In conclusion, I would like to say that I think it is inevitable that the government will be getting involved to an increasing degree in large-scale developments in the biomedical field. The government should be prepared to sponsor and handle such developments. The government should now assess carefully the proper and useful role university and hospital research laboratories, new or existing not-forprofit organizations, and industry can play in these developments. However, it is extremely important that we not make premature commitments in this area. We must be careful to avoid being seduced by the glamor of special projects, crash programs, and the lure of new devices. Premature starts on large developments are wasteful of dollars and talent and are demoralizing to everyone. It would be tragic indeed if these new medical programs are started by diverting funds and interest from the very productive and useful ongoing medical research programs.

Senator HARRIS. Very good comments. Would the projects approach, where the medical management role would be played, be only in the interdisciplinary field of engineering and medicine?

Dr. RUINA. Yes, those are the kinds of the projects I was talking about-projects that would involve not only the skills of physicians, and biomedical scientists, but also the knowledge and skills of the physical scientists and engineers. Take, for example, the area of computer-aided diagnoses to which Dr. Ebert referred. It would involve people who know about computers, computer programing, as well as hardware and physicians. I am referring only to those areas. Senator HARRIS. What about the problem that is faced by the NASA people when they commence to put together management teams? Are they the same sorts of problems you would envisage here?

Dr. RUINA. Yes.

Senator HARRIS. Do they have the same problem about the low status of the manager in the scientific situation?

Dr. RUINA. No. There are two differences. First NASA deals with much larger projects than we are talking about here.

Second, the engineering community, by and large, has had a long tradition and history of involvement with management. The picture an engineering student has of a successful engineer is one who is responsible for a large project. The chief engineer or the project engineer must be involved with costs, schedules, and personnel. He is rarely a loner. Research and analysis in engineering where people work alone or in small groups is relatively new; a postwar develop

ment.

Engineers are generally oriented toward large projects: so NASA has dealt with a community that is used to this. In medicine we are dealing with a community that isn't.

I imagine that to this day, and Dr. Ebert would be in a much better position to comment, a typical medical student sees himself spending most of his time at a bedside with a patient. He may relate professionally with a few fellow physicians but on a day-to-day basis he would not be part of a closely knit professional team working together for a common goal, with schedules and costs very much part of the picture.

Senator HARRIS. I think you are quite right in saying that, inevitably, the Government will come to this kind of approach. I also think

you are quite wise in saying that we should plan. It is an interesting thing that one of the failures of the Congress is the failure to recognize the necessity for planning in fields where the professionals have long since recognized that planning is needed.

Dr. RUINA. Yes.

Senator HARRIS. We wouldn't possibly have authorized several billion dollars to build a supersonic transport, unless planning and research money had been appropriated for some years. The same is true about the antiballistic missile system.

Dr. RUINA. Yes.

Senator HARRIS. If we ever move into the supersonic transport in a massive way, it will only be after we have, as we are now doing, made smaller appropriations in advance to plan for it.

It seems to me that we haven't been quite so willing to provide planning funds to move into some other programs. Take, for example, one that seems removed from what we are talking about, something like the war on poverty.

Dr. RUINA. Yes.

Senator HARRIS. The pressures were such that we moved into that in a rather large way, without first having a year or two of planning funds. There was planning done, of course, within the administration. But if general goals had been set by Congress and money provided on that basis it might have been that we would have avoided some of the difficulties we are experiencing in this year's appropriations hearings for that program. So I think you are quite wise in suggesting that if we move into this, and I think it is inevitable that we will, that we go about it in an orderly way after planning it.

The budget this year, as I said a while ago, provides for something in excess of $300,000 to look into the field of engineering in medicine. Dr. RUINA. Yes.

Senator HARRIS. Do you have any general comment on that?

Dr. RUINA. Yes. First of all, I consider the $300,000 hardly adequate, if it includes exploratory work, laboratory work, and so forth. I presume you meant by the term "planning" that would also involve laboratory and exploratory work.

