Vol. 36, No. 1-Winter
31
Issue
National Institute of Dental Research: Strategies for the Future Clair L. Gardner, DDS" When asked by Dr. Mecklenberg to participate in this meeting, it occurred to me that the objectives of the American Association of Public Health Dentists and those of the National Institute of Dental Research are very much in parallel. I am, therefore, particularly pleased to have this opportunity to discuss with you some of the ways in which we, at NIDR, develop strategies for accomplishing these objectives. When contemplating the future, one must consider the historical foundation upon which it rests. I would further note that the future is now. Dental science, in the modern sense of the term, is less than 50 years old and the NIDR is a vigorous youth of only 27 years. I have had the privilege of watching the evolution of dental research activities from a meager level of five million dollars to a fifty-million-dollar effort encompassing broad areas of the biological and physical sciemes. During the past two decades, a small but solid foundation has been established in terms of scientific manpower, research facilities, and fundamental knowledge. Certainly, the long arduous period that was required to accomplish this comes as no surprise to the members of this audience who are so well aware of the complexities of the oral cavity and its afflictions. In contrast, at the commemoration of NIDR's 25th anniversary in 1973, a senior bacteriologist remarked that he had come to the Institute as a young man expecting to solve the problem of dental caries in a couple of years and then move on to the challenge of pneumonia, but a quarter of a century later he was still studying caries. Society expects research in the biomedical sciences to solve problems that threaten life and the quality of life. While tremendous progress has been achieved, immense problems remain-problems that tragically limit personal fulfillment. The direct cost of disease, about $104 billion per year, represents only the most visible expense. Indirect costs, judged by measures such as decreased productivity, are enormous and even then fail to reflect the severe psychological and social burden of illness to individuals and their families. During the last few years, public attention has increasingly focused on problems concerning the accessibility, cost, and quality of health care. In much public discussion of these subjects, too little attention has been given to the fact that, whatever the system, the delivery of health care is at best only as good as the current state of knowledge. The latter is, obviously, determined and limited by the effectiveness of past research efforts. The realization of society's expectations depends on the extent to which resource allocation processes can be aligned with social goals. The fact that the federal government is the dominant source of support for health-related research has imposed major responsibility for program balance upon federal legislators and executives. Working in an environment of scientific and political constraints, these officials must constantly seek to optimize finite resources by achieving a reasonable balance among competing health problems. The efforts of the National Institutes of Health to justify its claims on the national budget have become increasingly more difficult for obvious reasons. This has been particularly true for the NIDR because public interest in health research has been focused on diseases that are highly visible, associated with high mortality rates, and often characterized by prolonged suffering or severe disability. The Dental Institute is further
"Then Acting Director, National Institute of Dental Research, Bethesda, Md.
32
Journal of Public Health Dentistry
handicapped because reliable estimates on the economic impact of dental diseases are not available even though we are well aware that social goals are usually expressed almost exclusively in economic terms. Thus, one of our first strategic objectives must be the acquisition of these data. Whether social goals are humanitarian or economic, one conclusion seems inescapable: the primary impetus for public support is the attainment of goals that are regarded as useful to society. In fact, the urgency of NIDR’s need to develop preventive measures is sufficient to require immediate exploration of all promising leads, even though additional basic research must be accomplished before the specific disease can be optimally controlled. Each year the NIDR develops a budget based upon an assessment of present and emerging opportunities, recognition of certain inescapable limitations, and a continuing awareness of its mission. In later stages of the process, the NIDR recommendations are subject to other limitations: the ceiling imposed on it by the NIH and the Department of Health, Education, and Welfare in accord with the latter’s ceiling imposed b y the Office of Management and Budget. The final recommendation of the NIDR then reflects the Institute’s best judgment, in terms of scientific and social merit, as to the proper allocation of whatever resources the President plans to make available. The budget for the immediate fiscal year is one thing, whereas a five-year projection is a considerably different matter. The discretionary funds actually available in a given year are limited as a consequence of the large amount of money that must be spent to sustain ongoing programs and to honor prior commitments. Estimates of such commitments become progressively unreliable for each succeeding year. Moreover, the capability to foresee opportunities is severely circumscribed by the very nature of research. What is not known today may, if it becomes known a year hence, exert a powerful and decisive influence over how the NIDR then programs its funds. The focus of the DHEW in its review of the NIH budget, which includes NIDR along with the other Institutes and Divisions, is largely in the broad context of health. One major objective is to ascertain that the proposal submitted, viewed in the light of submissions from other health agencies within the Department, reflects the most wellbalanced and potentially productive allocation of funds. The Department’s review also takes cognizance of its other social goals-Education and Welfare-and addresses the question of optimal balance among all of these missions. The Office of Management and Budget (OMB) review is also focused on intrinsic merit and balance. Its scrutiny, however, is in terms of the President’s grand strategy (which may be perceived differently in the OMB than in the Department or NIH), and its purview encompasses the entire Federal enterprise. It should be emphasized that the NIH budget recommendations strongly reflect the agency’s and the Institute’s perceptions of scientific opportunity. At higher levels, attention must focus on a broader range of society’s most pressing needs. Modifications in the budget proposals of the NIH reflect high-level decisions that there are social claims on the available funds which should be accorded a priority different from that reflected in the NIH budget. Even when the NIH assessment of scientific opportunity in a specific area is pessimistic, higher executive levels may take the position that the problem is so severe and its solution so important to the nationsthatmore funds should be provided. The President’s budget undergoes lengthy and searching review by the Appropriations Committees and their subcommittees in both the House of Representatives and the Senate. The President’s budget for NIH is defended by the Director of NIH and the Directors of the individual institutes. It should also be noted that a fairly large number of nongovernment witnesses interested in some aspect of the budget are permitted to testify. I would observe that the support of the latter group frequently has almost valuable impact.
