abuse or mental health services often lack appropriate primary health care, including breast cancer education, detection and treatment. Women-focused substance abuse and mental health programs funded by SAMHSA are designed to be comprehensive, delivering primary health care services to women who often are medically underserved. These services include education on breast self-examination and mammography services and counseling on risks for breast cancer. In addition, beginning with a groundbreaking November 1998 meeting, SAMHSA and NCI have been collaborating to help elucidate the effect of a parent's illness, such as breast cancer, on the family in general, and on children or teens in the family, in particular. That conference emphasized the need for new research, better program development, enlightened training for health and social services professionals, and changes in public health policy, each with a focus on better "listening to families." A second meeting a year later is taking a reading of the progress being made in this critical area affecting families touched by breast cancer, as well as by other cancers or illnesses.
HHS' Office of Women's Health (OWH)--The HHS Office on Women's Health has established a Federal Interagency Coordinating Committee on the Environment and Women's Health that focuses on how home, work, atmospheric pollutants, exogenous hormones, drugs, and other environmental factors may contribute to the risk of breast cancer and other disorders. In May 1999, NCI awarded a $4.8 million contract for development and implementation of a prototype geographic information system for breast cancer studies as part of the Long Island Breast Cancer Study. In October 1999, NCI held town meetings on Long Island, N.Y. to call for available background information about possible environmental hazards in the region.
HHS Centers of Excellence--Since October 1, 1996, HHS has established 17 National Centers of Excellence in Women's Health to serve as national models for improving the health care of American women. The Centers of Excellence program, with facilities located at academic institutions in different areas of the country, is integrating health care services, research programs, public education and health care professional training.
Cancer Survivorship--In October 1996, President Clinton unveiled the new Office of Cancer Survivorship at NCI. Recent success of cancer prevention, early detection and treatment efforts have 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 supports research covering the range of issues facing cancer survivors, including long-term medical and psychological effects; factors that predispose survivors to second malignancies; reproductive problems following cancer treatment; impacts on the family; insurance and employment issues; and interventions that result in improved quality of life and reduced morbidity and mortality.
In March 1998, NCI began including consumer advocates as full voting members of the peer review groups evaluating grant applications. This is much like the two dozen cancer patients and/or advocates who have assisted in cancer drug approval decisions since 1996 as voting members of FDA advisory committees.
NCI formed in 1997 a Director's Consumer Liaison Group, a formal committee of 15 cancer survivors who directly advise the NCI director and bring the patient's perspective to bear on the full range of NCI activities. This year, NCI will fully integrate patients and advocates into activities such as reviewing grant proposals and planning policy.
In September 1998, NCI earmarked $15 million over five years for new research into the physical and emotional well-being of cancer survivors who are alive five or more years after diagnosis. This is in addition to $20 million already earmarked by NCI for survivorship-related studies.
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