ANNALS O F CLIN ICA L AND LABORATORY SCIEN CE, Vol. 16, No. 1Copyright © 1986, Institu te for Clinical Science, Inc.

SPECIAL ARTICLE

Ethical Considerations of Artificial Heart Implantations*

Professor o f Christian Ethics,Southern Baptist Theological Seminary, andDirector, Clarence Jordan Center fo r Christian Social Ethics,Louisville, KY 40280 PAUL D. SIM M ONS, P h .D

Public attention to and interest in the artificial heart has been very much alive at least since the Barney Clark implant in 1982. B ut th e idea had b een th e re m uch longer. “T he 6 M illion D ollar M an” (L ee M ajors) and “T he B ionic Woman” (Lindsey Wagner) imaginatively portrayed the possibilities th rough the m edium of te lev is io n e n te r ta in m e n t. Now we are w itnessing the dram a unfold in our very midst. Imaginative visions of the future are being pursued in dramatic experim ents with innovative technology.

Along the way complex problems are being generated and our lives are being sub tly b u t ex ten siv e ly changed . The problem s are both technical and moral in na tu re— and the two are often related. The symbolic and ethical significance of this giant step in medical history is of trem endous interest. People disagree as to w hether we are making progress or simply making history. At a minimum, how ever, th e artific ia l h e a rt program represents a significant step in the effort

* Given at the opening session of the Applied Sem­inar on the Laboratory Diagnosis of Cardiovascular Disorders, Association of Clinical Scientists, Louis­ville, Kentucky, October 10, 1985.

to conquer the diseases which shorten hum an tem p o ra l ex istence. F o r th e unbridled optimist, this high-tech assault on the heart seems the last frontier to conquer before the dawn of the age of bionic persons.

At a symbolic level, the heart is a sign of the increased expectations on the part of the American public and of medical and scien tific re sea rch ers . P eop le are coming to expect a scientific fix for every m alady or life -th rea ten in g d isease . E xotic p ro ced u res seem d em an d ed w hether or not they are of dem onstrated benefit.

It also represents a preoccupation with life and death in our society. Some herald the heart as a step in the direction of elim inating death (or at least making it optional) probably to be elected only by a m iserable and unfortunate few. O thers see it as a type of denial-of-death syn­drom e, a neurotic-com pulsive effort to achieve immortality through science. At least it holds the promise of increased longevity, and perhaps of cheating death of its in tended victim — at least until a later date.

The m ystique of the heart causes all1

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2 SIMMONS

this to have enorm ous symbolic power for society. The public debate reflects the tensions within us religiously, philo­sophically and morally about life, death and the future. I t also captures our hopes and fears about technology and what it may do to and for us individually and col­lectively. T he p o in t is s ta ted w ell by Stanley Reiser in A fter Barney Clark:

The artificial heart, apart from its capabil­ities, has become for our society the fore­most symbol of the ambivalence we carry toward medical technology. The artificial heart is at once a metaphor of concern about unduly sustaining an aging popula­tion, the cost of medical care, plunging into technologic creation without adequate thought to consequences, and of an accu­mulation of means as an end in itself. It stands also as a metaphor of exhilaration about the wonders of our science and tech­nology. 1The artificial heart also poses signifi­

cant ethical issues, as R eiser suggests. New technology often com plicates and compounds the decisions that m ust be m ade w ith reg a rd to p a tie n t care and m edical therapy. T hese decisions pose moral dilemmas precisely because peo­ple are being affected both directly and indirectly . W e are all p a tien ts w ith a vested interest in high tech m edicine for both individual and social well-being are involved. W e will all benefit and/or suf­fer together as decisions for research and application are made.

Several ethical issues have been raised about the artificial heart, all of which are im portan t and d e se rv e a tte n tio n , b u t most of which cannot be dealt with in this p ap e r.2 They can b e d iv id ed in to two m ajor ca tego ries of concern : (1) those d irec tly involv ing th e p a tie n t, and (2) those involving social policy. The two are inter-related, of course, b u t distinctions will aid discussing the issues.I. Issues in Physician-Patient RelationsT h e E t h i c s o f I n f o r m e d C o n s e n t

The ethical issue of informed consent

has probably received most attention in d iscussions abou t xenographs and im plan ts. T he p ro b lem is th a t ex p e ri­m ental m edicine pushes at the frontiers of trad itio n a l m oral form ulations and estab lish ed m edical p ro ced u res . The research physician works in that ethical penum bra created by a com m itm ent to developing innovative and more effective tech n iq u es and th e risk of in ju ring p a tien ts by m oving too quickly w ith unproven therapies. The researcher has a m oral co m m itm en t to seeking new cures, new devices, new and more effec­tive therapies — all of which are impos­sible w ithout experim entation first on animals but, finally, on human subjects. I t requires boldness and courage to push at the boundaries.

