but, if one accepts it, the view of the problem changes appreciably. Rather than looking at the pool of knowledge generated by research that is categorized as biomedical and asking what can be done to make it applicable to health care, we should turn our primary attention to the field of health care and try to identify needs. Once needs have been identified, the knowledge base that we can draw on to fulfill them cannot reasonably be limited to that generated by biomedical research or to that generated by the research program sponsored by any single agency or group of agencies. In studying feasibility or in the execution of a program of development, we must be free to draw on a much broader base, the knowledge generated by scientific endeavors in all fields.

This brings me to the next aspect of development, its multidisciplinary character, the hitchhikers. One of the generally recognized major trends in science is the growth of interdisciplinary study. This ranges from the employment of instrumentation drawn from other fields of science or from engineering to the use of concepts drawn from other disciplines. Astronomy is often cited as the prime example of a fundamental science that is completely dependent upon other fields for its tools and its instruments. Without going into detail, one can mention the importance of the telescope, photography, spectral analysis, the radiotelescope, and the possibilities of non-ground-based astronomy now offered by our ability to orbit instruments beyond the earth's atmosphere. Modern high-energy physics is another, frequently cited example of a fundamental science that is heavily dependent upon the contributions of advanced electrical engineering for the construction of the huge and expensive instruments (a better expression is installations or complexes) which are absolutely necessary for experimentation.

The growing contribution of electronics to the biomedical field is illustrated by such a familiar device as the electrocardiograph and, of course, the instrument that promises to span all fields is the electronic computer.

The fact that the invention of the computer came about without substantial or, indeed, any knowledge base at all from biomedical research should in no way exclude its application in the health field.

This hybridization of tools and concepts that characterizes modern scientific and technological progress makes it evident that intensive interweaving of advanced engineering competence and biomedical competence is an approach of great power in dealing with the question of future development in the health field. It is possible now to identify areas of emerging promise and potential and to encourage research and development in them. It is wise to support students, to encourage the development of new curriculums, and to foster the creation of new patterns of institutional organization without knowing in advance precisely what practical results will eventually be forthcoming. In fact, this is being done increasingly, particularly in so-called biomedical engineering. The subcommittee will, undoubtedly, hear precise testimony concerning these and related programs that are underway or are contemplated for the future.

But programs of this kind must eventually be given point and emphasis by demands for development and application from the outside, and this demand must consist ultimately of a market-public or private—if the products of the laboratories are to be used extensively.

I do not mean to imply that the only possible incentive for development and application in the biomedical or any other field of endeavor is monetary profit but, certainly, it would be foolish not to accord this factor the importance that it deserves. It is not accident that this Nation's strength in basic research flows from the universities and its strength in applied research and development from industrial laboratories.

Dr. George Kistiakowsky, in discussing the importance of applied research prior to engineering development, has said, "The strengthening of such research in Government laboratories and in profitmotivated corporations is as vital to the Nation as that of basic research mainly in the universities."

Generally, the physical sciences have their eventual impact upon the daily life of our society through industry, manufacturing, or service, such as telecommunication or transportation. The application of the results of this type of basic research through these channels of our economy is a well-accepted part of our life. Our methods for putting to use scientific advances in the biological and medical sciences are somewhat more varied and less well structured but are probably most efficient in the field of agriculture. Certainly, they are relatively ill defined in the health field.

If we identify needs in the field of health care and then examine them against the background of the knowledge pool, there is likely to remain a considerable doubt about whether our aim, which is to fill the need, can actually be accomplished. Even if additional applied research indicates that the undertaking is technologically and scientifically feasible, there remains the very knotty question of whether the end result will really be practically applied in the social and economic environment of the real world, which can be a cold and inhospitable place, at times.

There is no substitute for a thorough investigation of this situationa market survey-before one embarks upon any substantial foray into the unknowns of a major program of development. We must remember that the decision to undertake engineering development and innovation implies financial commitments of no small measure and that the expenses of development must be met whether a product, even a prototype, becomes available or not. The commitment is all or none because one cannot ease into it any more than one can ease into pregnancy. There is no way in which the design can be tested or the market can be sampled in some small way until the development process has been completed.

Another question that is common to development programs in all fields but is particularly crucial in health, has to do with the possible incompatibility of a proposed innovation with customary usage and the existing organization of the system into which the new product or process will be introduced. The system of medical practice in this country is changing slowly but it is fair to say that it is not a system that, until now, has been distinguished by its rapid acceptance of structural reorientation and major alteration in traditional patterns of practice. The consumer in medicine is not, as we may think at first glance, the patient. The consumer, in the sense of the market, is the medical practitioner. It is the physician who decides upon the use of new products or processes or systems for health care and his professional judgment

can be interposed between the public and any innovation in the health field.

