APA NEWSLETTER ON

Philosophy and Medicine Rosamond Rhodes & Mark Sheldon, Co-Editors Fall 2003 Volume 03, Number 1
FROM THE EDITORS On the occasion of the publication of his book, The Future of Human Nature, Jurgen Habermas was asked to present a talk at the Centre Pompidou in Paris on December 3, 2001. That talk appears in print for the first time here in the pages of the Newsletter. Explaining that he is neither a biologist nor an expert in bioethics, Habermas makes clear that he is interested in the normative implications of the developments in genetic research, particularly the meaning of "liberal eugenics." What concerns him is the possible "self-instrumentalization of our species that would have an impact on the normative self-understanding of us as autonomous and responsible persons." As he explains, "My question is whether a future normalization of certain practices of genetic engineering might have an impact on how we claim the authorship for our own life and how we answer for the consequences of our actions." This leads him to a thoughtful analysis of the implications of parents making certain genetic choices for their children, and how these children will, in his view, have to struggle with the meaning of choices that are made for them on such a fundamental level and whether these choices are different for the struggles children have with naturally distributed talents and dispositions. He is also concerned with the line between positive and negative eugenics. In her commentary on his remarks, Christina Lafont shares Habermas’s concerns but questions whether his arguments accomplish their objective and also whether they accomplish too much. Unclear about the implications of genetic intervention, recognizing the lack of participation on the part of the one whose genetics are subject to such intervention, what should our response be and what response should we permit? Were the line between negative and positive eugenics clear, such intervention might be justifiable, but given that the line is not clear, what response is in order? Yet, as Lafont points out, a complete ban on genetic intervention and research, particularly in a democracy, becomes problematic. Lance Stell, in "Physicians’ Conflicts of Interests," provides an intricate analysis of the various conflicts of interests and the appearance of conflicts of interests that physicians encounter. As he states, "At virtually every point in the course of care, the physician is in a position to shift the expectable marginal advantage from the patient to himself, to his employer, to an insurance company, and to society." Conflicts of interest are unavoidable at every turn, argues Stell. The point is to identify them, and develop a framework that makes clear the costs of developing one or another response to their resolution. Last, in "Ex Post Facto IRB Review: Two Practical Hurdles, One Conceptual Mistake," Deborah Barnbaum considers three problems that result when research is presented to the IRB after the work has been completed. The first two she describes as practical: the IRB does not want to set the bad precedent of approving work that is finished, and, if the IRB does this, it will have no way of verifying the integrity of the consent process. Barnbaum argues that both of these practical problems are not significant problems. It is the third problem, theoretical in nature, which she describes as the most significant. This relates to the assessment of risk/benefit ratio. This problem is so important that she advocates denying the permissibility of ex post facto review. We are also fortunate to include another engaging story from Felicia Nimue Ackerman. "Have an After Eight Mint" raises interesting questions about mental health and who actually needs therapy. It’s refreshing. And last, we have a review of Cloning and the Future of Human Embryo Research, edited by Paul Lauritzen. It was reviewed for us by Valeska Fernandez. We want to remind you to please send along your announcements, letters, papers, case analyses, poetry, and stories. Directions for formatting your submission can be found at the end of the Newsletter volume. Please feel free to volunteer a book review. Your contributions and queries should be sent to Rosamond at the address below. Please include your phone and fax numbers and email address if you have one. Address mail to: Rosamond Rhodes Box 1108 Mount Sinai School of Medicine One Gustave Levy Place New York, NY 10029 Phone: 212-241-3757 Fax: 212-241-5028 Email: rosamond.rhodes@mssm.edu Mark Sheldon Department of Philosophy and Medical Ethics and Humanities Program Northwestern University Evanston, IL 60208 Phone: 847-328-2739 Email: sheldon@northwestern.edu
FROM THE CHAIR
Thoughts on the P&M Webpage
Kenneth Kipnis University of Hawaii at Manoa, HI Although it is rudimentary, the APA Committee on Philosophy and Medicine now has its own web page: http:// www.apa.udel.edu/apa/governance/committees/medicine/ The Delaware office has posted the Committee’s charge, our membership lists going back to 1998, our annual reports to the APA Board, the data from a 1997 survey on bioethics programs, and the contents of P&M Newsletters up to 2000 subsequent editions are available to APA members elsewhere on the APA site. More materials will be posted later on, pending deliberations by the Committee and the APA leadership As modest as its current contents are, the site’s existence opens up possibilities. There could be a directory of American philosophers with interests and expertise in medicine; a collection of syllabi and course materials developed by APA members; an electronic bulletin board where members can explore topics of common interest; a list of links to internet-based resources that are already available; commentaries on and assessments of pertinent articles and books, and goodness knows what else. For the last few years I have been hanging out with the mind-bending idea that, after 567 years, the most important invention of the second millennium - Gutenberg’s printing press and its mass-produced ink-and-cellulose product - may be nearing the end of its technological life. I now carry a PDA (a Palm Zire 71 personal digital assistant) that downloads current newspaper and magazine articles whenever I synchronize it with my home computer. While I still carry books printed in the old-fashioned way, I am more likely these days to pull out my palmtop on the airplane and read content on it, selecting my preferred typeface and screen lighting levels. Now I don’t want to argue that we are ready to lose the smell and feel of our beloved hard covers, or even that the best book-sized electronic content "readers" are ready for prime time. But I can recall the 1980s, which began with the omnipresent typewriter (at the end of its 113-year developmental history) and ended with the computer/printer combination. You could do a lot more, and a lot quicker, with the latter and, accordingly, the typewriter repair shop has gone the way of saddlery. Apart from the costs of its content, a publisher may take several months and pay several dollars to print, bind and ship a 300-page book to a consumer. Compare that to the unmeasurably small costs and the near-instantaneous speed of distributing the exact same content electronically. Although archival and "digital rights management" issues remain to be resolved, the virtual elimination of printing, binding and delivery costs will offer huge advantages to those organizations that can facilitate and ride out the transition. Even the trees will rejoice. On the horizon is a radical transformation in the way we disseminate and obtain literary materials. Rosamond Rhodes and Mark Sheldon, and those who have preceded them, have done a great service in their stewardship of this Newsletter. But the stewardship of the P&M website will likely require more in the way of resources and a broader involvement of APA members. We are at the very beginning. As Chair of the Committee, I would deeply appreciate having your ideas about what should be posted on our website and who we might be contacting for assistance. Please pass your suggestions along to me at kkipnis@hawaii.edu.
