RESEARCH IN THE SERVICE OF MAN: BIOMEDICAL DEVELOPMENT, EVALUATION OF EXISTING FED ERAL INSTITUTIONS THURSDAY, MARCH 16, 1967 U.S. SENATE, SUBCOMMITTEE ON GOVERNMENT RESEARCH, Washington, D.C. The subcommittee met, pursuant to recess, at 10:05 a.m., in room 1318, New Senate Office Building, Senator Fred R. Harris (chairman) presiding. Present: Senator Harris. Also present: Dr. Steven Ebbin, staff director. Senator HARRIS. The subcommittee will be in order. The Senate Subcommittee on Government Research of the Senate Government Operations Committee, is continuing its hearing entitled "Research in the Service of Man: Biomedical Development, Evaluation of Existing Federal Institutions." Our first witness this morning is Dr. Adrian Kantrowitz, director of surgery, Maimonides Hospital and Coney Island Hospital, Brooklyn, N.Y. Without objection we will place into the record at this point a biographical sketch prepared by the staff concerning Dr. Kantrowitz. Biographical Sketch: Adrian Kantrowitz, M.D. Director of Surgical Services, Maimonides Medical Center and Coney Island Hospital, Brooklyn, New York. Professor of Surgery, State University of New York Downstate Medical Center, M.D.-Long Island College of Medicine-1943. Background Data: Attending Surgeon, Maimonides Medical Center. Director, Cardiovascular Surgery; Director, Surgical Research; Chairman, Research Committee, Maimonides Hospital. Consulting Surgeon, Good Samaritan Hospital, Suffern, New York. Assistant Visiting Surgeon, Flower, Metropolitan, Bird S. Coler, Morrisania Hospitals. Adjunct Surgeon, Cardiovascular Research Fellow, Montefiore Hospital, Bronx. Associate Professor of Surgery, State University of New York Downstate Medical Center. Instructor in Surgery, New York Medical College. Teaching Fellow in Physiology, U.S.P.H.S. Fellow in Cardiovascular Physiology, Western Reserve University School of Medicine, Cleveland. Member of many professional societies. Recipient of many awards. Author of numerous publications, exhibits and films. Senator HARRIS. Dr. Kantrowitz, will you step forward please, sir, and have a chair. We are very happy to have you and I appreciate your taking time to be here and to prepare your testimony. I believe you have a prepared statement. You may read it or however you may desire. TESTIMONY OF ADRIAN KANTROWITZ, M.D., DIRECTOR OF SURGICAL SERVICES, MAIMONIDES HOSPITAL AND CONEY ISLAND HOSPITAL, BROOKLYN, N.Y. Dr. KANTROWITZ. Senator Harris, ladies and gentlemen. It is indeed gratifying that this distinguished committee has raised questions relating to the adequacy of Federal institutions for biomedical development. In the area of applying engineering technology in medicine, it is an especially timely and important examination. Here we have the exciting prospect of watching a new, hybrid field of science come into being and a challenging opportunity to guide it so that its enormous potential will be realized for the betterment and prolongation of human life. In speaking to you today I draw upon my experience as a practicing cardiovascular surgeon and investigator. I would like to remark upon the functioning of Federal agencies as they have affected my work: this is the only real area of my competence. I have taken the liberty of writing to a few of my colleagues in artificial organ research regarding the questions posed by this subcommittee and have with me their replies which I will incorporate into my remarks. It is my hope that some thoughts drawn from our associations in the engineering technologies will bear on the questions of concern to this subcommittee. It is universally recognized that the United States has earned preeminence in the world today in most areas of medical research and care. In my own field of cardiac surgery, although significant contributions have come from investigators in other countries, pump oxygenators and the techniques for surgery on the open heart are the accomplishments of American pioneers like Dr. John Gibbon, Jr., Dr. Clarence Dennis, and Dr. Walton Lillehei. In the decades since World War II, it is to the United States that young physicians have come for periods of training and research. This international leadership is directly related to the funds allocated by Congress to the National Institutes of Health. In the overall, these resources and their attendant power have been used judiciously and with the highest integrity. The Institutes have shown remarkable discernment in recognizing problem areas, in giving the investigator with far-out ideas the opportunity to test them, in permitting investigators flexibility in research, in its concern for patient welfare. In my experience, its professional staff has been sensitive, nonbureaucratic, and infailingly helpful in their advice on how best to use the machinery of the Institutes for the advancement of research. goals. Where new needs are emerging, the NIH should be strengthened and extended to meet them. But it is to be hoped that the record of accomplishment will be borne in mind: in the NIH we have a Federal institution whose structure and policies have enabled it to fulfill its role in helping create the conditions for medical advances. In evaluating the establishment of grant priorities, I must look to the past accomplishment of the NIH. The use of peer judgments to evaluate researchers' plans and proposals seems to me the very core of its strength. Dr. Bert Kusserow writes that ... it is not entirely