NOMINATIONS HEARING BEFORE THE COMMITTEE ON LABOR AND PUBLIC WELFARE UNITED STATES SENATE NINETY-FOURTH CONGRESS FIRST SESSION ON HAROLD L. HODGKINSON, OF CALIFORNIA, TO BE DIRECTOR, NATIONAL INSTITUTE OF EDUCATION DONALD S. FREDRICKSON, OF MARYLAND, TO BE DIRECTOR, NATIONAL INSTITUTES OF HEaLTH THEODORE COOPER, OF MARYLAND, TO BE ASSISTANT SEC- RETARY OF HEBLTH, EDUCATIOX, AND WELFARE (HEALTH) MAY 2, 1975 Printed for the use of the Committee on Labor and Public Welfare 64-760 0 U.S. GOVERNMENT PRINTING OFFICE WASHINGTON : 1976 The CHAIRMAN. We are going to move as quickly as we can. Our next nominee is Dr. Donald S. Fredrickson, the nominee to be Director of the National Institutes of Health. Dr. Fredrickson was born in Canon City, ~Colo. He received his B.S. at the University of Michigan in 1946, and was awarded his M.D. from the same university in 1949. After serving in various clinical positions in the Boston area, he joined the National Heart Institute in 1953. 21 In 196$ he became the Clinical Director of the Heart Inst.itute. He was appointed Director of the National Heart and Lung Institute in 1966, and served in that position for 2 years. From 1969 to 19'74, he served as Director of Intramural Research for that agency, and since 1974, he has served as the president of the Institute of Medicine of the National Academy of Sciences. Dr. Fredrickson is a member of numerous professional associations. He holds numerous ,academic appointments and has received quite a few national and international awards for his contributions to me.dical research. I would like to welcome you here this morning, and we would be happy to hear any statement you may wish to make. I have reviewed your financial statement, and it appears to be in proper order. That does not mean that your checkbook is balanced. I do not, know anybody here who would be qualified to pass on that. It means we find no conflict of record in the reports that you have presented. We will place the biographical sketch of Dr. Fredrickson in the record at this point. [The information referred to follows:] 22 CURRICULUM VITAE DONALD S. FREDRICKSON Born, August 8, 1924; Canon City, Colorado. Married, two children. Education: Attended University of Colorado 1942 and 1943, received B.S. in 1946 and M.D. in 1949 from University of Michigan. Certified by the American Board of Internal Medicine 1357 Chronology OF Employment: 1949-1950 1950-1951 1950-1952 1952-1953 1953-1955 1955-1961 1961-1966 1962-1966 1966-1968 1966-1974 1969-1974 House Officer, Peter Bent Brigham Hospital, Boston James Jackson Cabot Research Fellow in Medicine, Harvard Medical School, Boston Assistant in Medicine, Peter Bent Brigham Hospital, Boston Research Fellow in Medicine, Massachusetts General Hospital, Boston Clinical Associate, National Heart Institute, Bethesda Member, Senior Research Staff, Laboratory of Cellular Physiology and Metabolism, National Heart Institute, Bethesda Clinical Director, National Heart Institute, Bethesda . Head, Section on Molecular Diseases, Labora- tory of Metabolism, National Heart Institute, Bethesda Director, National Heart Institute, Bethesda Chief, Molecular Disease Branch, National Heart and Lung Institute, Bethesda Director of Intramural Research, National Heart and Lung Institute, Bethesda 1974-present President, Institute of Medicine, NAS, Washington, D. C. Present Academic Appointments: Special Lecturer in Internal Medicine, George Washingtcn University School of Medicine, Washington, D. C. Lecturer in Preventive Medicine, Georgetown University School of Medicine, Washington, D. C. 23 - 2- Member: Alpha Omega Alpha American Association for the Advancement of Science American College.of Cardiology, Fellow American College of Physicians, Fellow American Federation for Clinical Research American Heart Association, Council for the Study of Arteriosclerosis American Physiological Society American Society for Clinical Investigation American Society for Human Genetics Association of American Physicians British Cardiac Society (Corresponding Member) Deutsche Gesellschaft Ft'r innere Medizin (Corresponding Member) Harvey Society (Honorary) Institute of Medicine, National Academy of Sciences Institute of Society, Ethics and the Life Sciences (Associate Member) International Society of Cardiology Medical Society of Sweden (Honorary) National Academy of Sciences Peripatetic Club Phi Beta Kappa Phi Kappa Phi Research Interests: Lipoproteins, lipid transport and metabolism; medical genetics, the cause and prevention of arteriosclerosis, health science, education and care systems. 24 - 3- Related Professional Activities: Present: Chairman, Council on Arteriosclerosis and member, Board of Directors and Central Committee, American Heart Association; member Governing Board, National Research Council, NAS; member, Executive Committee, Assembly of Life Sciences, NAS; member, Executive Committee, Section on Atherosclerosis, International Society of Cardiology; member, NAS-NRC Committee for the Study of Inborn Errors of Metabolism; member, Advisory Council of the American Center for Chinese Medicine; Editorial Boards of American Journal of Medicine, Circulation, Circulation Research, Journal of Atherosclerosis, Physiology in Medicine; National Advisory Board, Modern Medicine Previous: Advisory Council on Research, New York State Heart Association.. .American Society for Clinical Investi- gation, Council and Secretary-Treasurer...Bethesda Conferences Committee, American College of Cardiology... Cardiovascular Research Program Evaluation Committee, Veterans Administration...Board of Directors, Founda- tion for Advanced Education in the Sciences...Cardio- vascular Study Section, NIH...NAS-NRC Committee on Fats, Food and Nutrition Board...Medical Advisory Board, Federal Aviation Agency...Medical Advisory Board, National Tay-Sachs Foundation...Chairman and Member, Medical Board, NIH Clinical Center... Nutrition Research Advisory Committee, National Dairy Council... Stouffer Prize Committee...U.S. Coordinator, Problem Area 1, Prevention of Arteriosclerosis, U.S.