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HHS FACT SHEET September 26, 1998 Contact: HHS Press Office (202) 690-6343
Overview: More than 40 percent of Americans will be diagnosed with cancer during their lifetime and more than 20 percent will die of it. But our concerted efforts to battle cancer are making progress. The National Cancer Institute reports that cancer death rates in the U.S. population fell between 1991 and 1995, the first sustained decline since national record-keeping was instituted in the 1930s. In the short term, this decline means that as many as 16,000 Americans will survive cancer this year who would have died if the rates were the same as they were in 1990. The decline in cancer mortality has been greatest among African Americans, although overall cancer rates remain significantly higher among this group than among white Americans. While this news is encouraging, the fight against cancer remains a top priority for the Clinton Administration.
To meet the challenge and continue the progress, the Administration has implemented a variety of initiatives to improve cancer research, encourage cancer prevention and make cutting edge treatment available to Americans through Medicare and Medicaid.
The President has proposed a $1.9 billion increase over five years in cancer research at the National Institutes of Health, an historic 65 percent increase to $4.8 billion in 2003. Medicare has instituted important new benefits for prevention and screening for breast, colorectal, and cervical cancers. Americans over age 65 make up half of all cancer patients, and are 10 times more likely to get cancer than younger Americans.
Across HHS, experts are working to understand, prevent, and treat cancer. On March 26, 1996, President Clinton announced the FDA Initiative on Reinventing the Regulation of Cancer Drugs, which outlined several initiatives to enhance cancer drug development and to provide opportunities for people to be actively involved in FDA's cancer drug advisory committee process. In the 30 months since the initiative was announced, FDA has approved 24 new therapies to treat more than a dozen different types of cancer, 16 new uses for already available cancer drugs, and 14 new medical devices to diagnose or treat cancer. The Centers for Disease Control and Prevention supports a variety of cancer-related programs, including early detection, surveillance, skin cancer prevention, and education projects.
Finally, the President and the Department of Health and Human Services have worked to prevent tobacco use among youth, step up the fight against breast cancer, decrease environmental hazards, and educate the public about the importance of prevention and early detection of breast, cervical, prostate, colorectal and skin cancer.
RESEARCH AND PREVENTION
Understanding Cancer. The National Cancer Institute at the National Institutes of Health leads the nation's efforts in cancer research. The most remarkable progress made in recent years has been in the knowledge of cancer biology. Research on how cancer develops has shown that cancer invariably involves altered genes and altered gene function. Studies in cancer genetics are providing unprecedented insight into the development and evolution of cancer and are generating knowledge about the most basic processes involved in the onset of cancer C those at the molecular level. In the past few years, scientists have made remarkable progress in the study of cancer genetics, identifying a number of genes that are involved in a number of cancers, including breast, prostate, kidney, skin, and colon. In fact, in the first year of the Cancer Genome Anatomy Project, more than 300,000 DNA sequences and 12,000 new genes have been identified - double what was initially expected.
Drug Development. Over the past year, the National Cancer Institute started an ambitious program to develop new and effective anticancer drugs. The "Chemistry-Biology Centers Program" brings together the best scientists in these two disciplines to focus their efforts on cancer drug discovery. These centers promise to help discover truly novel ways to prevent and treat cancer that were previously unimaginable.
For example, Herceptin, a new anti-cancer compound that was approved by the FDA on September 25, 1998, was developed by a biotechnology firm working with NCI and effectively attacks specific cancer cells that produce a protein called HER2. Studies indicate that Herceptin can help 25-30 percent of patients with advanced breast cancer. Also, early findings of a large, NCI multi-center trial show that the drug Taxol, when used in combination with other standard chemotherapy agents, has a small but significant benefit for breast cancer patients whose disease had spread to nearby lymph nodes.
In 1998, an NCI-sponsored study showed a 49 percent reduction in breast cancer incidence among the high-risk participants who took tamoxifen. The tamoxifen study proved for the first time that it is possible to reduce the short term incidence of breast cancer in women at high risk. An FDA advisory panel recently recommend approval of tamoxifen for reduction of short-term breast cancer incidence.
