STATEMENT OF DR. ADRIAN KANTROWITZ, DIRECTOR OF SURGICAL SERVICES, MAIMONIDES MEDICAL CENTER, BROOKLYN, N.Y.

Dr. KANTROWITZ. Thank you very much, Senator Harris. I feel somewhat at a disadvantage not coming from Minnesota.

I must apologize for my voice. My 14-year-old came home with a cold, and I have inherited that.

Senator Harris, gentleman, I am deeply honored to come before this distinguished subcommittee once again. The problems that engage you today are of immense and urgent significance to the biomedical sciences and, accordingly, to the world at large. In commenting on these problems I shall, of course, limit myself to matters that fall within my own areas of competence.

As it happens, our laboratory has been active for more than 15 years in the development of mechanical devices to assist the failing heart. And for 5 years it has also been exploring the possibility of replacing the irreparably damaged heart by transplantation. Developments in both these sectors of experimental medicine and surgery have been rapid.

In recent months, the pioneering achievements of Dr. Christian Barnard and others in the field of human heart transplantation have attracted understandable-if sometimes lamentably confused-attention. Public interest in the phenomenon of transplantation of organs from one human being to another has tended to obscure the at least equally bright promise of what we call heart-assist devices. I think we should bear in mind that such devices are likely to be even more important than transplantation in the future treatment of human heart disease.

Be that as it may, both paths of experimentation have already led to substantial achievement. Both must be followed with maximum energy, creativity and skill by persons now in the work and by others who, it is hoped, will be drawn to it.

Because the deliberations of this subcommittee will inevitably affect the future course and tempo of work in experimental heart surgery. I am anxious to contribute such clarity as I can. Especialy, I am anxious to dispel some of the confusion to which all of us have been subjected since the first announcements of heart-transplant operations a few months ago.

For real understanding of the meaning of those pioneer operations, it is vital to recognize that they were stages of development in an ongoing process of carefully planned biomedical investigation here and abroad. I have already pointed out that our own group has been active in the field for years. So have others.

For years, workers such as Dr. Norman Shumway and Dr. Richard Lower have been successfully transplanting the hearts of dogs. As of the present-may I make an aside to one of the comments Dr. Najarian made-numerous dogs among the 250 that we have transplanted have lived for periods ranging from 1 to 14 months in our own laboratory. And we have one dog that is doing very well with no evidence that we can detect of rejection 14 months after her transplantation.

With the immunological and physiological problems of animal transplantation quite well understood, and with animals surviving the procedures a year or more, the preconditions of clinical experimenta

tion had been met. The transition to transplantation of human hearts was necessary and inevitable.

I shall take up the ethical aspects of this inevitable turn of events. in a few moments. But I now would like to insist that no constructive purpose is served by representing the first human heart transplantation procedures as a sudden breakthrough, as if the idea had sprung full-blown from someone's brain and were perhaps a product of ill consideration as well as inspiration. The operations were breakthroughs only if a clinical trial-a forward step-can be adorned with so grandiose a label.

I feel that all of us, but especially the general public, would be far better served by a clear understanding that these so-called breakthroughs were the fruit of many years of toil by some of the most capable workers in the field, assisted to no small extent by the foresight and leadership of the National Institutes of Health.

I do not think this can in any way be overestimated. I think the greatness of medicine and medical research in our country, whether it be at Minnesota or New York or Palo Alto or Oklahoma, is based on the kind of leadership that the National Institutes of Health have given the health sciences in our country.

Senator HARRIS. I agree with you. I appreciate you pointing that

out.

Dr. KANTROWITZ. To see the transplant operations in that light is to see the truth. This is helpful not only for its own sake but because it encourages the introduction of calm into an area that badly needs it.

This brings me to a second focus of confusion-the question of whether experimental heart surgery contains ethical, moral, social, legal, economic, and political problems of a quality or magnitude never before encountered. As you know, this question has been raised on innumerable occasions not only in the general press but in journals of science and medicine. I am grateful that the subcommittee has invited comments.

The ethics of heart transplantation or of the implantation of a heart-assisting device are, first of all, the ethics of medicine, the ethics of reverence for human life. Where implantation of a heart-assisting device is contemplated the ethical problem is summarized in a few words: can the patient survive by any other known means? If the answer is affirmative, the physician recognizes that the patient is not a candidate for experimental use of a heart-assisting device. But if the patient is beyond the help of established procedures, it is entirely ethical to try to save his life with an experimental heart-assisting device which has demonstrated its effectiveness in animals.

The same process of ethical thought determines a patient's candidacy for heart transplantation. The process is not different from that which takes place in the mind of the physician prior to deciding whether a patient is an appropriate candidate for some new drug. Will anything else probably help the patient? Will the new drug expose the patient to unnecessary risk? Obviously, no surgeon would consider removing a human being's heart and replacing it with another except as a last-ditch effort to save life, all other possibilities having been exhausted.

