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Despite all this which, in my opinion, can hardly be regarded as a program of incentives, the American pharmaceutical industry leads the world and continues to grow and improve.

I am not here to plead the plight of the drug companies and I agree with the need for safety regulations and consumer protection. But the nature of the role that the Federal Government has played in this area of biomedical development and application should be included, I believe, in the considerations of the subcommittee. The fact that we are now contemplating Federal legislation to assure the safety and efficacy of medical devices and instruments, needed for protection of profession and public alike, is also an important part of the context for the subcommittee's deliberations.

This completes my discussion of the road conditions between Labtown and Bedside.

Let me now turn to those activities of the Office of Science and Technology that relate to providing travelers for this highway and to speeding the transit time along it. This brief description will also respond to the questions that the subcommittee has raised as a framework for its inquiry.

The areas that I will mention are patent policy, scientific and engineering personnel in the Government, the general field of health manpower, and decisionmaking concerning programs of directed research and development in the health field.

The Office of Science and Technology has been directly involved in the development of Government-wide policy on the allocation of rights. to inventions made in the course of federally financed research. A patent policy was adopted by President Kennedy in 1963 and has been reaffirmed by President Johnson.

Current policy permits exclusive rights to inventions stemming from biomedical research to remain in the universities or, in exceptional circumstances, in the hands of contractors where the exclusivity will promote the utilization of the inventions under conditions protecting the public interest.

OST has recently taken the initiative in cooperating with HEW to further explore whether, to what extent, and under what circumstances exclusivity and patent incentives are desirable to promote innovation and application of biomedical discoveries.

The standing committee of the Federal Council of Science and Technology has been studying ways and means of making the Federal Establishment an attractive and satisfying place of employment for highly competent scientists and engineers. Under the title, "The Competition for Quality," they published, in 1962, an assessment of the nonsalary factors affecting the selection, recruitment, development, and retention of superior personnel in the scientific service of the Government. In 1966, this assessment was updated and appeared as "The Environment for Quality." Additionally, in cooperation with HEW and NIH, OST has been participating in an informal examination of both the environmental and salary problems of obtaining and retaining competent biomedical scientists and administrators.

In May 1966, the President appointed a National Advisory Commission on Health Manpower. OST has helped to staff and support this effort although the Commission is an independent body which will report its findings and recommendations directly and not through OST.

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The study of the National Institutes of Health entitled "Biomedical Science and Its Administration" was carried out by a panel of the Office of Science and Technology, completed in 1965. This so-called Wooldridge report pointed out the desirability of certain moves in the direction of preparing for directed research and development above and beyond the traditional and highly effective project grant program used for basic research. The import and impact of this report may be the subject of additional testimony before the subcommittee.

Finally, at the suggestion of OST and with the cooperation of the Bureau of the Budget, there was created last year a special advisory group, composed of biomedical scientists as well as individuals from other technical and nontechnical fields to examine the broad problem of the treatment of chronic uremia, failure of kidney function. Central to this issue is the use of the artificial kidney. This group has been asked to report on technical feasibility, cost, the needs in the near and short term, and the implications in terms of economic benefits, allocation of health manpower, tradeoffs, and alternatives. The results of this trial exercise may be valuable in helping to guide decisions about the nature of a Federal program in this area and serve as a model for future studies. For the biomedical participants, at least, the experience should be an enlightening one in acquainting them with the many and varied factors that must be considered, weighed, and harmonized before embarking upon a major program of targeted research and development.

The Federal Government and the American people are committed to providing good health care to all and our present health system is strained to the breaking point.

The need for innovation is clear. I hope that these hearings will point the way to the new and imaginative approaches that the future demands and our citizens deserve.

We must take a new look and avoid the shortcomings pointed up by Hasan Ozbekhan when he said, "Today, the future tends always to be viewed, hence, methodologically approached, as if it were the mere extension of the present. Thus we wander in static time."

Senator HARRIS. Thank you, Dr. Bennett. Your allegorical story about Labtown and Pharmville and Bedside was not only enjoyable but constructive. We appreciate your complete statement here.

I would agree with you, as I said earlier, when you say, "The development process encounters many obstacles but an excess of basic research has not been shown to be one of them." I agree with that.