DEAR EDITORS As a potential terminally ill person (aren’t we all?) as well as a bioethicist, I take exception to Mary Devereaux’s glowing review of What Dying People Want: Practical Wisdom for the End of Life, by David Kuhl and Caring for Patients at the End of Life: Facing an Uncertain Future Together, by Timothy Quill (APA Newsletter on Philosophy and Medicine, 2, 2 [Spring 2003]: 21619). Devereaux seems unaware that Kuhl and Quill’s "call for a program of humanistic medical care designed to recognize the person in the patient" (review, 216, italics in original) and Kuhl’s insistence that "people who are dying are still living" (review, 217, italics in original) are unoriginal to the point of being cliched, as is the advice that doctors should listen to patients. Moreover, Devereaux overlooks the fact that Kuhl and Quill seem to be highly selective about which aspects of "the person in the patient" they will respect. Devereaux uncritically cites Kuhl’s insistence that the "time is now" to "remember, to talk about what individuals or families mean to one another, have given to each other, will leave behind" and Quill’s emphasis on "the doctor’s role in encouraging patients and their families not to wait" to do such things (review, 217). She overlooks the fact that not all patients want to do such things and that a doctor who truly respects "the person in the patient" will recognize that people vary and that the desire not to talk about one’s feelings is also worthy of respect. And what if "what dying people want" is a chance at a cure? Kuhl recognizes that "[p]atients and their families naturally tend to focus on a cure" (review, 217). But he calls this "the Magic Cure Problem" (review, 217). Why doesn’t he respect the person in the patient and help such patients in their search for experimental cures? It is fundamentally disrespectful to decide in advance what attitude terminal patients ought to have and to define patients’ unwillingness to conform as a "problem," no matter how well such disrespect is cloaked in the language of caring. (Perhaps we should call this "the Presumptuous Doctor Problem.") Kuhl is hardly alone among "humanistic" doctors in his dismissive attitude toward terminal patients whose top priority is life-prolongation and/or a longshot chance at a cure. For discussion of another such case, see my review of Sherwin B. Nuland’s How We Die, published in American Scholar, 64, 1 (Winter 1995): 131-35, reprinted in this Newsletter, 94, 2 (Spring 1995): 98-100. Doctors and bioethicists will not earn public trust until they learn to "listen to" and respect not only patients who are willing to "accept" death but also those who desire high-tech life prolongation and/or last-ditch experimental attempts at cure. Take the adventure, Felicia Nimue Ackerman Professor of Philosophy Brown University
ARTICLES
A Sketch of L’avenir de la nature humaine
Jürgen Habermas Northwestern University and University of Frankfurt I am grateful for the opportunity to sketch the pattern of argument that I have developed in L’avenir de la nature humaine. I understand this as an occasion to stimulate questions and objections. (1) The discussion on the normative implications ofrecent developments in the fields of genetic research and gene-technology is both complex and in many respects rather specific. Let me remind you in advance that I am neither a biologist nor even an expert in bioethics. I am interested in one philosophical aspect of an apparently growing capability to manipulate the genetic make-up of future persons: This is the question whether the prospects for eugenic interventions indicate steps toward a kind of self-instrumentalization of our species that would have an impact on the normative self-understanding of us as autonomous and responsible persons. Let me first explain what I mean by the peculiar "normativity" of a self-understanding that forms the background for a person’s everyday beliefs and practices. Common-sense thoughts and activities are accompanied by the implicit awareness of two things. In our encounters with natural environments we are certain that we can both take initiatives to cope with challenges and learn from failures. In our encounters with other persons we are equally certain that we are expected and able to take a stand on other people’s claims with either "Yes" or "No." In the performance of goal-directed actions we feel free to start something new; and in communication or social interaction we are prepared to offer reasons to those whom we owe justifications. Thus we intuitively attribute to ourselves the ability to act on our own and to accept or reject beliefs or normative expectations for good reasons. All this is in the back of our mind, when we tacitly regard ourselves as the authors of a life of our own choice, who are held to account for what we do and say. We always know these things while not necessarily knowing of them. But the background knowledge is made explicit when we become conscious of both "authorship" and "responsibility." This is the core of the normative self-understanding of a person. An however dim consciousness of authorship and responsibility is so deeply embedded in our symbolically structured forms of life that it will hardly ever be replaced by the sort of deterministic self-description that is suggested by a scientistic worldview. Some versions of naturalism suggest the ontological priority of a physicalist or neuro-biological or neo-Darwinist self-description of man. But the very performative nature of our consciousness of authorship and responsibility, of moral and ethical freedom, that can emerge only from a participant’s perspective, must escape any objectifying description from an observer’s point of view. Metaphysical determinism is a misunderstanding. Therefore, I do not expect any substitution for our normative background understanding. What might happen is a change in that background understanding that can be described only from within its own context. My question is whether a future normalization of certain practices of genetic engineering might have an impact on how we claim the authorship for our own life and how we answer for the consequences of our actions. (2) Those imagined practices are presently far beyond ourcapacities. The project of liberal eugenics that would give parents the possibility and the right to choose genetic designs for their children can be discussed only from a thoroughly hypothetical point of view. That vision goes by the science fiction label of "shopping in the genetic supermarket." But why bother at all with science fiction? Let me mention some responses pro and con. There is first the difficulty to predict the course and outcome of future research in general – nobody knows what kind of results will be achieved tomorrow. There is, secondly, the experience that much of past science fiction fantasy has become realized and even surpassed by actual innovations in the meantime. Rapid progress in genetic research and development, e.g., in the field of reproduction medicine, has thus overrun long-ranging processes of ethical debate, public opinion formation, and political decision making. Third, it is not unreasonable to assume that boundaries between a therapeutic and an enhancing use of gene-technologies cannot easily be established. Without clear criteria, the lines between negative and positive eugenics will be inconspicuously blurred, once technologies for genetic manipulation of certain phenotypical features are available. Though the expectation that they will be available one day is controversial, we are well advised to consider alternative scenarios. We are living, after all, in a risk society. I would like to stress also this uncertainty. The hypothetical anticipation of consequences of possible innovations must not play into the hands of cheap alarmism. We should not take all of the rash prospects and promises of fund raising bio-scientists and lobbyists for granted. A book that just came out carries the title What Genes Can’t Do (MIT Press, 2003). The author, Lenny Moss, attacks the prevailing conceptualization of genes as predictors for specific phenotypes. Today a "gene" is mainly defined by the phenotypical feature, interpreted as the outcome of a process which the gene is supposed to determine. This prevailing conceptual strategy for individuating genes fits the interest in the kind of knowledge that would allow one to extend the scope for the manipulation of phenotypes. Moss favors instead a holistic picture and maintains that the atomistic strategy cannot work.1 If this author were right, the scenario of liberal eugenics would not be realistic. (We would be able to control phenotypical features by genetic intervention only in those cases where the presence or absence of a gene is causally relevant to the disturbance of the spontaneous functioning of a complex, largely in-transparent order.) I am lacking the necessary competence for a judgment on biological controversies and their relevance. The excursus is just to remind us of the hypothetical status of the premises on which the following thought experiment rests. (3) Let us start from the assumption that a person, whosegenetic composition has been prenatally altered, learns in the course of her adolescent years of the design the loving parents had once chosen; and let us furthermore assume that the programmed person, in the light of an ethical reflection on her own life-project, faces difficulties in trying to identify with this genetic gift and to make it her own - whether we imagine a property like size or hair-color, dispositions like a gentle or an aggressive temperament, or generalized capacities like physical strength and good memory. And let us finally assume that she interprets the situation in the following way: For her such an intervention in the prenatal distribution of genetic resources has the meaning of a redefinition of those naturally fixed ranges of opportunities or scopes of decisions within which a future person will one day make use of the ethical freedom to shape her own life. This is not a presumption in favor of genetic determinism, as usually understood. We learn from striking individual differences between identical twins that an identical genetic make up does not determine similar life histories. And persons are to a large extent individuated only by the course of their biography. What is at stake in our scenario is the perception of an intended shift in natural constraints on the range and scope for a possible use of ethical freedom, that is for the freedom of each person to lead a life of one’s own. From the perspective of the programmed person, two relevant aspects come to the fore: She can now attribute a rejected feature, that was to become part of her identity, no longer to contingent circumstances but to the responsible decision of other persons, her parents; and she knows that the parents could not but make this choice according to their subjective preferences, even if these preferences emerged from an other-regarding reflection on what might be in the best interest of the future child. Insofar as the adolescent rejects a prenatal design that leads to a change in the scope for a possible use of ethical freedom, she will live hence with, and suffer from, the strange consciousness of sharing the authorship of her life with someone else. The designers are perceived as partly co-authoring her life. The programmed person, being no longer certain about the contingency of the natural roots of her life history, feels that an important boundar y has become permeable — the deontological shell around the individual person which assures the inviolability, the uniqueness and the irreplaceability of someone who deserves to be treated as an author of his life and who is alone responsible for what he says and does. Considering the long-term effect of a normalized practice of enhancing the genetic quality of the offspring, the dense stream of cumulative decisions would cut across the contemporary networks of interaction in a one-directional way and would thus lead to intergenerational asymmetries in the mutual recognition among supposedly equal-born persons. (4) This is an intuition in need