- U.S.S.R. Cardiovascular Exchange Program...Editorial Activities: American Physiological Society, Member and Chairman, Publications Committee; Editorial Board, Journal of Clinical Investigation; Editorial and Advisory Board, Journal of Lipid Research. Awards: Gold Medal Award, The American College of Cardiology, 1967 The James F. Mitchell International Award for Heart and Vascular Research, 1968 Department of Health, Education, and Welfare Superior Service Award, 1970, and Distinguished Service Award, 1971 Modern Medicine Distinguished Achievement Award, 1971 25 - 4 - Awards (Continued): The McCollum Award (The American Society for Clinical Nutrition), 1971 Election to the National Academy of Sciences, 1973 Jimenez-Diaz Award (Madrid), 1974 _ Intrascience Award, 1974 La Modannina Prize for Science (Milan) , 1975 Some Honorary Lectureships: American Swiss Foundation for Scientif ic Exchange University Lectures (Basel, Bern, Lausanne, Geneva, Zurich), 1964 John Kent Lewis Memorial Lecture (Stanford), 1967 Seventeenth Annual Convocation Lecture (The American College of Cardiology), 1968 Third Bernard H. Pastor Memorial Lecture (University of Pennsylvania), 1968 Marcus R. Caro Memorial Lecture (American Academy of Dermatology), 1968 The Carl Herzog Guest Lecture (The American Dermato- logical Association, Inc.), 1969 The Distinguished Lecture (Association of American Physicians), 1969 Second George C. Griffith Scientific Lecture (LOS Angeles County Heart Association), 1969 Plenary Lecture, Deutsche Gesellschaft fiir Klinische Chemi (Bonn), 1970 St. Cyres Lecture (National Heart Hospital, London), 1970 Wall Memorial Lecture (Children's Hospital of the District of Columbia), 1971 Cardiac Society of Australia and New Zealand and National Heart Foundation Lecturer, 1971 26 - 5 - Lectureships (Continued): Alpha Omega Alpha Lecture and Visiting Professorship (Johns Hopkins Medical School), 1972 Ernest William Goodpasture Lecture (Vanderbilt), 1972 John C. Higgins Memorial Lecture (University of Oregon), 1972 Harvey Lecture, 1973 Samuel Bellet Memorial Lecture (Philadelphia), 1973 The Jimenez-Diaz Lecture (Madrid), 1974 27 -17- 166. Stone, N. J., Levy, R. I., Fredrickson, D. S., and Verter, J.: Coronary artery disease in 116 kindred with familial type II hyperlipoproteinemia. Circulation XLIX: 476-488, 1974. 167. Fredrickson, D. S.: Prevention of atherosclerosis (Comment). Controvery in Internal Medicine II. F. J. Ingelfinger, R. V. Abert, M. Finland, and A. S. Relman (Eds.), W. B. Saunders Co., Philadelphia, 1974, p. 245. 168. Shulman, R. S. Herbert, P. N., Fredrickson, D. S., Wehrly, K., and Brewer, H. B.: Isolation and alignment of the tryptic peptides of apoLP-alanine, an apolipoprotein from human plasma very low density lipoproteins. J. Biol. Chem. 249: 4969-4974, 1974. - 169. Krauss, R. M., Levy, R. I., and Fredrickson, D. S.: Selective measurement of two lipase activities in post- heparin plasma from normal subjects and patients with hyperlipoproteinemia. J. Clin. Invest. 54: 1107-1124, 1974. - 170. Assmann, G., Fredrickson, D. S., Sloan, H. R., Fales, H. M., and Highet, R. J.: Accumulation of oxygenated steryl esters in Wolman's disease. J. Lipid Research. 16: 28-38, 1975. - 171. Ferrans, V. J. and Fredrickson, D. S.: The pathology of Tangier Disease. Am. J. Path. 78: 101-158, 1975. - 172. Shulman, R. S., Herbert, P. N., Wehrly, K., and Fredrickson, D. S.: The complete amino acid sequence of C-I (ApoLP-Ser), an apolipoprotein from human very low density lipoproteins. J. Biol. Chem. 250: 182-190, 1975. - 173. Fredrickson, D. S.: It's time to be practical. Circulation. 51: 209-211, 1975. - 174. Fredrickson, D. S., Morganroth, J., and Levy, R. I.: Type III hyperlipoproteinemia: An analysis of two contemporary definitions. Ann. Int. Med. 82: 150-157, 1975. - 175. Morganroth, J., Levy, R. I., and Fredrickson, D. S.: The biochemical, clinical and genetic features of type III hyperlipoproteinemia. Ann. Int. Med. 82: 158-168, 1975. - 176. Fredrickson, D. S.: Plasma Lipoproteins and Apolipoproteins. In The Harvey Lectures. %:185-237. Academic Press, 1975. - 28 -17a- In press: Fredrickson, D. S.: Gaucher's disease and Niemann- Pick disease. In Cecil-Loeb Textbook of Medicine, 14th Ed. P. B.3ec :son and W. McDermont (Eds.1, W. B. Saunders Co., Philadelphia. Fredrickson, D. S.: Hereditary systemic diseases of metabolism that affect the eye. (International Sympos- ium on the Eye and Systemic Disease, November 15, 1973.) Iowa City, Iowa. Assmann, G., and Fredrickson, D. S.: Function and structure of plasma lipoproteins. Presented at the International Symposium on Arteriosclerosis, Berlin, October 1973. Fredrickson, D. S.: Tonsils and apolipoproteins: Lessons about plasma lipoproteins derived from Tangier disease and other mutants. (The Jimenez-Diaz Lecture, presented in Madrid, May 21, 1974.) Kyner, J. L., Levy, R. I., Soeldner, J. S., Gleason, R. E., and Fredrickson, D. S.: Lipid, glucose and insulin interrelationships in normal, prediabetic and chemical diabetic subjects. Diabetes. 29 The CHAIRMAN. We would like to have your statement, if you have one, Dr. Fredrickson. STATEMENT OF DR. DONALD S. FREDRICKSON, NOMINEE TO BE DIRECTOR OF THE NATIONAL INSTITUTES OF HEALTH Dr. FREDRICKSON. Thank you, Mr. Chairman. I have no opening statement, but I stand ready to answer any questions you may have. The CHAIRMAN. I have had an opportunity to check with you, and have you visited many or all of the members of the committee? Dr. FREDRICKSON. I have visited nearly all the members of the com- mittee, yes. The CHAIRMAN. Senator Laxalt, would you wish to ask any qestions 8 Senator LAXALT. Yes. I am sorry I missed you yesterday. I under- stand a conflict between rollcall voting and an appointment is almost irreconciable.. Just basicallp, what do you view to be the function of NIH just. on an overall level ? Dr. FREDRICKSON. The major mission and function of the Institutes of Health is the conduct and support of biomedical research through- out this country, sir. By biomedical research? I mean a continuum of activity that extends from work on basic biological systems on up through possible appli- cations to improve t.he heahh and well-being of man. Senator