You also say: "Our real problem is to expand our strength by the creation of an establishment for research, development, and application that can function coherently and effectively," the word being "establishment." I wonder if you might elaborate on that.

Dr. BENNETT. I chose the word "establishment" there purposely because it was not my intent to imply that it should be a Federal establishment as opposed to an industrial establishment, or as opposed to an establishment that might have some of its roots in universities. I made the comment simply to point out that we really have built the foundation, and we don't want to destroy that foundation in attempting to create the additional structure.

I think that there are clearly some areas in which the strength of our industrial laboratories can make a contribution. It is possible that additional incentives might help in this area.

I certainly think the subcommittee will hear some testimony later in the course of these hearings that will point up some possibilities of adding onto the Federal structure itself.

Senator HARRIS. You said: "The mechanisms by which needs can be identified" and I wanted to ask you about the word "mechanisms." Are you still speaking in general terms about the diverse ways that might be done or are you thinking of a particular way?

We started in our conference in Oklahoma City, to make an inventory of needs in the biomedical fiield, and we want to do more of that in these hearings. But I was wondering if you might elaborate on the word "mechanisms by which needs can be identified."

Dr. BENNETT. I think one of the ways in which they could be identified would be to hear more individuals like Dr. Lederberg, who has certainly outlined a very pressing need, when he spoke about the need for additional information about populations on a long-term basis, and it seems to me that he has also outlined very well the contraints that one runs up against when one suggests the establishment of such a system.

I think it is illustrative of the fact that this particular need will have to be further evaluated in terms of the existing system that we intend to add it to, and it turns out to be not really a scientific or technological matter, because it is quite clear that given the funds and the direction, this could be established. It becomes a matter of legal definition of privacy, and a number of other things that have already been enumerated. So that I would say that I think it would be relatively easy, and indeed, through the National Institutes of Health, for example, there are certain needs that have been identified and they do carry out a regular review of the possibilities.

What I would like to emphasize is that one has to look at the system to identify the needs rather than at the knowledge pool to try to decide what we can do with this now that we have it. I think that that is the point of view that we have to adopt.

Senator HARRIS. Yes, and a very good one. I compliment you also for your comments about the need for increasing interest in biomedical engineering. You made some particular comments on that point in your statement.

I suppose the word we heard more than any other in our conference, "Research in the Service of Man", was "interdisciplinary." It seems to me that may be one of the most important words and concepts of our age. In almost any field of science you begin with an idea and you almost unavoidably get into a whole universe, and I think that is particularly true in the application, development and use of biomedical knowledge.

We have emphasized the social and behavioral sciences, for example. We know very well that political science is basically involved in the "how" of getting these things out in to the thinking of people. And then, too, on biomedical engineering, some of the people who testified, for example, on the artifical heart and the artifical kidney, talked about the difficulties that they encountered in finding medical people who know something about engineering and engineering people who know something about medicine. Sometimes there is a problem of finding people like that who want to know about the other. There is some talk about the engineer in the situation who feels inferior to some degree.

Perhaps that has been a deterrent to the kind of interdisciplinary work that you talk about.

You mentioned that "It is in the biomedical field that such institutions are largely lacking at present." Are you talking about institutions that are the means for accomplishing innovation and the application of knowledge?

You then mention some ideas, for example, the establishment of Federal research laboratories. Would you care to particularize on that? Some have said we might well, redeploy the mission of certain existing Federal laboratories into the biomedical field.

Dr. BENNETT. I would say that I would consider this a possibility, but there is a tendency it seems to me these days, whenever one is faced with a large, what I would call social and economic problem, that has the scientific and technological base, one of the routine suggestions that is made is "Perhaps we can turn some of our Federal laboratories to this purpose."

I have in mind the recent suggestion that was made that we should use some of the laboratories of the Atomic Energy Commission to do applied research on the pollution problem. I would simply say I would not rule out that possibility; but one must look carefully at the details of what would be involved. If you took national laboratories that had been created for quite a different purpose, and attempted to transform these into establishments that were dedicated to the translation of the results of biomedical research into application, you might well decide, after having tried this, that we would be better off if we had started a new establishment dedicated to this problem from the beginning. Because one again runs into the problem of the fact that, in general, people like to do what they have been doing before, and what they feel they can do best.

