[From the Congressional Record, Mar. 24, 1971]

SENATE

By Mr. MONDALE (for himself) and Mr. BAYH, Mr. BROOKE, Mr. CASE, Mr. FONG, Mr. HARRIS, Mr. HART, Mr. HUGHES, Mr. HUMPHREY, Mr. JAVITS, Mr. KENNEDY, Mr. MCGEE, Mr. McGOVERN, Mr. Moss, Mr. NELSON, Mr. PELL, Mr. RANDOLPH, and Mr. SCHWEIKER):

S.J. Res. 75. A joint resolution to provide for a study and evaluation of the ethical, social, and legal implications of advances in biomedical research and technology. Referred to the Committee on Labor and Public Welfare.

HEALTH SCIENCE AND SOCIETY

Mr. MONDALE. Mr. President, I introduce for myself and Senators BAYH, BROOKE, CASE, FONG, HARRIS, HART, HUGHES, HUMPHREY, JAVITS, KENNEDY, MCGEE, MCGOVERN, MOSS, NELSON, PELL, RANDOLPH, and SCHWEIKER for appropriate reference a joint resolution to create a National Advisory Commission on Health Science and Society.

Recent advances in biology and medicine make it increasingly clear that we are rapidly acquiring greater powers to modify and perhaps control the capacities and activities of men by direct intervention into and manipulation of their bodies and minds. Certain means are already in use or at hand-for example, organ transplantation, prenatal diagnosis of genetic defects, electrical stimulation of the brain. Others await the solution of relatively minor technical problems, while still others depend upon further basic research. All of these developments raise profound and difficult questions of theory and practice, for individuals and for society.

To consider and study the ethical, social, and legal implications of advances in biomedical science and technology, I propose in this measure the creation of a 15-member commission on Health Science and Society. This commission would also report on the public policy implications of its findings in interim reports and in a final report at the end of its 2-year study.

Mr. President, 3 years ago I introduced a joint resolution which was essentially the same as the one I am introducing today. At that time, heart transplants were a startling new medical breakthrough. Since then, several hundred heart transplants have been performed. When I reintroduced the resolution in the last Congress, the first successful test-tube fertilization of a human egg had just been reported. Now, just 2 months ago, Nobel Prize winner Dr. James D. Watson told the House Committee on Science and Astronautics that we will soon see the day when a baby will be conceived in a test tube and placed in a woman who will bear the child. As you may recall, Dr. Watson's reported prediction was that when such an implantation is successfully made, "All hell will break loose."

These brief comments indicate that the need for a sober and thoughtful analysis and evaluation of biomedical advance is even more urgent now than it was 3 years ago when I first proposed this commission.

The past 3 years have seen great advances in genetics. There have been major increases in the ability to detect genetic diseases, even in fetuses still unborn. By examining fetal cells present in fluid obtained from the wombs of pregnant women, diagnosis of diseases such as Mongolism are now being made. As treatment for most genetic diseases is not now available, the diagnosis is generally followed by abortion of the affected fetus.

But major steps have been taken toward developing a technology of genetic engineering which might eventually be able to provide a cure for diseases such as hemophilia, cystic fibrosis, or diabetes. Single bacterial genes have been recently obtained in pure form, both by isolation from biological material and by chemical synthesis from simple building blocks. And just 2 weeks ago, the Washington Post reported that British scientists had artificially corrected a genetic defect in mouse cells by inserting some healthy genetic material from chick embryos.

But these welcome prospects are accompanied by others which are frankly disturbing. In other areas of genetic research, work has progressed which may soon make possible the asexual production of large numbers of identical humans, by a technique known as cloning. Work is also in progress to make possible the predetermination of the sex of unborn children.

Research into the nervous system and behavior proceeds at an accelerated pace. The use of amphetamines on school children to treat the so-called "hyperactive syndrome," recently the subject of public concern and controversy, is only

a foretaste of things to come as the science of psychopharmacology becomes more sophisticated. New drugs offer possibilities both for novel therapies and for novel abuses. There has also been increasing experimentation with electrical stimulation and with selective destruction of certain areas of the human brain, in order to achieve desired behavioral changes.

