Policy Issues and Questions

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Policy Issues and Questions

POLICY ISSUES AND QUESTIONS

The following are the key policy issues and questions the CHSF plan intends to address.

BIOMEDICAL, SOCIO-CULTURAL AND
BEHAVIORAL R&D

How can the nation treat old and newly emerging disease?

What biomedical research agenda will successfully involve promising investigators and transfer discovery from the laboratory to the marketplace?

What research procedures will protect human subjects, and promote diversity in the populations involved in research?

What human capital is needed for the nation to utilize scientific knowledge to improve the cost-effective social, behavioral and economic development of our citizens?

HEALTH SYSTEMS AND SERVICES R&D

How can the nation increase the return on its health care dollars? What is the optimal and most cost-effective mix of personal care, prevention, and population-based public health services?

How can the nation enable U.S. citizens to assume greater responsibility for their individual decisions regarding the use of health services, their personal health and the health of their communities and workplaces?

HEALTH PROMOTION AND DISEASE AND
INJURY PREVENTION R&D

What are the best methods to incorporate health risks in the prioritization of public health interventions?

What are the policy barriers and information gaps that constrain our ability to create a healthy environment and promote healthy behaviors?

How can we most efficiently and cost-effectively involve individuals and communities in preventive intervention? How can we best develop sustainable health promotion and disease prevention programs?

How can we effectively evaluate the application of prevention programs to establish a sound science base?

FOOD SAFETY, SECURITY AND
PRODUCTION R&D

How can the nation assure an abundant, safe and sustainable world food supply and maximize productive capability for the 21st century?

How can the nation best preserve, maintain, characterize and utilize the genetic resources of life forms important to food production?

What food safety technologies and practices can minimize food-borne disease?

What data are required to improve risk assessment methods so that food safety and human health protection can be assessed?

HUMAN NUTRITION R&D

What is the range in intake of nutrients and other food components that will optimize health and reduce chronic disease risk at different physiological stages? What patterns of food intake and physical activity will provide the nutrition standard and appropriate energy balance to improve health and productivity?

How do nutrients interact with human genes to alter disease risk?

What factors affect the adoption and maintenance of behaviors that support optimal nutrition and physical activity patterns? How can scientific knowledge of optimal nutrition be translated into effective human interventions?

DATA NEEDS

In all areas of research, what is the optimal role for the Federal government in developing, collecting, updating, integrating, and maintaining the national data bases and information infrastructure needed for public and private health, safety and food R&D?

SCIENTIFIC GOALS AND RESEARCH PRIORITIES

CHSF's strategy development process identifies where ongoing research and development needs to be continued, redirected, supplemented, or shared. For example, in the biomedical and socio-cultural research area, recent assessments of Federal efforts to develop safe and effective HIV therapies have indicated that much basic research remains to be done. The National Institutes of Health has placed an increased priority on basic HIV research. Similar concerns about basic research have recently been expressed by the National Cancer Advisory Board. The CHSF biomedical, socio-cultural and behavioral research strategy includes a strong emphasis on basic biomedical and clinical research. Policy reviews and investments will be made to assure that beginning investigators are supported, that technology transfer and intellectual property policies give positive incentives to conduct necessary research, and that effective data systems and human capital resources are available to conduct the research and benefit from it. Similar program goals and plans are being developed to optimize the focus, balance and inter-disciplinary interaction of basic and applied research and effective human intervention and education in the areas of health systems and services research, health promotion and disease and injury prevention research; food safety, security and production research; and human nutrition research.

In addition, the CHSF strategies include initiatives to develop integrated health information systems to support necessary research and other health, safety and food issues. The need to maintain, update, build and better integrate data and information systems necessary to conduct research, operate surveillance and monitoring systems, and evaluate programs was the single largest obstacle to CHSF agency efforts. The following are CHSF's major scientific goals and research priorities.

BIOMEDICAL AND SOCIO-CULTURAL
AND BEHAVIORAL R&D

Biomedical research is the quest to understand the fundamental processes of human biology at a multitude of levels, from the macroscopic to the molecular. Socio-cultural and behavioral research gains insight into individual and population-based factors that contribute to risks for disease and injury, exposures to disease and injury processes, and health promotion and injury preventions. Research is an interactive continuum. Fundamental research lays the foundations for clinical research, applied research, and demonstration and public education. Improved public understanding of research results would increase the public's ability and willingness to use the results of research concerning the biomedical, social, cultural, psychological and behavioral factors of disease and injury, and the effectiveness of therapies and prevention interventions.