R esistance to change and fear of adverse outcome are often the primary factors in opposing th e re se a rc h e r’s work. Traditional moralists tend to err on the side of caution thus delaying or p re ­v en tin g m ore effective th e rap ies from b e in g dev e lo p ed . T he re se a rch e r is tem pted to e rr on the side of innovation, frustrated by the constraints of bureauc­racy or dogmatic moral formulations.

The first problem in seeking informed consent, therefore, is that of keeping the role of researcher distinct from that of the clinician. Care of and for the patient is and should rem ain the primary com­m itm ent of the physician. The ambition to achieve a “medical breakthrough” or make “medical history” is also a motiva­tion at work, making the tem ptation to shift priorities terribly strong. The spe­cial ro le of th e physician tow ard th e patient adds to the dilemma. The phy­sician is seen as strong, wise, caring and the source of hope and healing for and by the patient who is weak, dying, frus­tra ted and afraid. The physician has a special type of au thority in such cases and is easily ab le to m an ip u la te th e highly vulnerable patient.

The patient is convinced he has only hours or days to live at most. They are

ETHICAL CONSIDERATIONS OF ARTIFICIAL HEART IMPLANTATIONS 3

“grasping at straw s,” or to use Christiaan B arnard’s m etaphor, they are betw een the lion and the crocodile.3 The im m a­nence of d ea th is a coerc ive factor in patient decision-making. Physicians cer­tainly cannot entirely control how much anxiety will be p roduced by inform ing the patient of a term inal condition. But they can stop short o f exploiting the sit­uation as simply an expeditious way of furthering the cause of the experim ent. The researchers should live by the moral constraint stated so well by Paul Ramsey:

the sine que non of any morality at all is the realization that there are some things we can do that we ought not do. There are some things we cannot morally get to know.4A further complication arises from the

d ifferen t expec ta tions h e ld by p a tie n t and physician, respectively. The patient tends to think “therapy” and believe the experim ent holds g rea te r p rospect for extended health and longevity than the evidence will support. A part of this may be th e eu p h o ria c re a te d by early and extensive m edia hype. Some of it is an exaggerated expectation toward medical science in general. U ndoubtedly anxiety about death also contributes to a denial syndrom e th a t m akes rea lis tic assess­m ents difficult, if not impossible. W hen Jack Burcham declared that he did not see th e p ro c e d u re as a risk , he m an i­fested some of these dynamics. His death ten days after the im plant was a startling rem inder of the fledgling nature of the program and his u n re a lis tic op tim ism was laid bare.

Physicians, on the o ther hand, know th e p rogram is ex p erim en ta l. At th e same time, they hope for a positive and beneficial outcom e for th e patien t and believe strongly in the possibilities for therapy with further research and devel­opment. The danger is that the research­er’s excitem ent about the program will get translated as “promise of therapy” to the hopeful and anxious patient. As every

interview er knows, the way in which a question is posed has a great deal to do w ith th e answ er given. The e th ica l dilem m a is especially acute for the phy­sician researcher who is com m itted to the developm ent of new medical tech­nology. Keeping the role and goals of the researcher distinct from that of the cli­nician is vital to insure the integrity of the informed consent process.

All this makes the process of procuring informed consent of even greater im por­tance than the consent docum ent.5 Few people have the intellectual stamina, the physical energy or the mental discipline to digest the details of a lengthy consent form, m uch less a patient m edicated and dying from end-stage heart disease. The dynam ics betw een doctor and patien t, th e in n u en d o es and suggestions, th e body-language and rhetorical questions, all play a part in giving or withholding consent. Again, the special role of phy­sician as authority figure, providing aid, com fort and hope to th e dying, is all- im portant. That is why, if the patient has faith in the physician, he will sign.

The m oral basis of th e physician- p a tie n t re la tio n sh ip is h e re strong ly underscored. The special vulnerability of the patient requires special trustw orthi­ness of the physician. Different expec­ta tions on th e p a rt of re se a rch e r and su b jec t a re b o th p re d ic tab le and u n ­avoidable. The health care team bears particular responsibility for minimizing those differences to the point tha t the patient can honestly assess probable con­seq u en ces to him self. C are shou ld be taken to avoid ra ising false h opes and stress shou ld be laid on the fact th a t “there is absolutely no guarantee about longevity or qua lity of life” e ith e r expressed or im plied.6 The problem is so to confront the patient with the risk fac­tors involved as to be assured that con­sent is given in a realistic frame of mind.

F u rth e rm o re , th e consen t p rocess needs to include m em bers of the im m e­diate family. They should also be consid­

4 SIMMONS

ered patients since th e ir life and well­being will also be dramatically affected by th e ex p erim en t. A strong and supportive family is necessary, bu t their n eed for realism about th e program is also now m ore clearly understood. The im pact upon fam ily h e a lth resou rces n eeds to be assessed and in c lu d ed in judging the moral and medical accepta­bility of the implant. Refusing treatm ent will be morally awkward for family m em ­bers since there are strong social p res­sures and re lig ious com m itm en ts th a t make consent practically norm ative or m orally obligatory. T h a t th e h e a lth of other family m em bers may also be “on the line,” however, needs to be openly and honestly discussed.