of further explanation. Let me try this by way of discussing three objections. There is (1) the proposition that, from a moral point of view, there is no great difference between the genetic modification of hereditary factors and the shaping of personality structures in the course of socialization. However, socialization processes proceed only by communicative action and in the medium of propositional attitudes and decisions which, for the adult reference persons, are connected with internal reasons even at a time when the "space of reasons" is not yet widely open to the child itself. Due to the interactive structure of the formation process, in which the child always takes the role of a second person, those expectations guiding the parent’s efforts at "character building" remain essentially contestable, at least from hindsight. Later on, the adolescent, taking a reflexive attitude, will have the chance to respond to and retroactively break away from features acquired in the course of his socialization. He can retrospectively compensate for the asymmetry of filial dependency by a critical reappraisal of those parts of his cultural and personal heritage he comes to reject upon reflection. Yet, there is no such opportunity in the case of a genetic determination carried out according to the parents’ own preferences. At the time of the decision on genetic enhancement, there is no communicative scope for the projected child to be addressed as a second person and to be involved in a communication process. From the adolescent’s perspective a genetic design cannot, like a pathogenic socialization process, be revised by a revisionary learning process. The genetic program is a mute and, in a sense, unanswerable fact. There remains (2) the question, why a young person should not struggle with manipulated genetic predispositions in the same way as with naturally acquired ones? Why, for example, couldn’t she let a talent for mathematics lie unused, in one case just the same as in the other, if she preferred to become a musician or a professional athlete? Now, the difference between the two cases is that the preference of the parents to furnish their child with this genetic inheritance and not another has led to a decision of responsible actors. Exercising the power to dispose over the genetic predispositions of a future person means that such a person, whether she has been genetically programmed or not, can regard her own genome as the consequence of either a criticizable action or omission. The young person can call his designer to account, and demand a justification for why, in deciding on this or that genetic inheritance, the designer failed to choose athletic ability or musical talent, which would have been vastly more useful for the career that the athlete or musician had actually chosen to pursue. This scenario raises the question of whether we can ever assume the responsibility for the distribution of natural talents, and for that range of opportunities within which another person is able to freely develop and pursue her own conception of life. This touches already (3) on the question, why a person should at all refuse an "enhancement" of her genetic resources. The argument against an alien co-authorship for one’s own life determination only works, of course, if we assume that the child’s genetic endowment, chosen from among several alternatives, actually reduces the range of her future life choices. But the danger of prescribing a particular range of identities clearly decreases (if we give free rein to our imagination) in the sequence of properties (such as hair color), dispositions (let’s say, courage), capacities (athletic grace or musical talent) and ‘basic genetic goods’ (i.e., highly generalized capacities such as bodily strength, intelligence, or memory). Here too we face the question of whether we can ever know if a particular genetic endowment will in fact expand the latitude that another person has for giving shape to her own life. Can parents, wanting always only the best for their child, ever really presume to know all the circumstances in which a brilliant memory, for example, or high intelligence (however defined) will prove a benefit for their child? A good memory is often, but by no means always, a blessing. Not being able to forget can be a curse. The sense of relevance and the formative power of traditions can influence us depending on selectivity of our memories. Sometimes an overloaded storage hinders us from dealing productively with new data it takes in. Outstanding intelligence is, of course, in many situations a predictable advantage. But how will the "head start" of high intelligence play itself out in a competitive society—for example, in the character formation of the highly talented person? Not even the highly general good of bodily health maintains one and the same value within the contexts of different life histories. Parents can’t even know whether a mild physical handicap may not prove, in the end, to be an advantage for their child. (5) Which conclusion can we draw from these examples?We should certainly come to the aid of others, and do all we can to improve the conditions of their lives. But we are not permitted to determine, according to our own ideas about other people’s future lives, the range of opportunities these others will once face in their attempt to lead a life that can go wrong. Even in the best of cases, our finite spirit doesn’t possess the kind of prognostic knowledge that enables us to judge the consequences of genetic interventions within the unforeseeable context of a future life of another human being. Can we know what is potentially good for another? This may be so in particular cases. But even then our knowledge remains fallible, and may be applied only in the form of clinical suggestions for somebody who the advisor already knows as an individuated being. Irrevocable decisions over the genetic design of an unborn person are always presumptuous. A person who potentially stands to benefit from such a decision must always preserve the ability to say no. Since we can have no objective knowledge of values beyond moral insight, and since a first person perspective is inscribed in all of our ethical knowledge, we overtax the finite constitution of the human spirit by expecting that we can determine which sort of genetic inheritance will be ‘the best’ for the lives of our children. The dangers of constraining the ethical freedom of a genetically modified person can, therefore, never be ruled out a priori as long as the genetic intervention is performed one-sidedly, that is, not with a clinical attitude towards another person whose actual or counterfactual consent has always to be secured. Attributing such consent can only be justified in cases where there is a certain prognosis of extreme suffering. We can only expect a consensus amongst otherwise highly divergent value orientations in the face of the challenge to prevent extreme evils rejected by everybody. Such therapeutic reasons can in unambiguous cases justify a negative kind of eugenics. Citizens in a democratic community, which would want to permit therapeutic genetic interventions in cases of serious genetic disorders in the interests of the handicapped themselves will, however, not escape the heavy burden of anticipating the possible agreement or refusal of those affected by these practices. The entire project of separating positive from negative eugenics faces, in view of fluid boundaries between both, considerable difficulties. It is plausible to predict an effect of cumulative familiarization that will push the limits of tolerance for genetic interventions already regarded as "normal" ever further toward more and more demanding norms of health. However, there is at least a regulative idea for discrimination: All genetic interventions, including prenatal ones, must remain dependent on a consent that is at least counterfactually attributed to those possibly affected by them. 6) The threshold separating negative and positive eugenics is thus described in terms of a difference in attitudes. In the framework of clinical practice, the genetic therapist treats the living being on the basis of a justifiably assumed consensus, as if the embryo were already the second person that it will one day become. By contrast, the genetic designer assumes both an optimizing and an instrumentalizing attitude toward the embryo: The embryo’s genetic composition is to be improved according to subjective preferences. What takes the place of the performative attitude toward a future person, who is, in its embryonic state, already treated as a person who can say yes or no, is, in the case of positive eugenics, a hybrid combination of objectivating attitudes. I imagine a bricoleur, who combines the classic goal of the breeder and aims at improving the genetic potential of a species, with the operational mode of an instrumentally acting engineer, who implements his own design and thus works on the embryonic cells as material. In the end, I would like to use this difference in attitude for dealing with the question, how such a critical view of the anticipated practice of liberal eugenics bears on the present challenge to legally regulate both research on human embryonic stem cells and pre-implantation genetic diagnosis (PGD). Without going into details, let me just indicate the pattern of argument. The critique of positive eugenics provides a slippery slope argument if PGD and human embryonic stem cell research can be described as pacemakers that spur a development in that direction. I take this to be the case if both of them require the adoption of exactly those two attitudes that tend to promote the transition from negative to positive eugenics, that is, the attitudes that are tied to the improvement and the reification of pre-personal human life. The action context of PGD displays both of these attitudes. Unlike cases of unwanted pregnancy, here the protection of the life of the embryo does not compete with the woman’s right to self-determination. Parents instead know from the beginning that, following the diagnosis, they either have to choose amongst several options, or must decide between the implantation or the destruction of just one embryo. This reveals an intention to improvement. The selection is based on a judgment of the quality of a human being and expresses, insofar, a desire for genetic optimization. The prognosis itself then requires a reified interaction with the embryo in vitro. The desire for children makes the parents arrange a situation in which they have freely to dispose over the termination or the continuation of a pre-personal human life. This instrumentalization is an unavoidable part of the situation once pre-implementation genetic diagnostics is permitted. Research on human embryonic stem cells does not fit into the same perspective as breeding and self-optimization. But it obviously requires an instrumentalizing attitude toward the "embryonic cell line." Certainly, the experimental and "applied" effort doesn’t aim at a possible birth at all; thus it cannot fail to meet the expectation to maintain a clinical attitude toward a future person. Rather the action context is structured by the purpose of scientific progress and technical development. So it falls under a different description. If embryonic stem cells are manufactured, investigated and processed in the pursuit of such ends, it is a matter of another kind of praxis than the reproduction (and the selection or genetic modification) of a being to be born. But the fact that this research praxis requires a reifying mode of operation, and therefore the same attitude toward pre-personal human life that characterizes eugenic practices, tips the scales toward the "slippery slope" argument.
Endnotes 1. "The empirical fruits of several decades of research in molecular, cell and developmental biology have revealed that what distinguishes one biological form from another is seldom, if ever, the presence or absence of a certain genetic template but rather when and where genes are expressed, how they are modified, and into what structural and dynamic relationships their ‘products’ become embedded." Moss Loc. cit. XVII.
