additional research in a number of specific areas. The topic of cost is being addressed in a new NHLBI research program to identify alternative strategies for cholesterol reduction. A new NCEP expert panel report to be released this spring will provide guidance about cholesterol assessment and intervention in children and adolescents. The NHLBI has also initiated a clinical trial of cholesterol lowering in the elderly, which is expected to provide a firm scientific basis for treatment recommendations in older persons. In the upcoming year, the NHLBI will continue support for its five education programs in the areas of high blood pressure, cholesterol, smoking, asthma, and blood resources, placing special emphasis on ways to reach Americans at high risk, particularly minorities and those with low literacy skills. The Institute is also taking the first steps toward implementation of a new national education program intended to reduce premature morbidity and mortality from heart attack through early intervention. The initial efforts of this program will focus on educating health care professionals and their patients about the need for immediate identification and treatment of patients at the first symptoms and signs of a heart attack. Such efforts are expected not only to enhance survival, but also to contribute substantially to the quality of life of heart attack patients and their families. Mr. Chairman, the FY 1992 budget request for the National Heart, Lung, and Blood Institute is $1,209,924,000. I would be pleased to answer any questions that the committee may have. BIOGRAPHICAL SKETCH OF DR. CLAUDE LENFANT October 12, 1928, Paris, France Education: B.S., University of Rennes, France, 1948. M.D., University of Paris, France, 1956. Professional History: 1957-1958, Research Fellow, University of Buffalo, New York. 1958-1959, Research Fellow, Columbia University, New York. 1959-1960, Assistant Professor of Physiology, University of Lille, France. 1961-1965, Clinical Instructor of Medicine and of Physiology and Biophysics, University of Washington, Seattle. 1966-1967, Clinical Assistant Professor of Medicine and of Physiology and Biophysics, University of Washington, Seattle. 19681971, Associate Professor of Medicine and Physiology and Biophysics, University of Washington, Seattle. 1970-1972, Acting Associate Director, Collaborative R&D Program, National Heart and Lung Institute, NIH. 1970-1972, Associate Director for Lung Programs, National Heart and Lung Institute, NIH. 1971-1972, Professor of Medicine and Physiology and Biophysics, University of Washington, Seattle. 1972-1980, Director, Division of Lung Diseases, National Heart, Lung, and Blood Institute, NIH. 1981-1982, Associate Director for International Research, NIH. 1981-1982, Director, Fogarty International Center for Advanced Study in the Health Sciences, NIH. 1982-Present, Professional Organizations: Association of American Physicians, American Society for Clinical Investigation, American Physiological Society, American Federation for Clinical Research, French Physiological Society, International Federation for Medical Electronics, American Society of Zoologists, Society for Experimental Medicine and Biology, Undersea Medical Society, New York Academy of Science. Honors Awards: Thesis Prize, University of Paris, France, 1956. Authorship, Editorship: Author or Co-Author of 192 scientific publications EDUCATION PROGRAMS Senator HARKIN. Thank you very much, Dr. Lenfant. Dr. Lenfant, I have been looking at your biomedical research spectrum which talks about taking the research through the various steps from basic to clinical trials, demonstration, education, with the end product being knowledge dissemination. You have a very active series of education programs, including the national cholesterol education program, the national blood pressure education program, and the national asthma education program, and many others. First of all, I want to congratulate you on this effort, and I believe the last step, education and knowledge dissemination, is critical. It ties in with my strong feelings on prevention. Before you can have prevention, people have to have knowledge and information, and once they are educated, then they can perhaps better take care of themselves. My question to you is should we highlight these education programs more specifically in the budget so that we can see in your Institute and perhaps all the other institutes what is being spent on knowledge dissemination or education. Dr. LENFANT. Well, Mr. Chairman, this is a question that we are discussing extensively, and I have to tell you that as yet we have not come up with a definitive answer. If I may, let me tell you during the next 2 minutes about the pros and cons of having a line in our budget corresponding to all these programs. The advantage is that clearly it would give them much greater visibility. Everybody would know they are here, and they would be recognized. Also, administratively, it would clearly simplify greatly knowing the costs of these programs. Now, there are some disadvantages which I also would like to mention. As you see from the spectrum that you referred to, we view our programs as a continuum going basically from basic research to clinical research to demonstration projects and to prevention and dissemination. I think that the reason why our programs of dissemination are so successful is that they are based on up-todate research outcome. Now, if they were identified as a line in our budget, we feel that there would be a separation of sorts between the basic research, the clinical research, and this dissemination effort. In addition, there would be also some problems with the tracking of some of the I hate to use the word indirect costs today-management costs, if you want, FTE's and other costs which are necessary to conduct these programs. So, to summarize, there are some advantages, some disadvantages. We look at it continuously. We never came up with a definite answer. All I can say that if the Congress wants to have that as a special line in our budget, we could live with it, but we can live just as well if it is not a special line in the budget. Senator HARKIN. Dr. Raub, do you have any feelings about that? Mr. Hall just gave me this. Under each of the institutes, there is regular programs and research training, regular program, research training, regular program, research training. Should there be another line for prevention, education? That is really the question I had for Dr. Lenfant. Do you have any thoughts on this? Dr. RAUB. From my view, sort of along the lines that Dr. Lenfant has suggested, I think it turns on communication, that it is in our interest and yours and everyone else's that our budget requests provide the information in a way that is useful to everybody involved, at the higher levels of the executive branch as well as with the Congress. And we certainly would be open to discussions with the staff elsewhere in the