The helping professions — ministers, chaplains, social workers, and others — can be crucial in this aspect of the pro­cess. The task will be to enable and sup­port all those involved to reach a decision that reflects concern for their common well-being, openly and honestly explor­ing feelings and options, w ithout undue coercion or m an ip u la tio n . A ppeals to “the only alternative available” or “doing all we can” (for the patient) are morally problematic in that they exploit the grief process and family love for the patient. The moral principle is that the good of the many should not be com prom ised for a highly risky procedure whose benefits are difficult to calculate.

A s s e s s i n g B e n e f i t s a n d R is k s

The experim ental nature of the pro­gram is often obscured by references to “therapy” and discussions of benefit to the patien t. C riticism has been g ener­ated by the confusion that surrounds the ethical issues involved in assessing ben­efits and risks for those who receive the artificial heart. Several things should be noted.

F irst, th e FD A w aived th e n eed to

show therapeutic benefit for patients in the artificial heart program at Humana. * The two reasons that prom pted that p ro­cedural decision were (1) the lack of a sufficient data base from prior research with hum an subjects, and (2) the recipi­ents w ere in fact dying from end-stage heart disease and w ere not candidates for other types of therapy. Thus, no burden of proof for therapeutic benefit was borne by the im plant team. The heart was not approved as a device capable of achieving th e ra p e u tic ben efit. T he u n d erly in g assum ption was that the patien t could certainly be “no worse ofF’ with an arti­ficial heart since death was imminent.

As The Working Group said, the pro­cedures involve “innovative” practices and “investigational” devices. The pro­gram is designed for the purposes of eval­uating the “safety and efficacy” of using MCSSs and “to acquire information” use­ful to improving the devices. In a word, the program is experimental.

T hat in no way re lieves th e e th ica l necessity of evaluating the im plant pro­gram on grounds of therapeutic benefit, however. The Working Group w ent on to say that “such studies should be con­ducted in a fashion that does not under­m ine th e p rim arily th e ra p e u tic o b jec ­tives.”7 The ambiguous language in the docum ent reflects one of the concerns in discussions about ethical issues. R efer­ences to “therapy” or to the device as “ innovative th e ra p y ” have te n d e d to obscure the highly experimental nature of the heart. Understandably, criticisms w ere heard to the effect that such lan­guage prom ised more to the patient than could reasonably be expected and thus tended to underm ine the moral fram e­work of the inform ed consent process.

C ertain ly th e re is th e hope tha t the patien t will benefit from receiving the heart. Anything less would be unethical

* Hum ana H eart Institu te International, Louis­ville, KY.

ETHICAL CONSIDERATIONS OF ARTIFICIAL HEART IMPLANTATIONS 5

m anipulation of vu lnerable pa tien ts to serve ends or goals o th er than pa tien t interests. It is not enough to trea t this patient as a means to perfecting devices not in tended for his benefit. Thus, ref­erences to patient benefit are unavoid­able and understandable. Assessing what the heart does to this patient is a moral p re re q u is ite . As T he W orking G roup said, “a favorable balance of risks and anticipated benefits is req u ired .”8

C oncern for th e p a tie n t w ill also require respect for one’s attitudes toward life and death. The assumption m ust not be m ade that just anything can be done to a p a tie n t who w ould o th e rw ise be dead . N or can we accep t m orally th e assum ption th a t ju s t any co nd ition of “liv ing” (being alive) is p re fe rab le to death. W e may and will disagree as to th e te rm s u n d e r w hich one m igh t be preferable to another, b u t that death is a preferrable option under certain circum ­stances can find widespread agreem ent. Death has a proper, necessary, and vital role in the scheme of life and should not be regarded as an ultim ate evil against which all the weapons of medical tech­nology should be marshalled. How this religious and philosophical belief should affect heart implants is not clear. C er­tainly it yields no absolute prohibition to develop ing or im p lan tin g th e device. There are times it is right to intervene aggressively to prolong living. However, there are times it is b e tte r to allow the patient to die.

No am ount of rationalization or en thu­siasm can justify by-passing patien t con­sent. The person with acute cardiac fail­ure, as well as the conscious candidate m ust be given the respect and dignity of g ran tin g perm ission for th e im plan t. Patient rights can be violated as much by imposing as by withholding treatm ent.