Remarks on Habermas’s presentation of "L’avenir de la nature humaine"
Cristina Lafont Northwestern University, Chicago, IL Habermas’s fascinating book The Future of Human Nature (Polity Press, 2003) raises so many difficult and interesting issues that I cannot possibly address them all in the context of these short remarks. Instead, I will just focus on one aspect of Habermas’s general line of argument that I find problematic. But before I do so, I would like to first refer briefly to those aspects of Habermas’s presentation with which I substantially agree and that in my opinion come out clearer here than in the book. First of all, I find Habermas’s warning against an understanding of ourselves in accordance with neo-Darwinist dreams of genetic determinism essential and most needed in the context of a discussion on eugenics. For my impression is that, at least for the time being, the dangers related to the idea of "shopping in the genetic supermarket" are due less to the technical possibilities that may in fact become available as our genetic knowledge increases, than they are to the ideology of genetic determinism hidden behind the dream of what that shopping can actually accomplish (something like the complete control of future human beings). Genetic determinism cannot be taken for granted even for the sake of hypothetical thought-experiments, but rather it needs to be unmasked as a metaphysical misunderstanding in whatever cultural disguise it may (re)appear as a plausible self-description of humankind. There is no gene of human destiny or human freedom. We are condemned to be free, to put it in existentialist terms. I also think that Habermas’s presentation definitely succeeds in focusing on the central normative problem of a liberal eugenics, namely "whether we can ever assume responsibility for the distribution of natural talents, and for that range of opportunities within which another person is able to freely develop and pursue her own conception of life." (p. 7). I certainly share Habermas’s doubts regarding an unguardedly positive answer to this question. However, I also have doubts about his particular line of argument. The trickiest step in his argument, as I see it, is the move from an entirely plausible principle of counterfactual consent (PCC)1 to a much more problematic principle of abstention under uncertainty (PAU).2 What I find most problematic in this move is not so much that the latter principle is per se implausible, but that it is taken to follow automatically from the former. As a consequence, although only the latter principle can actually support Habermas’s opposition to positive eugenics, it seems that convincing arguments in favor of the principle of consent are all that is needed to justify the principle of abstention. In what follows I will try to show why I think that this is actually not the case. First of all, I would like to stress that I entirely agree with Habermas’s principle of counterfactual consent. The problem I see in his argument against positive eugenics is that this principle does not cut at the expected joints, that is, it does not by itself discriminate between negative and positive eugenics, as Habermas suggests (p. 9). But this is not because the principle is empty or irrelevant in this context. In fact, the principle cuts at the right joints when a different question is asked, namely, when or under which conditions genetic intervention is permissible in light of the not yet totally foreseeable risks of using a technology whose real consequences are still unknown and whose effects would be nonetheless irreversible. If one considers this question as the main problem of genetic intervention at the present moment, as I do, Habermas’s principle of consent already provides the most reasonable answer, namely, only interventions geared to prevent extreme suffering could possibly outweigh the dangers involved not only in the genetic intervention itself (where things can always go wrong), but especially in the unforeseeable consequences of a genetic manipulation whose long run consequences (which may extend to future generations as well) are still unknown. Thus, if we added to a plausible precautionary principle3 the equally plausible principle of consent, we could as citizens of a democratic community, draw a line for permissible genetic intervention that falls very close to the distinction between positive and negative eugenics, at least for the time being.4 But, of course, as the latter qualification already indicates, we would be doing so for entirely different kinds of reasons than those that Habermas’s argument aims to support. In fact, we would not have even taken sides at all on the issue that is the focus of his argument against a liberal eugenics, namely, whether positive eugenics is ethically permissible or not. But in any event, even if the only possible application of the principle of counterfactual consent in this context were with regard to the issue of the risks involved in genetic interventions, I think that this already would have proven its ethical relevance for questions of eugenics beyond any doubt. Now the question is whether it can also be applied to the issue that concerns Habermas, that is, whether the principle of counterfactual consent can be put to use to rule out positive eugenics in the way Habermas assumes that it does. Here is where I disagree. As I mentioned before, at first sight there may seem to be a direct way to get from the principle of counterfactual consent (PCC) to the principle of abstention under uncertainty (PAU). In a nutshell, the argument would run as follows: PCC: All genetic interventions must remain dependent on a consent that is at least counterfactually attributed to those possibly affected by them. 1) in cases of avoiding extreme suffering we can be certain that our intervention would meet with the counterfactual consent of those affected by it. 2) in cases of positive eugenics we cannot be certain that our intervention would meet with the counterfactual consent of those affected because we can never know what is potentially good for another person: "we overtax the finite constitution of the human spirit by expecting that we can determine which sort of genetic inheritance will be ‘the best’ for the lives of our children" (p. 9). Therefore, PAU: We should abstain from any genetic intervention beyond those geared to the prevention of extreme suffering (i.e., negative eugenics). The problem with this argument is that it relies on a symmetry that is only apparent. PCC tells us to make our decisions dependent on the counterfactual consent or dissent of those affected by the intervention at issue. Thus, whenever we are (reasonably) certain of the counterfactual consent of the affected, intervention should be permitted, and whenever we are (reasonably) certain of their dissent it should be prohibited. But for that very reason this principle has no application for cases in which we are uncertain about the counterfactual consent or dissent of those affected. Given that our uncertainty is as close to their dissent as to their consent, in such cases we cannot make our decisions dependent on either. Thus, PCC cannot but be silent with regard to intervention as much as abstention. According to PCC, the right action would be to intervene if the affected persons were to consent and to abstain if they were to dissent. Thus in the absence of both, abstention is as much of a gamble as intervention. There is no way to infer from our uncertainty alone that what is best for the affected persons would actually be abstention rather than intervention. And if this is the case, there is no free ride from abstention to blamelessness. This can perhaps be seen best just by focusing on Habermas’s own thought-experiment.
One scruple too many His thought-experiment focuses on the scenario of a person whose genetic composition has been prenatally altered and who faces difficulties identifying with such a genetic gift. As a consequence the following normative problem arises: "the young person can call his designer to account, and demand justification for why, in deciding on this or that genetic inheritance, the designer failed to choose athletic ability or musical talent, which would have been vastly more useful for the career that she had actually chosen to pursue" (p. 7). It is in view of this possible ‘dissent’ of the affected person at a future time that the principle of abstention under uncertainty seems to indicate the normatively appropriate course of action. In this context, Habermas remarks: Here too we face the question of whether we can ever know if a particular genetic endowment will in fact expand the latitude that another person has for giving shape to her own life. Can parents, wanting always only the best for their child, ever really presume to know all the circumstances in which a brilliant memory, for example, or high intelligence (however defined) will prove a benefit for their child? A good memory is often but by no means always a blessing. Not being able to forget can be a curse… Outstanding intelligence is, of course, in many situations a predictable advantage. But how will the "head start" of high intelligence play itself out in a competitive society — for example, in the character formation of the highly talented person? Not even the highly general good of bodily health maintains one and the same value within the contexts of different life histories. Parents can’t even know whether a mild physical handicap may not prove in the end to be an advantage for their child. Here, however, Habermas has shifted the standard of evaluation from the subjective criterion of the possible consent or dissent of the affected person to the objective criterion of what would in fact be best for someone’s life. It is because we never know what may in the end prove best for a person that we should abstain from any genetic enhancement. But, of course, this justification of PAU has a built-in possibility of clashing with PCC. For even if we could anticipate the consent of the affected person to, say, the elimination of a mild handicap (which is not hard to imagine especially at those early times of her life histor y in which she would suffer the most under its consequences), according to PAU we should still abstain from intervening in view of the fact that the handicap could turn out to be best for her in the end, regardless of her dissent at any prior time.5 In the perfectly imaginable situation of an affected person who faces difficulties to identify with such a parental decision and thus demands justification for why they failed to choose to eliminate the handicap, the answer that they could not know whether it could as well have turned out to be beneficial could hardly ameliorate her impression that her parents, to paraphrase Bernard Williams’s objection 7 to impartialist ethics6, had one scruple too many. In fact, Habermas seems to be aware of the normative difficulties involved in following what I call here the principle of abstention under uncertainty. In the postscript to the English edition of his book, he remarks: Each new authorization of a prenatal therapeutic genetic intervention constitutes a tremendous burden for those parents who have principled reasons for not wanting to make use of the license. Whoever deviates from a permitted or even a familiarized eugenic practice, and takes the risk of an avoidable birth defect into the bargain, has to fear accusations of neglect, and possibly the resentment of their own child. In this remark two things become crystal clear. First of all, PAU is a problematic principle in its own right, that is, it is so even if one measures it by the objective criterion of what would in fact be best for someone. For abstention under uncertainty is as close to what would be best for someone as to what would be worst. Consequently, the objection of neglect is in principle always possible.8 But, second and more important in our context, PAU cannot be derived from PCC. For if the clash between the two principles that Habermas anticipates in the latter remark is possible at all, that is, if it is thinkable that the principled reasons of the parents to opt for abstention could meet with the dissent (even resentment) of their own child, then those reasons, whatever they are, do not derive from the principle of consent. Worse yet, they may in fact override the unconditional validity of such a principle. This immediately raises the question of where such "principled reasons" in favor of PAU may actually come from.
The lost innocence According to Habermas, the crucial normative problem involved in genetic interventions stems from the fact that we cannot have "the kind of prognostic knowledge that enables us to judge the consequences of genetic interventions within the unforeseeable context of a future life of another human being" (p. 8). Given that this kind of knowledge is humanly impossible, Habermas’s normative conclusion is that "we are not permitted to determine, according to our own ideas about other people’s future lives, the range of opportunities these others will once face in their attempt to lead a life that can go wrong." (ibid.). However, this conclusion seems to assume a magical link between abstention and normative innocence. The suggestion is that abstention can take away from us the burden of determining the range of opportunities of another person’s life. But it is hard to see how abstaining from an intervention is less determinative of such a range of opportunities than intervention. The decision of not eliminating a mild handicap surely determines the range of opportunities of the person who will have that handicap just as much as the opposite decision would have. Habermas’s argument seems to be based on the assumption that the normative difficulties originate in the decision "to exercise the power to dispose over the genetic predispositions of a future person." This suggests that the option of not exercising that power would avoid the normative problems that follow from such exercise. However, as he clearly points out on one occasion, such problems are logically the same whether "the future person considers her own genome as the consequence of either a criticisable action or omission" (ibid.) If this is correct, then it seems clear that the normative problems originate much earlier, namely, in the very moment in which theoretical knowledge of most (technically) relevant genetic processes becomes available. Given that in order to address the most obvious and uncontroversial cases of negative eugenics we will need to know the actual function, structure and causal connections of all genetic processes, once that knowledge becomes available, we will be facing the normative problems discussed here, no matter where exactly the line between positive and negative eugenics is drawn. For once it is no longer possible to plead ignorance (as a way to justify omission), there is no way to avoid the possible objection of a future person as to why we failed to opt for what in her eyes would have been the optimal course of action.9 Once the innocence that only ignorance can provide is lost, we will be responsible for our specific choice (of action or omission), no matter whether we see ourselves as unable to assume the responsibility involved in such a choice (as I certainly agree that in many cases we may).10 Under these circumstances, the claim that "we are not permitted to determine, according to our own ideas about other people’s future lives, the range of opportunities these others will once face in their attempt to lead a life that can go wrong" (p. 8) seems to miss the point. For once all relevant genetic knowledge is available (whether we choose to use it or not), the problem would not so much be that we are not permitted to determine genetic predispositions of persons according to our own subjective ideas (whose else’s?), but that we are condemned to determine them (either by action or omission) under conditions that necessarily fall short of guaranteeing the objective correctness of the choice given our human condition (as fallible, non-omniscient beings). In this respect the situation is not essentially different from the case of cultural socialization, where we are equally condemned "to determine the range of (cultural) opportunities that our children will once face in their attempt to lead a life that can go wrong," and to do so "according to our own ideas about other people’s future lives." And, again, this is the case not so much because they are the right ideas, but because they are the only ones available at the time. Given this existential condition of the reproduction of human life, the claim that "a person who potentially stands to benefit from such a decision must always preserve the ability to say no" (p. 9) seems hardly a live option at least with regard to major socializing decisions, such as alphabetization and the like. Here I suppose that an important source of my disagreement with Habermas lies in the extent to which I see cultural interventions as even more irrevocable in their existential import than most of the genetic determinations one can realistically think of. But in any event, my point is that, unfortunately for us, the range of responsibilities, culpabilities, etc., that are imputable within a given community are a function of the range of possibilities (be they technical or cultural) that this community in fact has at its disposal, and not of the extent to which we feel able to take responsibility for the appropriateness of our choices. This brings me to my last point.
