Working in isolation or without constant refreshment of medically oriented direction, the engineer may expend time and effort and financial support with only naive concepts of the medical realities. It would be a grievous error to reduce the role of medical scientists from positions of guidance and control in any Government-sponsored distribution of funds in which the ultimate application affects human life. In summary, I feel that any work in support of a medical investigator must be under his leadership. Such assurance should form an integral part of the philosophy of the contract program. The National Institutes of Health system of reviewing proposals by a body of one's peers has proved to be effective and reasonable free from individual prejudice. I would not like to see any inhibition of this system, but feel rather, that it should be enhanced. I would also feel that, other than the creation of a National Academy of Medical Science, it would be unwise to hastily create any new agencies in the leadership of biomedical research. Mr. Senator, I have appended the letters from my colleagues to this statement, which I will not read at this time. Senator HARRIS. Dr. Kantrowitz, we will place in the record the letters to Dr. Kantrowitz' statement, without objection. (The letters referred to follow :) EXHIBIT 8 The accompanying letters are from the following: Michael E. De Bakey, M.D., Professor and Chairman, Cora and Webb Mading Department of Surgery, Baylor University College of Medicine, Houston, Texas. Pierre M. Galletti, M.D., Ph. D., Professor of Physiology, Emery University, Atlanta, Georgia. John H. Gibbon, Jr., M.D., Samuel D. Gross Professor of Surgery and Head of the Department, The Jefferson Medical College of Philadelphia, Philadelphia, Pennsylvania. Willem J. Kolff, M.D., Department of Artificial Organs, Cleveland Clinic, Cleveland, Ohio. Bert K. Kusserow, M.O. (Immediate Past President, American Society for Artificial Internal Organs), Associate Professor of Pathology, The University of Vermont, Burlington, Vermont. C. Walton Lillehie, M.D., Professor of Surgery, University of Minnesota, Minneapolis, Minnesota. Frank Spencer, M.D., Professor of Surgery and Director, Department of Surgery, New York University Medical Center, New York, New York. Sigmund A. Wesolowski, M.D. (President, American Society for Artificial Internal Organs), Mercy Hospital, Rockville Center, New York. ADRIAN KANTROWITZ, M.D., 4802 Tenth Avenue, Brooklyn, N.Y. BAYLOR UNIVERSITY COLLEGE OF MEDICINE, DEAR ADRIAN: As I indicated to you in our recent telephone conversation, I was delighted to learn that you are going to testify before the Senate Subcommittee on Government Research regarding the adequacy of federal institutions for biomedical development. I certainly agree with you that there is an urgent need to provide more intensive support in this field of endeavor. You will recall that the President's Commission on Heart Disease, Cancer and Stroke recommended (Recommendation No. 14) that "three Bioengineering Centers and three Rehabilitation Biomedical Engineering Research Centers be established over a five-year period in order to take advantage of the potential offered by bioengineering research in heart disease, cancer, and stroke." Our own experience with the artificial heart program in collaboration with the Rice University Enigneering School has clearly demonstrated the great value of this type of multidisciplinary program and the need for a Bioengineering Institute. In this connection, the National Institutes of Health established an agency for the development of Biomedical Engineering, and I would hope that this would be strongly supported. My best wishes. Sincerely, MICHAEL E. DE BAKEY, M.D. EMORY UNIVERSITY, Atlanta, Ga., February 27, 1967. Dr. ADRIAN KANTROWITZ, Maimonides Hospital of Brooklyn, DEAR ADRIAN: I consider it good news that you have been invited by the Senate Subcommittee on Government Research of the Committee on Government Operations to testify regarding the adequacy of federal institutions for biomedical developments. My comments will be restricted to the domain of biomedical engineering and more specifically to that of artificial organs, since in recent years federal agencies have played an increasingly important role in supporting development and clinical trials in this field. It may sound trivial to state that medicine in the last third of this country 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 Institute of Health, the Federal Drug Administration, the National Bureau of Standard, etc. The role of providing communication has so far been assumed largely by private organizations such as the American Society for Artificial Internal Organs, and various subgroups of professional societies in the field of surgery, medicine or engineering. The dispersion of initiative and responsibility both in government and in private agencies makes it difficult to express valid national goals and even research priorities and long term plans. Referring more specifically to the current practice of the Artificial Heart Program, I find the primary emphasis on the engineering aspects of the 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 towards this aspect of applied biophysics. On the engineering side, interest is present, but the complexity of the 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. I ask myself whether the federal government should not step in not only to set goals, but also to implement more fruitful cross-fertilization. Among the means