A second concern has been raised by c ritics who q u es tio n w h e th e r th e im ­p lan ts should be d one a t all. The objection is based on the belief that little

assurance of a positive outcome can be given the implant recipient. The argu­m ent centers on quality-of-life concerns which focus the same issues that would count morally for or against any proce­dure in medicine. Surgery is morally ju s­tifiable th a t (1) holds th e p ro sp ec t for m eaningfu l p a tie n t recovery or th e advance of medical knowledge with the know ledge and consent of the patien t, and (2) th a t does no t ex ten d suffering unnecessarily or w ithout compensatory factors such as the prolongation of m ean­ingful living. Simply extending the num ­ber of days one has before being declared dead is not necessarily a moral use of sci­ence. As a New York Times editorial put it, “ th e p u rp o se of m ed ic in e is to improve life’s quality . . . To prolong life beyond its natural span is no favor unless reasonab le quality is also p rov ided . W ithout it, the physician has only suc­ceeded in prolonging death. ”9 Restoring, im prov ing or ex tend ing th e p a tie n t’s function ing as a responsive , c rea tiv e , capable , in d e p e n d e n t and p ro d u c tiv e person able to resum e normal routines and pursue meaningful goals is the aim and purpose of therapeutic medicine.

It is also the hope of the artificial heart program. Admittedly in its early stages of developm ent, the heart is hardly able to ho ld o u t th e p rom ise of reasonab le recovery to the patient. The goal p u r­sued is that of a totally im plantable arti­ficial heart that enables patients to func­tion normally and pursue vocational goals and persona l in te re s ts m uch as h e a rt transplant patients are often able to do.

The problem is that the artificial heart is crude and incomplete when m easured by the vision of a sophisticated bio-med- ical device that is totally im plantable and reliably therapeutic. The te ther and con­sole co n stitu te eno rm ous res tric tio n s totally unacceptable in the finished prod­uct. Further, it contributes to o ther life- threatening problems. The “beneficial” or “therapeutic” value for the patient is

6 SIMMONS

clearly ambiguous. Some of the compli­cations have left p a tien ts sev ere ly impaired. Barney Clark was rarely lucid; he suffered severe depression, wanting and requesting to die bu t unable to use the key to turn off his console. Strokes have also com plicated the recovery of all o ther heart recipients.

Som e critics have a rg u ed th a t such complications are sufficient reason to te r­minate the im plant program. The argu­m ent goes som ething like this: “If m ea­sured by reasonable standards of patient recovery, the record is ra ther dismal. On ethical grounds, the procedures should not be perm itted at all because of what they do to the patien t.”

If th e focus is on Barney Clark and Jack Burcham, that conclusion is difficult to avoid. However, if one focuses on W il­liam Schroeder and Leif Stenberg, the calcu lation is q u ite d iffe ren t. W hile I hold considerable sympathy for quality- of-life concerns, I do not find the results sufficiently dismal to warrant term inating th e artific ia l h e a r t p rogram . E nough patient benefit has been realized to jus­tify the belief that an artificial heart can b e d ev e lo p ed th a t w ill qualify as a therap eu tic device. I concur w ith The W orking G roup’s recom m endation that “research on mechanical circulatory sup­po rt system s (M CSSs) shou ld con ­tinue.”10

The most persuasive rationale for pro­ceed ing is found in th e b en e fit th a t countless num bers of heart patients will experience in the future. Two consider­ations give support to the hope that that goal is reasonable to pursue: (1) patient consent for experim entation and (2) the need for further technical research.

As to fu rther research, the W orking Group anticipates that it will require at least two to th re e years to develop a m echan ical h e a r t th a t w ill p rov ide at least two years of reasonably good quality of life.11 Many of the moral issues about

the program are related to the technical p rob lem s w ith th e artific ia l h e a rt. At present, the device can be used morally only in extremis since patient benefit is likely to be marginal, at best.

As to patient consent, I basically agree with Robert Frost’s dictum that it is a person’s right to go to hell in his own way. Or, as Anthony Lewis pu t it, “If, in the process of averting death, a patient chooses to become a hum an guinea pig or to marry a bulky machine, he should be perm itted to do so.” Their com m it­m ent is more noble than that, to be sure. T he su b jec t is a v o lu n tee r, accep ting risks to h im se lf know ing th a t benefits may accrue p rim arily to o th ers . T he research patient is a necessary stage in d eve lop ing new techno logy b e tw een experim ents with animals and its useful developm ent for hum an subjects. W ith­ou t such vo lu n teers , th e accep tab le device will never be developed.

The human community both benefits from such sacrificial com m itm ents and lends support and approval to those who volunteer. Such pioneers enrich our soci­ety, add depth to moral ideals and give perspective to what is worthwhile about living. Perm itting people to volunteer for experim ental procedures while protect­ing their autonomy and informing them of the risks to be anticipated has long­stan d in g su p p o rt in bo th m edical and religious communities.