Innocence well lost Given that the normative problem of determining another’s life capabilities under conditions of uncertainty is real and that, once the technical possibilities of action are available, both intervention as well as abstention involve making such normatively problematic decisions, the only really effective way to avoid the problem that Habermas discusses would be to get back to the situation of normative innocence which we were in before such genetic knowledge was available. No matter whether genetic and socializing interventions pose the same normative problem or not, it is clear that the only way to avoid the problem in the latter case is not a live option (we could hardly collectively decide to stop procreation), whereas with regard to the former case we could indeed decide collectively to stop all genetic research. If citizens in a democratic society were to take the normative problem that Habermas situates at the center of the discussion so seriously as to feel obligated to solve it at all costs, the normative conclusion that genetic research should be stopped immediately would impose itself on them. It is this possible reading of Habermas’s argument that makes me afraid of a possible ‘slippery slope’ from the ban on enhancing genetic interventions intended by Habermas to the global ban on genetic research that his arguments nolens volens may seem to support. From my personal perspective, I must confess that it is not clear to me what exactly the reasons for my own misgivings with regard to positive eugenics are. I find the science-fictional idea of enhancing the human species somewhere between spurious (if not directly absurd) and repulsive (perhaps even horrifyingly so) depending on how the idea would materialize. But with regard to my spontaneous repulsion, I have the impression that the ethical issue of positive eugenics resembles cases such as incest. Although I would have a hard time explaining what exactly is wrong with them, such reflection does not make my negative feelings any less strong. However, with regard to negative eugenics there can surely be no doubts about the strong moral reasons that speak in its favor. As Habermas makes very clear, we have the moral obligation to "come to the aid of others and do all we can to improve the conditions of their lives" (p. 8), especially when these conditions involve extreme suffering or even death. So, all I can say for the time being is that if our normative innocence with regard to positive eugenics must be lost for the sake of negative eugenics, then in my opinion it is an innocence well lost.
Endnotes
    The principle of counterfactual consent (PCC) states: "all geneticinterventions, including prenatal ones, must remain dependent on a consent that is at least counterfactually attributed to those possibly affected by them." Habermas does not refer explicitly to such a principle, but its possibleformulation can be inferred from his argument against positive eugenics and pre-implantation genetic diagnosis. What I am calling here the principle of abstention under uncertainty (PAU) could be stated as follows: "we should abstain from any genetic intervention whenever there is no certainty that it would meet with the counterfactually attributed consent of those possibly affected by it." The precautionary principle states: "when an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically." (For a statement of the principle and several discussions about it see "The Wingspread Consensus Statement on the Precautionary Principle, January 1998" at http://www.sehn.org/ wing.html) Of course, once all necessary knowledge on the consequences of genetic interventions is available, it could turn out that some of them are totally harmless and that among them many fall on the side of positive eugenics. In such a case, the precautionary principle would no longer exclude positive eugenics in the way it might under the conditions of extreme uncertainty of our current scientific situation. And, as Aristotle made clear in the Nicomachean Ethics, that just means at any time. In "Persons, Character, and Morality," Bernard Williams famously objected to impartialist ethical theories by claiming that a person, who would base his choice to rescue his wife rather than another person at random on the thought that ‘it was his wife and in situations of this kind it is permissible to save one’s wife’ would have had "one thought too many" (Cf. Moral Luck, Cambridge University Press, 1981, pp. 1-19; here p. 18). Needless to say, if one were to apply PAU not just to the biological but also to the cultural context the consequences could be highly problematic. Similar second thoughts to the ones mentioned by Habermas on memory and intelligence could arise with regard to knowledge, education or even alphabetization. After all, as the saying has it, ignorance may be bliss. One scruple too many in that context could have devastating consequences. Such an objection could be raised by those with intuitions along thelines of Peter Singer’s preventive principle, which states: "For any condition X, if it would be a form of child abuse for parents to inflict X on their child soon after birth, then it must, other things being equal, at least be permissible to take steps to prevent one’s child having that condition." (Cf. "Shopping at the Genetic Supermarket," p. 4, at http:/ /www.petersingerlinks.com/supermarket.htm) Of course, in the case of a collective social decision to ban enhancinggenetic procedures, the objection would perhaps not be addressed to parents as subjects under the law (for they may actually have no legal way to pursue the genetic intervention without punishment), but it would surely be addressed to them as legislators (i.e., as those who endorse the ban as normatively correct). It seems obvious that if, as Habermas convincingly argues, parentscannot possibly know what would be best for their children, this implies that they cannot possibly know that a general policy of abstention would be best either. But given that, at least in the children’s own eyes, parents cannot settle for anything less than the best, this in turn implies that the normative problem so seen has no solution and thus that a fortiori PAU cannot be the solution. It is for this reason that whatever the normative scruple would be that motivates such a parental policy, it could always turn out to be "one scruple too many" in the children’s eyes.
Physicians’ Conflicts of Interest* Lance K. Stell, Ph.D. Davidson College, Davidson, NC "No physician, in so far as he is a physician, considers his own good in what he prescribes, but the good of the patient; for the true physician is not a mere moneymaker."1 "Every physician-patient encounter is a conflict of interest. Every physician-payer encounter is also a conflict of interest."2 The license to practice entitles the physician to hold himself out to the public as a professionally competent, trustworthy guardian of patients’ health interests. Caring for them includes evaluating their complaints, outlining his findings, identifying treatment/diagnostic options together with the expectable consequences associated with each option. If the physician’s best medical judgment is that the patient’s condition is self-limiting or will respond to self-doctoring, he has an ethical duty to say so. On the other hand, if his best medical judgment is that the patient’s condition requires further professionally-supervised diagnostic procedures or treatment, he must say so. At virtually every point in the course of care, the physician is in a position to shift the expectable marginal advantage from the patient to himself, to his employer, to an insurance company, or to society. "Payer-status" considerations and reimbursement mechanisms bring the physician’s financial interests into conflict with those of some of his patients, but into convergence with other of his patients. For example, patients covered by a (discounted) fee-for-service reimbursement scheme create an incentive for the physician to maximize resource use to offset the discount, irrespective decreasing marginal patient benefit. By accepting their physician’s recommendation of additional resource use, patients forego other uses of their time and are exposed to increased iatrogenic risk. Physicians who suffer from litigation anxiety have an incentive to prophylax their distress by practicing defensive medicine, thereby shifting some of the costs of anxiety to the patient and the patient’s sponsor. Capitated prepayment contracts, by contrast, seek to discipline physicians’ decisions by an array of incentives to economize on resource use. A physician’s conflicts of interest with his self-paying patients is more complicated. Insurance companies commonly negotiate discounts for their beneficiaries from physicians and hospitals. Medicare does not negotiate. It simply announces percentage reductions from nominal charges and prohibits balanced billing. Discounting creates an incentive to set high nominal charges from which discounts are figured. Unsponsored patients are actually billed the non-discounted charge, however, and they must pay in after-tax dollars – a double whammy. Since self-pay patients sometimes do not pay in full, will not pay in full or cannot pay, the physician has an incentive to insure against under-reimbursement and non-reimbursement by creatively shifting costs to his other patients and their sponsors wherever possible. Since the reimbursement picture overall does not actually preclude physicians’ doing well by doing good, their interests converge with patients’ interest in many ways. But their interests conflict in many ways too. The behavior of third parties, such as payers and the plaintiffs’ bar, complicate matters considerably. Physicians’ participation in sponsored clinical research (both for-profit and non-profit) complicates physicians’ conflicts of interest still more.
