1967 enacted appropriation___ Summary of changes Transferred to "Operating expenses, Public Building Service," Unobligated balance, reserve--- 1967 total estimated obligations---. 1968 estimated obligations-- Total change-. $164, 770, 000 -13, 000 -781,000 -315, 000 163, 661,000 167, 954, 000 +4, 293, 000 Research grants.-The net increase of $632,000 will provide $4,781,000 for the competing continuation of existing regular program project grants and $1,165,000 for general research support grants. These increases are partially offset by a decrease of $5,314,000 in noncompeting continuation awards. Fellowships.-The increase of $464,000 will provide $1,034,000 for the noncompeting continuation of current awards, partially offset by a decrease of $570,000 in new and competing awards. It will provide an increase of 33 awards over the 1967 level for the research career development award program. Training grants. The increase of $171,000 will provide for additional indirect costs in the undergraduate cardiovascular training area. Laboratory and clinical research. The program increase of $872,000 and 9 positions will provide: $32,000 and 2 positions for a blood donor program for dogs: $380,000 for increased dog procurement costs; $460,000 and 7 positions to outfit and utilize newly assigned space for expansion of present programs. Collaborative research and development.-The program increase of $1,093,000 will be used to further research and development of the National Blood Resource Program. Biometry, epidemiology and field studies.—The program increase of $131,000 will provide for grant-related contracts (example, vasoactive peptides). Direct training.-The program increase of $4,000 will provide for additional tuition costs. Review and approval of grants.—The program increase of $48,000 will provide for consultant services. Program direction. The program increase of $6,000 will provide for consultant services. AUTHORIZING LEGISLATION The legislative authority in Section 301 of the Public Health Service Act which provides for the award of grants for research, research training, and fellowships is included in the section of the justifications under the tab, "Preamble Paragraph." The Public Health Service Act, Title IV, National Research Institutes, Part B National Heart Institute "Sec. 411. There is hereby established in the Public Health Service a National Heart Institute (hereafter in this part referred to as the "Institute"). "Sec. 412. In carrying out the purposes of section 301 with respect to heart diseases the Surgeon General, through the Institute and in cooperation with the National Advisory Heart Council (hereafter in this part referred to as the "Council"), shall— (a) conduct, assist, and foster researches, investigations, experiments, and demonstrations relating to the cause, prevention, and methods of diagnosis and treatment of heart diseases; (d) make grants-in-aid to universities, hospitals, laboratories, and other public or private agencies and institutions, and to individuals for such research projects relating to heart diseases as are recommended by the Council, including grants to such agencies and institutions for the construction, acquisition, leasing, equipment, and maintenance of such hospital, clinic, laboratory, and related facilities, and for the care of such patients therein, as are necessary for such research; (g) in accordance with regulations and from funds appropriated or donated for the purpose (1) establish and maintain research fellowships in the Institute and elsewhere with such stipends and allowances (including travel and subsistence expenses) as he may deem necessary to train research workers and procure the assistance of the most brilliant and promising research fellows from the United States and abroad, and, in addition, provide for such fellowships through grants, upon recommendation of the Council, to public and other nonprofit institutions; and (2) provide training and instruction and establish and maintain traineeships, in the Institute and elsewhere in matters relating to the diagnosis, prevention, and treatment of heart diseases with such stipends and allowances (including travel and subsistence expenses) for trainees as he may deem necessary, the number of persons receiving such training and instruction, and the number of persons holding such traineeships, to be fixed by the Council and, in addition, provide for such training, instruction, and traineeships through grants, upon recommendation of the Council, to public and other nonprofit institutions.” Introduction REGULAR PROJECTS In its search for the cure, alleviation, and prevention of cardiovascular diseases, the National Heart Institute will support approximately 2,000 research projects through research grants in 1967 and 1968. Most of these projects are a continuation of ongoing research; in their great scope and diversity they range from epidemiological studies on large population groups down through studies on individual cells and cellular components and on the biochemical reactions occurring within them. The diversity of this research is dictated by the complexity of the problems posed by the cardiovascular diseases, for the most part, their causes are not known with certainty; but, in many instances, a constellation of complex factors-genetic, environmental, and physiological-may operate in their development and in their protein clinical manifestations. For example, atherosclerosis appears to be related not only to metabolic imbalance, but also to blood clotting mechanisms and the dynamics of flow in vessels; and susceptibility to the disease may be influenced by such factors as age, sex, diet, physical activity, psychic stress, and other factors. Congenital heart disease may arise from genetic factors or from a variety of noxious pre-natal factors affecting the fetus at critical stages of its development. For such reasons it has been both necessary and desirable to deploy our research manpower and resources along a wide variety of research approaches. The following list identifies the major cardiovascular-disease research areas. Atherosclerosis, the presence in arteries of fatty plaques that interfere with blood flow, is the most prevalent of all cardiovascular disorders, causing nearly one million deaths per year in America. Complications from this disease include heart attacks, strokes, and congestive heart failure. There has been nearly a ten-fold increase in the number of research projects in this field in the past decade and currently, in terms of research funds expended for regular grant programs. atherosclerosis is the largest single disease category in the Heart Institute program. Hypertension-high blood pressure-is one of the most commonly encountered forms of cardiovascular disease. It is estimated that seventeen million Americans between the ages of 18 and 79 have definite hypertension, with 10.5 million adults suffering from hypertensive heart disease, one of the consequences of hypertension. Hypertension aggravates and accelerates the development of atherosclerosis and is a major cause of strokes, heart failure, and kideny failure. Cerebrovascular diseases-strokes-account for the third largest cause of death annually in the United States-a toll exceeded only by heart disease and cancer. While the most common cause of stroke is blood clots forming in the arteries supplying the brain, strokes are not a discrete medical entity. They are inherently related to other circulatory diseases. Hypertension predisposes patients to strokes; atherosclerosis