Scientists working on such developments nearly always report on their projects as soon as they are convinced of the merit or usefulness of the device or system. The important point that I would like to emphasize is that the policy of the AEC Laboratories is one of open scientific interchange and discussion. Thus, long before a system or device has been perfected by its Laboratory of origin, others have picked up the basic ideas and are developing them according to their own viewpoints, knowledge, and subjective application.

I would now like to say a few words about what further steps might be taken to strengthen the Nation's potential for additional biomedical development without sacrificing or diminishing basic research. Some constructive steps that might be taken without interfering radically with the status quo include:

(1) It should be possible with the resources of this country to place greater emphasis on selective funding of promising practical or developmental applications but without any curtailment of the very important basic research program.

(2) It should be possible to provide equipment to scientists and technicians already trained in its use to encourage further development and applications. This would seem to be an appropriate part of our Nation's goal of making available to everyone the very best of medical care. In many instances, physicians and technicians and others trained in our Laboratories in the use of sophisticated techniques and equipment lose this benefit on return to their home institution or hospital because such equipment is not available. This is a waste of talent and training and one which needs to be rectified, I believe.

(3) Continuing many of the advances we have already made by stimulating professional interest in developmental activities. An approach to this would be to encourage applied scientists and engineers in universities, foundations and other laboratories to engage in a form of "biomedical engineering" such as exists, for example, in several of the AEC National Laboratories.

(4) In a similar context, it has been suggested that the Nation's medical schools consider a curriculum involving a "biomedical engineering" approach. Presumably, some funding by the Government might be neecssary to inaugurate such a change.

(5) It is probable that a substantial increase in developmental efforts could be achieved only by an increase in applicationoriented scientific and technical manpower. One way to alleviate this manpower shortage might be through an educational program, federally sponsored, commencing at the high school level. In conclusion, I wish to reemphasize that I see a healthy balance to exist now between basic and developmental research. But I also believe that the developmental side could be accelerated and improved through more direct attention. The most serious impedance to expanding any effort in this direction lies in the lack of support for expansion. My discussion has emphasized that developmental applications can be greatly enhanced and speeded up by an increase in support, independent of and in addition to that for basic research.

Senator HARRIS. I want to thank you very much, Dr. Nabrit, for your statement and for the more detailed answers to the questions we posed, which are certainly very responsive. Without objection we will place

83-470 0-67-14

in the record at this point the questions and answers which have also been filed with us by Dr. Nabrit.

(The questions and answers referred to follows:)

EXHIBIT 6

STATEMENT OF QUESTIONS AND ANSWERS FOR THE HEARINGS IN THE AREA OF BIOMEDICAL DEVELOPMENT

Question 1.-Is there a need for additional attention by Federal agencies in the field of biomedical development and application?

We believe that there is a need for additional attention by Federal agencies in the field of biomedical development and application. Specific examples of the areas that need this further attention can be given. Some of them are uniquely offshoots of the Atomic Energy Commission's biomedical program that has been developed under the authority of the Atomic Energy Act of 1954, as amended; other areas are common to a number of Federal agencies and are receiving our attention. Nevertheless, all, whether unique to AEC or more generally applicable to several Government agencies, need still more attention in terms of financial and scientific and technical manpower resources.

With regard to biomedical development and application in the Atomic Energy Program, which has evolved because of its statutory responsibilities, program purpose and incentive, professional interest, scientific competence and necessary laboratory facilities, one example stands out that would not have been accomplished had not the money and manpower existed to evaluate the potential of a given approach to a biomedical problem. Some years ago, AEC support was given to the development of teletherapy units. The first proposal for using cobalt 60 in a teletherapy unit came from the Oak Ridge Institute of Nuclear Studies' Medical Division in 1948. Today, thanks to the pioneering efforts and drive of the persons who had faith in the potential of such units for treating cancer patients, there are now over 800 teletherapy units in use in hospitals or medical centers in the United States.