In the area of clinical medicine, there has been considerable effort to resolve existing confusion concerning the definition of clinical death. This confusion is due to the fact that, thanks to medical progress, the traditional signs of lifeheartbeat and respiration--can now be maintained almost entirely by machines. Since many human matters depend upon the distinction between a man alive and a man dead, the importance of resolving this dilemma cannot be overemphasized. There is great ferment now in cancer research, and we may be nearing the day when men may live out their lives without fear of this dread disease. And while on the subject of longevity, we should not neglect the claims of some scientists that the time is now ripe for an attack on the biological processes of aging. If this attack is successful, the result could be many added years of healthy life for all.

While holding forth the promise of continued improvements in medicine's abilities to cure disease and alleviate suffering, these developments also pose profound questions and troublesome problems. There are questions about who shall benefit from and who shall pay for the use of new technologies. Shall a person be denied life simply because he does not have enough money for an organ transplant?

There will be questions about the use and abuse of power. When and under what circumstances can organs be removed for transplanting? Who should decide how long a person is to be kept alive by the use of a machine? Exactly what constitutes informed consent for a prospective transplant donor or recipient? The extent to which the consent is informed and voluntary may very well depend not only on what is said, but how it is said.

There will be questions about our duties to future generations and about the limits on what we can and cannot do to the unborn. Is it ethical for a man and wife, each carrying a gene for serious hereditary disease, to procreate, knowing that their children have a significant chance of acquiring the disease? Should the law enjoin certain marriages or require sterilization for such eugenic consideration? What rights do unborn children have to protect them in experiments involving genetic engineering or test tube fertilization? In a letter to the Washington Post, Dr. Leon Kass, executive secretary of the Committee on the Life Sciences and Social Policy of the National Research Council, warned: "One must not forget that there is a human being (the child-to-be) upon whom these experiments are to be performed and who may suffer for our zeal and ignorance, an ignorance no more excusable because well-meaning."

We shall face questins concerning the desirable limits of the voluntary manipulations of our own bodies and minds. Some have expressed concern over the possible dehumanizing consequences of increasing the laboratory control over human procreation or of the increasing use and abuse of drugs which alter states of consciousness.

We shall face questions about the impact of biomedical technology on our social institutions. What will be the effect of genetic manipulation of laboratory-based reproduction on the human family? If laboratory fertilization can produce children for sterile couples, what will be the consequences for those orphaned or abandoned children who might otherwise have been adopted by these couples? What will be the effect on the generation gap of any further increases in longevity?

We shall face serious qestions of law and legal institutions. What will the predicted new-fangled modes of reproduction do to the laws of paternity and inheritance? What would happen to the concept of legal responsibility if certain genetic diseases were shown to predispose to antisocial or criminal behavior? What would be done to those individuals with such traits?

We should expect that some people will try to have certain particularly frightening technologies banned by statute. Should this be done? Could such prohibition be effective?

Finally, we as legislators will face problems of public policy. We shall need to be informed of coming developments, of the promises they hold forth and the problems they present, and of public attitudes in these matters. We shall need to decide what avenues of research hold out the most promise for human progress. And we shall need to help devise the means for preventing undesirable consequences.

Mr. President, as serious and as vexing as these practical questions may be, there is yet another matter perhaps more profound. The biomedical technologies work directly on man's biological nature, including those aspects long regarded most distinctively human. Thus, we should expect major challenges to our traditional image of man as this technology unfolds. The impact on our ideas of free will, birth, and death, and the good life is likely to be even more staggering than any actual manipulation performed with the new technologies. These are matters of great moment, and we urgently need to take counsel from some of our best minds. I trust that the Congress will recognize this need by establishing this commission.

The questions raised require the competence of persons with different training and background. Accordingly, I propose that the commission include individuals drawn from the fields of medicine, law, theology, biological science, physical science, social science, philosophy, humanities, health administration, Government, and public affairs. The physician and the philosopher, the scientist and the theologian need to get together and to educate each other. We have much to gain from their collective learning. The commission I propose will provide the vehicle for this much needed exchange.

There is also a need for improved communication between laymen and scientists. The layman needs to learn more about the prospects and implications of expected developments. The scientist needs to acquire a broader understanding of the possible ramifications of his work and the concerns of the people it will affect. The Commission I propose will provide a vehicle for such communication.