The FDA works closely with both NCI and private industry to make promising products available to patients with cancer. These products included some novel and even breakthrough approaches. Many were available in the United States before they were approved anywhere else in the world:
Another example of targeted treatment, is anti-angiogenesis research. In cancer, tumors cannot grow or spread without developing new blood vessels that supply the cancer with oxygen and nutrients. About 20 compounds that inhibit the growth of blood vessels are being tested in human clinical trials.
Studies of Issues Faced by Cancer Survivors. Although cancer remains among the worst fears of Americans, it is becoming clear that -- thanks to research -- cancer is not the death sentence it once was. More than 8 million Americans today are cancer survivors who have special needs, and to help them, the National Cancer Institute is spending more than $13 million a year studying the issues and problems they face.
For the first time this year, the National Cancer Institute began including consumer advocates as full voting members of the peer review groups that judge the worth of grant applications. This year the National Cancer Institute also formed 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. By next year, NCI will fully integrate patients and advocates into activities such as reviewing grant proposals, and planning policy. Vice President Gore also announced on September 26, 1998, that NCI is funding $15 in new cancer survivorship grants to fund top-of-the-line research to examine cancer's impact on survivors and their families.
As part of its March 1996 announcement, FDA also initiated a program to educate and recruit cancer patients and their advocates to participate in meetings of FDA advisory committees - groups of outside experts that advise FDA on cancer-related therapies. More than two dozen cancer patients or their advocates have made important contributions to the advisory committees that review cancer-related therapies.
ENSURING RIGHTS FOR CANCER PATIENTS
With the "Consumer Bill of Rights," the Administration has proposed to protect the rights of all health care consumers and their families by assuring the health care system is fair and responsive to consumers' needs. Among the patient protections are two of special concern to cancer patients: guaranteed access to specialists, which would allow cancer patients to have direct access to their oncologists without having to see a primary care physician for a referral; and, transitional care, which would allow patients to continue with an oncologist for a period of time, even if their insurance changes or if the doctor leaves or is terminated from the managed care plan. The Administration continues to press Congress to pass a comprehensive Patients' Bill of Rights and has already applied the Bill of Rights to all Federal health care programs and plans.
On September 17, for example, the President announced that HHS had completed work on a new regulation establishing patient protections for Medicaid beneficiaries enrolled in managed care plans. The rule would bring Medicaid managed care in line with Patient's Bill of Rights, and provide Medicaid beneficiaries enrolled in managed care plans with comprehensive, easy-to-understand information about those plans, along with a list of providers and their locations. The Medicaid managed care regulation fulfills the President's promise to extend the Patient's Bill of Rights to the tens of millions of Americans enrolled in public health care programs, including the more than 20 million Americans in Medicare and Medicaid managed care plans.
MEDICARE PREVENTIVE BENEFITS
On January 1, 1998, Medicare expanded several preventive procedures to detect diseases at early stages when they are most treatable. These new benefits were part of the Balanced Budget Act of 1997. Expanded benefits include: annual mammogram screenings for women age 40 and over; a one-time baseline mammogram for women age 35-39; expanded pap smear coverage to include both a pelvic exam and clinical breast exam every three years for most women; annual pap smear coverage for women at high risk for cervical or vaginal cancer; and coverage for colorectal cancer screening.
ELIMINATING RACIAL DISPARITIES
President's Clinton's Initiative on Race and Health has set, among other goals, a target of eliminating longstanding disparities in cancer rates that afflict racial and ethnic minority groups by the year 2000. Though overall health statistics have improved since 1993, research shows minorities suffer from certain diseases at up to five times the rate of white Americans. For example, African-American men under 65 suffer from prostate cancer at nearly twice the rate of whites; Vietnamese women suffer from cervical cancer at nearly five times the rate of whites; and Latinos have two to three times the rate of stomach cancer.
Surgeon General Dr. David Satcher has launched an outreach program to educate the public about the risks of cancers and other public health problems, and the President's budget proposal contains a $250 million investment over five years to strengthen public health programs such as prostate cancer screening for African American men and breast and cervical cancer screening for Native Americans. Overall, the plan sets a national goal of eliminating health disparities in six areas by the year 2000: infant mortality; cancer screening and management; cardiovascular disease; diabetes; HIV/AIDS rates; and child and adult immunization levels.