There is, of course, the problem of making as sure as possible that the patient and/or his family understand what is involved. But, as

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know, the concept of informed consent has been elucidated throughout the U.S. medical profession, with the help of the National Institutes of Health, and is rigorously adhered to in all institutions that enjoy U.S. Public Health Service support. I must emphasize that consent for an experimental procedure is not sought by any honorable physician, regardless of his enthusiasm, if he thinks that some established procedure might benefit the patient.

In heart-transplant surgery, the problem of the patient's informed consent is essentially the same as in other experiments undertaken on a life-or-death basis. There is, however, an additional element-the donor of the transplanted heart. And here the ethical problem derives from a scientific-philosophic question: What is death? At what point do we pronounce the donor dead and remove the heart?

We now know more about death than we used to. We know, for example, that there probably is no such thing as "the instant of death." Like life, death is a process. Certain tissues can be preserved for months after removal from human patients. When reimplanted, they live and function again. A human heart can be revived approximately half an hour after technical death has deprived it of its blood supply. A leg muscle can be revived 8 or 10 hours after death. The nails, hair, and parts of the skin continue to grow for days after death.

The brain, however, is extremely vulnerable. If deprived of oxygenated blood for as little as 3 or 4 minutes, it suffers irreversible damage. In the rare event that the patient is saved, his heart, kidneys, and liver may function for years, but his brain will be gone. He will be alive, but only in a limited sense-without a human personality.

I think, to try to save some time for the subcommittee, Senator Harris, I would like to forego the rest of this statement, which could become part of the records of your hearing, and would be willing to answer any questions that you might have as to our own experiences or in any area of competence that I might add.

Senator HARRIS. All right. Without objection we will place the balance of the statement in the record as if read.

PREPARED STATEMENT OF DR. ADRIAN KANTROWITZ

Senator Harris and gentlemen: I am deeply honored to come before this distinguished Subcommittee once again. The problems that engage you today are of immense and urgent significance to the biomedical sciences and, accordingly, to the world at large. In commenting on these problems I shall, of course, limit myself to matters that fall within my own areas of competence.

As it happens, our laboratory has been active for more than fifteen years in the development of mechanical devices to assist the failing heart. And for five years it has also been exploring the possibility of replacing the irreparably damaged heart by transplantation. Developments in both these sectors of experimental medicine and surgery have been rapid.

In recent months, the pioneering achievements of Dr. Christian Barnard and others in the field of human heart transplantation have attracted understandable if sometimes lamentably confused-attention. Public interest in the phenomenon of transplantation of organs from one human being to another has tended to obscure the at least equally bright promise of what we call heartassist devices. I think we should bear in mind that such devices are likely to be even more important than transplantation in the future treament of human heart disease.

Be that as it may, both paths of experimentation have already led to substantial achievement. Both must be followed with maximum energy, creativity and skill by persons now in the work and by others who, it is hoped, will be drawn to it.

1

Because the deliberations of this Subcommittee will inevitably affect the future course and tempo of work in experimental heart surgery, I am anxious to contribute such clarity as I can. Especially, I am anxious to dispel some of the confusion to which all of us have been subjected since the first announcements of heart-transplant operations a few months ago.

For real understanding of the meaning of those pioneer operations, it is vital to recognize that they were stages of development in an ongoing process of carefully planned biomedical investigation here and abroad. I have already pointed out that our own group has been active in the field for years. So have others. For years, workers such as Dr. Norman Shumway and Dr. Richard Lower have been successfully transplanting the hearts of dogs. With the immunological and physiological problems of animal transplantation quite well understood, and with animals surviving the procedures a year or more. The transition to transplantation of human hearts was necessary and inevitable.

I shall take up the ethical aspects of this inevitable turn of events in a few moments. But I now would like to insist that no constructive purpose is served by representing the first human heart transplantation procedures as a sudden breakthrough, as if the idea had sprung full-blown from someone's brain and were perhaps a product of ill-consideration as well as inspiration. The operations were breakthroughs only if a clinical trial-a forward step-can be adorned with so grandiose a label.

I feel that all of us, but especially the general public, would be far better served by a clear understanding that these so-called breakthroughs were the fruit of many years of toil by some of the most capable workers in the field, assisted to no small extent by the foresight and leadership of the National Institutes of Health. To see the transplant operations in that light is to see the truth. This is helpful not only for its own sake but because it encourages the introduction of calm into an area that badly needs it.

This brings me to a second focus of confusion-the question of whether experimental heart surgery contains ethical, moral, social, legal, economic and political problems of a quality or magnitude never before encountered. As you know, this question has been raised on innumerable occasions not only in the general press but in journals of science and medicine. I am grateful that the Subcommittee has invited comments.

The ethics of heart transplantation or of the implantation of a heart-assisting device are, first of all, the ethics of medicine, the ethics of reverence for human life. Where implantation of a heart-assisting device is contemplated the ethical problem is summarized in a few words: can the patient survive by any other known means? If the answer is affirmative, the physician recognizes that the patient is not a candidate for experimental use of a heart-assisting device. But if the patient is beyond the help of established procedures, it is entirely ethical to try to save his life with an experimental heart-assisting device which has demonstrated its effectiveness in animals.

