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development work for which industry is better suited. For example, a drug might be patentable only at the stage where it could qualify for FDA approval, the company being allowed some period of time after preliminary registration during which to pursue the development work, the registration itself entailing a substantial commitment of effort.
Do you care to make any comment on the suggestions contained in that paragraph?
Dr. TISHLER. Mr. Chairman, there are so many thoughts given here, some of which I think are not well thought out, that I think I would find it very difficult to answer them, in part because they have to do with the business aspects of the industry in which I am involved as a director of research and a scientist, but in which I have very little to do with the marketing and business parts of the problems related to them.
I do think patents are very important. I know they are important from a research point of view. Those countries that do not have patents are the ones that are most backward in the development of research, at least in drugs.
I feel patents are very fundamental to our whole system. Without this type of motivation, my company, which has always had a very real interest, going back some 35 years, in causing research in the pharmaceutical industry to be on a par with university research, could never afford to have done what we have done without having the protection of patents. We have today a tremendous research organization, one that is very successful, and without the patent system this could not have been arrived at.
Senator HARRIS. Apparently you feel from what you say, that there have been inhibitions on collaboration between Government, industry, and the universities by reason of what you call "unnecessarily restrictive patent policies applied to grant-supported research during the past several years."
Dr. TISHLER. Yes. It has been discouraging, Mr. Chairman. On the other hand, I think probably a better understanding is being achieved with Government agencies, particularly the National Institutes of Health.
I would like to point out that one of the great assets we have had over the years in our industry and in our company has been the collaboration with university scientists. I am very proud of the fact that I have hanging on my wall a document commenting affirmatively on the values of industry research which was presented at one of the hearings here a number of years ago, signed by 14 Nobel Prize winners, with whom we had collaborated. In some cases the men went on to win Nobel Prizes for the work in which we collaborated.
This kind of collaboration has been slowed down. The grantees in universities have had directives specifying Government rights to inventions, and all kinds of complications that have arisen for those whose research is being supported by Government funds. I think, however, progress is being made. Certainly, NIH understands the needs for this kind of collaboration and they as well as industry are doing everything we can to get a workable procedure. I think progress is being made.
Senator HARRIS. Where do you have laboratories?
Dr. TISHLER. We have large laboratories in two different areas and then we have smaller ones.
The large ones are in Rahway, N.J., where we have around a thousand people, and about 20 miles northwest of Philadelphia, in a place called West Point, where we have around 700 or 800 people. We also have laboratories throughout the world. They are, for the most part, developmental laboratories, but they are an important part of our whole research organization.
Senator HARRIS. Are they in close proximity to universities or hospitals?
Dr. TISHLER. Yes. Rahway is 20 miles out of New York City, about 30 miles from Princeton, about 15 miles from Rutgers, and we are right in an area of a great deal of university stimulation.
As a matter of fact, we have in our research facilities in Rahway, I would say, two or three visiting research people a week from universities, from all parts of the world. This keeps us alert, on our toes, and a lot of good exchange of ideas takes place.
Senator HARRIS. That is what I was wondering about, the interchange, as it relates to the nearness to a university community.
Dr. TISHLER. It is almost impossible for me to describe this. I would hope, Senator, sometime you would make a trip to visit a few of our laboratories. It is a vital organization. I am sure you would find it exciting and productive.
Senator HARRIS. I suppose from the Rahway location that you also need to be close to hospitals where you can observe clinical testing. Would that be right?
Dr. TISHLER. Well, we go anywhere in the country, anywhere in the world for clinical testing, depending on where the best capacity exists. It doesn't necessarily have to be close by. As a matter of fact, in the case of cortisone, the first clinical studies were done at the Mayo Clinic with material we supplied based on the collaboration we had with them.
Senator HARRIS. From your standpoint, and of course I understand you are not directly in the business part of your company, do you feel that there might be some service performed by the subcommittee if it held a seminar, where we might bring together those interested in this ield to talk about the role of private industry in biomedical development in relation to existing incentives and the possibility of devising better incentives?