DETECTING AND FIGHTING BREAST CANCER
Breast cancer is the most commonly diagnosed cancer, and the second leading cause of cancer deaths among American women. Early detection through mammography and clinical breast exams are essential to reduce deaths from this disease. For women age 50-69, having regular mammograms can reduce the chance of death from breast cancer by one-third or more. Despite the potential benefit, 33 percent of women ages 50-64, and 45 percent of women age 65 and older reported not receiving a mammogram during the past two years.
National Action Plan on Breast Cancer. The Clinton Administration has responded to the significant threat posed by breast cancer with increased efforts in research, prevention and treatment. HHS Secretary Donna E. Shalala convened a conference in December 1993 to establish a National Action Plan on Breast Cancer, which has awarded more than $9 million in grants for 99 innovative research and outreach projects. In 1995, First Lady Hillary Rodham Clinton launched a campaign urging older women to obtain mammograms, and, in particular, to promote use of Medicare coverage for mammography. Both the President and the First Lady have appeared in TV public service announcements encouraging older women to get mammography screening.
Breast and Cervical Cancer Early Detection Program. The Centers for Disease Control's Breast and Cervical Cancer Early Detection Program brings critical screening services to underserved women in all 50 states, including older women, women with low income, and women of racial and ethnic minority groups. To date, more than 1.7 million screenings have been provided.
Mammography Quality Standards Act (MQSA). The Mammography Quality Standards Act (MQSA), published October 1997, gives FDA the authority to set high standards for mammography facilities and certifies those which meet the standards. The roughly 10,000 mammography facilities nationwide certified by the FDA must meet quality standards for both equipment and personnel, and are inspected annually. MQSA regulations require 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 and patients be fully and quickly informed of results so that any follow-up testing or treatment can begin immediately.
PREVENTING YOUTH TOBACCO USE
Each day, almost 3,000 young people in the United States become regular smokers, and nearly 1,000 of them will die prematurely from diseases related to tobacco use. Each year, more than 400,000 Americans die from smoking-related diseases, more Americans than are killed each year by AIDS, alcohol, car accidents, murders, suicides, illegal drugs, and fires combined.
In August, 1996, President Clinton announced the FDA tobacco rule designed to reduce the incidence of youth smoking. The FDA rule made it a federal violation to sell cigarettes or spit tobacco to anyone younger than age 18, and required retailers to ask for photo identification from anyone under age 27 who attempts to purchase tobacco products. In February, 1998, Vice President Gore announced a new national education campaign to educate consumers and help retailers prevent illegal sales of tobacco products to children. The Vice President also announced progress by the Substance Abuse and Mental Health Services Administration (SAMHSA) in implementing the Synar Amendment, legislation that requires states to monitor retailer compliance to ensure they prohibit tobacco sales to children.
The administration is also working to pass comprehensive national tobacco legislation, encompassing the President's five key principles: (1) a comprehensive plan to reduce youth smoking; (2) full authority for the FDA to regulate tobacco products; (3) changes in tobacco industry policy, including an end to marketing and promotion to children; (4) progress toward other public health goals, including biomedical and cancer research, a reduction of second-hand smoke, promotion of smoking cessation programs, and other urgent priorities; and (5) protection for tobacco farmers and their communities.
OTHER PREVENTION ACTIVITIES
Protecting Children from Environmental Exposures: In April 1997, President Clinton issued an executive order assigning high priority to addressing environmental health and safety risks to children. The executive order established a Task Force on Environmental Health Risks and Safety Risks to Children, which has identified four priority areas: 1. Asthma, 2. Unintentional injuries, 3. Developmental disorders, 4. Cancers. Through this task force, HHS is working with the Environmental Protection Agency (EPA) to promote policies and practices that emphasize child health. On September 3, 1997, HHS and EPA announced that they are creating the first federal research centers dedicated to the protection of the health of children from environmental threats. A total of $ 10 million has been allocated for the initial year of the centers. The agencies plan to establish six centers nationally.
"Choose Your Cover" Skin Cancer Prevention Campaign. In May 1998 HHS Secretary Donna E. Shalala launched a national, multi-year awareness initiative to prevent skin cancer among Americans. The "Choose Your Cover" public service announcements target 18- to 25-year-olds, an age group that spends many hours out in the sun. The "Choose Your Cover" initiative will also reach out to 9- to 18-year-olds -- a critical time when adolescents set patterns of behavior that they carry with them into adulthood. The campaign was designed by the Centers for Disease Control and Prevention.