The exhaustion of Principled Bioethics. In search of new solutions
Gonzalo Herranz, department of Bioethics, University of Navarra.
lecture Delivered at the School de Medicina de Málaga, 1997.
History and triumph of Principlism
The internal history of the Principles
The impossible balance and hierarchy of Principles
The Effects of Principlism on the Doctor/Patient Relationship
Criticisms and counter-criticisms of Principlism
Greetings and thanks.
A thought-provoking topic .
For a few years now, the rumour has been slowly growing, which is gradually turning into a clamour, that the famous Principles of Bioethics are in crisis. There is even talk that a revision of the model of the ethics of principles, which has been dominating the thinking and the internship of Bioethics for the last 20 years, is necessary.
Whether this is just another manifestation of the itch for change that is attacking us as we approach the new century or the new millennium; or whether it is a movement that will last and profoundly change things: nobody knows. We will have to wait. We cannot dismiss the idea that, under the banner of the 2000s, high quality goods, but also some trinkets, are circulating.
For the moment, it is worth asking ourselves what is being said and written about the exhaustion of the Bioethics of Principles, of Principlism (I use this expression, incorrectly in Spanish, very much used in English, although it inevitably has a pejorative accent, to make it clear that I am referring specifically to the four Principles, to the tetrad of principles (respect for autonomy, non-maleficence, beneficence and justice, which, since the United States, has colonised Bioethics everywhere).
And it is also worth asking what is being said and written about the alternatives and replacements that are on the horizon. These questions and the answers we can give to them, if any, ask us what we are going to do. If things are going to change, are we going to be mere spectators of change or are we going to participate in it?
I believe that this is one of the most interesting phenomena in the brief but intense history of bioethics.
History and triumph of Principlism 
To inquire into the fate of Principlism, we need first to consider, however briefly, how it came into being and developed, why its triumph has been so spectacular, and how, in spite of this, there are those who predict a weak future for it. That is, we need to take a brief medical history to find out whether or not he is ill and whether his illness has a poor prognosis.
In the early 1970s, when the field of bioethics was, as it will be forever, dominated by the confrontation between deontologists and utilitarians (consequentialists), it was thought worthwhile to cool down the temperature of the discussions and to increase the spectrum of practical solutions to ethical problems and dilemmas by introducing some new ideas and procedures. Because, all too often, when discussing basic problems, consequentialists and deontologists were entrenched in irreconcilable positions, they pushed the problems into dead ends, into situations where there was no longer any way to progress towards satisfactory solutions. It also happened, paradoxically, that when minor issues were raised, deontologists and utilitarians usually arrived easily at conclusions, if not identical, then quite similar, which was the cause of a certain boredom.
Lastly, bioethical discussion ran the risk of remaining at discussion , a highly sophisticated academic site that was involved in in-depth meta-ethical issues, in which it was very difficult for doctors and nurses, patients and their families, who were, after all, those involved in the daily conflicts of medical ethics, to participate.
In order to achieve a path average between deontologism and consequentialism, between rules and regulations and discipline professional and ethical subjectivism, and, finally, to democratise the bioethical discussion , to achieve these ambitious aims, Principlism was born.
It was a very good solution internship, as it diverted the attention of those concerned from the serious basic problems of ethical theory rules and regulations, to focus on the more down-to-earth issues, namely the decision-making process. This made it possible to resolve the situations I have just pointed out: to set aside the insoluble problem of the fundamentals and to create instruments capable of offering more varied solutions, of broadening the range of responses, to concrete bioethical problems.
In effect, Principlism was saying that it was more interesting to move on the level of what could be called middle-level Principles, that is, not on the foundations of normative theories, but on the instruments, the tools that everyone uses in their daily life, and independently of their basic convictions, to reach practical conclusions, than to worry uselessly about making peace with metaethical foundations. They were convinced of one thing: that it is easier to reach a agreement if the premises of the ethical discussion consisted not in arguing at the deepest level of theory rules and regulations, but in using all the same instruments, the same process, to make decisions.