Dr. TISHLER. Mr. Chairman, what you say makes me feel very good because for the last few years we have heard so much on the other side.
I think the time has come when we ought to recognize that there is a positive side to our private sector, and a positive contribution. This is what has made our Nation great. This is what made the big technological advances that exists today and that we ought to nurture. I agree wholeheartedly with that concept.
Senator HARRIS. Thank you very much and thank you for your response to these questions. We certainly appreciate your presence.
We meet again tomorrow at 10 a.m., here, at which time we will hear from Dr. Edward Glaser, president of the Human Interactions Research Institute, in Los Angeles; Dr. James Shannon, Director of the National Institutes of Health; and Mr. Mike Gorman, director of the National Committee Against Mental Illness.
So, until 10 o'clock tomorrow the committee will stand in recess.
(Whereupon, at 4:05 p.m. the subcommittee recessed to reconvene at 10 a.m., Wednesday, March 1, 1967.)
RESEARCH IN THE SERVICE OF MAN: BIOMEDICAL
DEVELOPMENT, EVALUATION OF EXISTING FEDERAL INSTITUTIONS
WEDNESDAY, MARCH 1, 1967
Washington, D.C. The subcommittee met, pursuant to notice, at 10:05 a.m., in room 3302, New Senate Office Building, Senator Fred R. Harris, chairman, presiding
Present: Senator Harris.
Senator HARRIS. The subcommittee will be in order. We are continuing today the second day of hearings entitled "Research in the Service of Man: Biomedical Development, Evaluation of Existing Federal Institutions."
Without objection, we will insert in the record at this point a written statement from Dr. René Dubos of Rockefeller University, who, unfortunately, is unable to be here in person. Dr. Dubos did participate in our conference in Oklahoma last October and we are pleased to have his written statement for these hearings. We will place a brief biographical sketch concerning Dr. Dubos in the record at this point.
Biographical Sketch: Dr. René Dubos Professor and Member, Rockefeller University, New York, N.Y. Ph. D. 1927. Field: Bacteriology.
Background Data : Assistant Editor on Staff of International Institute of Agriculture. Research Assistant of Soil Microbiology at Rutgers. Fellow, Assistant Professor, Associate Professor, Associate Member and Member of the Rockefeller University, George Fabyn Professor at Harvard Medical School.
Recipient of numerous awards and author of many publications.
STATEMENT OF DR. RENÉ DUBOS, PROFESSOR AND MEMBER,
ROCKEFELLER UNIVERSITY, NEW YORK, N.Y. The Federal Government is committed to a program of social and environmental improvement for the creation of a Great Society. The American Institute of Planners is conducting a series of symposia focused on The Optimum Environment-With Man as the Measure. The Ford and Rockefeller Foundations have decided to devote most of their resources to problems of human ecology.
Irrespective of the phrase used, the intent of all these enterprises is clearly the same; namely, to develop technological and social practices directly applicable to the problems of man in the modern world. In my judgment, the greatest limitation of these ambitious and wellmeaning projects will be the lack of knowledge concerning the longrange effects of evironmental factors on the well-being and development of man. For example:
(a) Everyone agrees that it is desirable to control evironmental pollution. But what are the pollutants of air, water, or food that are really significant? The acute effects of pollutants can be readily recognized, but what about the cumulative, delayed, and indirect effects? Does the young organism respond as the adult? Does he develop forms of tolerance of hypersusceptibility that affect his subsequent responses. Priorities with regard to the control of environmental pollution cannot be established rationally until such knowledge is available.
(6) Everyone agrees that all citizens should be given the same educational opportunities. But what are the critical ages for the development of mental potentialities, and for receptivity to the various kinds of stimuli? In this regard, what are the effects of prenatal and early postnatal influences on physical, physiological, and psychical characteristics of the adult? To what extent can the effects of early deprivations be corrected? And which ones of these effects are irreversible?