The nation needs a research agenda harnessing the rapid growth of knowledge and technologies to improve the health of its citizens and to support national growth and competitiveness. For example, progress in biomedical research has contributed greatly toward improved detection and treatment of many disease/conditions. Advances in molecular biology and genetics have identified genes for colon cancer, familial breast cancer, Huntington's disease, cystic fibrosis, and many others from the Human Genome Project. Scientists and clinicians have used gene therapy to correct a number of congenital conditions, and to retard the growth of tumor cells and disease progress. These examples are illustrative of bridging fundamental biomedical and clinical research. Future research must continue to foster effective interfaces so that research findings are appropriately channeled toward improved clinical and health care and technology development. To further improve health, research is also needed on the biomedical, social, cultural, psychological and behavioral factors which influence individuals' exposure, susceptibility, treatment and recovery from disease. Variations in ability to comply with treatment regimens need to be better understood. The influences of social context, peer, family and community pressure in such situations also need to be better understood. Gender, socioeconomic, as well as racial/ethnic differences in disease incidence and prevalence must be examined.

We must foster collaboration among academia, industry and government, not only to share resources, but also to advance commercial research applications and technological progress. For example, bioinformatics (the science and technology of managing, modeling, and manipulating biological data) may lead to major industrial growth as large pharmaceutical companies seek sequence/analysis partnerships that merge computer software capabilities with medical diagnosis and therapy. We need to protect human research subjects and ensure that research includes an appropriate mix of the population. Support for productive beginning investigators, increased understanding of the wide range of human capital resources necessary for cost-effective human interventions, utilization of innovations, transfer of innovation into economic growth, and data systems for research and development are necessary. CHSF plans to focus future effort on a partnership for beginning investigators, a partnership for human productivity, and information dissemination and public education (science literacy) to help consumers make more informed choices.

HEALTH SYSTEMS AND SERVICES R&D

Although health care spending has risen from 9.1% of the Gross Domestic Product in 1980 to 14% now, by many indicators, Americans are receiving less for their health care dollars than citizens of several other countries. Americans deserve a quality health care system that improves personal and public health and quality of life at lower cost. Every month, two million Americans lose their health insurance. Over the next 2 1/2 years, about one out of four Americans will have a lapse in their health insurance coverage for some period of time. U.S. health care resources are not distributed efficiently, equitably or cost-effectively, and the escalating costs of health care services continue to impoverish and erode our public health infrastructure, resulting in outbreaks of preventable disease and injury.

In an era of constrained resources, health systems and services research and development is beginning to show how the U.S. can improve the return on its existing health care investment. For example, two recent clinical practice guidelines, addressing problems of low back pain and fluid in the inner ear of children, could reduce health care expenditures by more than $15 billion if these two guidelines are followed. Research and development on the effectiveness of the entire health care system--from clinical, preventive, and public health interventions to managerial, organizational, and financial strategies--coupled with research on the effective dissemination of these findings-- can improve the value we receive for our health care dollars. It is also important to link existing public health and personal care data bases in the public and private sectors. This will call for an unprecedented level of federal-state and public- private sector cooperation. CHSF plans to focus future effort on an integrated multi-disciplinary health systems and services research and development agenda.

HEALTH PROMOTION AND DISEASE AND
INJURY PREVENTION R&D

In health promotion and disease and injury prevention research, the strategy is to establish a national research and development agenda that will provide the knowledge base to decrease and control the human and financial burden of preventable injury, disease and disability. This strategy will also support individuals and local communities with the information they need to choose a healthy life with reduced disease and disability. This includes monitoring problems, developing and testing effective strategies, and involving individuals and communities in sustainable prevention activities. Research and development in health promotion and disease and injury prevention is an investment that can cost-effectively reduce the great personal, social, and economic toll from premature birth, childhood illness, cancer, heart disease, mental illness, disabilities, existing and emerging infectious disease, drug abuse, and tobacco use. Identification of risk factors for disease and development of effective interventions have contributed to increased survival and quality of life. However, more research and development remains to be done in identifying and modifying personal risk for disease.