The model was developed, proposed and disseminated by Tom Beauchamp and James Childress, building on the ideas that had shortly before informed the famous Belmont report , which the Commission for the Protection of Human Subjects in Biomedical and Behavioural research had produced at a meeting held in February 1976. The first edition of his Principles of Biomedical Ethics appeared in 1979, although his foreword is dated December 1978. The success of the book was spectacular. The second edition was published in 1983, the third in 1989, the fourth in 1994. The book has grown in size (from 314 pages in the first edition to 364, 470 and 546 pages in successive editions), in subject matter and, apparently, in prestige. It is undoubtedly the most cited of all Bioethics books. It has been, in today's pluralistic society, an element, if not unifying, then omnipresent. American principlism is informing many texts on medical and nursing ethics, it appears as a guideline in the regulations of hospital ethics committees, it has provided the logical skeleton for many court rulings. It has capillary infiltrated the fabric of medical ethics. It has become the dominant way of thinking in medical ethics, for it has had a dissemination apparatus unrivalled in the world. As Beauchamp himself has noted, "In the early history of modern bioethics, the Principles were used to create a hempen canvas of general guidelines in which the core elements of morality were condensed and provided people coming from different fields with an easy-to-understand set of moral standards. The Principles were the anchor of the youthful bioethics of the 1970s and early 1980s and created a sense that bioethics stood on something firm, something more solid than disciplinary prejudices or subjective judgements.
But the success was not only in the promise and accessibility of the Principles themselves. A powerful apparatus was put at the service of their dissemination. Pellegrino, in 1994, explained an important reason for this overwhelming success: "The doctrine of the four principles has been taught to hundreds of health professionals through a bioethics course taught every year for the past 18 years by the academic staff of the high school Kennedy School of Ethics at Georgetown University. Through its graduates, some 200 each year, this programme has had a strong influence on health professionals and on ethicists who teach in medical schools or serve on committees in clinical settings. A large issue of young doctors and nurses have had as their ethics teachers graduates of high school Kennedy who are now directors of bioethics centres. The tradition of the four principles is now so widely accepted that some of its critics have branded it with the label mantra, to imply that it is often applied automatically and without a solid intellectual and moral foundation". Pellegrino, DE. The Metamorphosis of Medical Ethics. A 30-Year Retrospective. Arch Patol Lab Med 1994;118:1065-1069).
The internal history of the Principles
Why are there four Principles, and are there those four? Beauchamp and Childress basically did nothing more than add the principle of non-maleficence to the three that had been included in Belmont's report . And the Commission that had drafted the latter did not rack their brains to justify and substantiate their decision. It simply said: "Three general prescriptive principles or judgements have been identified in this report , which are of relevance to the research on human beings. There may be other principles equally relevant. But these three are very broad (...) and can provide an analytical framework to guide the resolution of the ethical issues raised by research on human subjects".
design Beauchamp explains this with commendable sincerity: there was no deep theoretical purpose , no task of substantiation, but a mere discretionary choice, a pragmatism of common moral sense, a conviction that the principles chosen would be a financial aid and would work: "The choice of these four moral principles as a framework for decision-making in health care derives in part from the role they have always played in professional action and tradition. The obligations and virtues of health professionals had been stamped, over many centuries, by professional commitments to provide medical care, to protect patients from the harms of illness, and to provide benefits over and above the harms that medical intervention might cause. These obligations were contained in the rules of non-maleficence and beneficence, and are preserved and expressed in the two principles built upon this tradition.
But the structure of the principles goes far beyond these commitments, as it includes traditionally neglected fragments of morality, such as respect for autonomy and justice. In the early days of modern bioethics, the traditional preoccupation with ethical models based on beneficence and non-maleficence needed to be corrected and directed towards an autonomic model of patient care and, at the same time, needed to address a set of moral and social concerns, in particular those related to the implementation of social justice that would protect the vulnerable and create a social system of benefit and burden sharing. These four principles were thus necessary to provide sufficiently comprehensive coordinates for biomedical ethics". (Beauchamp TL. Principlism and its alleged competitors. Kennedy Inst Ethics J 1995;5:181-198).