Vol. 36, No. 1-Winter Issue
33
Thus one must conclude that the ultimate decisions are made through the political process. Fortunately, during the last quarter of a century, the budgets proposed for the NIH have come before a Congress genuinely concerned with the health of the nation and quite convinced that research is vital to the solution of health problems. The NIDR role in this review process is to formulate budget justifications that are responsive to the Institute’s statutory mission, that recognize scientific opportunities as well as practical limitations, and that reflect the most sophisticated judgments on the use of discretionary funds. One of the most important responsibilities of the NIDR is the prudent management of the funds appropriated for dental research and related activities. I should like now to briefly touch upon a major issue which impacts on the allocation of resources-the translation gap that exists between biomedical research and the effective application of its findings. During recent years, NIH has become increasingly occupied with questions relating to the scope of its mission. A current reexamination of the NIH role has been prompted by the concerns of the President’s Biomedical Research Panel and the Senate Appropriations Committee. One of the most significant issues of the future role of NIH, now being discussed, has to do with increased participation in demonstration and control activities. In several of the Institutes this would be a broadened responsibility. However, as the major research organization in the United States charged with improvement of the oral health of the nation, NIDR has had, since its establishment in 1948, broad-ranging authorities for the achievement of this goal. The exercise of these authorities has been dictated by various factors-the most important being the level of knowledge in each area of oral disease research. It should be recalled that demonstration programs in water fluoridation were a major activity of the Institute during its early years of existence. This was followed by approximately 20 years of predominant concentration on fundamental research. Beginning some six years ago, a gradual change in direction has come about. This occurred in large part because the knowledge evolving from basic research suggested that the major dental health problem of dental caries might be ameliorated by an intensive research and development effort. Similar, but less advanced, shifts in program emphasis have occurred in several other areas, including periodontal disorders, viral infections, and craniofacial anomalies. The changing emphasis from problem definition to problem solving is best illustrated by the creation of the targeted National Caries Program to achieve the public health goal of caries prevention. All activities of this program are designed to contribute to this goal. These activities include a mixture of knowledge-gathering basic research on the subtleties of caries etiology as well as highly applied clinical testing and field trials of caries-preventive agents. Experience has clearly shown that the conduct and reporting of experiments which prove a certain agent to be effective in preventing caries will not in itself result in widespread use of that agent by the public. It is essential, therefore, to inform the public and the dental profession regarding the nature, desirability, cost-effectiveness, and feasibility of employing such an agent. So-called demonstration programs are, at present, the best known method of accomplishing these objectives, and are the only method of acquiring data on the cost and feasibility of a preventive method, once its safety and efficacy have been established. In caries research, demonstration programs are thus far limited to fluoride mouthrinses and tablets, to school water fluoridation, and, to a lesser extent, adhesive sealants. Despite the many preventive agents and methods which have already advanced to clinical testing stages, only these methods fully satisfy requirements of efficacy, safety, and ease of delivery, as judged by caries investigators in this country and elsewhere. When demonstration activities are discussed, the concern is frequently raised that
34
Journal of Public Health Dentistry
their implementation will dilute available resources for more fundamental research, and thus damage the latter effort. However, if an institute’s mission is the solution of disease problems, then the combination of research activities must be dictated solely by program goals and scientific opportunity, rather than by a priori decisions about program balance between so called “basic” and “applied” research. Therefore, having made a small beginning in the caries program, the NIDR is committed to pursue all necessary activities, including demonstration programs, to meet its public health responsibilities in each disease area. The actual implementation of such programs will, of course, depend upon scientific timeliness and the availability of the necessary resources. With a view to providing additional assurance that the gap between research and service is fully bridged, the NIDR is also committed to collaborate and cooperate with the Center for Disease Control and other health agencies in the area of public health education. In conclusion, I would like to share with you my personal conviction that NIDR must relate more closely to the practicing profession. I would like to invite your comments about how to achieve this greater rapport. The Senate Appropriations Committee apparently has similar views, as they have recently urged the Institute to take a more active role in disseminating research information so that practitioners and dental students, as well as communities and schools, can be provided the most recent techniques