Senator HARRIS. I think we need to make some inventory of goals that are realizable within the foreseeable future.

Dr. RUINA. Yes.

Senator HARRIS. Perhaps that would involve some laboratory work as well.

Dr. RUINA. The other comment I would like to make in this regard is to point out that I differ a little with Dr. Walker, when he indicated that more bioengineering departments or the equivalent would be very fruitful.

It may be, but I think real incentives are needed. Creation of departments, institutions, and small projects is hardly enough. A clear goal must be set.

If a national decision were made to developing a device, an artificial heart, for example, although this may be a very bad example. We would have to assemble the proper group in the proper environment and I am not sure I know what that environment is—I think the research laboratory is probably not the right environment nor is an industrial laboratory. The group would have a clear goal of work

ing 1 or 2 years and I think it will take substantially more than $300,000 to support them, to see what alternatives are possible, what engineering designs make sense, and to see what risks there are in each of the designs. They can present to the decisionmakers alternatives, risks, costs, and so on.

Here you would have a group working toward a clear goal and purpose. There would be a clear purpose. This differs from a group forming a bioengineering department for the purpose of allowing communication between disciplines. They may have nothing to communicate about. There must be a common purpose and a clear goal, and only then can you get effective communication between disciplines; just collecting people together in a department would hardly do it, in my opinion.

Senator HARRIS. You have to have something mutually worthwhile. Dr. RUINA. That is right. The eyes of the community are on them. They may be out to produce a product, which is the alternative solutions of how one might proceed on a certain problem. That would be the equivalent, I think, of your planning money. At the end, one can make a decision, it is worth the risk or isn't worth the risk. Of course, many times the Government has made choices which in lookback were bad ones. We have gone ahead and produced hardware which did not turn out to be terribly useful. In other cases, it was. Senator HARRIS. Yes. I would think that it would be very good though perhaps not possible that we would be just as willing to forgive mistakes in the life science fields

Dr. RUINA. Yes.

Senator HARRIS (continuing). As we have, say in the defense fields?

Dr. RUINA. Yes. The money involved is obviously much, much greater in the defense fields. We have talked about the planning money in ballistic missile defense. That is an area in which I have been very deeply involved. The so-called planning money you refer to is over $1 billion.

Senator HARRIS. A very, very good point. Some have said that it is really not quite so feasible to have goals set and plans made and teams put together in the life science field, because there aren't the basic kinds of principles running through the biological fields as there are in the physical fields. For example, Mr. Einstein wrote to President Roosevelt about the possibilities of nuclear fission. The basic theory was there, which led to the success of the Manhattan project. The challenge was to get people together who could apply the basic theories to the practical problems of building an atomic bomb. But, some say there is really not such an applicable situation in the life science field.

Dr. RUINA. I think one has to be a little more specific, whether it be a specific area, or a specific device-the atomic bomb, although very expensive and important, was only one device.

One didn't talk about the physical science field there. The community of physical scientists had deliberated about this device and had done some exploratory work before Mr. Einstein went to the President.

They then decided, and there was almost universal agreement within the community-that they could develop an atom bomb. There were,

of course, engineering problems to be solved, important parameters to be measured, but they estimated the likelihood of success to be high enough and the payoff great enough to get this kind of support. Now it may well be that in the biomedical field that we are ready to do this kind of thing, too. It would be a little more difficult to assess. There is a severe shortage of competent physicians and engineers, so that in staffing a new area of activity another is deprived of, both talent and money and the judgment must be made whether the payoff warrants the cost.

Senator HARRIS. What do you think about the suggestion that has been made here, I believe by both Dr. Glaser and by Mr. Mike Gorman, in slightly different ways, that the various Institutes of NIH, and perhaps others of the Federal Government involved in the life sciences might establish 5-year goals, and also an annual statement of needs, which might run from very generally stated goals and needs to very basic kinds of information that is needed.

Do you think that there is any merit in that kind of suggestion?