The Ethical Importance of Conflicts of Interest A conflict of interest presents a judgment-biasing risk to a physician’s medical decision making. Depending on the physician’s susceptibility to its associated incentives at any particular time, a conflict of interest will have some tendency to motivate decisions that subordinate patients’ interests to the physician’s interests, or to other interests the physician is in position to promote at the patient’s expense. Conflicts of interest may be financial or non-financial. Research subjects may be put at increased risk because physician-investigators subordinate subject’s interests to the social interest in generalizable knowledge or to their own interests in prestige and career advancement. Financial interests may be part of such subordination, but not necessarily the most important part. Other interests may be more or less significant than financial interests. Harm may or may not result from the conflict.
Motivation and Motives The incentives associated with a conflict of interest may influence a physician’s conscious motives by insinuating a new one that tends to crowd out of his consideration of faith-keeping motives that are ordinarily present and otherwise effective. More indirectly, a conflict of interest may weaken the physician’s loyalty to patients, or strengthening his trust-betraying motivations, or some combination. A conflict of interest may color a physician’s judgment and exert marginal motivational influence on his medical decision-making. For example, the success of a pharmaceutical company’s efforts to influence physicians’ prescribing behavior is not gauged by the extent to which advancing the drug company’s interests becomes one of physicians’ conscious motives. On the contrary! Thus it is not necessarily disingenuous for a physician to disclaim that promotion of a drug company’s interest is one of his conscious motives, despite that his prescribing behavior reveals a clear preference shift toward that company’s products after attending their sponsored CME sessions. Here are some further examples of where conflict of interest may have influenced the judgement of individuals:
    Surgical extraction of cataracts is performed on 1.4million patients per year. It is Medicare’s largest expenditure. The procedure is performed at higher rates under fee-for-service reimbursement than under pre-paid reimbursement. Prima facie, it seems implausible to suppose that medical indications for cataract surgery would vary with reimbursement model. On the other hand, it seems naive to suppose that medical judgment must somehow be immune to changes in reimbursement, especially in marginal cases. Indeed, standards of care cannot be easily disentangled from the reimbursement schemes under which they develop.3 In 1991, Genentech, a for-profit biotechnology industry leader, contributed $2.5 million to the American Heart Association (a non-profit corporation) for construction of its national headquarters in Dallas, Texas. In the mid-1990s, the AHA launched a health care initiative to reduce morbidity and mortality secondary to "brain attack," its campaign term for acute ischemic stroke. The AHA touted the promising results of a clinical trial
of a new bioengineered fibrinolytic agent, tPA (tissue plasminogen activator). The AHA estimated that tPA might save as many as 400,000 lives per year, reduce stroked-related morbidity, perhaps even reverse paralysis secondar y to stroke. During the 1990s, Genentech’s contributions to the AHA exceeded $11 million. Genentech’s support was not disinterested. It developed, patented, and wanted to market tPA. In 1996, the FDA approved tPA (Alterplase) for use in ischemic stroke. The expert panel that issued the favorable recommendation (8-1) contained only one member not known in advance to favor tPA approval. His professional history was uniquely devoid of ties to Genentech. By contrast, six out of eight supporting panel members had financial ties to Genentech. Four out of eight supporting experts were members of Genentech’s paid-speakers bureau; Two out of eight had received research support from Genentech.4 The American Heart Association never published the dissenter’s opinion, which pointed out that the AHA’s initial enthusiasm for tPA was based on only one trial and that a statistical analysis of that trial’s results showed that chance alone could explain its finding of tPA’s apparent efficacy. Subsequently, no fibrinolytic trial demonstrated that tPA confers a mortality benefit in treatment of acute ischemic stroke. On the other hand, several studies found an association between tPA and increased mortality. More worrisome, one fifth of patients initially diagnosed with stroke by expert-teams were found subsequently not to have suffered stroke. Patients falsely diagnosed "positive" for stroke who receive tPA emergently are exposed to risk unbalanced by benefit.5 Nevertheless, in August of 2000, the AHA upgraded its recommendation for tPA from "optional" (class II b) to "definitely recommended" (class I). Having won FDA approval and treatment-guideline support from the AHA, Genentech perceives no advantage in funding a comparative efficacy study matching tPA against streptokinase (a very cheap, generic fibrinolytic agent). One of its scientists explained, "We don’t know how another trial would turn out. And if we don’t come out ahead, we would have a tremendously self-inflicted wound."6
    Medicare does not pay for prescription drugs. However it will reimburse physicians for drugs they administer themselves to Medicare beneficiaries. Oncologists obtain cancer drugs from pharmaceutical companies at wholesale prices. When they administer the drugs intravenously to outpatients, they bill Medicare for administering the drugs and charge for the drugs at sharply marked-up retail prices. Oncologists who treat their patients in the hospital cannot profit from retailing intravenous cancer drugs. The hospital procures the drugs and charges for them. Would it be cost-effective for Medicare to require that all intravenous chemotherapy be administered in hospitals? Would it be cost-effective to make cancer patients go to the hospital? Medicare has been reducing physician reimbursement over the past several years. This makes Medicare beneficiaries comparatively costly to have as patients. If Medicare were to discontinue reimbursing oncologists for drugs administered intravenously to outpatients, would oncologists’ conflicts of interest with their cancer patients increase or decrease? Clinical trials sponsored by drugs companies are muchmore likely to report positive results than trials that have non-profit sponsors. Does this show that
physicians who conduct drug company sponsored clinical trials have a conflict of interest which increases the likelihood of their producing positive results for a fee? Perhaps. However, it is estimated that drug development costs that eventually lead to FDA approval average $500 million. If so, wouldn’t a drug company have a strong incentive to use adverse selection to disfavor submitting for clinical trials a drug antecedently regarded as less likely to win approval? Similarly, if a study sponsor were comparatively indifferent to whether a study yielded negative results, wouldn’t it be reasonable to predict that more of its sponsored studies would be negative? Non-financial conflicts of interest may also distort investigators’ judgment. An interest in winning desirable academic appointments, in securing tenure and promotion, in publishing articles in prestigious journals, in vindicating one’s pet theories, etc., may present judgment-biasing incentives as powerful as any financial incentive.
    Phase I clinical trials are conducted to establish safety. Consent forms for these trials avoid any mention of direct benefit for research subjects, other than their contributing to socially useful knowledge. Consent forms also emphasize the seriousness of any risk as well as its unpredictability. Nevertheless, only about one-third of research subjects understand the nature of the trial and most anticipate direct clinical benefit from participation. Are research subjects misled by physicians who are compensated on a capitated basis for enrolling them in the study? Or is the power of wishful thinking so strong in people who have failed conventional therapy that no disclosure, however candid, can eradicate it? Research is subject to bias by sponsor interests, whetherpublic or private, and to investigator bias. Professional journals are imperfect bias-filters. They do not disclose the identity of a published manuscript’s reviewers. Professional qualifications that better qualify a reviewer to evaluate a manuscript also make it more likely that he will have conflicts of interest with its authors. Readers cannot tell whether favorable publication decisions may have been marginally influenced by "reviewer-kickback." For example, protégé promotion, mentor gratitude, or collegial reciprocity may motivate shifting a reviewer’s recommendation to "definitely publish" from one that otherwise might have been "provisionally accept" or even "reject." Similarly, frank envy, tit-for-tat retaliation against professional rivals, or vicariously against their sponsors, may color reviewer judgment, shifting a recommendation that otherwise would have been "provisionally accept" to "reject." Reviewers vary substantially in their susceptibility to think less well of a manuscript that ignores their own contributions to the field or treats them dismissively, without "due respect." Drummond Rennie, longtime journal editor and a sturdy critic of the professional medical literature has written, "there seems to be no study too fragmented, no hypothesis too trivial, no literature citation too biased or too egotistical, no design too warped, no methodology too bungled, no presentation of results too inaccurate, too obscure, and too contradictory, no analysis too self-serving, no argument too circular, no conclusions too trifling or too unjustified, and no grammar and syntax too offensive for a paper to end up in print."7