LAXALT. What areas is NIH concentrating on at the present time, if you know `4 Dr. FREDRICKSON. Its activities are extraordinarily broad, as they have been from its inception, Senator Laxalt. Its `activities are dis- tributed through a variety of Institutes, most of which are identified in terms of one or several groups of diseases for which they are par- ticularly concerned. It supports, in addit,ion to that. a broad substratum of biologica* research which is not easy to identify with a given disease at. this par- ticular period of time. Senator LAXALT. Are you heavily involved in cancer research at this time? Dr. FREDRICKSON. Yes. Cancer research is the largest single sector of the budget of the National Institutes of Health at the present time ; that is? about one-third of its current budget of approximately $2 billion. Senator LAXALT. How do you view our effort in cancer research? Dr. FREDRICKSON. I think that this is an exciting time for new initia- tives in cancer. Cancer is not one disease but many diseases, and the progress will inevitably be uneven and limited from time to time to one of these specific areas, but basically I think we are making real strides in cancer research. I think there is real promise for a gradual conquering of at least some of these very serious diseases. ' Senator LAXALT. Do you think the Federal Government is fulfilling its proper role in imple.mentinp this vital research ? Dr. FREDRICKSON. Yes; I think it is, sir. 30 Senator LAXALT. There has been a substantial increase in the orga- nization in the area of cancer research. Dr. FREDRICKSON.YS. Senator LAXALT. What is the relationshi'p of NIH to the various foundations throughout the country engaged in various types of medi- cal research, if any ? Dr. FREDRICKSON. Mainly an informal one of information exchange and awareness of the areas in which other foundations are active, sir. Actually, the number of foundations in the country supporting med- ical research per se, particularly laboratory research, is not large. Senator LAXALT. How is your research disseminated? Dr. FREDRICKSON. The initial product of research, as in all the nat- ural sciences, is first disseminated in the scientific journals where, in fact, its validity is tested by reviewers and referees who determine the quality of that research. From these primary sources of publication it then enters the common domain, although publication often lags far behind the communication by mouth or by exchange among experts at various meetings held both nationally and internationally. The Institutes maintain inform,ation activities that help to boil down the important ingredients of the research conducted by the Insti- tutes so that it might be made available to the press, and to lay people, large number of whom write in for information about a tremendous variety of conditions. We seek at all levels to see that this information is as readily avail- able to the,public as it possibly can be. Senator LAXALT. Considering the overall spectrum of medical research, what percentage would you say of that total program is pres- ently borneby NIH, or can you tell ? Dr. FREDRICKSON. The figures for the total support of biomedical research in the country are somewhat uncertain primarily because of the difficulty in evaluating the contribution from industries, particu- larly the pharmaceutical industry. But, roughly two-thirds of biomedical research is supported by the Federal Government `and about two-thirds of this is borne by the Na.tional Institutes of Health. Senator LAXALT. What is the relationship of NIH to private medical research, particularly on the part of the pharmaceutical industry ? Dr. FREDRICKSON. There is an active program of cooperation and awareness between NIH and the industry in activities t.hat assist the propulsion of discovery or the evaluation of many of the products of the pharmaceutical industry in clinical trials,.trlals of efficacy, and so forth ; so that there is a close relationship m this regard. Senator LAXALT. It is not a watchdog type, I gather! Dr. FREDRICKSON. The NIH per se is not fulfilling a regulatory role with regard to the pharmaceutical industry in the same manner that the Food and Drug Administration does ; no. The CHAIRMAN. How many Institutes are there? Dr. FREDRICKSON. There are 11, sir. The CHAIRMAN. What was the last to be ,added? Dr. FREDRICKSON. `The very last to be added was the National Insti- tute on aging. It is the smallest of the Institutes at this time. It is under an Acting Director. It has not yet had a Director, but it was the last created by legislation during this past year. 31 The CHAIRMAN. Prior to that what was the last to be added to the National Institutes of Health ? Dr. FREDRICKSON. I believe, although I could be mistaken, it was the National Eye Institute. The CHAIRMAN. We have created within the last few years two other health-related agencies called Institutes that are not within the umbrella of the National Institutes of Health: the Bureau of Drugs and Alcohol. Dr. FREDRICKSON. Yes; that is correct, sir. They are in another agency. The CHAIRMAN. First of all, thank goodness you come to this posi- tion with a deep background of activity within an Institute, so t,here is no on-the-job training in getting to know the philosophy, the organi- zation of the National Institutes of Health. Dr. FREDERICKSON. It is true, Mr. Chairman. I am very familiar with it. The CHAIRMAN. That I might say is a great plus factor. You have been most importantly associated with the Heart and Lung; is that right? Dr. FREDRICKSON. That is correct? sir. The CHAIRMAN. We have a great institution in the National Insti- tutes of Health. We are dealing with the same goal of the physical well- being of human beings, and we all have a part of that human anatomy to understand and to try to find ways to cure or to prevent disease from attacking the area of their particular concern. Is that correct? Dr. FREDRICKSON. That is correct. The ,CHAIRMAN. It seems to me that the body's relationship is such an integrated thing, and so much as one aspect has a relationship so closely to another disease, that I would think