AEC has funded development of other special purpose equipment that would be useful in clinical facilties. Small accelerators for the production of shortlived radioisotopes which are useful in many diagnostic applications are one example. At present, the cost of such equipment must compete with many other equipment needs. Other types of biomedical apparatus such as computers specifically designed for diagnostic applications and linear accelerators for patient treatment all should receive attention in terms of where they are needed and could be put to the best use for the benefit of the greatest number of patients. Therefore, it would be beneficial if a way could be found to support the purchase of a carefully considered number of these special purpose biomedical devices.

Turning to a problem common to several Federal agencies, there are probably numbers of more or less basic items of information already discovered or in the process of being identified, which might be put to work if more effort were to be put into bridging the gap between the findings or results of research and the immediate and most obvious applications. The inquisitive and inventive minds of our time are already at work on this frontier and many breakthroughs can be given as examples of their contributions. (See attachment No. 1) Nevertheless, those things that have been accomplished simply serve as a stimulus to attain more and better things to improve health care in our society. Additional attention should be given to the support of certain groups in one or morc agencies which would be specifically charged with identifying workable basic data and showing how that information could be translated into specific utilitarian objects or ideas. These groups might be idea-think-analyst-engineer groups without direct operative responsibility but they would have a hand in shaping the product itself— an extremely forceful stimulus. Already some agencies have set a foot on this pathway to translating basic research to applied technology. Private industry has shown increasing interest in participating in these developments on a commercial scale. Several agencies now have programs to make readily available to industry findings which may have potential for application. Methods should be explored that would result in quicker sifting, evaluating, accepting or rejecting ideas.

It should be also emphasized that much attention to biomedical development is already being given by Federal agencies. Clearly and rightly, in accordance with

their statutory responsibility, primary advances are emerging from the National Institutes of Health. In addition, the area of aerospace medicine also benefits from research activities of the National Aeronautics and Space Administration and the Air Force. Within the Atomic Energy Commission, the Division of Biology and Medicine makes unique contributions to biomedical developments through the Argonne Cancer Research Hospital, the Oak Ridge Institute of Nuclear Studies' Medical Division, the Brookhaven National Laboratory Medical Department, the University of California's Radiation Laboratory at Berkeley and through other contracts at medical schools and hospitals. At these very locations, benefits from earlier breakthroughs are accruing which enhance their own usefulness in accomplishing goals. These "spin-offs" from developmental programs now in use include laminar airflow clean rooms for protecting patients from infection, whole-body counters and radionuclide generators. Certainly advances could still be made in the fields of better radiopharmaceuticals for diagnosis, more research on instrumentation, blood cell separators and techniques for grafting bone marrow. There are far too few chemists who now deovte enough time to work on clinical pharmaceuticals labeled with radioisotopes.

While it is true that accretion of knowledge occurs at a measured rate and one cannot "do more" until one "learns more", it is possible still to be able to say at any given time what one would "want to do" if possible. This can be brought out by the inquiring mind asking the pertinent question. In this context Dr. Glenn T. Seaborg noted in the foreword to AEC's report, Fundamental Nuclear Energy Research, 1966: "What is pure science one day may be applied the next. Neither the pure nor the applied would be possible without the other, for from the efforts of those interested only in advancing knowledge come the ideas and devices which create new technologies; and without the stimulus and products of technology pure science would certainly not prosper."

A few notable examples of practical Atomic Energy Commission biomedical developments would include the following:

1. Zonal Ultracentrifuge

A cooperative effort by specialists in the biological and physical sciences at the AEC's Oak Ridge, Tennessee, facilities has led to the development of a highspeed zonal ultracentrifuge which can be used for the large-scale isolation and purification of viruses. The machine was developed as a result of technology attained during work on centrifuge methods to separate uranium isotopes. The practical result of this development is a continuing cooperative research study by the AEC's Oak Ridge National Laboratory and the National Cancer Institute, along with the National Institute of Allergy and Infectious Diseases, for applications ranging from studies of leukemia to attacks on the common cold.