Technological advances provide significant challenges and opportunities for the future. Some technological advances save and prolong life--while others have produced hazardous waste sites, and environmental contamination in the food chain. For example, radiation research has provided many beneficial diagnostic and treatment uses, but has also increased the need to understand the health impact of natural and man-made sources of radiation exposure. Research is needed to better understand the human risks of technological innovations.

Research and development on societal changes and their impact on health also provide significant challenges and opportunities. Lifestyle, community, and workplace diversity have altered exposure patterns and consequent patterns of injury and disease. Such changes have prompted the need to better understand the influence of cultural, behavioral, and socioeconomic factors on health. The following areas of research and development have received increasing attention by the scientific community, policymakers, the media, and the general public. CHSF plans to expand or form new research and development partnerships in the areas of vaccine development, emerging health threats, aggressive and violence-related behaviors, prevention of mental disorders, environmental and occupational health risks, computer aided design (CAD) tool and databank for injury control and prevention, and surveillance. These prevention partnerships are research investments that can reduce avoidable human suffering and monetary health care costs.

Effective interventions in these and other areas will require proactive involvement of federal, state and local programs; universities, medical schools, industry and other institutions. Coordinated effort spanning diverse fields of basic and applied science expertise are needed. Such research and development collaboration will result in more effective solutions to complex health promotion and disease and injury prevention issues.

FOOD SAFETY, SECURITY AND
PRODUCTION R&D

The overall goal is to utilize research and development to meet the food needs of the U.S. and the world in 2100. The world population is expected to double by 2050, resulting in growing needs for food and water. This strategy will harness the potential of the genetic resources of plants and animals, coupled with improved food safety technologies and practices. This strategy will support the sustainable production and efficient delivery of an abundant, safe, and nutritious food supply in the face of environmental and economic constraints. Top priorities are: sustainable production systems targeted toward long term food security, a comprehensive food safety, food production, processing and delivery program; novel food products keyed to human needs and development of lower risk pest management programs and agricultural practices less dependent on chemicals. Sustainable systems, or those that maintain renewable capabilities for life at local, regional, and global scales, will support agricultural productivity, growth and competitiveness. Cohesive national policies aimed at environmental sustainability are necessary to achieve future food security. For U.S. success in the long term, international cooperation is needed to prevent critical ecological or food-related crises and promote global sustainability. We need to implement comprehensive HACCP programs to meet short-term needs, while investing aggressively in research to promote optimal health, minimize adverse human and ecological effects associated with food production and consumption, and deliver accurate information to consumers. This will enable consumers to make more informed food safety and dietary choices. CHSF plans to focus on future R&D in two areas: technology to assure the safety and quality of food for consumers, and comprehensive programs to preserve, maintain, characterize, and utilize the genetic resources of life forms important to food production.

HUMAN NUTRITION R&D

Nutrition plays a pivotal role in optimizing health and productivity and reducing the risk of diet-related disease. The National Academy of Sciences states, "For the majority of Americans who do not smoke, do not drink excessively, and are not exposed to environmental hazards in their work, the food they eat is the largest controllable factor determining their long-term health." Physical activity is another substantial, controllable factor that is linked to food consumption and plays a major role in health. The overall goal is to achieve a healthier and more productive society through research on the critical role of diet and physical activity in human health and disease.

Dietary factors profoundly affect growth, development, and the risk of many chronic diseases--including diabetes, heart disease, cancer, and osteoporosis. We need to better understand the mechanisms underlying nutrient effects on disease and health, and to improve dietary guidance. Recent advances in molecular biology and genetics provide new opportunities to apply cutting edge insights on bionutrition. Despite the tremendous health potential of sound nutrition, major segments of the U.S. population suffer from poor nutrition and activity habits. Over the past decade, obesity in the U.S. has increased dramatically. Over 1/3 of adults are obese, and obesity is also on the rise among children. The level of physical activity of the average citizen has also greatly declined in recent decades. A major goal of nutrition research is understanding the effects of diet and exercise on nutrient balance, to assure lowest possible risk of morbidity and mortality.

An important goal for nutrition research must be to enhance the scientific basis for recommending guidelines for nutrients and food patterns, as well as to develop the means to implement what is already known about good nutrition in the American diet. To effectively change energy balance and nutrient intakes for a target audience, it will be essential to understand their food choices and physical activity patterns as well as the cultural, socioeconomic, attitudinal and educational factors that influence lifestyles. CHSF intends to focus future efforts on an integrated multi- disciplinary human nutrition research agenda.