T e r m i n a t i n g t h e E x p e r i m e n t

P erhaps th e m ost d ifficu lt e th ica l quandary is confronted in making deci­sions about term inating the experiment. Severe neurological complications leav­ing th e p a tie n t com atose, w ith loss of com m unicative skills or w ithou t cogni­tion are certainly possibilities that must reasonably be anticipated. The greatest problem with the consent form signed by

ETHICAL CONSIDERATIONS OF ARTIFICIAL HEART IMPLANTATIONS 7

Barney Clark was that it assum ed either he would be able to make decisions about treatm ent or that he would die. It m ade no provision for the possibility that he m ight survive b u t w ith “severe confu­sion, m ental incom petence or com a.”12

That oversight was not fully corrected in subsequent consent forms, which in fact, do designate a surrogate to act for the patient, bu t only in m atters perta in­ing to add itio n a l co rrec tiv e surgery . W hat is needed is an explicit anticipation of patient wishes in the event of adverse outcom e in w hich th e question of te r ­m inating the experim ent altogether b e ­comes an issue. This can be dealt with in the consent form, through attaching a Living Will or by designating a person with the durable pow er of attorney.13

There are people who object to any talk of term inating an experim ent which is “life susta in ing .” H ow ever, tha t the p a tie n t has b o th a legal and p e rso n a l right to have treatm ent refused on their behalf was clarified in the Quinlan case. T he co u rt ru led th a t it was p rec ise ly “because if they w ere com petent, they would have that right, and to deny it to them because they could no longer p e r­sonally exercise it would devalue their lives.”14

The case of the com petent patient who desires to term inate the experim ent p re ­sen ts an even th o rn ie r d ilem m a. The problem was touched upon bu t not fully reso lved by The W orking G roup on M echanical C irculatory S upport of the National H eart, Lung and Blood Insti­tu te (May, 1985). The study actually side­stepped the touchy issue of w hether the patient had a right e ither to order the machine turned off or to do so him self It acknowledged that “gratuitous” activ­ities “not designed to serve his health in te rests” could certain ly be d iscontin­ued at patient discretion. Included, how­ever, w ere those tests th a t serve only “th e in terests of re sea rch .” The s ta te­

m en t hedges, however, w here discon­tinuing “medical therapy” or “withdraw­ing from th e p ro to co l,” is co n cerned . S trong and significant qualifiers are introduced: first, the decision is not the patient’s acting alone, bu t would involve “ d iscussion” w ith h ea lth professionals and th e p a tie n t’s family, and second, som e “o th e r su itab le th e ra p y ” m igh t have to be substituted.

The net result of this logic is to place the patient in a frightening “Catch-22.” Yes, the docum ent says, you may freely volunteer for the experim ent and you are free to withdraw from it. But, no, once you have received the implant, it is no longer your choice acting alone to opt out of the program. The statem ent makes it clear that the patient is not simply to be handed a key to the device and left to do as one chooses. The reason given for this significant co n stra in t is th a t such a patient decision would “create consider­able disturbance.”

A generous interpretation of this doc­um ent is that such “discussions” are nec­essary to p rev en t precip itous and p re ­m ature actions on the part of the patient. The health care team is responsible for patient well-being and that includes at tim es p ro tec tin g p a tien ts from th e m ­selves. It is well not to be cavalier about such serious decisions. They are and should be the result of deliberations in a community context of caring and love.

A nother read in g of th e d o cu m en t yields a portrait of the implant patient as a ward of the intensive care unit (ICU) w ith whom m en ta l gam es are b e ing played, assuring him of “freedom to dis­con tinue” while all th e tim e in tending quite the opposite. The docum ent hints at this saying that the decision-making process w ould be “ sim ilar to th a t of choosing to disconnect a patient from the ventilator.” This is an appropriate pro­ced u re in th e case o f th e com atose or b ra in dead p a tien t. H ow ever, if it is

8 SIMMONS

in tended to apply to the com petent, con­scious patient, the procedure is morally problematic.

The tragic story of William Bartling, for instance, makes this requirem ent te r­rib ly d iscom forting . H e was n o t only denied the right of having a respirator tu rn e d off b u t his hands w ere tie d in order to prevent his removing the tubes; he became, in effect, a “Prisoner in theI.C .U .” If one of the “disturbances” to which the study refers is the social con­troversy over the right to die, focus on patient rights in experim ental medicine becom e neg o tiab le if n o t expendab le . The moral rule that should be protected against all assault is that of patient auton­omy and th e freedom to d ec id e th e course of action accep tab le to them . W here th e p a tie n t is co m p e te n t to d ec ide , his decision and no t som eone else’s should prevail. The sentence most to be em phasized in the study docum ent is that which says “. . . the patient may choose to discontinue the device, know­ing that his act will result prom ptly and certainly in his or her d eath .”15

The key given to Barney Clark contin­ues to have enormous symbolic signifi­cance on the moral use of this innovative device. The “key” m ust rem ain in the hands of the patient. The right to refuse treatm ent is an im portant moral corollary to the basic principle of medical ethics, namely, to treat the patient as a person, a free moral agent. As the Saikewicz case showed, the value of life is enhanced by liberty. It is “lessened not by a decision to refuse treatm ent, bu t by the failure to allow a com petent hum an being the right of choice.”16