as you break it into institutes you would relate one with the other. It has to be that findings in one area have direct ,applicability to the mission of another one, I would think. Dr. FREDRICKSON. That is `absolutely correct, Mr. Chairman. Although the Institutes are identified primarly under disease cate- gories, underlying the problems of human disease are biological sys- t,ems that man indeed shares with many other species, and this information does have relevance across the whole field of the Institutes. I think that is the beauty of the organization of biomedical research today into a consortium of single units, which are called Institutes, which must be integrated with regard to management ,and to their common activities. The sizes of the various Institutes and the problems they are assigned in their authorities are very large, and I think they make useful subdivsions for the labor involved in seeking to extend knowledge and translate it to diagnosis and treatment. There are many things that the Institutes are able to do with rela- tively high degrees of autonomy, but there has to be some point at which all this is brought together and where the opportunities year by year in a field that changes rapidly can be assessed, and scientific judgments and recommendations made to you and to the public as to where we may go from here with the greatest probability of success. 32 The CHAIRMAN. Do you know of how well the NIAA is within the area of administration that you are going to? Dr. FREDRICKSON. No. sir. The CHAIRMAN. Yet it is a health problem ? Dr. FREDRICKSON. Yes, it is. The CHAIRBXAN. It is separately organized within the Department of HEW for various reasons: One, it is an action program. It is an action Institute. It is a sponsoring agency for program activity in the country. Dr. FREDRICKSON. That is correct: sir. The CHAIRMAN. That is different from any of your Institutes. Dr. FREDRICKSON. In a quantitative sense,*it is different. Within the Institutes there are activities tha,t bear upon the move- ment of Iknowledge into the field of active practice, and there are programs called demonstration or control programs within certain of the Institutes themselves. I think that perhaps one of the tasks for the next Director of the NIH is to help successfully articulate where the proper boundary lies between NIH and other agencies that carry out this kind of activity. The CHAIRMAN. Do you know whether there is any relationship, any informal communication, between NIAA and any of the National Institutes of Health? Dr. FREDRICKSON. I cannot point to specific instances but I am cer- tain that there must be, sir. The CHAIRMAN. Are you certain that there should be? Dr. FREDRICKSON. Yes, I am. `The CHAIRMAN. And if there are not, there will be? Dr. FREDRICKSON. I assure you there will be. The CHAIRMAN. We, as you know-and I will say parenthetically I have had the benefit of a good discussion with you, Doctor, and I am sure other members of the committee have had the opportunity to meet you-how many have you met of our committee? Dr. FREDRICKSON. I should say approximately 12 to 14. The CHAIRMAN. I know that you made yourself available to all members. Dr. FREDRICKSON. Yes, sir. The CHAIRMAN. It was most appropriate. We attach the highest importance to the National Institutes of Health, as I indicated to you. I am sure the historical record will show that the high priority was put upon the Institutes here in Congress on the Executive side in creation and the support over the years. We think that it is of such fundamental importance to the health of our Nation. There are big questions that we know about, questions of morale within the Institutes, questions of dissemina.tion. You have dealt with that to some degree in your studies, to a useful area within the communities of the country. First, on the question of morale, any research agency has to be certain of a high level of it, and I feel things are improving. Would you just give a statement of your evaluation of that factor with regard to the personnel of the Institutes today ? Dr. FREDRICKSON. Yes, sir. I believe there has been some deteriora- tion in the morale of the agency. There has been a sense of instability 33 with regard to the position of the Director from the time of the National Cancer Act when it became a Presidential appointment. Perhaps there has been a misinterpretation of greater instability than actually does exist. I think probably the main problem that one has in dealing with scientists in regard to morale is to assure them that what they believe are the essential processes of discovery are not threatened by the attempt on the part of the public to be sure the activities of federally supported scientists have a bearing on the improvement of the well- being of man. No scientist is opposed to that, but there are always differences of opinion as to which is the best road to discovery. A particular source of tension lies in the. area of targeting or selection of priori- ties or emphases within a given area. I think some of the scientists both within and without the Institutes have a justifiable basis for being concerned as to whether the funda- mental research process is threatened by current methods of priority selection. But I return to NIH without any preconceptions on this point other than that it needs to be fairly reevaluated. There is no denying that in receiving public support science has an obligation to society in regard to the translation of its discoveries to serve purposes both meaningful sand useful to society. I think there is a problem of morale, but I think it is one that can be much restored by the recognition of the fundamental processes of science and by the reassurance-which indeed the Congress has con- tinued to give us-that medical research is a very important and public enterprise that must go on. We still lack a tremendous amount of knowledge to bear on the chronic diseases, the major biomedical problems we still have left to solve for mankind. I think there is basis for optimism that we will make tremendous strides against these diseases in the next quarter century. Senator