I would certainly think that it is worth contemplating, that is, the possibility of providing incentives that might stimulate the far more flexible talents of the industrial research laboratories in this country. But here again, I would think that prior to a consideration of providing such incentives, it would be extremely important to obtain the best possible advice from individuals who are directly involved in endeavors of that type.

Senator HARRIS. You have touched on an idea that you mentioned in your paper, as well. As I indicated earlier, the role of the private sector in the broad spectrum of public interest is a concern of this subcommittee, and I think we are going to be hearing a lot about that in this session of the Congress and for many sessions to come. We are realizing more and more that the Federal Government, or the Federal Government in connection with State and local governments, cannot alone attack all the problems of modern life, as, for example, of housing and of urbanization. What do we do about those people who live in depressed areas insofar as enhancing economic opportunities?

In another broad field, how can we stimulate the private sector to take a larger, more active role in the application, development and use of knowledge. I think this will become one of the major focuses of the subcommittee as we proceed.

Senator Hansen?

Senator HANSEN. I don't think I have any questions, Doctor. I am certainly most impressed with your testimony. I think you have focused

attention on a number of areas of interest that are deserving of far closer scrutiny and examination than they have had so far.

Senator HARRIS. Thank you very much, Doctor.

Our next witness is Dr. Walsh McDermott. Dr. McDermott is chairman of the Department of Public Health, Cornell University Medical College, New York City. He holds an M.D. degree which he received in 1934.

He was an instructor of medicine, assistant professor and associate professor at Livingston Farrand, professor at Cornell University, and recipient of the Lasker Award and the Trudeau Medal. I will place in the record without objection a brief biographical sketch concerning Dr. McDermott.

Biographical Sketch: Walsh McDermott, M.D.

Chairman, Department of Public Health, Cornell University Medical College, New York, N.Y.

M.D. 1934-College of Physicians and Surgeons, Columbia University Background data: Instructor, Assistant Professor, Associate Professor of Medicine; Livingston Farrand, Professor of Public Health, Cornell University Medical College

Recipient of Lasker Award and Trudeau Medal. Member of National Academy of Sciences and many other associations.

Dr. McDermott, we are very pleased that you are here. We will be pleased to hear your statement at this time.

TESTIMONY OF WALSH MCDERMOTT, M.D., CHAIRMAN, DEPARTMENT OF PUBLIC HEALTH, CORNELL UNIVERSITY MEDICAL COLLEGE, NEW YORK CITY, N.Y.

Dr. MCDERMOTT. Senator Harris, members of the committee, in your letter of invitation to testify on the adequacy of Federal institutions for biomedical development, you listed five questions the subcommittee has posed for specific consideration. In presenting my ideas on these questions, I find it easier to proceed in a different sequence than they were listed, but plan to give an answer to each one in summary form at the end.

I shall start with the assumption that there are problems of major importance to society whose management is greatly facilitated when it can be based on a body of knowledge and techniques derived from biomedical research. From this arises the question as to the capability of our present biomedical institutions (1) to identify these social problems in terms of the role of biomedicine; (2) to insure proper attention to them in terms of research and development; and (3) to insure that once available, any research results that can be applied are in fact widely applied, for man's benefit.

In approaching these questions it is appropriate at the outset to examine the delivery systems we have developed for the application of biomedical science and technology. If we consider the total sum

1 Most of the material presented in this statement has been presented in greater detail in the following articles: (1) "Modern Medicine and the Demographic-Disease Pattern of Overly Traditional Societies: A Technologie Misfit." Part 2, The Journal of Medical Education, September 1966. vol. 41, pp. 137-162. (2) "Medical Institutions and Modification of Disease Patterns." The American Journal of Psychiatry, June 1966, vol. 122. pp. 1398-1406. (3) "Summary Remarks, Dedication of the Institute for Biomedical Research." Journal of the American Medical Association, December 27, 1965, vol. 194, pp. 1374-1375. (4) "The Role of Biomedical Research in International Development." The Journal of Medical Education, July 1964, vol. 39, pp. 655-669. (5) "Science for the Individual-The University Medical Center." Journal of Chronic Diseases, 1963, vol. 16, pp. 105-110.

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