and methods of preventive dental care. In addition to the use of publications, we plan to make a much greater effort to reach the profession face to face by presenting frequent reports of new developments at major dental meetings. NIDR staff members have occasionally met with state and local dental societies, but we need to do more of this in greater scope and depth. As another approach, we have initiated a series of state-of-the-art film reports. The first one, premiered last year at the annual meeting of the American Dental Association, is on the prospects of a caries vaccine. The second, which was just released, is on topical fluorides in caries prevention. But we must find still other avenues for productive dissemination of information, and we look to you for suggestions. We would especially like you-as public health dentists-to be informed of what NIDR is doing, particularly as we progress into the clinical and demonstration stages in various projects; to be willing to participate, as the need arises, in some of these projects; and to give us the necessary support in the community to assure the success of these public health approaches. We recognize our interdependence, and we earnestly seek your cooperation as we move toward our common goal of improved oral health. It is my opinion that the prospects for the future are indeed favorable-so long as we grapple successfully with the major issues and do not drop the ball.
The Triumverate of Control People in this country live under a system of mixed economy. Control is exercised by competition, governmental regulation, and self-regulation. Professional persons, as a matter both of pride and self-interest, should strive for greater self-regulation. If enough members of their associations can be taught to conform for what is best, control will come largely through voluntary codes that are formulated by professional equals in rank whose primary concern is for the public’s interest. Much of the control then becomes the responsibility of professional peers. -The RoyaE Bank of Canada Monthly Letter for July, 1975 (KAE)
31
Issue
National Institute of Dental Research: Strategies for the Future Clair L. Gardner, DDS" When asked by Dr. Mecklenberg to participate in this meeting, it occurred to me that the objectives of the American Association of Public Health Dentists and those of the National Institute of Dental Research are very much in parallel. I am, therefore, particularly pleased to have this opportunity to discuss with you some of the ways in which we, at NIDR, develop strategies for accomplishing these objectives. When contemplating the future, one must consider the historical foundation upon which it rests. I would further note that the future is now. Dental science, in the modern sense of the term, is less than 50 years old and the NIDR is a vigorous youth of only 27 years. I have had the privilege of watching the evolution of dental research activities from a meager level of five million dollars to a fifty-million-dollar effort encompassing broad areas of the biological and physical sciemes. During the past two decades, a small but solid foundation has been established in terms of scientific manpower, research facilities, and fundamental knowledge. Certainly, the long arduous period that was required to accomplish this comes as no surprise to the members of this audience who are so well aware of the complexities of the oral cavity and its afflictions. In contrast, at the commemoration of NIDR's 25th anniversary in 1973, a senior bacteriologist remarked that he had come to the Institute as a young man expecting to solve the problem of dental caries in a couple of years and then move on to the challenge of pneumonia, but a quarter of a century later he was still studying caries. Society expects research in the biomedical sciences to solve problems that threaten life and the quality of life. While tremendous progress has been achieved, immense problems remain-problems that tragically limit personal fulfillment. The direct cost of disease, about $104 billion per year, represents only the most visible expense. Indirect costs, judged by measures such as decreased productivity, are enormous and even then fail to reflect the severe psychological and social burden of illness to individuals and their families. During the last few years, public attention has increasingly focused on problems concerning the accessibility, cost, and quality of health care. In much public discussion of these subjects, too little attention has been given to the fact that, whatever the system, the delivery of health care is at best only as good as the current state of knowledge. The latter is, obviously, determined and limited by the effectiveness of past research efforts. The realization of society's expectations depends on the extent to which resource allocation processes can be aligned with social goals. The fact that the federal government is the dominant source of support for health-related research has imposed major responsibility for program balance upon federal legislators and executives. Working in an environment of scientific and political constraints, these officials must constantly seek to optimize finite resources by achieving a reasonable balance among competing health problems. The efforts of the National Institutes of Health to justify its claims on the national budget have become increasingly more difficult for obvious reasons. This has been particularly true for the NIDR because public interest in health research has been focused on diseases that are highly visible, associated with high mortality rates, and often characterized by prolonged suffering or severe disability. The Dental Institute is further
"Then Acting Director, National Institute of Dental Research, Bethesda, Md.