LAXALT. Are you having serious problems attributable to the wage freeze? Dr. FREDRICKSON. Yes; ,there a.re problems particularly at the level of senior scientific admmistrators. Scientists will always be paid less than those in medical practice, and I think this is not necessarily inappropriate, for there is a tremendous source of satisfaction to be derived from the work of science itself. Senator LAXALT. How long have they been frozen? Dr. FFZDRICKSON. I think we are now in the fifth or sixth year. The wage problem at NIH is one of competition with outside institutions which must have the same types of people, particularly the universities. Our greatest problem lies in certain of the clinical specialties which are required for optional operation of the NIH Clinical Center. The wage differential makes it extremely difficult to attract these people from the outside. The CHAIRMAN. Finally, Doctor, at- this point, out of this com- mittee has come all of the legislation dealing with equality of oppor- tunity in employment, and discrimination is the enemy, and we have been in the forefront of legislating those methods that will insure that the quality is honored in our country. 34 We know that there is litigation involving individuals at the Insti- tute. We are obviously concerned about that, but that is not particu- larly any of our business. Let me just ask if there is a way you could describe your attitude about equality, and how can we in administration guard against any possibility of discrimination in employment? Dr. FREDRICKSON. I can assure you, Mr. Chairman, that I have wholehearted support for both the letter and intent of those statutes that deal with programs of equal opportunity *and of affirmative action to protect the rights of minorities, of women? and others, to equal opportunity without any discrimination in the fields of sciences and medicine, and in all the activities of the National Institutes of Health. I think one has to be constantly aware, vigilant, and active in an attempt to be sure that. we do foster in the best way we can, com- pliance wit,h the intent of those statutes. Senator LAXALT. Is there discrimination in the health fields con- cerning women Z Dr. FREDRICKSON. I think that there is not now sex discrimination against women in the health fields, but there are still many inequities in the distribution of the sexes at all professional levels within medical schools and in activities relative to research. The same is true for minorities. Senator LAXALT. What. can be done by the Institutes to correct that type of thingZ Dr. FREDRICKSON. I t.hink the Institutes must constantly seek in every instance to search out good candidates from among women and ~n;$ties, to fill professional vacancies whenever it can possibly The real problems in regard to these inequitable distributions have not begun on the level of postgraduate education but far earlier. Senator LAXALT. Do.you sense any discrimination in the admissions to medical schools agamst women at the present time in the country ? Dr. FREDRKKSON. I would say there is not at the. present time in this countrv? Senator Laxalt. The number of women in medical schools is increasing very rapidlv, and I think the medical schools are finding it a very delightful experience. Senator LAXALT. On another subject, is there any indication as to when we could expect an administration proposal on national health insurance ? Dr. FREDRICKSON. I am not able to answer that question, Senator Laxalt. I really do not know. The .CHAIRMAN. I have nothing further. Senator Randolph. Senator RANDOLPH. I believe I heard you say it was rather delight- ful to have women around ; is that correct? You used that expression Z The CHAIRMAN. `That is a rather loose extension of what he said. He is not going to deny that. Dr. FREDRICKSON. I said I felt that the medical schools were finding their increased emphasis in enrolling women to be a very profitable and I might have said delightful experience. 35 Senator RANDOLPH. Of course, Woodrow Wilson said it earlier. He said he would not. give a thought for a man who did not want to be surrounded constantly by a bevy of beautiful women. That was a few years ago. I still remember having been around at that time. Seriously, I am delighted to see Dr. Virginia Trot'ter here this morning. Mr. Chairman, I think it is very fine when Virginia Trotter takes time from her busy schedule-and perhaps along with ot,hers-to come up to the Hill to attend a hearing of this kind where Dr. Hodgkinson has been one of those to be questioned as to t,he position that he is to undertake in our educational structure. I have to take a moment to tell you where I was last night, not t.hat it is important where I was, but I think we should remember that as they come to the Hill, men who have worked all day go out from Washington to try to help others in the field of education. I accompanied Senator Claiborne Pell last night to West Virginia University where he made a notable address to the annual awards dinner for approximately 200 of the top. West Virginia students who have had qua1it.y education which is so important to be continued in our country. His speech was a very significant and a very moving one, and it was gratifying, I t'hink, to him-1 know it was to me-to see the intense interest exhibited by the students ; not just because he was the speaker, but also because of the subject matter that he was discussing, the quality of education, the look ahead for 25 years as he looked back 25 vears as to what the educational process has been and will be, wonder- ing whether we will reach a. certain point in the so-called physical development of the world, and whether we should not move back and think in terms of perhaps a more balanced life. It was a wonderful occasion. I could not help but think as I sat there last night listening to him, and looking at those young people, to understand their concerns going back to what someone said a long t,ime ago, long before the period in which Woodrow Wilson lived. It was Francis Bacon who said: "A good presence and a good fashion carry continued letters of recommendation." I