Beauchamp insists that the principles should not be understood as rules to be applied according to a model of "applied ethics", but as guidelines, as protocols, to be interpreted and specified when it comes to making clinical decisions or proposing courses of action.
It is true: the Principles were not born with the intention of becoming a system. But when people started to apply them, they demanded that they become a system, that they become a way of thinking, not a toolkit. And there, their crisis of success began.
The impossible balance and hierarchy of Principles
Real history has shown that the Principles were born disjointed, that they were going to go their separate ways, due to the different dynamism that each of them carries within them, to the different ethical lineage from which they were born. And also the cultural terrain in which they were born.
In fact, as Søren Holm has shown (Not just autonomy. The Principles of American biomedical ethics. J Med Ethics 1995;21:332-338), the place of birth, the American citizenship of model, implied, because of individualism and a mentality more juridical than ethical, more inclined to rights than to virtues, a compulsory underdevelopment of the obligations implicit in the principles of beneficence and justice, in their aspects of social justice.
In fact, the principle of autonomy became the pole star that guide both the theoretical reflection on, and the internship of, the negotiations of patients and doctors in order to decide what should be done. This can easily be made visible. It occurred to me, in preparing this draft , to consult the Bioethics-line bibiographical database for the period from 1973 to December 1996. These are the data. Autonomy is a topic dealt with in 6774 papers. Justice in 3251. Beneficence in 1937. The fourth principle, non-maleficence, appears in only 20 papers. Autonomy takes the lion's share: it accounts for more works than all the others put together.
It is clear: the principle of autonomy has become increasingly dominant, not only on bibliography, but in the real world. It has irreversibly defeated the harsh paternalism of the old days, it has added energy to the patients' rights movement, it has made the process of obtaining a patient's informed consent as ordinary as taking his temperature or measuring his blood pressure. It has made the decision-making process an easy sport: it allows us to reach almost any answer we like.
It is worth considering things in some detail. There is no doubt that, at the beginning, the Principles were offered as tools of work, as instruments of analysis and decision, which could be used ad libitum, choosing the one or ones that best suited each problem, the one that best adapted to the solution of each case. The choice was almost intuitive, it was made prima facie. At the beginning, the main problem was to determine how many and which were these tools, that is, to specify the principles. And these were the four known ones.
But, as the years went by, a second and fundamental problem had to be addressed: that of coordinating them, of balancing them. Nothing sample does this better than Beauchamp and Childress' own book. Although its degree scroll has not changed in its four editions, its content has undergone profound changes, which have made each edition almost different from the previous ones. And a large part of the authors' effort has consisted in confronting the tendency of the four principles to disperse, to compete with each other, to overcome their resistance to articulate themselves into an integrated and organic whole.
Many efforts have been made to balance and articulate the principles, starting with Beauchamp and Childress, especially in the fourth edition of their book. One of the most serious efforts at integration is that developed by Diego Gracia in his book Fundamentos de Bioética and in subsequent works, in which, in addition to showing that the principles are fallible, lack absolute character and admit exceptions, that they are neither purely deontological nor purely teleological, he proposes to organise them hierarchically and strip them of their horizontal structure. After recognising that there is only one absolute principle of moral life, which consists of abstract and general respect for the human being, he points out that in determining the material content of this respect, there is no choice but to make use of certain principles which are, in themselves, contingent and relative. Consequently, he postulates that, in all moral reasoning, there must be at least three moments. One is absolute, but merely formal: the respect to be had for every human being. And two others, relative and material. Of these, the first is constituted by the four bioethical principles, divided into two levels: one private, which includes the principles of autonomy and beneficence; and the other public, which includes the principles of non-maleficence and justice. The second material moment, which deals with singular and specific cases, requires the analysis of their context, including their circumstances and consequences. In Diego Gracia's opinion, only when these are followed and, therefore, balancing principlism with contextualism, can one arrive at a moral reasoning that is correct and complete.