Managing Physicians’ Conflicts of Interest The main strategies for managing physicians’ conflicts of interest are "professionalism," civil and criminal liability, and external regulation. By candidate selection, education, and peer socialization, the professionalism strategy inculcates a sense of ethical integrity resulting in physicians’ adherence to the fiduciary principle – to put patients’ and research subjects’ interests first when these conflict with the physicians’ interests or the interests of others who the physician is in position to advance. The professionalism strategy has advantages and disadvantages. On the one hand, integrity-motivated self-control is cheap and it economizes on social monitoring and enforcement costs. On the other hand, self-control and peer review are routinely criticized as inadequate to control conflict of interest problems. The efficacy of peer review requires that the procedures are not transparent to the public by design: More open procedures would compromise the efficacy of peer review and professional correction. The alternative to peer review is external regulatory oversight, often premised on allegations of fraud and abuse. It is commonly asserted that 10% of health care spending ($1.15 billion in 1998) is lost to fraud, waste and abuse. Since this "common wisdom" percentage seems to remain constant, aggregate loses from "fraud and abuse" must grow inexorably with increases in health care spending. The Federal courts have interpreted payments for Medicare or Medicaid services to be subject to federal anti-kickback and fraud legislation. The courts makes it unlawful for a provider to pay or receive any "remuneration" in exchange for purchasing, prescribing, or recommending any item or service, or referring any patient for treatment for which payment may be made under Medicare or Medicaid. Additionally, HIPAA (Health Insurance Portability and Accountability Act, 1996) criminalizes any "scheme or artifice" to defraud, or obtain money by false pretenses from, any health plan (federal or not). The prohibitions are sweeping in their scope. For example:
    Federal law is violated if even one purpose (as opposed to a primary or sole purpose) of a payment, whether received or given, is in exchange for or to induce the referral of patients or the ordering, purchasing, or recommending of items or services. It may be a defense that the improper purpose was "incidental," "minor," or "not material."8 Although courts recognize that some benefits received or given by providers may be de minimis, any payment or other benefit may violate the law when the amount is sufficient to influence the physician’s reason or judgment.9 The fact that a fee charged is reasonable will not serve as a defense if the intent underlying the arrangement that generated it can be shown to be an exchange of payment for referrals.10 There need not be proof of an agreement to make referrals, or to order, purchase, or recommend medical items or services. Intent may be inferred from the circumstances of the case.11 The mere potential for increased charges to, or a payment to be made by, a federal health care program may be sufficient to violate the law; no actual payment is necessary so long as the challenged charge for an item or service might be reimbursed by a federal health care program.12
• The fact that an arrangement is "common" in the health care industry is not a defense to a kickback violation.13 These prohibitions are so sweeping that virtually every financial relationship in the health care industry potentially violates federal law. The resulting uncertainty about where the line is between permissible and criminal has added a substantial increment to physicians’ costs. The magnitude of threatened penalties, despite the unlikelihood of their imposition on any one of the million health care providers in the United States, creates an incentive for each to direct resources toward reducing the hazard of federal prosecution. Indeed, the sweepingly broad definition given to unlawful conduct in federal law implies that the only restraint on the number of enforcement actions is the size of the enforcement budget. The federal government encourages providers to adopt "voluntary compliance programs" and to self-disclose improper billing. Law firms market protective services to their client health care providers. At least two competing trade associations credential compliance officers and hospitals purchase insurance against the consequences of filing false claims – an irony, since a predicate of insurance is uncontrollability of risk. It might be argued that these provisions effectively weaken trust-betraying motivations while strengthening trust-upholding motivations. But if the number of law-enforcement actions are an index to over-all trustworthiness, HIPPA seems to make physicians and other providers less and less trustworthy. For the past six years, civil, criminal, and administrative fraud enforcement has logged an increasing number of cases. Despite the fact that this federal remedy for alleged physician untrustworthiness has failed to make physicians more trustworthy, it promises inexorable increases in physician’s costs. Resources that might have been directed to improving quality of care, to increasing access to health care, and toward enhancements in professional competence are consumed by the compliance industry instead.
Conflicts of Interest in the Conflict of Interest Industry Comparatively high public confidence in the medical profession makes it comparatively "bullet-proof." Achieving political victories against it is harder as a result. Winning legal victories against its members in medical malpractice cases tends to be hard, too. Making the public more fearful of (or angry at) physicians because of their alleged conflicts of interest makes winning political and legal contests with the medical profession easier. Any economic or political interest that would gain by discouraging the utilization of physicians’ services makes the public more doubtful about physicians’ trustworthiness. Painting a discouraging picture of physicians’ trustworthiness will have some tendency to encourage patients to pursue and form allegiances with "alternative providers" who are currently spared scrutiny by the conflict of interest detection and treatment industry. Increasing the public’s anger about physicians’ conflicts of interest makes the service environment more adversarial. It also stimulates demand in the public policy market for the "safety products" offered by advocates favoring increased regulatory oversight of the health care environment and the medical profession.14 Selling the public regulatory oversight as a precautionary measure to offset concern about physicians’ conflicts of interest creates employment opportunities for a wide array of political interests. It also creates employment opportunities for consultants who specialize in minimizing the resulting harm to physicians’ interests.
Cost-Effective Management of Physicians’ Conflicts of Interest 2500 years ago, Plato gave the fiduciary principle prominence in medical ethics because he recognized that conflicts of interest cannot be eliminated from the physician-patient relationship. Zero-tolerance for physicians’ conflicts of interest is equivalent to zero-tolerance for physicians. If so, strategies for reducing patients’ or research subjects’ risk associated with physicians’ conflicts of interest should be assessed in terms of their cost-effectiveness. There are large information costs associated with monitoring and suppressing conflicts of interest. If physicians must spend time assembling compliance-related information for external authority review, then necessarily they must also forego those alternative uses of their time and skill which might better advantage their patients. If external authority must gather and evaluate the information, the quality of the information will depend on the knowledge and skill of those who do this work. The social costs to the health care system might be lower than having physicians do it themselves, but it also might be more costly still. It is a truism that physicians are not perfectly competent and fully trustworthy. We incur risk when we trust them more than they deserve. We also incur costs when we trust them less than they deserve. James Madison succinctly characterized the basic ethical problem: If men were angels, no government would be necessary. If angels were to govern men, neither external nor internal controls on government would be necessary. The great difficulty lies in this; you must first enable the government to control the governed; and in the next place oblige it to control itself.15
Endnotes *This paper developed from a presentation "Coercion, Opportunities & Prohibitions" as part of a conference on "Medicine, Money & Morals." Issues in Medical Ethics: 2001, Mount Sinai School of Medicine, November 2, 2001.
    Plato. The Republic BK1. Jowett, BJ (trans.) (Oxford University Press,1875). Todd J., "Professionalism at Its Worst," JAMA, 266 (1991): 3338. Goldzweig CL, Mittman BS, Carter GM, et al. "Variationsin cataract extraction rates in Medicare prepaid and fee-for-service settings," JAMA, 30 (1995): 90-105. Lenzer J., "Alterplase for stroke: money and optimistic claims buttress the ‘brain attack’ campaign," BMJ USA, 2 (2002): 283-291. Hoffman JR., "Should physicians give tPA to patients with acute ischemic stroke? Against: and just what is the emperor of stroke wearing?" West J Med, 173 (2000): 149-150. Dr. Elliott Grossbard, Genentech scientist, is quoted in Marsa L., Prescription for profits (New York: Scribner, 1997) 160. Rennie D., "Guarding the Guardians: A Conference on EditorialPeer Review," JAMA. 256 (1986): 2391-2, quoted in Rennie D., "The Present State of Medical Journals," Lancet, 352 (2002): 1-11. United States v. Greber, 760 F.2d 68, 72 (3d Cir.), cert. denied, 474
U.S. 988 (1985). 9. Inspector General v. Hanlester Network, Dec. No 1275 (DHHS Dept. App. Bd., App. Div., Sept. 19, 1991), also see, Hanlester Network v. Shalala, 51 F.3d 1390 (9th Cir. 1995).
    United States v. Lipkis, 740 F.2d 1447, 1449 (9th Cir. 1985); Bay State, 874, 874 F.2d at 29. Hanlester, [1992-1 Transfer Binder] Medicare & Medicaid Guide (CCH) par. 39, 566 at 27, 740, 27, 748, 27, 759, 27, 763. Ruttenberg, 625 F.2d at 177. Hanlester, [1992-1 Transfer Binder] Medicare & Medicaid Guide (CCH) par. 39, 566 at 27, 763.
14. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, D.C.: National Academy Press, 2000; Brennan, TA. "The Institute of Medicine Report on Medical Errors – Could it Do Harm?" NEJM. 2000;342:1123-5; Medication Errors Reduction Act of 2001, Pub. L. No. H.R. 4889 (2002). 15. Federalist 51. The Federalist Papers: Hamilton, Madison, Jay. New York: Mentor Books, 1961, 321-2.