Mr. President, we can ill afford to wait until the crush of events forces us to make hasty and often ill-considered decisions. We cannot again allow events to pass us by. We face an increasing number of new and far-reaching technological possibilities, touching the very nature of man. We face the need for some wise, deliberate, and sober decisions. These questions are not going to go away or answer themselves. They will become progressively more difficult as time goes on. As Dr. Watson said in his testimony:

"If we do not think about the matter now, the possibility of our having a free choice will one day suddenly be gone."

It would be foolish to expect the Commission to provide answers to all the questions we face, but we can expect that it will provide help in making some of our difficult decisions. The findings and considered judgments of excellent minds with a wide range of experience and training will be invaluable to individuals who must struggle with the awesome responsibility of coping with these new technologies.

We make no prejudgments. We do not call for controls. We ask only for a thorough and thoughtful consideration of every aspect of these complex, difficult, and profound questions and problems. I and the Senators who join with me in sponsoring this resolution sincerely hope that Congress will act with dispatch in creating this much needed Commission.

Mr. President, I ask unanimous consent that the text of the joint resolution, together with a number of articles, letters and statements bearing on these profound problems, be printed in the Record.

(There being no objection, the joint resolution and material were ordered to be printed in the Record, as follows:)

(The text of the bill appears on p. 3 of this hearing volume.)

[From the New York Times, Sept. 15, 1970]

CHIMP'S BRAIN SIGNALS ITSELF BY COMPUTER
(By Robert Reinhold)

NEW HAVEN, Sept. 14.-Direct two-way radio communication between an animal's brain and a computer has been established for the first time by a team of scientists at Yale University. It was used to enable the brain to control artificially one of its own functions.

In an experiment, electrodes implanted in a chimpanzee's brain picked up electrical brain waves, which were then transmitted to a computer by a small receiver-transmitter atop the animal's head.

The computer, programed to recognize special characteristics of the wave, returned a control signal to another part of the brain through the receiver.

Stimulated by the control signal, the latter part of the brain internally turned off the brain activity originally sensed by the computer.

While the exchange is of the most rudimentary sort, the feat is said by the Yale team to suggest promising new ways of treating mental and physical disorders in human beings. Moreover, it raises the prospect of establishing direct electronic communication from one brain to another.

The head of the team is Dr. José M. R. Delgado, a 55-year-old Spanish-born neurophysiologist at the School of Medicine. Dr. Delgado, a pioneer in this field, has attracted both attention and controversy in the past for his experiments inducing anger, fear, affection, pleasure and other emotions in animals and human beings by telemetery stimulation of specific regions of the brain.

The new work represents the first time that a two-way radio network has been devised, in which the brain itself determines the outside signals it receives without using the senses as intermediaries to convey information to the brain.

"We are now talking to the brain without the participation of the senses," said Dr. Delgado in an interview at his laboratory. "This is a pure and direct communication-I call it 'nonsensory communication." "

Dr. Delgado said he expected to use the new technique on human beings within a year. One possible application is in the treatment of epileptics.

Theoretically, the computer could recognize the pattern of brain waves associated with the onset of a fit and trigger the inhibitory areas of the brain or inject a chemical.

To simulate natural conditions, Paddy was placed on an artificial island in the company of three other chimpanzees at the 6571st Aeromedical Research Laboratory at Holloman Air Force Base in New Mexico.

Dr. Delgado's work was supported by the Air Force until recently, when it was decided that it had no direct military application. Congress recently forbade the armed forces from supporting nonmilitary research.

The transmitting and receiving equipment was mounted nearby, and Paddy's brain and motor activity were monitored 24 hours a day. The experiments hinged on the pattern of electrical activity in a small almond-shaped structure in the brain called the amygdala.

WAVE PATTERNS OF BRAIN

The amygdala spontaneously produces electrical wave patterns with a characteristic shape called spindles at the rate of about 1,000 an hour. Spindles are thought to be linked to olfactory, or smelling, functions and are one of the easiest patterns to recognize.

The spindles were converted by the stimo-Receiver into FM radio signals and fed into a Donner Analog computer. The computer was programed to recognize the spindles and to produce another signal for the duration of each spindle.

This signal was then converted into another FM radio wave and transmitted back to the animal, where it was picked up by the stimoceiver. The stimoceiver then triggered an impulse to the reticular formation, an area in the brain stem connected with arousal.