This is not easy. As Holm rightly points out, the content of the Principles is applicable only in an American context: they cannot be immediately transferred to other cultural contexts, without a thorough reworking of the content of the principles to each cultural context and without an explicit recognition that the four principles need to be supplemented by other ethical considerations. Diego Gracia has done much to "Europeanise" the Principles. But their acclimatisation is not easy: either the Principles are cultivated in the confined and artificial environment of a greenhouse, with the mimetic ethics of informed consent imported from the USA that sometimes becomes a naïve exaltation of the principle of autonomy; or they are subjected to a pruning of excess branches and the grafting of local traditions, which renders them unrecognisable.
The American David Thomasma tells a significant anecdote of the America/Europe polarity around the Principle of Autonomy, which for him meant something like his Damascus gate. The anecdote reveals how deeply localist, in the American sense, the primacy of autonomy is. He tells of attending, in 1984, a meeting with colleagues from the Netherlands to discuss the book he and Pellegrino had written on the Philosophy of medicine. During the meeting, his Dutch colleagues continually criticised the value placed on individualism: on individual rights and the primacy of the individual patient in the doctor/patient relationship. Thomasma was puzzled, because in the book under review no special emphasis was placed on the notion of autonomy. Exasperated by the allusions and reticence of his Dutch colleagues, Thomasma exploded. And he told his colleagues to keep in mind that the notion of individual autonomy was the most revolutionary thing in human history, because it served and serves to place limits on the power of the state and the community, on their ability to govern the lives and conduct of individuals. None of the 30 Dutch colleagues attending meeting agreed agreement with this statement. Thomasma confesses that it was a culture shock for him to learn that, for his European colleagues, the most revolutionary concept in human history was social solidarity. Obviously, it is not possible to separate principlism from its social-historical context. (Thomasma DC. Beyond autonomy to the person coping with illness. Cambridge Quart Healthcar Ethics 1995;4:12-22).
Principlism is therefore in need of a profound revision. To my mind, nothing is more pathetic in this regard than Beauchamp and Childress' acknowledgement in the 4th edition of their book of the inability of the four principles to solve the problems of medical ethics. Here is their humble confession of inadequacy: "It is not our attempt to formulate a general ethical theory, nor do we claim that our four principles imitate, are analogous to, or substitute for the fundamental principles of the great classical theories, such as utilitarianism (with its principle of utility) and kantism (with its categorical imperative)... As we have already pointed out, the principles we propose are so modest that they cannot provide an adequate basis for deducing most of what can fairly be required to be known about moral life".
But the Principles that Beauchamp and Childress coined and circulated are still the common currency in many places and in many mindsets. It is hard to give up an authoritative and popular system of moral reasoning, "even though it is not capable of giving definite answers to moral problems, or, perhaps more accurately, because it is capable of producing almost all the answers we could wish for" (Holm). In fact, the Principles are still out there, and, like the genie escaped from the vial, there is no way to reinstate it in its place.
For me, the greatest reproach that can be levelled at Principlism is that it has morally weakened the doctor/patient relationship.
The Effects of Principlism on the Doctor/Patient Relationship
The Principles, by demolishing the old wall in which the hard paternalism of yesteryear was entrenched, has at the same time opened up an ideological gap in the doctor/patient relationship, small at first, but widening as the pre-eminence of the principle of autonomy has become more radical. There is no doubt that the massive expansion of the principlist mentality has had a profound effect on the internship of medicine. It has changed it, especially with regard to the ethics of doctor/patient relations.
Dan Brock tells it well (Brock DW. The Ideal of Shared Decision making Between Physicians and Patients. Kennedy Inst Ethics J. 1991;1:28-47). Brock points out that the principle of autonomy has allowed what he calls the division of work to take root in the doctor/patient relationship. Brock states that, on the one hand, the physician has been left with the function of providing data about the diagnosis and of providing prognostic predictions in relation to the different treatment alternatives. His information must be empirical, scientific, factual, neutral, not ideologically or ethically biased, so as not to limit the patient's autonomy. It is up to the patient, on the other hand, to provide the values, his concept of what is good for him and the good life he wants to lead, and, with these values, he evaluates the treatment alternatives and chooses the one that suits him best.