The consent docum ent should clearly spell this out as establishing a covenant betw een physician and patient that will be honored after appropria te consulta­tions. That it would have acceptable legal standing is fully established. It is not a m atter o f aiding suicide or of m urder.17

D enying patien t rights to refuse tre a t­m en t in th e p o st-im p lan t stage raises questions of the agreem ents en tered dur­ing the informed consent process. The patient has no way of knowing the full im pact psychologically, physically and spiritually of being attached to an MCSS. The te ther and the ever-present console will place considerable strain on a p er­son’s capacity to endure the frustration of constraint and limitation of mobility. The noise of the drive mechanism may place an intolerable burden on one’s ner­vous system far beyond what m ight have been reasonably anticipated.18 The result can be virtually disastrous for one’s m en­tal state driving th e pa tien t into acute claustrophic or o ther anxiety reactions. Should that happen, the very invention designed to aid the patient becomes the device that destroys the ego strength of th e p a tien t. T hen to use th e p a tie n t’s m ental state as the basis for declaring him “incom petent to decide” would be to u n d e rm in e th e m oral basis for th e experim ent itself.

T he consen t d o cu m en t th e re fo re n eed s to p rov ide a clearly w orded “escape clause” that anticipates various negative outcom es and assures th e patient that he will not have “to bear the u n b earab le and to le ra te th e in to le ra ­b le .” 19 W e are again d ealing w ith th e problem of differing expectations. The patient enters the agreem ent expecting ce rta in benefic ia l ou tcom es and even willing to bear discomforts for the sake of th e ex p erim en t. B ut th e re a re o u t­comes the patient has no way of reason­ably expecting since he has no experi­ence upon which to base his imaginative projection into the post-im plant phase. H e may even be “denying” such possi­bilities.

In any case, th e re are ou tcom es to which reasonable people would certainly not agree and these can be discovered only in situ. Should th a t h ap p en th e

ETHICAL CONSIDERATIONS O F ARTIFICIAL HEART IMPLANTATIONS 9patient’s consent for treatm ent is w ith­drawn in the form of a request to te r­minate the experim ent. He has not and should not be thought to have agreed to any and everything that m ight happen by entering the experim ent. Permission to do one thing or even to do many things is not the same as perm ission to do any­thing or to be m aintained in any state. Plainly some conditions of “survival” are u n accep tab le in th e value system s of most people and some circumstances of existence in a conscious state can be a horror too great to imagine. Im prison­m ent or coerced confinem ent is degrad­ing to medicine and depersonalizing to patients. As N elson puts it, “research w hich v io lates hum an freedom is no t moral progress.”20 It is a possible result of the artificial heart program that is to be avoided at all costs.II. Social Policy: The Ethics of Cost

Som e of th e m ost vexing q u estio n s about the artificial heart are posed by the costs of developing and making available the artificial heart. Dr. Lewis Thom as says that the program is “insupportably expensive.”21

The costs are enormous. The National In s titu te of H ea lth (N IH ) has a lready invested over $200 million in research, some of which is represented in the Jar- vik-7. Barney Clark’s im plant and m ain­tenance cost $250,000. The Report of the National Heart, Lung and Blood Insti­tute Working Group on Mechanical C ir­culation recently estim ated that the heart program would cost the nation approxi­mately $3 billion. (O ther estimates range up to $40 billion.)

By 1990, Federal costs for health will be in creased by 10 p e rc e n t from th e heart program but will treat less than two p e rc e n t of th e p a tie n t popu la tion . Expenses for the heart are comparable to o ther exotic trea tm en ts or procedures such as liver transplants, bone marrow

tran sp lan ts , h em o p h ilia trea tm en ts , renal dialysis, and pacemakers.

Estimates of cost are likely to be far too conservative . In 1972, C ongress voted to pay for renal dialysis for every American who needed it thinking the bill would be about $140 million per year. The first year’s cost was over $241 million and it now exceeds $2 b illion and accounts for 10 percent of all M edicare paym ents for physicians. O ver 80,000 patien ts are trea ted including octogen­arians and those dying with term inal ill­ness.

As many as 50,000 victims of heart dis­ease stand to benefit from the artificial heart. If each costs only $150,000, the bill would be a staggering $7.5 billion. W hat is being purchased? One scenario was th a t w ith o u t a h e a rt im plan t, th e patient would live perhaps six months at a cost of approximately $22,000. W ith an im p lan t o p e ra tin g at m axim um effi­ciency, one m ight expect a 54-month sur­vival costing $150,000. At b est, four years would be purchased for a cost of $38,000 per year. These would be p e r­sons totally dependent on others to pro­vide the costs. To health care expenses must be added the costs of Social Secu­rity, housing and attendant costs for what will likely be debilitated persons. Taken all together costs may be more like $40 billion per year.F u n d i n g

Several problem s can be isolated. The first is the economic question: how many d e p e n d e n ts can a p roduc tive society carry? Already health costs are 10.8 p er­cent of the gross national product. More could certa in ly be b o rn e b u t at w hat po in t does th e younger g en era tio n become too taxed to tolerate the burden?