INTERNATIONAL DIMENSIONS

Health, safety and food are global concerns, and health safety and food R&D are highly interactive international endeavors. The strategies outlined in this plan have significant international dimensions, and will require continued international partnerships. For example, in biomedical, socio-cultural and behavioral R&D, programs have been established to enhance the international perspective of the next generation of scientists by providing international research experience during early stages of their careers, and to encourage continued cooperation and mutually beneficial partnerships between U.S. and foreign scientists. The investment in human resources is necessary to improve the long-term economic strength and social health of the U.S. and the world.

In health systems and services R&D, data standards should be developed cooperatively with other countries to facilitate future international collaborative and comparative research. Such comparative research would greatly improve understanding of all areas in health systems and services. Descriptive and evaluative studies usually focus primarily on the financing, organization and delivery of personal care services. There is a dearth of information on the nature, cost, and effectiveness of public health strategies in other countries. In addition, many of the metrics on which international comparisons are based, such as infant mortality, lead to misleading comparisons because of lack of standardized data.

In health promotion and disease and injury prevention R&D, the major challenges and opportunities have immediate and wide-ranging global implications and applications. International travel and trade have made the world a global community, but has also contributed to the rapid spread of new and re-emerging infectious diseases. Once expected to be eliminated as a public health problem, infectious diseases remain the leading cause of death worldwide. Emerging infectious disease threats are a reminder that no nation can be complacent regarding human vulnerability to the microorganisms with which we share our environment. Domestically and internationally, infectious disease increasingly threatens public health and contributes significantly to the escalating costs of health care. Disease prevention activities in individual countries have a direct international impact. In order to address these international health challenges, cooperative scientific partnerships across national boundaries benefit all.

In food safety, security and production R&D, new sustainable practices and information will be needed to help slow global environmental degradation and help assure adequate food and water supplies now and in the future. Other benefits include a safer supply of food imports for U.S. consumers, reduced costs of U.S. economic or military aid, the elimination of needless food waste, environmentally sound production, processing, and storage strategies; and the potential to eliminate malnutrition and starvation and improve worldwide health. Global information transfer must be actively coordinated and pursued, and policies to address foreign needs in the absence of sustainable practices elsewhere must be developed to protect U.S. interests.

The private sector depends on the germplasm and knowledge provided by the public sector to maintain its supply of seeds, tree and fish stock, and animals to food producers. The U.S. has long depended on foreign sources of germplasm for developing and maintaining strong food production systems, but if increasingly restricted access to foreign germplasm continues, the U.S. must conserve its native and acquired genetic resources. The U.S. should take a lead role to help resolve the global controversy over patents and intellectual property rights affecting genetic resources. Barriers to international trade and technology transfer must be overcome. Competitiveness in international markets hinges on illustrating to importing countries that U.S. products are safe and produced under safe conditions (e.g. with HACCP quality assurance systems). The same assurances should be required for food imports. Research is needed to resolve technical barriers to trade, particularly the presence of pests and pathogens in foods, and to provide a scientific basis for trade embargo policies.

In human nutrition RD, better understanding of the best diet and exercise patterns for optimizing health and productivity has global importance. Likewise, unraveling the role of nutrients in gene expression and disease will benefit the international community. Nutrient influences on disease and impact on health is a major concern in developing countries, as is deficit energy balance. At the 1992 International Conference on Nutrition, 159 countries entered into a plan of action that includes the commitment to basic and applied scientific research "to more clearly identify the factors that contribute to the problems of malnutrition and the ways and means of eliminating these problems, particularly for women, children and aged persons." This strategy also addresses the Year 2000 goals of the World Summit for Children. In countries whose people are becoming more affluent, research on populations that are moving from undernutrition towards obesity and a more sedentary lifestyle will be important for understanding the development of chronic diseases. The possibility of nutritionally detrimental environmental contaminants is also an issue that transcends national borders. Finally, improved understanding of how to design effective community interventions could have significant international influence on setting nutrition/food policy at the national and community levels.

Health, Safety and Food R&D - Table of Contents

Strategic Planning Document - Health, Safety and Food R&D

Foreward

Implementation Part 3

Strategic Planning

Implementation

Executive Summary

Policy Issues and Questions

Committee

Implementation Part 2