Dr. RUINA. I think they are probably referring to what might be called basic and clinical research areas. I think the merit of making planning documents is that the people involved are forced to think about the status of the field and to bring out into the open what the issues are. I don't see how it would help us in the matter that I have been talking about-bioengineering.

Senator HARRIS. Mr. Gorman serves on an advisory committee for the National Institute of Mental Health.

Dr. RUINA. Yes.

Senator HARRIS. He said that he found himself spending a tremendous amount of time reviewing individual applications.

Dr. RUINA. Yes.

Senator HARRIS. His decisions were made on individual research grants, without any relation to real overall policy considerations. You just look at a particular application, what this man wanted to do, what his ideas were, what his qualifications were, and you make an individual decision. It didn't necessarily fit into the overall planning goal. He had tried to move the National Institute of Mental Health toward more overall planning and a statement of goals, by which these applications might be judged-if I paraphrase him correctly. That was a new endeavor for them, and it was being taken up somewhat by other national institutes. Does that approach have any particular merit?

Dr. RUINA. Well, I think that most of the activities of Institutes of the National Institutes of Health and most of the work they sponsor are in undirected research. Ideas come from the research scientist and these may or may not fit into any national pattern. They usually fit into a very local pattern of his own mind. This type of research is extremely important.

You can't plan on the results. You can't have every project occupy a well-defined space in a large puzzle, and say to individual researchers you do this and you do that, with the hope that results will all fit together and we will have magnificent new patterns of knowledge.

The whole spirit of undirected research requires that it go just the way I think it is going. What Mr. Gorman had in mind, is more approached for directed research, where you have specific goals and

where you can judge whether, the state of the art is such that you can. achieve these goals. But you can't program invention and discovery. You can program development, and I think there may be some confusion of those two points. The mental health field is probably a bad one to talk about for this purpose.

But let's consider the area of artificial hearts. There are people who are interested in aspects of blood chemistry, and, if they are good, and they have a history of success in research, sponsoring this research is fine. But then, research may or may not be useful to the development of an artificial heart.

For a successful development you have to make sure that everything is covered. You can't start the program and find that you left out of considerations some of the relevant fluid mechanics, or some of the key problems blood clotting. You have got to have everything covered. There has to be a total plan and it has to be managed. This is just the kind of thing I am talking about. This is the kind of managed effort that is required for large-scale developments.

Senator HARRIS. I think that Mr. Gorman and Dr. Glaser were not suggesting that you cut out the unsolicited applications for research money, or make them all fit into any plan. I think they were thinking about the good results that might flow from some statement of goals and needs.

There are two potential benefits. The first is an ongoing assessment of a 5-year plan on a yearly basis of the state of knowledge in a given field and what basic and more general things are needed to be known. The second is the effect that such a public statement of a 5-year plan on an annual basis might have toward exciting the interest of investigators around the country who might not otherwise make applications on those particular questions. Do you think that has any merits?

Dr. RUINA. I don't know the medical community very well but in the physical sciences, nationally stated goals in research areas would probably have very little effect on the research scientist in the laboratory. He is not concerned with what the national goals are. He doesn't read statements about where national goals should be in research, with respect to what he does in the laboratory. He is stimulated by the fellow in the next office, or by his colleague, the person who made a statement at a meeting or presented a paper which he disagrees with. Those are his sources of stimulation, and I can't imagine setting up in the fields of chemistry or physics any national goals for research, or preparing planning documents or schedules that would have much effect on the individual researcher in the laboratory.

Senator HARRIS. Lastly, what about your suggestion on the inevitability of the project approach and the planning necessary for it, and the difficulty that present structures in the Government, NIH particularly, have with that. Would that require some new agency outside of NIH or within NIH, or do you have any suggestion about that?

Dr. RUINA. I think it would have to be looked at very carefully. But a year ago when we did, and I think I can speak for the rest of the panel, we thought separating this activity from the undirected research areas and from the intramural areas would be very helpful. One shouldn't dilute the efforts involved there with this engineering effort which is of a different style and a different character.