Thus, the physician provides the science and technique; the patient, the ethics. In this division of work, the doctor is practically freed from ethical responsibilities: he is much more an efficiency than a conscience. He is obliged to move in ethical neutrality and will carefully refrain from invading his patient's private field of freedom and decision.
But this way of seeing things presupposes the exorbitant and unacceptable assumption that medicine is a science, and even a profession, free of values. It means that the concepts of health and illness, of normal and pathological, of suffering and adaptation are pre-moral notions for the physician, as they fall entirely and exclusively in the territory of evaluation and the patient's decision.
Moreover, the accentuation of extreme autonomism, that is, of autonomy as the dominant principle, leads to a conclusion, devastating for medical ethics, that ethical judgements lack cognitive content, are mere emotion or mere attitude, and are therefore neither true nor false, right or wrong. Ethical dialogue and negotiation is not a rational exercise, but an attempt at non-rational persuasion. The patient's ethical power is absolute, his or her convictions incorrigible, says Brock, in the sense that they impose themselves per se, may be unchangeable, and override those of the physician.
This is expressed in the widespread doctrine of Engelhardt. He elevated autonomy to a position of primacy among other principles and considered it as a condition for ethics to exist, not only in the field of health care, but in the heart of any pluralistic society. Engelhardt argues that in a pluralistic environment nothing can be taken for granted, nothing is certain or acceptable. The starting point of any "peaceful discussion" and the only a priori of ethical coexistence must be respect for the self-determination of the individual. In particular, the physician's strong moral convictions must be relegated to his or her internal regional law . Respect for the client's autonomy obliges, in the public context - and medicine is per se a public relationship - to renounce imposing or expressing one's own moral convictions in order to give those of the person requesting an intervention from us, even if we disagree with their morality. (Engelhardt HT. The Foundations of Bioethics. New York. Oxford University Press, 1988 and 1995).
Criticisms and counter-criticisms of Principlism
The critique of principlism began openly in 1990, when the Journal of Medicine and Philosophy devoted its April issue to a "Philosophical Critique of Bioethics". Danner Clouser and Loretta Koppelman, the editors of that monographic issue highlighted, as a characteristic feature of the first 20 years of biomedical ethics, its esprit de corps, its massive adherence to the Principles, which is in stark contrast to what was happening in the other fields of ethics and Philosophy, where individualism and disagreement are the hallmarks of intellectual business . They explain the phenomenon in the fact that bioethics was a newborn discipline , extremely novel, dedicated to an intense exploratory work , with fresh concepts. But they added that, with the advent of the third decade, it was time for self-criticism.
In this issue of the journal, Clouser and Gert (Clouser KD, Gert B. A critique of principlism. J Med Philos 1990;15:219-236) set out to expose the inadequacy and deviance of principlism. They denounced the principles as useless as guides for action, which could function at most as a list of points to be considered when discussing bioethical problems. They also stressed their status as loose, mutually unconnected pieces, each of which functioned as an incomplete ethical theory that easily collided with the others. What was most serious for Clouser and Gert was that there was no ethical theory that could serve as a unifying basis for them and could make them into a system.
Clouser and Gert's article was followed by others. Some continued the dismantling of principlism; others tried to repair the damage of the criticisms. In 1991, Dan Brock (Brock DW. The ideal of shared decision making: between physicians and patients. Kennedy Inst Ethics J 1991;1:28-47), in his analysis of the two polar models of the doctor/patient relationship, while subjecting paternalism to a harsh critique, considers the destructive consequences of the submission of the doctor to the radical autonomism of the patient. He includes in this work his interpretation of the division of work, to which I alluded earlier, and considers the ethical poverty of the models of the doctor as a mechanic or engineer of the body, models that necessarily result when respect for people degenerates into a servile attitude.