think these are matters that we ought to remember, at least briefly, along the way. I am sorry I was not here when Dr. Hodgkinson testi- fied. I talked with Dr. Hodgkinson, and I will have certain questions for him that I hope will be made a part of the record. Dr. Fredrickson, personally I have known many people from the State of West Virginia who have been helped by the programs of NIH, especially in the treatment of cancer. Research dollars pay off, by and large, although sometimes it takes considerable patience along the way. I am sure you agree with that. Dr. FREDRICKSON. Yes; Ido. Senator RANDOLPH. People want to stop and wonder. They wonder whether what they have done is worth while. I think we must not sell research projects short. We are inclined sometimes, when we do not get the instant answer, to feel that we have to stop. I notice some new developments, possibly through virus detections, in the detection of cancer. I am not certain that it is valid, but at least constantly there appear on the surface those indications of studies that possible development will make worth while. 36 So I have letters in my file, Mr. Chairman, from people expressing their appreciation for what has been done for them and members of their families through the Institute of Health. One came from a man who thought he had but a few weeks to live, but his whole life was turned around somehow or other by what was done at the National Cancer Institute. I just mention it today. I think there are numerous concerns, Doctor, as to the future of these research programs at NIH. These concerns I presume are partially prompted by the proposed reductions in the President's fiscal year 1976 budget, as well as the proposed rescissions. It seems to me these cutbacks are ill advised. I understand the need at times, of course, for tightening of the budget, but if I felt there were to be a weakening of valid research, why, I would want to take a very close look at it. I can understand that there might be real chaos within the research community resulting from such cutbacks, in that way may lose the opportunity of which I have spoken, for development. How do you answer these concerns Z I am not asking you to say that the proposed reductions are in being, but I am asking you about your concept and belief in research programs, and the need to fund them adequately. Dr. FREDRICKBON. I believe, Senator, that we have as scientists a tremendous responsibility to keep our budgets as lean and reasonable f&s we csm. We must be sure that we can use the resources effectively that are supplied to us. I do believe there is no lack of opportunity for further discoveries that are necessary for the advancmg of knowledge that is still so lacking, There is no lack of application for the degree of resources with which we are supported today. I think those moneys are being well spent, and I shall make it my endeavor to make sure that continues to be the case. Senator RANDOLPH. Thank you very much. Senator, do you have further questions? Senator LAXALT. I have concluded my own questions, but I would like to indicate to Dr. Fredrickson that Senator Real1 was unable to be here. He wanted very much to introduce you and Dr. Cooper, and to let you know that he strongly supports and endorses your being here and your nominations. He indicated specifically that he was very pleased that these two key health provisions are being filled with individuals who are so qualified and who will be able to work together as a team. [Senator Randolph `assumed the chair.] Senator LAXALT. So, Mr. Chairman, I ask unanimous consent- which would not be overcomplicated here today-that Senator Beall's most recent letter to the President regarding the nomination of Drs. Cooper and Fredrickson be included in the hearing record, and I recommend that you see this because it is an exceedingly strong endorsement. Senator RANDOLPH. Without objection, it will be so included. 37 [The letter referred to follows:] U.S. SEIVATE, COMMITTEE OX LABOR ,AND PUBLIC WELFARE, Wash/inggton, D.C., March 19,197s. Hon. GERALD R. FORD, President of the United States, The White House, Washington, D.C. DEAR MR. PRESIDENT : As a member of the Health Subcommittee, I am deeply concerned about the delay in filling two key health positions, namely the Assistant Secretary for Health and the Director of the National Institutes of Health. I have previously conveyed this concern to the White House. Today I wish to reiterate my concern and urge that you fill these positions by naming Dr. Theodore Cooper to be Assistant Secretary for Health and Dr. Donald S. Fredrickson as the Director of the National Institutes of Health. This Congress will have many health issues and health measures before US. Among these issues are health manpower, medical devices, extension of the heart and lung act, health services and numerous biomedical issues. These issues are too important for resolution by an Acting Secretary or an Acting Director. With specific reference to the individuals I endorse, Dr. Cooper has had a distinguished educational and professional background. Presently serving as the Acting Assistant Secretary for Health and prior to that as Deputy Assistant Secretary for Healmth, he has demonstrated his administrative and leadership caoabilities. Particularly noteworthy was his development of the "Forward Plan for Health." This document certainly indicates that he has a broad overview in the health fleld. Also, he earlier served as Director of the National Heart and Lung Instl- tute at NIH. Thus, his former research and administrative background, coupled with hia new expt%lences and greater expoaure to health services delivery and its problems, will serve him well if he is named as the Assistant Secretary. Most important, he has completed the on-the-job training for this position. He will not have to go through the "basic training" period in order to understand and learn his way around HEW. In short, he should be ready to take over the health helm and to provide our nation with the required leadership in the health area. This is important because we cannot afford drift and indecision