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QUESTIONS SUBMITTTED BY SENATOR ARLEN SPECTER

MINORITY HEALTH AND TRAINING REPORT

Question. Dr. Mason, the Conference Report accompanying the Labor, HHS and Education and Related Agencies Appropriations Bill for fiscal year 1991 directed your office to prepare and submit to the Committee a plan for increasing resources to minority health and training over the next four years within the Public Health Service. What is the status of this report and when can we expect or receive it?

Answer. The Conferees directed NIH, HRSA and ADAMHA to develop plans. These plans are in various stages: the NIH plan is in final and should be transmitted to the Committees by May 1; the HRSA plan is currently undergoing review and we anticipate that it will be finalized and sent to the Committees no later than May 15; ADAMHA is currently drafting their plan and will submit their draft for review by May 1. The ADAMHA plan should be available to the Committees by June 1.

PREVENTION

Question. Dr. Mason, the president's FY 1992 budget indicates that disease prevention is a high priority for the Administration. Would you please outline for the Subcommittee the initiatives in the budget for cancer prevention?

Answer. The National Cancer Institute (NCI) translates the results of its basic and clinical research into the means to prevent cancer, to find efficient and effective ways to detect the disease early when it is most treatable, and to assure that the public and professionals alike have access to the knowledge and tools that can reduce the burden of cancer.

NCI's objectives, recently incorporated into the Department of Health and Human Services prevention objectives "Healthy People/2000," call for significant smoking reduction to less than half the level of 1985, a decrease in dietary fat to 30 percent of calories, an increase in dietary fiber to between 20 to 30 grams per day, and a substantial increase in breast and cervical cancer screening.

Descriptive studies by NCI staff continue to examine the characteristics of cancer in the United States, with emphasis on geographic patterns, historical trends, and sexual and racial disparities. Investigations have been undertaken due to concerns about cancer risks associated with indoor and outdoor air pollution. Esophageal cancer occurs more often among Chinese-Americans than Caucasian Americans. Dietary factors will be evaluated in Linxian, China, which has the world's highest rates of this cancer.

A growing body of epidemiologic, basic science and clinical trial data support the efficacy and merit of chemoprevention of cancer. Currently, there are 22 agents undergoing clinical testing, 250 agents in preclinical investigations and 1,000 agents under study. The program also includes preclinical studies to evaluate the toxicity and safety of chemopreventive agents where necessary. A number of these trials are intermediate endpoint studies and are testing biological and biochemical parameters which may serve as surrogate markers for cancer endpoints in chemoprevention trials.

Several ongoing trials focus upon those at high risk for lung cancer. One such trial has been initiated to determine whether markers of early lung carcinoma can be identified and whether beta-carotene can modify either their frequency and/or progression. In another trial, participants will receive the vitamin A derivative 13-cis retinoic acid or a placebo and be evaluated for decreases in bronchial squamous metaplasia/dysplasia, a possible precursor lesion of lung cancer.

Because as much as 25 to 35 percent of cancer mortality could be related to diet, nutrition studies seek to establish an association between dietary intake of fiber, micro- and macronutrients, vitamins, minerals or other food stuffs and the prevention or development of cancer.

The diet and cancer studies combine the results of the chemoprevention studies along with epidemiological research to test the role of the diet and nutrition interventions in the prevention of cancer. A number of intervention studies have been initiated in three broad areas, including etiologic studies, clinical nutrition studies, and prevention trials. These projects represent collaborative efforts in investigating dietary, nutritional, and constitutional factors relating to cancer prevention and involve NCI researchers in the United States and abroad.

The NCI has designed a dietary intervention trial to test whether a low-fat diet can reduce the incidence of breast and other cancers as well as mortality from all causes. Prior to launching this trial, the NCI will conduct a feasibility study to test the methods for dietary change among a broad cross-section of the American population including minority populations, as well as those less-educated, and the poor. Primary objectives are to determine whether adoption of a lowfat dietary pattern will reduce breast cancer incidence, reduce combined breast cancer and colo-rectal cancer incidence, and reduce mortality from all causes including coronary heart disease.

State and local health departments form a national infrastructure through which cancer prevention and control efforts may be addressed. Since 1987, NCI has funded 21 states plus Los Angeles County and the District of Columbia to build their cancer control capacity or utilize existing data resources to develop a state cancer plan and to initiate interventions based on that plan. In addition, NCI staff have provided technical assistance in such areas as planning, program development, and data and registry improvement. Monthly mailings of materials related to cancer prevention and control are sent to each of the 50 state health departments and the District of Columbia. In addition, NCI staff collaborate with representatives from states across the country to produce reports for guiding public health agency activities, and for developing state tobacco prevention and control plans, and for promoting screening mammography. The resulting reports have been disseminated to key cancer control individuals in every state.