Department and with the committee staff here to look at formatting. Senator HARKIN. Well, let's take a look at it. Dr. RAUB. I would not want to see, nor do I think you are suggesting, that a formatting change in the budget display change the style of management within Dr. Lenfant's Institute, for example. But I think that we ought to be able to be sure that we are communicating in a way that you have the information you need readily at hand to make the judgments and oversight that is your responsibility, and we will be glad to cooperate on that. Senator HARKIN. We will discuss this in the next few weeks or so. I'm not committed to that. I'm just asking the question if that would be a proper way to go or not. I don't know. I can understand what you mean. It's a continuum. If you separate it out, it looks like you are separating these functions out, and how do you assign full-time equivalents to it. I understand all that. Dr. LENFANT. Mr. Chairman, I cannot underscore_ enough the point that what is important to assure the success of these prevention education programs is that they be based on research outcome not on some vague ideas. At each of our meetings, for example, where we discuss prevention, we have a science presentation to tell the people who are going to advise us on our next move relative to prevention about the latest information and best information that we have as a basis for that prevention program. STUDY ON DIET AND FITNESS Senator HARKIN. Do you have any more comments on the diet fit study other than what Dr. Broder said? Dr. LENFANT. Yes, we do. Dr. Broder and I are discussing this from time to time and our respective staff discuss that a lot. I really would like to underscore the point which he was making that the difficulty before making a decision is that we have to assess two factors, one is the feasibility of the study; by this I mean, is it feasible to really reach out to the population group that we want to include in this study. And the second factor is the acceptability. This is a very important point: Assume that it is feasible to reach the population groups we need to include, but would it be acceptable to these people that we ask them to change diets very significantly because changing the diet is going to cost money. It is going to modify the budgetary constraints which may exist in this family. And for this reason, all our urging to change the diets may, in fact, not be accepted. Therefore, we think acceptability needs to be assessed as well as feasibility. We do participate in this study. We are not as generous as Dr. Broder is, but we have our fair share in this program. Senator HARKIN. I am wondering, is it under your department where you do the studies on cholesterol-right? Dr. LENFANT. Yes. Senator HARKIN. I'm going to have my staff get a hold of you. I would like to set up some time in the next few weeks to talk with you and anyone else that you might designate about what the latest findings are on cholesterol, treatments. Dr. LENFANT. We will be most pleased, Mr. Chairman. We will call Mr. Hall and set up a time at your convenience. QUESTIONS SUBMITTED BY THE SUBCOMMITTEE Senator HARKIN. Thank you very much, Dr. Lenfant. There will be some additional questions which will be submitted for your response in the record. [The following questions were not asked at the hearing, but were submitted to the Institute for response subsequent to the hearing:] Question. QUESTIONS SUBMITTED BY THE SUBCOMMITTEE ROLE OF VIRUS IN ATHEROSCLEROSIS Dr. Lenfant, as you know, atherosclerosis eventually kills more Americans than almost any other condition. The popular press has reported that "a common viral infection may be the first step in a complex process in which human arteries become clogged as people age...". What can you tell the Committee about the possibility that a common virus may cause atherosclerosis? Answer. It cannot yet be stated with any certainty whether the known association of viruses of the herpes family with human atherosclerosis is a cause or a consequence of the disease. However, a herpes virus infection is among the plausible hypotheses for early damage to the cells of the blood vessel wall, leading to the subsequent progression of atherosclerosis. herpes virus causes atherosclerosis-like plaques to form in the arteries of chickens. Experiments using animal cells in culture have shown how herpes viruses may enhance the early stages of atherosclerosis. And herpes viruses One are commonly found in the human artery wall. One particular herpes virus cytomegalovirus (CMV) appears to increase the risk and severity of the atherosclerosis that often develops in the transplanted heart, compromising its survival. Because our understanding of the role of viruses in the development of human atherosclerosis is incomplete, and because of the potential for clinically important results, the Institute will continue to support studies in this area. EVALUATION FUNDS Question. Dr. Lenfant, I noticed that your research management line or the funds you have for Institute management increase $7,728,000 or 14 percent compared to the 6 percent growth rate for your Institute overall. The research management and support for NIH grows 15 percent overall, so you are not out of line with the rest of NIH. Why is your overhead funding growing so fast? Answer. The overhead funding growth has increased primarily as the result of decisions outside the control of the Institute to utilize more fully the evaluation authority authorized by Section 2711 of the Public Health Service Act. Section 2711 authorized the Secretary to make available for evaluation up to one percent of any appropriation for payments under any provision of the Public Health Service Act. The increased amounts made available through the evaluation set-aside will support activities of the National Center for Health Statistics' National Health Interview Survey, and initiatives on Health Promotion and Disease Prevention, as well as the activities of the Agency for Health Care Policy and Research. NATIONAL MARROW DONOR REGISTRY Question. As of January this year, I understand you have over 260,000 donors in the Bone Marrow Registry. Just a year ago, you had 110,000. would like to congratulate you on the expansion. number of donors? What is your goal for the Answer. There are not yet enough HLA typing data available to determine definitively how many donors are needed. Extrapolation from the best analysis available suggests that a world-wide file of 2 million donors would provide a better than 90 percent chance of finding a donor for patients needing an unrelated-donor marrow transplant. The United States could contribute 1 million or more to such a world-wide file. More information is needed to determine the ethnic and racial composition of the potential U.S. donor population. It is very clear, however, that at least as many minority donors will be needed as their proportionate share of the American population. On |