which federal agencies could consider I suggest first the institution of training programs in the field of artificial organs, clearly designed to increase manpower on a nationwide basis and not only for the benefit of a particular institution or geographical area; second the creation of some formal or informal group of experts who could be assigned to collaborate with a particular contractor, when a promising lead is hampered by shortage of manpower; third the support of academic institutions broadly committed to the field of artificial organs in the best tradition of university-industry relationship. Since the artificial heart program is sometimes compared to the space program, I may in conclusion 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. Cordially yours, PIERRE M. GALLETTI, M.D., Ph.D., Dr. ADRIAN KANTROWITZ, THE JEFFERSON MEDICAL COLLEGE OF PHILADELPHIA, March 3, 1967. DEAR ADRIAN: I was very much interested in your letter of February 21, 1967. I am delighted that the Senate Subcommittee on Government Research of the Committee on Government operations has invited you to testify regarding the adequacy of federal institutions for biomedical development. I am afraid that I am too far removed from the current field of medical investigation aided by engineers from American industry to answer the questions you raised in your letter, with the exception of the final one. It is, of course, absurd to award a contract to industry for technological backup to a particular medical investigator and then to have the company directly responsible to the National Institutes of Health rather than to the collaborating investigator. In the many years that I worked with IBM engineers in developing several different types of heart-lung machines, I worked intimately, of course, with the engineers. They made suggestions to me concerning the type of physiologic research we should be carrying on, and we similarly made requests and suggestions to them concerning the apparatus that they were constructing for us. I cannot imagine any more satisfactory arrangement than this close collaboration. To introduce a third party into the picture to whom the industrial company is responsible, seems to me a great mistake. I am sorry that I cannot be more helpful to you, other than making the above comments. Sincerely yours, Dr. ADRIAN KANTROWITZ, JOHN H. GIBBON, Jr., M.D. CLEVELAND, CLINIC, Cleveland, Ohio, February 28, 1967. DEAR DR. KANTROWITZ: Thank you for your letter of February 21. I appreciate your request. Artificial organs is strange to many members of study sections and it strikes the members who are traditional researchers and doctors in a funny way. Their natural reaction is negativistic. When the word "development" is mentioned the committee believes it is gadgeteering. Communication could be more effectively obtained if special funds were made available for holders of grants and their collaborators to travel. I am concerned that according to NIH rules new methods are abandoned too early. For example, application of a new artificial kidney may no longer be considered as research but is confused with patient care. Actually the question of how to apply the new kidney to patient care is research of a high order. Regarding supervision of contracts to industry, I have found trustees of hospitals and universities unwilling to come near or even close to great financial responsibilities and I believe that the NIH should lend and supervise the contracts. The need to quickly dispense monies when they have become available late in the fiscal year gives rise to hurried preparation of contract proposals and hurried assignment. It would be far better if these monies could be transferred into the next fiscal year without being subtracted from that year's budget. Sincerely yours, W. J. KOLFF, M.D. THE UNIVERSITY OF VERMONT, ADRIAN KANTROWITZ, M.D., DEAR ADRIAN: The questions posed in your letter of recent date are very broad ones. I am somewhat hesitant to pose as an authoritative information resource on this problem since my administrative activities in this area, other than those concerned with the A.S.A.I.O., have not been especially extensive. Nevertheless, a few comments which may be helpful are enclosed. Questions One and Five may perhaps be handled jointly, since they deal with the question of increased federal participation in the biomedical area. Here, and at the present time, the federal government can effectively assist and further biomedical development by the continued and perhaps expanded support of biomedical training programs in educational institutions. Such serious and widespread problems as communication difficulty and differences in background knowledge and training between medical and nonmedical members of the biomedical community, can best be resolved at the training stage. While it is true that the current generation of biomedical researchers are overcoming these problems to a degree by means of on-the-job techniques, this can hardly be envisioned as a definitive solution for succeeding generations of biomedical scientists. With respect to question Five, I do not now see any particular advantage in the creation of a new federal institution to further development and application of biomedical knowledge. This may perhaps be something to consider at a later time. 