while a new person learns the ropes. Dr. Fredrickson also has excellent academic and professional credentials. Presently he serves as the Director of the National Institute of Medicine. Prior to that he had extensive experience in research and held numerous administrative positions. Incidentally, while at the Heart and Lung Institute, he served as Director of Intramural Research working closely with Dr. Cooper. His research and academic and administrative background also provides him with broad prospective in health. The appointment of Dr. Fredrickson to be Director of NIH would be most welcomed by the research community in general and would be particularly applauded by the researchers at NIH. Undoubtedly, his appolnt- ment would boost the morale of this worldwide preeminent biomedical research center. In sum,mary, these two leaders in the health fleld have a record of academic and professional excellence ; have demonstrated leadership capabilities in their professional positions which have provided them `with experience in both blo- medical research and health services delivery ; and most importantly, they have worked together and done so effectively as a team. In recent years the usual excellent relationship between HEW and NIH has deteriorated. Certainly, the team of Cooper and Fredrickson would reduce or eliminate such a problem. Again, Mr. President, it is decision time with respect to a number of health issues and. therefore, it is critical. in my judament, that the Administration move to All these key health positions with people who'can give the Administration, the Congress, and the country leadership equal to the chal- lenges we face in the health area. Drs. Cooper and Fredrickson are two individuals who have the necessary nrereaulsites to do the iob. They eniov the confidence of the health communlts. !L'hey are available and"ready to as&&e and act in these positions now. Thus,-1 hope that you will immediately fill these two key health positions by naming these two excellent lndivldual,s whom I have endorsed. With kindest regards, I am Sincerely youra, J. GLENN `BIULL, Jr. 38 Senator RANDOLPH. I believe I am correct in saying that Dr. Pred- rickson will be asked certain questions through communications from Senator Kennedy who was unable to be here. You will, of course, respond to these for the record. fir. FREDRICKSON. Yes ; I will, Mr. Chairman. [The information referred to follows :] NATIONAL ACADEMY OF SCIENCES ZlOl CONSTlT"TlcJN AVENUE W**H,NCTON, 0. c. 20418 A - May 5, 1975 The Honorable Edward M. Kennedy Chairman Senate Health Subcommittee Committee on Labor and Public Welfare United States Senate Washington, D.C. 20510 My dear Senator Kennedy: I am pleased to supply the following answers to the questions contained in your letter dated May 2, 1975 delivered to me by Mr. Goldman at the hearings on that date. The opinions expressed are my own. 1. Do you believe there is a serious imbalance of biomedical research support among the various institutes at the NIH? If you believe this to be a problem, what mechanisms do you realistically believe will be available to you to remedy it? At present, the NIH's budget is at least half devoted to two major disease categories, cancer and cardiovascular. I am not yet persuaded that acquisition of biomedical knowledge still required to deal with these or many other important diseases is adequately guaranteed by such apparently uneven distribution of the current resources of the Agency. Thus I believe there currently may be an imbalance of biomedical research support among the various institutes at NIH and that it might be serious. This question is one that I would give maximum attention to upon returning to NIH. The best mechanism presently available to the Director of NIH for remedy of this situation is a searching analysis of the assumptions underlying the present allocations and the presen- tation to the Administration and to the Congress of continuing candid appraisal and recommendations that combine perceptions of need and the constant shifts of technical opportunity for advance- ment and effective use of knowledge. It is my belief that the NIH Director must afford the first point of convergence of the diverse interests, ambitions and arguments of the many program areas and constituencies into which biomedical research is subdivided. It is in that office that the technical quality of those arguments must be assessed and an opinion of priorities developed that is honest, fair and impartial, and directed at the public good. 40 The Honorable Edward M. Kennedy May 5, 1975 Page Two 2. What is your view with regard to the necessary and appropriate role for the NIH in the support of research and manpower? Specifically, do you think it is essential for the NIH to support both pre and post doctoral training? I believe that the NIH mission to support and conduct biomedical research requires that it be directly responsible for support of a program to train research manpower. The apparatus constructed for conduct of such research is critically dependent on a steady and well-regulated influx of new personnel. it the present time. I do not believe the needs can be met without NIH support of post doctoral training. It should not be responsible for subsidizing the training of all biomedical scientists. The estimate of numbers and identification of special areas for support requires more thorough analysis than I have yet seen articulated. In this regard, I am fully aware of the NAS-NRC study now being conducted. I believe this must not relieve the NIH of responsibility to improve its own methodology and efforts to project realistic needs and defend its current mechanisms for meeting them. I must reserve judgement with regard to support of pre doctoral training by NIH until I have had more opportunity to examine the evidence of need and weigh it against competing demands for resources. 