Results from intervention research trials have suggested that community-based and sustained programs produce larger, more cost-effective treatment results. Therefore, in 1988, the Community Intervention Trial for Smoking Cessation (COMMIT) began the evaluation of a four-year community-based intervention protocol integrating all previous trial results. Across the intervention communities, COMMIT involves more than two million people with particular emphasis on the heavy smokers (25 or more cigarettes a day) due to their greater cancer risk and their difficulty in quitting.

While significant progress was made in the 1980s in tobacco control, the major reduction in tobacco use targeted by both NCI and the Public Health Service will not be reached without an accelerated effort. Recognizing this need, NCI has initiated the American Stop Smoking Intervention Study for Cancer Prevention (ASSIST). ASSIST is a large-scale demonstration project conducted through and in collaboration with health departments serving states or large metropolitan areas, and with the American Cancer Society (ACS). In each of the selected states or large metropolitan areas, comprehensive smoking prevention and control programs are planned for implementation in 1992 to disseminate the best available tobacco control technologies currently available.

The potential impact of ASSIST will depend upon the size and number of award sites. The upper estimates for the program are that up to 97 million Americans, including 27 million smokers, could be reached by ASSIST. Up to 20 sites will be funded for a 24 month planning period beginning in July of 1991.

The reduction of disproportionately high cancer death rates found in minority and medically underserved groups continues to be a major focus of the NCI. These populations include Black Americans, Hispanics, and Native Americans (American Indians, Alaska Natives and Native Hawaiians) as well as low-income groups. Lifestyle factors have been hypothesized by experts as contributing heavily to the disproportionate rate of deaths from cancer in minority and medically underserved populations. Some of the factors implicated are tobacco use both smoking and smokeless forms of tobacco, alcohol, diets high in fat and low in fiber, occupational risks, and patterns of .care related to early detection, diagnosis, and treatment. It is important to stress that many of the issues discussed here are linked to poverty and the special circumstances posed by poverty-driven lifestyles.

The Community Clinical Oncology Program (CCOP) is a network of community cancer specialists, primary care physicians, and other health care professionals who conduct both clinical treatment research and cancer prevention and control research studies in the areas of early detection and screening, chemoprevention, smoking, patient management, continuing care, and rehabilitation.

In June 1990, 51 community programs in 29 states were funded through the CCOP with awards varying in length from three to five years. The current program involves over three hundred hospitals and 2,100 physicians. Approximately 5,000 patients per year are entered onto treatment clinical trials through the CCOP Program, which represents about one-third of the Phase III annual accrual to NCI-approved randomized clinical trials. In addition, the CCOP contributes substantially to the NCI's effort to increase accrual to high priority intervention trials. The development of cancer prevention and control research in the cCoP network has been increasing steadily since funding for this effort was begun in 1987, with approximately 7,000 patients/ subjects enrolled annually in cancer prevention and control studies.

The CCOP includes twelve programs with greater than 50 percent of new cancer patients from minority populations were funded for three years, beginning in 1990. Through this effort, NCI aims to meet a need of minority cancer patients and individuals at risk for cancer by establishing a system of oncology programs for participation in research trials through the NCI network.

Question. What have we learned in recent years concerning cancer prevention?

Answer. Much has been learned from basic and clinical research about cancer prevention over the last decade. The research and application program initiated by the NCI has focussed on nutrition as both a cause and means of preventing and controlling cancer, and the NCI Chemoprevention Program is addressing at a fundamental level the role of chemical elements, both natural and synthesized, in the prevention of cancer. Over this year Dr. Wayne K. Hong reported the first definitive chemoprevention study to show that a vitamin A derivative is able to prevent head and neck cancers in high risk persons. In addition, we heard several months ago, that & study of dietary fiber has shown that a low-fat, high-fiber diet can reduce the incidence of rectal polyps in persons with a family history of such polyps. These are but the first of what I am sure will be a plethora of results from the chemoprevention and diet and nutrition studies.

Using its Surveillance, Epidemiology and End Results (SEER) database, NCI's Surveillance Program tracks cancer incidence and survival rates throughout the country to identify regions where progress has been made as well as areas where problems remain. This tracking system provides the information necessary for program planning not only for the Institute but for the Nation as a whole.