2. Laminar Airflow Clean Room

Originally developed at the AEC's Sandia Laboratory as a part of a program to provide the cleanest possible conditions for assembly of nuclear weapon components and systems, the laminar airflow clean room has revolutionized the design of industrial clean rooms throughout the country and shows considerable promise as a means of controlling the dispersion of bacteria. A recent study indicates that the development may be widely useful in controlling bacteria in surgery rooms, autopsy rooms, rooms for vaccine preparation and rooms for raising germ-free animals for research. It also promises to be helpful in treating patients with allergies and second and third degree burns.

3. Electronic Cell Separation

A device has been developed at the Los Alamos Scientific Laboratory that is capable of physically separating biological cells according to their volume. Experiments using animal cells have shown that after separation virtually all the cells are viable and will continue to grow at their normal rate. The device also has potential for use in diagnosing pathologic conditions.

4. Biomedical Pattern Recognition

Work is in progress to investigate the use of automatic data processing techniques and pattern recognition devices for the analysis of biomedical data at a variety of installations (Lawrence Radiation Laboratory-Livermore, Oak Ridge National Laboratory, Argonne National Laboratory and Tufts Medical School). Building on technology developed for the analysis of bubble chamber photographs for high energy physics research, investigators at these installations are developing rapid automatic methods for analyzing the structure of human

chromosomes and the dynamics of bone growth and metabolism. It should be stated that the detailed analysis of human chromosomes has led to clues to the genetic nature of certain, well-known familial diseases.

5. Teletherapy Units

The Oak Ridge Institute of Nuclear Studies played a major role in developing the use of cobalt 60 and cesium 137 in teletherapy devices as a substitute or supplement to high voltage X-ray machines. Over 800 teletherapy units are now in use in the United States for treatment of patients and their use is now taken for granted in many parts of the world.

6. Scintillation Camera

First developed by H. Anger at the University of California Lawrence Radiation Laboratory at Berkeley, this device has proved to be a valuable instrument for medical diagnosis. The major advance achieved in the stationary scan systems is the capability of viewing entire organs, such as brain, liver and kidneys, at one time. Significant scan records can be obtained in extremely short time intervals, less than a second per scan, by the use of short-lived radioisotopes. This makes it possible to investigate dynamic function of organs.

7. Extracorporeal Irradiation of the Blood

Radiation is being used to stem for a time the body's production of antibodies which lie at the heart of achieving successful grafts of tissues and organs. Through the techniques developed, radiation causes enough depression in the body's immune reaction to give the transplanted elements time to gain a hold. This technique, which was developed at Brookhaven National Laboratory, is also being evaluated for the treatment of certain blood disorders.

8. Nuclear Powered Pacemaker and Heart Pump

A radioisotope-powered pacemaker is being developed for the heart; not a mechanical heart but a device for providing a regular stimulus to the heart muscle in persons in whom the natural pacemaker that controls the heart rhythm has failed. An isotopic device of this sort producing a few hundred microwatts could be implanted under the skin and be expected to provide regular impulses to the heart muscle for some ten years. Present devices using tiny conventional batteries work for about one year before their battery must be replaced.

Farther off is the possibility of a small pump powered by radioisotopes which will take over much of the pumping load from a severely damaged heart. AEC is exploring small nuclear power supplies for this purpose.

9. Whole-Body Counters

Two types of whole-body counters were developed rather early in the Atomic Energy Commission program to measure radium, cesium-137 and other gammaemitting elements in people. In 1955, a whole-body counter was developed at the Argonne National Laboratory employing multicrystal arrays of solid crystals. In 1956, the 4-psi liquid scintillation counter was developed at the Los Alamos Scientific Laboratory. Whole-body counters are used now not only to monitor workers at atomic energy installations but also as research tools to learn more about the distribution in the human body of radionuclides or compounds tagged with radionuclides. Such studies are made in both normal persons and in patients who have medical problems such as anemia or other blood disorders or metabolic deficiencies. At present some 50 sites in 22 states and the District of Columbia have whole-body counter installations; some locations have more than one counter. In addition, a point of interest is that five of the sites maintain mobile counters. These could be put to work during a radiological emergency or accident. It also should be noted that not all developments of potential value in the treatment and care of patients arise from basic biomedical research. Clinical potential is frequently found in research and development programs conducted with very different end results in mind. The early development of pattern recognition devices for bubble chamber photograph analysis, the development of pion factories for nuclear physics studies, the separation of americium in the course of transplutonium chemistry programs are illustrations of this point. Question 2.-What means are employed by your agency to establish research priorities and long-range research plans?