W e are now moving toward 30 percent of the American population being depen­dent — counting those over 65 and those under 18. Thirty percent of all Medicare

10 SIMMONS

costs occur in the last year of life. Only slowly do Americans realize they cannot afford everything they want. The stag­gering deficit is a financial burden for our children to pay. W here do we cut the budget?

“ I t ’s ju s t too e x p en siv e ,” says Dr. Robert Wilson. “W e just can’t afford it. It will im prove the health of com para­tively few people. The costs will be astro­nomical to take care of a few older people whose lifestyle may have contributed to their health problem s.”

W ilson’s alarm is echoed by certain so­c io lo g is ts w h o a re p r e d ic t in g th e makings of a m ajor in te r-generationa l conflic t. As th e p opu la tion becom es older and exercises enorm ous political leverage, the productive m em bers will begin to resen t the economic burden.

Governor Richard Lamm’s (D-Colo.) sage advice is hard to accept by people who have begun to believe that clinging to this life is all im portant, regardless of cost to society or family. Lam m re ­m inded us all of “our duty to die and get out of the way with all our machines and artificial hearts, so that our kids can live a reasonable life. High tech m edicine,” he said, “is really the Faustian bargain, where for a few extra days of life, we have to pay the price that could bankrupt the country. ”22

The artificial heart is ushering in a new era in many ways. One question it will force upon us is th a t o f th e ju s tif iab le expense of ex ten d in g life. P erh ap s as David B lum enthal has suggested, this will be “the first instance in which . . . the price of preserving the myth that life is priceless may prove too h igh.”23

P r i o r i t iz i n g

A related problem is the fact that while exotic m edical p ro ced u res have high media priority, 15 percent of Americans go w ithout basic health care. W hat Alex

Capron has called the “dirty little secret” is th a t we a lready have h e a lth care rationing in America. Access is by insur­ance, and insurance is related to income level. Thirty-four million Americans go w ithout basic care while vast sums are lavished on a fortunate few. A man may die of a stab wound to the head — for which relatively inexpensive and thera­peutic care is available — even though he has no other life-threatening diseases. Another man with end-stage heart dis­ease has enorm ous sum s of m oney, energy, and exotic technology lavished upon him — with little or no prom ise of cure.

The basic com m itm ent to justice of any system must be questioned w here exotic technology, not human need, is the p ri­m ary c rite rio n for a llocating scarce resources. The m om entum is even fur­ther in that direction, however m uch it may contradict the egalitarian ideal upon which this society is based.24 As the pub­lic burden grows, exotic m edicine will be available only for th o se w ho can pay. Some will be able to buy an extension of life; others will not. (Already countries like Britain do this since renal dialysis is not available through Public H ealth Ser­vice for those over 55; however, it can be obtained privately.) This tren d simply re fle c ts w hat we a lready ex perience: M oney is pow er and costs for n e e d e d goods and services m ust be provided. If the public sector cannot or will not, only those with private resources can obtain them .

A possible resolution of this problem may lie in allocating public funds p ri­m arily for preven tive and health m ea­su res and allow ing p riv a te funds to u n d e rw rite exotic (and optional) h igh tech research and developm ent. In this way a g rea t dea l m ore longevity and health, for that matter, can be purchased with public funds while not burdening or breaking the back of the national bank to

ETHICAL CONSIDERATIONS OF ARTIFICIAL HEART IMPLANTATIONS 11provide costly care for a precious few. The Artificial H eart Program at H um ana Hospital* is a step in that direction.

A l l o c a t i n g

A th ird e th ica l issue re la te s to th e selection process th a t w ill b e u sed to d e te rm in e who rece iv es scarce resources.

The p ro b lem is c re a ted w hen m ore p a tien ts than reso u rces ap p ea r on th e scene. Pressure will increase for scarce artificial organs in c lu d in g th e h ea rt, eyes, pancreas, ear, skin tissue, etc.

The panel sponsored by the National H eart and Lung Institu te recom m ended that availability not be based on o n e’s ability to pay, but should be part of social financing of m edical care in g enera l. They also re je c te d m aking decisions based on social w orth criteria, believing in the notion of the “equal w orth” of all persons. The criteria favored w ere those of medical indicators (patients who have the best chance for recovery and do not qualify for other therapies) or that of ran­dom se lec tion by lo tte ry — a ty p e of blind test that presum ably institutional­izes the notion of equal dignity and equal access.