(c) Everyone agrees that our cities must be renovated, or even rebuilt. But while technologies are available for almost any kind of scheme imagined by city planners, architects, and sociologists, who can tell how the environments so created will affect human well-being, and will influence the physical and mental development of children?
These three classes of examples illustrate that environmental control has been considered so far almost exclusively from the point of view of technology, in ignorance of the responses that the organism makes to environmental forces and of the distant consequences for human welfare. Whether approached from the scientific or practical point of view, environmental improvement must take into consideration both the permissive and the formative effects of the environment, not only in the present, but also in the future.
Of great importance in this regard is that most environmental effects are slow in developing, and extremely indirect. They cannot be recognized, let alone understood and controlled, by observing the organism's responses only in the here and now. The effects of environmental forces must be followed throughout the whole life
whole life span of the organism, and indeed for several generations. Of even greater importance is the fact that the effects are most profound and most lasting, when environmental forces impinge on the organism during the formative years, very early in life. Knowledge of the lifelong effect of early influences should be a sine qua non of environmental control.
The need for prolonged studies of points to the limitations of the knowledge of environmental effects that can be derived from observations by clinicians, epidemiologists, sociologists, and educators. Such knowledge is limited to gross effects and end results; it offers little opportunity for control measures. For example, the increase in the prevalence of cardiovascular disease, certain forms of cancer, or bėhavioral disturbances, is certainly the delayed end result of environmental insults. Therapeutic procedures may correct some of the damage, but they do not go to the root of the problem because the initial cause occurred at some early phase in the life of the person concerned.
Fortunately, experience has shown that for practically any problem of human life, it is possible to find in animal life a model that presents
a close analogy to the human situation. This is true not only for physical and physiological characteristics, but also for pathological states, behavioral patterns, and social organization. By taking advantage of this fact, it would be possible to create a new scientific discipline that could be called "environmental biomedicine"-and that would include problems such as:
(a) lasting effects of early influences, i.e., of the effects exerted on the organism during the formative stages of its development;
(6) effects of crowding on hormonal activities and on behavioral patterns;
(c) effects of the physical aspects of housing on the development of sense organs and of various physiological processes;
(d) delayed and indirect effects of biologically active substances, such as drugs and environmental pollutants;
(e) adaptive potentialities and distant consequences of tolerance to injurious agents. For anyone of these problems, as already mentioned, it is possible to imagine experimental models in animals that duplicate one aspect or another of the human situation. But the development and exploitation of such experimental models would require facilities and institutional organizations very different from those found suitable for the study of the usual kind of biomedical problems. The following items immediately come to mind among the many new types of unusual facilities that will be required:
(a) experimental animals of known genetic structure and of controlled experiential past;
(6) quarters for maintaining animals under a wide range of conditions throughout their whole life span and indeed for several generations.
(c) quarters for maintaining populations of various sizes and densities, exposed to different types of environmental stimuli;
(d) equipment (especially telemetry) for measuring the responses of intact, undisturbed organisms.
(e) equipment for recording, retrieving, and analyzing the complex data derived from complex populations and multifac
torial systems. The mere listing of these facilities points to the need for new types of institutions with a special organization of highly integrated personnel.
One can anticipate that few, if any, universities or research institutes will find it possible to finance, administer, and maintain the large and complex facilities envisioned here. It might be worth investigating, therefore, the possibility of establishing collective research facilities, perhaps on a regional basis. Advantage could be taken of the experience gained from the operations of research centers of the Brookhaven National Laboratory type, their advantages and limitations. Such biological research centers might remain integral parts of the university systems, even though operating as collective enterprises.
Social preoccupations have often influenced in the past the formulation of scientific goals as well as the development of scientific methodology and have thereby played an important role in the evolution of science. The present situation of the neglected fields of biomedicine is not unlike that of the physicohemical sciences related to medicine