In the biomedical research and development area the establishment of research priorities and long-range research plans is a continuing process and one which is subject to periodic review. The procedure employs many mechanisms,

some geared to the budget cycling process and the remainder to formalized, internal program management, along with external committee advisors.

The budget cycle process involves an annual comprehensive evaluation of biomedical research programs planned for the forthcoming budget year. It necessarily requires a thorough review of current projects and the development of financial needs within the framework of over-all Commission budget projections and limitations. The system further provides for a five-year forward projection of research plans and financial estimates, this being reviewed and updated each succeeding year.

A highly important element of the planning process is an awareness of the biomedical program activities of other Federal agencies. This is accomplished quite effectively through constant staff contact with other agencies, membership on many review committees of these agencies, as well as through participation on committees of the President's Federal Council for Science and Technology, exchange of research data and budgets, etc.

Another effective means of establishing biomedical research priorities and developing long-range plans is through an advisory committee mechanism. Some examples of this would include:

(1) Advisory Committee for Biology and Medicine.--A high-level group of prominent scientists who meet several times annually to review the Atomic Energy Commission's biomedical program at the policy level and to advise the Commission accordingly.

(2) Biomedical Program Directors Group.-The biomedical laboratory directors of the AEC's supported program meet several times annually with the Director and staff of the Division of Biology and Medicine to review and discuss research underway, primarily for the purpose of developing program critique and formulating future plans.

(3) Ad Hoc Advisory Committees.-The Division of Biology and Medicine frequently appoints special advisory committees of scientific experts to review and advise on segments of the biomedical research program for the primary purpose of developing long-range planning and, in addition, establishing priorities within the area reviewed.

In the final analysis, the responsibility for judgment in priorities and the fixing of long-range plans rests with the Director, Division of Biology and Medicine, and his senior staff, within the framework of the management tools already discussed and strongly influenced by the mission-oriented needs of the Agency itself. All of the decisions are, of course, subject to the approval of the Commission and the Agency's top management.

Question 3.-How do you evaluate and maintain a continuing examination of ongoing projects and programs?

PROCEDURES FOR REVIEW, EVALUATION, AND ADMINISTRATION OF THE BIOMEDICAL

RESEARCH PROGRAM

The Division of Biology and Medicine has the primary responsibility for the development and administration of both the on-site and off-site biomedical research programs supported by the Atomic Energy Commission.

For the on-site research program, consisting of 20 laboratories which are owned by or operated for the AEC, and amounting to about two-thirds of the total Bio-Med Research program, methods of program management are generally prescribed by the various AEC Manual Chapters dealing with functions and delegations, budget preparation, fiscal management and the like. Essentially, the various laboratories plan projects best suited to fulfill Commission Bio-Med research requirements. The plans are then subjected to complete review and evaluation by the staff of Division of Biology and Medicine in the light of priorities established and budgetary limitations. Scientific evaluation and followthrough in performance of programs is provided by review of scientific progress reports and frequent visitations by DBM staff members.

The off-site research program consists of more than 600 separate research projects supported at over 220 universities, research institutions and hospitals, as well as some abroad, constituting about one-third of the Bio-Med funds available annually.

The line organization structure of the Division of Biology and Medicine (Director, Associate Director, Assistant Directors, Branch Chiefs, Scientific Staff) discharges the Division over-all responsibilities including policy determinations, program planning, budgetary formulation and the day-to-day adminis