may weaken blood vessels supplying the brain, predisposing them to rupture, and atherosclerosis deposits in such vessels create conditions favorable to the formation of blood clots. Congenital heart disease is the main cause of death in infants under two years of age and is one of the costliest of all diseases in its medical care. Knowledge of the causes, development and natural history of congenital heart disease is far from adequate. Rheumatic fever and heart disease continues to occur in significant numbers even though the full application of existing knowledge and techniques could prevent a large proportion of initial and recurrent attacks. Continued prevalence of this disease is due to several deficiencies: existing methods of disease control fall short of the ideal, gaps remain in current methods of prevention, and existing knowledge is not applied. During the last two decades there has been increasing recognition that the heart and lungs are not two systems, but one-the cardiopulmonary system. The incidence of cardiopulmonary diseases, particularly emphysema, is increasing. Not less than 10% of middle-aged and elderly Americans are afflicted with emphysema. As a disenabling disease, it is second only to heart disease; disability allowances now exceed eighty million dollars each year. The problem of congestive heart failure and shock is a large and diffuse one. These are not discrete diseases, but rather symptom-complexes that are often the end results of underlying cardiovascular diseases. Death and disability from coronary artery disease represents the greatest single challenge to modern medicine. The mechanisms by which coronary atherosclero sis causes death and disability involve a broad range of biologic phenomena and of medical manifestations. These range from life-threatening events such as myocardial infarction and cardiac arrhythmias, to major disability from angina pectoris, and must also include psychological problems. All of these may interrelate in complex ways with normal and abnormal function of other body systems. Maintenance of the normal state of the blood bears an essential relationship to the health of the heart and blood vessels. Thrombosis or clotting of the blood within vessels is one of the principal immediate causes of death. Conversely, failure of the blood to clot properly is responsible for much morbidity and mortality from a variety of bleeding diseases and from hemorrhage at surgey. Furthermore, blood factors are indispensible in the management of diseases including anemia, leukemia, infectious diseases, hemorrhage and thrombotic diseases and traumatic shock. Summaries of some of the results of research support in 1966 pertaining to these research areas appear in the research highlights that accompany the statement of the Director, National Heart Institute. Program plans in 1967 and 1968 Plans for these two years are primarily a continuation of current research areas as indicated in the following research grants program analysis table. A decrease of $5,314,000 in noncompeting continuations is offset by a corresponding increase in competing projects. This change is needed to continue support of 14 program projects whose long term noncompeting commitment (7 years) expires with their 1967 award and which have been approved as competing renewal awards for 1968. Special Programs The only request for increased support in 1968 is for $1,165,000 for General Research Support Grants. This increase represents the Institute's proportionate share of the proposed National Institutes of Health increase in this area. The same level of support, $4,500,000 is continued from 1967 to 1968 in Categorical Clinical Research Centers for the research resources of in depth, multidisciplinary investigations in the cardiovascular area. Undoubtedly, atherosclerosis and its complications represent this country's foremost health challenge. In the desire to reduce heart attacks and strokes, the major (and more difficult) objective is reducing atherosclerosis. In this problem there is a scientific consensus, based upon a host of well validated studies, that atherosclerosis may be prevented or its advance in the population greatly decelerated; it may be partially reversible. The Heart Cooperative Drug Study is a planned, directed effort toward these ends. The Heart Institute is undertaking to establish and support a limited number of highly selected Specialized Cardiovascular Research Centers of excellence in which large and stable investments are deliberately made in groups of investigators capable of imaginative and creative research of which clinical investigation will be an important element. This coordinated approach was developed when it became evident that only by the combined efforts of specialists in various basic and clinical disciplines could causes be uncovered and cures achieved for such complex and pervasive disorders as the cardiovascular diseases. Moreover, within each discipline, the complexity of methodology and technology have created subdisciplines requiring discrete skills and knowledge. To bring together representatives of these numerous specialties to focus on a common problem requires an environment where they can interact and profit from each other's knowledge and experience. Equally important are the training opportunities to be provided in such a setting for the development of young scientists who can think beyond their own specialties and who can grow with the rapidly changing modern scientific scene. Viewed in an even larger context, advances in such disparage fields as materials research, electrical engineering, chemistry, and analytical methodology often contribute to the solution of cardiovascular disease problems. However, if the benefits from these advances are to be made available to the patient with heart disease, a research environment must be provided in which scientists from these varied fields can find professional satisfaction in what would otherwise be regarded as a purely clinical setting. This consideration imposes the requirement that the research setting acquire a certain "critical mass" in order for it to be maximally effective as an interdisciplinary activity. Finally, if research results are to be applied to improve patient care in the shortest possible time, the biomedical research environment must include clinicians concerned with problems of patient care. The symbiotic collaboration between clinician and researcher represents the final step in the development of new treatments of heart diseases. The National Heart Institute proposes to provide support for interdisciplinary research programs mainly through two support devices: the program project grant (for which Categorical Clinical Center funds provide resource support) and the Specialized Cardiovascular Research Center grant. Both of these grant mechanisms are designed to encourage the team approach. However, they differ in that program projects are concerned in depth with a specific aspect of heart disease, whereas cardiovascular research centers will be equipped to implement clinical and basic research and training programs of considerable depth and breadth. During 1966 the National Heart Institute awarded four planning grants for the future development of Specialized Cardiovascular Research Centers. It is expected that the planning phase will continue through 1967 and 1968 at a level of $800,000. The primary objective of the fellowship programs is to increase the number of scientists qualified to carry on independent cardiovascular research. |