32
Journal of Public Health Dentistry
handicapped because reliable estimates on the economic impact of dental diseases are not available even though we are well aware that social goals are usually expressed almost exclusively in economic terms. Thus, one of our first strategic objectives must be the acquisition of these data. Whether social goals are humanitarian or economic, one conclusion seems inescapable: the primary impetus for public support is the attainment of goals that are regarded as useful to society. In fact, the urgency of NIDR’s need to develop preventive measures is sufficient to require immediate exploration of all promising leads, even though additional basic research must be accomplished before the specific disease can be optimally controlled. Each year the NIDR develops a budget based upon an assessment of present and emerging opportunities, recognition of certain inescapable limitations, and a continuing awareness of its mission. In later stages of the process, the NIDR recommendations are subject to other limitations: the ceiling imposed on it by the NIH and the Department of Health, Education, and Welfare in accord with the latter’s ceiling imposed b y the Office of Management and Budget. The final recommendation of the NIDR then reflects the Institute’s best judgment, in terms of scientific and social merit, as to the proper allocation of whatever resources the President plans to make available. The budget for the immediate fiscal year is one thing, whereas a five-year projection is a considerably different matter. The discretionary funds actually available in a given year are limited as a consequence of the large amount of money that must be spent to sustain ongoing programs and to honor prior commitments. Estimates of such commitments become progressively unreliable for each succeeding year. Moreover, the capability to foresee opportunities is severely circumscribed by the very nature of research. What is not known today may, if it becomes known a year hence, exert a powerful and decisive influence over how the NIDR then programs its funds. The focus of the DHEW in its review of the NIH budget, which includes NIDR along with the other Institutes and Divisions, is largely in the broad context of health. One major objective is to ascertain that the proposal submitted, viewed in the light of submissions from other health agencies within the Department, reflects the most wellbalanced and potentially productive allocation of funds. The Department’s review also takes cognizance of its other social goals-Education and Welfare-and addresses the question of optimal balance among all of these missions. The Office of Management and Budget (OMB) review is also focused on intrinsic merit and balance. Its scrutiny, however, is in terms of the President’s grand strategy (which may be perceived differently in the OMB than in the Department or NIH), and its purview encompasses the entire Federal enterprise. It should be emphasized that the NIH budget recommendations strongly reflect the agency’s and the Institute’s perceptions of scientific opportunity. At higher levels, attention must focus on a broader range of society’s most pressing needs. Modifications in the budget proposals of the NIH reflect high-level decisions that there are social claims on the available funds which should be accorded a priority different from that reflected in the NIH budget. Even when the NIH assessment of scientific opportunity in a specific area is pessimistic, higher executive levels may take the position that the problem is so severe and its solution so important to the nationsthatmore funds should be provided. The President’s budget undergoes lengthy and searching review by the Appropriations Committees and their subcommittees in both the House of Representatives and the Senate. The President’s budget for NIH is defended by the Director of NIH and the Directors of the individual institutes. It should also be noted that a fairly large number of nongovernment witnesses interested in some aspect of the budget are permitted to testify. I would observe that the support of the latter group frequently has almost valuable impact.