Thus the information received by the reticular formation was directly contingent on the pattern of electrical activity in a distant area, the amygdala.

The results showed that each impulse to the reticular formation inhibited electrical activity in the amygdala. After two hours of such feedback—that is, a signal is modified by its own deviation-the rate of spindling was cut to about half of normal. It disappeared almost completely after several days.

At the same time, behavior changed. The return impulses caused a slight grimace. Paddy became less aggressive and excitable, and lost much interest in food. After the computer was disconnected, these changes persisted for two weeks, after which behavior and spindling rate returned to normal.

ONLY ONE ANIMAL USED

The experiment was done on one animal only, but repeated successfully several times over a year and a half. The animal has suffered no apparent ill effects from the electrodes.

Collaborating with Dr. Delgado were Dr. Victor S. Johnston, Dr. Jan D. Wallace and Dr. Ronald J. Bradley.

The experiment, Dr. Delgado said, demonstrates the feasibility of artificial feedback between two cerebral structures and "on-demand" stimulation of the central nervous system.

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According to Dr. Delgado, all of this has important implications for research and medicine. Various conditions, including multiple sclerosis, Parkinson's disease, anxiety, fear, obsessions, violent behavior, could conceivably be controlled by direct stimulation of the brain, which ultimately underlies all mental and physical activity.

Dr. Delgado has also experimented with imparting sight and hearing to blind and deaf persons through direct stimulation of specific areas of the brain.

A number of researchers, including Dr. Delgado, have permanently implanted electrodes in human beings. One of the leaders in this field is Dr. Robert Heath at Tulane University in New Orleans. Dr. Heath has been using the technique to correlate brain activity with behavior and to treat explosive and depressed patients.

NEW INSTRUMENTS NEEDED

To make such treatment practical, Dr. Delgado believes it will be necessary to develop radio instruments that can be completely buried under the skin. An experimental model of such a device is being tested in monkeys at his laboratory, but application is some years off.

The doctor recognized that the philosophical implications of this kind of work are as great as the medical. However, he says that brain stimulation should be treated much like other biological interventions we have become accustomed toinnoculations, tranquillizers, fluoride treatment of water, food additives.

He believes brain research can provide a window to the understanding of personality and social behavior-not to manipulate but to improve.

Technology, he says, has neglected man. So little is known of what goes on in the brain, he says, that "we are not civilized in human behavior."

In his recent book, "Physical Control of the Mind," Dr. Delgado wrote: "We are now on the verge of a process of mental liberation and self-domination that continues our evolution. Its experimental approach is based on the investigation of the depth of the brain in behaving subjects.

"It's practical applications do not rely on direct cerebral manipulations but on the integration of neurophysiological and psychological principles leading to a more intelligent education.

"We must create a future man with greater personal freedom and originality— a member of a psychocivilized society, happier, less destructive and better balanced than present man."

[From the Washington Post, June 3, 1970]

SCIENTISTS CREATE FIRST GENE IN A TEST TUBE

U. OF WISCONSIN TEAM'S FEAT MAY LEAD TO CONTROL OF LIFE

(By Victor Cohn)

The first synthesis of a gene, the basic unit of heredity, was announced yesterday as the result of a momentous five-year effort at the University of Wisconsin. The historic feat hastens the day of genetic engineering: mastery by man of the very control chemistry of life. It was accomplished by a team headed by Dr. H. Gobind Khorana.

Nobel-prize-winning geneticist Joshua Lederberg at Stanford University called the achievement a "milestone" and one that came "two years earlier than I expected."

On some future day, scientists may manufacture genes or parts of genes to order, and use them to cure or prevent diseases, or even change personality. Some scientists even foresee-or fear-future production of "tailor-made" human beings as the result of such engineering.

Others call this unlikely. There is sure to be wide agreement however, that the shy, 47-year-old Khorana-a native of India who won the Nobel prize for several earlier steps in 1968-has probably opened an epoch.

In their Madison, Wis., laboratory, Khorana and his colleagues duplicated the structure of one of nature's simpler genes: one found in yeast RNA (for ribonucleic acid). Specifically, they synthesized an alanine transfer-RNA gene, one