clear precisely how research priorities are established at the Federal level. For example, I do not know where, by whom and by what mechanism the very early and crucial policy decisions were made which ultimately resulted in the establishment of the artificial heart program. Nevertheless, it is my feeling that the value judgments and other assessments necessary for the establishment of research priorities should be heavily influenced by the thinking of leading investigators in the field. In this regard the history of science has repeatedly shown the danger of permitting research to fall to the marketplace or the political arena. Institutional grants can facilitate an investigator's obtaining relatively small amounts needed for preliminary testing of new ideas. The availability of such funds for seed money has many advantages. I too am not familiar with the inner mechanisms of the NIH system of priorities but I would hope that it will provide funds for favorable consideration of grant applications from the young, little-published investigator with a fresh insight or an unorthodox approach who may be unappreciated within his own institution. The problems of communication between engineer and physician are summarized by Dr. Galletti. I find the primary emphasis on the engineering aspects of the (artificial heart) problem somewhat naive. Reviewing proposals for contracts certainly reveals a scarcity of original ideas. What strikes me on the medical side is the shortage of personnel with background, competence, and inclination toward this aspect of applied biophysics. On the engineering side, interest is present, but the complexity of physiologic, surgical, and human aspects of the problem is often ignored to such an extent that one really wonders what kind of fruitful collaboration may be obtained by some industry-university partnerships. The several methods currently used by the NIH and other Federal agencies for communication with the scientific group are effective in a limited way. Their letters, brochures, and descriptive literature are informative and appraise grantees or prospective grantees of important developments. A beneficial addition would be more frequent symposia and the publication and dissemination of their results. As Dr. Galletti points out, up to now this has been principally the responsibility of private organizations such as the American Society for Artificial Internal Organs and subgroups in various fields. Symposia, particularly in limited fields rather than large, general meetings, have been enormously valuable in the past and I personally would like to see as many as two a year. On methods and means of increasing communication between physicians and engineers, Dr. Lillehei is of the opinion that— It might be well to consider a National Conference on this subject again inviting all of those interested including physicians, engineers, and basic scientists. It has been approximately three years, I believe, since the last one and much new information has been developed. The success of this type of conference in regard to extracorporeal circulation and development of artificial heart valves is well known. Though I can well understand the need to keep a tight rein on funds designated for travel, I think that this is one area where a relaxation of policy would result in a valuable and lively exchange of ideas. Dr. Kolff feels that, "Communication could be more effectively obtained if special funds were made available for holders of grants and their collaborators to travel." Dr. Kusserow writes that It seems that a good beginning has been made by increased participation by engineers and others from the exact sciences in conferences and meetings of a biological or medical nature. Coupled with this is the trend on the part of the individuals of both groups to avail themselves of appropriate course work. A solid educational base in the form of sound academic biomedical training pro grams across the country should minimize this problem for future biomedical investigators. Almost without exception, the educational factor was mentioned by each of my colleagues. I believe that long-range planning for adequate communications must center around government support to training programs and fellowships for both engineers and doctors. The inception of biomedical-engineering internships within the framework of present institutions might be helpful. Dr. Kusserow further adds— Differences in background knowledge and training between medical and nonmedical members of the biomedical community can best be resolved at the training stage. The on-the-job training techniques can hardly be envisioned as a definitive solution for succeeding generations of biomedical scientists. Dr. DeBakey has written me Our own experience with the artificial heart program in collaboration with the Rice University Engineering School has clearly demonstrated the great value of this type of multidisciplinary program and the need for a Bioengineering Institute. In this connection, the NIH established an agency for the development of Biomedical Engineering, and I would hope that this would be strongly supported. I do feel that the type of bioengineering institutes proposed by Dr. DeBakey can provide the type of professional training for bioengineers of the next generation. I would foresee one or more centers with the full array of medical and engineering specialties working side by side. Besides serving as a