The same process of ethical thought determines a patient's candidacy for heart transplantation. The process is not different from that which takes place in the mind of the physician prior to deciding whether a patient is an appropriate candidate for some new drug. Will anything else probably help the patient? Will the new drug expose the patient to unnecessary risk? Obviously, no surgeon would consider removing a human being's heart and replacing it with another except as a last-ditch effort to save life, all other possibilities having been exhausted.

There is, of course, the problem of making as sure as possible that the patient and/or his family understand what is involved. But, as you know, the concept of informed consent has been elucidated throughout the United States medical profession, with the help of the National Institutes of Health, and is rigorously adhered to in all institutions that enjoy United States Public Health Service support. I must emphasize that consent for an experimental procedure is not sought by any honorable physician, regardless of his enthusiasm, if he thinks that some established procedure might benefit the patient.

In heart-transplant surgery, the problem of the patient's informed consent is essentially the same as in other experiments undertaken on a life-or-death basis. There is, however, an additional element-the donor of the transplanted heart. And here the ethical problem derives from a scientific-philosophic question: What is death? At what point do we pronounce the donor dead and remove the heart?

We now know more about death than we used to. We know, for example, that there probably is no such thing as "the instant of death." Like life, death is a

process. Certain tissues can be preserved for months after removal from human patients. When reimplanted, they live and function again. A human heart can be revived approximately half an hour after technical death has deprived it of its blood supply. A leg muscle can be revived eight or ten hours after death. The nails, hair and parts of the skin continue to grow for days after death. The brain, however, is extremely vulnerable. If deprived of oxygenated blood for as little as three or four minutes, it suffers irreversible damage. In the rare event that the patient is saved, his heart, kidneys and liver may function for years, but his brain will be gone. He will be alive, but only in a limited sense without a human personality.

Modern medicine faces this problem thousands of times a day. A patient suffers cardiac arrest. The respirator and other cardiac resuscitative measures may revive the heart after it has been at a standstill for ten or twenty minutes. Is the patient alive? Without a vestige of human personality? Without a glimmering of human consciousness or the slightest possibility that consciousness can be restored? With every established diagnostic procedure demonstrating that the brain is, for all practical purposes, dead?

Every day, as I have said, members of the medical community are required to face the ethical problem of when to terminate resuscitative procedures. In general, they turn off the respirator and pronounce the patient dead when they have conclusive evidence of irreversible brain damage of the sort I have been discussing.

To repeat for emphasis, every day thousands of persons are pronounced dead even though many of their internal organs-often including the heart-remain viable. A fundamental problem in heart transplantation is, therefore, to identify the so-called "moment of death”—which actually is better described as the point of no return in a death process. In our own work, a physician who is not a member of the surgical team must be satisfied that everything possible has been done on behalf of the dying patient and that no more can be done. Once this problem has been confronted and resolved, and the patient has been pronounced dead, it is perfectly ethical to remove viable organs for the use of some urgently needful, living individual-provided, of course, that fully informed consent has been obtained from the survivors of the donor.

If I may turn now to the social implications of heart-assist devices and heart transplantations, I should like to recite some figures. About 500,000 patients a year would be candidates for workable mechanical hearts or successful heart transplants. If transplantation of human hearts were the preferred modality, a poignant situation would arise. It is estimated that about 10.000 persons die every year of serious brain injuries. Perhaps half that number might be available as heart donors. Who then would decide which of several dying heart patients should get the available organ and the chance to live? I hardly need observe that we are not now organized to make such decisions. Government leadership will be needed.

As to legal aspects of the questions before us today, I should like to suggest re-examination of the legal definition of death. It varies, I believe, from community to community and, insofar as statute is concerned, usually involves the moment at which the heart stops beating. It would be constructive-and would help to save many lives-if death were redefined in terms more consonant with the findings of modern science. Our local statutes might well be amended to define death in terms of irreversible brain damage.

Persons interested in heart transplantation and heart-assisting devices make frequent reference to two economic problems. One of these is real and immediate. It has to do with the quite considerable cost of developing these procedures, which hold so much promise for the prolongation of life. I find it unthinkable that our country, the richest and most productive on earth, should not have ample resources with which to support projects of this magnitude. I am reluctant to compare the financial needs of the biomedical sciences with the needs of other undertakings of government or of the private sector. I would fear for us if these sciences had to vie for favor as if they were in competition with, for example, the military.

I referred a moment ago to two economic problems, and I have now discussed the one that I see as real and immediate. The other is neither real nor immediate. It has to do with conjecture that heart-assisting devices and heart transplantation might keep human beings alive long beyond their productive years, imposing grave burdens on the economy. This fear is easily allayed. The truth is that old age affects not only the heart but most of the other organs. Persons who have