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 reasonably satisfactory mechanism for the time being. I refer of course to the various grant agencies such as the N.I.H., etc. With respect to question Four, dealing with communications, it seems that a good beginning is being made by increased participation by engineers and others from the exact sciences in conferences and meetings of a biological or medical nature, and vice versa. Coupled with this is the current trend on the part of individuals of both groups to avail themselves of appropriate course work, lectures, etc. Again, a solid educational base in the form of sound academic biomedical training programs across the nation should minimize this problem for future biomedical investigators. Questions Two and Three are interesting ones to me in that it is not entirely clear precisely how research priorities are established at the federal level. For example, I do not yet 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 shown repeatedly the danger of permitting research to fall to the market place or the political arena. The above are certainly very random comments, but perhaps they may be of some help. Best of luck at the hearings. Sincerely, BERT K. KUSSEROW, M.D., Associate Professor of Pathology. UNIVERSITY OF MINNESOTA, Minneapolis, Minn., March 8, 1967. Dr. ADRIAN KANTROWITZ, 4802 Tenth Avenue, Brooklyn, N.Y. DEAR ADRIAN: I am very pleased to have the opportunity to support your testimony to the Subcommittee on Government Research of the Committee of Government operations in regard to the biomedical development with particular reference to cardiac assistance and/or replacement. The heart is nothing more than a pump, and there is no logical reason that successful methods cannot be developed to assist the failing heart for temporary periods. This in turn would ultimately lead to complete, permanent replacement of the heart and/or lungs in those cases in which the damage is irreversible. These objectives can undoubtedly be achieved much sooner through participation of the Government, and specifically NIH, in support of the necessary research. I believe that the greater level of participation of the Federal Government in support of these objectives can be augmented with a consequent increase in the rapidity of progress. I feel that the general guidelines that have been developed and followed over the past decades by the NIH are entirely adequate to deal with this program. In regard to the question of methods and means of increasing communication between interested physicians and engineers, there is no doubt that this needs improvement. 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. In the awarding of contracts and grants to specific individuals or groups, I do think that it is very important that one person be the designated responsible investigator. I doubt that any program can function satisfatcorily and efficiently if there is not some one person ultimately responsible for making decisions that might be associated with considerable differences of opinion. With very best regards, I remain C. WALTON LILLEHEI, M.D., Professor of Surgery. NEW YORK UNIVERSITY MEDICAL CENTER, SCHOOL OF MEDICINE, DEPARTMENT OF SURGERY, New York, NY., February 27, 1967. Dr. ADRIAN KANTROWITZ, Maimonides Hospital of Brooklyn, DEAR ADRIAN: As we agreed on the telephone today, Monday, February 27, I am writing to specify my thoughts about facilitating biomedical research. My main conviction in this regard is that existing facilities are too restrictive to readily initiate such research. It is easy enough to obtain the funding when one has data and a specific project to support this, but the exploratory stages with an early marriage of industry and medicine is very difficult to initiate without some unrestricted monies to start. Usually, this requires a lot of ingenuity and and energy on the part of the investigator to get such a study launched before enough data are available to obtain support from the National Institutes of Health under existing regulations. Such monies could be allocated much as current institutional grants are awarded for the support of cancer or cardiovascular teaching. They could simply be specified biomedical institutional grant, and then leave the disposition of such monies to the individual institution. I mention the specific experience of Joe Ransohoff of the Department of Neurosurgery here, whose energy and efforts has resulted in the development of a particularly useful pump for hydrocephalic children. This is magnetically powered, and represents a beautiful blending of talents from engineering and medicine. It was striking, however, in the initiation of this project that the obtaining of financial support required a lot of help from local agencies who more or less supported the project on a basis of faith, rather than any precise scientific evaluation, and after the initial results were encouraging, funding in the amount of about $100,000 per year was readily obtained from NIH, but not before the initial studies had been done over a period of about two years. I hope this information is of help. Sincerely, FRANK C. SPENCER, M.D., Professor of Surgery and Director, New York University Department of Surgery. MERCY HOSPITAL, Rockville Centre, N.Y., March 3, 1967. ADRIAN KANTROWITZ, M.D., Chairman of Surgery, Maimonides Hospital, Brooklyn, N.Y. DEAR ADRIAN: Concerning your letter of February 21, 1967 dealing with the testimony that you will give to the Senate Subcommittee on Government Research of the Committee on Government Operations I'll take a crack at the 5 questions that they will ask: 1. Is there need for additional attention by federal agencies in the field of biomedical development? |