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are in the process of combining their heterosexual transmission studies by adopting a similar protocol which will result in comparable data that will be merged resulting in a more meaningful analysis of research questions. NIDA has worked to assure that HIV natural history and transmission studies that are funded complement, rather than duplicate each other and also that, as much as possible, they complement work being done by other agencies or institutions. This has involved close coordination between NIDA program staff and both NIDA grantees and representatives from other agencies. ADAMHA and CDC have established å formal work group for facilitating coordination and collaboration between the two agencies.
Question. The PHS is to be commended for its recognition of the disproportionate impact AIDS has had on minority communities. However, I am concerned about the coordination and duplication of programs targeted at minorities at risk. The budget justification for the Office of Minority Health says: "grants are made to national minority and community-based organizations which conduct health education and prevention activities directed to minority groups." The CDC justification says that the CDC Office of Minority HIV Policy Coordination is "providing funds directly to approximately, 100 national, regional, and community-based organizations which represent or serve minority populations.' How do these programs differ? What is the reason for separate administration of these programs?
Answer. CDC's direct-funded community-based organizations (CBOS) serving racial and ethnic minority populations must be nonprofit and must serve minority populations within the 31 high AIDS incidence metropolitan statistical areas, and the memberships of their governing bodies must have at least 50 percent racial and minority representation. CBO8 currently funded by OMH may serve high, medium or low HIV incidence geographic areas, both urban and rural. OMH tends to fund organizations in areas with a lower incidence of HIV/AIDS. OMH-Funded grants range from $50,000 to $75,000 annually, compared with CDC's which range from $20,000 to $225,000 annually.
Both CDC and OMH maintain ongoing collaboration to ensure that grantees of either agency are not funded to conduct the same activities. This is essential in ensuring that funds are wisely allocated and that a range of community needs are addressed.
CDC and OMH are currently discussing the relative benefits of separate administration, conjoint administration or the transfer of the OMH program to the sole administration of CDC. It is quite possible that OMH will merge and/or transfer its national and local HIV grants program with those of CDC.
Question. Similarly, the OMH justification says that it will "continue to support data collection and studies related to the knowledge, attitude and behavior of minority populations relative to AIDS as well as the incidence of AIDS among minority groups." At the same time the CDC justification lists numerous surveys to assess HIV knowledge and attitudes. How are these different and how are these coordinated? Could they be merged to save administrative costs?
Answer. The CBOs funded by either OMH or CDC may be involved with data collection and studies as part of their activities; these efforts are likely to represent different research methodologies and sample populations.
Merging efforts in at least some of these research areas in which it is feasible may benefit both CDC and OMH, as well as enhance the quality of data collection, replications and interpretation. This is being investigated as part of the initiative to develop a single administration for all of these efforts.
RYAN WHITE CARE FUNDING
Question. No increases are requested for funding of the Ryan White CARE programs HRSA and CDC. Given the rising number of AIDS cases and the Increasing burden on our public hospitals as reported in recent studies, why is the Administration not increasing funding for these programs?
Answer. In FY 1992, we are requesting the same level of support as Congress provided in FY 1991. We remain concerned about establishing fragmented approaches to health care on a disease specific basis. We prefer to address health services needs through existing mechanisms. To this end I would note that the estimate of services provided by the Health Care Financing Administration for HIV/AIDS increased 30 percent in FY 1992, to $1.36 billion.
Question. As you know, Title III of the CARE bill provides for early intervention services for people with HIV infection.
These services are designed to provide testing, counseling, and drug treatment that will delay the onset of full-blown AIDS. In its budget justifications, the NIH reported that there is "an apparent decrease in the expected incidence rate of AIDS in the U.S. population. This decrease was abrupt and began in 1987. The most. plausible explanation for the decrease is the impact of therapy on preventing seriously immune compromised persons from progressing to AIDS.... It is noteworthy that decreases were most prominent in groups with the best access to care, but were not seen in groups (e.g., drug abusers) who have limited access to therapy." This would seem to underscore the need for expansion of the early intervention programs in Title III, since this is what they were designed for. Why hasn't the PHS requested more funding in this area?
Answer. We have multiple health problems in the United States that need to be addressed. The FY 1992 for Ryan White is maintained at the FY 1991 level and budget increases are directed to other high priority areas such as Project Healthy Start, National Health Service Corps Recruitment, and the Health Care for the Homeless. Some of these programs also will increase services for people who are HIV infected, although they are not specifically targeted for this group.
QUESTION SUBMITTTED BY SENATOR HARRY REID
CHRONIC FATIGUE SYNDROME
Question. In recent years, Chronic Fatigue Syndrome has been of great concern nationally, and especially in Northwest Nevada, where there has been a "cluster' of this illness. Who is supervising PHS activities related to this illness?
Answer. The activities related to Chronic Fatigue Syndrome (CFS) are performed independently by two agencies of the Public Health Service, the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health and the Centers for Disease Control (CDC).
The NIAID has initiated two epidemiologic studies: one to estimate the prevalence of CFS in a population-HMO and the other in a general medical practice.
The CDC will continue to enroll new patients in its surveillance system across the y.s. These studies will help CDC to identify whether there are immunologic or virologic markers associated with CFS.
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.
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?