3. Does NIH funding support medical education? Approximately what proportion of the annual NIH effort is so directed? And do you think the continuation of the support subsidy of medical educa- tion via the NIH is either necessary OF appropriate? I am not now aware of direct subsidy of medical education by NIH, such instruments as undergraduate training grants and clinioal training grants having been discontinued. Certainly the NIH is responsible for indirect support of medical education in terms of the research activities it necessarily supports within academic institutions. An enrichment of the quality of undergrad- uate education in the medical schools as a result of this would seem inevitable and desirable to the extent that the scientific base of a physician's training is essential. 4. What is your view of the mission and mandate of the President's Biomedical Research Panel? The mandate of the President's Biomedical Research Panel appears to me to include a broad review and fairly detailed assess- ment of the mannwer in which biomedical and behavioral research is 41 The Honorable Edward M. Kennedy May 5, 1975 Page Three now being conducted and supported at both NIH and NIMH, in the light of its (the Panel's) analysis of present and projected scientific opportunities and social needs for research as an instrument for improvement of health. I expect its recommendations may have important implications for NIH in particular, and federal support of biomedical research, in general. As Director of NIH, I would seek to cooperate fully with the Panel in its study. 5. The Association of American Medical Colleges has urged the adoption of an amendment which in effect would exempt research protocols from public scrutiny as required by the Freedom of Infor- mation Act. Do you personally believe such an amendment is necessary and in the public interest? Will you urge the Administration to seek the adoption of such an amendment? I believe that an agency such as the NIH, which expends public funds and conducts research that bears so directly on human welfare, has a special responsibility to comply fully with the spirit of the Freedom of Information Act. I am concerned about two aspects of the research process which could be placed in jeopardy by unrestricted interpretation of The Act. The first is the protec- tion of certain elements of the review of research proposals, These involve the ability of experts and peers to arrive freely at a con- clusion concerning the scientific merits of both the researcher and his idea, deliberations which require a degree of confidentiality. The second is the equity of the researcher in hia or her idea, On this point, prevailing attitudes clearly diverge. Although any commercial or proprietary interest in such research ideas is diffi- cult to defend, their value to the investigator is nevertheless real. for they constitute his major stock-in-trade in a highly competitive enterprise. The researcher needs some protection of his idea until he is able to act upon it or until his priority to it is establiahad. This is best achieved by a modest period of non-disclosure, although some protection of priority conceivably will be afforded by limiting disclosure to specific requests for information. Where the research idea involves direct participation of human subjects, I find the principle of non-disclosure most difficult to defend. If, upon further study, I find that there appears to be no other means for protecting the two major aspects of the research and review process I have addressed above, I would support an amend- ment for this ournose as beina in the oublic interest and urge the Administration'to-seek its adoption. I Sincerely, Donald S. Fredrickson, M.D. President 42 Senator RANDOLPH. Thank you ver much. Senator LAXALT. Please do not eel, Doctor, that the scarcity of P committee members indicates any lack of endorsement on the part of the committee. We have a tremendous problem with the small number of Senators who are being too thinly spread. At times that could be misinterpreted. I would not want you or any of the other witnesses to feel that way. Senator RANDOLPH. Senator, what you are saying here is important, but I do not want to belabor the point. I do want to tell you that Senator Pell came back at 1 o'clock this morning, after working for 14 hours yesterday, going out into the field. He did not do rt for something that was to come to him but in an effort to help people who understand the concerns that he had. Thank you, sir. We will hear next from Dr. Theodore Cooper. Dr. Cooper, I have talked with you. I am sure other members have. Do you have a statement to make? STATEMEET OF THEODORE COOPER, M.D., BOMINEE TO BE ASSIST- AMT SECRETARY OF HEALTH, DEPARTMENT OF HEALTH, EDU- CATION, AND WELFARE Dr. COOPER. No; I do not. Senator LAXALT. I had an extended discussion with Dr. Coo yesterday, and whatever inquiries I had I think were fully satis H er ed yesterda -, Senator Randolph. I wou 4 d like to read into the record a statement of Senator Mathias in your behalf, Dr. Cooper, which is highly laudatory. I would suggest that you too secure a copy of this statement for your own records, and I ask unanimous consent that statement be so included. Senator RANDOLPH. Yes ; it will be included, preceding the biograph- ical sketch of Dr. Cooper. [The statement of Senator Mathias and other information follow :] PREPARED STATJZMENT OF HON. CHARLES 31cC. MATHIAS, JR., A U.S. SENATOR FROM THE STATE OF MARYLAND Senator MATHIAS. Mr. Chairman and members of this committee, I deeply re of intro ucing to you a most distinguished Maryland resident, cf ret that a prior engagement will not allow me the privilege Dr. Theodore Cooper, who has the honor of bein nominated by the President of the United States to be the Assistant & ecretary for Health in the Department of Health, Education, and Welfare. Since February of this year, Dr. Cooper has served with great dis- tinction as the Acting Assistant Secretary for Health. Ted Cooper's career of service to the N'ation as a commissioned officer in the U.S. Public Health Service, however, spans a period of nearly 20 years, during which time he has gained national reputation and respect, including several high honors for his demonstrated excellence as a sur eon, Y educator, scientist, and health `administrator. The Nation is we1 served by his nomination.