Ex Post Facto IRB Review: Two Practical Hurdles, One Conceptual Mistake
Deborah R. Barnbaum Kent State University, Kent, OH An Institutional Review Board (IRB) must review and approve all research projects using human beings before researchers are permitted to begin their projects. In their recent article on the ethics of clinical trials, Miller and Brody echoed Emanuel, Wendler, and Grady in stating that "independent review" by a committee such as an IRB is a necessary ethical requirement for all clinical research.1, 2 Despite the widespread endorsement of IRB approval, the Office for Human Research Protection’s (OHRP) new Quality Improvement Program cites "the failure to 1) obtain prospective IRB approval" as the first of five problems the new Program aims to address.3 In cases in which researchers fail to obtain prospective IRB approval, one of two outcomes may ensue. First, the researchers may never obtain IRB approval. Not surprisingly, there are few data on the frequency of researchers’ failure to obtain IRB review. Matot, Pizov, and Sprung’s one-year retrospective study of critical care research in seven leading medical journals found that 24% of published studies do not contain any evidence of IRB review (including approval of informed consent procedures).4 While the publication of these studies did not cite evidence of IRB review, the studies may have been conducted with an IRB’s approval, with the published results failing to cite this fact. Merz cites a second possible outcome: "Either the authors failed to document in the manuscript that the study was submitted and approved by the appropriate IRB(s), or (the researchers) failed to submit the research protocol to their institutional IRB(s)."5 Perhaps IRB approval was not sought prior to data collection. A failure to obtain prospective IRB review may result in researchers petitioning for ex post facto IRB approval — IRB approval after the data have been collected. Is there a means by which IRBs can best consider projects that did not receive prospective approval, but for which researchers are requesting ex post facto approval? When the researcher has failed to properly protect the interests of the participants, or the risks of performing the research outweighed the benefits, the answer to this question is clear-cut: if the project would not have passed muster with the IRB before the data were collected, it clearly should not pass muster with the IRB after the data are collected.6 But imagine the best-case scenario, in which every protection that the IRB would have hoped for was in place. What should be done in this circumstance? This situation is more challenging, because the participants were protected, and the benefits did outweigh the risks. The spirit of the IRB’s mandate was upheld. A qualification — failure to obtain prospective IRB approval, and the question as to whether the IRB should then grant ex post facto IRB approval, is a question that is less likely to emerge in high-risk clinical studies, in which life-threatening adverse events are possible. The investigator who petitioned for ex post facto IRB approval for a phase I clinical study would soon be out of a job. Instead, ex post facto IRB review is more likely to become an issue in cases in which the investigator either was not aware that IRB purview extended to the research, or the investigator was not at all aware of IRB regulations. Social science research that the investigator didn’t realize was in fact "human research," or education research in which the investigator was unaware of IRB requirements, or comparatively low-risk research undertaken by novice PIs (including graduate students, or even undergraduates) are the types of research that are most likely to be considered for ex post facto review.7
Is There a Regulatory Context for Ex Post Facto Review? Many granting agencies require that IRB review be documented prior to awarding of funds.8 §46.101(a)2 states that even the research projects that are "neither conducted nor supported by a Federal Department or Agency" but are nonetheless subject to the Federal Regulations "must be reviewed and approved" by an IRB. "Must be reviewed and approved" may imply that the review already should have taken place prior to data collection. However, the common rule does not explicitly require that this review take place prior to data collection. "IRB approval," as defined at §46.102(g), "means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements." While this definition is not explicit as to when IRB approval must be obtained, the spirit of the common rule requires that IRB approval take place prior to data collection. Since the research "may be conducted" only "within the constraints set forth by the IRB," the assumption is that the IRB has reviewed the research protocol prior to commencement of the research. However, as OHRP’s Quality Improvement Program indicates, failure to obtain these "prospective" approvals continues to be a problem, which raises a question: isn’t an ex post facto approval better than no approval at all? Why couldn’t an IRB grant ex post facto approval, especially given a best-case scenario of the responsible researcher/s, adequate subject protections, and a favorable risk/benefit ratio?9 There are two practical hurdles, and one theoretical mistake, in granting ex post facto approval. The first practical hurdle is IRBs’ reluctance to set a bad precedent in granting ex post facto approval. The second of the practical hurdles is that IRBs have no way of verifying the integrity of the consent process for projects that are granted ex post facto approval. While both of these considerations present difficulties to IRBs, they do not, in themselves, constitute unsurpassable obstacles for an IRB. More significantly, there is a theoretical mistake in applying the assessment of risk/benefit ratios when conducting an ex post facto review. This theoretical mistake is the most significant barrier to granting approval after the research has been completed, because it demonstrates that one of the federally mandated standards for assessing research protocols is inappropriate for ex post facto reviews. Since such reviews cannot be accommodated using current IRB standards, we must either abandon one of the cornerstones of IRB review, or we deny the permissiblity of ex post facto review. I advocate the latter of these two options.
Practical Hurdle #1: Setting a Bad Precedent A first consideration is concern about the negative precedent set when ex post facto review is undertaken. When word leaks out that such a review was granted to one researcher, the argument goes, other researchers will soon follow suit. Soon enough, the IRB will be inundated with requests for ex post facto reviews. Almost certainly, some of these requests will not mirror the best-case scenarios in which subjects were best protected, and for which the IRB would not have requested any changes. Furthermore, researchers may fail to submit protocols to the IRB prior to data collection, anticipating that ex post facto review is a viable option. The concern here is founded on a slippery-slope argument: once the door is opened at a given institution to ex post facto review, it will be impossible to close the door. Slippery slope arguments, however, are fallacious: there is no guarantee that one ex post facto review will open the institutional floodgates. Additionally, the IRB should be savvy enough to distinguish the best-case scenario research project from one in which participants were not offered sufficient protections, or in which risks were not adequately minimized. The problem posed by a slippery slope is that we don’t know where to "draw the line." But IRBs are given clear direction as to where the line should be drawn, and should readily be able to distinguish between research projects that adequately protect participants and those that do not. The researcher who knowingly does not submit a protocol on time, counting on an ex post facto approval, is taking a chance in assuming that the protocol in question is in fact one of the best-case scenario protocols. This is a chance that many researchers may not be willing to take. The rule that requires researchers to obtain IRB approval prior to data collection is in place because we assume that following this rule will result in the best consequences for all parties concerned. This is simple rule utilitarian reasoning But locating rules that result in the best consequences for all parties concerned is only a first step: For every rule, there may be exceptions, which may further the best consequences. The rule that demands that researchers obtain approval prior to data collection is a rule that will result in the best consequences. Granting approval to best-case scenario research projects may be a legitimate exception to that rule, because granting approval in this one case may in fact result in the best outcome for all parties concerned. While the IRB may be reluctant to set a bad precedent, the IRB should also be aware that the rules are in place for a reason, and if those reasons are best satisfied by breaking the rules, then breaking the rules is what is called for. This is not to say that there are not pragmatic reasons for an IRB to resist ex post facto approval. But these institutional concerns, such as a perception that the IRB is unfair in granting ex post facto approval to one researcher, and not to another, are not ultimately about participant protection.
Practical Hurdle #2: Were the Participants Adequately Informed? A second concern is that many assurances about participant protection must be taken as a matter of faith when an ex post facto review is performed by the IRB. Receipt of signed consent forms after data have been collected may provide hard evidence that some steps have been taken to satisfy legal requirements for informed consent. However, signed consent documents are merely one step in the consenting process. Not surprisingly, more vulnerable populations — populations for whom greater assurances are needed to demonstrate competency, voluntariness, and informedness as a condition of their participation — are the very populations for whom assurances that they were well-informed are most difficult to determine after the fact. Cognitively proficient, healthy, literate, non-institutionalized, autonomous adults can be expected to get more out of a signed consent form than children, persons with cognitive disabilities that may affect decision making, persons with illnesses that may affect the voluntary nature of their participation, incarcerated individuals, etc. Even though the discussion of ex post facto IRB review is best restricted to social science, education, and similar studies, participants in such research are not necessarily autonomous individuals. Some participants in this type of research may require special protections, including more thorough documentation of informed consent guarantees. The greater the need for continued documentation of informed consent, the less likely that evidence of this need will be fulfilled in an ex post facto review. Despite these difficulties, best-case scenario research projects may not encounter these obstacles. Perhaps such a project would include only the most autonomous participants, for whom a signed consent form is strong, albeit not sufficient, evidence that informed consent had been obtained. While questions about informed consent may persist in some studies, for other studies the signed consent forms, along with assurances from responsible and experienced researchers, may be all that the IRB would have required. In such a case, the IRB would not see a failure in the consenting process, even in an ex post facto review. In this case, there may be no real hurdle in offering IRB approval, on the basis of inadequate subject protection. However, one significant concern remains when IRBs undertake ex post facto reviews.
A Theoretical Hurdle: Assessing the Risk/Benefit Ratio A final problem remains for IRBs that are asked to perform ex post facto review. The problem is a theoretical one, which calls into question the conceptual framework in which IRBs evaluate research protocols. In particular, the reviews in question present a challenge to the evaluation of the risk/benefit ratio, an evaluation that all IRBs are required to undertake. IRBs are charged to make two assessments regarding the risks and benefits inherent in any research project. First, IRBs must determine that the risks of the research are minimized. If there are alternative means by which the same data could be collected, the researchers must take care to choose the method that will minimize risks to the participants. This is not to say that the research project must be risk-free. Rather, care must be taken to expose participants to the lowest level of risk that is compatible with the data collection. Second, IRBs must determine that the risks inherent in the protocol are outweighed by the benefits of performing the research. It is possible that the risks (usually borne by the participants) accrue to a different population than those who experience the benefits (sometimes the participants, but also the researchers, the scientific community as a whole, cohorts or future cohorts of the participants). However, the fact that the risks accrue to one population while the benefits accrue to another does not alter the fact that the risks must be outweighed by the benefits. Any project in which the risks outweigh the benefits should be deemed by the IRB to be unethical. In summary, protocols should have 1) the fewest risks possible, compatible with collection of the data, and 2) a favorable risk/ benefit ratio. The challenge of