Equally as important, SEER has proven to be an important tool for the collection and analysis of data specific to minority populations. NCI has significantly expanded its efforts and improved its ability to monitor cancer incidence, mortality, and survival among Black Americans, Hispanics, and rural populations. For example, the 1992 Cancer Control Supplement to the National Health Interview Survey (NHIS) is an additional sampling of Hispanics. These data will provide a more precise estimate of cancer screening knowledge and practices, dietary intake, smoking habits and attitudes, and medical care for approximately 5,000 Hispanic adults. Coupled with comparable data from the 1987 NHIS Cancer Control Supplement, the Nation will have information with which to measure change in the prevalence of cancer risk factors for this population subgroup.

In 1985, NCI established six cancer control objectives. Their purpose was to define those activities that--based on current knowledge--would lead to significant reductions in the morbidity and mortality from cancer. Recently these objectives have been incorporated into the Department of Health and Human Services prevention objectives known as "Healthy People 2000."

NCI's objectives call for significant smoking reduction to less than half the level of 1985, a decrease in dietary fat to 30 percent of calories, an increase in dietary fiber to between 20 to 30 grams per day, a substantial increase in breast and cervical cancer screening, and an increase in the use of state-of-the-art treatment. We estimated in our report that, with full achievement of these objectives, mortality could be reduced by 25 percent and by 50 percent if we increase the rate of progress in our development of new

treatments.

In 1992, through the National Health Interview Survey conducted by the National Center for Health Statistics, under co-sponsorship of the National Cancer Institute, we will obtain national estimates of smoking rates, dietary patterns, and screening behavior. From these figures we will be able to gain our most precise assessment of progress toward the prevention goals. The most recent National Health Interview Survey that stressed cancer control was conducted in 1987.

In 1987 some 32 percent of males smoked as did 27 percent of females. These figures were down significantly from the 1965 figures of 52 percent for males, but down only 7 percent from the 1965 figure of 34 percent for females. State trends seem to indicate that the smoking figures are continuing to drop, and in 1992 we will be able to assess progress from a national sample. Turning to breast cancer screening, we believe there has been considerable progress since 1987. In 1987, only 36 percent of women over 40 had had a mammogram. From smaller surveys conducted in 1989 and 1990, we believe that figure to be at least 60 percent today. Although this is a considerable improvement, we need to determine whether breast cancer screening has become routine practice. It is only through periodic screening, rigorously adhered to, that we can hope to achieve the full potential of screening: a reduction in breast cancer mortality rate by 30 percent. Data from NCI's cancer database, the Surveillance, Epidemiology, and End Results Program, strongly suggests that screening for cervical cancer is continuing, and correspondingly, the cervical cancer mortality rates are continuing to decline. It is this same database that shows that lung cancer incidence rates for males appear to be on the decline.

Together with the Centers for Disease Control and the Food and Drug Administration, we have developed a National Plan for Breast and Cervical Cancer Screening aimed at achieving the breast and cervix cancer control objectives. Representatives from state and local government, academe, and a variety of public and private sector agencies participated in two national meetings held to assist in development of the plan.

Directing cancer prevention and control efforts at those who suffer most or disproportionately from cancer is a cornerstone of the program. The National Black Leadership Initiative on Cancer (NBLIC) was established by the National Cancer Advisory Board and NCI in late 1987 and is a continuing activity. The purpose of this health education initiative is to solicit the assistance of Black Americans who are leaders in the business, civic, religious, and lay communities to develop coalitions to promote NCI's cancer prevention and control goals and to stimulate the involvement of the Black American community in this effort.

Substantial reductions in cancer incidence and mortality can be achieved with preventive technologies currently available. Where we see the least improvement in cancer statistics is among poor and minority populations: The challenge now posed is to disseminate the available information to these populations by culturally relevant means. To meet the Healthy People/2000 objectives, it is essential that we transfer the results of research as fully and as expeditiously as possible. Our task is to forge partnerships with other Federal agencies, and with the public and private sectors. To fully effect this transfer, NCI has developed a number of approaches keyed to particular risk factors, behaviors, and population groups, and all involving the broad public and private sectors who, working together, will help to achieve these objectives.

These are but a few examples of NCI's initiatives aimed at the full application of our knowledge. If the Nation were to quit smoking tomorrow, fully adopt the breast and cervical cancer screening guidelines, reduce fat in the diet to 30 percent of calories, increase fiber as recommended, and fully apply all of our existing knowledge regarding treatment, believe that we would see, by the end of this decade, a significant reduction in cancer mortality. Although we cannot achieve the needed public and health profession behavior

we

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