training center, such an institute would carry on a high level or interdisciplinary research. The Soviet Union's Institute for Development of Surgical Instruments is a limited type of such a center. Most investigators in the field would share Dr. Galletti's appraisalSince the Artificial Heart Program is sometimes compared to the space program. I may hazard the opinion that there is no large untapped reservoir of competence with respect to the bioengineering of artificial organs and that overly ambitious programs may shrivel unless an effort is made to prepare competent new investigators. My colleagues and I have varying opinions on the need for new Federal institutions. Dr. Galletti feels that It may sound trivial to state that medicine in the last third of this century will no longer be dominated by the practice of surgery and drug administration, but will consider an extensive use of extracorporeal or implantable organs. That existing federal agencies are not fully prepared for this evolution is demonstrated by the fact that presently responsibilities and leadership in the field of artificial organs are scattered among various divisions of the National Institutes of Health, the Federal Drug Administration, and the National Bureau of Standards. The dispersion of initiative and responsibility both in government and private agencies makes it difficult to express valid national goals and even research priorities and long term plans. My own feeling is that new Federal institutions are not only not needed, but might prove harmful. I share Dr. Kusserow's view— The field is very young and some time should be allowed for the evolvement, recognition, and definition of trends, aims and problems before any regulatory or controlling mechanism is established. The current federal supporting and funding structure seems to be a reasonable satisfactory mechanism for the time being. As I am sure is already being done, the decisionmaking and advisory bodies of the NIH should be broadened to include members of the engineering profession and the physical and chemical sciences in their leadership. The one Federal agency which I and others would like to see created is the National Academy of Medicine which, to quote Dr. = Wesolowski— Would be associated with the National Academy of Engineers and which could be used by Congress and other governmental bodies in exactly the same fashion as the National Research Council is presently being used. As to existing techniques for implementing plans, in biomedical #engineering, we are considering a field in transition. Until recently, the traditional role of electronics in medicine has been limited to instrumenation-recording and monitoring. Only in the past few years has this technology been turned to the treatment of disease and the alleviation of its ravages. Advances in miniaturization and reliability coupled with the development of new materials has made it possible to consider implanted, long-lasting devices such as a cardiac pacemaker for patients with heart block, a bladder stimulator for paraplegics with neurogenic bladder and pumps for patients in intractable left ventricular failure. We can only guess at the number of possible applications untapped because the physician is unaware of the technological development, because the engineer is unaware of the medical need, or, when both are recognized, the means for effecting the collaboration are lacking. As we plan for a future in which medicine and engineering are successfully cross-fertilized, we must not overlook some of the built-in difficulties. While certain pressures exist for the investigator in an academic institution-whether in medicine or engineering-there is identity between the goals of his research and the goals of his institution. For the engineer in industry interested in working on biomedical problems, unhappily this is not often true. There are, of course, a few industrial laboratories where he may be given a free hand, but more usually as soon as a problem makes important demands, understandable pressures are felt. Faced with the uncertainty of ultimately developing a marketable product, corporate management must be inhibited about investment of company resources. There are certainly numerous instances of successful collaboration between industry and medical investigators in recent years. Several types of cardiac pacemakers in widespread clinical use evolved from engineer-physician collaboration. But a pacemaker is a relatively simple development; the medical problems were frank and welldefined-and the electronics and materials solutions within the state of the art. Where more complex answers have been sought, it has proven difficult to develop stable, productive relationships. The extensive funding, the investment of time and personnel, problems of communication have militated against the large-scale joining of American industry in biomedical efforts. Subsidized and directed research and development such as the NIH artificial heart program holds promise of alleviating insecure and erratic liaisons between the specialties and bringing the great talents in American industry to bear in the development of mechanical methods of assistance to the failing heart. Dr. Lillehei feels that “these objectives can undoubtedly be achieved much sooner through participation of the Government, and specifically NIH, in support of the necessary research." This utiliaztion of our talent resources from |