Vol. 36, No. 1-Winter Issue
33
Thus one must conclude that the ultimate decisions are made through the political process. Fortunately, during the last quarter of a century, the budgets proposed for the NIH have come before a Congress genuinely concerned with the health of the nation and quite convinced that research is vital to the solution of health problems. The NIDR role in this review process is to formulate budget justifications that are responsive to the Institute’s statutory mission, that recognize scientific opportunities as well as practical limitations, and that reflect the most sophisticated judgments on the use of discretionary funds. One of the most important responsibilities of the NIDR is the prudent management of the funds appropriated for dental research and related activities. I should like now to briefly touch upon a major issue which impacts on the allocation of resources-the translation gap that exists between biomedical research and the effective application of its findings. During recent years, NIH has become increasingly occupied with questions relating to the scope of its mission. A current reexamination of the NIH role has been prompted by the concerns of the President’s Biomedical Research Panel and the Senate Appropriations Committee. One of the most significant issues of the future role of NIH, now being discussed, has to do with increased participation in demonstration and control activities. In several of the Institutes this would be a broadened responsibility. However, as the major research organization in the United States charged with improvement of the oral health of the nation, NIDR has had, since its establishment in 1948, broad-ranging authorities for the achievement of this goal. The exercise of these authorities has been dictated by various factors-the most important being the level of knowledge in each area of oral disease research. It should be recalled that demonstration programs in water fluoridation were a major activity of the Institute during its early years of existence. This was followed by approximately 20 years of predominant concentration on fundamental research. Beginning some six years ago, a gradual change in direction has come about. This occurred in large part because the knowledge evolving from basic research suggested that the major dental health problem of dental caries might be ameliorated by an intensive research and development effort. Similar, but less advanced, shifts in program emphasis have occurred in several other areas, including periodontal disorders, viral infections, and craniofacial anomalies. The changing emphasis from problem definition to problem solving is best illustrated by the creation of the targeted National Caries Program to achieve the public health goal of caries prevention. All activities of this program are designed to contribute to this goal. These activities include a mixture of knowledge-gathering basic research on the subtleties of caries etiology as well as highly applied clinical testing and field trials of caries-preventive agents. Experience has clearly shown that the conduct and reporting of experiments which prove a certain agent to be effective in preventing caries will not in itself result in widespread use of that agent by the public. It is essential, therefore, to inform the public and the dental profession regarding the nature, desirability, cost-effectiveness, and feasibility of employing such an agent. So-called demonstration programs are, at present, the best known method of accomplishing these objectives, and are the only method of acquiring data on the cost and feasibility of a preventive method, once its safety and efficacy have been established. In caries research, demonstration programs are thus far limited to fluoride mouthrinses and tablets, to school water fluoridation, and, to a lesser extent, adhesive sealants. Despite the many preventive agents and methods which have already advanced to clinical testing stages, only these methods fully satisfy requirements of efficacy, safety, and ease of delivery, as judged by caries investigators in this country and elsewhere. When demonstration activities are discussed, the concern is frequently raised that
34
Journal of Public Health Dentistry
their implementation will dilute available resources for more fundamental research, and thus damage the latter effort. However, if an institute’s mission is the solution of disease problems, then the combination of research activities must be dictated solely by program goals and scientific opportunity, rather than by a priori decisions about program balance between so called “basic” and “applied” research. Therefore, having made a small beginning in the caries program, the NIDR is committed to pursue all necessary activities, including demonstration programs, to meet its public health responsibilities in each disease area. The actual implementation of such programs will, of course, depend upon scientific timeliness and the availability of the necessary resources. With a view to providing additional assurance that the gap between research and service is fully bridged, the NIDR is also committed to collaborate and cooperate with the Center for Disease Control and other health agencies in the area of public health education. In conclusion, I would like to share with you my personal conviction that NIDR must relate more closely to the practicing profession. I would like to invite your comments about how to achieve this greater rapport. The Senate Appropriations Committee apparently has similar views, as they have recently urged the Institute to take a more active role in disseminating research information so that practitioners and dental students, as well as communities and schools, can be provided the most recent techniques and methods of preventive dental care. In addition to the use of publications, we plan to make a much greater effort to reach the profession face to face by presenting frequent reports of new developments at major dental meetings. NIDR staff members have occasionally met with state and local dental societies, but we need to do more of this in greater scope and depth. As another approach, we have initiated a series of state-of-the-art film reports. The first one, premiered last year at the annual meeting of the American Dental Association, is on the prospects of a caries vaccine. The second, which was just released, is on topical fluorides in caries prevention. But we must find still other avenues for productive dissemination of information, and we look to you for suggestions. We would especially like you-as public health dentists-to be informed of what NIDR is doing, particularly as we progress into the clinical and demonstration stages in various projects; to be willing to participate, as the need arises, in some of these projects; and to give us the necessary support in the community to assure the success of these public health approaches. We recognize our interdependence, and we earnestly seek your cooperation as we move toward our common goal of improved oral health. It is my opinion that the prospects for the future are indeed favorable-so long as we grapple successfully with the major issues and do not drop the ball.
The Triumverate of Control People in this country live under a system of mixed economy. Control is exercised by competition, governmental regulation, and self-regulation. Professional persons, as a matter both of pride and self-interest, should strive for greater self-regulation. If enough members of their associations can be taught to conform for what is best, control will come largely through voluntary codes that are formulated by professional equals in rank whose primary concern is for the public’s interest. Much of the control then becomes the responsibility of professional peers. -The RoyaE Bank of Canada Monthly Letter for July, 1975 (KAE)