The harshest and most penetrating criticisms of principlism came later, from Edmund Pellegrio and David Thomasma. Already in 1988, in one of their best known and most influential works (Pellegrino DE, Thomasma DC. For the Patient's Good. The restoration of beneficence in health care. New York, Oxford University Press, 1988), they study the role and limitations of paternalism and autonomy in the doctor/patient relationship. The critical study of principlism is continued in their 1993 book on the role of virtue in medical internship (Pellegrino DE, Thomasma DC. The Virtues in Medical Practice. New York, Oxford University Press, 1993).
Thomasma, in fact, directs the publication of a issue of the Cambridge Quarterly of Healthcare Ethics which, under the degree scroll Beyond Autonomy, is dedicated to the critique of the Principles. He points out that this critique comes from at least four quarters: first, from clinical resistance to accepting the pre-eminence of patient autonomy in the relationship between doctors and their patients; second, from the analysis of the methodological inadequacies of principlism: This appears divorced from the realities of clinical ethics and the history staff of individuals; third, from the revision to which the postmodern crisis is subjecting all Western thought; and fourth, from the reaction against the subjugating, almost colonialist character that some attribute to the typically American liberal root of the principles, especially those of autonomy and justice.
Finally, in 1995, two strong isolated criticisms of principlism appeared.
One comes from Denmark, from the solid department of Philosophy of Medicine and Clinical Theory, University of Copenhagen. Holm, in analysing the 4th edition of the Principles, subjects not only the weak points of the principle of autonomy to very harsh criticism, but also those of justice and beneficence, which he considers to be strongly tinged with selfish individualism, an American liberal version, which has nothing to do with the sense in which inter-human relations are experienced in continental Europe or on the Asian continent. He considers them empty of substantive content, subjected to a process of depauperation of content that ends up offering a watered-down version, lacking in strength and moral punch. His conclusion is strong: the principles can help to analyse specific moral problems, but for this they need to be reworked in each cultural context and completed with further moral considerations that articulate and unify them.
The other considers the validity of principlism in the context in which its gestation began: biomedical experimentation. Meslin et al. in a article published in Bioethics point out that the ethics of biomedical experimentation has relied on Belmont's report binomial and the principlist tetrad, but that here, as in the ordinary therapeutic context, principlism is under scrutiny. They recognise that in themselves they are neither adequate nor sufficient to inspire the behaviour of experimenters and subjects. They can be a heuristic financial aid for uncovering problems, but, if they are to be ethical decision-making tools for discerning which clinical trials should be approved, they need to be specified and supplemented by incorporating what they call "context sensitivity" (Meslin EM, Sutherland HJ, Lavery JV, Till JE. Principlism and the ethical appraisal of clinical trials. Bioethics 1995;9:399-418).
Future alternatives
With the same insistence with which the Principles were embraced, with the same regularity there is now talk of proposals for new ethical constructs to take their place when their ruin is imminent. Beauchamp himself and the proponents of these alleged competitors of principlism have critically reviewed them in a 1995 monograph of the Kennedy Institute of Ethics Journal issue . These are Clouser and Gert's alternative, called the theory of the impartial rule ; Jonsen's proposal of the recovery of casuistry as a means of deciding on individual cases and solving problems; the theory of virtue in the clinical internship proposed by Edmund Pellegrino. There is no lack of, so to speak, minor solutions, which do not claim to solve all problems, but offer partial ways of dealing with ethical conflicts, such as feminist ethics.
Beauchamp recognises the values that are embedded in these alleged competitors. He is open to the possibility that principlism can articulate with them through their necessary specification and contextualisation. It proclaims that the Principles are compatible with the new theories that seek to supplant them. He concludes that, in bioethics, the principles can still provide a normative and defensible framework of reference letter , despite all the criticisms that have recently been levelled at them. He argues that their immediate competitors (the theory of impartial rule , casuistry, virtue ethics) are compatible, rather than rivals, if the understanding of principles is properly conceived.
This is precisely the basic weakness of Principles and Principlism: their extreme malleability, their capacity to justify everything, their sophisticated and sophistic polyvalence. They need a firm support, but however firm the point of support may be, the most elementary of machines, the lever, is inoperative if it does not itself have a solidity, a rigid texture, that can transmit the power to overcome resistance.