However, in light of the total complex of issues re la ted to th e fu tu re can the utilitarian calculus finally be avoided? The e th ica l q u estio n goes b ey o n d th e notion of equal dignity and w orth and includes social well-being and survival.

Suppose one h ea rt is available at a h e a rt in s titu te and two cand ida tes appear. O ne is a d ru g ad d ic t, a s tre e t derelict afflicted with heart disease. The other is a prom inent physician known for community service and caring, com pe­ten t surgery (just to make the case easy!) who is suffering from the same disease. By now th e h e a r t is so p h is tica ted and

* Louisville, KY

to tally able to p rom ise m eaningfu l patient recovery. W ho gets the device?

The way th a t q uestion is answ ered reveals our moral and religious assump­tions about equal w orth and dignity of persons, distributive justice and the eth ­ics of economic calculus. Joseph F letcher says it would be stupid and immoral not to use social worth criteria in allocating scarce resources. The lottery is irrespon­sible for it runs the risk of wasting social investm ents and p e rp e tu a tin g d e p e n ­dency rather than supporting those who in tu rn su p p o rt th e social system . In purely economic terms, it is a re tu rn on a social investm ent. “To those in whom we have invested so much, let us invest more that they, in turn, can render ser­vice to the com m unity.”

This may shock ears accustomed to tra­ditional moral approaches. But it is a shift th a t is b e in g forced by th e in ev itab le forces of advancing technology and the increasing complexity of society with all their attendant and consequent costs.

ConclusionIn short, the technology of exotic m ed­

ical science is facing old moral questions th a t m ust be d ea lt w ith in new ways. There can be little question that hum an­kind is playing God — acting out god­like powers through sophisticated tech­nological gadgetry that manipulates life and death in ways unimaginable a gen­era tion ago. All th ese p rocesses — w hether intervening to sustain life or to shorten the dying process — are god-like decisions. W e are playing God in new ways, for new stakes and with new pos­sibilities for the future. Let us do so res­ponsibly, w ith due regard for our cor­porate finitude, an unquestioning caring for each patient, and a stewardship of our resources th a t will assure a reasonable and desirable future for those who come after us.

12 SIMMONS

References1. Stanley J. Reiser, “The Machine as Means and

End: The Clinical Introduction of the Artificial H eart,” in A fter Barney Clark, ed. Margery W. Shaw (University of Texas, 1984).

2. See, for instance, “The Artificial Heart and Assist Devices: Directions, Needs, Costs, Societal and Ethical Issues,” The Working Group on Mechan­ical Circulatory Support of the National Heart, Lung, and Blood Institute, May 1985. (Hereaf­ter, cited as The Working Group.)

3. Christiaan Barnard, One Life (Macmillan, 1969), p. 348.

4. Paul Ramsey, Fabricated Man (Yale University Press, 1970, p. 151.

5. See IRB: A Review o f Human Subjects Research.6. See IRB: A Review o f Human Subjects Research.7. The Working Group, p. 21 (see reference 2).8. The Working Group, p. 22 (see reference 2).9. Quoted by Dick Kaukas, “Artificial H earts,”

Scene Magazine, The Louisville Times, Saturday, September 22, 1984, p. 5.

10. The Working Group, p. 35, (see reference 2); see also Harry Schwartz, “Don’t Pull the Plug on Artificial Heart Tests,” The Wall Street Journal, Sept. 1985.

11. The Working Group, p. 25 (see reference 2).12. George J. Annas, “C onsent to the Artificial

Heart; the Lion and the Crocodile,” Hastings Center Report, April, 1983, p. 21.

13. George J. Annas, “Lion . . . ,” p. 20 (see refer­ence 12).

14. See George J. Annas, “Prisoner in the I.C .U .: the Tragedy of William Bartling, ” Hastings Cen­ter Report, Dec. 1984, p. 29; and “Reconciling Quinlan and Saikewicz: Decision-Making for the Incompetent Patient, ” American Journal o f Law and Medicine, 3 (1979), 367.

15. The Working Group, p. 23 (see reference 2).16. Superintendent o f Belchertown V. Saikewicz,

370 N .E . 2d 417, 426 (Mass. 1977; cited by Annas, “Prisoner . . . p. 28.

17. George J. Annas, “Prisoner . . . p. 29 (see ref­erence 14).

18. The Working Group, p. 27 (see reference 2).19. Foster v. Tourtellotte, USDC No. ev-81-5046-

RMT, Cent. Dist. CA (1981), cited by Annas,“Prisoner . . . ,” p. 29 (see reference 14).

20. James B. Nelson, Human Medicine (Augsburg, 1973), p. 95.

21. Time, Dec. 10, 1984, p. 70.22. Time, Dec. 10, 1984, p. 70.23. The Courier-]ournal (Louisville, KY), Nov. 27,

1984, Tues. p. A-6.24. Thomas A. Preston, “Who Benefits from the

Artificial Heart?” Hastings Center Report, Feb.,1985, p. 87.