Lest this statement be interpreted as a complaint or an objection to this professional role of the physician, I would point out that it is not something that I would wish to see changed any more than I would wish to see each citizen become his own attorney. I mention it, however, because it is a characteristic of our health system that must be considered carefully in planning for innovation.

The decision to exploit scientific advance by launching into a development program must be reconciled with the facts of life, including such scientifically irrelevant factors as capital obsolescence of present equipment, the requirements and demands of labor groups, national distribution networks, compatibility with existing systems, patterns of professional activity, and even local building codes or State licensure requirements.

The smaller the impact of an innovation (such as the introduction of a new dosage form of a drug or modification of an existing surgical instrument), the less likely is there to be a long series of interrelated changes to be weighed. This subject is a very complicated one because of the tremendous variety of technical and economic conditions that our society presents. It deserves emphasis, however, because those who fail to comprehend this peculiar difficulty in decisions about programs of development are very likely to level accusations of foot dragging which are wholly unjustified.

Increasing experience in biomedical development is confirming what has been known for some time in other science-based enterprises-that the planning and management of programs of directed research and development is critical to success and that it is a far more difficult undertaking than the type of research endeavor to which most biomedical scientists are accustomed. The planner and the manager are likely to be involved in relatively unexplored areas, demanding decisions of probable performance and judgments concerning reliability where evidence is equivocal, experience nonexistent, and expense substantial. A mass of details involving complex economic and social matters must be harmonized with elaborate technical aspects of the undertaking if success is to be achieved.

If, after all of these matters have been considered, there is a reasonable chance that the desired result can be achieved, the development project can be undertaken at whatever pace and whatever level of funding the country's interests demand.

On the other hand, one may elect to delay a program in the hope of being able to accomplish something better at a later date.

The Panel on Invention and Innovation of the Department of Commerce issued last week a report in which they distinguished between invention, the conception of an idea, and innovation, the process by which an invention or idea is translated into the economy.

Innovation, the application of knowledge, is not something that just happens spontaneously; it has to be accomplished through an institution or agency in the biomedical field and it is in the biomedical field that such institutions are largely lacking at present. The industrial laboratory is clearly appropriate for many situations, witness the drug industry. Bode has characterized such institutions as follows: "To flourish, such a laboratory should be fairly large, with a

technical mission that is well defined and yet broad enough to maintain a diversified intellectual atmosphere, with stable financial support, and without overwhelming competitive pressures." As we look at this need, of course, research institutes and Federal laboratories come to mind as other possibilities.

Not only are new institutions or agencies needed for biomedical development, but, as was noted by a committee appointed by the Secretary of Health, Education, and Welfare last year, chaired by Dr. Jack Ruina, managers for large projects of directed research and development are in critically short supply. The traditions of the biomedical community mitigate against the choice of this type of career and neither status nor remuneration within the Federal structure is sufficient to ameliorate this deficiency.

These factors, compounded by the fear of basic researchers that the initiation of large directed projects will in some way interfere with continuing strong support of their endeavors, combine to form a problem of major proportions in planning for a Federal role in directed. biomedical research and development. I was a member of that committee, but I understand that Dr. Ruina is going to testify before the subcommittee personally, and I know that you are already familiar with the general findings and recommendations of the study. I will not pursue the subject further but I emphasize it as one of the nonscientific, nontechnical facts of life which governs realistic planning in this field.

Much of what I have said about need, demand, the importance of a market to use, the considerations before making a decision to undertake development, the interdisciplinary character of development for application, the need for an appropriate institutional base, and the key role of project managers has clearly been accomplished by the Pharmers of Pharmville, the drug industry in the United States.

Because the problem of innovation and application in this health area has been faced successfully and because we are here examining the role of Federal agencies in fostering innovation, I believe that a brief look at some of the relations between this industry and the Federal Government might be revealing and might alter our perspective.

It is difficult to see that the Federal Government has had to make a major effort to encourage application in the drug field. The members of this industry have seen Federal regulations altered so that they are now required not merely to produce evidence of safety but also to file evidence of effectiveness, a judgment that was previously left to the medical profession at large. Additionally, the Federal regulations governing the testing of the efficacy of drugs in human subjects have been greatly reinforced, to the point that many researchers are very reluctant to undertake such studies. The industry has been accused of making exorbitant profits; a study of drug costs under medicare has been ordered. Their advertising, limited largely to physicians, has been criticized by both the Government and the profession as overdone, wasteful, Madison Avenue in type, and even misleading or “unethical." Their market is worth a glance. Large amounts of drugs manufactured abroad have been procured by Government agencies because they were available at lower cost and, lately, the companies are again threatened by advocates of "generic name prescription" with the loss of the effectiveness of the trade names that are so valuable to individual companies in competing for the market.

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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